Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators.

Evaluation of a policy to reduce youth tractor crashes on public roads.

OBJECTIVE: Evaluate the effectiveness of a United States state law, Wisconsin Act 455, in reducing highway tractor crashes involving youth operators. DESIGN: Policy outcome evaluation involving review of a retrospective case series. SETTING: Youth highway tractor crashes from Wisconsin for the years 1994-2003 that resulted in a fatality, injury, and/or property damage. SUBJECTS: One hundred and forty six tractor crash cases involving operators younger than 16 years. METHODS: Describe and model the tractor crash patterns before and after enactment of the law, and examine the relation between the contributing circumstances identified in the crash reports and the content covered in the mandated tractor certification course. RESULTS: There was neither a significant change in the number of youth tractor crashes after the law was passed, nor any reduction in the proportion of crashes where the youth operator was designated at fault. The tractor certification course did not cover the major factors contributing to youth tractor crashes on public roads. CONCLUSIONS: No significant effect of the law was detected and crash rates at the end of the study period were similar to those before Wisconsin Act 455. The authors'findings should not be construed to suggest that public policy, in general, is an ineffective strategy for the prevention of pediatric agricultural injuries. Negotiating a balance in public policy debates will be a challenge, but it is clear that future policy initiatives need to identify and implement the right policy for the right problem.