What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of produc
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PHARMACOEPIDEMIOLOGY AND PRESCRIPTION
What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics Abdullah Albassam 1 & Dyfrig A. Hughes 2 Received: 7 May 2020 / Accepted: 16 September 2020 # The Author(s) 2020
Abstract Purpose Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK. Methods PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs. Results Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. “take as soon as possible”); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm. Conclusions Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary. Keywords Medication adherence . Labelling instructions . Patient information leaflets . Compliance
Introduction Medication non-adherence is highly prevalent, impacts on patients’ quality of life and survival, and is costly to manage [1]. Adherence is a complex behaviour, which may be conceptualised in three parts: initiation (which occurs when the patient takes the first dose), implementation (the extent to which a patient’s actual dosing corresponds to the prescribed
* Dyfrig A. Hughes [email protected] 1
Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait City, Kuwait
2
Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor LL57 2PZ, UK
dosing regimen—from initiation until the last dose), and persistence (the time until the patient stops taking the prescribed medication) [2]. A common concern of patients who variably implement their prescribed medicine is what to do when a regular dose is occasionally delayed or
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