annual report 2011/12 - UKTIS Report (FINAL 09-10-2012).pdf · RDTC ANNUAL REPORT 2011/2012 5...

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annual report 2011/12

Wolfson UnitClaremont PlaceNewcastle upon TyneNE2 4HHPhone: 0191 260 6181Fax: 0191 260 6191www.nyrdtc.nhs.uk

1RDTC ANNUAL REPORT 2011/2012

ContentsPage No.

FOREWARD 3

EXECUTIVE SUMMARY 4

INTRODUCTION 6

QUALITY IMPROVEMENT 7

OVERVIEW 7

Prescribing Support 7

Medicines Information / NHS Direct 14

Poisons Information 16

Teratology 19

INNOVATION 22

OVERVIEW 22



Teratology 24

IMPROVING PRODUCTIVITY 29

OVERVIEW 29



Teratology 36

PREVENTION OF HARM 38

OVERVIEW 38


Medicines Information / NHS Directy 40

Yellow Card Centre 41

Teratology 43

APPENDICES

Appendix I Prescribing Support Publications 49

Appendix II Financial Summary 51

Appendix III External Training and Development 52

Appendix IV In-House Training and Development 55

Appendix V Lectures, Workshops and Presentations 56

Appendix VI Publications in Scientific and Medical Journals 57

Appendix VII Staffing Establishment 59

Appendix VIII External Positions Held 60

Appendix IX Business Plan 62


Aims

“The aims of the Regional Drug and Therapeutics Centre are to promote the safe, effective and economical use of medicines in the National Health Service in the former Northern and Yorkshire Region; and other stakeholder areas to promote the highest quality of care for people exposed to the toxic effects of drugs or chemicals; and to disseminate and develop knowledge in these areas through teaching and research”


Foreword

It is always a pleasure to present the work of the Regional Drug and Therapeutics Centre through the Annual Report. The report for 2011/12 showcases innovative new developments across all areas of the centre from new reports and mechanisms of delivery in Prescribing Support, to reporting of electronic Yellow Cards via MiDatabank, new websites and databases within the UKTIS through to the preparation of poisons monographs in advance of the 2012 London Olympics for NPIS. Such new developments have not been at the expense of quality and our Quality Assurance mechanisms continued to demonstrate the high regard in which our information services are held by enquirers and other stakeholders.

This is a period of unprecedented change for the NHS and in particular the organisations and healthcare professionals we support and already work is well underway to re-configure and rationalise outputs to reflect the needs of emergent organisations. We are actively engaging with such organisations as their plans and structures develop as well as strengthening links with other potential commissioners who have become aware of the work of the centre and the benefits our support can bring. It is clear that the NHS as a whole needs to find new ways of working in order to manage some of the financial and demographic challenges ahead and we are keen to play a part in this work through better use of the information we can provide.

Encouraging RDTC staff to work across therapeutic areas allows a pooling of knowledge and shared resource thus creating efficiencies in the system as well as increased resilience. As ever we would like to take this opportunity to thank our colleagues for their hard work and professionalism over the past twelve months.

Feedback is always welcomed from individuals or organisations both on any aspect of the services we provide or the content of this annual report.

Sue Dickinson Simon ThomasDirector of Pharmacy Medical Director and Consultant Physician


Executive Summary

During 2011/12, the Regional Drug & Therapeutics Centre (RDTC) continued to provide high quality services outlined in the Business Plan and in its associated Service Level Agreements whilst also responding to in-year pressures for new developments and information.

Quality Improvement

A continual drive to increase the quality of service provision led to changes in report format as well as • exploring links between prescribing data and evidence base. Practice level reports were made available in greater numbers and attendance of RDTC staff at external groups to disseminate findings continued.

Within Medicines Information an external audit confirmed our contribution of high quality active work to the • national arena.

Poisons information staff answered more than 16,000 enquiries with over 98% of enquirers rating the • service as good or excellent. Similarly for UKTIS, satisfaction scores remained high with over 90% of responders highly satisfied with the service received

Innovation

During 2011/12 all primary care prescribing reports and support materials were made available on a • password protected part of the RDTC website. New publications as well as increased numbers of excel based reports allowed increased flexibility in use at a local level.

The centre started submitting Yellow Card reports directly to the MHRA via the latest version of • MiDatabank as one of the early implementer sites and remains one of the most frequent submitters of Yellow Cards via this route.

UKTIS launched a redesigned public facing website with openly available summaries of many pregnancy • monographs and a subsequent tripling of ‘hits’. A new follow up database became operational with a particular emphasis in the period given to the Schmallenberg virus amongst other lines of interest.

Improving Productivity

Streamlining systems released capacity to enable production of increased numbers of reports at a • lower organisational level as well as aligning other reports along the new Clinical Commissioning Group boundaries. In turn, this information was used to identify possible areas for optimising medicines use and increasing the value realised from medicines spend.

The centre exceeded its target for the production of nationally available UKMi Q&As writing new • documents as well as updating others. Our contribution to the national horizon scanning document Prescribing Outlook further demonstrated the value of collaboration in reducing areas of duplication.

UKTIS produced over 100 more new or updated pregnancy monographs compared to previous years • whilst also making alterations to style and format to facilitate updating in the future.


Executive Summary

Prevention of Harm

Prescribing reports as well as evidence-based reviews served to support ongoing work in this area. • Within the work of the Yellow Card centre, total reports for 2011/12 rose by 25% with a notable increase of 40% in GP reporting. Short individualised versions of earlier YCC annual reports were circulated to PCTs and Hospital Trusts. Reporting by hospital pharmacists also rose by an impressive 51% reversing the gradual decline of earlier years but was in turn eclipsed by the 92% increase in community pharmacist reporting following promotional activity by members of RDTC staff.

Over half of the top enquiries to UKTIS related to the use of various antidepressant therapies in • pregnancy, with just under half of enquiries relating to women who had already been exposed to a drug or chemical.

6RDTC ANNUAL REPORT 2011/2012 6RDTC ANNUAL REPORT 2011/2012

Introduction

The Newcastle based Regional Drug and Therapeutics Centre (RDTC) is responsible for a range of issues relating to medicines use and drug safety. These include monitoring and advising on prescribing and medicines use in primary and secondary care across stakeholder organisations.

The Centre was established in 1991 as a collaboration between Newcastle University and the former Northern Regional Health Authority. Over the course of the last twenty one years, services provided by the Centre have developed and increased in volume as we have acquired larger contracts and has also expanded the geographical areas covered. The Centre is housed on the Newcastle University campus and is hosted by the Newcastle upon Tyne Hospitals NHS Foundation Trust, which is responsible for employing most of the staff.

Core funding for the Centre is obtained from local Primary Care Trusts under a Service Level Agreement; the Centre also has substantial contracts with other organisations (e.g. the Health Protection Agency) which allows a more cost-effective delivery of services for all stakeholders.

The Centre delivers a broad range of services relating to prescribing and the use of medicines. These include:

Prescribing Analysis and Support Services• Regional Medicines Information Services• Regional Yellow Card Centre Northern & Yorkshire• National Poisons Information Services (NPIS)• The UK Teratology Information Service (UKTIS)•

The Centre is also active in education and training and in research relating to all aspects of medicines and therapeutics, with a particular focus on the safe and effective utilisation of medicines, management of poisoning, prevention of adverse drug reactions and the appropriate use of medicines during pregnancy.

7RDTC ANNUAL REPORT 2011/2012 7

A continual drive to increase the quality of service provision led to changes in report format as well as exploring links between prescribing data and evidence base. Practice level reports were made available in greater numbers and attendance of RDTC staff at external groups to disseminate findings continued. Within Medicines Information, our external audit confirmed our contribution of high quality active work to the national arena. Poisons information staff answered over 16,000 enquiries with over 98% of enquirers rating the service as good or excellent. Similarly for UKTIS, satisfaction scores from users remained high with 90% of responders highly satisfied.

Quality Improvement

Overview

Prescribing SupportWork has continued to improve the quality of the prescribing report and data analysis service provided to our stakeholders. Ongoing changes in primary care mean that the RDTC has had to be responsive to changing external circumstances and providing information in different formats. For example, short ad hoc reports are produced to accompany some of our evidence-based publications and also cover particular areas of prescribing raised by one or more stakeholders. We have also been able to produce more practice-level reports and prescribing data charts.

Prescribing quality and cost effectiveness

Quality and Outcomes Framework report

This report presents comparative PCT- and SHA-level data on prescribing costs per patient on QOF disease registers against QOF target achievement, (see Figure 1) disease prevalence and hospital admission data for relevant disease areas (against prescribing cost, where appropriate). It continues to be well received, and stakeholders continue to request charts at practice level.

