Content Related to Older Adults in Canadian Innovator-Drug Product Monographs: An Exploratory Analysis.

Babadagli, Hazal; Cor, M.; Sadowski, Cheryl

Background: Drug product monographs are an important source of information for drug inquiries. There has been little investigation of the content of product monographs for geriatric data. Objective: The purpose of this study was to determine the amount and clinical relevance of geriatric-related information in Health Canada-approved new brand (i.e., innovator) product monographs and to describe changes over time. Methods: We identified all monographs of currently available new innovator products (introduced to market 1994-2012) through Health Canada's Notice of Compliance Database (launched 1994). Data were abstracted by a standardized process for eight categories for each monograph. Each category was coded dichotomously for whether it made any reference to the geriatric population as well as whether it included clinically relevant geriatric information. We compared the amount and type of information across categories using dependent sample t tests, and used linear regression to investigate trends over time. Results: In total, 283 monographs were analyzed. On average, 44.8 % (95 % confidence interval [CI] 43.4-46.3) of monograph categories contained any geriatric information; 38.7 % (95 % CI 37.3-40.0) contained clinically relevant geriatric information. 'Precautions' had the highest number of geriatric references and clinically relevant data (86.5 and 69.0 %, respectively), whereas the 'Pharmacodynamics' category had the lowest (2.5 and 1.8 %, respectively). The number of references to geriatrics ( R = 0.60, p < 0.001) and clinically related content ( R = 0.44, p < 0.01) improved over time. Conclusions: Although improving, there is limited content, with even less clinically relevant content, in geriatric data in product monographs. Information provided in Canadian monographs may be insufficient for informing clinical decision making in geriatric care.

PHARMACODYNAMICS; COMORBIDITY; PHARMACOKINETICS; ANOREXIA nervosa; CLINICAL trials

Pharmaceutical Medicine, 2016, Vol 30, Issue 3, p149

1178-2595

Academic Journal

10.1007/s40290-016-0142-x