Newsletter - WHO | World Health Organization Newsletter • Page 2• VOL. 20, N 3 (Special issue on...

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ISDB Newsletter • Page 1 • VOL. 20, N° 3 (Special issue on INNs),NOVEMBER 2006 Column INN: an essential tool A drug’s INN is its internationally recognised scientific name. Employed both by patients and healthcare pro- fessionals the INN frees users from the commercial names used by the drug companies. INNs restore each player to his or her proper role: the prescriber can concentrate on patient care, the pharmacist on monitoring drug treatments, and the patients on the informed use of drugs. With consumers and patients being bombarded with advertising for brand names (TV commercials for direct-to- consumer advertising in the United States), it is high time for healthcare professionals, consumers and healthcare providers to unite and promote not-for-profit education that uses drugs’ real names, i.e. INNs. ISDB bulletins can play a great role in favor of INN use (see results of ISDB survey on INN use pages 2-14). INN prescribing and dispensing should be professional practice; it contributes to rational drug use, reduces waste, and prevents medication errors. In short, it promotes better care (see “Think INN, Prescribe INN, Dispense INN” pages 5-10). Trying to teach INN use to readers is an important issue. Pijus Sakar in Bodhi’s March-April editorial couldn’t have been clear- er: “How many doctors in our country use on principle INNs in their prescrip- tions? The number by all esti- mates must be microscopic and that it is a pity. (…) Some prescribers yield to the prevailing culture and toe the line. We want to remind them that it is not merely a question of using one name for another. It is on the other hand, a con- flict of two cultures; a choice between the role of a stooge of some giant pharmaceutical companies and the still small voice of conscience. (…) Let us start using INNs in our prescriptions. Let us make the commitment today, for tomorrow may be too late.” Campaigning for INN use is spreading thanks to ISDB bulletins (see “Bulletin Roundup” on pages 12-13). It will take more than a few months for INNs to be widely adopted, and it will take determination, patience and persuasion. With INNs, everything is simpler, clearer and more precise. Let’s continue to regularly push in favor of INNs! ISDB Survey on INN Use of INNs among members ......................................................2 Good professional practice Think INN, prescribe INN, dispense INN ......................................5 INNs and generics: different things ..............................................11 INN use: proposals for improvement ............................................11 Bulletins Roundup ........................................................................12 Primary research on INN issues Prescribing drugs by INN ............................................................14 A survey on the place of INN in initial education ........................14 Editorial methods Leaflets in favor of INN use ........................................................15 Common stem ............................................................................16 Good sources WHO INN website ......................................................................17 Contents Newsletter November 2006 RESTRICTED TO MEMBERS News of ISDB Executive committee meeting: minutes ...................................18 Ongoing campaigns Joint Declaration: Relevant Health Information for Empowered Citizens ..........................................................19 ISDB survey on INN use: complete answers to the questionnaire ..................................................................20

Transcript of Newsletter - WHO | World Health Organization Newsletter • Page 2• VOL. 20, N 3 (Special issue on...

ISDB Newsletter • Page 1 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

Column

INN: an essential tool

Adrug’s INN is its internationally recognised scientificname. Employed both by patients and healthcare pro-

fessionals the INN frees users from the commercial namesused by the drug companies.

INNs restore each player to his or her proper role: theprescriber can concentrate on patient care, the pharmaciston monitoring drug treatments, and the patients on theinformed use of drugs.

With consumers and patients being bombarded withadvertising for brand names (TV commercials for direct-to-consumer advertising in the United States), it is high timefor healthcare professionals, consumers and healthcareproviders to unite and promote not-for-profit education thatuses drugs’ real names, i.e. INNs.

ISDB bulletins can play a great role in favor of INN use(see results of ISDB survey on INN use pages 2-14).

INN prescribing and dispensing should be professionalpractice; it contributes to rational drug use, reduces waste,and prevents medication errors. In short, it promotes bettercare (see “Think INN, Prescribe INN, Dispense INN” pages5-10).

Trying to teach INN use to readers is an important issue.Pijus Sakar in Bodhi’s March-April editorial couldn’t have

been clear-er: “Howmany doctorsin our countryuse on principleINNs in their prescrip-tions? The number by all esti-mates must be microscopic and that it is a pity. (…) Someprescribers yield to the prevailing culture and toe the line.We want to remind them that it is not merely a question ofusing one name for another. It is on the other hand, a con-flict of two cultures; a choice between the role of a stoogeof some giant pharmaceutical companies and the stillsmall voice of conscience. (…) Let us start using INNs inour prescriptions. Let us make the commitment today, fortomorrow may be too late.”

Campaigning for INN use is spreading thanks to ISDBbulletins (see “Bulletin Roundup” on pages 12-13). It willtake more than a few months for INNs to be widelyadopted, and it will take determination, patience andpersuasion. With INNs, everything is simpler, clearerand more precise. Let’s continue to regularly push infavor of INNs!

ISDB Survey on INN Use of INNs among members ......................................................2

Good professional practice Think INN, prescribe INN, dispense INN ......................................5INNs and generics: different things ..............................................11INN use: proposals for improvement............................................11

Bulletins Roundup ........................................................................12

Primary research on INN issuesPrescribing drugs by INN ............................................................14A survey on the place of INN in initial education ........................14

Editorial methodsLeaflets in favor of INN use ........................................................15Common stem ............................................................................16

Good sourcesWHO INN website ......................................................................17

Contents

News let terNovember 2006

RESTRICTED TO MEMBERS

News of ISDBExecutive committee meeting: minutes ...................................18

Ongoing campaignsJoint Declaration: Relevant Health Information for Empowered Citizens ..........................................................19

ISDB survey on INN use: complete answers to the questionnaire ..................................................................20

ISDB Newsletter • Page 2 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 2 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

ISDB Survey on INN

A number of ISDB members havelaunched a campaign to raiseawareness among healthcareprofessionals and the public about theneed to use INNs. The aim of this ISDBsurvey is to get a clearer picture of INNuse in ISDB bulletins and in theircountries.

Methods

5 questions were asked to ISDB mem-bers via the ISDB forum:

1. Do you use INNs, trade names, orboth, for designating drugs in all of yourarticles? If so, do you use special prints(italics, CAPITAL letters, else?) to distin-guish INNs from trade names? Pleasespecify your editorial policy if any.

2. Have you encouraged healthcare pro-fessionals to use INNs instead of tradenames, or do you intend to do so? How?

3. Do you encourage patients and con-sumers to become aware of INNs? If so,what kind of actions have you undertak-en?

4. In your country, is the medical/phar-maceutical communication INN- or tradename- oriented (in academia, profession-al meetings, continuing education, publichealth bodies)?

5. Have you got any comment on yourexperience, success and/or difficultieslinked to the use and acceptability ofINNs?

The answered were collected inAugust/September 2006.

Results and discussion

The answers were collected come from24 different countries worldwide andfrom 31 different bulletins. You’ll findbelow the main trends as shown inanswers (see appendix to this Newsletterpages 20-27 for complete answers to the

questionnaire, country by country andbulletin by bulletin: available in the fulltext version of this Newsletter; to bedownloaded from the “Member only sec-tion” of ISDB Website).

