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European Journal of Clinical... Aug 2018Unclear labeling has been recognized as an important cause of look-alike medication errors. The aim of this literature review is to systematically evaluate the current... (Meta-Analysis)
Meta-Analysis
PURPOSE
Unclear labeling has been recognized as an important cause of look-alike medication errors. The aim of this literature review is to systematically evaluate the current evidence on strategies to minimize medication errors due to look-alike labels.
METHODS
A literature search of PubMed and EMBASE for all available years was performed independently by two reviewers. Original studies assessing strategies to minimize medication errors due to look-alike labels focusing on readability of labels by health professionals or consumers were included. Data were analyzed descriptively due to the variability of study methods.
RESULTS
Sixteen studies were included. Thirteen studies were performed in a laboratory and three in a healthcare setting. Eleven studies evaluated Tall Man lettering, i.e., capitalizing parts of the drug name, two color-coding, and three studies other strategies. In six studies, lower error rates were found for the Tall Man letter strategy; one showed significantly higher error rates. Effects of Tall Man lettering on response time were more varied. A study in the hospital setting did not show an effect on the potential look-alike sound-alike error rate by introducing Tall Man lettering. Color-coding had no effect on the prevention of syringe-swaps in one study.
CONCLUSIONS
Studies performed in laboratory settings showed that Tall Man lettering contributed to a better readability of medication labels. Only few studies evaluated other strategies such as color-coding. More evidence, especially from real-life setting is needed to support safe labeling strategies.
Topics: Drug Labeling; Health Personnel; Hospitals; Humans; Medication Errors; Product Labeling; Reaction Time
PubMed: 29754215
DOI: 10.1007/s00228-018-2471-z -
European Journal of Clinical... Feb 2021Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed....
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.
Topics: Drug Administration Schedule; Drug Labeling; Humans; Medication Adherence; Prescription Drugs; United Kingdom
PubMed: 32989529
DOI: 10.1007/s00228-020-03003-x