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Patient information leaflets--helpful guidance or a source of confusion?
1Research 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.