Every registered medication has an information insert in its package. This patient information leaflet (PIL) provides data on the product, which includes clinical pharmacology, recommended dose, mode of administration, how supplied, and a large section contains warnings and contraindications, adverse reactions, and precautions. With easy access of patients to information on drugs they use, mainly through the electronic media, it is very important that the text and contents of these patient leaflets are simple to understand and readable. Discussing the PIL with German patient focus groups resulted in agreements that (a) PILs contained too much risk information which was conveyed in a way that led to reduced patient compliance; (b) the current description of potential side-effects and drug interactions caused negative emotions which led to undesirable patient reactions; (c) PILs provoked certain behaviors in patients including accessing information from alternative sources or seeking support from professional and lay persons [1]. Also, most people thought that reliable information on efficacy and adverse effects of drugs should come from the treating physician, pharmacists being the second-line source. The forum suggested that, because current PILs convey risk information in a way that provoked feelings of fear and anxiety in the reader, regulators and producers of such written information should consider greater involvement of target patient groups at all stages of the production process.
Author(s)
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Amos Pines
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Citations
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Herber OR, Gies V, Schwappach D, Thürmann P, Wilm S. Patient information leaflets: informing or frightening? A focus group study exploring patients emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices. BMC Fam Pract 2014;15:163
http://www.ncbi.nlm.nih.gov/pubmed/25277783 -
Liu F, Abdul-Hussain S, Mahboob S, Rai V, Kostrzewski A. How useful are medication patient information leaflets to older adults? A content, readability and layout analysis. Int J Clin Pharm 2014;36:827-34
http://www.ncbi.nlm.nih.gov/pubmed/24986267 -
Ziegler A, Hadlak A, Mehlbeer S, König IR. Comprehension of the description of side effects in drug information leaflets: a survey of doctors, pharmacists and lawyers. Dtsch Arztebl Int 2013;110:669-73
http://www.ncbi.nlm.nih.gov/pubmed/24167524 -
Burgers C, Beukeboom CJ, Sparks L, Diepeveen V. How (not) to inform patients about drug use: use and effects of negations in Dutch patient information leaflets. Pharmacoepidemiol Drug Saf 2014 Jul 15. Epub ahead of print
http://www.ncbi.nlm.nih.gov/pubmed/25044310 -
Watkins ES. “Doctor, are you trying to kill me?”: ambivalence about the patient package insert for estrogen. Bull Hist Med 2002;76:84-104
http://www.ncbi.nlm.nih.gov/pubmed/11875245 -
Manson JE, Goldstein SR, Kagan R, et al. Why the product labeling for low-dose vaginal estrogen should be changed. Menopause 2014;21:911-16
http://www.ncbi.nlm.nih.gov/pubmed/25140698
