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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 -
BMC Public Health Jul 2020The United States (US) Food and Drug Administration (FDA), under the 2009 Family Smoking Prevention and Tobacco Control Act, banned characterizing flavors in cigarettes;...
BACKGROUND
The United States (US) Food and Drug Administration (FDA), under the 2009 Family Smoking Prevention and Tobacco Control Act, banned characterizing flavors in cigarettes; however, mentholated tobacco products were exempt. Since 2009, over 20 US jurisdictions and numerous countries around the world have extended this restriction to menthol. Currently, the FDA is reconsidering its position on a nation-wide menthol cigarette ban. However, the effects of such a ban remain unclear. We conducted a scoping review to explore the impact of a menthol cigarette ban on individual behaviors (initiation, cessation, and product switching), sales, and compliance.
METHODS
We conducted a search of the international literature using PubMed, EBSCO, and Web of Science (to November 25, 2019). We retrieved articles relevant to the impacts of an implemented or hypothetical menthol ban. We also included studies of flavored tobacco product bans due to their potential relevance in gauging compliance and product substitutability.
RESULTS
The search identified 493 articles, of which 24 were included. Studies examined the effects of implemented menthol bans (n = 6), hypothetical menthol bans (n = 12) and implemented flavor bans that exclude menthol (n = 6). Menthol bans were found to reduce sales and increase smoking cessation with only partial substitution for non-menthol cigarettes. US smokers' reactions to a hypothetical ban indicate that about 25-64% would attempt to quit smoking and 11-46% would consider switching to other tobacco products, including 15-30% to e-cigarettes. Flavor ban studies indicate reductions in initiation of 6%. Ban compliance was high, but studies indicate that the tobacco industry and retailers have attempted to circumvent their impact via packaging changes and online sales.
CONCLUSION
Our review finds that extending the US cigarette flavor ban to menthol products would promote smoking cessation and reduce initiation. This evidence supports further action by the FDA towards mentholated tobacco products. However, few studies have been conducted in the vaping era.
Topics: Cigarette Smoking; Commerce; Flavoring Agents; Humans; Menthol; Smoking Cessation; Taste; Tobacco Industry; Tobacco Products; United States; United States Food and Drug Administration
PubMed: 32641026
DOI: 10.1186/s12889-020-09055-z