A majority of ISDB bulletins preferINNs for designating drugs in theirarticles, but also help the reader withcorresponding and well known tradenames. Almost all ISDB members have aclear editorial policy and use INNs intheir articles (one exception for mandato-ry reason: a drug agency bulletin has touse trade names (Sweden); one bulletinprefers trade names in 3 exceptionalcases: combination drugs, medicaldevices, and vaccines).

ISDB bulletins try to make INNs par-ticularly visible to readers. Differentmethods are used: style (italics, bold, oreven capital letters (1 bulletin), colors (3bulletins), etc.

ISDB bulletins are aware that readersoften know only trade names. A majorityof bulletins systematically mention tradenames the first time the INN is used fordesignating a drug. The trade name is inmost bulletins written in brackets, withthe first letter in capital (or entirely in cap-ital letters in 2 bulletins), and accompa-nied by a sign in subscript (® or °) (in onecase the trade name is also followed bythe name of the drug company). 3 bul-

letins chose to not use any trade names intheir reviews; they use correspondingtables at the end of their articles, listingthe main trade names corresponding tothe INNs cited.

Some bulletins have specific rules,according to 2 types of constraints: spaceand editorial policy.

Limitation of space doesn’t allow alltrade names to feature in tables at the endof short articles: they use INNs accompa-nied with trade names in brackets the firsttime INNs are mentioned in the article.

Editorial policies can differ from sec-tion to section of the same bulletin.Editorial policies often reflect the editori-al aim in a specific context. For instance,some bulletins prefer trade names whenthe text refers to specific aspects of aproduct or when they have to deal withmajor adverse drug reactions, or in caseof litigation.

Many ISDB bulletins encouragehealthcare professionals and/or con-sumers to use or get accustomed toINNs. The answers to questions 2 and 3are presented together in the followingtable, classifying the bulletins accordingto the mean used to encourage INNs: arti-cles dedicated to INNs or generics (readpage 11 of this Newsletter “INNs andGenerics: different things”), workshops,campaigning in favor of INN use.

USE OF INTERNATIONALNONPROPRIETARY NAMES (INNs)AMONG MEMBERSAn ISDB survey

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ISDB Survey on INN

Bulletins that wrote specific articles onINN issues seem to be more likely tocampaign and to encourage INN use inpatients and consumers, even if theirreaders are mostly healthcare profession-als.

Several joint campaigns are underway(3 ISDB bulletins together in Italy,Medecines in Europe Forum togetherwith consumers and health professionalsin France).

Medical/pharmaceutical communi-cation worldwide: the private sector ismainly trade name oriented, due topharmaceutical companies influence.All over the world (except in the UK),trade names are mainly used in the “pri-vate sector” (healthcare professionalsmeetings, trainings, continuing education,etc.). Of note, the influence of pharma-ceutical companies was explicitly men-tioned 7 times to explain the use of tradenames in communication (sponsoringmeetings and advertising). Prescribingassistance software that compels pre-scribers to use trade names make INN usevery difficult if not impossible.

In the “public sector”, scientific publi-cations and educational basic books aremainly INN based. In some countrieswith an Anglo-Saxon culture (Australia,Canada, England, New Zealand) and inother countries (Nepal, Nicaragua,Croatia, Czech Republic, Slovenia), aca-demia uses mainly INNs, often for practi-cal reasons (the drug lists in hospitals is inINNs, etc.) or because it’s mandatory inthe “public sector” (Nicaragua). In othercountries academia and hospitals tend touse mainly trade names (France, India,Netherlands, etc.).

Drug regulatory agencies or theirequivalent use both trade names andINNs in the majority of countries. On thisissue, one underlying impression is that:“in academia, professional meetings, con-tinuing education and even public healthbodies tend to use INN especially in deal-ing with adverse reactions/events andineffectiveness of a special drug. Butwhen they deal with the positive aspectsof a medicine, they tend to prefer brandnames.”

The role of policies in favor of genericsfacilitating INN use was pointed out(Australia, Germany, Switzerland, etc.),with a risk of confusion between INNsand generics.

The importance of labeling and drugpackaging was underlined as a key issueto improve INN visibility. On drug pack-aging, INNs are usually mentioned insmaller size than brand names. Even withgenerics, which usually mention the INNfollowed by the name of the company,there is a tendency in some countries(Germany, Australia, etc.) to brand thename in order to improve marketing com-munications.

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INN acceptability: difficulties mainlyreported by healthcare professionalsand proposals for improvement. Manyanswers cited the same difficulties forINNs to be widely accepted by healthcareprofessionals, particularly specialists andgeneral practitioners.

Healhcare professionals’ resistancemainly comes from:

- a confusion between INN names andgeneric products (mentioned 5 times). Insome cases, doctors do not wish to allowpharmacists to choose among severalcopies of a drug that is available as gener-ic on the market, forgetting that theycould write the trade name in bracketsnext to the INN to prevent the pharmacistfrom replacing. Confusion with genericscan also slow down INN use in a doubtfulgeneric quality context (see “BeingConvinced that Generics are Better” page12 in this Newsletter).

- pharmaceutical company influence(mentioned 4 times): financial advantagesfor pharmacists or doctors linked to theuse of trade names may slow downhealthcare professionals’ interest in INNs.

- habits (difficulty to change mentioned3 times).

INN prescribing faces some limits:drugs with narrow therapeutic margins,formulations (combinations, insulinsetc.), patients at particular risk of memo-ry disorder (elderly).

Unlike healthcare professionals, con-sumers seem to appreciate initiatives infavor of INNs, leading to more trans-parency and understanding of the drugsused. The confusion with generics canalso be an obstacle to INN use for con-sumers which have experienced repeatedchanges in generics, which preventthe INN to be identified.

Many simple improvementsto overcome these obstacleswere proposed. Amongthem the roles of regulato-ry bodies and policy mak-ers (amending regula-tions, etc.) were stressed(4 times). Drug regulato-ry agencies should useINNs instead of tradenames in their commu-nications and on web-sites, and INN prescrib-ing should be lawful incountries where it is not,etc.). Another simple

improvement cited was a bigger labelingsize of INNs on drug packaging in orderto avoid confusion.

Conclusion

Nearly all ISDB members use INNs intheir articles. INN prescribing is some-times confused with generic prescribing,which can be an obstacle to INN use, clar-ification is therefore needed. The need toencourage INNs is accepted by the major-ity of ISDB members. Research testingacceptability of INNs and regulatorychanges are underway in a number ofcountries. ISDB bulletins can play amajor role in raising awareness and cam-paigning for INN use. Improvement inhealth policies and regulations wouldhelp increase INN use in many countries.

Christophe Kopp and Florence Vandevelde

Many thanks to those of you whoanswered the questionnaire (in the alpha-betical order of the country): Australia: John Dowden (The Australian Pre-scriber); Bangladesh: Zahed Masud (Drug andhealth); Burkina Faso: Clotaire Nanga (La Let-tre du CEDIM); Canada: Ciprian Jaunca (Ther-apeutics Initiative); Croatia: Bozidar Vrhovac(Bilten o lijekovima & pharmaca); CzechRepublic: Blanka Pospisilova (Farmacoter-apeuticke Informace); France: Christophe Kopp(La revue Prescrire, Prescrire International);Germany: Wolfgang Becker-Brüser (arznei-telegramm); Jörg Schaaber (Pharma-Brief);India: Pijus Sarkar (Bodhi and Asukh Bisukh);P.K. Lakshmi (DIC Newsletter); Indonesia: SriSuryawati (Lembaran Obat dan Pengobatan);Israel: Philip Sax (Pharma Drug Bulletin); Italy:Maria Font (Dialogo sui Farma-

www� For more details on theresults, see annex to thisNewsletter (pages 20-27), avail-able in the full text version.