Again, practice-level QOF charts replicating data presented in the PCT-and-SHA-level reports have been very well received by prescribing advisers, GPs and other practice staff and often form the basis of discussions around prescribing costs and quality at practice meetings. They provide a starting point for peer review, discussion and sharing of practice among prescribers, practices and groups of practices, which will be of value when clinical commissioning groups assume commissioning roles in the future. Presenting data for QOF target achievement against prescribing costs and prescribing costs against hospital admissions highlights “outliers”. Further discussion around apparent “outliers” may help identify differing patterns of service provision, and areas of prescribing where cost effectiveness of prescribing and quality of care could be improved.

Therapeutic prescribing reports

Fourteen therapeutic reports (9 new topics and 5 updates) were produced in the financial year 2011/12. These provide more in-depth analysis of cost, safety and clinical issues than is possible in our regular prescribing reports, and cover other therapeutic areas. Whenever possible, examples of work carried out by stakeholder medicines management teams are included in these reports and relevant support materials provided by stakeholders are made available on the Shared Resources section of the RDTC’s NHS website. Examples of reports produced are outlined below.


Genito-urinary prescribing report

In November 2011, this report providing an overview of prescribing of drugs for genito-urinary disorders (including urinary retention, urinary frequency and erectile dysfunction) was produced, as the costs of prescribing these drugs was growing markedly (see Figure 2). Detailed analysis of prescribing of drugs for various genito-urinary conditions, summaries of national guidance and relevant clinical evidence, and practice points were presented with the aim of promoting cost effective prescribing. Stakeholders kindly provided their organisations’ policies and guidelines on prescribing for these conditions. These were referred to in the report and made available on the Shared Resources section of the RDTC’s NHS website.

Vitamin D prescribing report

In March 2012, in response to stakeholders’ requests, a short report on prescribing of vitamin D preparations (see Figure 3) was produced to complement the UK Chief Medical Officer’s (CMO’s) advice to Healthcare Professionals on the prescribing of vitamin D supplements. Stakeholders requested this report as they were faced with rising costs of prescribing these preparations, as high-cost imported products and preparations that had to be specially manufactured were being prescribed for vitamin D deficiency, and as there was no UK-licensed product available. Information on resources to aid development of local consensus on prevention, detection and treatment of deficiency was included.

Figure 1 Example of SHA-level QOF data relating cost/patient of drugs for diabetes to the three diabetes QOF target achievement

levels (percentages of patients with diabetes whose HbA1c was 7 or less, 8 or less and 9 or less in the last 15 months

Key: HbA1c: glycosylated haemoglobin (a measure of blood glucose control)


Figure 2 Example of genito-urinary drug prescribing cost trends July 2008 - June 2011

Figure 3Example of vitamin D prescribing cost trends April 2008 - September 2011


Managing the entry of new drugs

New Drug Evaluation publications

The RDTC remains committed to promoting high quality care for patients. One of the most important objectives of our various publications is to manage the introduction of new medicines into the NHS. The New Drug Evaluations are concise, structured reviews of new drugs recently launched within the NHS which are considered to be primary care orientated and are expected to have a large financial or clinical impact. Drugs that are likely to be initiated in secondary care but transferred to primary care are also evaluated. In line with current Quality, Innovation, Productivity and Prevention (QIPP) national initiatives, New Drug Evaluations are designed to support quality and efficacy at a local level by guiding primary care organisations in promoting appropriate, effective and efficient prescribing. Recent publications include evaluations of newly licensed Rivaroxaban to treat atrial fibrillation and deep vein thrombosis and Asenapine, a new antipsychotic drug.

Illustration: New Drug Evaluations

Detailed evidence based reviews

Effective medicines management is central to the quality of patient care and has never been more important given the financial pressures that the NHS faces in the future. The RDTC is ideally placed to support the commissioning of medicines locally. Detailed guidance to support the NHS with rational decision-making about medicines is contained in our evaluation reports. These provide a comprehensive appraisal of the efficacy, adverse events, place in treatment and arrangements for prescribing of drugs that are likely to have a significant clinical or financial impact on the NHS. They provide advance objective appraisals of the clinical and cost effective use of medicines in secondary care before NICE (National Institute of Health and Clinical Excellence) issues guidance. These reports describe the important clinical aspects of a particular disease and also aim to give commissioners estimates of the potential uptake across a population, and highlight service and financial implications where possible. Recent topics have included fampridine for the improvement of walking ability in multiple sclerosis and use of protease inhibitors (boceprevir and telaprevir) in the treatment of hepatitis C.


North East Treatment Advisory Group (NETAG)

The RDTC, in its collaborative arrangement with NETAG, has continued to act as the lead author in the production of a number of detailed treatment appraisal reports. These are the principal source of evidence used by NETAG members to make recommendations on the commissioning of treatments within NHS North East. The principal aims of the work undertaken by NETAG are to provide regionally consistent advice to primary care organisations within NHS North East and to ensure that patients requiring treatments that NICE has not approved receive equitable access to a clinically defined and appropriate range of treatments. Although NETAG has a remit to consider drug and non-drug treatments such as medical devices and interventional procedures, the majority of treatment appraisal reports produced by the RDTC have assessed new or unlicensed pharmaceutical treatments. Recent topics have included the use of Botulinum toxin for chronic migraine, and dexamethasone ocular implants for uveitis. In light of the significant changes planned for the commissioning structure of the NHS, the RDTC will continue to work with NETAG to identify potential new treatments and provide commissioners with advance notice of developments, through horizon scanning signposting and critical appraisal of evidence, safety and cost-effectiveness as appropriate.

Attendance at meetings of groups involved in new drug approvals

Senior prescribing team pharmacists attend specific new drugs meetings such as the Greater Manchester Interface and New Therapies meeting. The RDTC provides independent advice alongside local medical and pharmaceutical representation to make recommendations on new drugs and the Red-Amber-Green status to the parent medicines management group (GMMMG) and local Drug and Therapeutics Committees (D&Ts) of Greater Manchester NHS organisations. Recommendations are based on clinical evidence in order to manage the introduction of new medicines which have health economy-wide implications for primary, secondary and specialist care. This group provides prescribers with guidance on newly licensed therapies and indications with regard to the products’ place’s in treatment. This will ensure that prescribers have balanced information with which to inform their prescribing decisions. A drug’s priority for funding, or whether it should be funded at all, is also discussed. All agendas, minutes and recommendations are available on the GMMMG website. Other groups to which the RDTC provides independent advice on new drugs include the North of Tyne Area Prescribing Committee (APC), County Durham and Darlington APC and D&T, Greater Manchester Neuroscience Medicines Subgroup and the Gateshead Medicines Management Committee.

Support to the Greater Manchester cancer commissioning process

The RDTC continues to provide advice and support to the Greater Manchester Cancer Commissioning process in partnership with the Greater Manchester and Cheshire Cancer Network ensuring that innovative and cost effective new cancer medicines are prioritised and commissioned through a Greater Manchester-wide development process. The aim of the process is to have a prioritised list created by clinicians that supports PCTs with a clear and robust commissioning tool. This process is supported intensively by the RDTC through the provision of evidence based evaluations and considered recommendations by senior staff.

Support to formulary groups

The RDTC provides support to the Greater Manchester Formulary Subgroup. This group was tasked with producing a joint primary and secondary care formulary for implementation across Greater Manchester. The formulary is one of five main work streams of the medicines management QIPP plan (optimising use of the drug of choice) with the aim being to maximise safe, effective and economic prescribing. The formulary also ensures that patients receive seamless care across the primary-secondary care interface and reduces the need for drug switching programmes. The RDTC facilitated the process by coordinating the writing and


commenting on the chapters, developing the process and designing and managing the website that hosts the formulary. An open access consultation was also developed and the numerous comments that were received following this were coordinated and responded to appropriately. Continuing support to the formulary group in developing further procedures, designing an ongoing review process and ensuring recommended clinical governance guidelines are adhered to is in place. A ‘do not prescribe’ list which suggests specific drugs that may represent disinvestment opportunities for a trust or area, was developed alongside the formulary. This process also continues to evolve.

Prescribing reports

Charts showing comparative prescribing (at North of England-, PCT- and SHA-level) of new drugs continue to be included in the Quarterly Prescribing Report.

In addition, prescribing of new drugs is covered in relevant therapeutic reports, e.g. the New Drugs for Diabetes report issued in July 2011.

