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

Abdullah Albassam, Dyfrig Hughes

    Research output: Contribution to journalArticlepeer-review

    539 Downloads (Pure)

    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.

    Original languageEnglish
    Pages (from-to)251-260
    Number of pages10
    JournalEuropean Journal of Clinical Pharmacology
    Volume77
    Issue number2
    Early online date29 Sept 2020
    DOIs
    Publication statusPublished - Feb 2021

    Keywords

    • Compliance
    • Labelling instructions
    • Medication adherence
    • Patient information leaflets

    Fingerprint

    Dive into the research topics of 'What should patients do if they miss a dose? A systematic review of patient information leaflets and summaries of product characteristics'. Together they form a unique fingerprint.

    Cite this