Full text version to be downloadedfrom the “Member only section” ofISDB Website or on request (contact:[email protected]).

ISDB Survey on INN

ci); Anita Conforti (Focus PharmacovigilanceBulletin) ; Maurizzio Bonati (Ricerca & Prati-ca); Japan: Rokuro Hama (Kusuri-no-Check);Kyrgyz Republic: Baktygul Toktobaeva (DrugInformation Center); Moldova: Natalia Ceb-otarenco (Medex Drug Info Moldova); Nepal:K.K.Kafle (Drug and Therapeutics Letter); Bhu-pendra B. Thapa (Drug Bulletin of Nepal);Netherlands: Dick Bijl (Geneesmiddelenbul-letin); New Zealand: Sarita Von Afehlt (Pre-scriber Update); Nicaragua: Benoit Marchand(AIS-COIME); Slovenia: Jelka Dolinar (Far-makon); Spain: Joan Ramon Laporte (ButlletíGroc); Sweden: Björn Beerman (Informationfrom Läkermedelsverket); Swizerland: EtzelGysling (Pharma-Kritik (Infomed)); UnitedKingdom: Andrea Tarr (Drug and TherapeuticsBulletin).

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Good professional practice

Translated from Rev Prescr September 2000; 20 (209): 606-623

THINK INN, PRESCRIBEINN, DISPENSE INNGood professional practice

� International nonproprietary names(INN) for drugs were invented aboutfifty years ago, under the aegis of theWorld Health Organisation, to providea common language for health profes-sionals and patients worldwide.

� No country forbids INN prescrip-tions. Some countries actively recom-mend using INNs.

� INN prescription empowers pre-

Abstract scribers and pharmacists in their choiceof treatment.

� The choice between a prescriptionbased on the INN or the brand namewill depend on the type of treatment(short term or chronic), the nature ofthe drug (especially its therapeutic mar-gin) and any specific risks related tothe patient (age,disease condition,aller-gy, and adherence).

� A pharmacist’s decision to dispensea brand name drug from an INN pre-

scription must be based on usual dis-pensing precautions.

� Adopting INN prescribing meanshaving to reflect on one’s knowledge ofdrugs, and to challenge the quality ofone’s initial and continuing educationin pharmacology and therapeutics.TheINN system is a means of improvingprescribing and dispensing practices :it involves paying more attention to thepatient, explaining the treatment ingreater detail, and respecting his/herchoice.

REPRINT Extract from “Think INN, Prescribe INN, Dispense INN” Prescrire International 2000; 9 (50) : 184 - 190.

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Synthetic and semisynthetic sub-stances are designated in severalways, in addition to the internal

coding system used by the company:-the chemical name, which is oftenincomprehensible to the non specialistand may vary according to the inter-pretation of the chemical nomenclature;-the chemical formula, which can beused to calculate the molecular weight,but is otherwise not very useful;-the entire formula, which is a graph-ic representation of the chemical com-position; its significance is clear for thechemist but not for the non specialist; - the Chemical Abstracts Service regis-tration number, or CAS RN, which isattributed to all products mentioned inreports published since 1965; it is a goodidentifier but is also somewhat obscure;- registered trademarks, which can benumerous, differ from country to coun-try, and suggest little or nothing of thenature of the substance or its properties; -finally, the international nonpropri-etary name, or INN (a)(1).

A WHO mission. The explosion inchemical synthesis of drugs in the earlytwentieth century rapidly led to prob-lems of nomenclature. The first attemptto coordinate nomenclature programmesin the United States, the UnitedKingdom, Scandinavia and France wasin 1945 (2). Following a resolution bythe World Health Assembly in 1950, theWorld Health Organisation (WHO) wascharged with setting up an INN systemby 1953 (b)(3).

Currently, INN claims are submittedto WHO by national nomenclaturecommissions or directly by pharma-ceutical companies. They are accom-panied by precise information on thechemical nature of the substance, itspharmacological activity and its field ofuse (3,4).

A precise code. After examiningeach application, the WHO expertgroup on the International Pharmaco-poeia and pharmaceutical preparationsproposes a INN that:- is clearly recognisable, both when

written and spoken;- is short;- is unlikely to be confused with othercommonly used names;- comprises a key segment (suffix, pre-fix or mid-segment) common to all sub-stances of the same group, and basedon pharmacological activity or chemi-cal structure;- is adapted to the largest possible num-ber of languages (the letters “h” and“k”, “ae”and “oe” are avoided; the let-ter “f” is used instead of “ph”, etc.) (c).

The candidate INN is published in theWHO Drug Information Bulletin,

Chapter 1 - The INN system:a clear, international language

International non proprietary name paracetamol bromazepam (1)(INN)

chemical name 4’-hydroxyacetanilide 7-bromo-1,3-dihydro-5-(2-pyridyl)- or N-(4-hydroxyphenyl) acetamide 1,4-benzodiazepin-2-one

empirical chemical formula C8 H9 NO2 C14 H10 Br N3O

empirical chemical formula

Chemical abstracts service 103-90-2 1812-30-2registration number (CAS)

proprietary names in France (2) : Aféradol°, Claradol°, – in France : Anxyrex°, Bromazépam Compralsol°, Dafalgan°, Dolflash°, MSD°, Bromazépam-Ratiopharm°,Doliprane°, Dolko°, Efferalgan°, Fébrectol°, Bromazépam RPG°, Lexomil°, Quiétiline°Geluprane°, Oralgan°, Panadol°, – in other countries : Bromiden°, Gityl 6°, Paracétamol Bayer°, Paracétamol Biogaran°, Lexostad°, Lexotanil°, Normoc° (3)Paracétamol GNR°, Paracétamol Merck°, Paracétamol RPG°, Paralyoc°, Sédarène°

Naming drug substances: the examples of paracetamol and bromazepam

O

HO C CNH H3

1- The suffix -azepam generally corresponds to anxioylitic diazepam derivativesin the WHO list of key segments.2- In an indicative list, Martindale - The Complete Drug Reference cites234 proprietary names corresponding to single-agent paracetamol preparationssold in the 15 countries covered by this reference book, including Kratofin Sim-plex, St Joseph Aspirin-Free to Children, Finlweh and Miradol (“Paracetamol”.

In: Martindale - The Complete Drug Reference, 32nd ed, The PharmaceuticalPress London 1999: 72-75).3- We only cite a few European examples to illustrate the diversity (“Bro-mazepam”. In: Martindale - The Complete Drug Reference, 32nd ed, The Phar-maceutical Press London 1999: 643).

� �

a- National nonproprietary names, such as the BritishApproved Name (BAN) or United States Adopted Name(USAN), are not mentioned here, because they areincreasingly being replaced by INNs. European direc-tive 92/27/EEC recommends the use of INNs by allmember states.b- This task was conferred to WHO as part of its con-stitutional mandate to develop, establish and encouragethe adoption of international standards for foodstuffsand pharmaceutical and biological products (ref 3).c- INN lists are published by WHO in six versions:English, Latin, French, Spanish, Russian and Arabic(a Chinese version is planned), but differences betweenversions are minimal.

