BPC 2009: covering science · pushing the frontiers of cancer research pB28 Growth of...

BPC 2009This supplement to ThePharmaceutical Journal coversmany of the sessions from BPC2009, held in Manchester from 6to 9 September. It completes thecoverage of the conferencepublished in The Journal on 12September

PracticeIn an article based on his addressto the conference, this year’sPractice Chairman discusses thenature of practice research andthe challenges faced in sustainingit.There are also sessions oninnovation, remote supervision,medicines use reviews, andspecialist and advanced practice

ScienceIn addition to the ScienceChairman’s address and scienceabstracts, the supplement coversa number of sessions related toinnovations in discovery, deliveryand diagnostics for cancer,infectious diseases and diabetes

BPCTVThis supplement is accompaniedby a DVD that gives acontrasting flavour of whathappened at the conference

BPC 2009: covering scienceand practice

October 2009Vol 283 Supplement ISSN 0031-6873

October 2009 The Pharmaceutical Journal (Vol 283) Supplement B1www.pjonline.com

October 2009Vol 283 (Supplement)

■ Leading article Innovation is the key pB1

■ PresidentSociety’s President urges

profession to unite to createa brighter future (S.Churton) pB3

■ Practice Chairman Why research pharmacy

practice? (P.Noyce) pB6

■ Practice sessions Five principles of effective

regulation pB9Assessing risk within pharmacy

practice pB9Drive for quality and

innovation must not be lostduring financial challengespB10

How remote supervision isbeing used to benefitpatients in Canada pB12

Simulated patient project tobenefit all pB13

UK is European leader inreclassificationof drugspB13

Pharmacist prescribers: latestlessons and developmentsfrom the field pB14

Communication andintegration key to successfulMURs pB15

Student wins prize for prisonpharmacist logo pB15

Health checks: benefits andchallenges pB16

Speed dating sessions withspecialist and advancedpractitioners pB17

Analysis of problems in primarycare pB18

Reducing preventable adversedrug reactions pB18

Innovation central to takingservices forward inchallenging financial timespB19

■ Practice abstracts Review (P.Mason) pB20

■ Science ChairmanNanomedicines in sharp focus

(I. Uchegbu) pB23

■ Science sessions Debate: are medicines too

expensive? pB25Temozolomide: a pharmacist’s

tale pB26Pursuing effective anti-

infectives pB27Steroid sulphatase inhibitors:

pushing the frontiers ofcancer research pB28

Growth of pharmaceuticalindustry in currenteconomic climatequestionable pB29

Methylene blue for Alzheimer’sdisease pB30

Thinking differently to driveinnovation pB31

Vaccine against HIV moves astep closer, according to USresearchers pB32

Cell senescence may be usefulcancer drug target pB32

NICE has approved 28pc oftreatments pB33

Diagnostic testing should gohand-in-hand with drugdevelopment pB33

Developments in diabetesmanagement pB34

Glucose-sensitive hologramcould remove need forfinger prick test pB34

Dismissing health inequalitiesin diabetes care pB35

Tackling hypertension inpatients with diabetes pB35

■ BPC on cameraConference on camera pB36

■ Science abstractsReview (J.Chamberlain)

pB38

President pB3

Practice pB6

Science pB23

www.pjonline.com

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BPC 2009

B2 The Pharmaceutical Journal (Vol 283) Supplement October 2009

Innovation is the keyT

his year’s British Pharmaceutical Conference — once again held in Manchester —

was something of an innovation. It was divided into two,with the practice sessions

starting on Sunday 6 September and the science sessions beginning the day after.

Innovation was also the underlying theme running through the two parts: the practice

sessions were entitled “Quality and safety: old values, new vision”; and the science sessions

“Technologies for healthcare: from laboratory to practice.”

Practice, almost by definition, is about the here and now

— how pharmacists care for their patients,what lessons can

be learnt from leading edge practitioners that can be

integrated into normal activities. Science,on the other

hand, is more about the future — what today’s

developments and breakthroughs will do for patient care

tomorrow.

With the expectation that the NHS will face some

years of austerity from 2011 following the banking crisis

of 2008, there is an even greater imperative for pharmacists to play their part in ensuring

that scarce resources are used wisely and effectively.The Department of Health has come

up with an acronym to define how the NHS should be tackling service reform in

financially challenging times.QIPP — quality, innovation, productivity and prevention are

the drivers underlying new activity in healthcare.

The chief pharmaceutical officer for England,Keith Ridge, said that the safe and cost-

effective use of medicines will feature prominently in the coming years under QIPP

(pB10).And a QIPP project in secondary and tertiary care is being led by Martin

Stephens, national director for hospital pharmacy in England,who outlined the approach

in another session (pB19).

This was echoed by Jeremy Savage, deputy chief pharmaceutical adviser to the Welsh

Assembly Government.He pointed out that judicious use of automation and new

technology in hospitals in Wales has reduced dispensing errors and improved the efficient

use of the workforce (pB11). In another session the benefits of remote supervision in

Canada were described (pB12),which may have lessons for the future in the UK.

Dr Ridge also acknowledged the part that the pharmaceutical industry will play in

helping the UK economy recover as new medicines come to market.Although the days of

the massive blockbuster may be over, and the industry faces an uncertain short-term future

(pB29), speakers also emphasised how important innovation is in protecting

pharmaceutical revenues in order to ensure research and development can flourish (pB31).

The conference also covered many examples of drug development in oncology, anti-

infectives and diabetes — all clinical areas where significant progress has been made in recent

times and where innovation must continue if the health needs of Britain are to be met.

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Greater imperativefor pharmacists toplay their part in

ensuring thatscarce resourcesare used wiselyand effectively

PJ, Oct, p02 BPC 1/10/09 09:53 Page B2

www.pjonline.com October 2009 The Pharmaceutical Journal (Vol 283) Supplement B3

President’s address

Society’s President urges professionto unite to create a brighter future In his address to BPC 2009, the Royal Pharmaceutical Society’s President, Steve Churton, described recent initiatives that demonstrate how the

Society has become more member-focused and spoke of the new professional body’s “commitment to pharmacy”

This is a historic conference for us — thelast one with the Royal PharmaceuticalSociety as joint regulator and professional

body.The last one of a long and proud line ofconferences that have marked the milestonesand celebrated the high points in our profes-sion.

As we take this opportunity to realignourselves, it is right that we recognise and paytribute to our founding fathers, and thosewho followed in their footsteps, to buildupon their vision.

It is also right that we learn from their ex-periences and I genuinely believe that wehave the responsibility and the ability to leaveas our legacy a body fit to lead a modern, pro-gressive and respected profession, which fu-ture generations will thank us for.

It is an undisputed fact that pharmacy isregarded by millions of people, patients orotherwise, as a fundamental component of ef-fective healthcare delivery. It is also undis-puted that we are now on the brink ofachieving arguably the most significantchange in our profession in nearly 170 years.

InitiativesThere are numerous examples of initiativeswe have embarked upon during the year thatdemonstrate, without doubt, that the Societyhas a purpose far beyond the regulatory role,which many see as our overriding focus.

Working with other pharmacy bodies tograsp the opportunities presented in the phar-macy White Paper for England, seizing the pa-tient safety agenda, launching the workplacepressures initiative and leading the campaign todecriminalise dispensing errors.These are justsome of the initiatives we can proudly point to.

When I was elected President last year, Iknew that the issue of workplace pressureswas one I wanted to tackle and in January Ilaunched our campaign. The campaign hasbeen successful in raising the profile of whatmany of us experience but perhaps do nothave the confidence or opportunity to speakout about effectively.You have told us that theincreasing number of prescriptions, the lackof rest breaks, not being able to delegate ef-fectively, feeling unsupported to deliver ex-tended services, unrealistic targets, longworking hours and burdensome paperworkall contribute to a more stressful working environment.

We are now leading the debate on theseissues and this coming year will see progressmade with many of them. We have a pro-gramme of work stretching ahead of us, to

work in partnership with those who canbring about the improvements and solutionswe are all looking for.

We have also taken the highly unusual andsignificant step of issuing a formal Councilstatement [about rest breaks] to the profession(PJ, 5 September, p229). Such statements arereserved for issues where we wish the profes-sion to take immediate action.

Decriminalising dispensing errorsStanding here last year I know it did not crossmy mind that we would see the prosecutionof a pharmacist for making a human error. Agenuine dispensing error — yet defined bylegislation, laid too long ago, as a criminal of-fence — and one which quite understandablyoutraged the profession.

We responded quickly and robustly, re-solving to campaign vigorously to stop the

continuing criminalisation of dispensing er-rors.We campaigned hard, and engaged withthe profession to lobby MPs and senior polit-ical figures. We — the profession as a whole— captured political hearts and minds acrossall parties, and we won the debate inParliament and in Whitehall.

We have had outstanding parliamentarysuccess. The Early Day Motion has beensigned by over 220 MPs, which places it inthe top 1 per cent of EDMs this year — afantastic response by any standard and onethat I would like to sincerely thank the pro-fession for getting behind.

In time the law will be amended and, aswe continue to work to deliver this perma-nent change, we will strive to raise the profileof this in the mind of every pharmacist, toensure that he or she does not fall foul of thecurrent legislation. In the meantime, activediscussions are now under way with theDepartment of Health, the Medicines andHealthcare products Regulatory Agency andthe Crown Prosecution Service.

We have instigated and participated inmany discussions with the main political par-ties, building relationships with key decision-makers and influencing those in a position toinfluence policy and legislation in England,Scotland and Wales.

This is only the start.We will continue todevelop our relationships with policy-makersto promote your views, interests and con-cerns.

We have also had another hugely success-ful year in the media, shaping public aware-ness of the services and expertise we offer,and reinforcing positive perceptions of thevalue we contribute.

Charter changesThe proposed Charter changes, and the en-couraging vote in favour [of them], were amajor milestone for the profession during theyear.You told us that it is important for us tokeep our Royal Charter but that changes toenable a more relevant, progressive, efficient,inclusive, supportive and representative or-ganisation should be made.

The changes you voted for mean that wenow have the prospect of a different organi-sation to the one you have been used to.Thework of the new body will be largely de-volved to the national pharmacy boards in thethree countries, with policy-making, repre-sentation and professional leadership all tak-ing place where they should be — closer tomembers, closer to those who can be

Steve Churton: no representationmeans no influence

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B4 The Pharmaceutical Journal (Vol 283) Supplement October 2009 www.pjonline.com

BPC 2009

influenced to shape the pharmacy agenda andcloser to those who are better placed to pro-vide the local support that our people need.

The boards will take a far more substantialrole, enabling us to engage more effectivelywith the devolved administrations, and torecognise and influence the increasingly di-verse national healthcare programmes. Thecentral assembly will play an important role aswell, providing the necessary strategic direc-tion, financial management and appropriatedegree of overarching governance for thenew organisation.

The changes to the Charter also removeall references to regulation to set free this or-ganisation so that it can be truly independentfrom the Government and focus on support-ing the interests of members — so you canachieve your professional ambitions and bethe very best you can.

Throughout the year we have been work-ing hard through the Pharmacy Regulationand Leadership Oversight Group — thegroup brought together to oversee the estab-lishment of the new regulator, the GeneralPharmaceutical Council — and directly withthe Department of Health, to ensure that thetransition goes smoothly.

I regard regulation as a privilege. It be-stows trust and confidence in the professionand the Society’s track record as the profes-sion’s regulator has again been acknowledgedby the Council for Healthcare RegulatoryExcellence. Next year, when the GeneralPharmaceutical Council opens its doors forbusiness, when it starts to maintain the regis-ter of pharmacists, technicians and premises, itwill act in the public interest. It will establishand promote standards and requirements forpharmacy owners, superintendent pharma-cists and premises. It will be concerned withproficiency, conduct, ethics and performance,and it will require all registrants to demon-strate evidence of continuing professional de-velopment.

These activities are hugely important forus all, and your professional leadership bodywill play a crucial role in advising and influ-

encing the regulator, and in supporting andinspiring members to achieve the standardslaid down.

Improved communicationYou have told us that this year has seen amarked improvement in the way we havecommunicated with you.You have said thatyou now feel more informed about what ishappening in the profession and engaged inmeaningful conversations with the Council,the national pharmacy boards and the peoplewho support us in London and in our na-tional offices.You have also said that you feelmore listened to and that we are now moreresponsive to your needs.

We have had to make some really tough de-cisions this year. The debate around the re-stricted title that led to a Special GeneralMeeting, the changes to the Royal Charter, thecalls to delay the implementation of the re-sponsible pharmacist regulations — these wereall issues where we had to make decisions thatwe believe to be right for the profession, evenif unpopular with some members.

I ask the profession to reflect on our col-lective record of achievement. Are we nowmore member-focused, genuinely seeking tounderstand what you want and need from us?Have we acted with integrity in a straightfor-ward, transparent and principled manner?Have we demonstrated courage and convic-tion, often in the face of adversity?

Being a professionalI believe that being a professional is about fo-cusing on our patients, putting their safety,health and well-being first and foremost.[Among other things] it means using our pro-fessional judgement to deliver excellent careand working within a relevant and moderncode of ethics and a shared value system. Itmeans not shirking those tough decisions thatwe are all required to make from time totime. It means being brave, standing up forwhat you know to be right in the interests ofyour patients, and knowing when it is right tomake a stand.

It involves doing the best you possibly can,taking responsibility to keep your practiceand knowledge up to date, showing a com-mitment to both personal and professionaldevelopment.

For me, being a professional is also aboutcollaborating with others, within and acrosssectors of our own profession, as well as pro-moting strong and effective relationships withcolleagues in other healthcare professions.

As a professional, I value excellence in ac-ademia and recognise the benefits of develop-ing pharmacy specialists. I also value the roleof science and original research, and how thiscan be most effectively translated into prac-tice in the shortest possible time, for the ben-efit of patients.

As busy professionals we all know it is noteasy to live up to these ideals, to always de-liver excellent care, to stay up to date, to takethose hard decisions, to extend our practice,to meet with fellow professionals and shareideas.We all need support to be professionalsin a modern and rapidly changing world, anda modern and rapidly changing profession.

The more I think about this, the more Italk to others, the more I see what the futurecould look like if we join together — andwhat it might be like if we do not — themore I genuinely and passionately believethat all of this can only be delivered by astrong leadership body.

There surely cannot be anyone who seri-ously thinks we can do all of this — let alonesurvive as a profession — without the effec-tive, representative and inclusive professionalbody we are building.

In bringing about the necessary changeswe consulted you. I have sensed a feelingamong some that we should just “get on withthings”. But it is not quite that easy of course.We are facing a period of austerity withinhealthcare and we will need to fight our cor-ner to achieve our ambitions, especially theservices and opportunities laid out in thepharmacy White Paper [for England].We willneed to continue the fight to achieve paritywith other healthcare professionals and to

Steve Churton, Society Chief Executive and Registrar Jeremy Holmes and shadow health minister Andrew Lansley

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President’s address

take control of the public debate, raising is-sues of concern to us as a profession and tothem as patients.

It is vital that your new body receives yoursupport. Without it, pharmacy as a wholewould lack an authoritative voice whenmajor decisions are being made. No represen-tation means no influence. The professioncould well retreat to a position of submissionand compliance, passive to the changes im-posed upon it.

Commitment to pharmacyOver the past few months you will have seen[the “commitment to pharmacy”] brandingappearing in many of our communications.Quite simply, we wanted to highlight to youwhat we really care about. The words, andthe meaning behind them, were chosencarefully.

I recognise that “commitment” is a bigword. It is more than just a promise, it is a ded-ication, an assurance, an obligation. It shouldbe considered a strong signal of our intent tochange, to demonstrate an unwavering com-mitment to you and to the profession.

Now I do not think many would arguewith the commitments [the professional bodyis making to the profession] (PJ, 12September, p259 and p272) but I do think weneed to deliver on these in a tangible andmeasurable way. I fully understand that mem-bers will want to see evidence of delivery.

We are currently finalising the next waveof deliverables during the 100 days immedi-ately before the “go live” date [for the com-mitments]. We will continue to listen, plan,resource and deliver. We will continue to beas faithful as possible to the original prospec-tus and we will continue to recognise theneed to nurture and support your new pro-fessional body as it comes into being.

The shape, feel and personality of the neworganisation is becoming clearer. It is rightlydeveloping from within its own membership.This is exactly how it should be and I applaudall who have been so actively involved andgiven so freely of their time to benefit theprofession, and all of us who are so privilegedto be part of it.

Thousands of pharmacists are now begin-ning to realise the implications and opportu-nities before us.Those actively supporting thisprocess are not asking what the Society cando for them, they are asking what they can dofor the Society.

How refreshing it is to know that there arethose who recognise the importance of thisventure. How inspirational it is to see the pas-sion on the faces of so many involved. Howsatisfying it is to hear so many speak in favourof what we are collectively trying to achieve.

Trust is a precious commodity, which ishard to define, harder to win and all too easyto lose.Without mutual respect and trust weare nothing.

During the course of the year I have metwith many pharmacists. Not all, it has to besaid, speak with affection of the Society and Iunderstand the reasons for this. But it seems

to me that there is far more which binds andunites us than there is which divides us.

Together we can be strong.You only needto look at the successful decriminalisationcampaign — the result of a groundswell ofsupport from members, and effective and de-cisive leadership from many quarters — to seethat. A lack of trust inevitably leads to frag-mentation and weakness, and we simply can-not afford to let this happen at this importanttime.

The Charter vote is now behind us andyou have given us a mandate for change. Mythanks to those of you who voted “yes”, forunderstanding the importance of thechanges we proposed and for trusting us todeliver on our commitments. It is clear tome that those who voted “no” also caredeeply about the future of our professionalbody.To those who have since said to me “Ididn’t particularly agree with your proposalsbut I am still joining the professional body”,I say “welcome”.

And to those pharmacists who did notvote at all — those who have yet to find thetime or energy to engage with these changes— I understand the pressures you face. I un-derstand that debates about Charters and newbodies can all seem dry and remote from yourdaily life. But I urge you to get involved be-cause this professional body will be your pro-fessional body and will be there to supportand help you.We need you to help shape it so

that it meets your needs and gives you whatyou want.

We are now less than 150 working daysaway from the planned launch date and I askeveryone in the profession to trust and tosupport me, and to work with me throughthese momentous changes.

Our new professional body will bestronger than any single-interest body andwill speak with one voice for the whole pro-fession. Our new professional body will em-power and enable. It will ensure that each andevery pharmacist can truly fulfil their poten-tial and realise their ambition. It will supporttheir professional development and it willshape the environment in which they canflourish and succeed.

I believe that a body which speaks up forpharmacy, a body which is truly representa-tive of the collective will of its membership,and a body which acts with conviction andintegrity, will thrive and will be powerfullyinfluential in carving out the future that weall wish to see for our profession.

Brighter futureWe can have a brighter future and it is up tous to make it happen. No one else is going todo this for us. We are limited only by ourimagination and our energy. So please useyours and join me today in creating some-thing special — a profession for the future, afuture for our profession.

Commitment to pharmacy: evidence of delivery needed

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BPC 2009

Practice Chairman’s address: why research pharmacy practice?Drawing on his own research over the past 15 years, BPC Practice Chairman Peter Noyce discusses the nature of pharmacy practice research, the

insights it provides, its impact and the challenges faced in terms of its capacity and sustainability

The Nuffield Committee of Inquiry onPharmacy identified the need for practiceresearch in pharmacy, and to develop an

academic discipline in the subject nearly 25years ago. Geoffrey Booth, a former presidentof the Royal Pharmaceutical Society, was ap-pointed the first professor of pharmacy prac-tice — at the University of Bradford — in thelate 1980s.

Despite this, pharmacy at large has rela-tively little awareness of practice research orits purpose. Responses from “practising”pharmacists to practice research findingsrange from the prosaic,“Isn’t this a statementof the bleedin’ obvious?” through the ironic,“Why do you need to know all that detail?”to the surprised,“Didn’t know that was beingresearched, actually that’s quite useful”.

Much in the way that some of the leadingworld-class universities have recognised theneed to create chairmen in the public under-standing of science, I, as the 2009 Practice

Chairman of the British PharmaceuticalConference, have taken as my challenge rais-ing the awareness and understanding of prac-tice research within pharmacy.

As a basis I draw upon 15 years of researchon community pharmacy within the drugusage and pharmacy practice group at theSchool of Pharmacy and PharmaceuticalSciences, University of Manchester, to illus-trate the range of studies undertaken, the in-sights they provide and their impact. I havealso attempted to outline the contemporaryscope of pharmacy practice research, conveyits responsive and dynamic nature and revealits vulnerability.

Addressing the criticisms of Which?Our early studies were prompted by the re-peated adverse criticism of advice-giving incommunity pharmacies by Which? magazine,based on various consumer exercises under-taken by the Consumers’ Association.Although previously a variety of studies hadreported on advice-giving1 they did not pro-vide a definitive response on whether it wasinadequate or otherwise inappropriate.

The great strength of including investiga-tors from social science backgrounds in phar-macy practice research groups becameapparent at this time.They were familiar, forexample, with observational methods and so aseries of revealing studies was instigated in-volving week or part-week long observationsin a range of community pharmacies.

What became clear was that there wasconsiderable variation between communitypharmacies in responding to symptoms,2 re-quests for over-the-counter medicines,3 refer-ral to other health professionals4 and whethercustomers were seen by a pharmacist or amedicines counter assistant.The participatingpharmacists also confessed that they were un-aware of how their advice-giving routines, in-cluding referrals, compared with others, andwere keen to reflect on the anonymised re-sults of the studies to benchmark their ownservice level.

Another parallel study captured the essen-tial nature of advice-giving in communitypharmacy5 (see Panel 1) and demonstratedcommon mismatches between patient priori-ties in seeking advice, and the advice given.

Following these findings, the RoyalPharmaceutical Society introduced standardoperating procedures to cover advice-givingand required medicines counter assistants toundergo training to support OTC recom-mendations and sales.

What is striking to the impartial observeris how differently community pharmaciesdeal with prescription and non-prescriptionmedicines.Yet to many patients it is the costof medicines to them that is their main inter-est or concern.6 From our studies we realisedhow pivotal this was in determining whethera patient purchased an OTC medicine orsought a GP’s prescription for the product.7,8

Therefore we postulated that if we couldarrange for those patients who were exemptfrom prescription charges to have non-prescription medicines supplied free ofcharge under the NHS directly from phar-macies then the management of minor ail-ments could be transferred from GPs topharmacists.

The feasibility of this intervention wastested in what was known as the “Care at thechemist” scheme (details of which appear inPanel 2).With findings published in both theBritish Medical Journal9 and The PharmaceuticalJournal10 in 2001, the framework and evidencebase for minor ailments schemes were cre-ated. By 2006, over 2,000 pharmacists (one infive) in England were participating in minorailment schemes as an NHS enhanced serv-ice. By 2007, the minor ailments service wasintroduced nationally in Scotland as an NHSpharmaceutical service.

