E-DRUG: Differences in Drug Datasheets (5)
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The paper that Joel mentions in his message Differences in Drug Datasheets (3) is
Herxheimer A. Leaflets with NSAIDs do not warn users clearly - a UK survey. Pharmaceutical J 1999; 262: 559-61. [17 April]
I can't find a copy of this paper [it seems as if PJ only started putting content online from the next volume (263)! Moderator]
What I did was to compare the PILs for all the oral NSAIDs then on the UK market:
they were inconsistent. The regulators had never required class labelling, and I believe that they still don't.
It would be interesting and useful to know to what extent class labelling exists now.
I know only of the admirable CMI [Consumer Medicines Information] process in Australia.
It is not enough for regulators to check companies' draft SPCs and PILs in isolation - that allows easily avoidable muddles and miscommunication.
[Formally, i.e. from regulators, it does not exist in Europe or the US anyway. Denmark has even been critisised by the EU for having started a process of harmonisation on their own! (not waiting for EU). But many formularies have class labelling. Another article on this: see below. Moderator]
Andrew Herxheimer
9 Park Crescent, London N3 2NL UK
Phone : +44 20 8346 5470
Fax : +44 20 8346 0407
e-mail: a.herxheimer@ntlworld.com
Bjerrum L, Foged A. Patient information leaflets--helpful guidance or a source of confusion? Pharmacoepidemiol Drug Saf 2003; 12(1): 55-9.
Research Unit of General Practice, University of Southern Denmark, DK-5000 Odense, Denmark. lbjerrum@health.sdu.dk
BACKGROUND: According to the European Community Directive 92/27, pharmaceutical companies are responsible for working out patient information leaflets (PILs) for all products marketed, and every PIL should comply with the Summary of Product Characteristics (SPC) and be phrased so that it is easily understandable by the patient. However, the volume of information included in the PIL may differ for different brands, and furthermore, the same drug may be registered for different indications. Patients may therefore receive different drug information when they renew prescriptions for the same generic drug.
OBJECTIVES: To examine if PILs on different brands of generically identical drugs contain inconsistent and diverging information that may lead to confusion.
DESIGN: Case-finding among patients who contacted a pharmacy because of problems related to the information retrieved from the PIL. SETTING: Inquiries to a Danish pharmacy during one year (1 June 2000-31 May 2001). RESULTS: Different brands of generically identical products included PILs with substantial inconsistencies. Diverging information about indications for drug use, adverse effects, drug-drug interactions and precautions and considerations concerning pregnancy and breastfeeding resulted in inquiries to the pharmacy.
CONCLUSION: Patients may be confused by inconsistent information in PILs from different brands of generically identical drugs. Confusion about drug treatment may lead to reduced compliance and initiatives should be taken to coordinate information in PILs covering the same generic product.