Good professional practice

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Good professional practice

and any comments and criticismsare collected over a 4-month period(d). The finalised candidate INNbecomes a recommended INN (rec.INN) and, once published, is definitive(5). A list of proposed and recom-mended INNs is published regularly (e).

According to the WHO departmentresponsible for the INN system, theselection process has become morecomplex in recent years owing to themultiple mechanisms of pharmacolog-ical effects and specificities claimed bypharmaceutical companies. New con-cepts have been adopted to designatebiotech products (f)(4,6).

Despite its critics the INN system con-tinues to play a crucial role, by simpli-fying identification of pharmaceuticalsubstances worldwide in a commonand fixed language.

d- The main criticism is that some INNs may be con-fused with brand names of competing substances (ref 5).However, confusion between INNs is less likely to occurthan between proprietary names (see note h, page 189).e- The INN list is available from http://mednet.who.intf- The key segment “mab”, for example, which desig-nates monoclonal antibodies, has sub-keys to indicatethe source of the product (for example, xi for chimeric)and the target disease or population (for example, cifor cardiovascular), giving rise to strictly coded INNs.Abciximab, for example, is a monoclonal antibody ofchimeric origin for cardiovascular indications (ref 13).

Chapter 2

INN prescribing haspharmacotherapeuticlimitations

Agiven drug formulation, doseand treatment duration is cho-sen to obtain a specific positive

effect. All drugs carry a risk of adverseeffects, which must also be taken intoaccount.

When prescribing or dispensing adrug, everything should be done tomaximise efficacy and minimise risks,notably by discussing the treatmentwith the patient. INN prescribing canfacilitate these goals, but may be inap-propriate in certain circumstances.

Short term versus chronicprescriptions

What matters when treating an acutecondition, such as traumatic pain or aninfection, is the choice of the active sub-stance and dose regimen. Short termtreatment is the ideal setting for INNprescribing.

INN prescribing is also appropriatewhen starting long term therapy. As inthe above setting a proper formulationcan be chosen easily, taking intoaccount problems with excipients andthe patient’s preferences. One consid-erable advantage is that the patient mayfind it easier to obtain the same drugwhen travelling abroad. The same drugcan be used for as long as necessary if itis safe and effective.

Switching to an INN can be done atthe time of the first repeat prescriptionbut pharmacokinetic, psychological andpractical problems may favour contin-uation of a brand name product.

Remember the excipients

Both adults and children may dislikeexcipients with certain tastes or smellsand may not continue to take treat-ments that include them. Otherpatients, for personal, cultural, religiousor other reasons, prefer one formula-tion rather than another (solid versusliquid, topical cream versus solution,

non alcoholic formulations, absence ofanimal gelatine, etc.). Some patientsmay have trouble dealing with certaintypes of packaging, such as tricky stop-pers or poorly labelled unit dosepipettes.

Prescribers and pharmacists shouldalso check that the preferred formula-tion does not expose patients to unjus-tified risks (intramuscular injection ver-sus oral intake, for example).

Some patients must avoid excipientssuch as saccharose, ethanol, sodiumand potassium (contraindication or riskof interaction); or preservatives such asmercury derivatives and quaternaryammonia (in eye drops), injected sul-phites and topical lanolin (known aller-gy). In these cases prescribing a brandname may be safer.

Psychological factors

INN prescribing can empowerpatients and increase their confidencein the treatment and the professionals.Some patients may be reluctant to useINNs, however. Indeed, familiarity witha given trade name may facilitateadherence by some patients. In thesecases the prescriber or pharmacistshould ask the patient if he/she has anyparticular preferences.

Bioequivalence

In France, bioequivalence betweentwo drugs is defined in the Public

NAMES

INN

BRAND

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Good professional practice

Health Code as “the equivalence ofbioavailability”, and bioavailability as“the rate and degree of absorption, from apharmaceutical formulation, of the activesubstance or its therapeutic fraction,designed to be available at the target site”.

The European Court of Justice con-siders that two drugs are bioequiva-lent if they are “equivalent or alterna-tive pharmaceutical products” and if“their bioavailability (degree and rate)after administration, at the same molardose, is so similar that their effects (effica-cy and safety), are essentially thesame” (7).

Strict bioequivalence is rarely neces-sary. But, in some circumstances over-dose or inadequate dosing should beavoided. This is particularly importantfor drugs with narrow therapeutic mar-gins, and for some patients with par-ticular risk factors (see inset page oppo-site) (g)(8).

Although reports of clinical prob-lems linked to a lack of bioequiva-lence are rare, recommendations mayvary from country to country, rang-ing from maintaining the same for-mulation for such drugs and patients,to close monitoring and detailedinformation for the patient whenswitching to INNs (8).

The bioequivalence of some phar-maceutical formulations and routesof administration is difficult todemonstrate by conventional meth-ods. This is especially the case whenplasma concentrations are low (top-ical preparations, metered-doseinhalers). In these cases it is best tocontinue with the same formulation.The same applies to preparations thatrequire training of the patient(inhalers, spacer devices for exam-ple), given the risk of errors (8).

Changing the appearanceof a drug may worrythe patient

Opponents of INN prescribing oftenargue that elderly patients and thosewith mental disorders are particular-ly at risk and that such patients maybe perturbed by an abrupt change inthe colour of his or her pills.

It is up to prescribers, pharmacistsand other care-givers to inform thepatient and to take any such problemsinto account. This also applies to pro-prietary drugs whose occasionalchanges in packaging, colour and shape

are not always clearly announced bydrug companies.

The patient’s preference

It is perfectly reasonable that a patientbearing an INN (or brand name) pre-scription should be able to chooseamong the different preparations con-taining the same substance, at the samedose, for the same route of adminis-tration, according to the drug’s shape,taste and price.

This particularly applies to commonanalgesics (e.g. paracetamol) and fre-quently prescribed antibiotics (parentsmay prefer some amoxicillin presenta-tions for their children, because of famil-iarity with a particular measuringdevice). Some patients will prefer theleast costly preparation.

Provided the above-mentioned phar-macotherapeutic risks are taken intoaccount, there is no reason to refuse

such requests. This may pose storageproblems for the pharmacist, whereasINN prescribing generally allows stocksto be reduced. A reasonable compro-mise can usually be found with thepatient.

g- Immunogenicity of proprietary drugs containing thesame substance but produced by different biotechnolo-gies (e.g. growth hormone) might differ. The few avail-able data do not currently confirm this potential risk(ref 8).

Pharmacotherapeutic limitationson INN prescription

The following list is by no means exhaustive. It takes into account international publi-cations and recommendations (1), and chiefly aims to highlight potentially risky cir-

cumstances which require extra care on the part of the prescriber and pharmacist. Inthese situations it may be preferable to prescribe or dispense brand names.

Drugs with narrow therapeutic margins:-anticonvulsants: carbamazepine, phenytoin, sodium valproate, primidone;-digitalins: digoxin, digitalin;-theophyllines;-quinidine;-oral anticoagulants;-diuretics (especially in very elderly patients).