Insights into the 2005 contractA comprehensive description of the imple-mentation of the new community pharmacycontract in England, based on a national sur-vey of primary care trusts, was published inThe Pharmaceutical Journal in 2006.11–14

Panel 1: Advice-giving incommunity pharmacy“. . . consumer-led, with pharmacy staff mostlyresponding to customer requests for namedproducts.”

“. . . characterised by its didactic nature, theemphasis being on checking, instruction andinformation, at the expense of explanation . . .”

“Pharmacy staff are aware of the potential dangerof medicines and their prime concern is safety . ..consumers appear to be interested in theeffectiveness of products.”

Hassell K et al. Journal of Health ServicesResearch and Policy 1998;3:219–25

Practice ChairmanPeter Noyce is professor of pharmacy practice anddirector of The Workforce Academy at theUniversity of Manchester. He was appointedchairman in pharmacy practice at the university in1991 and founded the drug usage and pharmacypractice group. He has now been appointed byministers as professional adviser for theestablishment of the General PharmaceuticalCouncil.

Professor Noyce has a general interest inhealth services research applied to medicines andpharmacy and is particularly interested inimproving the use of resources and reducing therisks within healthcare systems. His majorinterest is in community pharmacy, both informingand evaluating policy. Recent work has focused ongaining insights into the factors that determine thecontribution of community pharmacy to primaryand self-care, the commissioning of NHSpharmaceutical services and improvingunderstanding of the culture within communitypharmacies.

Current activity in The Workforce Academy is aimed at the development of quality indicatorsand strengthening the safety of processes andsystems. The academy is also looking to develop a programme of work to inform the debate on“fitness to practise” within pharmacy and itsassessment, and underpin the modernisation of regulation of pharmacists and pharmacytechnicians, and the establishment of the GPhC.

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Practice

Using this information as a baseline wehave now begun to explore particular featuresof NHS pharmacy services to chart their evo-lution and assess their impact. A mixed-methods study of medicines use reviews(MURs) revealed a marked difference in thelevel of engagement between independentsand multiples.15 It also identified several unin-tended outcomes of the introduction ofMURs, including indications of a mismatchbetween service provision and patient need,adverse responses from GPs compounded bypoor communication and unacceptable pres-sure to maximise MUR volumes by somemultiple employers.

There is now a concerted campaign byNHS and pharmacy bodies nationally toimprove the quality and targeting ofMURs.

A recent study of the impact of the relax-ation of control-of-entry regulations inEngland16 has revealed that the opening ofnew NHS pharmacies is concentrated in aminority of PCTs, commonly within 500metres of other pharmacies. Approximatelytwo-thirds of the new pharmacies are open-ing under the 100-hour exemption, withnearly 40 per cent being opened by three ofthe largest supermarket chains.This relaxationof the criteria for awarding new NHS con-tracts will have a particular impact on the dis-tribution of NHS pharmaceutical servicesand demand for pharmacists in the northwest, where the number of new in-store su-permarket pharmacies is double that inLondon.

(A comprehensive review of the develop-ment of policy and practice in communitypharmacy in the UK and how this has beeninformed by practice research has recentlybeen published for an international audi-ence17).

The nature of practice researchAt its core, pharmacy practice research com-prises the study of pharmacy practice andmedicines use. In studying pharmacy practice,the organisation, setting and culture of prac-tice is important. Equally important is an un-derstanding of the interplay between thenature of pharmacy practice and the practi-tioners themselves. For example, the perspec-tives and attitudes of the following

pharmacists towards workload, financial re-wards, practice innovation, and quality of pa-tient experience are likely to vary: anindependent owner planning to sell his phar-macy within the next two years; a mother ofyoung children working as an independentpharmacist prescribing part-time in residen-tial homes; and a newly qualified pharmacist

working shifts in a 100-hour supermarketpharmacy.

The dynamics and influences on phar-macy practice are pivotal in determiningservice quality and innovation, and patientsafety (minimisation of errors). Therefore, anunderstanding of these is important to phar-macy employers, PCT commissioners, gov-ernment health departments, and the newGeneral Pharmaceutical Council and profes-sional body.

As the benefits of having an evidence baseare gradually being recognised in pharmacypractice itself, the horizon of pharmacy prac-tice research is extending.The need to under-stand learning and motivation of pharmacistsand pharmacy technicians, and to assess theircompetence and fitness to practise effectivelyand appropriately, becomes a priority withthe modernisation of professional regulation.

Prescribing and medicines managementare established research workstreams whichpharmacy has often shared with health eco-nomics and clinical pharmacology. Now, withthe emergence of pharmacist prescribers —

Peter Noyce addresses the British Pharmaceutical Conference 2009

Panel 2: “Care at the chemist” schemeIntervention: Provide patients exempt from prescription charges with non-prescription medicines under theNHS (for 12 defined conditions) directly from community pharmaciesPeriod of intervention: Six monthsSetting: One general practice serving approximately10,000 patients and eight community pharmacies (93per cent prescription items exempt from charges)Results: For GPs, the number of consultations for acute, minor ailments per 1,000 population per week fellfrom 6.3 at baseline to 3.9 during the intervention. For community pharmacists, it rose from 8.0 at baseline to10.4 during the intervention.

The total number of consultations with community pharmacists during the intervention was 576 (37.8 percent transfer from GPs). Reconsultation rates for the same condition within 14 days were not significantlydifferent between community pharmacists and GPs.

Hassell K et al. British Medical Journal 2001;323:146–7

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within the wider development of non-medical prescribing — new collaborations arebeing created with nursing researchers.

Medicines useThere are two main focuses to research onmedicines use: medicines and patients.Pharmacoepidemiology, comprising popula-tion-based studies of medicines, and pharma-covigilance, involving the identity andprevalence of adverse drug reactions, have in-terested a cadre of pharmacy researchers,often working in groups led by clinical phar-macologists.

With the priority on patient safety, phar-macy researchers have extended their interestsfrom the risks of medicines themselves to therisks of medication systems — the prescrib-ing, dispensing and administration of medi-cines. The focus is on preventable drug-related morbidity, particularly the study of thenature, prevalence and causality of adversedrug events, so enhancing the understandingof medicines-related errors and underpinningthe development and evaluation of strategiesfor error reduction. These investigations in-volve pharmacists working with occupationaland organisational psychologists and applyingsystems-based approaches from the “high-risk” oil and gas, airline and railway industriesto improve medicines safety.

Undoubtedly a major factor affecting pa-tient benefit and safety from prescribed med-icines is patient non-adherence. Although aneveryday phenomenon, it has a multifactorialcause, and requires empathetic and resource-ful pharmacists working in partnership withwilling and persistent patients to manage suc-cessfully. Pharmacy practice researchers, usingtechniques and approaches borrowed fromhealth psychology, have made great strides inunderstanding patients’ beliefs about medi-cines and the nature and causes of non-adher-ence, particularly in long-term conditions.Now the challenge is to develop validatedsmart interventions that can be readily ap-plied in routine practice.

Challenges for practice researchEssentially, these are two types of challengesfor pharmacy practice research:

■ Awareness and use of practice research■ Succour and sustainment of practice

research

The drivers for academic research are im-pact of outputs, mainly academic and profes-sional articles, and securing competitivefunding. Impact depends on methodologicalrigour and often originality. Within the aca-demic community impact is characterised bypublications in peer-reviewed journals with ahigh bibliometric impact and an impressivecitation level.Within health services research,“soft” indicators of research quality includethe impact on policy and practice at a na-tional or international level. Health servicesresearch funding sources also usually demanda demonstration of relevance, achievability

and applicability of proposed research projectsand programmes, and a commitment to effec-tive dissemination of the findings.

In reality, once a research team has re-ported to the funder and secured publicationin a reputable journal, it sees its commitmentas essentially complete and the focus moves toraising funds for the next project or pro-gramme. It is therefore important that thenew professional body bridges the gap be-tween generation and application of researchfindings to pharmacy practice and policy.

A considerable body of pharmacy practiceresearch has been produced over the past 15years, with over 880 outputs from theManchester group alone, including 49 reportson commissioned research. Pharmacy practi-tioners and policy makers generally have yetto recognise and make best use of the grow-ing evidence base in pharmacy practice.

Creating and developing a new academicdiscipline within pharmacy has been exciting,but remains immensely challenging. Whileunique in its focus and pharmaceutical over-sight, pharmacy practice research is essentiallythe application of health services research topharmacy and medicines.

Health services research is well establishedas a multidisciplinary activity in leadinghealth or medical faculties with particularstrengths in primary care, public health, gen-eral medical practice and nursing. Pharmacypractice research has had a particular advan-tage in settings where it has been able to drawon the expertise and resources of a widerhealth services research and clinical researchenvironment. Now it is beginning to berecognised as making a valued and uniquecontribution to informing health care policy,management and practice more widely.

The landscape of pharmacy practice re-search is now fairly well defined. It is sus-tained by an appreciation of thepharmaceutical sciences and an understand-ing of the clinical use of medicines, and theorganisation and delivery of pharmaceuticalservices. It also relies heavily on the applica-tion to healthcare of the population-basedsciences of psychology, sociology and economics.

What is currently lacking is capacity and,at risk, sustainability. Practice academics gen-erally have heavy teaching loads and so theircapacity for research is limited.There are nodedicated funding streams for developing re-search capacity through doctoral and postdoctoral fellowships or sustaining research ca-reers in pharmacy, as there are for medicine,dentistry and nursing. It is not surprising,therefore, the continued supply of senior research-active practice academic staff de-pends on a handful of schools of pharmacy.

The absence of funding streams for phar-macy-related practice research through gov-ernment health departments, and thecessation of a programme of commissionedresearch through the Pharmacy PracticeResearch Trust, means that the capacity andskill base of the pharmacy research workforcewill shrink even further. Without a cadre of

pharmacy researchers with diverse method-ological skills, practice research will becomeless responsive and the evidence base forpharmacy depleted.

Pharmacy practice research like any otherendeavour — such as wealth-creation, manu-facturing or healthcare — requires investment.

References1. Tully MP, Hassell K, Noyce PR. Advice-giving in community

pharmacies in the UK. Journal of Health Services Researchand Policy 1997;2910:38-50.

2. Bissell P, Ward PR, Noyce PR. Variation within communitypharmacy. 2: Responding to the presentation of symptoms.Journal of Social and Administrative Pharmacy 1997;4(2):105-115.

3. Bissell P, Ward PR, Noyce PR. Variations within communitypharmacy. 1: Responding to requests for over-the-countermedicines. Journal of Social and Administrative Pharmacy1997;14(1):1-15.

4. Bissell P, Ward PR, Noyce PR. Variation within communitypharmacy. 3: Referring customers to other healthprofessionals. Journal of Social and AdministrativePharmacy 1997;14(3):116-123.

5. Hassell K, Noyce PR, Rogers AE, Harris J, Wilkinson J. Adviceprovided in British community pharmacies: what peoplewant and what they get. Journal of Health Services Researchand Policy 1998;3(4):219-225.

6. Atella V, Schafheutle EI, Noyce PR, Hassell K. Affordability ofmedicines and patients’ cost-reducing behaviours: empiricalevidence based on SUR estimates from Italy and UK AppliedHealth Economics and Health Policy 2005;4(1):23-35.

7. Schafheutle EI, Cantrill JA, Nicolson M, Noyce PR. Insightsinto the choice between self-medication and a doctor’sprescription: a study of hay fever sufferers. InternationalJournal of Pharmacy Practice 1996; 4:156-161.

8. Thomas DHV, Noyce PR. The interface between self-medication and the NHS. British Medical Journal 1996;312:688-691.

9. Hassell K, Whittington Z, Cantrill JA, Bates F, Rogers AE,Noyce PR. Managing demand: transfer of management ofself-limiting conditions from general practice to communitypharmacies. British Medical Journal 2001;323:146-147.

10. Whittington Z, Cantrill JA, Hassell K, Bates F, Noyce PR.Community pharmacy management of minor conditions —the “Care at the chemist” scheme. The PharmaceuticalJournal 2001;266:425-428.

11. Elvey R, Bradley F, Ashcroft DM, Noyce PR. Commissioningservices and the new community pharmacy contract: (1)Pharmaceutical needs assessments and uptake of the newpharmacy contract. The Pharmaceutical Journal2006;277:161-163.

12. Bradley F, Elvey R, Ashcroft DM, Noyce PR. Commissioningservices and the new community pharmacy contract: (2)Drivers, barriers and approaches to commissioning. ThePharmaceutical Journal 2006; 277:189-192.

13. Bradley F, Elvey R, Ashcroft DM, Noyce PR. Commissioningservices and the new community pharmacy contract: (3)Uptake of enhanced services. The Pharmaceutical Journal2006;277:224-226.

14. Elvey R, Bradley F, Ashcroft DM, Noyce PR. Commissioningservices and the new community pharmacy contract: (4)Governance and performance management. ThePharmaceutical Journal 2006;277:251-253.

15. Bradley F, Wagner AC, Elvey R, Noyce PR, Ashcroft DM.Determinants of the uptake of medicines use reviews(MURs) by community pharmacies in England: A multi-method study. Health Policy 2008; 88:258-268.

16. Wagner A, Hann M, Noyce P, Ashcroft D. Equity in distributionof community pharmacies in England: impact of regulatoryreform. Journal of Health Services Research and Policy2009;14:243-248.

17. Noyce PR. Providing patient care through communitypharmacies in the UK: Policy, Practice and Research. TheAnnals of Pharmacotherapy 2007;41:861-868.

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Five principles of effective regulation Gareth Malson and Francesca Rivers report on the new regulatory framework and on the work of the Practice Research Conference Award winner

Bob Nicholls, chairman designate of theGeneral Pharmaceutical Council, sharedfive principles that he intends to bring to

his new role.The first is that independence of the regu-

lator and the full contribution of lay membersare of critical importance when establishingtrust and confidence in professional regulation.Independence is assured by appointing councilmembers who are free from the obligation torepresent any particular interests, and by ap-pointing equal numbers of lay and registrantmembers, he said. The latter would allow reg-ulation to be seen to be a partnership betweenthe public and profession.

“Of course, real engagement with the pro-fession and other stakeholders could never beachieved simply through the composition of acouncil of 14,” said Mr Nicholls. “It is muchmore about genuine outreach and engage-ment, and the GPhC will make this a priority.”

Secondly, effective regulation is aboutworking in partnership with the professions,he said. “Partnership working clearly startswith the people who are appointed to thecouncil and statutory and non-statutorycommittees working effectively together,” ex-plained Mr Nicholls. “But, importantly, it alsomeans making sure there is a wide variety oftrusted mechanisms through which we canlisten to and genuinely involve professionals.”

Thirdly, effective regulation is about listen-ing to and involving patients and the public.

“The new council will be endeavouring toget inputs from patients and the public, andtheir representative organisations, in all itswork,” said Mr Nicholls.

Fourthly, regulation must be proportion-ate. “I know many professionals fear the so-called burden of regulation,” said MrNicholls. “Proportionate means regulationmust be fair but not over-burdensome. Whiletoo little regulation or professional domi-nance is clearly not an option, we must avoidduplication and the cost of regulation must bereasonable.

“All aspects of regulation should deliverclear benefits to the public. This will be achallenge to the new council and I’m surewe’ll be able to rely on many of you to pointout if you think we are letting regulation be-come disproportionate.”

Finally, regulation should be about work-ing to sustain and improve standards and thequality of services, rather than simply disci-plining or punishing poor practice, he said.

“Standards will help professionals developthe knowledge and skills they need to buildrewarding careers, and provide a clear frame-work for innovation and improvement,” heexplained. “The key issue, I believe, is aboutusing standards to create a culture of learning— so that where there is poor practice or be-haviour, we seek to learn from it rather thansimply punish the individual.

“I hope you will agree this is a worthwhileaspiration for the whole profession, and onein which we can work together.”

He announced that the formal consulta-tion on the draft standards for the GPhC wasdue to be launched later this year, but alsothat they will available for early commentuntil 18 September on the GPhC website(www.pharmacyregulation.com).

He concluded: “Clearly pharmacists havebeen regulated well and effectively by theRoyal Pharmaceutical Society. It is my inten-tion that the GPhC builds on this excellenttradition as a foundation for its work.”

Assessing risk within pharmacy practiceMany of the risks faced by patients in hospi-tals and community pharmacies are preventa-ble, and could be averted by the use oftargeted interventions, said Darren Ashcroft,director at the Centre for Innovation inPractice, Manchester School of Pharmacy andPharmaceutical Sciences.

Dr Ashcroft spoke to the conference afteraccepting the Practice Research ConferenceAward at the British PharmaceuticalConference for his research into medicinesuse and safety. Often medication problems arenot pharmacological, but stem from issuessuch as wrong diagnosis, prescription of thewrong drug or incorrect drug administration— which represent failures in the medicinesmanagement system, he said.

In an early study examining 60,525 pre-scription items dispensed from 34 pharma-cies, Dr Ashcroft revealed that 0.71 per centof dispensed items required pharmacist inter-ventions — with 10.7 per cent of these inter-ventions averting potentially seriousprescribing errors.

He followed this up with an examinationof dispensing error rates via a prospective

study involving 35 community pharmaciesand 125,395 dispensed prescription items. Anoverall dispensing error rate of 26.3 errors per10,000 items dispensed (95 per cent confi-dence interval 23.6–29.3) was discovered,with errors mainly caused by the misreadingof a prescription or similarity of medicinenames or packaging. Dr Ashcroft’s researchshowed that distractions and excessive work-load were associated with 34.5 per cent of thedispensing errors, with staffing issues at playin 25.9 per cent of cases.

Dr Ashcroft has developed a number oftools based on his research, including theManchester Patient Safety AssessmentFramework (MaPSAF), developed in con-junction with community pharmacists andbacked by the National Patient SafetyAgency. The framework is designed to bringthe concept of safety culture to communitypharmacies and is available from theManchester university school of pharmacywebsite (www.pharmacy.manchester.ac.uk).

Dr Ashcroft has also developed aPharmacy Safety Climate Questionnaire(PSCQ) to survey staff attitudes towards

safety. Responses from 998 community phar-macies in the UK have revealed that 29 percent of staff believe patient safety incidents inthe pharmacy tend to recur. Nearly 40 percent of respondents (39 per cent) reported aninsufficient number of staff to handle theworkload, with a quarter reporting longerworking hours than are sensible for patientcare. Tensions between staff members werealso noted by nearly a quarter of respondents(24 per cent). Locum pharmacists and na-tional chains scored lower safety ratings thanpharmacy owners and employees, or inde-pendent pharmacies and small or local chains.

The study is currently being extended tothe US and the questionnaire is being trans-lated in order for it to be used in five coun-tries across Europe.

Dr Ashcroft has also recently secured fund-ing from the Royal Pharmaceutical Society toundertake a detailed assessment of risk withinpharmacy practice. “It is intended that theseresults will start to underpin the developmentof revalidation standards and feed into thework programme of the General Pharma -ceutical Council,” he said.

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Drive for quality and innovation mustnot be lost during financial challengesIn this session, representatives of the four UK health departments spoke about the importance of quality and innovation to deliver the savings and

efficiencies that will be required within the NHS in the financially challenging times ahead. Harriet Adcock reports

Pharmacist practitioners will need to em-brace the principles of quality, innova-tion, productivity and prevention,

known collectively as QIPP, Keith Ridge,chief pharmaceutical officer for England, toldconference participants. QIPP is currentlybeing trumpeted by the Government as anapproach that will help tackle service reformin financially challenging times.

Dr Ridge said that QIPP is a priority forthe Government, being seen as the most im-portant challenge for the NHS, alongside thecurrent influenza pandemic.

He argued that pharmacists must not losethe momentum for change and improvementin quality created over the past few years inthe current financial climate. “Over the pastdecade there have been record levels of in-vestment in the NHS,” he said. “This hasmade things much better for patients — therehave been more nurses, more doctors, morepharmacists, more new technologies and soon to deal with the considerably higher levelsof demand for healthcare.”

These improvements, Dr Ridge ex-plained, have been in part due to a renewedenergy around improving quality.“Quality isa great prize,” said Dr Ridge, “and is some-thing we as clinicians should not allow todrift away.”

He suggested there would be more tocome, a greater focus on quality and on usingthe skills of the pharmacy team to improvehealth.

Financial challengeDr Ridge gave a flavour of the financial chal-lenge ahead. The economic downturn willhave some direct impacts on health, for ex-ample, lower incomes leading to poorer diets,more demand for primary care, increased lev-els of depression and debt-related stress.

Savings will have to be found, said DrRidge, and for the foreseeable future, publicfinances will be highly stressed and will re-main so, even if the wider economy recoversrapidly.

“NHS funding will enter a more challeng-ing period in the next few years,” warned DrRidge, but added that with the challenges,come opportunities.

“The level of real savings and efficienciesthat the NHS will need to make from about18 months time onwards are so significantand so substantial that only radical and inno-vative thinking, developments and changewill deliver the savings and efficiencies re-quired,” he said.

Despite the financially challenging timesahead for the NHS, it is seen as a solid foun-dation on which to build and develop newtechnologies, in partnership with the life sci-ences industry.

Dr Ridge argued that the life sciences in-dustry, incorporating pharmaceutical compa-nies and medical biotech companies, wouldbe key to the future of the UK economy.“The intention is to ensure that the UK of-fers an attractive environment to life sciencescompanies to do business in,” he said.

As part of the NHS’s aim to create this en-vironment, the National Institute for Healthand Clinical Excellence will develop the in-novation pass, making selective innovativemedicines available on the NHS for a limitedperiod, giving faster access to cutting edgemedicines, explained Dr Ridge. Other meas-ures include building a more integrated lifesciences industry through skills developmentacross the workforce and supporting the for-mation of an internationally recognised UKlife sciences “super cluster” to co-ordinate work across industry, higher educa-tion and the NHS.

“I hope that you will all immediately seethat this work will be very relevant to the fu-ture of healthcare and therefore to pharmacypractice in every setting,” he said.

In order to build a more integrated life sci-ences industry there must be a continued

supply of high calibre skilled employees. Tohelp with this a higher education forum is tobe established and one of its first tasks will beto assess the curriculum of clinical pharma-cology in both medicine and pharmacy.

“This is complementary to the WhitePaper’s ongoing Modernising PharmacyCareers programme that will, in the fullnessof time, deliver pharmacy practitioners withall the necessary skills to care directly for pa-tients and to support R&D in the UK, for ex-ample, through clinical trials.”

The drive for qualityFocusing on the QIPP programme of work,Dr Ridge explained that the aim is to drivequality while addressing the financial chal-lenge through increased productivity.To thisend, the DoH has recently appointed an NHS director for improvement and efficiency.

“There is recognition that QIPP cannotbe delivered from the top down,” said DrRidge. “Real changes have to be designedand delivered locally with the centre playingan enabling role.”