Provision of strategic medicines management advice and support

Members of the RDTC prescribing support team work closely with medicines management groups across the North of England. This includes direct support in the form of attendance by senior members of the prescribing support team at meetings of groups involved in medicines management and also the provision of general support and advice. Some specific examples of this strategic advice and support are as follows:

Report interpretation / monitoring

Key prescribing reports are presented at some meetings (e.g. County Durham and Darlington D&T, Greater Manchester Medicines Management Group, North East Heads of Medicines Management meetings) outlining the key areas for the group to focus on and areas of potential improvement. Support has also been provided at SHA level for specific disease areas, e.g. the North East SHA Respiratory Clinical Advisory Group. This involved provision of prescribing data, interpretation and analysis of which highlighted potential areas for improvement or further investigation. This localised, specific interpretation of data is highly useful to group members because it is immediately relevant and points out key areas to consider in improving care of their patients.

Provision of overviews of comparative budgetary performance

Highlighting areas where costs could be reduced and cost effectiveness improved, this very specific interpretation of local data at meetings accompanied by ad-hoc email and telephone queries allows our respective NHS colleagues to be aware of key issues they might otherwise have missed. Information is presented in a variety of formats to ensure the data are understandable and easily interpreted.

Local decision making (LDM)North EastArrangements for making decisions about the use of medicines in the NHS in the North East of England have evolved with existing commissioning processes and have many recognised strengths. Nonetheless, the NHS in the North East, as elsewhere, will need to adapt arrangements for making decisions about drugs to contribute to QIPP plans and to take account of planned changes to commissioning arrangements.


The RDTC provided support and advice to facilitate a review of local procedures and ensure compliance with the NHS constitution and Department of Heath (DH) directions, support development of a local ethical framework for decision making groups to ensure consistency of approach and to ensure transparency of decisions made. The report has been presented to the North East Chief Executives and the way forward is currently being finalised. Details of the review were presented at the NICE conference in May 2011.

Greater ManchesterSeveral senior members of staff have also been involved in ensuring that local decision making groups in Greater Manchester are compliant with the NHS constitution and DH directions, ensuring consistency of approach and transparency of decisions made. This has been particularly important with the setting up of new subgroups such as the Greater Manchester Neuroscience Subgroup, a new subgroup of GMMMG. Ensuring consistency of decision making across all such groups will be increasingly important in the future as membership changes to reflect the changing structures in primary care.

Support to GP commissioning consortia

With the forthcoming changes, clinical commissioning groups will become increasingly interested in promoting cost effective, evidence-based prescribing as a means of quickly freeing limited resources to reinvest in other services. Strategic support can be provided to individual commissioning groups to help them in achieving this objective. A senior member of staff provides regular strategic medicines management advice to a specific locality in Sheffield. This support is in addition to local medicines management team support and includes independent advice on specific projects such as utilising the decision support tool ScriptSwitch®, education and training events, support on the introduction of new drugs and in-depth evaluation of prescribing data.

Strategic meetings that the RDTC prescribing team support include:The North of Tyne APC• County Durham and Darlington APC• County Durham and Darlington D&T• North East Senior Pharmacy Managers Group• The North East SHA Heads of Medicines Management meeting• Yorkshire and Humber Prescribing Leads meetings• Central Sheffield Commissioning Consortium Prescribing Subgroup• Greater Manchester Medicines Management Group• Greater Manchester Formulary Subgroup• Greater Manchester Interface and New Therapies Subgroup• Greater Manchester and Cheshire Cardiac Network• Greater Manchester Prescribing Advisers’ Group• Greater Manchester and Cheshire Cancer Network• Greater Manchester Neuroscience Medicines Subgroup•

Education and training

The RDTC prescribing support team have provided, when requested, training on various topics such as critical appraisal, academic detailing, management of prescribing and prescribing data. Further details of specific training provided can be found on the RDTC website.

On a strategic level an RDTC member of staff represented the UKMi Executive on the Modernising Pharmacy Careers Workstream II working group examining the post registration period for pharmacists


Medicines Information / NHS DirectDuring 2011/12, the RDTC provided medicines information support to a broad range of healthcare professionals. A multidisciplinary staff team including pharmacists, information scientists and nurses answer enquiries. All enquiry answering staff undertake initial locally-delivered training and assessment in medicines information, teratology and management of poisoning, ongoing learning is supported by regular CPD sessions, courses and attendance as appropriate at national training events such as the UKMi National MI training course and UKMi Professional Development Seminars.

Call recording for medicines information enquiries was introduced this year. The opportunity for call review is now available in response to any complaints but also as a reflective training tool.

Three hundred quality assurance user survey forms were sent to a random selection of MI service users with a response rate of 54%. UKMi has devised a scoring system out of 5 for responses received as a measure of the service provided. Our scores indicated that users were ‘pleased with the service’ for answer satisfaction, general helpfulness and ease of contact. The decision was taken during the year, in response to some comments on the QA forms, to ensure that an additional MI line was staffed to improve ease of contact and timeliness of response.

A1 Initially able to contact the service easily 96% Agree

A2 I was informed when I could expect an answer 96% Agree

A3 The answer provided was sufficient for my needs 93% Agree

A4 In general I found the service to be helpful 94% Agree

A5 I had to contact the MI centre > 1 before I received a response 88% Disagree

A6 I received the answer too late for it to be useful 91% Disagree

A7 The information was received when requested 90% Agree

A8 I did not receive the information I required 89% Disagree

A9 I received the answer to my enquiry within the time requested 92% Agree

A10 I was happy with the answer to my question 93% Agree

A11 My question was answered in full 92% Agree

Table 1User Satisfaction

In addition to the standard UKMi User Survey questions, the RDTC has added some questions exploring the value of our service by asking about the use to which the answers were put (Figure 4). Several responses chose more than one option from the selection offered. The main use identified was to ‘initiate or modify a patient’s management’. Patient safety features in many of the responses with 2.8% saying that their enquiry answer was used to investigate or report an adverse drug reaction and many of the 3.8% in the ‘other’ category were also safety related including:

“Investigate the safety of new route of administration with an established drug”• “Ensure patient safety”• “Safeguarding issue re patient unable to consent”•


National Medicines Information Activities

As in previous years, we have contributed to the work of the UKMi network. Developments from this collaboration included:

The senior MI Pharmacist (Pharmacovigilance) is a member of the UKMi Clinical Governance Working • Group. The Principal Pharmacist MI deputised during her maternity cover and contributed to discussions about UKMi Service KPIs, database risk and recommended resource list updates.

The RDTC was audited in March 2011 as part of the UKMi Internal audit process and the final written • report was positive with no causes for concern identified. ‘The service contributes to a wide range of high quality active work that is beneficial to the NHS and the wider UKMi/NHS network’.

In addition to enquiry answering support the Centre, through its NHS Direct Pharmacist Lead, has played • an active role in delivering the National NHS Direct / UKMi SLA and extended its remit to support NHSD staff working at the Wakefield site as well as Newcastle. This work included:

Collaboration with national colleagues within the UKMi NHS Direct Working Group, to develop • national training packages and guidance documents which support the National NHS Direct Medicines, Poisons and Pharmacy procedures and Best Practice documents.

Figure 4 The use made of MI answers received during 2011-12 as a % of the total QA responses

* Figures may not add up to 100% due to rounding


Continuing support of the local site in implementing national protocols, ‘best practice’ and training.•

Induction, role preparation, assessment and refresher training sessions for nurse advisers and • health information advisers. Our training has focussed on Health Information Advisers (HIAs) as Newcastle and Wakefield are two of five sites with this staff group and it is part of NHS Direct Strategy to ensure all HIAs have successfully completed the medicines training to enable them to handle non-symptomatic medicines calls.

Contributing to the NHS Direct action plan in response to their audit of toxic ingestion calls.•

Contributing to the NHSD plans for the change to providing a 111 service from the 0845 service • currently offered in terms of handling medicines-related enquiries.

Medicines Information training delivered during 2011/12 included:

NHS DirectNurse Adviser, Dental Nurse Adviser and Health Information Adviser Medicines training• Ongoing updating of the Poisons ‘Train-the-Trainer’ package• Development and delivery of a ‘calculations’ webinar training package• In the early stages of developing a ‘Blended Learning’ package for handling poisons enquiries’•

RDTCInternal comprehensive initial training and assessments, ongoing CPD attendance at courses and • relevant conferencesCall recording enabling reflective learning and follow up of any complaints•

Pre-Registration Trainee PharmacistsRegional half day training session and workshop• Three week RDTC MI rotation for a local Trust’s Pre-registration trainee pharmacists where in-house MI • expertise and appropriate supervision is unavailable

For PCT PharmacistsProvision of a PCT Pharmacists and Technicians Medicines Information Resource Pack•

Poisons Information

The National Poisons Information Service (NPIS) is commissioned by the Health Protection Agency (HPA) on behalf of the Department of Health to provide telephone advice for frontline NHS staff on the diagnosis, treatment and care of patients who have or may have been poisoned. As well as Newcastle, there are NPIS units in Birmingham, Cardiff and Edinburgh. All NPIS units are closely affiliated to the Northern Ireland Regional Medicines and Poisons Information Service in Belfast and the National Poisons Information Centre in Dublin.