Formulations:-solutions or powders for metered-dose inhalers (especially when the patient has diffi-culties handling the device);-sustained-release formulations, including patch delivery systems (especially when there aredifferent types, with different proprietary names, containing a given substance, in whichcase an INN prescription may lead to confusion (2));-topical forms (for highly active substances).

Patients at particular risk if a drug is switched:-epileptics;-very elderly persons (especially those with heart disease);-diabetic patients (when treatment monitoring is inadequate);-asthmatic patients (when they are not yet used to handling the different drugs);-persons with known allergy to certain excipients.

This list does not consider the psychological or psychosocial aspects that can also influ-ence the decision to prescribe by INN.

©PI

1- Prescrire supplement “Les médicaments génériques - De la pharmacologie à une politique rationnelle”.2- “Guidance on prescribing - General guidance”. In:“British National Formulary” British Medical Association- Royal Pharmaceutical Society of Great Britain, London March 2000; (39): 1-3.

ISDB Newsletter • Page 9 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 9 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

Good professional practice

INN prescribing avoids both the needto remember, and to choose from,a plethora of proprietary names.

This leaves the prescriber free to focuson diagnosis and treatment, and, ofcourse, on good prescribing practice.

Getting to know drugs

The database of the French data sheetcompendium contains about 11 000references corresponding to CIP bar-codes, each of which represents a pro-prietary name with a specific pharma-ceutical formulation, dosage and pres-entation (9). There are about 6 500 dif-ferent brand names. In contrast thereare only about 1 700 INNs on theFrench market (9).

There is clearly a higher risk of errorwith 6 500 brand names than with 1700 INNs (h).

Beware educational tools. Frommedical school onwards, pharmaceu-tical education often focuses on brandnames, in lectures, books and electronicmedia. Continuing medical educationalso tends to use brand names moreoften than INNs. Conferences, work-shops, brochures, professional journals,web sites, etc. also mainly use brandnames.

This is the inevitable consequenceof widespread funding by pharmaceu-tical companies which, in exchange,expect to see their brand names usedon prescriptions. As a result, health pro-fessionals do not always know the com-position of drugs they prescribe or dis-pense.

INNs facilitate access to inde-pendent information. “Thinking INN”helps one to become more familiar withthe active substances one prescribes ordispenses. This avoids, for example, inad-vertently prescribing combined drugshidden behind a single brand name (10).It also helps to avoid errors when thecomposition of a given preparationchanges without a corresponding changein the brand name(and vice versa) orwhen the same proprietary name is usedfor a range of preparations with differentcompositions.

To some extent, thinking in termsof INNs also frees the health profes-sional from the influence ofpharmaceutical advertisingcampaigns. By rejecting edu-cational material thatuses brand names infavour of comparativeinformation based onINNs, prescribers, phar-macists and otherhealth profession-als can improvetheir knowledge oftherapeutic strate-gies.

Drugs are desig-nated first (andoften solely) bytheir INN in reliable sources of com-parative information, treatment guide-lines, recommendations, clinical trialsand meta-analyses, whatever the coun-try. Health professionals who do notknow drugs by their INNs cannot seri-ously expect to keep up to date withthe latest independent information.

Prescribers and pharmacists:division of roles

It is up to pharmacists to check pre-scriptions (errors, dose regimen, inter-actions with concomitant treatments,etc.), and to explain (or re-explain) tothe patient the modalities and precau-tions for use.

The following information should benoted on the prescription:

- the patient’s name and sex (it is notalways the patient who comes to thepharmacy), age and, often, body weight(especially for children, and very thin oroverweight patients), and even thebody surface area in some cases;

- the INN, leaving it to the pharma-cist and patient to choose a specificproduct (this may be explicity men-tioned on the prescription).

If the prescription mentions a brandname, for a medically good reason, theprescriber should state it explicitly. Thepharmacist must then dispense the pre-scribed product, unless he or she finds

an error or problem that places thepatient at risk.

- the dose regimen and treatment peri-od: once the substance has been cho-sen, the prescriber can choose the for-mulation and dose regimen (unit dose,daily number of intakes, timing ofintakes, and duration of treatment) (i).

It’s not for the prescriber to worryabout how many drops there are pervial, or whether boxes contain 28 or30 tablets: the pharmacist has all thenecessary information to hand.

INN prescribing allows the pharma-cist to limit the number of otherwiseidentical preparations he/she stocks, inboth community and hospital phar-macies. This is one of the practical rea-sons for INN prescribing mentioned inthe British National Formulary (11).

Towards a common international drug terminology

At present in France, prescriptions inhospitals may be written in either theINN or the brand name. The patientreceives a drug with a brand name(sometimes different from the one pre-scribed), and the nurse who administersthe drug may be used to another brandname.

The same patient, on returning home,is generally prescribed the same treat-

Chapter 3

Four good reasons for INNprescribing

ISDB Newsletter • Page 10 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 10 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

Good professional practice

ment, usually under a brand name(sometimes different from the onereceived in hospital), and the drug heor she receives from the communitypharmacist can bear yet another brandname.

One of the patient’s acquaintancesmay be taking the same drug, but underanother brand name, or a very differentdrug with a similar proprietary name.In the family medicine cabinet, sever-al boxes may contain the same sub-stance under different brand names.

Use of the INN system throughoutthe health service would facilitate com-munication among health profession-als and patients provided, of course,that INNs are clearly legible on pack-aging.

When travelling abroad, it is impor-tant for patients to know the INN ofany drugs they are taking, mainly sothat they can obtain them more read-ily if necessary (j). This is one reasonthat led the WHO to promote the INNsystem.

Improving communicationbetween health professionalsand patients

The prescription is not just a “shop-ping list” or an accounting source forhealth insurers: it can also be used tonote advice on the mode of adminis-tration, accompanying cautions andevents to watch for during treatment.

By using the INN system the pre-scriber should be encourage to spendmore time explaining the treatment tothe patient, being less concerned withthe choice of drug names and differentcosts.

Use of the INN system also frees theprescriber from the pressures createdby drug lobbies, who sometimes makeadvertising slogans sound like thera-peutic guidelines.

A patient who knows the INN of thedrug he or she is taking can identify itin other preparations (prescription andnon prescription drugs), and therebyavoid potentially dangerous concomi-tant treatments (12).

Providing patients with clear infor-mation is also a mark of respect.

h- There is also a certain risk of confusion betweenINNs, but it is less frequent and easier to prevent. Forexample, the name change from amrinone to inamri-none by the US Nomenclature Commission, followingcases of dangerous confusion between the two names,

and after a survey of health professionals, is an inter-esting case, although the WHO has not yet respondedto this very recent decision (refs 14,15).i- To avoid mistakes it is crucial that the dose regimenshould be written very clearly (by hand or printed).Confusion can especially occur between milligrams (mg)and micrograms (µg) and between milligrams (mg) andgrams (g). Mistakes can also arise when decimal pointsare illegible (prefer 500 mg to 0.5 g); or when the num-ber of units per intake and the number of daily intakesis confused because of excessive abbreviation (prefer 500mg 3 times a day to 2 tb tid) (ref 16).j- A study of enquiries concerning foreign drug equiv-alence by a French Documentation Centre during the1998 soccer World Cup illustrates the diversity of brandnames given by patients from other countries. The risksare compounded by a lack of effective documentationcentres or documentary tools in some countries (ref 17).