He added that to do this the NHS willbe encouraging the use of the four changeprinciples that underpin Lord Darzi’s NextStage Review — co-production, subsidiar-ity, system alignment, and clinical ownershipand leadership. On clinical ownership and

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leadership, Dr Ridge argued that to deliverquality it was critical that clinicians wereempowered and mobilised across the sys-tem. “Without that we will get nowhere,”he said.

QIPP challenges need to be embraced atall levels, said Dr Ridge, who suggested thatsenior NHS managers would be looking forhelp and to work with many stakeholders, in-cluding pharmacy.

He pointed out that many of the initiativesin the English White Paper for pharmacywere relevant. “It goes without saying thatsafe, clinical and cost-effective use of medi-cines and pharmaceuticals will feature promi-nently. So local and national pharmacy leadersmust try to get involved.”

He argued that innovation, in its variousforms, will be critical in addressing the NHS’sfinancial challenges while still improvingquality as well as in developing the future ofthe UK economy.

“Pharmacy practitioners, both now andmore so in the future, will need to fully em-brace the principles of QIPP, including hav-ing the R&D skills to support UK Plc,alongside patient care.”

Norman Morrow, chief pharmaceutical of-ficer for Northern Ireland, argued that moreemphasis needs to be placed on the measure-ment of outcomes. “We need to invest moretime and effort in the design of initiatives andin the specification of measures that will allowfor assessment of wellness and efficiency.”

He also emphasised the importance of pa-tient experience.“As we anticipate a more in-

formed society we will have to ensure a moremeaningful engagement with those we treat,”he said.To achieve this end, there needs to bea stronger emphasis on research and develop-ment and work at the interface between sec-ondary and primary care, as well as a strongerfocus on practice research.

Mr Morrow also argued that savings andincreased productivity could be achieved byconcentrating on safety and quality. “Financeoften dominates but it can militate againstimportant progress,” he said.

Clinician on the high streetWhen charged in 2005 with saving £55mfrom the drugs bill by 2008, it was not the fi-nancial argument but the safety and qualityargument that gained involvement of theclinical community to achieve the target, MrMorrow said.

He added that pharmacy would be criticalto the quality agenda, and that clinical phar-macy services in hospitals need to be en-hanced while community pharmacists needto embrace the role of clinician in the highstreet. “That will require a radical rethinkabout the design and the nature of the com-munity contract.We have a choice here to bedefensive and protective or bold and innova-tive,” Mr Morrow concluded.

Bill Scott, chief pharmaceutical officer forScotland, also spoke about his vision of the“clinician on the high street” and the changesneeded to achieve it (PJ, 12 September, p261).

Responding to a question about develop-ing the pharmacists of the future and whetherfive years of training was enough for a pharma-cist to be in sole charge of a pharmacy, MrMorrow said that community pharmacy couldlearn from the teamwork seen in hospitals.

“We have all seen young inexperiencedpharmacists achieving significant things.Thishas occurred largely in the context of a teamwith good leadership.” This, he argued, wasmissing from community pharmacy, wherethere is a degree of professional isolation. Hesuggested that once the formal five years oftraining had been completed, pharmacistsshould then move into a safe, encouraging,innovative environment. “It’s about goodearly teamwork,” he said. “And this supportsthe concept of group practices.”

Role of automation and technology in improving qualityThe rise of technology in pharmacy has been slow but inevitable,said Jeremy Savage, deputy chief pharmaceutical adviser to theWelsh Assembly Government.

The implementation of automated dispensing in 17 majoracute hospitals across Wales has given sustained improvementin dispensing error rates of around 60 per cent and madesignificant improvements in the use of manpower and skill mix,he pointed out. “The sceptics said it could never be done. That iswould never catch on.”

The rationale for the use of automation is simple, said MrSavage: “The robot does it more quickly, more accurately, moresecurely.” Staff can be redeployed and their tasks focused ondirect patient care.

Mr Savage conceded that some technological developments— electronic prescribing and the electronic transfer ofprescriptions — have not produced the desired outcomes yet butsaid that progress was being made. Simple solutions such as the2-D barcode on prescriptions were beginning to deliver thepromise of reduced transcription errors, speeding up data entry and delivering ETP.

Information sharing, including the uploading of data to out-of-hours services and medical admissionswards, enables the safe transfer of patients between care settings.

To respond to well informed patients, healthcare practitioners must have access to the same resources astheir patients, argued Mr Savage. “The key goal for us all must be to ensure that pharmacists in the nextdecade have the web at their fingertips.” He said that the electronic health record would become a reality andthat the public would expect and demand that pharmacists offer fast and convenient access to medicines,information and other services.

“Professionals must use the available technology to keep abreast of current hazards and alerts,” he said.“We must ensure that all pharmacists are connected to these systems to ensure that adverse incidentreports can be readily accessed and overcome the corporate barriers that may obstruct direct access at themoment.”

The roll out of automation will continue into community pharmacy, argued Mr Savage. “Patients aredemanding easier access to services — over the internet, using mail order. Why not give patients directaccess to pharmacy services 24 hours a day, seven days a week” he asked. “We have embraced automatedhole in the wall technology in banking. Why not think laterally about how that can be applied to pharmacy,” hesuggested, adding that the “pharmacy ATM” is already a reality in Germany and Canada [see p12].

Mr Savage cited another example of a German service that involves 10 pharmacies linked together —“Medicines 24” — a service where there is always an online pharmacist available and medicines can bedispensed by robots direct to the patient. “Facilitation of remote dispensing is simply something we must do,”he said.

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How the dispensing machine works

The PharmaTrust Med Centre works as follows:

■ A patient approaches the machine and inserts his or her prescription■ The machine dials a video telephone located in the pharmacy that owns the machine — if the pharmacist

answers he or she appears on a screen on the front of the machine■ If the pharmacist cannot answer, or if the patient uses the machine outside of working hours, the call is

rerouted to a central office where it is taken by another pharmacist ■ Both sides of the prescription are scanned and an image of it appears on screen for the pharmacist to

view■ The pharmacist checks whether the machine stocks the prescribed medicine (most machines stock

around 400 items but newer models stock 1,800 products) ■ Speaking to the patient over a video telephone, the pharmacist obtains a full medication history and

confirms whether the patient is allergic to any medicines (this information is used to create a patientprofile, which is updated every time a supply is made)

■ If the pharmacist is happy for the medicine to be supplied, the machine is instructed to select, dispenseand label the product

■ Before the product is released, the pharmacist is shown a full breakdown of its manufacturinginformation (for example, batch number, expiry date, product weight) and can view the dispensedmedicine from several angles using cameras mounted inside the machine

■ Once the pharmacist is happy that the medicine has been dispensed correctly, he or she can instruct thedispensing door on the machine to open and the patient can take the medicine

■ The pharmacist provides any required counselling over the telephone and the patient is given a chance toask any questions before the process is completed

How remote supervision is being used to benefit patients in CanadaRemotely supervised dispensing machines recently introduced in Ontario, Canada, enable pharmacy services to be extended to people living in

remote areas without compromising patient safety, conference participants heard. Gareth Malson reports

Aglimpse of how technology and remotesupervision regulations can be used toextend pharmacy services to patients in

remote areas was offered to participants at theBritish Pharmaceutical Conference.Residents of Ontario, Canada, are now ableto obtain some prescription medicines, andget advice from pharmacists during theprocess, from dispensing machines in an in-creasing number of GP surgeries and emer-gency departments in the province.

The machines, known as “Med Centres”,have been cropping up across Ontario sinceprovincial law was amended earlier this year.The amendments included several legisla-tory reforms that have expanded the role ofpharmacists (for example, to allow pharma-cist prescribing). Legalising the remote su-pervision of medicines dispensing was onesuch amendment. Peter Suma, co-founderand chief operating officer of PharmaTrust,the company that manufactures the MedCentre, said that convincing pharmacists ofthe value of the machine has been no easytask.

“When I first went into the OntarioCollege of Pharmacy and put up a picture ofour machine, their jaws hit the table,” said MrSuma. “Anger followed; I’ve been yelled at bypharmacists, I’ve been sworn at, I’ve been

called the antichrist by the chief executiveofficer of the largest pharmacy chain in thecountry — he has just asked for exclusivity[for the machine].”

The technology is patient-focused and pharmacist-reliant, said Mr Suma, suggestingthe machine could be a similar technologicaladvance to that seen in the banking industrywhen the automatic teller was introduced. “If

you walk up to the machine and the pharma-cist chooses not to answer, it’s a dead lump ofmetal.”

“This is about serving patients,” he wenton. “It’s about extending the pharmacy towhere the patient is. It is not about replacingpharmacists.”

“It’s all about the pharmacist’s profes-sional discretion,” Mr Suma added.Therefore, if the pharmacist has any con-cerns about the prescription, such as thedose prescribed or the appropriateness of themedicine, he or she can instruct the patientto attend a pharmacy in person to get theprescription dispensed.

The machine offers an opportunity forpharmacists to offer a service to remote pop-ulations with poor access to a pharmacy. MrSuma also pointed out that the machine ispopular with patients, according to his com-pany’s data. “Pharmacists are divided, patientsaren’t. Like it or not, patients have come toexpect a multichannel service fromproviders.”

He also mentioned that the machine ap-pears to increase pharmacist-patient consulta-tion time. “We have found that theinteraction time between patients and phar-macists goes up — both patients and pharma-cists have attested to that.”

Mr Suma concluded that UK pharma-cists would need to decide for themselveshow remote supervision should be adoptedin this country. He urged participants notto dismiss remote supervision, but to consider how it can best be used to benefitpatients.

The PharmaTrust Med Centre

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Practice

Simulated patient project to benefit allBenedict Lam reports on the Royal Pharmaceutical Society’s simulated patient project and on the importance of pharmacists in reclassifying drugs

Asimulated patient is an individual who istrained to visit a pharmacy to enact astandardised scenario, said Margaret

Watson, senior research fellow, University ofAberdeen. A common descriptor for a simu-lated patient is “mystery shopper”, she added.

Dr Watson explained that the purpose ofthe simulated patient project, which is beingdeveloped by the Royal PharmaceuticalSociety and the National PharmacyAssociation, is:

■ To measure current practice in commu-nity pharmacy

■ To assess the effects of intervention■ To change behaviour (of pharmacists and

pharmacy staff)

She believes that there are many benefitsto using the simulated patient project, includ-ing that it is a rigorous and robust method ofmeasurement, it is internationally applicable,it assesses actual behaviour (of pharmacists orpharmacy staff), it resembles “real” patientsand it avoids the Hawthorne effect [wherebyindividuals improve an aspect of their behav-iour being experimentally measured simplyin response to the fact that they are beingstudied].

The project involves a simulated patientmaking a visit to a pharmacy. After the sce-nario, the simulated patient will leave thepharmacy, prepare feedback and return to thepharmacy (on the same day). He or she willidentify himself or herself and provide feed-back to the member of staff involved (prefer-ably in the presence of a pharmacist). Thesimulated patient will ask the member of staffhow he or she felt the consultation went andwhat aspects of the consultation could he orshe improve on. This, Dr Watson explained,

encourages those involved to identify howthey could improve on their behaviour in thefuture. A feedback form is provided to thepharmacy and detailed feedback will be sentto the pharmacy a few weeks after the visit.

Dr Watson stressed that feedback is neededbecause it promotes and reinforces goodpractice and corrects poor performance. Sheadded that community pharmacists are oftenisolated health professionals and, by givingfeedback about their service, they can be in-formed of what is going well and what is notgoing so well.

Valerie De Ruyter, project manager forthe simulated patient project, Royal

Pharmaceutical Society, said that the projectonly involves pharmacy medicines and is ameasure of good practice (not fitness-to-practise). Phase 1 of the project will involve 5per cent of all community pharmacies inBritain.

The six simulated patient scenarios are:

■ Potential drug interactions■ POM-to-P products■ Medicines that have abuse potential■ Medicines that have misuse potential■ Patient is not present in the pharmacy (ie,

the simulated patient is buying a medicinefor someone else)

■ Confidentiality issues

Ms De Ruyter believes that there aremany benefits for pharmacists, patients andpharmaceutical companies. Pharmacists, shesaid, could improve their performance, im-prove the reputation of the profession, anduse the experience as a contribution to theircontinuing professional development and asan evidence base of their good practice.

For patients, the programme could lead tothem gaining confidence in communitypharmacists as primary care providers andbeing educated towards self-care.

The benefits for pharmaceutical compa-nies could include having access to aggre-gated data that stem from the project, beingviewed as supporters of good clinical practice,an increase in the market for pharmacy med-icines and an increase in the potential formedicines reclassification, she said.

Ms De Ruyter explained that phase I ofthe project will last for approximately 11months and the start date would depend onfunding (financial contributions are beingsought from pharmaceutical companies).

UK is European leader in reclassification of drugsPharmacists are key players in the reclassifica-tion process, said Colette McCreedy, special-ist in self-medication at the Medicines andHealthcare products Regulatory Agency.

She said that, since the publication of theNHS plan in 2000, many NHS policy docu-ments have made reference to making moremedicines available without prescription andempowering people to look after themselves.Also, the pharmacy White Paper in Englandand pharmacy policy documents in the otherUK countries envisage a greater role forpharmacists in self-care, public health andscreening, and all of these can be supportedby POM-to-P reclassification.

Mrs McCreedy emphasised that the abilityof pharmacists to deliver the rigorous type ofsupervision and professional intervention re-

quired to supply medicines safely and effec-tively without prescription — whether thesupply is made by a pharmacist or by mem-bers of the pharmacy team — is a key factorin deciding whether a medicine is suitable forreclassification.This, she said, has contributedto the increasing range of medicines that wesee in pharmacies today.

Mrs McCreedy believes that the UK is theEuropean (if not world) leader in reclassifica-tion of medicines, citing the recent reclassifica-tion of azithromycin for the treatment ofchlamydia as an example. Medicines that havebeen reclassified at EU level, such as orlistat, arealso emerging.These medicines become avail-able at the same time in all 27 member states.

Mrs McCreedy believes that the UK hasan advantage with regards to reclassification

because UK legislation allows the MHRA toput in place safeguards that ensure safe salesand supplies involving pharmacists. Manymember states do not have the leglislativeframework to do this, she added.

However, Mrs McCreedy said that withthis ground-breaking work comes the needto continuously monitor safety in use, such asusing the yellow card reporting system.

Moreover, pharmacists can help by sup-porting risk minimisation measures that theMHRA puts in place when safety in use ormisuse is discovered, Mrs McCreedy said. Forexample, pharmacy controls have ensuredthose who seek to buy pseudoephedrinefrom pharmacies for the illicit manufactureof crystal methamphetamine have not succeeded.

Margaret Watson: feedback needed toreinforce good practice

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BPC 2009

Current issuesDuring group discussions, participants considered the following current issues:

What might be the niche market for PIP services? ■ Needs are emerging within specialist teams, such as addiction services, care homes support, clozapine

clinics, skin allergy testing ■ In clinical areas, such as anticoagulation, hypertension■ In areas involving pharmaceutical expertise, such as therapeutics/kinetics, formulation, interactions,

which add value beyond nurse prescribers■ Improving patient experience and enhancing the overall service, such as sexual health, public health

campaigns, healthy living centres

What support systems would need to be in place?■ Access to medical and administrative support are fundamental■ Robust referral pathway and clinical governance■ Funding via specialist clinical teams, especially regarding meeting targets■ Multiprofessional training — this supports PIPs because it promotes understanding of their contribution ■ More case studies which show how PIPs and also doctors and nurses work effectively together within a

service (not as sole practitioners)

What value is a pharmacist prescriber adding to this service?■ Stopping ineffective or unnecessary prescribing■ Complementing the skills of other non-medical prescribers, for example, nurse and pharmacist

prescribers■ Improving hard outcomes, such as GP callouts, hospital admission, falls and fractures, benzodiazepine

prescribing and better end-of-life care

What seem to be the factors that have determined success?■ A critical mass of qualified pharmacist prescribers available locally — if they are spread too thinly this

deters commissioners from using them■ Creating an evidence base through pre- and post-service audits■ Starting small■ Staying within competencies

The overall ambition is to provide a convenient, comprehensive service within a PIP’s competence.

Pharmacist prescribers: latest lessonsand developments from the fieldBeth Taylor, Anne Adams and Zoe Girdis report on a workshop examining the latest developments and research relating to prescribing by pharmacists

Current issues for pharmacist prescriberswere explored in this interactive work-shop session, which was introduced by

Beth Taylor, member of the EnglishPharmacy Board.

Throughout the session, ideas on how thenew professional leadership body could sup-port pharmacist independent prescribers(PIPs) at both national and local levels werecaptured to inform future developments.

Alison Blenkinsopp, professor of the prac-tice of pharmacy at Keele University, pre-sented some emerging findings from thenational evaluation of nurse and pharmacistindependent prescribing, of which she is thepharmacy lead. Her presentation focused onclinical governance and risk managementstrategies, based on survey results for PIPs andnurse independent prescribers (NIPs), and atelephone survey of trust non-medical pre-scribing leads.

Over 80 per cent of the 142 PIPs who re-sponded practised in general practice or NHStrust settings and the most common clinicalconditions treated were (in decreasing order)hypertension, coronary heart disease, cardiol-ogy, diabetes, care of older people, asthma andchronic obstructive pulmonary disease.Abouthalf of trusts have a written plan or strategy toguide non-medical prescribers’ (NMPs) de-velopment, and most NIPs and PIPs reporthaving a regular appraisal and personal devel-opment plan, although these were reportedby higher percentages of NMPs in hospitalsthan in primary care.

A range of tools is being used to qualityassure NMP prescribing, including prescrib-ing activity reports, significant event analysis,peer review and evidence portfolios.There isalso scope to increase the use of patient feed-back to inform the future development ofPIP services, and Professor Blenkinsopp em-phasised that commissioners have moved onfrom simple patient satisfaction surveys to agreater focus on patient experience and com-parisons with other options.

Karen O’Brien, associate director of pri-mary care commissioning for NHSManchester, has a pharmacy background andgave a commissioner’s viewpoint. She empha-sised that pharmacists must understand theNHS commissioning cycle and its implica-tions when developing proposals using PIPs.Commissioners have choices on routes forobtaining medicines and will want to makevalue for money comparisons, she said.Worldclass commissioning competencies may helpto shift attention to prevention and well-being, where pharmacy strengths may lie, sheadded.

As a commissioner, Mrs O’Brien looks foropportunities where pharmacists can bestserve the local population’s needs.These may

include: GP practices that underperformunder the quality and outcomes frameworkor do not want enhanced services such as sex-ual health; prescribing statins as part of theNHS health check; and clinics for long-termconditions and hypertension.

Mrs O’Brien encouraged pharmacists tobe proactive, to engage with the primary caretrust strategy at an early stage and, as a “will-ing provider”, to be on the lookout for adver-tisements for tenders and other opportunities.National bodies could help to support phar-macists in the tendering and biddingprocesses, she suggested.

Participants at the workshop (who in-cluded many active PIPs) believed that mostsuccessful prescribers had already established along-term trusting relationship with their GPor doctor colleagues. There was support for“pharmacist prescriber champion” roles, sothey could more effectively pitch to commis-sioners.

Alison Blenkinsopp presented findingsfrom the national prescribing evaluation

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Communication and integration key tosuccessful medicines use reviewsParticipants heard how pharmacists are delivering medicines use reviews in practice and how the Royal Pharmaceutical Society’s audit tool can help

to demonstrate the quality and benefit of MURs at a national level. Heidi Wright reports

Communication is the key to medicinesuse reviews (MURs), said SamiahTambra, a community pharmacist, who

spoke of her experience of setting up a suc-cessful MUR service in the Midlands. Thismeant not just communication with the pa-tient who is undergoing the MUR, but com-munication with other healthcareprofessionals, for example, the patient’s GPand district nurses, she added.

Miss Tambra has worked in her pharmacyfor over 15 years so has had the opportunityto build up good relationships with local GPpractices and this has helped with the imple-mentation of the MUR service.

Shane Gordon, a GP based in Colchester,Essex, talked about the need to integrateMURs into primary care trust plans and tomake sure that they are targeted at patientswho will get the most benefit from them.

Dr Gordon described the service inColchester, where MURs are undertakenafter discharge from hospital. He emphasisedthe importance of working with otherhealthcare professionals for the benefit of patients.

Kevin Noble, a PCT pharmacist based inthe Isle of Wight, spoke of his involvement insetting up targeted MURs — MURs whichhave been targeted towards specific patientgroups, in this case people with asthma. Thisapproach has proved highly successful and the

service is being evaluated (PJ, 31 January 2009,p99).Targeting MURs makes them relevant tothe PCT and to local practices, he said.

The final speaker was Heidi Wright, headof practice at the Royal PharmaceuticalSociety. She described a new MUR audittool that has been developed by the Societyin collaboration with the Royal College ofGeneral Practitioners and the Clinical AuditSupport Centre. She talked about the variousways of implementing this audit and how data

would be collected nationally to help demon-strate the quality and benefit of MURs at anational level.The tool was launched in July.

Session attendees then took part in alively debate about MURs, concluding that,although they were perhaps not introduced inthe best way, MURs have now proved to bebeneficial providing they are used in the rightway — communicated properly, targeted andintegrated, and focused on quality rather thanquantity.

Session attendees took part in a debate about MURs

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Student wins prize for new prison pharmacist logo A logo is essential to recognising a particularorganisation or specialty.To that end, pharma-cists who work in secure establishments re-cently embarked on finding a suitable logo toidentify their group.

A competition was launched at the annualBritish Pharmaceutical Students’ Associationconference, inviting students to design a logofor the secure environment pharmacistsgroup. The prize was a visit to a prison and£75 of vouchers donated by RPS Publishing.

The photograph shows the award winnerJainaba Nije from Portsmouth University(centre) receiving her prize from (left toright) Davan Eustace, representing the SecureEnvironment Pharmacists Group, BobBolick, managing director RPS Publishing,and Jonathan Mason, national clinical directorfor primary care and community pharmacyin England. The award was presented at theBPSA stand during BPC 2009.

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BPC 2009

Opportunities and challenges for pharmacists offering NHS Health Checks

Health checks: benefits and challengesBenedict Lam, Nicola Cree and Francesca Rivers report on progress with NHS Health Checks and on the research poster winners at this year’s BPC

One of the aims of NHS Health Checks [avascular risk management programmeoffered to people in England aged 40 to

74 years] (PJ, 11 April, p417) is to offerstraightforward risk assessment for diseases af-fecting the cardiovascular system, includingdiabetes and chronic kidney disease, saidRichard Daniszewski, vice-chairman of theEnglish Pharmacy Board.

The longer-term aims, he added, are to re-duce premature death from related vascularconditions, including coronary heart disease,chronic kidney disease, diabetes, stroke, tran-sient ischaemic attacks and peripheral arterialdisease. Also, it aims to identify those in thepopulation at risk of vascular disease earlierrather than later and narrow inequalities inthe number of premature deaths.