The Newcastle unit of the NPIS provides service to users in Northern and Yorkshire, Greater London and Kent during normal office hours (9 am to 6 pm). Since 2005, the Newcastle unit has participated in a national rota with two other NPIS units (Birmingham and Cardiff) for provision of out of hours services to the United Kingdom and Ireland.


Newcastle NPIS answered 16,188 poisons enquiries during 2011/12. The service continues to be most frequently accessed by doctors (45%), with 29% of the calls received from hospitals and a further 42% and 21% from primary care and NHS Direct/NHS/24 respectively (Figure 5).

Figure 5Source of Enquiry

Childhood poisoning remains important, with 28% of enquiries involving children under 5 years. The next most common age group subject to enquiries was the 20 to 29 years age band (13%) (Figure 6).

Figure 6Age of Patient


Accidental poisoning and therapeutic errors comprised 68% of total calls followed by intentional self harm (23%). Recreational abuse exposures accounted for 2.6% of enquiries. As with previous years, most episodes (84%) occurred in the home. Pharmaceuticals are involved in the majority of incidents (65%), with industrial chemicals accounting for 13% and household products 12% of enquiries. Paracetamol was by far the most common pharmaceutical agent involved, featuring in more than 11% of enquiries, with ibuprofen the next most common (4%). Other common pharmaceuticals ingested were antidepressants and hypnotics. Alcohol and recreational drugs accounted for 4% and 3.5% of enquiries respectively (Figure 7).

Figure 7Category of Poison

The severity of cases is routinely recorded using the Poisons Severity Score (PSS) developed by the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT), which categorises clinical features as none, minor, moderate or severe. PSS is documented at the time of the call and the maximum PSS is also recorded, describing the most severe symptoms the patient has experienced from the time he/she was poisoned until the enquiry to NPIS. Of the calls taken 89% were recorded as having a PSS of none or minor, 4% as moderate and 2% as severe. The more severe scoring enquiries will often require consultant input, reflecting NPIS policy to ensure that severely poisoned patients receive optimal treatment by offering the enquirer the expertise and experience of a NPIS Consultant Clinical Toxicologist. During 2011/12, 591 cases were referred to a Consultant Toxicologist.

Cases with severe features or when an NPIS consultant had been contacted are routinely followed up. The outcome data is used to influence clinical management guidance on a national level. Enquiries relating to toxic alcohols and pesticides were also reviewed as part of prospective studies. During 2011/12, a total of 940 (5%) cases were followed up, of which complete outcome data is available for 490 cases.

TOXBASE is an internet database maintained by the NPIS and the first point of contact for Poisons Information for health professionals in the UK. NPIS (Newcastle) contributes to TOXBASE by participating in national editing group meetings and updating, reviewing and producing new monographs. In addition, monographs prepared by other units are critically assessed. In 2011/12 in preparation for the Olympic period, a large proportion of our TOXBASE workload has involved producing monographs on selected chemicals in case of deliberate release. Chemical TOXBASE entries include public information sheets as well as the management


advice intended for the use of the healthcare professional. NPIS (Newcastle) has continued to increase TOXBASE related productivity compared to previous years by submitting 342 monographs during 2011/12 (46 new, 200 checked, 31 revised and 65 updated

The Newcastle unit aims to provide a very high quality of service and continually seeks to improve by collection the views of users and stakeholders. At least 4% of telephone enquiries for the unit are selected at random and a nationally agreed quality assurance questionnaire is used to collect data.

During 2011/12, NPIS Newcastle sent out 828 questionnaires with a good response rate of 41% (341 returned); 28% of respondents were GPs and 17% nurses. The overall satisfaction ratings were high with 98.5% of users rating the service as very good or excellent, an increase compared to 2010/11. User satisfaction across all domains remained above 90%, except for call answering time (83.9%).

Question *Satisfaction Score (%)

The person I spoke to was polite and pleasant 97.0

The information was given to me at an appropriate speed 96.7

I had confidence in the reply I was given 96.1

I was given an appropriate amount of information for my needs 95.8

Once my call was answered by a specialist in Poisons Information the enquiry was dealt with promptly

95.5

The reply from NPIS was relevant and useful 94.6

My telephone call was answered without delay by a Specialist in Poisons Information 83.9

* Satisfaction score is the proportion of respondents who agree ‘completely’ or ‘a lot’

Table 2 Telephone Quality Assurance Survey Satisfaction Scores

TeratologyDuring 2011/12 the UK Teratology Information Service (UKTIS) has continued to concentrate on improving the quality of both the information provided to service users, mainly through written summaries (monographs) on pregnancy exposures, as well as that of the patient data collected from health care professionals by the service. As in previous years, improvements to the service have been informed by both formal and informal feedback from service users.

UKTIS Monographs

UKTIS monographs provide a summary of all available information relating to the teratogenicity or reproductive toxicology of a specific exposure in pregnancy. Full monographs are available, at no charge, to all NHS healthcare professionals through TOXBASE (www.toxbase.org). As of November 2011, summaries of each monograph were made openly accessible via the UKTIS website (www.uktis.org) and have attracted interest worldwide.

http://www.toxbase.orghttp://www.uktis.org


Published studies on the safety of drug use in pregnancy have continued to increase year on year, resulting in substantial complex and often conflicting data for commonly prescribed medications. During the year 2011/12 UKTIS has strived to improve the accessibility of this information by restructuring the monograph design to enable quick and easy access to information. Complex data is now tabulated, and concise statements summarising the data pertaining to each specific adverse pregnancy outcome have been introduced to assist clinicians by providing a quick and easy overview of the potential fetal risks associated with a particular exposure in pregnancy.

Monographs are updated on a rolling basis with priority given to commonly asked about exposures and where possible in response to new data becoming available for existing monographs. During 2011/12 UKTIS also produced several new monographs, either in relation to specific requests from service users, or where media attention around a specific health topic was anticipated to increase concern amongst pregnant women, for example silicone breast implants and vitamin D.

Other completed documents considered potential teratogenic maternal conditions and medications used in their treatment, including diabetes and obesity; both of which are increasing in frequency and are expected to become major public health issues in the future.

Staff training and development

Presentation of UKTIS research and surveillance data at national and international meetings has enabled staff to remain abreast of new developments in the field of reproductive toxicology and to deliver enhanced specialist teratology training to staff within the RDTC. Meetings attended over the course of 2011/12 included teratology, genetics and poisoning conferences, teratology specific training courses and importantly the first joint meeting of the European Network of Teratology Services (ENTIS) and the American Organisation of Teratology Specialists (OTIS), in Jerusalem. Attendance at these meetings offers invaluable educational opportunities to gain up-to-date knowledge of new research and findings in the field of reproductive toxicology. Information obtained from these meetings has been incorporated into monographs and training material for internal CPD sessions and teaching as well as local and national external lectures and workshops. These meetings also offer a forum for discussion of improved service delivery and have proved excellent opportunities for establishing collaborative international working.

UKTIS surveillance of known and emerging teratogens

Over the past two years UKTIS has focused on improving the breadth and quality of information collected, and now requests pregnancy outcome data for all types of exposures. Reporting by service users of maternal identifiers to enable follow-up, and of maternal characteristics which may affect fetal wellbeing independently of a drug exposure has improved markedly since the introduction of the new UKTIS database and questionnaires. Additional administrative and scientific support has also enabled ‘real-time’ chasing of missing data and processing (including ICD coding) of this information. It is anticipated that this will support more accurate interpretation of the data collected by UKTIS, and in turn improve surveillance of new and emerging teratogens.

Significant effort has also been invested in collating information collected by the service over the past 30 years on women exposed to substances considered to be non-teratogenic to create a reference or ’control’ group against which to compare drugs being investigated for safe use in pregnancy. The creation of this control group will not only improve surveillance of potential teratogens within the UK, but has enabled UKTIS to participate in international collaborative research projects.