Our literature search was based on contin-uous prospective scrutiny of the main inter-national journals likely to deal with drugnames, prescription and replacement, andon reference textbooks and databases inchemistry and pharmacy.We reviewed for-eign and French pharmaceutical regulations,and WHO documentation on internationalnonproprietary names published since thecreation of la revue Prescrire in 1981.1- “Comparaison des modes de dénomination desmédicaments - Avantages - Inconvénients”. In:Association Française des Enseignants de ChimieThérapeutique “Dénomination chimique - nomen-clature et dénominations - applications aux sub-stances pharmaceutiques” Tec & Doc - Lavoisier,Paris 1992 - Volume 1: 5.2- Wehrli A “Protection and promotion of INNs”Conférence au “Congress on rational use of drugsin primary health care” Madrid 17-20 September1985: 10 pages.3- Kopp-Kubel S “Dénominations communes inter-nationales (DCI) pour les substances pharmaceu-tiques” Bulletin OMS 1995; 73 (4): 425-429.

4- Programme on International NonproprietaryNames (INN) ”The use of common stems in theselection of International Nonproprietary Names(INN) for pharmaceutical substances” WHO/ EDM/QSM/99-6 April 2000: 138 pages.5- Wehrli A “The ins and outs of INNs” ManagingIntellectual Property March 1992: 18-24.6- Wehrli A “Generic names for biotechnology-derived products” Drug News & Perspectives 1992; 5(1): 55-58.7- EU Court of Justice, 3 December 1998, aff. C-368/96. Cited in: Bensoussan A et Pottier I “Guidejuridique du droit de substitution” MMI éditions,Paris 2000: 9.8- Prescrire supplement “Les médicamentsgénériques - De la pharmacologie à une politiquerationnelle”.9- Communication to la revue Prescrire – Estimatesfrom OVP - Éditions du Vidal following search of itsdatabase on April 11 2000.10- Prescrire Rédaction “Publicité à la loupe:Questions pour un champion” Rev Prescr 2000; 20(205): III de couverture.11- “Guidance on prescribing”. In: “British NationalFormulary” British Medical Association - and RoyalPharmaceutical Society of Great Britain; London,March 2000; (39): 1-3.12- Pelouze G-A “Les génériques: une occasiond’améliorer le système de soins” Angéiologie 1997;49 (5): 65-70.13- Prescrire Rédaction “abciximab-Réopro°” RevPrescr 1997; 17 (169): 13-16.14- “Amrinone becomes inamrinone” USP QualityReview 2000; (73): 1-2. United States Pharmacopeia:http://www.usp.org.15- Gundersen L “The complex process of namingdrugs” Ann Intern Med 1998; 129 (8): 677-678.16- “Prescription writing”. In: “British NationalFormulary” British Medical Association - RoyalPharmaceutical Society of Great Britain, LondonMarch 2000; (39): 4-5.17- Rougier F et al. “Équivalences de médicamentsétrangers durant la Coupe du monde France 98”Pharmacie Hospitalière Française 1999; (130): 178-183.

Literature

ISDB Newsletter • Page 11 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 11 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

DEFINITIONS

INNsAND GENERICS:DIFFERENT THINGS

The INN is a drug’s true name, thename of the active substance; ageneric is a copy of a drug.

• INN: The INN (InternationalNonproprietary Name) is quite simply adrug’s real name: it is the name of theactive substance. Created by the WorldHealth Organization (WHO), the INNsystem is used throughout the world. Itallows healthcare professionals andpatients to identify a drug precisely andwith confidence, and to avoid potentiallyserious adverse effects due to confusionbetween drugs.

• Generic: A generic is a copy of thedrug that arrives on the market a fewyears later, after the patent providing for anumber of years’ exclusivity has expired.All generics are copies of the originatorproduct and contain the same active sub-stance (named by an INN), and have thesame effects.

Some generics have brand namesincluding the INN, such as DiclofenacWonder° or Diclofenac Gold°, but otherslike Voldal° and Xenid° don’t.

Every drug has its own INN, but not alldrugs have generics.

References :Prescrire Editorial Staff “The generic name isnot the same as the INN” (leaflet) (freely avail-able from:http://www.prescrire.org/cahiers/dossierDciAccueilEn.php).Donald J. Birkett “Generics - equal or not?” AustPrescr 2003 ; 26 : 85-7 (freely available from:http://www.australianprescriber.com/maga-zine/26/4/85/7/)

INN USE: PROPOSALS FOR IMPROVEMENTIncrease in INN use is under theresponsibility of all actors of the healthfield.

• Pharmaceutical companies:

drug packaging with bigger INNs thantrade names (the INN should supersedethe trade name);

• Regulators (Health authorities and other related bodies):

put public health first and showing thelead by systematically using INNs (druglists; websites; publications);

• Ministry of Health:

promoting INN use in healthcare pro-fessionals (initial education in academia)and consumers (campaigns in favor ofINNs instead of generics);

banning trade name use in advertisingsand in continuing education;

• WHO:

providing easy to remember and coher-ent INNs;

improving transparency of the decisionprocess leading to the choice of INNs;

• Healthcare professionals:

- Think in INNs: remembering a fewhundred INNs (and only the useful ones)is easier than remembering thousandbrand names;

- Prescribers: write and explained theirprescriptions using INNs (trade namescan also be mentioned if necessary);

- Pharmacists: systematically highlightthe INN on drug packaging when dis-pensing.

• Patients and consumers:

being more involved in their treatment,paying attention to the drug they take.

Good professional practice

ISDB Newsletter • Page 12 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 12 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

Bulletins Roundup

The following texts were selected inISDB bulletins received at the ISDBlibrary in 2006. If we did not identifyarticles you wrote on INN or genericissues due to language difficulties (orlack of attention…), please feel free topost their references on ISDB websitewith contact details (name and e-mail)so that people could ask you for thetext. Thank you!

Bodhi

2 editorials

Theses texts invite Bodhi’s readers to jointhe worldwide campaign in favor of INNuse, insisting on ethical aspects (“Let’sjoin the global campaign”) and explainingthat doubts on the quality of products onthe Indian market and in developingcountries is no reason to avoid usinggenerics (“Being convinced that genericsare better”).

“Let’s join the global campaign”

“One brand name may be so much pop-ular and so deeply entrenched in the publicmind that the International NonproprietaryName (INN) maybe almost effaced. Andthere is no reason to believe that does nothappen without unethical inducements.Many excuses are provided in favour ofuse of brand names but they cannot beaccepted as reasons. A suspicion of anunderlying system of give and takebetween the prescriber and the manufac-turer cannot be ruled out. That is the waypharmaceutical empires have been holdingdoctors and the public in subjugation (…).When doctors write out a brand name theypick out one brand in preference to the oth-ers. They take upon themselves a responsi-bility they are not supposed to bear andinvite the stigma of having received illegalinducement. Their prescriptions would beviewed with suspicion.”

➤ Bodhi 2006; 69 (March-April): 1-2.Langage: EnglishAvailable on request: Pijus Sakar

“Being Convinced that Generics are Better”

There are many medical professionalswho wholeheartedly support the idea ofINN (also called generic names) in pre-scriptions, but suffer from a lingeringdoubt in their mind as to how far it ispracticable and how far it will be benefi-cial.

