16 March, 2015
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 . 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.
How many of you read the patient information leaflets (PILs), the package inserts of the medications you prescribe? How many of you face the situation when your patient challenges you with questions based on the PIL or other external sources of information? Is it time to see how patients address the PIL and even criticize its format and contents? A study from the UK, while examining 48 PILs related to cardiovascular and diabetes medications found that only a few of the documents were fit specifically for the older population, either by failing to mention side-effects that could occur in the older generation, or by using small fonts and problematic phrasing .