Clinical Governance

UKTIS regularly asks for feedback from service users. During 2011/12 a random sample of 350 enquiries, (10.7% of the total enquiries), made directly to UKTIS were selected for quality assurance monitoring over the course of the year. Questionnaires were sent out to enquirers between one and four weeks after the enquiry. As of May 2012, 122 (35%) of these forms had been returned.

The responders were hospital consultants (15), junior hospital doctors (2), pharmacists (25), community pharmacists (1), GPs (66), nurses (4) and other healthcare professionals (6). The occupation of three responders was not reported. Of the responders, 38% had used the service between one and five times previously, with a further 29% being first-time enquirers, reflecting a 6% increase in the latter compared with 2010/11.

Satisfaction scores were high - in particular, 90% of responders agreed or strongly agreed that they were highly satisfied with the service they received with 98% agreeing that they found it easy to contact UKTIS. The majority were happy with the amount of information they received from the service (88%). Of the enquirers, 94% reported that they spoke to someone who was polite and pleasant, and 88% had confidence in the reply that they were given.

Rank Question *Satisfaction Question

(%)

1 The person I spoke to was polite and pleasant (agree) 94

2 I had confidence in the reply I was given (agree) 88

3 The reply from UKTIS was relevant and useful (agree) 88

4 The information was sufficient for my needs (agree) 87

5 Once I got through, the enquiry took a long time to be dealt with (disagree) 79

6 The information was given to me too quickly (disagree) 73

*Satisfaction score is the proportion of respondents who scored 5 and 6 (in agreement) or 1 and 2 (in disagreement)

Table 3 Summary of UKTIS enquirer satisfaction scores


Innovation

Overview

During 2011/12, all primary care prescribing reports and support materials were made available on a password protected part of the RDTC website. New publications as well as an increased number of excel based reports allowed increased flexibility in the use at a local level. The centre started submitting Yellow Card reports directly to the MHRA via the latest version of MiDatabank as one of the early implementer sites and remains one of the most frequent submitters. UKTIS launched a redesigned public facing website with openly available summaries of many pregnancy monographs and a subsequent tripling of ‘hits’. A new follow up database became operational with a particular emphasis in the period given to the Schmallenberg virus amongst other lines of interest.

Prescribing Support

A novel package of medicines management and prescribing support has been devised and will continue to be significantly developed over the next year. The service is now much more responsive to stakeholder needs and to changes in national policy, and support is tailored to each region. Regular review and staff development have ensured that outputs continue to remain fit for purpose and are not duplicated elsewhere. The RDTC is unique in that it combines prescribing data analysis with critical appraisal of the current evidence base and all staff are highly skilled in both these areas. This type of support helps organisations meet some of the challenges associated with the medicines optimisation agenda and aims to help improve the quality and cost effectiveness of prescribing.

All primary care prescribing reports and support materials are now available on the RDTC’s NHS website, under password protection, to enable easy access by stakeholders. New publications have been developed to help support the changing needs of stakeholder organisations. All new documents form the basis of a package of support materials (e.g. evaluation documents, academic detailing aids, prescribing reports and sharing of best practice) for medicines management teams to help them promote good prescribing practice. Patient information leaflets are being developed to complement the support package. This represents a new approach for the RDTC.

Hot Topics

These documents were introduced in response to stakeholder requests for rapidly produced, evidence-based overviews of current medicines management-related issues, many of which have major financial implications for PCTs, and some of which may be controversial in nature. Such documents were identified as needed to assist advisers, commissioners and / or prescribers in deciding what course of action to recommend for their health economies. Recent topics to be published include prasugrel, particularly relating to the NICE technology appraisal published on its use in acute coronary syndrome, and the application of this in the NHS. A further topic covered the use of bevacizumab in age-related macular degeneration. This document covered efficacy and safety as well as the legal issues surrounding this particular topic and associated patient consent points.

Briefing Documents

The aims of these publications are to assist medicines management teams and other healthcare professionals in influencing and changing prescribing behaviour (for clinical, financial and / or safety reasons) and to facilitate sharing of experience, good practice and locally developed support materials.


Two recent briefing documents covered the linked topics of ‘Hypertension - Diagnosis and Monitoring’ and ‘Hypertension - Stepped Care Management’. These documents built on the information in the recently published NICE clinical guideline (CG 127) and its applicability in primary care. Detailed practice points in both documents allowed the practical aspects of these documents to be highlighted for stakeholders.

These documents are available to stakeholders (under password protection) on the RDTC’s NHS website.

Prescribing reports in Excel

More reports are now produced in Excel, enabling stakeholders to manipulate data and present them in formats suitable for reporting and other purposes, and to copy and paste charts and tables into their own reports. Many of the RDTC’s Excel reports include pivot tables, enabling stakeholders to select different data and presenting charts and tables in various ways, according to their needs. A dashboard view presenting an overview of a report’s content was included in several reports.

Drug Tariff Monitor

Work to develop this tool, which provides estimates of prescribing expenditure changes that may result from fluctuations in drug prices, was carried out at the end of 2011 and the beginning of 2012, and stakeholder feedback was obtained, in preparation for launch in April 2012. This tool is intended to be used by primary care advisors as an aid to informing budgetary discussions. Monthly potential savings / cost increases are calculated for all generic drugs in the BNF, and include Category M generic drugs as a particular subgroup. The Monitor will be updated quarterly to reflect the most recently available Drug Tariff prices.

Medicines Information / NHS Direct

As part of our SLA with NHS Direct the RDTC has a remit to support the safe, effective and efficient management of poisons enquiries within NHS Direct. This has involved:

Designing and delivering training• Exploring new and more efficient ways of training NHSD staff including webinars, podcasts, workbooks • etc.Reporting or commenting on poisons-related serious untoward incidents• Designing decision support tools and the training packs to support their introduction• Supporting the NHS Direct Pharmacy Director in dealing with poisons related issues• Liaising with NPIS / TOXBASE®• Promoting and supporting ‘best practice’ in relation to the handling of toxic ingestion calls•

Version 3 of MiDatabank was introduced at the RDTC during this year. Several improvements have been made but the most noteworthy is the innovation which enables submission of adverse drug reaction data directly to the Medicines and Healthcare Regulatory Authority from enquiries received as part of our routine medicines information activities. The RDTC were one of the early implementers of this development sending our first yellow card report from MiDatabank on 17 June 2011. To date, 32 MI Centres have reported a total of 253 electronic Yellow Cards to the MHRA, of which 163 are considered serious. The RDTC has submitted 22 reports which is the third highest number, 10 of which were ‘serious’.

Promotional activities have included developing the medicines information section of the RDTC website, supplying promotional material for distribution at conferences, medicines management meetings etc, attendance and presentations about our service at LPC meetings and securing advertisements in their


newsletters as well as producing ‘The Medicines Information News Today’ (The MINT) newsletter for frontline primary care healthcare professionals. There have been a total of 422 hits on The Mint section of the RDTC website from 397 visitors between 01/11/2011-30/04/2012. It is e-mailed to 211 subscribers, which is an increase from 163 last year

Work was also started on providing information for community pharmacies carrying out New Medicine Service reviews for patients, a key service to help patients get the best from their medicines.

Teratology

The launch of the newly redesigned UKTIS website (www.uktis.org) has provided a fundamental platform from which to promote, develop and advance the scope of the service. This, together with concerted efforts of the team to raise the service profile amongst potential service users, patient support groups and relevant national organisations, has attracted increased national and international recognition of UKTIS.

UKTIS website development

In October 2011 the redesigned UKTIS website (www.uktis.org) went live. This new website was designed in-house to promote the service and raise awareness amongst professionals of the available expertise within UKTIS, and amongst members of the public regarding the specialist advice available to pregnant women on medication and recreational substance use in pregnancy. The new public UKTIS website holds openly

Home page of the newly designed UKTIS website

http://www.toxbase.orghttp://www.toxbase.org


accessible summaries of the 340 detailed pregnancy monographs which are accessible via TOXBASE.org to NHS health providers only. Members of the public requiring specific advice or further information are directed to their healthcare provider who can contact UKTIS on their behalf. The new website will encourage members of the pubic to raise any pregnancy related exposure issues with their healthcare provider. Future plans include provision, via the website, of patient tailored information leaflets on medication use in pregnancy.

