Accelerated Approval of Aducanumab: Where Do We Stand Now?

Aducanumab was approved by the Food and Drug Administration (FDA) in June 2021 to treat Alzheimer disease (AD). Its path to approval has been highly scrutinized, with many experts arguing that the FDA's decision was premature. Accelerated approval was based on a surrogate end point, with evidence to support clinical effectiveness pending a postapproval trial by the drug company sponsor Biogen. As a result, the role of aducanumab in treating AD remains uncertain. A summary of key areas of controversy to guide informed decisions about use of this drug is provided, along with a timeline describing preapproval and postapproval events.

Potentially Inappropriate Medications in Older Adults: Why the Revised Criteria Matter.

The 2 most widely used explicit criteria regarding inappropriate medication use in older adults are the American Geriatrics Society's Beers Criteria and the Screening Tool of Older People's Prescriptions/Screening Tool to Alert to Right Treatment (STOPP/START). Both documents were updated recently. They are important educational tools that highlight medications for which risks of use may often exceed benefits in older adults and situations in which potentially appropriate medications should be considered for use. The application of these tools has the potential to significantly affect patient care. Thus, it is important for clinicians to be familiar with both documents.

Self-administered medication-risk questionnaire in an elderly population.

OBJECTIVE: To evaluate and validate a 10-item self-administered questionnaire for use by elderly patients to identify who is at increased risk of potentially experiencing a medication-related problem (MRP). METHODS: Forty participants aged >/=60 years who took >/=2 prescription drugs regularly completed the questionnaire. Data collection was based on patient interviews, review of pharmacy or medical records, and drug regimen reviews (DRRs). Outcome measures included feasibility, inter-rater reliability, test-retest reliability, internal consistency, and validity of the questionnaire. DRR severity scores were determined for each participant based on published guidelines for appropriate use. RESULTS: The questionnaire was easily administered to this group of older adults. Overall inter-rater reliability was high (r = 0.847). Nine of 10 individual questions matched well between the investigator and participants (kappa 0.4-0.6 for 3 questions; >0.6 for 6 questions). Test-retest reliability was significant for all 10 questions (kappa > 0.6). Internal consistency was acceptable (alpha = 0.69). DRR severity scores were correlated with questionnaire responses to determine validity. The number of yes answers correlated significantly with higher DRR severity scores (p < 0.001). Furthermore, 5 individual questions significantly correlated with DRR severity scores. CONCLUSIONS: This study suggests that a self-administered questionnaire can be used in an older adult population to identify patients potentially at increased risk of MRPs. Clinicians in ambulatory care settings with similar patient populations can use a modified form of the questionnaire to screen for patients who should receive a medication review.