Mr Daniszewski said it is estimated, basedon known effective management applied toindividuals who are at high risk, that the pro-

gramme will prevent 1,600 heart attacks andstrokes, 650 cardiovascular deaths and 4,000people from developing diabetes per year.

Programme roll outThe scheme, he said, was introduced on 1April 2009 across all primary care trusts inEngland and they will be expected to imple-ment and deliver the service between nowand 2010. The economic modelling under-pinning the vascular checks programme isbased on the assumption that PCTs will com-plete roll out by 2012–13. However, MrDaniszewski emphasised, the actual pace ofimplementation is for PCTs to decide —some will be faster than others.

Spearhead PCTs [the 88 most health-deprived areas in England] are likely to be thefirst to receive funding to help implement theprogramme, Mr Daniszewski suggested.Vascular disease also makes up approximately

one-third of the difference in life expectancybetween spearhead areas and the rest ofEngland.

Practice poster prizes Awards given for science postersAn assessment of treatment culture on theprescribing of psychoactive medication innursing homes for older people won firstprize at the practice poster session during theBritish Pharmaceutical Conference.

Ailis Donnelly, of Queen’s University,Belfast, was presented with an Amazon.comvoucher for £150 by Peter Noyce, BPCPractice Chairman, at a reception sponsoredby Boots The Chemists. The prizes weresponsored by the Royal PharmaceuticalSociety.

Second and third prizes, vouchers for£100 and £50, respectively, were awarded toPeter Knapp, of the University of Leeds, for aposter entitled “User testing of participant in-formation for a phase 3 trial of cholesterol-lowering therapy”, and to Anne Hinchliffe, ofCardiff University, for a poster entitled “Theimpact of community pharmacy advice onsafe storage and administration of medicinesin adult care homes”.

A study of a polyamidoamine dendrimer-based drug delivery system to bypass the P-glycoprotein efflux transporter was awardedone of three prizes for best science poster ofthe day on the penultimate day of this year’sBritish Pharmaceutical Conference. H. M.Teow, of the University of CentralLancashire, was presented with a cheque for£100 by Dave Elder, a director atGlaxoSmithKline, which sponsored theawards along with the Academy ofPharmaceutical Sciences.

Also awarded £100 prizes for best sci-ence poster of the day were John Willets,from the University of Birmingham, for aposter entitled “Investigation into the ef-fects of blend energy input at differentscales on alpha-lactose monohydrate”, andOladayo Adenuga, from the University ofBrighton, for a poster entitled“Development of an in vitro model for oralbiofilm studies”. The teams behind both of

these posters included researchers fromGSK.

On the final day of the conference, HudaZughaid, of King’s College London, won a£150 prize for her poster on solubilisation ofsteroid drugs by simulated intestinal fluidscontaining lipids.

Ben Staley, of the University ofManchester, and Melinda Chau, from theUniversity of Wolverhampton, also won£150 prizes for their posters.

Mr Staley’s poster was entitled“Observation of the uptake of TAT peptideat nanomolar concentration” and MissChau’s poster was entitled “Quantitativeanalysis of konjac glucomannan (KGM) extracted from corms of Amorphophallus konjac”.

The prizes were presented to all threewinners by Eddie French, chairman of theAcademy of Pharmaceutical Sciences, andJames Butler, scientific investigator, GSK.

Pharmacists offering NHS Health Checks can include people who are not ill butmay need to modify their lifestyle, while GPs are trained to deal with those whoare ill, suggested Helen Williams, consultant pharmacist, Southwark Health andSocial Care.

Because most pharmacies are open for long hours, including evenings andweekends, they are ideal places from which to offer health checks and identifythose who may be at risk of vascular disease, Miss Williams argued. They are alsosuited to offering lifestyle advice as well as other services, for example, smokingcessation, signposting to other services, like local exercise programmes, or tomaking referrals to GPs.

However, Miss Williams believes there are issues that need to be consideredwith pharmacies offering health checks. These include patient engagement,

delivering lifestyle interventions and making appropriate medical interventions.Also, to reduce inequality, consideration needs to be given to certain populations,for example, those who are not registered with a GP and ethnic minority groups.

Another barrier to offering health checks is that, not only does a pharmacyneed to have a consultation room, it also needs to be equipped with a wash basin.Many pharmacies with consultation rooms do not have this facility, said MissWilliams. Continuity of service also needs to be considered, for example, locumswho are not accredited to provide the health checks working in pharmacies thatusually offer the service.

Moreover, pharmacy needs to maintain a competitive edge with offering healthchecks since other healthcare professionals, such as optometrists and dentists,want to provide this service as well, Miss Williams emphasised.

Richard Daniszewski: spearhead PCTslikely to receive funding first

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The expertsThe pharmacist prescribers included Zoe Girdis, primary care prescriber at Portsmouth Primary Care Trust,who specialises in cardiovascular disease and obesity, and Nina Barnett, prescriber in intermediate care forolder people, Harrow PCT, who is also a consultant pharmacist.

The consultant pharmacists were Steve Williams, who specialises in medicine and patient safety and isbased at the University Hospital of South Manchester, with a one day per week at Manchester University, andHelen Meynell, from Doncaster and Bassetlaw hospital, who provides a referral service for pharmacistscaring for patients with complex pharmaceutical care needs, particularly in the areas of respiratory medicineand palliative care. These are two different models of consultant practice, both of which fall within the DoHguidance for the post.

The two pharmacists with a special interest were Linda Hirst, from Bradford and Airedale PCT, and JanineBarnes, from Dudley PCT. Ms Hirst provides an anticoagulation monitoring services at a weekly clinic and MsBarnes provides a specialist service in neurology at Dudley PCT.

Speed dating sessions with specialistand advanced level practitionersThis session, organised by the Royal Pharmaceutical Society’s Community Pharmacists Group, featured pharmacists from community and secondary

care who led a speed dating style meeting to describe their experiences of advanced and specialist practice. Nina Barnett reports

There is no agreed definition for advancedand specialist practice and a lack of na-tional pharmacy accreditation for indi-

viduals across all areas of practice, said NinaBarnett, chairman of the consultant pharma-cists group for England, as she outlined the is-sues around defining advanced and specialistpractice.

Ms Barnett described the consultant phar-macist post, and practitioners within thoseposts, as well as the role of pharmacists with aspecial interest. Both of these roles are definedby Department of Health guidance and un-derpinned by the advanced and consultantlevel competency framework, she explained.

Ms Barnett outlined the potential charac-teristics of a higher level practitioner, includ-ing:

■ Expertise in an area of practice■ Multidisciplinary working ■ Use of judgement and reasoning to sup-

port clinical decisions where clear evi-dence is not apparent

The place of pharmacist prescribing interms of higher level practice, now and in thefuture, was considered. Ms Barnett suggestedthat some prescribing by pharmacists may beundertaken soon after qualification in the fu-ture whereas other areas of prescribing mightremain a higher level practice activity.

Carol Evans, head of professional develop-ment at the Royal Pharmaceutical Society, de-

scribed the key objectives of the Society’s ad-vanced and specialist practice project.These in-cluded combining competency frameworks toprovide support for national recognition of ad-vanced and specialist practice, and personalachievement awards for individual pharmacists.

Mrs Evans explained the goals of the proj-ect group, which followed from theTransitional Committee report on improved,advanced and specialist practice, and updatedparticipants with current progress, outliningthe project timetable.

Stakeholder reference meetings started inJuly 2009 and were due to continuethrough 2010. There is a working group,which includes representation from all sec-tors of the profession in England, Scotlandand Wales, and a wider reference group to

ensure maximal stakeholder involvement,she explained.

Speed datingThe remainder of the session was devoted togroup discussions. These were based on the“speed dating” concept but allowed 20 min-utes per table for each “expert” to be inter-viewed by conference participants. Theexperts were two prescribers, two consultantpharmacists and two pharmacists with a spe-cial interest (see Panel).

The idea of the session was to give partic-ipants an opportunity to find out how thesepathfinder postholders reached their currentpositions, what their roles entailed and theopportunities and challenges that they hadexperienced along the way.

Young pharmacists learn what careers are possible

PJ editor Olivia Timbs (centre) chairs the annual BPC-PJ Careers Forum

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Analysis of problems in primary care Gareth Malson and Nicola Cree report on problems in primary care and how pharmacists can reduce adverse drug reactions

Researchers in the US estimate that, in long-term care settings, for every dollar spent ondrug and nursing facilities $1.33 is spent ontreating drug-related problems, said NeilMackinnon, associate professor, DalhousieUniversity, Canada.

Research from the Commonwealth Fundhas shown that 13 per cent of patients in theUK have reported having experienced amedication, medical or laboratory error inthe past two years, Dr Mackinnon said. Thiscompares with 17 per cent in Canada and 20per cent in Australia and the US.

Quoting a physician at Harvard,Massachusetts, Dr Mackinnon told the con-ference that any symptom in an elderly pa-tient should be considered a drug side effectuntil proved otherwise.

There are eight key factors (see Panel) thatconstitute a complete and safe medication usesystem. If one of these key things is missing,patients are at increased risk of experiencingan adverse event, he said.

There are a number of things that pharma-cists can do to reduce adverse drug events.Pharmacists should ensure that for every pre-scription they dispense, they know why thepatient is taking the medicine, not just whatthe medicine is for. Pharmacists should alsotry to eliminate the “quality tax” — whereone pharmacy provides better care than an-other when they receive the same reimburse-ment, Dr Mackinnon said.

Pharmacists should be engaging patients inmedicines use management and providingfamily level pharmaceutical care, that is, carethat you would like your family to receive.Pharmacists should also be aiming for cus-tomer satisfaction and should ensure that theyimplement best-demonstrated practices, hesaid.

Pharmacists should be considering whatthey can do that will change a patient’s qual-ity of life, Dr Mackinnon added.

In order to help raise their profile, phar-macists should wear a badge that says “Ask

me about your medicines”. Pharmacists canalso improve their relationships with pre-scribers, Dr Mackinnon suggested, by pro-viding positive feedback since the majorityof interactions prescribers have with pharmacists are because of problems withprescriptions.

Medication use systemEight key factors constitute a complete and safemedication use system:

■ Timely problem recognition and diagnosis■ Safe, accessible, cost-effective medicines■ Appropriate prescribing■ Distribution and tailored patient advice■ Patient participation and intelligent adherence■ Monitoring■ Documentation and communication■ System evaluation, measurement and

improvement

The reason for varying levels of clinicalservices commissioned from pharmaciesacross the UK is not due to a lack of na-

tional policy, said David Jenner, practice-based commissioning lead for the NHSAlliance. “The current Government has notbeen idle in producing policy and docu-ments,” he said, citing documents such as“World class commissioning” and LordDarzi’s next stage review of the NHS as ex-amples.These policies promote commission-ing from all primary care clinicians, not justGPs. However, he went on to say:“The truthis: it is all about GPs because we hold regis-tered lists [of patients] and we, directly or in-directly, commit most of the resources byprescribing or referring.”

The problems are financial, says Dr Jenner,and the use of Payment by Results (PbR) topay hospitals for the care they provide has nothelped the commissioning of services fromprimary care providers. He said PbR was, infact, “payment by activity” and that it haddone little to improve healthcare quality. “Ithas driven capacity, it has driven supply, it hashelped us meet targets, but it has cost a lot ofmoney,” he said.“As a commissioner, I cannotset a budget with my [acute] trust because ifthey do more work, they get paid more.” Hewent on:“There are no disincentives for acutetrusts to manage demand.”

Lack of commissioningMost pharmacists will not have noticed a dif-ference since practice-based commissioningbegan, said Dr Jenner. Although he accepted

that some commissioning consortia were opt-ing to keep money in general practice, hedoes not believe that is the crux of the prob-lem.“A lot of my colleagues would commis-sion more from pharmacy if they could, butthe access to the care record is one of thebiggest stumbling blocks for pharmacy tocompete with general practice,” he explained.

He expressed concern that some pharma-cists working for multiples had told him that

staffing levels were being reduced because ofthe credit crunch.This meant that there werenot enough staff to deliver enhanced services.

Future workingDr Jenner understands that most primary carecommissioners have been told to look for 20per cent “efficiency cuts” over the next fiveyears. “We know there are tough decisionsahead but, at the moment, we don’t knowwhat that will mean.”

Nonetheless, he believes this will only beachieved through collaboration between allhealthcare providers. In particular, he high-lighted collaboration between pharmacy andgeneral practice: “Couldn’t we be workingcloser together? Couldn’t pharmacies moveinto GP practices more?

“Pharmacists sometimes feel restrictedfrom doing clinical services by the need tosupervise dispensing but why can’t pharma-cists provide clinical services through generalpractices? Why can’t people have joint con-tracts?” He admitted there were legislative is-sues to resolve, and issues regarding conflict ofinterests, but concluded: “It just makes suchgood sense.”

Although he acknowledged that Tory pol-icy was still evolving, he hypothesised that aConservative government would promotecompetition among healthcare providers.Thiscould lead to control of entry for pharmaciesbeing deregulated, a devaluation of PbR pay-ments and a cap on acute trust incomes, plusa renegotiation of the community pharmacyand the GP contract.

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BPC 2009

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Practice

Innovation central to taking servicesforward in challenging financial timesHospital tsar Martin Stephens highlighted how pharmacists can help the NHS to maximise productivity within limited resources. Harriet Adcock reports

Innovation will be central to taking phar-macy services forward in challenging fi-nancial times, argued Martin Stephens,

national clinical director for hospital phar-macy in England, in his address to conferenceparticipants.

He explained that, in the past, the NHShad often responded to funding squeezes byclosing a ward or shutting down a service.“That is not a choice for the NHS anymore,”he said, pointing out that such moves led todecreases in efficiency, patients becomingmore ill and quality of care dropping.

“We need innovation to drive up produc-tivity and improve quality. Or at least to sus-tain it,” he said.

Mr Stephens highlighted the need forquality, innovation, productivity and preven-tion, principles also emphasised by KeithRidge, chief pharmaceutical officer forEngland, in his speech to the conference (seep10).

These principles, known collectively asQIPP, are a priority for the Department ofHealth and feed into its work to see the NHSthrough the funding crisis.

“Good use of medicines is part of this,” ar-gued Mr Stephens, who has been asked bythe DoH to lead a QIPP project in secondaryand tertiary care. “Avoiding admissions re-lated to poor medicines use, whether errorsor adverse events, or failing to optimise care,these are important areas where we can in-crease quality and make the service more efficient.”

In his role at the top table, Mr Stephenssaid he would point out the importance, notjust of cost-effective medicines, but of usingmedicines to make the whole of healthcarecost-effective.

Transfer of patients between care settingsis an area of tension that can be improved todeliver quality and productivity, suggested Mr

Stephens, who highlighted a forthcoming re-port from the Care Quality Commission onthis topic. The report, which would empha-sise the need for timely, clear and accurate in-formation about medicines when patients aredischarged from hospital, would be an oppor-tunity for pharmacists to raise the issuewithin their own organisations.

Mr Stephens signalled the prospect ofpost-discharge medicines use reviews as a na-tional directed service. “These must be usedwisely and be aimed at patients most likely tobenefit,” argued Mr Stephens. The issue iscurrently being discussed by thePharmaceutical Services NegotiatingCommittee and NHS Employers as part oftheir negotiations on the community phar-macy contract for England, he said.

“It would be great if secondary care couldrefer particular patients to community phar-macy as a way of using this service. This iscertainly an area for local discussion betweenhospitals and community pharmacy throughlocal pharmaceutical committees once it hasbeen established.”

Another area in need of innovation is theway the health service makes use of pharma-cists as prescribers in secondary care.Pharmacists are leading the way in prescrib-ing on admission, he said, through taking theharder to manage therapies, such as surgicalprophylaxis and post-operative antibiotics.“All this could lead to safer, better care andmore efficient use of resources.”

Mr Stephens also argued that, going for-ward, patient experience of the health servicewould be just as important as the outcomesdelivered. “As front-line practitioners andservice managers it does us good to look atour services from a patient’s perspective. Arewe engaging with patients enough, do wetreat them with dignity, are we seriousenough about patient confidentiality, and do

we keep people waiting too long outside ourdispensaries,” he asked.

Clinical audits often look broadly atwhether a series of standards are being met.“This is important . . . but high-quality care isalso about meeting individual needs.”

There is a lot more that pharmacists cando in terms of patient experience and indi-vidualising medicines regimens, Mr Stephensargued.

Returning to the financial challengesfaced by the NHS, Mr Stephens said thatpharmacists’ ability to innovate would beneeded to help the NHS maximise its pro-ductivity with limited financial resources.

And although financial recovery in theeconomy might come sooner,“gaps in publicfunding will be with us for much longer”, asituation he described as the most challengingperiod pharmacists are likely to see in theircareers.“We have got 18 months to get readyfor harder times,” he warned.

Pharmacy leaders at all levels need to re-spond to this challenge, he told conferenceparticipants, calling on chief pharmacists tobe open to automation and new ways ofworking. “Front-line teams need to be fullyengaged,” Mr Stephens added. “We reallyneed your creativity and your ability to inno-vate.That will be the solution.”

Mr Stephens’s counterpart for primarycare and community pharmacy, JonathanMason, also spoke about transfer of patientsbetween primary and secondary care and thethe need to develop a set of quality indicatorsfor pharmacy (PJ, 12 September 2009, p260and p261).

Martin Stephens: engage with patients

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BPC 2009

Pharmacy practice research reviewedOne hundred and two practice research papers were presented at the 2009 British Pharmaceutical Conference. Pamela Mason reviews a selection

of the most interesting papers, including studies on medicines use reviews, non-prescription medicines, public health and workforce issues

Change is the watchword this year.Reading through all the practice re-search papers presented at the BPC

2009, I was conscious of a profession passingthrough huge change. Indeed, change in rela-tion to practice is mentioned more than 50times in the papers overall.

Pharmacy services — from medicines usereviews (MURs) to public health — are also,not surprisingly, a strong theme. My overallimpression is that, despite significant work-load issues, which are also the focus of severalpapers, pharmacy is vibrant with the profes-sion at all levels working towards a sustainablefuture.

Our journey through this year’s papersstarts with MURs, then moves on to practicearound non-prescription medicines. Nextcomes public health, patient safety, thenlearning and development before endingwith workforce issues in the pharmacy team.

Medicines use reviewsMuch of the research on MURs was aboutopinions: the opinions of patients, pharma-cists and doctors.

Youssef (Derby and DeMontfortUniversity, Leicester) found that patients onwarfarin benefit from a structured MUR. Inthis study, patients having warfarin MURswere recruited in a community pharmacy inDerby to fill in a patient satisfaction surveyregarding their experience of MUR. Of the17 survey respondents, 15 felt they had learntwhat to do if they missed a warfarin dose and14 had learnt when to take their warfarin.Patients also felt they had learnt about foodsupplement interactions and the importanceof avoiding alcohol binge drinking. Patients’attitudes towards pharmacists discussing war-farin treatment with them were extremelypositive and most felt they would be happy tohave their international normalised ratio(INR) measured in the pharmacy.

In another study looking at patients’ per-ceptions of MURs, in this case in a ruralcommunity, Patel and Lefteri (School ofPharmacy, University of Hertfordshire), alsofound that patients value MURs. This was astudy involving a face-to-face questionnaireon 83 patients, 29 of whom had received anMUR carried out in the study pharmacy.Among these patients, 90 per cent claimedthe MUR had improved their knowledge oftheir medicines. Eighty three per cent ratedthe service as good and a further 17 per centrated it as excellent. All patients said theywould recommend an MUR to others.

So, if patients have positive views ofMURs, what are pharmacists’ perceptions?Khideja (Aston University, Birmingham)surveyed community pharmacists via a focus

group and 21 semi-structured telephone in-terviews. Community pharmacists’ under-standing of the term MUR and their role inproviding MURs varied widely from think-ing they involved clinical interventions togiving basic information on use of medicines.Opinions also varied as to the purpose ofMUR accreditation and the extent to whichthe training prepared the pharmacist to un-dertake MURs. But all agreed that ongoingtraining is vital.

In a further study from the same depart-ment Bassi and Wood (Aston University)surveyed 100 community pharmacists andfound that employee pharmacists still thinkthat quality of MURs is being compromisedin the effort to achieve target numbers.Interestingly, more than half the pharmaciststhought that patients were not aware of the MUR service and that changing thename of the service from MUR to, for example, “medicines check-up” might im-prove awareness.

Moving on to GPs’ views of MURs, astudy by Patel (King’s College, London) andRosenbloom found that a majority of GPsbelieved that MURs did not resolve patients’problems or only partially did so. This studysurveyed 135 local GP practices, from which61 GPs replied. When asked what theywanted MURs to achieve, GPs said it wasvital that MURs gave patients understandingof how to take their medicines. Most GPs alsowanted MURs to be able to identify and re-solve poor or ineffective use of medicines, es-

tablish patients’ anticoagulant clinic atten-dance and frequency of INR monitoring,identify drug interactions and side effects thatmay affect compliance, establish actual medi-cines use and reduce medicines wastage.

MURs provide a useful opportunity forcommunity pharmacists to review non-prescribed products. However, a study byJohn (Welsh School of Pharmacy, CardiffUniversity) et al found that few MURs ap-peared to include the use of non-prescribedproducts.The researchers evaluated all MURforms over a three-year period in six pharma-cies from one multiple in one city. Of the1,639 MUR forms completed, only 22 con-tained a reference to a non-prescribed prod-uct, which was actioned, for example byreferral to the GP. The products concernedwere a laxative, an antacid, a sedating antihis-tamine, a topical antifungal, aspirin, paraceta-mol and food supplements.

Non-prescription medicinesContinuing with the theme of non-prescription medicines, a study by Hannaand Hughes (Queen’s University, Belfast)evaluated pharmacists’ attitudes in relation tothe application of an often poor evidencebase for over-the-counter (OTC) medicines.A questionnaire was sent to all 529 registeredcommunity pharmacists in Northern Ireland,of whom 209 (39 per cent) responded. Mostrespondents were familiar with the conceptof evidence-based practice, but when think-ing about the effectiveness of OTC medi-

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cines, they tended to rely on feedback frompatients, healthcare colleagues and personal orfamily use of OTC medicines rather than theevidence base.

Prescription-only to pharmacy medicineswitches are welcomed by pharmacists ac-cording to research conducted byColquhoun (Health Attitudes Direct,Tunbridge Wells) et al.The majority of the 40community pharmacists participating in thissurvey said POM-to-P switch products addvalue to the profession, allowing the provisionof quality products and empowering pharma-cists. The main things that encouraged rec-ommendation of a switched product werebelief in the therapeutic superiority of theproduct, exclusive pharmacy availability andopportunity for patient counselling. Majorbarriers to recommending switched productsincluded the cost to the patient, lack of coun-selling time and the need to fill in a question-naire to see if the product was suitable for thepatient.