Since the launch of the redesigned UKTIS website in November 2011, hits to the site have tripled from a monthly average of 700 hits to 2,100 hits (Figure 8). New UKTIS pregnancy monographs are now advertised via the UKTIS.org website, as well as through the National electronic Library for Medicines website (www.nelm.nhs.uk). Antidepressant medications, in particular psychotropics, featured heavily in the top 20 most accessed summaries via UKTIS.org (Table 4), with three of these also featuring in the most frequently accessed monographs on TOXBASE (Table 5, page 37), reflecting the recognised trend towards increased numbers of women conceiving whilst on antidepressants. Visitors from within the UK accounted for the majority of hits to the website between April 2011 and the redevelopment of the website in October 2011, totalling 2,491 visitors. Since the launch of the new website, UK visitors have increased by a further 11%, and the number of international visitors by almost three times

Figure 8UKTIS.org website hits before and after the redevelopment of the site in October 2011

http://www.nelm.nhs.uk


Pregnancy Monograph Number of hits

Diclofenac 209

Hyoscine 213

Gentamicin 188

Co-amoxiclav 151

Propranolol 152

Mefanamic acid 129

Pregabalin 142

Quetiapine 129

Codeine 114

Doxycycline 119

NSAIDs 129

Lithium 121

Amitriptyline 109

Clozapine 98

Sertraline 100

Fluoxetine 109

Citalopram 110

SSRIs 110

Warfarin 101

Flucloxacillin 98

Table 4 Top 20 most accessed pregnancy summaries on UKTIS website in 2011/12

UKTIS profile

a) Healthcare professionals“increase awareness of this very useful service ... publicise ... advertise more widely”

New service users and professionals involved in reproductive health have consistently commented on the need to increase awareness of the expertise and resources offered by UKTIS. In response to this feedback, during 2011/12 UKTIS focused on raising its profile amongst potential service users through targeted promotional activities, and amongst scientific and academic groups through the presentation and publication of UKTIS research and surveillance data.

This year, UKTIS delivered spoken presentations and workshops at several national conferences and training courses. UKTIS surveillance data has been presented at national and international teratology and poisoning conferences. The 2012 UK / Dutch Clinical Genetics Societies Spring Conference included a dedicated session on Teratology, with an introductory presentation highlighting the support available to clinicians from UKTIS. In September 2011 UKTIS exhibited information about the service at the UK Medicines Information


Practice Development Seminar, in October at the Royal College of General Practitioners annual conference, and in March 2012 at the UK / Dutch Clinical Genetics Societies & Cancer Genetics Group Spring Conference.

Surveillance of known and emerging teratogens

a) UK surveillanceThe acquisition of a new, more automated state-of-the-art enquiry follow-up database in 2011 has facilitated improved surveillance of UK exposures amongst patients within the UK by enabling follow-up of every enquiry to UKTIS that relates to a pregnant patient, rather than limiting data collection to certain specified exposures. In addition to this routine day-to-day surveillance, UKTIS has established specific and enhanced surveillance mechanisms in response to the potential for widespread threats from novel viruses.

Schmallenberg virus (SBV)1. In autumn 2011, maternal infection amongst cattle and sheep with the novel Schmallenberg Virus (SBV) resulted in increased rates of stillbirth and congenital malformations including arthrogryposis in lambs and calves. Experience from similar viruses suggested that the risk of human disease was low, however risk to humans could not be excluded.

UKTIS were tasked with responsibility for coordinating HPA surveillance for any early signals of Schmallenberg Virus (SBV) infection and teratogenic effect in humans. A two pronged approach was adopted with ‘astute clinicians’ across the UK and internationally being approached through links with established paediatric pathology, neuromuscular paediatric and genetics networks to report unusual or unexplained cases or clusters of arthrogryposis to UKTIS. In addition, a collaboration with UK congenital malformation registries has been formalised to provide a review of arthrogryposis rates for previous years, with a view to registries analysing arthrogryposis and related malformation rates prospectively for the following five years on a quarterly basis

H1N12. Follow up of cases reported to UKTIS during HPA surveillance of the 2009 H1N1 pandemic has now been completed, and pregnancy outcome data analysed for submission to a peer reviewed journal.

Collaborative working has also been established between UKTIS and The Immunisation Department of the Health Protection Agency who are undertaking surveillance of fetal outcome for specified vaccinations in pregnancy (VIP). UKTIS are assisting with the analysis and interpretation of the pregnancy outcome data from this initiative.

b) Global surveillanceSurveillance of agents that are rarely used in pregnancy or new to the market is hampered by fragmentation of pregnancy exposure data, with UKTIS, and other teratology services and pregnancy registries around the world, often individually aware of only a small number of exposures.

In March 2012, an international collaboration between UKTIS and members of the European Network of Teratology Information Services resulted in a publication confirming mycophenolate as a newly recognised teratogen. The case series including 57 prospectively ascertained pregnancies after maternal therapy with mycophenolate confirmed a high incidence of major malformations (26%) after first trimester exposure. High rate of spontaneous abortion, prematurity (62%), and low birth weight (31%) were also found. This was the first


study to analyse prospectively collected pregnancies and, while there is still much to learn about mycophenolate exposure in utero, this data provides clinicians and patients with evidence based information on which to base difficult choices regarding the risks and benefits of mycophenolate use in pregnancy.

Research and Development

a) H1N1 influenzaDuring the H1N1 influenza (‘swine flu’) pandemic of 2009, UKTIS obtained research grants from NIHR and the H1N1 vaccine manufacturers Glaxo Smithkline and Baxter, to carry out a prospective observational study examining the effects of swine flu, antivirals and vaccination during pregnancy. Pregnancy outcome data was obtained from over 650 women with the study concluding in September 2011. A detailed statistical analysis of the data has been carried out and reports to the manufacturers have been submitted. A paper of the results has been submitted for peer review.

b) PROTECTUKTIS collaboration in a European multi centre research project with 31 public and private partners is ongoing. The project, Pharmacoepidemiological Research on Outcomes of Therapeutics (PROTECT) has been funded by IMI to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. PROTECT will trial direct patient data collection using web-based and telephone systems. It will test the transferability of the data into a common language and explore linkages to data from electronic health records and registries. In the past financial year the project team from UKTIS have worked on the data collection methods, promotional material and ethical requirements for the UK arm of the study. Data collection is due to start in the autumn of 2012.

c) Mechanisms of teratogenesisDuring 2010/11 UKTIS initiated and led on a collaborative project to improve understanding of the molecular mechanisms that orchestrate gene expression during fetal development. This work aims to identify epigenomic signatures during development and then to further interrogate these signatures in relation to exposures known to influence pregnancy outcomes (e.g. potential teratogens, maternal obesity). The ultimate goals are twofold:

1. To define epigenetic signatures that may have clinical utility as early biomarkers of exposure and thus assist in more accurate and specific risk prediction and counselling

2. To increase our understanding of the molecular mechanisms occurring in fetal development and thus the pathogenesis of health problems later in the lifecourse that have antecedents in utero, therefore informing appropriate interventions.

Pilot data, funded by an NIHR FSF grant and Newcastle Healthcare Charity award are currently being analysed, and will hopefully support future grant applications to further this project.

d) Collaborative projects with other international teratogen information servicesA collaborative ENTIS paper has been submitted for peer review regarding the use of statins in pregnancy. Two studies on the teratogenic effects of antidepressants and anti epileptic medication, which include UKTIS data pooled with data collected in Europe and Canada, are currently at the analysis stage.


Improving Productivity

Overview

Streamlining systems has released capacity to enable increased numbers of reports at a lower organisational level as well as aligning other reports along the new Clinical Commissioning Group boundaries. In turn, this information is used to identify possible areas for optimising medicines use and increasing the value realised. The centre exceeded its target for the production of national Q&As writing new documents as well as updating others. Our contribution to the national horizon scanning publication Prescribing Outlook further demonstrated the value of collaboration in reducing areas of duplication. UKTIS produced over 100 more new or updated pregnancy monographs compared to previous years whilst also making alterations to style and format to facilitate updating in future.

Prescribing Support

Service delivery

We have continued to improve the productivity of our prescribing report and ad hoc data provision and analysis service to stakeholders. The streamlined systems now in place for data analysis have increased capacity and we now can produce more ad hoc short reports on particular areas of prescribing. In addition to delivering increased numbers of practice-level reports, we have been responsive to the changing structures within primary care and have developed systems to report data at clinical commissioning group level.

Support provided by the RDTC in prescribing and medicines management aims to help primary care organisations address some of the challenges associated with high deprivation and high disease prevalence and the impact these have on the prescribing budget. Regular prescribing data comparing organisations motivates organisations to make changes to prescribing, particularly in areas where they may be considered to be outliers. Highlighting areas where savings could be made and cost effectiveness improved assists stakeholders to target therapeutic areas in the localities where further investigation may yield cost savings that enable more patients to be treated, and / or can be invested in other areas of prescribing or services.

