Evidence-based data for newly approved medications' use in older adults: An analysis from clinical trials to monographs.

BACKGROUND: Older adults have historically been excluded from clinical trials, limiting evidence-based data. An updated picture of the situation with newly marketed medications is needed. We aimed to describe (1) the recommendations specific to older adults in monographs of newly marketed medications; (2) the representation of older adults in clinical trials of those medications. METHODS: In November 2020, we listed all medications that received a notice of compliance from Health Canada between January 2006 and September 2020, excluding those with indications irrelevant to community-dwelling older adults and locally acting medications. We assessed the availability and clarity of recommendations in monographs regarding older adults. Using Clinicaltrials.gov, we identified randomized controlled double-blind Phase III-IV trials led in Canada/United States of a sample of 30 commonly used medications among those previously listed. We extracted information on study design, participants, and efficacy/safety analysis specific to older patients. We used simple linear regression and Chi-square/Fisher's exact tests to analyze time trends in the representation of older adults over different periods. RESULTS: A total of 195 monographs were included. Of the 130 monographs reporting a dosing recommendation in older adults, 53 (41%) also reported limited/insufficient data in this population or its subgroups. Of the 373 trials included, 217 (58%) did not integrate a maximum age as an inclusion criterion. However, only 113 (30%) reported including a proportion of older adults representative (or over-representative) of the Canadian older population. Most trials (n = 289; 78%) did not provide efficacy or safety data specific to older adults. In our sample, the number/proportion of older adults in trials seemed to be increasingly reported over time, either explicitly or implicitly (e.g., inclusion criterion specifies <65 years old). CONCLUSIONS: Newly marketed medications still appear to under-represent older adults. The resulting lack of clear recommendations in monographs compromises evidence-based practice, thereby perpetuating the risk to older adults' health.

Do health care providers trust product monograph information regarding use of vaccines in pregnancy? A qualitative study.

BACKGROUND: Influenza immunization is recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet vaccine uptake remains low. Studies suggest that cautionary language in vaccine product monographs regarding safety and use in pregnancy affects health care providers' perceptions of vaccine safety and how they counsel pregnant women. OBJECTIVE: To conduct a qualitative analysis of health care provider perceptions of the safety of inactivated influenza vaccines and their recommendations for use in pregnancy based on product monograph language statements. METHODS: Health care providers were recruited at two international health conferences and from teaching programs in Ethiopia, Ghana, Uganda, and Laos during September and October 2015. After reading the product monograph excerpts for three licensed inactivated influenza vaccines, participants completed a ten-item online survey with quantitative and qualitative components that captured perceptions of vaccine safety. RESULTS: Health care providers identified a lack of trust in manufacturers' and product monograph information. They perceived product monograph language as ambiguous and not "up-to-date" with current evidence. Health care providers wanted product monograph language that clearly conveyed evidence for the risks and benefits of the vaccine in an understandable manner. CONCLUSION: This study suggests that adopting best practices in the wording of product monographs would help to support evidence-based use of vaccines in pregnant women.