Even more than that, they have a ques-tion as to whether this noble effort—rational, logical and scientific - couldsomehow prove counter-productive forthe patient. After all it is the best interestof the patient that the doctor ought tohave in his or her mind. And a situationwhere the medicine shop has dispensed aproduct (not of the best quality) becausethe doctor used a generic name as pre-scription would be most unfortunate.Well then, why not prescribe in a brandname - of a “reputed” pharmaceuticalcompany.

Why then would the product dispensedby the medicine shop not be of the bestquality?

First, the product could be spurious. Itis true that there are a large number ofspurious products in the market. So theproduct dispensed from the medicineshop could be spurious. But manufactur-ers of spurious drugs are naturally moreinterested in producing spurious vari-eties of those brands that sell more. Bythis logic, the brand name product of bigand reputed pharmaceutical companiesare naturally more interested in produc-ing spurious varieties of those brandsthat sell more. By this logic, the brandsof big and reputed pharmaceutical com-panies are the most vulnerable of havingspurious products in the market.

Second, the product of a less-knownpharmaceutical company could be lessefficacious. But how does the prescrib-ing doctor reach this conclusion? Has he

really found lack of response when thebrand from the less-known company wasused? If the fact cannot be substantiated,then the doctor would continue to be sus-pect for having undue favoritism (!) orpreference for a particular company? Ifthe fact can be substantiated, then seri-ous interventional measures would berequired from drug regulatory authori-ties to ensure that the products allowedto be marketed as medicinal preparationsare of adequate standard. This cannot bethe job of the practitioner.

Third, there is a trend in recent times(with a tendency to increase with pas-sage of time) for large national or inter-national companies to have their prod-ucts manufactured by smaller compa-nies. There are now defined rules forsuch business collaboration, but the sys-tem will stay. By this system, applied tomanufacture of medicinal products, it isquite possible that the reputed pharma-ceutical company whose products areconsidered superior have actually beenmanufactured by the smaller companywhose own products might have beenconsidered inferior by the practitioner(See the accompanying table).

Fourth, there is an unfortunate mindsetthat less costly products are less effica-cious. When this thought process isapplied to prescriptions, the effect couldbe disastrous. The mindset is unfortunatebecause it is wrong, and even the personwith this mind set would agree in privatethat cheap things can be good. So longthat all preparations coming under ageneric name (INN) are not standardizedin terms of quality and good manufac-turing practices, it may not be irrationalto suggest an alternative system.

This is to write the names of two ormore different brand names for any med-icine prescribed. It covers the drawbackof “backing” (preferring) a particularcompany’s product. There are doctorswho get gratification (in material terms)out of favoring particular pharmaceuti-cal companies. There is no denying ofthis fact. The public has little scope todecide whether a particular doctorbelongs to this category or not. So thepublic holds all doctors as suspect. Eventhe doctor who is not gratified may bepresumed to be corrupt. Why should the‘good’ doctor share a blame meant for

ABOUT INNs AND GENERICS IN ISDB BULLETINS

REPRINT

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ISDB Newsletter • Page 13 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 13 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

the ‘bad’ doctor? Well one way for the‘good’ doctor to set himself apart fromthe ‘bad’ doctor could be by followingthe principle of generic prescribing. Heshould do so with full conviction that itis rational, logical and beneficial. Hewould probably do so with greater con-viction after the inputs of this editorial. ➤ Bodhi 2006; 70 (May-June): 25-26.Langage: EnglishAvailable on request: Pijus Sakar

Dialogo sui Farmaci

“Prescrivere e dispensare per DCI.Luci ed ombre di un linguaggiocomune”http://www.dialogosuifarmaci.it/main.asp?dove=rivista➤ Dialogo sui Farmaci 2006; 3 : 120 -123 Langage: ItalianAvailable free

Informacioni suiFarmaci

“Prescrivere per principio attivo.Luci ed ombre di un linguaggiocomune”➤ Informacion sui Farmaci 2006; 30 (4):106-109 Langage: ItalianAvailable on request: Maria font

La Lettre du CEDIM

“Prescrire les médicaments dans unlangage clair, précis aussi bien pour lessoignants que pour les soignés” ➤ La Lettre du CEDIM 2006; 11 (29):37-38 Langage: FrenchAvailable on request: Clotaire Nanga

La Lettre du GRAS

“Papy fait de la résistance” [Dad puts up resistance]Follow-up on the INN campaingn inBelgium ➤ La Lettre du GRAS 2006; 50 : 29-30 Langage: FrenchAvailable on request: Michel Jehaes

Ricerca & Pratica

“Una questione di… principio. Perchéprescrivere e dispensare per DCI”[A matter of principle. Why we shouldprescribe and dispense using the INN] ➤ R & P 2006; 26 (May-June): 108-113 Langage: ItalianAvailable on request: Maria font

Colophon Newsletter editors and coordinators: Christophe Kopp and Florence VandeveldeThe following people contributed to this Special Newsletter issue on INN:John Dowden; Zahed Masud (Drug and Health); Clotaire Nanga; Ciprian Jaunca; Bozidar Vrhovac; BlankaPospisilova;Wolfgang Becker-Brüser; Jörg Schaaber; Pijus Sarkar; P.K. Lakshmi; Sri Suryawati; Philip Sax;Maria Font; Anita Conforti; Maurizzio Bonati; Rokuro Hama; Baktygul Toktobaeva; Natalia Cebotarenco;K.K.Kafle; Bhupendra B. Thapa; Dick Bijl; Sarita Von Afehlt; Benoit Marchand; Jelka Dolinar; Joan RamonLaporte; Björn Beerman; Etzel Gysling; Andrea Tarr.Design and lay out: Nathalie Froment Illustrations: Olivier Huyghe with Alain Savino

Bulletins roundup

ISDB Newsletter • Page 14 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006ISDB Newsletter • Page 14 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

Primary Research on INN issues

A survey was conducted last year bythe ISDB member Bulletind’Information de Pharmacologie (BIPToulouse) in a French region. Asummary is reprinted bellow.

Abstract reprinted from Therapie 2005Jul-Aug; 60 (4) : 401-7.

Aim. The aim of this study was to eval-uate the perceptions of health profession-als and non-health professionals withregard to prescribing drugs by their inter-national non-proprietary name (INN) inthe Midi-Pyrenees area, France.

Methods. We developed a score toassess the perception of the four criteriathat make up therapeutic progress:

A SURVEY ON THE PLACE OF INN IN INITIAL EDUCATION

What was, and what is now, the placeof the international nonproprietarynames (INNs) in initial education ofhealthcare professionals in France? There is scarce data available forresponding to this question, which iswhy Prescrire has launched asubscribers’ survey. The results will(anonymously) be published inPrescrire, and will also be assessed in ageneral practice thesis.

About 4 000 subscribers in France and1 000 subscribers in other French speak-ing countries were asked to answer thefollowing questions (2 questions withboxes to be ticked, 3 open questions).