Prescribing budget management

The data presented in our Monthly Performance Summaries and Quarterly Reports assist advisers and commissioners in identifying drugs and therapeutic areas where investment or conversely, disinvestment may be required.

The Monthly Performance Summary continues to show comparative information on SHA, PCT, North of England and national prescribing outturn against budget, cost and item growth, generic prescribing rates, per capita prescribing costs and frequency. A quarterly addendum to this report presents expenditure and cost growth of the Top 40 most costly drugs in the same format as the Top 40 most costly BNF sections (see Figure 9). Stakeholders can now select how many of these Top 40 drugs to display (5 to 40) and how cost growth data are presented (in percentage or monetary terms). Displaying growth in terms of increased expenditure compared with the same period in the previous financial year assists the user in identifying particular drugs that are driving cost growth.

The Quarterly Report shows comparative information focusing on therapeutic areas (BNF sections) accounting for the highest expenditure. PCT-Level cost and item growth charts presented in an addendum identify each stakeholder PCT’s highest cost and item expenditure and growth - the user can choose how many (5 to 40)


sections are displayed (see Figure 9). Cost and item growth can also be displayed in a table as percentages or as increased expenditure / number of items compared with the same period in the previous financial year. This helps the user focus on BNF sections that may require further more detailed investigation at local level. Overall cost trends and detailed breakdowns of the drugs in the therapeutic classes prescribed (cost and frequency) help to highlight where review of drug choice may be appropriate.

Figure 9Expenditure and cost growth of the top 10 BNF sections (by cost) in the North of England for the

financial year 2011/12 compared with 2010/11

Cost Savings report

One Cost Savings Report was produced in March 2012. It includes data on prescribing of the antidepressants venlafaxine and escitalopram and estimates of potential savings resulting from switching from modified-release (M/R) capsules to immediate-release (I/R) venlafaxine tablets (see Figure 10), venlafaxine M/R capsules to M/R tablets, and escitalopram to citalopram. The aim of this report is to aid PCTs who are working on this therapeutic area as part of their QIPP programmes. Various support materials were kindly provided by several stakeholders who had worked on these formulation switches, and these are available on the Shared Resources section of the RDTC’s NHS website for others to share.

Cost impact estimates report

In June 2011, this new report, which analysed the potential impact on prescribing costs of implementing the NICE Technology Appraisal review on drugs for Alzheimer’s disease was produced to assist decision-making groups assess the impact of this guidance on their local health economies. Data on prevalence and projected prevalence from QOF and the North East Public Health Observatory, as well as prescribing data, were incorporated into this report, which presented various possible future scenarios.


Figure 10Examples of the potential monthly savings that could result from switching 70% of venlafaxine M/R capsules to I/R tablets

(based on prescribing data for December 2011

QIPP reports

In 2011/12, we continued to produce these reports, which enable medicines management teams to benchmark and monitor changes in prescribing in therapeutic areas where programmes to change practice have been initiated. These reports are tailored to the specific requirements of stakeholders working on prescribing aspects of the QIPP agenda. For the North East and North West stakeholders, data on specific key performance indicators related to prescribing were produced quarterly, and these data were replicated at practice-level for some stakeholders. The Yorkshire & The Humber quarterly QIPP report presented a PCT-level overview of prescribing in therapeutic areas requested by stakeholder medicines management teams, as well as selected therapeutic areas in the National Prescribing Centre’s Key Therapeutics Topics for QIPP.

‘NCSO’ reports

We continued to produce these reports, which were first produced in January 2011, until July 2011. The aim of this report was to alert stakeholders to the potential cost impact of unexpected / temporary price increases of generic drugs where the Department of Health agreed to allow “no cheaper stock obtainable” (NCSO) endorsements and concessionary price increases to apply to drugs in short supply. Many of the drugs involved were commonly prescribed, and the increased costs were considerable at a time of financial constraint. By July 2011, the majority of the supply issues had been resolved and the impact of such price changes had diminished (see Figure 11). The situation continued to be monitored, but it was not necessary to produce this report for the remainder of the financial year.


Figure 11Example of total extra costs incurred in the North of England as a result of NCSO and concessionary price increases

May 2010 - July 2011

To further support the QIPP agenda our Drug Updates are produced in response to regular multidisciplinary scoping exercises to identify topics that have the potential to improve the quality of care and release substantial efficiency savings, whilst maintaining or improving patient safety. With the aim of reducing variation in care and outcomes, Drug Updates provide concise, structured reviews of drugs which have been available within the UK for some time. Many of these publications include clear cost charts comparing the range of appropriate products for that particular disease state. These provide a powerful message to prescribers about the wide variation in costings that is often seen. To help support the delivery of QIPP a number of academic detailing aids have been produced to complement the Drug Update series. Through its horizon scanning role, the RDTC aims to identify further areas where it is possible to improve the quality of care and release substantial efficiency savings.

Cost Comparison Charts

Updated quarterly, these charts show, at-a-glance, comparative treatment costs of drugs in therapeutic classes (BNF sections).

Switch Savings Calculators (SSCs)

This tool, which calculates savings that will result from switching one drug or formulation to another with the same / similar therapeutic effect or constituents, respectively, was changed from individual web-based calculators to a flexible downloadable Excel® version including all our SSCs. This is now available on the RDTC’s NHS website.


Medicines Information / NHS Direct

While the RDTC hosts the UK Teratology Information Service (UKTIS), our Medicines Information service also acts as the UKMi national specialist medicines information service for teratology enquiries, providing information on the effects of drug exposures on the fetus. Because of the large volume of enquiries and the requirements of the HPA, all enquiries, except those referred from NHS Direct, are handled and reported separately to MI enquiries. NHS Direct pregnancy enquiries were recorded with the general MI enquiries.

In the year 2011/12 the RDTC answered 1467 MI enquiries (875 general, non-pregnancy and 592 therapeutic pregnancy) from all stakeholders in the former Northern and Yorkshire region. A total of 1165 (79.4%) enquiries were from primary care (807 general MI and 358 therapeutic pregnancy enquiries). This is similar (-3.7%) to last year’s total primary care enquiries (1211).

Most general medicines information enquiries originated from primary care (Figure 12). During 2011/12, the number of general non-pregnancy enquiries from primary care remained stable compared to last year (807 from 812). The number of enquiries from secondary care was slightly lower than in 2010/11 (46 compared with 58). Due to alterations to the national SLA we no longer took enquiries from NHS Direct which had counted for 29% of MI enquiries in 2010/11.

Most of the non-pregnancy enquiries from primary care came from community pharmacists (362), general practitioners (438), PCT pharmacists (222) and primary care nurses (63) (Figure 13). “Other NHS” represents enquirers where each had a low number of enquiries. This includes enquiries from dentists and allied healthcare professionals. “Non NHS” includes prison pharmacists and the police.

Figure 12Medicines Information Enquiries 2011/12 by local origin


All medicines information enquiries received are reviewed monthly to identify any common issues facing the PCTs that commission our services. This information is then discussed in our regular publications meetings, with consideration given to an in-depth review of evidence, following which a UKMi Q&A or Drug Update on the topic may be published.

Figure 14 provides detail of the types of enquiries answered during 2011/12 from primary care in the former Northern and Yorkshire region. “Other” enquiries include those categorised as dental, renal and hepatic disease, compatibility of injectables and travel medicines

Figure 13All Medicines Information Enquiries from Primary Care 2011/12 by Enquirer

Figure 14All Medicines Information Enquiries from Primary Care 2011/12 by Enquiry Subject


The RDTC contributed to the Medicines Question and Answer documents which are available on the NeLM website (www.nelm.nhs.uk). Medicines Q&As are evidence based, fully referenced answers to commonly asked MI enquiries. In 2011/12 the RDTC reviewed four and completed eight new Q&As and comfortably exceeded our UKMi target of six. Our senior MI pharmacist is accreditated to lead on, check and sign off Q&As. Certain Q&As are used by NHS Direct and are available on their intranet. We also reviewed and updated our document on Travel Health as part of the UKMi ‘Thinking Ahead’ series.

Those Q&As produced by the RDTC include:

Is memantine effective in the treatment of nystagmus?• Do Statins cause amnesia?• Do gastric adverse events influence the choice of bisphosphonate for the treatment of osteoporosis?•

Some of those Q&As written by the RDTC have been selected to be included in summary form in the Clinical Pharmacist.

Which medicines can cause neuroleptic syndrome? CP 2012;4: 175• How do different enteral feeding tubes affect drug administration? CP 2012;4: 142• How should ankle oedema caused by calcium blockers be treated? CP 2011;3: 308•

We are one of the authoring centres for the New Medicines Section of the Prescribing Outlook Series - a horizon-scanning publication providing independent and evaluated information on new drugs and reducing duplication of effort across the UK.