Turning to specific POM-to-P switches,Chappell (University of Bath) et al exploredthe views of community pharmacists and po-tential patients on the reclassification ofazithromycin for the treatment of chlamydiainfection.Among the 230 pharmacist who re-sponded to the questionnaire, 78 per cent be-lieved that reclassification would increasepublic awareness of chlamydia and 87 percent believed it was positive for communitypharmacists.A majority also said that conven-ience and rapid access would encourage pa-tients to use pharmacies. Most of the 981potential patients surveyed said they woulduse a pharmacy as a source of information,testing and product supply for future chlamy-dia treatment. Cost was an issue, with 81 percent of those surveyed being willing to payup to £20 for treatment. Pharmacists consid-ered the costs of over-the-counter testing andtreatment prohibitive for those under the ageof 25 years.

Concerns about inappropriate use of chlo-ramphenicol eye preparations following re-classification were tackled by Walker(National Public Health Service, Cardiff) andHinchliffe. This study involved a retrospec-tive analysis of prescribing data from 2003–08and OTC sale data from 2005–08. The aimwas to see if reclassification of chlorampheni-col eye drops and eye ointment had any im-pact on prescription volume and overall useof ophthalmic chloramphenicol. What hap-pened was that the number of prescriptionitems for ophthalmic chloramphenicol didnot change following introduction of OTCchloramphenicol. However, sales of chloram-phenicol exceeded 27 per cent of the pre-scription volume, indicating increased use ofchloramphenicol overall.

Public healthReduction and prevention of alcohol misuseis a key public health aim, and Dhital (King’sCollege, London) et al investigated whetherpeople would use community pharmacies foran alcohol screening service. Interestingly, in

this study, there seemed to be almost twicethe proportion of risky drinkers among phar-macy customers compared with estimates ofthe proportion within the general popula-tion. Regardless of their drinking status, how-ever, most customers were interested in usinga pharmacy-based alcohol service.

If pharmacists have not been heavily in-volved in alcohol services, they are increas-ingly providing public health services aroundcardiovascular disease. Horgan (NHS SouthBirmingham, Birmingham) et al surveyedclients participating in the “Heart MOT”, acommunity pharmacy vascular risk assess-ment service delivered in areas of deprivation.Of the 176 clients who responded to thequestionnaire (44 per cent), 98 per cent saidthey were happy with the service and all buttwo said they would recommend it to others.Thirty eight clients identified areas for im-provement, including space and privacy of thepharmacy consulting room and the need formore advertising.

Time is an important factor in providingany pharmacy service. Thornley (Boots UK,Nottingham) et al looked at consultationtimes with clients using the Boots “Healthyheart” service. Among the 214 clients forwhom consultation times were recorded, 78per cent chose the tier 3 service, which in-cluded measurement of blood pressure, bodymass index, waist circumference, blood glu-cose, total cholesterol, and high densitylipoprotein (HDL) cholesterol, to enable cal-culation of lipid fractions. Clients were re-ferred to their GP, signposted to otherservices or given lifestyle advice as appropri-ate. About half of these tier 3 consultations,including paperwork, lasted between 21 and30 minutes and 94 per cent were conductedwithin 30 minutes.

Medicines-related falls can be a cause ofconsiderable morbidity in older people, andHall (Leicester, School of Pharmacy, DeMontfort University) et al have developed ascreening tool designed to assess the risk offalls associated with medicines. The tool waspiloted in 101 patients over the age of 65years. It was able to differentiate between pa-tients at low, medium and high risk of falls, inthat there was a significant difference be-tween the risk seen in patients taking morethan 10 medicines compared with those tak-ing fewer than four.

Patient safetyAdverse drug reactions (ADRs) are a report-ing category in the National Patient SafetyAgency hospital patient safety incident re-porting system. Davies ((Royal Liverpooland Broadgreen University Hospitals NHSTrust) et al, set out to compare this systemwith the Medicine and Healthcare productsRegulatory Agency’s yellow card scheme. AllADRs identified in a study of hospital inpa-tients were graded for severity according tothe NPSA scheme and the yellow cardscheme.ADRs occurred in 15 per cent of pa-tient episodes but reporting of ADRs accord-ing to NPSA guidance seemed to offer little

additional value in efforts to improve patientsafety over and above the yellow card scheme.The authors suggested that the availability ofmore than one system could confuse ADRreporters.

McLernon (University of Aberdeen) et alfound differences between yellow card re-ports submitted by patients and healthcareprofessionals. In this study of 26,129 yellowcard reports patients reported more reactionsper yellow card report (three versus two),more reactions involving the nervous system(40.5 per cent versus 20.4 per cent), generalreactions (38.4 per cent versus 22.9 per cent)and gastrointestinal disorders (32.5 per centversus 19.5 per cent). However, fewer of thereactions reported by patients resulted in seri-ous events.

ADRs are known to be a cause of hospitaladmission, but little is known about their in-fluence on hospital readmission. In a furtherstudy by Davies et al, ADRs were found tobe a significant — but potentially avoidable— cause of hospital readmission. One fifth ofpatients in this study were readmitted to hos-pital within one year of discharge due to anADR. The most frequent drugs responsiblefor ADRs were antiplatelet drugs and loopdiuretics, with bleeding or renal impairmentthe most frequent ADRs.The researchers saidthat 57 per cent of the ADRs were potentiallyavoidable.

Tangiisuran (Brighton and SussexMedical School) evaluated the incidence ofADRs in very elderly patients (>80 years old)in hospital, a patient group in whom therehave been no recent studies examining thisproblem. One in seven of the study patientsexperienced an ADR with three out of fourof these reactions being serious and lifethreatening and a significant proportion pre-ventable. Factors associated with ADRs in-cluded the use of six or more medicines, useof hypoglycaemic agents, hyperlipidaemia,raised white cell count and hospital stay ofmore than five days.

On a more positive note, a drug alertposter improved clinical practice in relationto insulin in 74 per cent of staff in an acutetrust, according to a study by Ledger-Scott(County Durham and Darlington NHSAcute Trust). The poster was sent by e-mailwith a printed copy also sent to each wardfor display. This method of disseminationworked particularly well for pharmacists andnurses, but only 65 per cent of junior doctorshad read the alert compared with all thepharmacists and 98 per cent of the nursingstaff.

Poor communication during transfer ofpatients between hospital wards is a rootcause of patients missing doses of medicationin hospitals. This finding emerged from astudy by Sedgwick (County Durham andDarlington Foundation Trust) et al. Of the 73 patients included in the study, 32 missed at least one dose of medication despite itbeing available on the ward. Missed doses included insulin, Parkinson’s disease drugsand antibiotics.

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Continuing with the importance of com-munication on medicines as patients movesettings, Terry (Department of Pharmacy,Birmingham Children’s Hospital) et al foundthat the introduction of medicines reconcili-ation in children is likely to reduce medication-related harm, mirroring similarfindings in adults. This study involved 100children admitted to a paediatric neurosurgi-cal ward. Medicines reconciliation performedby a pharmacist identified 38 disparities in 22children between the initial hospital prescrip-tion and the medication prescribed beforeadmission.

Learning and developmentOur schools of pharmacy continue to de-velop new methods of teaching and learning.Robert Gordon University has recentlybegun to combine face-to-face with elec-tronic instruction for teaching pharmaceuti-cal public health. Diack (The RobertGordon University, Aberdeen) et al have de-veloped a module in which internal staff, e-tutors and students work together online ingroups of 10 to 12 to complete directedstudy, coursework and assessment. Studentsare encouraged to develop their own publichealth practice by creating a service develop-ment bid. Student engagement, analysedusing online tracking tools and course evalu-ation tools, was found to be exceptional.

Many of us learn well by doing, whichwas confirmed in a study by Apampa(Medway School of Pharmacy, Kent) et alwho surveyed second-year undergraduatesand graduates of Medway School ofPharmacy to ask them what they thoughtabout learning in a community pharmacyunder the supervision of an instructor.Results suggested that students valued theirearly practice experience in a communitypharmacy while studying for their degree.They said it helped them to develop theirprofessional skills and attitudes, which as theauthors state, is important at a time when theprofession is taking on a more patient-fo-cused approach.

Leadership skills are essential to supportthe profession through these times of hugechange. Lambat (Welsh School of Pharmacy,Cardiff University) et al explored the viewsand experiences of 18 participants in thePharmacy Leadership Programme for Wales.This programme consisted of two nationaltwo-day workshops and up to eight regionalaction learning sets (ALSs). The aim of theALSs was to identify learning needs and pro-vide a vehicle for resolving leadership dilem-mas. The ALS format was found to be apowerful tool for personal development andindividuals were already making changes totheir professional practice as a result of theprogramme.

Turning to the learning of registered phar-macy technicians, a study by Schafheutle(University of Manchester) et al found that aCentre for Pharmacy Postgraduate Education(CPPE) workshop on influencing skills forpharmacy technicians resulted in positive

learning outcomes. Over half of the 122 re-spondents who gave detailed feedback on thecourse explained how they had introduced,changed or improved a system within theirworkplace. Some said the knowledge gainedat the workshop had helped them gain a newjob or additional responsibilities while otherscommented on how the workshop hadhelped them to make a case for new equip-ment or to improve communication withinthe pharmacy team.

Workforce issuesIt will come as no surprise to PJ readers thatchanges in pharmacy have increased profes-sional workload. Ferguson (University ofManchester) et al interviewed 26 pharmacistsand found that all of them were struggling tocope with increased volumes of work, staffshortage and deteriorating work conditions,all of which compromised their job satisfac-tion.

In another study from Manchester,Sestonand Hassell found that community pharma-cists seemed to experience more difficulty

balancing work and home commitmentscompared with hospital pharmacists, whilemen experienced greater problems withwork-life balance than women.

Willis (University of Manchester) et alfound that career commitment was higheramong white women than among any othergroups in the study and was noticeably loweramong men from minority ethnic groups.Those who felt satisfied with, and in controlat, work and those who saw good career de-velopment opportunities in the future werealso more likely to feel committed to work-ing as a pharmacist.

Does an accredited checking technician(ACT) improve work-related stress? The an-swer seemed to be “no” according to a studyby McCann (Queen’s University, Belfast) etal.Although the six surveyed pharmacists be-lieved that an ACT was a valuable member ofthe pharmacy team with the potential to freepharmacy time, most said that they were ulti-mately responsible for checking and the costof ACT training did not produce sufficientbenefits.

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Science

Science Chairman’s address:nanomedicines in sharp focusIjeoma Uchegbu describes how nanoparticles can be used advantageously to alter drug biodistribution and unlock the potential of various compounds

Drug delivery is a fairly new discipline, al-though the compounding of medicinesto facilitate drug administration is a rea-

sonably well established field of endeavour.However, controlling the distribution of drugcompounds after they have been administeredis probably a “teenage” science — still uncon-trolled yet full of promise.

If drug biodistribution could be controlledabsolutely there would be minimal side effectsand greater compliance. More importantly,drug compounds that at the moment cannotbe used because they are unable to get to thesite of action, could be. This class of com-pounds includes genes, promising therapeuticsstalled by a lack of delivery options, peptidesand high molecular weight pharmacologicallyactive agents with central nervous system ac-tivity that cannot get into the brain, andpoorly soluble drugs that are not absorbed insufficient quantities to guarantee activity.

In our laboratory we use nanoparticles toattempt to alter advantageously drug biodis-tribution and hence unlock the potential ofvarious compounds (see Figure 1). Our toolsare polymers, which are large moleculessometimes a thousand or more times higherin molecular weight than aspirin.

A key feature of our laboratory is the en-gineering of particles. Self assembly is theprocess by which polymers are turned intoparticles and is directed by the polymer’schemistry.We focus on making sure that par-ticles have the right morphology (see Figure2) — particles may be hollow or filled — andon making sure that particles are able to en-capsulate the drugs that we want to deliver.Our activities are also geared towards gettingthe size of the particles right since particlesize influences drug biodistribution, for ex-ample, particles smaller than 400nm are betterat delivering drugs to the brain. We have

found that polymer molecular weight impactsdirectly on particle size and have exploitedthis to produce optimum sized particles.

A further area of activity is constructingdrug particle formulations that are stable forprolonged periods — up to nine months —and producing particles of various shapes,since this, too, can influence drug delivery.

We have also constructed particles thathave a very high drug load, with up to 45

per cent of the particle being the drug.Thishigh drug load is useful because it allowsformulators to work with less of the polymer excipient. It is especially helpfulfor delivering medicines required in highdoses.

Once functional nanoparticles such as ourshave been loaded with drugs they are knownas nanomedicines, simply because the nano-technology is enabling.

Figure 1: Nanoparticles can advantageously alter drug biodistribution

Conference ScienceChairmanIjeoma Uchegbu occupies the chair ofpharmaceutical nanoscience and is director ofpostgraduate research studies within thedepartment of pharmaceutics at the School ofPharmacy, University of London. She waspreviously professor of drug delivery at the Schoolof Pharmacy, University of Strathclyde, Glasgow.

Her research is concerned with the design,synthesis and use of amphiphilic polymers andlow molecular weight dendrimers to effect drugand gene delivery solutions.

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So what can these particles do for phar-macy? In the case of drugs with poor watersolubility, these nanomedicines promote drugabsorption via the oral route, producing a for-mulation that results in a three-fold increasein drug absorption. This was demonstratedwith ciclosporin A as a model drug and inpreclinical studies in rats.

Our nanomedicines also promote drugdelivery to the brain. Delivery of drugs to thebrain is limited because the brain is protectedby the blood-brain barrier: a barrier of tightblood vessel cells that do not allow most mol-ecules to cross. This keeps the brain healthybut it often limits the amount of drug thatcan access a diseased part of the brain. Byusing our nanomedicines, we have been ableto increase the activity of drugs in the brainby up to 10-fold, and this was demonstratedusing propofol in a mouse sleep model.

A final area of success with this nanotech-nology is gene therapy in preclinical cancermodels. Genes and ribonucleic acid se-quences could be used to treat cancers if onlythey could be successfully delivered.Tumouricidal genes which result in tumouri-cidal proteins have been shown by us to resultin complete tumour shrinkage once thegenes are packaged into our nanoparticles.The nanoparticles ensure that the gene is notdestroyed by plasma enzymes and is able toenter the cell to produce the protein. In ourstudies, which were conducted in tumour-bearing mice, the protein was tumour necro-sis factor-alpha, which, on being produced inthe cell, caused tumour shrinkage (see Figure3).

In summary, nanoparticle engineering hasresulted in nanomedicines that significantlyimprove the pharmacological activity of phar-

macologically active molecules that posea problem for pharmaceutical development,such as various hydrophobic drugs and genes.

Further reading1. Wang W, Qu XZ, Gray AI, Tetley L, Uchegbu IF. Self assembly

of cetyl linear polyethylenimine to give micelles, vesicles anddense nanoparticles. Macromolecules 2004;37:9114–22.

2. Wang W, Tetley L, Uchegbu IF. A new class of poly-L-lysinebased polymers forms nanoparticles on probe sonication inaqueous media. Langmuir 2000;16:7859–66.

3. Wang W, McConaghy AM, Tetley L, Uchegbu IF. Controls onpolymer molecular weight may be used to control the size ofpalmitoyl glycol chitosan polymeric vesicles. Langmuir2001;17:631–6.

4. Qu X, Omar L, Le TBH, Tetley L, Bolton K, Chooi KW et al.Direct evidence that polymer branching leads to disk shapedplanar morphologies. Langmuir 2008;24:9997–10004.

5. Qu XZ, Khutoryanskiy VV, Stewart A, Rahman S,Papahadjopoulos-Sternberg B, Dufes C et al. Carbohydratebased micelle clusters which enhance hydrophobic drugbioavailability by up to an order of magnitude.Biomacromolecules 2006;7:3452–9.

6. Cheng WP, Gray AI, Tetley L, Hang TLB, Schatzlein AG,Uchegbu IF. Polyelectrolyte nanoparticles with high drugloading enhance the oral uptake of hydrophobic compounds.Biomacromolecules 2006;7:1509–20.

7. Kirkpatrick P. Pressures in the pipeline. Nature Reviews DrugDiscovery 2003;2:337.

8. Deeken JF, Loscher W. The blood-brain barrier and cancer:transporters, treatment, and trojan horses. Clinical CancerResearch 2007;13:1663–74.

9. Pardridge WM. The blood-brain barrier: bottleneck in braindrug development. Journal of the American Society ofExperimental Neurotherapy 2005;2:3–14.

10. Begley DJ. ABC transporters and the blood-brain barrier.Current Pharmaceutical Design 2004;10:1295–312.

11. Khuntia D, Brown P, Li J, Mehta M. Whole-brain radiotherapyin the management of brain metastasis. Journal of ClinicalOncology 2006;24:1295–304.

12. World Mental Health Day 2006: building awareness —reducing risks: suicide and mental illness. World HealthOrganisation 2006. Available at www.who.int/mediacentre/news/releases/2006/pr53/en/ (accessed 1 October 2009).

13. Uchegbu IF, Schatzlein AG, Lalatsa A. Oral delivery ofhydrophilic drugs to the brain. British Patent Application GB0903559.3. 2009.

14. Are the number of cancer cases increasing or decreasing inthe world? World Health Organisation 2008. Available atwww.who.int/features/qa/15/en/index.html (accessed 1October 2009).

15. Mathers CD, Loncar D. Projections of global mortality andburden of disease from 2002 to 2030. PloS Medicine2006;3:2011–30.

16. Schatzlein AG. Delivering cancer stem cell therapies — arole for nanomedicines? European Journal of Cancer2006;42:1309–15.

17. Peng Z. Current status of gendicine in China: recombinanthuman Ad-p53 agent for treatment of cancers. Human GeneTherapy 2005;16:1016–27.

18. Zinselmeyer BH, Mackay SP, Schatzlein AG, Uchegbu IF. TheLower generation dendrimers are effective gene transferagents. Pharmaceutical Research 2002;19:960–7.

19. Dufes C, Keith WN, Bilsland A, Proutski I, Uchegbu IF,Schatzlein AG. Synthetic anticancer gene medicine exploitsintrinsic antitumor activity of cationic vector to cureestablished tumors. Cancer Research 2005;65:8079–84.

20. Chisholm EJ, Vassaux G, Martin-Duque P, Chevre R, LambertO, Pitard B et al. Cancer-specific transgene expressionmediated by systemic injection of nanoparticles. CancerResearch 2009;69:2955–62.

21. Bell HS, Dufes C, O’Prey J, Crighton D, Bergamaschi D, Lu X etal. A novel p53-derived apoptotic peptide de-represses p73to cause tumour regression in vivo. Journal of ClinicalInvestigation 2007;117:1008–18.

Figure 3: Nanoparticles allow the gene to enter the cell and reduce the tumour

Figure 2: Particle structure can influence drug delivery

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Science

Debate: are medicines too expensive? Who is to blame when the high cost of medicines prevents patients from receiving optimal treatment? This issue was debated by a speaker from

Oxfam and one from The School of Pharmacy, University of London,during a BPC 2009 science session. Gareth Malson reports

The high price of medicines is caused bygreed on the part of the pharmaceuticalindustry, said Mogha Kamal-Yanni, sen-

ior health and HIV adviser for Oxfam. Shewas speaking in support of the motion:“This house believes that medicines are tooexpensive.”

Dr Kamal-Yanni believes the core argu-ment for the industry charging a high price— to recoup the vast cost of research anddevelopment — does not tell the wholestory. For example, she highlighted researchthat estimated the cost of getting a newmedicine onto the market to be around$1.3bn. “Is the cost that high,” she asked.“This figure is based on one study —funded by [the industry] so for a start we’vegot conflict of interest.

“The data are not available to anyone.Wecan’t examine [the data], we just have to be-lieve it.” She went on to suggest that thisfigure incorporates marketing costs and theassumption that if the manufacturer had notspent money on research, it would other-wise have invested it in something else andmade a healthy return. She also pointed outthat the tax allowances that become avail-able as a result of investing in research werenot considered in this amount.

R&D is expensiveArguing against the motion, David Taylor,professor of pharmaceutical and publichealth policy at The School of Pharmacy,University of London, said there was nopoint quibbling over the exact cost of re-search.“Is research and all the things you doto get the drug on the market expensive?Yes,” he said.“The cost of producing it onceyou get there is often low . . . but what is afair price?

“Do you charge the moderate cost ofproduction — the idealised generic price —or do you charge a price that, over a givenperiod, is intended to give you a return oninvestment and an incentive to go on invest-ing?” He went on: “Investing in things thatare reasonably safe, like, hopefully, houses, isvery different from investing in things thatare really hazardous.”

Dr Kamal-Yanni criticised the practiceof developing “me-too” drugs and ques-tioned whether it was innovative to tinkerwith existing drugs just to create new onesin the same class.

She pointed out that, during the past fewyears, only about 15 per cent of the medi-cines approved by the US Food and DrugAdministration were better therapeutic op-tions than what was already on the market.Furthermore, she highlighted that the costof research for such me-too drugs was

unlikely to be as great as the research costsfor “innovative” medicines.

End of the blockbuster eraDr Kamal-Yanni said that the “blockbustermodel”, by which many pharmaceuticalcompanies had operated for many years, wasno longer working. Furthermore, becausethere were no new blockbusters in thepipeline, pharmaceutical companies wereemploying different tactics to protect theirbank balances.These included vigorous pro-tection of patent, expansion into new mar-kets for which only small numbers ofpeople could access expensive treatments,more expenditure on marketing and in-creased drug prices. Consequently, she be-lieved the industry was failing to honour its“social contract”.

Professor Taylor disagreed: “I genuinelybelieve the pharmaceutical industry to beone of the more successful institutions inhuman society . . . its contributions are use-ful.”

He concurred that the blockbuster erawas over, but argued that it was becausethere were few blockbusters left to discover,not because manufacturers had stopped try-ing to discover them. In addition, when acompany does invent an innovative productit is often only suitable for small numbers ofpeople. This, along with the fact thatgeneric prices were so low, meant that thecost of new drugs had to be much higher,he said.

He also pointed out that governmentfunding for research often follows privateprofit. So, funding for research is unlikely tobe forthcoming unless it expects to yieldprofit for private companies.

A higher causeProfessor Taylor decreed that solving worldhealth problems should be the focus ofeveryone’s efforts. “Personally, I would ex-tend pharmaceutical product patent livesconsiderably . . . in return for guarantees ofworld supply to all populations.”

Dr Kamal-Yanni responded by suggest-ing that extending patent licences would be“a disaster” because it would preventgeneric competition from forcing pricesdown and would just mean it took longerfor the price to drop to a level that develop-ing countries could afford.

She believes it is unfair that healthcareworkers, particularly those in developingcountries, are put in a position where theyneed to decide who is treated and who isnot — therefore potentially who lives andwho dies. “I’ve done that before, I wouldn’twant to do it again,” she said.

