What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics

Albassam, Abdullah and Hughes, Dyfrig A ORCID: 0000-0001-8247-7459
(2021) What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics. EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 77 (2). pp. 251-260.

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<h4>Purpose</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.

Item Type: Article
Uncontrolled Keywords: Medication adherence, Labelling instructions, Patient information leaflets, Compliance
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 12 Jul 2021 09:34
Last Modified: 18 Jan 2023 21:36
DOI: 10.1007/s00228-020-03003-x
Open Access URL: https://doi.org/10.1007/s00228-020-03003-x
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3129745