Regular meetings of the local MI Network have been held at the RDTC to promote national UKMi activity, deliver CPD and encourage and support collaboration between MI specialist pharmacists and their respective centres.

NHS Direct

During 2011/12 we continued to provide support to NHS Direct in a number of key areas through a national NHS Direct / UKMi service level agreement.

Reorganisation, cost improvement measures and preparation for competing for the 111 service at NHSD led to a different focus for delivery of the SLA in 2011/12.

These changes have prompted the development of alternative support mechanisms (such as additional UKMi prepared factsheets, Q&As, and delivery and development of different modes of training).

http://www.toxbase.org


‘...more of your excellent monographs on Toxbase please...’

During 2011/12 UKTIS produced more written information than in previous years.

Monographs

UKTIS consistently receive comments and feedback requesting more monographs as a top priority. This is reflected in the trend of service use over the past 5 years which shows a decrease in telephone enquiries and increased use of online monographs. Delivering more documents without compromising accuracy has presented a challenge given the increasing complexity and volume of relevant published data. Additional scientific staff members have however enabled UKTIS to produce 109 new and updated pregnancy monographs during 2011/12 (Table 5), a 9% increase on the previous year. The move to a new style of monograph, as described previously, will hopefully facilitate more efficient updating of monographs in the future, whilst supporting easy interpretation of the data by service users.

Teratology


3,4-DAP Escitalopram Paint

Acamprosate Etanercept Paroxetine

Adalimumab Ethylene glycol Phosgene

Adenosine Eyedrops Phosphine

Alendronic Acid Fluoxetine Photographic chemicals

Allergic rhinitis Gabapentin Pilocarpine

Anthelmintics Glaucoma Piperazine

Anthrax Glibenclamide Pregabalin

Arsenic Hydrocarbon solvents Primodos

Arsine Hep B Vaccine Prussian blue

Benomyl Hepatitis A Vaccine Pyridostigmine

Beta Interferon Hot tubs Ricin

Bisphosphonates Hydrogen Sulphide Rifampicin

Butane Hydroquinone Rituximab

BZ (Agent 15) Hyoscine Sarin

C1 esterase Inhibitors Insulin Sertraline

Carbamates Insulin glargine Sodium thiosulfate

Carbamazepine Latanoprost Soman

Chlorine Lewisite SSRIs

Ciprofloxacin Malarone Strychnine

Citalopram Mebendazole Sulphur Mustard

Cocaine Mifepristone Sulpiride

Corticosteroids Metformin Sunbed

CS Gas Methyl ethyl ketone Tabun

Cyanide Methyl Isocyanate Tacrolimus

Cyclosarin Minocycline Tetracycline

Cyclosporin Misoprostol Tetrodotoxin

Diabetes Mellitus Morphine Thallium

Diazepam Natalizumab Tobacco

Dicobalt Edetate NRT Topiramate

Dihydrocodeine Obesity Tranexamic Acid

Disulfiram Occupational cytotoxic medication Trichloroacetic acid

DMSA Ondansetron Typhoid

Dosulepin Organophosphate poisoning Valproate

Duloxetine Oxytetracycline Venlafaxine

ECSTASY UX

EGBE Xylene

Table 5New and updated pregnancy exposure monographs added to TOXBASE in 2011/12


Prevention of Harm

Overview

Prescribing reports as well as evidence based reviews served to support ongoing work in this area. Within the work of the Yellow Card Centre, total reports for 2011/12 rose by 25% with a notable increase of 40% in GP reporting. Short, individualised versions of earlier annual reports were circulated to PCTs and hospital Trusts. Reporting from hospital pharmacists rose by 51%, reversing the gradual decline of earlier years. This was eclipsed by the 92% increase in community pharmacist reporting following promotional activity. Over half of the top enquiries to UKTIS related to the use of various antidepressant therapies in pregnancy, with just under half of enquiries relating to women who had already been exposed to a drug or chemical

Prescribing SupportThis year we produced a new prescribing report (non-steroidal anti inflammatory drugs), updated two (antipsychotics and quinine) that focused on patient safety, and published two Safer Medication Use (SMU) reviews.

NSAID prescribing

This report presented prescribing data to accompany news published in October 2011 on the relative cardiovascular (cv) risks associated with NSAIDs, and to complement national QIPP NSAID benchmarking. Prescribing frequency trends for NSAIDs and diclofenac (an NSAID particularly associated with CV risk) and a breakdown of the relative prescribing frequencies of individual NSAIDs were included. In addition, trend charts showing the proportion of ibuprofen + naproxen (NSAIDs considered to be associated with the lowest cv risk) prescription items as a percentage of all NSAID items (a national QIPP prescribing comparator) were

Figure 15Example of trends in the national QIPP NSAID prescribing comparator April 2007 - June 2011

Key: QIPP %: proportion of ibuprofen + naproxen prescription items as a percentage of all NSAID items


presented. Therefore, a high ibuprofen + naproxen percentage is considered to reflect good prescribing practice. Overall, this percentage has been increasing progressively in most stakeholder PCTs (see Figure 15, page 38).

Antipsychotic prescribing

In August 2011, the Primary Care Prescribing of Low-dose Antipsychotics Report was updated. This report was first produced in June 2010 to provide PCTs with benchmarking and trend data for low-dose antipsychotic prescribing. Such data were required subsequent to publication of the DH report ‘The use of antipsychotic medication for people with dementia: Time for action. November 2009’, in which the use of antipsychotics in elderly patients with dementia was examined, revealing an unacceptable level of deaths as a result of being prescribed such medication. Reducing prescribing of low-dose antipsychotics in these patients is now a national priority, and it is included in the NPC’s key therapeutic areas for the QIPP agenda. As yet, no national benchmarking data are available, and no national prescribing comparator has been developed, so the data presented in this report provide stakeholders with information on changes in prescribing (although it has to be remembered that low-dose antipsychotics are prescribed for many different indications, which confounds the use of prescribing data in this context).

Quinine for nocturnal leg cramps

This report was first produced in June 2010 to promote the safety advice issued by the Medicines and Healthcare products Regulatory Agency (MHRA) in its June 2010 Drug Safety Update. The MHRA recommended that quinine should not be prescribed routinely for nocturnal leg cramps. The initial report provided benchmarking data (up to March 2010) on quinine prescribing, it was updated six months later to ascertain whether prescribing had changed, and where it had, the relevant PCTs were contacted to find out how, and information that could be shared with other stakeholders was requested. In November 2011, a further update was produced and more support materials were obtained and made available on the RDTC’s NHS website. The update shows evidence of reductions in quinine prescribing in several stakeholder PCTs since the MHRA issued its advice, but almost all PCTs show higher prescribing than England.

Safer Medication Use reviews

The two SMUs covered the use of statins from the perspectives of managing adverse drug reactions and managing drug interactions. Appropriate prescribing advice on the management of these situations was included and guidance provided as to when adverse drug reactions should be reported to the MHRA.

Controlled drug (CD) prescribing report

The quarterly Controlled Drug Prescribing Report presents, at PCT level, trends in prescribing frequency and breakdowns of prescribing of drugs in the various controlled drug (CD) schedules. These reports can provide a starting point for further local analysis at practice level.

Antimicrobial prescribing report

This biannual report presents comparative data, including prescribing frequency trends of various types of antibiotics. In particular, the cephalosporin, quinolone and minocycline prescribing frequency trend charts enable PCTs to monitor changes in their prescribing, as reduced prescribing of these classes of antibiotic is included in the National Prescribing Centre’s QIPP document. An example of such a trend chart is shown in Figure 16.


Figure 16Weighted minocycline prescribing in the North of England SHAs April 2008 - March 2012

Key: Item - one item on a prescription form; antibacterial STAR-PU - specific age-related therapeutic prescribing unit, based on prescribing frequency, that relates the age and sex of patients for whom antibiotics are usually prescribed

Non medical prescribing report

This report is produced annually, and highlights general trends in prescribing costs across all BNF sections, and also focuses on therapeutic areas that are most frequently prescribed by non-medical prescribers.

Medicines Information

Two prescribing reports focused on patient safety

annual report 2011/12 - UKTIS Report (FINAL 09-10-2012).pdf · RDTC ANNUAL REPORT 2011/2012 5...

Documents

Transcript of annual report 2011/12 - UKTIS Report (FINAL 09-10-2012).pdf · RDTC ANNUAL REPORT 2011/2012 5...