Mogha Kamal-Yanni: blockbustermodel no longer working

David Taylor: cost of new drugs has tobe high

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BPC 2009

Temozolomide: a pharmacist’s tale The discovery of anticancer drug temozolomide and its turbulent journey to market was described by Malcolm Stevens, emeritus professor, University

of Nottingham, and chief scientific officer, Pharminox, during the Academy of Pharmaceutical Sciences annual award lecture. Harriet Adcock reports

Mitozolomide (Azolastone) became anexample of what not to do in anti-cancer drug discovery, Malcolm

Stevens, emeritus professor at the Universityof Nottingham and chief scientific officer atPharminox, told conference participants dur-ing the Academy of Pharmaceutical Sciencesannual award lecture. Professor Stevens de-scribed how his research group at AstonUniversity worked on the development ofmitozolomide in the 1970s, where he hadfunding to synthesise pharmaceutically inter-esting molecules.

The group, which included several phar-macists (many of whom have gone on to holddistinguished positions in the field of drugdevelopment), developed six molecules thatwere taken into clinical trials, two of whichfound their way to market. This was allachieved over 20 years at a cost of less than£10m, said Professor Stevens.

“We were successful because we had ex-pertise spanning chemistry, supplementedwith lots of PhD students and undergraduateprojects, we had pharmacologists, toxicolo-gists and a pharmaceutical development phar-macist,” he explained.

Mitozolomide was rapidly taken into theclinic after being found to clear lymphomafrom mice using a single dose, but proved tobe disastrous, said Professor Stevens. “It wasdisastrous clinically and disastrous politically,”he said. In trials, its antitumour effects werenot observed and it showed unpredictablethrombocytopenia.“This spelt the end of mi-tozolomide,” said Professor Stevens, who atthis point developed a personal strategy fordiscovering molecules that were easy to syn-thesise and named it “molecule whispering”.

Professor Steven’s approach to drug devel-opment was simple — all compounds putinto clinical trials had to be easy to synthe-sise, for example, using a two-step process,and only 50 to 60 molecules in any classwould be synthesised. Molecules taken for-ward needed to interfere with a novel bio-logical mechanism and had to have robustpharmaceutical properties.

“The art is getting these three processesworking together over a programme of syn-thesising 50 to 60 molecules,” he said.“If youcan’t do it within those molecules, you’re un-likely to do it in 5,000 or 50,000 molecules,”he said.

He added that another feature of moleculewhispering was that, to be successful, re-searchers must be prepared to “fall in love”with the molecules they are working with.

Following the ill-fated mitozolamide,Professor Stevens’ group used his moleculewhispering strategy to develop other com-pounds. Among them was temozolomide —

a simpler molecule than mitozolamide, with-out DNA cross-linking capability.

The reaction used to synthesis temozolo-mide — known as the Stone reaction — wasa one-pot reaction, with cheap starting mate-rials and a high yield. However, at the timethe research group wanted to take synthesis oftemozolomide forward, the Bhopal disasterhappened in India, Professor Stevens re-ported. The culprit molecule in the Bhopaldisaster was methyl isocyanate, required tomake temozolomide via the Stone reaction.“We got diverted looking for different waysof making it — but none was as good and thedrug is still made commercially by thisprocess,” he added.

Temozolomide’s antitumour propertieswere explored and the molecule put intoclinical trials, where it produced some ex-traordinary results, said Professor Stevens.Most remarkably of all, a series of patientswith brain tumours experienced a major clin-ical response.

“Cancer Research UK went out on theroad to show temozolomide to various phar-maceutical companies. Sadly, there were noBritish companies that were interested —they thought it was too risky to synthesise.”However, temozolomide was eventually li-censed to Schering Plough and marketed in1999.

Further work was carried out to explorethe drug’s mechanism of action. By puttingvarious isotopes into temozolomide — 15N,11C and 14C — it was possible to account forwhat happens to all the atoms in the molecule.

“Critically, using 11C isotope we couldshow that the carbon is expired as CO2 gas,

leaving a methyl group doing the business. . . .So we know precisely what happens to themolecule — its ring opens and then undergoesa cascade of degradation, eventually generatinga very short-lived reactive methyl diazoniumion that methylates the guanine base in DNA.”

The methylated guanine hydrogen bondsto thiamine resulting in a so-called DNAmismatch, which then alerts the mismatch re-pair machinery of the cell. “We now knowthat the success or failure of temozolomide inpatients depends on the presence or absenceof a DNA repair protein — MGMT —methyl guanine methyl transferase. . . . Patientswhose tumours are proficient in MGMT canreverse the repair and so respond poorly,” ex-plained Professor Stevens.

Further along temozolomide’s journey, theNational Institute for Health and ClinicalExcellence came down hard on the drug andoriginally would not approve it for reim-bursement. This caused great concern tosome of the clinicians involved in its develop-ment, who were unable to prescribe it on theNHS, said Professor Stevens. However, itproved to be a wonderful example of transla-tional research, he said, adding that the drugsold over $1bn in 2008.

Asked if he would do it all again, ProfessorStevens said that he would recommend phar-macy as a career for anyone interested in sci-ence.“It gives you all the options — of beinga microbiologist, a chemist, a physiologist anddisciplines that did not exist when I was a stu-dent, such as tissue engineer and nanotechnol-ogist. There are pharmacists making majorimpacts in all these areas and I would certainlydo it all again,” Professor Steven concluded.

Malcolm Stevens developed a personal strategy for discovering molecules

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Science

Pursuing effective anti-infectivesThe emergence of drug-resistant infectious diseases is being met with a dearth of new anti-infective medicines — but there are new treatment

options to be explored. Francesca Rivers reports

Resistance is a recurring challenge in thebattle against infections, limiting the life-time of a drug and providing a constant

need for new drug targets. Meanwhile thedrugs pipeline has dried to a trickle, withhigh research and development costs and ap-proval issues holding back a much-neededdrive for new treatments. Such was the mes-sage from many of the speakers on infectiousdiseases and anti-infective medicines at thisyear’s British Pharmaceutical Conference.

Drug resistanceWe have created some monsters through theoveruse and misuse of antibiotics, the confer-ence heard. Rachel McKendry, of theLondon Centre for Nanotechnology atUniversity College London, argued that un-less new discoveries are made, the burgeon-ing problem of multi-drug resistancethreatens to return us to the pre-antibioticsera.

Professor McKendry described a newmethod for assaying microbial resistance toantibiotics, using nanomechanical cantileversensors to study reactions and assess bacterici-dal activity. Her research team recently re-ceived two grants to progress their workfurther. A £2m grant from the Engineeringand Physical Sciences Research Council willgo towards developing a hand-held system formeticillin-resistant Staphylococcus aureus test-ing, while the second project will see themproducing nanosensors for both MRSA andHIV.

New therapeutic directions Peter Taylor, of the School of Pharmacy,University of London, argued that there is notenough investment in, or teaching about, in-fectious diseases in schools of pharmacy inthe UK.

The pharmaceutical industry is also nolonger investing heavily in antibacterialchemotherapy, focusing instead on moreprofitable areas, such as chronic and lifestyle-related diseases, he added.“Things are shiftingnow, but it may be a little bit too late,” hewarned, stressing that new partnerships needto be developed to address the pressing needfor new therapeutic agents.

Alternatives to conventional antibioticchemotherapy are required, Professor Taylortold participants.

Conventional antibiotics have single bio-chemical targets, giving bacteria the opportu-nity to circumvent the action of the antibioticvia discrete changes to its cellular biochem-istry.Agents that inactivate or disable the bac-teria through modification of the bacterialphenotype may be preferable, he argued, cit-ing photosensitive bacterial inactivation and

bacteriophage-derived enzyme therapy as ap-proaches currently being investigated.

Professor Taylor’s research group has iden-tified a specific enzyme that can alter thecourse of systemic infection with neonatalbacterial meningitis by removing the protec-tive poly-sialic acid capsule expressed on thesurface of most of the pathogenic strains ofEscherichia coli.

“[The sialic acid is] actually a host anti-gen that is expressed during embryonic de-velopment, and the bacteria mimic this toescape detection by the immune system,”said Professor Taylor, explaining that the en-zyme they have identified is specific to thebacterial capsule and does not attack thehost cells.

Studies using a rat model of neonatal bac-terial meningitis have demonstrated that di-rect administration of the enzyme into theintraperitoneal cavity can cure or prevent in-fection and almost eliminate brain inflamma-tion in 90–100 per cent of the animals.“Thisdemonstrates that the idea of modifying thephenotype at the site of the infection willwork,” said ProfessorTaylor.

His group is alsoinvestigating com-pounds that modifybacterial resistance,such as catechin gal-lates, compoundsfound in green teathat have been shownto modify the beta-lactam susceptibilityof MRSA.

ImmunotherapyImmunotherapy wasproposed by GreggSando, founder andchief executive officerof cellular therapeu-tics company CellMedica, as another al-ternative to antibioticsfor the treatment ofviral infections. CellMedica research hasexplored the possibil-ity of using cell-basedimmunotherapy totreat cytomegalovirusin immunocompro-mised patients whoseweakened immunesystems leave themvulnerable to reactiva-tion of latent infec-tions.

Approved for routine use in the UK by theMedicines and Healthcare productsRegulatory Agency, the therapy is given tobone marrow transplant patients via a bloodinfusion.

Phase I and II trials have demonstratedsuccessful protection against cy-tomegalovirus, with no significant side ef-fects, but graft versus host disease has proveda key complication to the treatment.A clini-cal trial is currently under way in 13 hospi-tals across the UK in order to develop areimbursement case to present to the NHS,explained Mr Sando.

T-cell immunotherapy has been under ac-tive development for around 20 years nowand we will see it emerge into clinical use, hepredicted.The therapy has potential for use inthe treatment of autoimmune disease, as wellas preventing certain cancers that are relatedto immune system dysfunction, such as cervi-cal cancer and human papilloma virus, hesaid. Cocktail treatments that would targetmore than one infection at a time are also alikely progression, he added.

Pharmacist Support is a registered charity, No. 221438, and is funded by donations from pharmacists. This registered charity was previously known as The Benevolent Fund of the Royal Pharmaceutical Society of Great Britain.

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PJ, Oct, p27 BPC 1/10/09 10:55 Page B27


BPC 2009

Steroid sulphatase inhibitors: pushingthe frontiers of cancer researchDiscovery of a new class of anticancer agents saw professors Barry Potter and the late Michael Reed awarded the 2009 GlaxoSmithKline Industrial

Achievement Award. Accepting the award, Professor Potter detailed the development of the new agents. Francesca Rivers reports

The traditional approach to treating cancerusing cytotoxic therapies that simply in-terfere with rapidly dividing cells is giving

way to the concept of targeted therapy,whereby cancer cell growth is blocked via in-terference with specific molecules involved inthe disease pathway, said Barry Potter, profes-sor and head of medicinal and biologicalchemistry at the University of Bath.

At this year’s British PharmaceuticalConference, Professor Potter accepted the2009 GlaxoSmithKline Industrial Achieve-ment Award on behalf of himself and his lateresearch partner Michael Reed, professor ofsteroid biochemistry at Imperial College,London. The award was given for their in-volvement in the discovery of steroid sul-phatase inhibitors — which are currently inclinical trials and promise to emerge as a newclass of anticancer drugs in the near future.In a lecture mapping the development of the compounds, Professor Potter said thesearch for new therapeutic targets for canceris progressing.

Research into new treatments for hor-mone-dependent breast cancer focuses onfinding compounds that can interfere withoestrogens (particularly 17β-oestradiol),steroid hormones that play a part in car-cinogenesis via the activation of transcrip-tion. Tamoxifen, which works by blockingthe binding of oestradiol to its receptor, hasbeen the gold standard treatment for years,said Professor Potter, but his research groupcame to the conclusion that they needed toadopt a different approach, based on con-trolling the levels of these hormones withinthe tumours themselves. “Our aim was totry to define a new type of endocrine ther-apy that would block the effects of oestro-gen on tumour cell proliferation,” heexplained.

Interrupting oestradiol productionThe current dogma is that the aromatase en-zyme — which converts androstenedione tooestrone, which is subsequently converted tooestradiol — is a good drug target, a theorythat has been borne out in the clinic for sev-eral years, said Professor Potter. The block-buster drugs anastrozole and letrozole exerttheir effect through aromatase inhibition andare becoming the new gold-standard in anti-endocrine therapy, in some cases supplantingthe use of tamoxifen as first-line therapy, heobserved.

But a large amount of oestrone is pro-duced in cancer cells by the action of oe-

strone sulphatase, a steroid sulphatase (STS)that thereby provides a source of oestradiolthat cannot be blocked by an aromatase in-hibitor. Another steroid, androstenediol, isalso active at the oestradiol receptor and pro-duced through an aromatase-independent(but sulphatase-dependent) pathway. Both ofthese pathways are exciting targets for a newtherapeutic approach, he said.

Unlike aromatases, STSs are expressed byall breast tumours and are easy to detect inthe cytoplasm of carcinoma cells. High levelsof STS often correlate with a worse progno-sis for breast cancer patients, making STS in-hibition a good target for the treatment ofcancer. Professor Potter and his team carriedout structure-based design work to producea series of compounds that were structurallysimilar to the STS substrate oestrone sul-phate, and tested their ability to inhibit theenzyme.

A steroidal sulphamate ester, oestrone 3-O-sulphamate (EMATE), emerged as an ef-fective time- and concentration-dependentinhibitor of STS. EMATE was found to beunsuitable for development as an anticancerdrug, but has been taken forward into phaseI and II clinical trials as a candidate prodrugfor hormone replacement therapy.Meanwhile, the group produced a series ofsimilar but non-steroidal sulphamates andstudied their effects on STS activity, leadingto the identification of a lead drug candidate:STX64.

STX64As well as being an easy compound to syn-thesise, STX64 has been shown in in vivo tri-als in mice to be highly potent and non-oestrogenic, with a high oral bioavailability.An important feature of the compound is thatit is sequestered into red blood cells followingoral administration, and thus avoids primarymetabolism and emerges later to exert itspharmacological action.

Professors Potter and Reed founded aBath and Imperial College University spin-off company called Sterix in order to takethe promising compound forward into“first-in-class” clinical trials, with the mainobjectives of establishing a toxicity profilefor the drug and discovering the oral doserequired.

A dual-centre phase I trial involving 14postmenopausal breast cancer patients admin-istered either 5mg (nine patients) or 20mg(five patients) doses of STX64 produced ex-citing results, recalled Professor Potter. The

drug was well tolerated and could producecomplete inhibition of STS. Interestingly, andsurprisingly, said Professor Potter, the drugdid not just produce a decrease in STS activ-ity but also reduced levels of the steroidserum androstenedione, which is a substratefor the aromatase enzyme. Five patients whohad previously shown disease progression, in-cluding on aromatase inhibitor therapy, hadclinical evidence of stable disease after treat-ment with STX64.

Three further clinical trials of reformu-lated STX64 are currently under way inFrance, Belgium and the UK under the aus-pices of the pharmaceutical company Ipsen.“We hope to see results coming throughshortly,” said Professor Potter.

Other applicationsSTS inhibitors also have the potential to treatother diseases that have a hormonal element,such as endometriosis, endometrial cancerand androgen-dependent prostate cancer, ex-plained Professor Potter. Clinical trials of STSinhibitors for some of these indications arecurrently under way.

Barry Potter accepting the award

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Science

Hormone-independent tumours are morechallenging than their hormone-dependentcounterparts, explained Professor Potter, andhis new streams of work include finding anddeveloping anticancer compounds that workindependently of STS-inhibition — such asmicrotubule disruptors and anti-angiogenicagents — for the treatment of hormone-independent cancers. STX140 is one suchorally active drug candidate, which is deliv-ered by the blood transport system and hasdemonstrated anti-proliferative and anti-angiogenic action, with profound effects ontumour vasculature. Both STX140 and a fel-low candidate STX243 have produced excit-ing results in trials with murine models ofandrogen receptor negative prostate cancer.

Recent press coverage of the group’s workon a potential treatment for hormone-

independent breast cancer has grossly exag-gerated some of the progress that has beenmade, commented Professor Potter. He saidthat while it is good for the work to have ex-posure, it is not desirable for patients to be-lieve a new pill is available when thecompound has not even yet progressed intoclinical trials.

He added: “We’re very hopeful this drugwill go further, and will be very successful inat least one of the indications. If it does, it willbe . . . proof that you can take compoundsfrom the university bench way beyond whatyou might have imagined would be dream-able.”

The labours of Professor Potter and his re-search group have led to the developmentand patenting of a first-in-class aryl sulpha-mate pharmacophore, which he hopes will

prove applicable in many disease areas andallow the design of drugs in addition to thosethat have already entered clinical trials.

A stronger focus on drug discovery isneeded in academia in order to plug the in-novation gap that has formed, said ProfessorPotter, observing that the pharmaceutical in-dustry has invested enormous amounts ofmoney in drug discovery over the pastdecade, with a diminishing output of com-pounds submitted for approval.

“I feel personally that we should be engag-ing far more, in the academic community,with our industrial colleagues, to think upnew ideas for [drug] discovery,” he said. “Weneed much more use of the good minds inuniversities, to apply them in a sensible fash-ion to drug discovery.”

Growth of pharmaceutical industry incurrent economic climate questionablePersonalised medicines, and disease modification and prevention, represent opportunities for the pharmaceutical industry. Nicola Cree reports

There are a number of challenges facingthe pharmaceutical industry, Brent Vose,vice-president, global drug development,

AstraZeneca, told the conference.Whether growth of the industry will con-

tinue in the current economic climate isquestionable, he said, adding that growth hadalready slowed in the US, UK and Japan,leaving the industry to rely on emergingmarkets.

In the past 10 years sales of pharmaceuti-cals have increased 160 per cent, Mr Vose said.Research and development (R&D) expendi-ture has increased by 80 per cent, but produc-tivity — measured by the number of newmedical entities to be approved — has de-creased by 43 per cent. “We’re putting moremoney in, it’s taking us longer and we’re get-ting less out,” he said.

To bring one drug to market it is esti-mated that it costs over $897m. It takes 12years to develop a new medicine but 80 percent of drugs do not show a positive returnon investment, leaving only 20 per cent tofund the R&D engine, said Mr Vose. Pricingpressures, the impact of the National Institutefor Health and Clinical Excellence and patentexpiry leaving very little time to recoupR&D costs, are all challenges the industryfaces, said Mr Vose.

OpportunitiesThere are a number of opportunities for theindustry, added Mr Vose. It is important to tryto move away from symptomatic treatment todisease modification and prevention. It is alsoimportant to move towards personalisedmedicines, he said, adding that AstraZeneca

estimates that over time, 50 per cent of itsportfolio will have associated with it a patientsegmentation tool. Part of AstraZeneca’sR&D operating model is to look at whetherthere is a patient segmentation opportunityfor each target it takes on board. The com-pany is also looking to work with providers ofdiagnostics.

“Predictive science and personalisedhealthcare are . . . an approach to thinking

about attrition,” said Mr Vose.There needs tobe greater disease understanding so thattreatments are interfering with diseasemechanisms in an effective way, he said.Predictive science will help ensure the safetyof medicines, and improve efficacy and success rate.

Biologics and genetics also offer an oppor-tunity to the industry, he added. There arefewer toxicology issues with biologics, hesaid.

The development of emerging markets isan opportunity for the industry and it leads tothe question “Should the industry pursue dif-ferent disease targets in different locations?”,said Mr Vose. Examination of cancer speci-mens in China has shown that diseases aredifferent in different locations, he said,adding: “It is fantastically important for us tostop this UK-centric, or Western-centric,view of the world and start to reach out andaddress these other problems.”

Design strategyWhen talking about how AstraZeneca aimsto improve its design strategy, Mr Vose toldparticipants: “The world of science is chang-ing and is changing faster and faster, and ifyou don’t stay with it, you will certainly beleft behind.”

A large part of the development of drugsis satisfying regulatory bodies, said Mr Vose.Patients, regulatory bodies and NICE mayhave different demands, and it is important toknow what those demands are and to satisfythem — “otherwise you will be in the 80 percent that don’t make a return on investment”,he said.

Brent Vose: try to move away fromsymptomatic treatment

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Methylene blue for Alzheimer’s diseaseThe serendipitous discovery that methylene blue may an effective treatment for Alzheimer’s disease was described by John Storey, senior lecturer,

University of Aberdeen, in a session on the search for novel drugs. Nicola Cree reports

Methylene blue may be the next treat-ment for Alzheimer’s disease, accordingto John Storey, senior lecturer,

University of Aberdeen.The serendipitous discovery by Dr Storey’s

team of methylene blue as a treatment for thecondition has led to phase II trials.

Dr Storey explained that it is now believedthat the effects of Alzheimer’s disease arecaused by neurofibrillary tangles caused bytau protein in the brains of those sufferingfrom the disease.There are two ways to dealwith the tangles — stop the formation, or de-vise a mechanism to break down the tangles,Dr Storey said.

When staining slide samples of the tangles,Dr Storey’s team discovered that methyleneblue degraded the tangle. His team has sinceworked to develop a pure formulation ofmethylene blue that can be taken orally, heexplained.

In the phase II trials, there was a slight im-provement in symptoms in the first 12 weeksof treatment, and in some patients there was adramatic improvement, said Dr Storey.Following treatment patients did not regressand progression of the disease was halted inover 80 per cent of the patients over 102

weeks, Dr Storey said.The 60mg dose ADAS-cog score (Alzheimer’s Disease AssessmentScale-cognitive subscale) at 84 weeks was notsignificantly different from baseline(P=0.216).A dose of 60mg three times a dayappears to be the minimum effective disease-modifying dose which also has an acceptablebenefit/risk profile, said Dr Storey. The effi-cacy is supported by molecular brain imag-ing, Dr Storey added.

Side effects of the drug include blue urine,which Dr Storey admits can be a problem tothose suffering incontinence, and bright bluediarrhoea, which occurs at 12 weeks.

Methylene blue treats Alzheimer’s progres-sion from an early stage, a stage that is diffi-cult to detect by psychologists,Dr Storey said.However, his team has developed a diagnosticligand, detected by a positron emission to-mography scan, designed to detectAlzheimer’s disease at the earlier stage, headded.

Combining therapies It is difficult to find new drug targets andtherefore thought should be given to com-bining therapies, said Gavin Whitlock, asso-ciate research fellow, Pfizer global research

and development. It is a challenge, however,to combine more than two pharmacologicalactivities in a human while maintaining asufficient safety window — it is critical tounderstand the in vitro and in vivo correla-tion and the potential for drug-drug interactions and pharmacokinetic, pharma-codynamic and formulation incompatibili-ties, he added.

There are three ways this can be done, DrWhitlock explained. Two active compoundscan be conjugated with a linker, where thereare structural similarities in the two types ofligands two pharmacophores can be inte-grated using a ligand overlap, and there is alsoa fused approach — optimising a structurethat already has both the activities that youare looking for.