1- In your initial education duringclasses, medicines were designated most-ly with:

❏ INNs ❏ brand names ❏ don’t remember

1.2-During hospital training, medicineswere discussed, prescribes or writtenmostly with:

❏ INNs ❏ brand names ❏ don’t remember

1.3-During training in the field (gener-al practice (prescriptions, conversation),community pharmacy dispensing,advices), else), medicines were mostlyused and designated with:

❏ INNs ❏ brand names ❏ don’t remember

2- In your daily practice (prescribing,dispensing, advices), you use the INN:

❏ never❏ sometimes ❏ often ❏ very often ❏ always

-efficacy, -safety, -convenience,-and cost for the National Health

Insurance. Changes in perception under these cri-

teria were scored between 0 and 10 (0 forno change and 10 for maximal change).The questionnaire was answered by 142general practitioners, 161 pharmacistsand 132 healthy subjects (public).

Results. The median value (first quar-tile to third quartile) for the perceivedchange in efficacy was 0 (0-3) for physi-cians and pharmacists, and 0 (0-0) for thepublic.

The median value for the perceivedchange in safety was 0 (0-3) for practi-

tioners and pharmacists, and 0 (0-5) forthe public.

The median value for the perceivedchange in convenience was 0 (0-6) forpractitioners, 5 (0-6) for pharmacists and0 (0-0) for the public.

The median value for the perceivedchange in cost was 6 (3-8) for practition-ers, 8 (5-10) for pharmacists and 10 (6-10) for the public.

Conclusion. This study shows thatthere is generally favorable acceptance ofprescribing by INN by those in the healtharea. However, general practitioners seemto be more reluctant to accept this thanpharmacists or the general public.

Full article available on request Language: French

Contact: Jean-Louis Montastruc([email protected]) for more information on

this survey.

3- Why do you use INNs in your dailypractice?

4- What are the problems (if any) thatprevent you from using INNs in yourdaily practice?

5- Could you specify key measures thatwould facilitate the use of INNs in thedaily practice of the medical profession?

6- Free comments

PRESCRIBING DRUGS BY INTERNATIONAL NON-PROPRIETARY NAMEThe perception of health and non-health professionals

ISDB Newsletter • Page 15 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

Editorial methods

A public campaign entitled "The INN, a drug's realname" that was launched in France in October 2005 byseveral organizations. This INN campaign is spear-heading as part of the Medicines in Europe Forum,in association with the Fédération Nationale de laMutualité Française (health care providers) and theUnion Fédérale des Consommateurs (UFC) - QueChoisir (consumer group). This campaign aims toraise public awareness and promote the use of theINN, a drug's real name, using information sheets.

The information leaflets were reprinted in each issueof la revue Prescrire and a number of press release onthe subject were sent to the media.

The main message of this campaign is that using adrug's INN is a valuable aid to patients, carers andmedical staff. INN helps patients to recognize the realname of a drug they are taking, in order to be able touse that medicine correctly and to avoid adverse effects,especially those due to overdose, interactions, or admin-istration errors.

LEAFLETS IN FAVOR OF INN USE

ISDB Newsletter • Page 16 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

� Nicole would like to understand theINN systemThe INN is clearer and less confusing

� A holiday trip ends in hospitalThe INN: one drug, one name, every-where in the world

� The INN on drug packaging: practi-cal and safe!Placing INN on drug packagingreduces the risk of error

� Avoiding rechallenge with a con-traindicated drugThe INN system helps patients to avoidside effects

� Fewer drugs make for an safer homemedicine cabinetUsing INN reduces the risk of confu-sion

� Leo’s spots: due to a drugThe INN helps to prevent allergic drugreactions

� Identifying the INN on drug packag-ingAsk your pharmacist to highlight theINN on your medication packaging

� The generic name is not the same asthe INNThe INN is a drug’s true name, a gener-ic is a copy of drug

� Starting treatment without delayThe INN is the only reliable way ofidentifying a drug

� Non informative brand names some-times hide combinations of severaldrugsWith the INN system you know exact-ly what drug(s) you’re taking!

In each issue of la revue Prescrire (inFrench), every month, Prescrire uses a“teasing tool”: a regular box detailingcommon INN stems. This brief text isdedicated to a stem common to allsubstances of the same group (based onpharmacological activity or chemicalstructure). Lists of corresponding tradenames are also given. The objective isto help healthcare professionalsunderstand the rationale behind INNs.An example is reprinted opposite.

Editorial methods

List of other INN leaflets available in English:

A file on the INN campaign can befreely accessed on Prescrire website:

click on:http://www.prescrire.org/cahie

rs/dossierDciAccueilEn.php.

Practical information sheets can bedownloaded for distribution and post-ing on notice boards.

The leaflets are available, along withexplanations of the reasons for usingthe INN and the (rare) drawbacks.

The pdf files are unprotected inorder to allow the copy of the text.Feel free to use and to disseminatethem if you wish to!

The International NonproprietaryName (INN) of vasopressin-derivedvasoconstrictors ends with the suffix–pressin (1).

There are 7 pressin-ending sub-stances in the current list of INNs of theWorld Health Organization (WHO) (2).

Two of them are marketed in France:desmopressin (Minirin°, MinirinMelt°(that we will present in a next issue),Octim°) and terlipressin (Glypressine°).

©LRP

1- World Health Organization “The use of commonstems in the selection of International Nonpropri-etary Names (INNs) for pharmaceutical sub-stances” WHO/EDM/QSM 2004; 5: 100. 2- “Substances names ending with pressin” Websitehttp://mednet.who.int accessed 29 May 2006: 1page.

THE MONTHLY INN STEM

-pressin

COMMON STEMTranslated from “Le segment clé du mois: -pressine” Rev Prescr 2006; 26 (275): 576

ISDB Newsletter • Page 17 • VOL. 20, N° 3 (Special issue on INNs), NOVEMBER 2006

A World Health Organization mission:WHO has a constitutional mandate to“develop, establish and promoteinternational standards with respect tobiological, pharmaceutical and similarproducts.”

International Nonproprietary Names(INNs) aim to facilitate the identificationof pharmaceutical substances or activepharmaceutical ingredients. Each INN isa unique name that is globally recognizedand is public property.

The World Health Organization collab-orates closely with INN experts andnational nomenclature committees toselect a single name of worldwide accept-ability for each active substance that is tobe marketed as a pharmaceutical.

To avoid confusion, which could jeop-

Good source

ardize the safety of patients, trade-marksshould neither be derived from INNs norcontain common stems used in INNs.

The selection and publication of INNsfalls under the responsibility of theHTP/PSM/QSM team of the INNProgramme.

The INN programme website sectionprovides more information on theseissues:

http://www.who.int/medicines/servic-es/inn/en/

The link to the INN general Guidance:http://whqlibdoc.who.int/hq/1997/WH

O_PHARM_S_NOM_1570.pdf

WHO INN WEBSITE

For more information or to submitproposals for improvement of the INNWebsite, do not hesitate to contact:

Dr Raffaella G. Balocco Mattavelli; INN Programme ManagerDepartment of Medicines Policyand StandardsWorld Health Organization

Tel. 22-791.3695/3660Fax. 22-791.4730

e-mail: [email protected] or [email protected]

ISDB Newsletter full version:available in ‘documents’ on ISDB Website:www.isdb-web.org > For ISDB members only - Documents > Register and download the FullNewsletter.

In the full version you will find:- News of ISDB: Minutes of last Committee meeting- Ongoing campaigns: Information on the campaign “Promoting good sources of

patient information” – Strategy to counter attack Direct to Consumer Advertisingthreat coming back in Europe.