Healthy Skepticism Library item: 7650

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Publication type: Journal Article

Bjerrum L, Foged A.
Patient information leaflets--helpful guidance or a source of confusion?
Pharmacoepidemiol Drug Saf 2003 Jan-Feb; 12:(1):55-9

Abstract:

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 consistent 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 maybe confused by inconsistent information in OILS 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. Copyright © 2002 John Wiley & Sons; Ltd.

Keywords:
Community Pharmacy Services Drug Industry/legislation & jurisprudence Drug Industry/standards Drug Information Services/legislation & jurisprudence Drug Information Services/standards* Drug Interactions Drug Labeling/standards Drugs, Generic Pamphlets* Patient Education/standards* Prescriptions, Drug