The conjugated approach is successful fornon-oral molecules because the molecules arefairly large.The integrated approach is betterfor oral drugs, Dr Whitlock said.

Going forward, Dr Whitlock said, it is im-portant to understand what the key safetyrisks of pulling two or more pharmacologicalactivities together are.There is a long way togo with regards to methods of validating thebiological approaches, Dr Whitlock added.

BPC 2009


Sharon Hart (left), NHS Connecting for Health, in conversation with Heidi Wright, head of practice, Royal PharmaceuticalSociety, at the new professional body stand

New professional body: the future is orange!

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Science

Driving innovationSteve Wicks, vice-president of pharmaceuticalscience and technology at Pfizer, gave some insightsinto how biotechnology and pharmaceuticalcompanies are thinking differently in order to driveinnovation and maximise revenue.

Dr Wicks explained that companies try to stacktheir development programmes so that as genericcompetition emerges another new product comes tomarket, producing a sustainable business model. Insuch an environment, companies can afford toindulge in speculative development. At the moment,however, gaps are appearing in companies’development cycles so industry is becoming morerisk averse.

Companies are having to think about other waysto shift their product development cycles. They needto decrease research and development costs,reduce time lines and they need new businessmodels.

Dr Wicks argued that the move intounsustainable cycles is driving innovation —innovation is being seen in the way drug candidate screening is conducted, the types of assays used intesting and in the number of test points that can be completed every day. Automation is providing competitiveadvantage to maximise the speed of the development process, Dr Wicks explained.

Science is also being applied to maximise efficiency and companies are using more computationalmodels to give them intellectual control over drug candidates, he said.

“We are now in a highly unstable phase, and will be for the next five to 10 years. We have to assure returnon investment through exquisitely good pharmaceutical science, done very quickly,” Dr Wicks concluded.

Thinking differently to drive innovationTwo speakers described how pharmaceutical companies are protecting their revenues through innovation. Harriet Adcock reports

Enhanced product development was thetheme of a talk given by Andy Lewis, di-rector of operations for Critical

Pharmaceuticals.Dr Lewis pointed out that enhanced bio-

pharmaceutical products allow companies toprotect their revenues, given the limited lifeof patents and the costs of getting new prod-ucts to market.

He described some of the techniques thathave been used to try to deliver human growthhormone (hGH), a therapy traditionally ad-ministered via injection because of its propen-sity to aggregate. Techniques have includedsustained release formulations and pegylationin order to prolong the activity of the therapyand reduce the need for frequent injections.

One sustained release growth hormoneproduct that got to market was Nutropindepot, Dr Lewis said. However, it was with-drawn due to poor manufacturing efficiency.Hormone levels were also found to dropbelow therapeutic levels so children had to begiven multiple injections.

Most of the companies marketing hGHhave attempted to use molecule modification,such as pegylation, to enhance their formula-tions, said Dr Lewis. However, attempts havegenerally been abandoned due to problemswith increased toxicity and loss of activity.

The need for enhanced formulations re-mains, Dr Lewis suggested, pointing out thatin a recent survey, 70 per cent of children ortheir carers reported that they do not likehaving to inject hGH on a daily basis, with 30per cent considering halting treatment.“If wecan develop products that make it easier forchildren to take their growth hormone or atleast make it less unpleasant then there is thepotential to increase efficiency and reducehealthcare costs,” he said.

Dr Lewis went on to describe the devel-opment of two technologies that can be ap-plied to enhanced biopharmaceuticalproducts — CriticalMix and CriticalSorb.

CriticalMix uses supercritical CO2 to en-capsulate drugs into polymers. Drug andpolymer are added to the manufacturingchamber as solids, with CO2 pumped in andthe temperature increased to 32C until theCO2 becomes supercritical.At this point, ex-plained Dr Lewis, the polymer liquefies andthe drug remains solid. The components aremixed then expelled from the chamber viaatomisation producing microparticles.

The advantages of the CriticalMix processis that it avoids some of the issues that hinderother encapsulation technologies, said DrLewis — it is a dry process with no shearstresses and no organic solvents, and theprocess works at an ambient temperature sothere are no concerns about the protein de-naturing.

The process has successfully been usedwith hGH and 20 to 30 other proteins andpeptides, said Dr Lewis. The proteins retaintheir activity and structure and the micropar-ticles produced are injectable through fairlysmall needles (for example, 25 gauge needles).There is a high encapsulation efficiency and,

since it is a single step process, drug is not lostthrough extraction procedures.

The hGH formulation has been tested innon-human primates and plasma levels aresustained for at least seven days, reported DrLewis. “We think that such formulations willbe injected every two weeks.”

Turning to CriticalSorb, Dr Lewis ex-plained that, although he could not reveal ex-actly what the technology involves, it is amarketed pharmaceutical excipient used as asolubility enhancer with small molecules andis regarded as safe and non-irritant.

It has been shown with simple formula-tions to promote nasal absorption of proteinsand peptides.And when used to deliver hGH,it results in the highest bioavailability of theprotein ever reported for nasal delivery, DrLewis claimed.

CriticalSorb is unlike other absorptionpromoters, said Dr Lewis, which have re-ceived a bad press because of their tendencyto strip epithelial cells from mucosal mem-branes. In tests, CriticalSorb was well toler-ated after repeated dosing over five days, withno signs of damage to nasal mucosa, he reported.

Dr Lewis’s company is currently arrangingfunding for phase I clinical trials for itsgrowth hormone nasal spray, which will takeplace in 2010.

Steve Wicks: industry is becomingmore risk averse

Andy Lewis described new technologiesfor delivering growth hormone

PJ, Oct p31 BPC 1/10/09 10:34 Page B31

Vaccine against HIV moves a stepcloser, according to US researchersCarl Alving, of the US Walter Reed Army Institute of Research, described recent progress in the development of a prophylactic vaccine against HIV and

Nicol Keith, of the University of Glasgow, discussed new targets for cancer treatment. Francesca Rivers and Gareth Malson report

Until recently the HIV research field hasbeen unable to induce broadly neutralis-ing antibodies by immunisation. Now a

research team in the US has accomplishedthis feat, said Carl Alving, of the Division ofRetrovirology at the Walter Reed ArmyInstitute of Research, Maryland, representinga step towards the development of a prophy-lactic vaccine against HIV.

The challenge is to develop a vaccine thatrecognises both the 160kD glycoprotein(gp160) that is found on the surface of theHIV cell and the phospholipid bilayer of thecell envelope, explained Dr Alving.

A better understanding of cellular senescencecould yield new targets for cancer treatments,said Nicol Keith, professor of molecular on-cology at the University of Glasgow.

Senescence, he explained, refers to the fi-nite number of growth cycles that a normalcell is capable of undergoing. “Cancer cellskeep on growing,” he said. “They seem toovercome this natural barrier.”

“Triggering senescence in cancer cellsmay be a useful strategy for anticancer drugs,”he went on to suggest. Furthermore, he be-lieves such research is warranted and timely,even though the process of cellular senes-cence is not fully understood. Nonetheless, heconfirmed, it is known that cellular senes-cence can be induced by:

■ Oncogenes■ Cellular stress■ Erosion of telomeres (DNA sequences at

the end of chromosomes)■ Drugs

Of these four, the process that is best un-derstood is telomere-induced senescence, saidProfessor Keith. It is believed that telomeresshorten over time and that senescence occurs

Cell senescence may be useful cancer drug targetwhen they become tooshort. Professor Keith de-scribed research that hasbeen conducted at theUniversity of Glasgow toidentify compounds thatcould inhibit the produc-tion of telomerase — anenzyme capable of slow-ing telomere erosion or,in certain circumstances,lengthening telomeres.“Inhibiting the expres-sion of this gene willcause cell senescence,” heexplained.

Scientists at the uni-versity assessed “libraries”of compounds and identi-fied several that repressedthe gene that encodestelomerase. “Three of these were glycogensynthase kinase [GSK] inhibitors,” he said.Further research went on to show that GSKinhibitors reduce cell growth and studiesconducted on mice have shown that GSK in-hibitors can delay tumour growth.“This givesus an animal model which we can use to

build up pharmacody-namic endpoints,” hesaid.

The experiments didnot induce full senes-cence, said ProfessorKeith, and this might be because most cellularprocesses can be per-formed using several dif-ferent genetic pathways.

To circumvent thisproblem, research needsto identify which tran-scription factors act onthe genetic pathways thatare involved with cellularsenescence. It might thenbe necessary to targetmore than one of thesefactors at the same time.

Translating this to the clinical situation willtake many years, said Professor Keith.However, he noted that his team had not iden-tified any toxicity issues so far with GSK in-hibitors and he believes targeting cellularsenescence, in general, is a promising approachfor future anticancer treatment.

With this objective, his research group cre-ated a potential HIV-1 vaccine formulationthat included lipid A — a potent adjuvantthat can be embedded into liposomes and isalready used in the production of a number ofvaccines, including the hepatitis B vaccine. Asynthetic peptide containing the HIV-binding amino acid sequences of 2F5 and4E10 (see Panel), which confer gp41-bindingspecificity, was added to the lipid A liposomeformulation. In immunisation trials in mice,the formulation induced production of twomouse monoclonal antibodies, which neu-tralised HIV-1 and bound both phospholipids

and gp41 (at both the 2F5 and 4E10 bindingsites), said Dr Alving.

The use of a vaccine that induces antibod-ies with phospholipid-binding specificity hasraised concerns among the scientific commu-nity, noted Dr Alving, because phospholipidsare abundant in host cells. “People are wor-ried that if you are to produce antibodies likethis it will produce an autoimmune disease,which is quite incorrect,” he said. He ex-plained that, although the antibodies pro-duced in this case are autoantibodies, theypose no danger because the lipids of normalhuman cells are concealed by a layer of pro-tein that the antibody cannot penetrate.

Dr Alving concluded: “We have createdhighly specific monoclonal antibodies thatapparently reproduce the binding sites of 2F5and 4E10, using an adjuvant liposome formu-lation that would be suitable for human use.”He emphasised that the constituents of theformulation are all well tolerated and relatively inexpensive generic compoundswith potential for use as part of a human formulation.

HIV antibodies for vaccine designA number of broadly neutralising monoclonal antibodies against HIV have been obtained in the past fromblood samples taken from infected individuals, explained Dr Alving. Each is active against a number of thedifferent HIV clades, and works by binding to either the gp41 or gp120 subunits formed from the gp160polypeptide on the surface of HIV, thus preventing the virus from binding and entering host cells.

The most broadly neutralising of the antibodies identified are 2F5 and 4E10. These antibodies recognisepractically all HIV clades and bind to both gp41 and phospholipids on the surface of HIV cells, and havebecome models for vaccine design, explained Dr Alving.

Nicol Keith: need to betterunderstand cellular senescence

BPC 2009


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Science

NICE has approved 28pc of treatmentsNicola Cree reports on the aims and achievements of NICE and the development of companion diagnostic testing

The National Institute for Health andClinical Excellence’s budget has increasedseven-fold in the past 10 years to £60m

per year, chairman Sir Michael Rawlins toldthe conference.

This budget is expected to increase by£20–30m over the next three years, subjectto what happens to public expenditure, headded.

The purpose of NICE is to supply healthprofessionals with advice on attaining thehighest standards of clinical care for NHS pa-tients and to promote and sustain publichealth not only through the NHS but also tothe wider public, said Sir Michael.To do this,two factors need to be taken into considera-tion — clinical and public health effective-ness and cost-effectiveness. NICE is requiredby law to take cost-effectiveness into account,he added. The cost of healthcare is gettingmore difficult, he said — monthly costs ofcancer drugs have risen since 2007.

NICE guidelines have different statuses indifferent areas of the UK, Sir Michael ex-plained. Technology appraisals are valid inEngland and Wales.They are mainly valid inNorthern Ireland — where different legali-ties, such as abortion being illegal, have to beconsidered — and only partly cover Scotland.

Clinical guidelines cover England, Walesand Northern Ireland, interventional proce-dures cover all nations and public healthguidance is confined to England. In Englandtechnology appraisals carry with them a“funding direction” — a legal requirementwhereby NHS trusts are obliged to provideany NICE-approved treatment providing aclinician wishes to use it and a patient wishesto receive it, he explained.

NICE bases its guidance on five principles:

■ Guidance is technically, clinically and sci-entifically robust

■ Guidance is inclusive — so that everyonewith an interest has chance to have a say

■ The processes used and decisions made aretransparent

■ Advice is timely ■ Guidance is independent — decisions are

made by independent advisory bodies

Time-dependent advice is the one areawhere NICE has fallen down, Sir Michael ad-mitted, mainly because ministers have to refertopics to NICE — this has, hopefully, beenovercome, he added.

So far NICE has undertaken 180 appraisals— which may have included more than onedecision — looking at 360 condition treat-ment plans. In about 28 per cent of cases,NICE has agreed to the use of treatmentswithin the licensed indications, in over half ofcases NICE has recommended restricted useand on a few occasions NICE has recom-mended treatments only for research —mainly for devices and procedures, not phar-maceuticals, Sir Michael said.

In about 10 per cent of cases, NICE hasnot recommended treatments and in fivecases, manufacturers have declined to make asubmission. This has mainly occurred re-cently, Sir Michael added, stating that it wasprobably because the company knew thetreatment would not be affordable to theNHS — all of the drugs affected were anti-cancer treatments, he said.

There are always gaps in data on clinicaland cost-effectiveness and members of advi-sory committees have to exercise judgement,he added.

As well as taking into account clinical ef-fectiveness and cost-effectiveness, NICE hasto balance efficiency and fairness, Sir Michaelsaid. “We cannot spend £10m on one per-son’s life.To do so would deprive many otherpeople of life-saving forms of treatment,” hedeclared.

Treatments costing below £20,000 perquality-adjusted life year (QALY) will beconsidered cost-effective; treatment costingabove £30,000 per QALY will be consideredcost-ineffective. However, there are some in-cidences when the appraisal committee willgo higher.

Referring to the newly launched NHSEvidence, Sir Michael explained that it wasdesigned to give healthcare professionals reli-able information online. It is not currentlyperfect, he added but said that release 2 willbe launched in October. “It will get better,”he told participants, and he asked health pro-fessionals to continue using it.

Diagnostic testing should go hand-in-hand with drug developmentDiagnostic testing should be combined withthe development of pharmaceuticals, saidEddie Blair, managing director, IntegratedMedicines.

Companion diagnostic testing can increasethe return from a drug and can prevent thedrop-off of profit after so many years — thepattern that usually occurs with pharmaceuti-cals, he said. Although there are some earlycosts with the development of diagnostics, itcan give about a 10 per cent uplift in profit, headded. It is important to start the developmentof diagnostics at the end of phase I trials of thedrug at the latest, Dr Blair added, since diag-nostics can take up to 10 years to develop.

There are a number of key requirements ofpoint-of-care diagnostics, said Ben Arlett,product development director, Atlas Genetics.It is essential that devices offer laboratory qual-ity results in around 20 minutes — since it isbelieved that 20 minutes is the length of timea patient is willing to wait for a result.The sys-tem must be simple to use, he added, and ca-pable of carrying out multiple tests on a singlesample.The system must also have the abilityto perform nucleic acid amplification tests andimmunoassay, he said. In addition, it should below cost and portable, he said. Point-of-caretests, other then pregnancy testing and glucosetesting, have been slow to emerge because cur-

rent technology cannot deliver tests at an ac-ceptable speed, cost and sensitivity, he said.Point-of-care diagnostic testing offers reducedcosts while improving patient care, he added.However, benefits are generally only realised ifaction can be taken immediately (for example,quarantine or treatment). Point-of-care diag-nostics can be used to test for sexually trans-mitted infections, screen for meticillin-resistantStaphylococcus aureus/Clostridium difficile/novovirus and to screen livestock at shows,races and auctions, he said.

Companion diagnostics are a stepping-stone towards personalised medicines, DrBlair concluded.

Sir Michael Rawlins: release 2 of NHSEvidence to be launched in October

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Developments in diabetes managementDiabetes is fast becoming a global epidemic — and the therapeutic options available are developing almost as rapidly. With diabetic patients often

taking several drugs, medicines management is key to tackling the disease. Francesca Rivers and Nicola Cree report

A lthough early glycaemic control is im-portant to reduce the risk of diabetes-associated complications, data suggest it

is not achieved by most diabetic patients inthe UK, said Michael Feher, consultant in di-abetes and endocrinology at the Chelsea andWestminster Hospitals NHS Trust.

Most oral therapies for type II diabetesonly address one aspect of beta-cell dysfunc-tion with few focusing on islet dysfunction asa whole, observed Professor Feher. In addi-tion to this, many of the existing treatmentscause weight gain, hypoglycaemia and gas-trointestinal side effects, and the durability ofthe glycaemic control achieved with any ofthe antidiabetes medicines declines overtime.

Dr Feher also argued that the overall ap-proach to treating diabetes represents poorpractice. Using rising HbA1c levels as amarker for progressing a patient on fromlifestyle advice to monotherapy and dualtherapy, and finally to insulin and oral combi-nation therapy, amounts to a “waiting for fail-ure” approach, he said.

Anthony Barnett, professor of medicine atthe University of Birmingham, agreed thatcurrent diabetes therapies have shortcomings,but highlighted incretin-based therapies as anexciting therapeutic development offeringdecided advantages over other drug classes interms of their tolerability, weight neutralityand low hypoglycaemia risk.

“I believe there is a very significant placefor these agents in diabetes management,which will get greater as time goes on,” hesaid, adding that a once weekly injection ofliraglutide may appear on the market in the

next month. Bariatric surgery, such as gastricbypass surgery and gastric banding, is alsogaining pace, and is a significant option forsome types of patient, he added.

Dr Feher told the conference there is astrong pipeline for new diabetes medicines,with an explosion of novel drugs and targets,as well as new formulations of existing agents,seen over the past 20 years. But there remainsa definite need to look for new treatments totackle the global epidemic of the disease.

There are a number of physiologicalprocesses that new drugs could target, he ar-gued, such as the glucose-fatty acid cycle, orthe rate of gastric emptying or carbohydratedigestion and absorption.

Miriam Kidron, of Oramed Pharma-ceuticals, told conference participants aboutwork currently under way to develop a softgel capsule for the oral administration of in-sulin. Clinical trials of the drug have shownpromising results, with a reduction in thelevels of glucose and C-peptide achieved, andan increase in plasma levels of insulin, shesaid.

“We submitted a package to the [USFood and Drug Administration] in July 2009,and we hope to get a response in October,”said Dr Kidron. She added that the technol-ogy is not particular to insulin, and could beapplied to the oral administration of otherpeptides.

BPC 2009


Islet cell transplantationIslet cell transplantation is being developed by Stephanie Amiel and a research group at King’s CollegeLondon as an option for the treatment of a subset of patients with type I diabetes.

Professor Amiel explained that few patients will be suitable for the procedure. It is not possible tointroduce enough islets to overcome insulin resistance, so the treatment is not effective for the treatment of type II diabetes. For patients with type I diabetes, the period of immunosuppression requiredafter transplantation makes it a high-risk treatment, and the procedure does not eliminate the need forinsulin.

However, the transplantation — which involves administration of purified and concentrated islet cellsdirectly into the portal vein via a drip, and brings about an improvement in glucose control — has proved awelcome new option for type I diabetic patients with severe hypoglycaemia that seriously affects their qualityof life.

There are currently three islet cell isolation centres and six transplantation centres in the UK, and lastyear the programme was awarded NHS funding. Professor Amiel said the programme’s current areas offocus includes improving immunosuppression and islet cell survival, and gaining better and moreestablished sources of islets. At present, a single transplantation of islet cells requires the cells from twopancreases and ideally this would become a one-to-one donation. However, Professor Amiel is reluctant toabandon the multiple donor approach at this stage because of the high islet load required for successfultransplantation.

Glucose-sensitive hologram technology could remove need for finger prick blood glucose test Patients could soon find themselves monitor-ing their blood glucose levels via a hologramplaced in a contact lens, Chris Lowe, directorof the institute of biotechnology, Universityof Cambridge, told participants at the confer-ence.

Professor Lowe explained how his teamis working on hologram research that wouldremove the need for patients to undertake afinger prick blood glucose test and allowthem to measure their glucose levels in realtime via a hologram placed in a contactlens.

The holograms, which are cheap, ProfessorLowe said, will change colour based on a

chemical or biological signal, which changesthe wavelength of visible light.

The glucose-sensitive hologram is basedon a boronate system because boronate is oneof the only substances that binds to glucose inan aqueous solution, said Professor Lowe.Before the contact lens technology becomesa reality, Professor Lowe’s team has a few chal-lenges to tackle, including the pH of tearfluid, which varies when eyes are closed, andsensitivity issues — because the tear level ofglucose is about 0.3mM, whereas it is about5mM in the blood.

There have also been issues with thephysics of detection, Professor Lowe ex-

plained, because most holograms only readover about five degrees before their wave-length changes. However, the team now has ahologram that will read over 120 degreeswith no changes.The envisaged contact lenswould be changed daily by users, he said.

Currently, a glucose-sensitive hologram isundergoing in-dwelling catheter testing inhumans.

Professor Lowe’s team has created holo-grams as small as 10µg2 and expect to be ableto create them as small as 2µg2 , he said.Therewill be an electronic output from the holo-gram system to send the results to GPs orhospital recording systems, he added.

PJ, Oct, p34–35 BPC 1/10/09 10:40 Page B34


Science

Cultural aspects affect the treatment of dia-betes,Alia Gilani, health inequalities pharma-cist, NHS Greater Glasgow and Clyde, toldthe conference.

The occurrence of diabetes is six timeshigher in those of South Asian origin than inwhite Europeans. In the area Miss Gilaniworks in Glasgow, there is a high number ofsuch patients.

Within their culture many have a fatalisticattitude to the disease with a belief that theirfate is in the hand of god, Miss Gilani ex-plained. A lot of family life revolves aroundfood and exercise is not common — withsome believing prayer is a form of exercise,she added.There are concerns about the sideeffects of treatment and there is frequently asocial stigma attached to the disease. It is alsoimportant to consider that patients may wantto fast or take part in the haj, she said.

In addition to all the cultural considera-tions she has to consider when treating dia-betes in patients of South Asian origin, MissGilani also explained how genetics can leadto a higher risk of long-term conditions.Although their body mass index is the sameas that of patients of other origins, patients ofSouth Asian origin have more centrally ori-ented fat distribution, which is a risk factorfor cardiovascular disease. And although theirtotal cholesterol measures are similar to thoseof indigenous populations, patients of SouthAsian origin have a lower high-density

lipoprotein and a higher triglyceride level, sheexplained.

Many patients of South Asian origin alsohave problems accessing healthcare. To com-bat this problem Miss Gilani told participantshow she works in the minority ethnic long-term medicines service (MELTS) — a servicethat invites patients to attend healthcare serv-ices conducted in their native language andoperates outreach clinics in places such as

mosques, Sikh and Hindu elderly centres, vol-unteer groups and community pharmacies.Miss Gilani also works with other ethnic mi-norities as well as those of South Asian origin.

Patients can be referred into the service byothers and she currently has 80 patients.Withan average of two appointments per patient,Miss Gilani explained that her job entails un-dertaking a medication review and referringpatients on to other services they may re-quire, such as podiatry, exercise or socialwork. Miss Gilani said that she frequentlytexts patients to remind them to go to theseappointments. In her clinic she is able to pre-scribe or change oral antiglycaemic agents,statins, antiplatelets and antihypertensives.Theconsultations have also led to the diagnosis ofother conditions, such as cancer and thyroiddisease, she added. She works closely withdoctors, social workers and diabetes specialistnurses.The service also gets patients’ familiesinvolved, since the culture is often familybased, she said.

Citing an example of a 36-year-oldAfrican-Caribbean male, Miss Gilani told theconference how it took her 18 months — in-cluding three letters and six telephone calls —to get him into the service. The patient be-lieved he was not diabetic because this is whathe had been told by a doctor in Africa, shesaid. Miss Gilani explained that she managedto get him to have blood tests and start takingan oral antidiabetic drug to treat the disease.

Dismissing health inequalities in diabetes care

Tackling hypertension in patients with diabetesEighty per cent of diabetic patients die fromcardiovascular problems, so it is important toremember that diabetes is a cardiovasculardisease, said Candy Norris, consultant phar-macist — cardiovascular, Harrogate andDistrict NHS Foundation Trust.

Blood pressure targets are the key, MissNorris said, adding that in the past 10 yearsthere has been a big change in blood pressuretargets, which has given pharmacists the op-portunity to participate in helping patients tomeet these targets.

Many clinical trials have failed to meetblood pressure targets, with systolic bloodpressure being the most difficult to control,she said. Diabetic hypertension is the mostcomplex part of diabetes management, sheadded.

The key thing in treating hypertension isto get the blood pressure down and not toworry about which drug is used, she added.On average, in Miss Norris’s Harrogate clinic,patients need three antihypertensive drugs —similar to results found in trials.

Pharmacists need to be directly manag-ing the patients and helping with medicinesmanagement since these patients often takea large number of medicines, she said.Patients with diabetes also appear to have

more of a problem with drug intolerances,she added.

Miss Norris told participants about thesecondary care clinic she runs, which focuseson cardiovascular risk and medicines manage-ment. Patients are seen for 20 minutes everyfour weeks and drug changes are initiated sothat the patients can be discharged to theirGP. A lot of these patients have medicinesmanagement problems that are discussed in amultidisciplinary team, Miss Norris said.

When dealing with patients on multipledrug treatments, it is important for pharma-cists to build a relationship with each patientto help improve his or her confidence, shesaid. Miss Norris’s clinic helps to enable pa-tient to self-manage through hand-heldrecords and a telephone helpline.

It is important that therapies are reinforcedlong term because there is evidence thatblood pressure control starts to disappear intime, she added.

In the clinic, 68.3 per cent of patients re-ferred achieved their blood pressure target ondischarge. Feedback from GPs has also shownthat they support the service and believe it iseffective.

Eighty-eight per cent of patients felt veryconfident about a pharmacist looking after

their blood pressure tablets — the remaining12 per cent were fairly confident.

In addition, 100 per cent of patients be-lieved pharmacists listened to their concernsand provided reassurance.

Alia Gilani: social stigma attached todiabetes in South Asian culture

Candy Norris: building relationships isimportant

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BPC 2009

Clockwise from top left: Fred Ayling, Pharmacists’ Defence Association, demonstrates online services to Christine Lorenz,locum pharmacist, and Kay Seden, research and clinical trials pharmacist; Gul Root, principal pharmaceutical officer,Department of Health (left); Brian Curwain, chairman of the English Pharmacy Board, Royal Pharmaceutical Society; GillianHawksworth, former Society President, talks to conference participants; and Lesley Morgan, member of the shadow GeneralPharmaceutical Council with Steve Acres, technician member of the Society’s Council

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Conference on camera

Clockwise from top left: Victoria Buyer, Protomed, and Elsabe Jones, pharmacist intern, Department of Health; Karen Hassell,professor of social pharmacy and school research director at the School of Pharmacy and Pharmaceutical Sciences,University of Manchester; Christine Gray, shadow General Pharmaceutical Council staff, with Surider Kumar, prescribingsupport pharmacist; Sandra Melville, chairman of the Scottish Pharmacy Board, Royal Pharmaceutical Society; and WendyHarris, the Society’s deputy registrar and director of regulation

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BPC 2009

Science abstracts — review 2009A sample of the work reported in the science sessions at the British Pharmaceutical Conference is reviewed here by Joseph Chamberlain

Over 180 submitted science abstracts werepresented at the British PharmaceuticalConference. The highlights reported

here were selected from the specialist podiumsessions, with a short section on a personalchoice from work presented as posters only.

Pharmaceutical technology Grant et al (University of Liverpool) de-scribed how they overcame the problems as-sociated with water-insoluble drugs. Organicnanoparticles were prepared in situ in aporous polymer by the technique of freeze-drying emulsions. The nanoparticles wereslowly released from the polymer scaffold toform stable aqueous nanoparticle dispersionsat neutral and basic pHs at room temperature.When the pH of the aqueous phase was re-duced to 2, there was a much faster release oforganic nanoparticles.

Williams et al (University of Notting-ham) investigated some aspects of the effectsof high-fat meals on the bioavailability of ex-tended release formulations. Hydroxypropylmethylcellulose (HPMC) matrices rapidlyformed gel-layer barriers and improved theirextended release in milk and other emulsionscontaining up to 30 per cent fat. Drug releasewas progressively reduced with increasingmedia fat content.This work suggests that anenvironment containing emulsified fats is un-likely to promote accelerated drug releasefrom HPMC matrices.A slowing of drug re-lease is more likely, through an enhanced bar-rier at the gel-layer surface following fatdeposition.

Rauf et al (Jamia Hamdard University,New Delhi) described a comparative evalua-tion of different techniques of taste-masking,including microencapsulation, ionic cross-linking, and drug-resin or ion-pair complex-ation. The products obtained for a water-soluble bitter drug, dicyclomine hydrochlo-ride, were evaluated for taste masking anddrug release.All the optimised products weretasteless and showed no drug release in bufferpH 6.8, the pH of saliva. For a sustained re-lease of drug at physiological pH values, themicrosphere-based formulations were thebest.

New scientists session Baclofen is absorbed in the stomach or prox-imal part of the intestine and often shows lowbioavailability. The development and evalua-tion of a novel floating in situ gelling systemfor stomach-specific drug delivery of bal-cofen was described by Jivani et al (Smt.R.B. Patel Mahila Pharmacy College, Atkot,India). Gelling systems were prepared by dis-solving various concentrations of sodium al-ginate in deionised water, to which varyingconcentrations of drug and calcium bicar-bonate were added. Gel was evaluated for in

vitro buoyancy and in vitro drug release. Theprepared gel remained buoyant for 12 hoursand released balcofen over the same period.

Mercuri et al (University of East Anglia)described the assessment of drug release anddissolution in the stomach by means of a dy-namic gastric model (DGM), said to be amore bio-relevant approach than that usingstandard dissolution procedures. Duringfasted digestion, the release of nifedipine fromtwo commercial formulations was differentand consistent with in vivo data, supportingthe claim that the DGM may provide a real-istic temporal and dynamic model for thestomach environment.

Medicinal chemistry Metal ions, especially iron, mediate neurotox-icity in Alzheimer’s disease, either by favour-ing beta-amyloid plaque formation or byredox cycling. Roy et al (King’s CollegeLondon) aimed to identify iron chelators ableto cross the blood-brain barrier (BBB) andexhibit neuroprotective efficacy against ox-idative stress in the brain. Several bidentateiron chelators (3-hydroxypyridin-4-ones)were synthesised based on the structure ofdeferiprone, a chelator used in the treatmentof iron-overloaded thalassemia major. In situbrain perfusion was carried out on guinea-pigs using these chelators and deferiprone.

Chelators with a higher BBB influx effi-ciency than that of deferiprone were selectedfor neuronal cell culture studies to evaluatetheir neuroprotective efficacy against variousoxidative insults. Four out of the 10 3-hy-droxypyridin-4-ones fared better than de-feriprone on the BBB influx index. Somechelators failed to cross the BBB.The molec-ular weight, lipophilicity, molecular volumeand total polar surface area did not correlatewith their BBB influx efficiency. Four 3-hy-droxypyridin-4-ones with superior BBB in-flux efficiency to deferiprone were identified.

Siddiqui et al (Jamia Hamdard University,New Delhi) synthesised a series of newpiperidyl indanone thioamides and assessedtheir anticonvulsant activity and neurotoxic-ity. All the compounds showed encouraginganticonvulsant activity and most were foundto be less neurotoxic than the standard drugphenytoin. The most highly active com-pounds were subjected to further investiga-tion by estimating the gamma-amino butyricacid (GABA) levels in the different regions ofrat brain. It was suggested that the concentra-tion of GABA increased significantly in theolfactory lobe and the mid-brain region of ratbrain after administering some compounds.The thioamide derivatives of piperidyl in-danone can be regarded as a newer class ofanticonvulsant agents with potentially lessneurotoxicity.

The ethanobotanical drug cryptolepine,used in malaria treatment and glycaemic con-trol of diabetes mellitus, is usually obtained bytime-consuming Soxhlet extraction of thedried roots of Cryptolepis sanguinolenta. Ismailet al (Liverpool John Moores University)sought procedures that diminished the risk ofsolvent ignition and toxicity by the use of microwave-induced extraction. A variety ofpolar solvents, especially ethanol in the pres-ence of ammonia, proved highly efficient atextracting the crude alkaloidal material.Using microwaves ensured increased alkaloidextraction depending on the irradiation time.Trifluoroacetic acid proved superior to aceticacid as an extraction solvent. This methodproduced cryptolepine with less impuritiesassociated with oxidation and dimerisationcompared with conventional aerobic Soxhletextraction.

Materials scienceDuring the process of micronisation to re-duce the particle size of active pharmaceuti-cal ingredients, a large amount of energy isapplied to a material that can lead to changesin surface properties in an uncontrolled man-ner. Parker et al (Molecular Profiles,Nottingham) investigated the link betweenthe mechanical properties, micronisation be-haviour and surface energy of carbamazepinepolymorphs using atomic force microscopy.

BPC science abstracts 2009The BPC science proceedings abstracts have beenpublished as a supplement to The Journal ofPharmacy and Pharmacology. The abstracts canalso be downloaded from www.pharmpress/jpp.

Extract of the antimalarial drugcryptolepine: Ismail et al usedmicrowave extraction methods toenhance yield and reduce impurities

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Science

Carbamazepine polymorphs could be rankedby Young’s modulus and indentation hardness.Surface energy measurements showed an in-crease in surface energy after micronisation inall forms, which underwent a relaxation insurface energy following storage for fourweeks.

Meng et al (University of East Anglia) ex-plored the relationship between the composi-tion and the associated thermal events ofethylcellulose films loaded with fractionatedcoconut oil, using modulated temperaturedifferential scanning calorimetry and dy-namic mechanical analysis to measure theglass transition temperature (Tg) and detectpotential phase separation processes. An en-dothermic event was observed around 180C,which was ascribed to melting of microcrys-tallites in the film.The Tg decreased when thecoconut oil was added. However, on addingcoconut oil beyond 20 per cent, the Tg re-mained constant at approximately 97C, whilea lower temperature peak was observed at ap-proximately 53C. Such phenomena havebeen associated with phase separation, so thepresence of multiple mixed phases was indi-cated. The authors suggest the formation of binary mixed systems rather than purecomponent separation and proposed a novel method for estimating the associatedcomposition.

Garland et al (Queen’s University Belfast)described studies to aid in the optimisation ofa formulation for use in controlled transder-mal iontophoretic drug delivery by showingthat the dielectric properties of poly(ethyleneglycol) (PEG) crosslinked poly(methyl vinylether-co-maleic acid) hydrogels were de-pendent on polymer concentration, PEGmolecular weight and swelling.The study wasseen as evidence that these systems can bemodified to serve as an electrically conduct-ing matrix, which may suggest a method ofaltering the drug release profile of these filmsfollowing the application of an electric field.

Pharmaceutical science Cronin et al (Liverpool John MooresUniversity) assessed the potential of an in sil-ico method to identify the skin sensitisationpotential of active pharmaceutical ingredi-ents. Such information was retrieved frompublicly available safety datasheets supplied bypharmaceutical companies on their corporateinternet sites. The analysis indicated that thecoding of mechanistic chemistry is signifi-cantly associated with identifying the skinsensitisation potential of active pharmaceuti-cal ingredients. Any misclassified compoundsprovided useful information to develop theserules further to handle issues such as metabo-lism and to extend the domain of the models.This provides a basis to extend the coverageof the rules for protein reactivity associatedwith skin sensitisation. Further, analysis of thestructure of compounds that are identified insilico as having the potential for skin sensiti-sation, but for which there is no evidence,will provide information on structural miti-gating factors such as deactivating groups.The

results showed that useful toxicological infor-mation may be extracted from safetydatasheets, which will assist in the develop-ment of in silico toxicological approaches.

Cyclodextrins can form inclusion com-plexes with terpenoids and, therefore, reducetoxicity, volatility and hydrolysis of precur-sors. They can also increase product yieldthrough protection of formed products.Abdelkader and Lockwood (ManchesterUniversity) used beta-cyclodextrin to en-hance biotransformation of terpenoids usingplant cell cultures. Beta-cyclodextrin greatlyextended concentrations of both substrateand product over extended periods at some-what constant levels. Beta-cyclodextrin alsoenhanced biotransformation of terpenoids bydecreasing availability of substrate in the sus-pensions, through inclusion complex forma-tion, thus reducing its toxicity to plant cellsand allowing for increased amounts of sub-strate to be fed without any harmful effect tothe cells.

Drug deliveryDisulphide-crosslinked polymers are redox-sensitive vectors that are stable in the extra-cellular medium but undergo dissociation inthe reductive environment of the cell to facil-itate plasmid release. Since crosslinking is be-lieved to increase the molecular weight andsize of the polymer, it has not been applied tohigh molecular weight polymers and thereare always residual thiol groups on the poly-mer since not all thiols are crosslinked.

Aravindan et al (Reading School ofPharmacy) set out to investigate the nature ofdisulphide crosslinks, the role of thiols and thedegree of crosslinking on transfection effi-ciency by comparing thiolated andcrosslinked derivatives of polyethylenimine.Disulphide-crosslinking in crosslinked poly-mers is intramolecular and hence does not in-crease the molecular weight of the polymer.Therefore, disulphide crosslinking can be ap-plied to relatively high molecular weightpolymers without detrimental effects on cy-totoxicity. Optimising the degree of cross-linking, and hence the concentration of residual thiol groups, can provide optimal polyplex stabilisation and increasecellular uptake, thereby increasing transfec-tion efficiency.

Rahmou and Elkordy (University ofSunderland), noting that the formulation ofstable and biologically active proteins is com-promised by their chemical and physical in-stabilities, evaluated the crystallisation andspray-drying of lysozyme, a model protein, inthe presence of different concentrations oftwo different surfactants (Caprol PGE860 andCremophorRH40) not previously used tostabilise proteins. Preparations were charac-terised using a bioassay and standard physico-chemical methods. Storage stability studieswere conducted for protein solutions foreight weeks at room temperature and above.The stability and biological activity of spray-dried lysozyme were found to be improvedby the addition of surfactants. The best bio-

Presentation of JPAG’s Conference Analytical Science award

Isobel Cook (BioPharma Technology Ltd, Winchester, Hampshire) became the fourth recipient of the JointPharmaceutical Analysis Group's (JPAG) Conference Analytical Science Award at the British PharmaceuticalConference this year.

The award is a certificate and a bursary of up to £2,000 for the recipient to attend a scientific meeting ofhis or her choice. It was awarded on the basis of the scientific quality, originality and potential impact of thework presented at the “Short papers in pharmaceutical analysis” session at BPC, in a paper entitled “A studyof vial headspace moisture in an entire freeze-dried batch and the factors affecting moisture contentvariability”.

The picture shows Ms Cook receiving her award from JPAG chairman Ray Munden.

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logical activity of lysozyme was observedwith CaprolPGE860 in crystalised and spray-dried forms. The results show promise forpreparation and delivery of stable and effec-tive protein pharmaceuticals.

Vaginal rings are currently being devel-oped by McBride et al (Queen’s University,Belfast) for sustained delivery of single HIVmicrobicide compounds. The feasibility ofproviding simultaneous sustained release ofmaraviroc (an entry inhibitor) and dapivirine(a non-nucleoside reverse transcriptase in-hibitor) from matrix-type vaginal rings wasevaluated. The study demonstrated for thefirst time that microbicide combinations maybe effectively incorporated within a singlematrix-type vaginal ring device to providesustained release of HIV microbicides at ratesindependently determined by their initialloading. Such combination vaginal rings mayultimately be useful in providing broad pro-tection against sexually transmitted HIV infection.

Pharmaceutical analysisFreeze drying (lyophilisation) is used for pro-duction of pharmaceuticals, vaccines, diag-nostics and other materials to prevent loss ofactivity and increase product shelf life. Todemonstrate uniformity of the process Cooket al (Biopharma Technology,Winchester) de-veloped a method of determining residualwater content throughout a batch.Vial head-space moisture was mapped using frequencymodulated spectroscopy (FMS) after differentlyophilisation cycles in a laboratory freezedryer. FMS is a high-sensitivity laser absorp-tion technique and can be used to measurepartial pressure of water within the headspaceof each vial. For sucrose and mannitol excip-ients, the effect of varying product andprocess parameters on headspace moisturecould be assessed and these values correlatedwith total residual moisture as measured bythe conventional Karl Fischer method.Thus,FMS may enable complete batch inspectiondue to the speed of the analysis and its non-destructive nature and has the potential to befitted into a quality-assurance framework. Forthis presentation Isobel Cook was awardedthe Conference Analytical Science Award,sponsored by the Joint PharmaceuticalAnalysis Group (see Panel, p28).

The chemical shifts of different non-exchangeable aromatic protons of mebever-ine hydrochloride migrate to different extentsas the concentration of the analyte is varied inaqueous solution. This concentration-dependent chemical-shift variation is linearacross a useful range, and it has, therefore,been applied by Elmasrya et al (Universityof Bath) to the quantitative analysis ofmebeverine HCl in its pure form and inpharmaceutical tablets. Comparison of thenuclear magnetic resonance (NMR) spectraobtained at different concentrations showedthat the chemical shift of the mebeverineHCl aromatic protons changed with chang-ing concentration in D2O solution; a quanti-tative NMR assay of mebeverine HCl in

D2O was thus developed showing acceptablecharacteristics regarding accuracy, precisionand robustness.

An increased level of discomfort has beenreported from specific batches of some in-jectable hyaluronic acid products, and it hasbeen proposed that this may be due to thepresence of traces of bacterial M protein frag-ments, membrane proteins remaining afterhyaluronic acid purification. Taylor andRae (Reading Scientific Services) reportedon the development of an analytical methodto identify and confirm the presence of Mprotein fragments in hyaluronic acid prepara-tions. Proteomic fragments were identified bythe enzymatic digestion of hyaluronic acidsolutions using trypsin protease, and liquidchromatography-mass spectrometry analysiswas carried out to compare the digested andundigested samples.The M protein fragmentswere detected in samples of hyaluronic acidpreparations where an inflammatory responsehad been previously reported, and subsequentanalysis of samples where no inflammatoryresponse was reported yielded no detectableM protein fragments.This work supports thehypothesis of streptococcal M protein con-tamination of hyaluronic acid preparationsbeing responsible for the inflammatory re-sponse reported.

Assi et al (The School of Pharmacy,London) demonstrated the identification oftablets still contained in their blister packag-ing by near-infrared spectroscopy. Twenty-seven batches of various products incolourless transparent blister packaging werepurchased from the world market. Ciproxin,which was available in multiple batches, wasused to standardise the system.The spectra ofthe tablets were produced with a FOSS 6500near infrared (NIR) spectrometer using aSmart Probe and processed as standard nor-mal variate second-derivative spectra.Comparison of the spectrum of a standardCiproxin tablet with a variety of other tabletsin their blisters was made using correlation inwavelength space and principal componentanalysis to provide a numerical and graphical

profile of the tablets. Of the 20 products, onlythree mismatches were observed, which maybe due to the similar composition of excipi-ents in the particular products. The preciseposition of the probe in relation to the blisterand the tablet was investigated and found tohave little effect. However, NIRS could notbe applied to coloured, opaque or aluminium foil-packaged tablets.

PostersDearden et al (Liverpool John MooresUniversity) proposed a new quantitativestructure-activity relationship (QSAR) modelfor human skin using readily available molec-ular descriptors.The high cross-validated cor-relation coefficient indicates that the QSARcan reliably be used for predictive purposes.Several other authors proposed computerroutines for predicting toxicity or carcino-genicity of drug molecules, including toxicitymodelling of benzodiazepine drugs by partialleast square analysis by Suzuki and Funar-Timofei (Toyo University, Tokyo), carcino-genicity modelling of diverse chemicals basedon substructure grouping and support vectormachines by Tanabe et al (University ofTsukuba, Japan) and prediction of environ-mental toxicity of pharmaceuticals byMadden et al (Liverpool John MooresUniversity).

Teow et al (University of CentralLancashire) described the use of a dendrimercarrier to enhance paclitaxel delivery and by-pass the P-glycoprotein efflux transporter.Enhanced permeation of paclitaxel across themonolayers of Caco-2 cell was found whenconjugated to surface-modified G3 dendrimer.

Patel et al (De Montfort University,Leicester) described the development of adried blood spot (heelstick), and thus the mi-crovolume sampling methodology, for dex-amethasone to facilitate pharmacokineticstudies in paediatrics.

Zughaid et al (King’s College London)investigated the age-old problem of improv-ing the absorption of hormones cortisol andprogesterone by studying their solubilisationby simulated intestinal fluids containinglipids. Incorporation of lipid digestion products in the formulation increases the solubility of these lipophilic drugs and such complex media may provide more relevant fluids for dissolution and permeabil-ity screening.

Li and Wakeman (Eden HealthcareTechnologies, Leicester) used high-performance liquid chromatography to char-acterise eight beneficial secondary plantmetabolites in the flesh and peel of 15 vari-eties of apple. There were significant differ-ences in the levels of beneficial phytoalexinsbetween different varieties of apples and ap-ples grown organically and apples grownnon-organically. Organic apples consistentlycontained higher levels of all analysed com-ponents, and more healthy components wereconcentrated in the peel. A 12th centuryapple, Pendragon, contained the highest levelsof all components.

Apples grown organically contain morehealthy components, according toresearch by Li and Wakeman

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