"This will be possible because drug dispensing can be linked to individuals' other health information," explains Platt. Covering more than 40 million people, Medicare data can transform our ability to assess drugs in real-life conditions, particularly in this vulnerable population of beneficiaries, which is often underrepresented in clinical trials.
The lack of systematic collection and analysis of post-marketing utilization and outcomes of medication has delayed discovery of some serious problems, which were only realized when millions of people were exposed. Therefore, it is important to review patients' full medical records in the small number of cases for which this information makes a critical difference. Two existing programs, one in the CDC and one in the FDA, share features that can be adopted for Medicare data.
Platt states that Medicare data will offer a great opportunity to improve the nation's ability to understand the balance of risks and benefits of drug treatment, and if taken advantage of, there will be increased data about whether drugs are used as intended, whether they have their intended effects, and how risky they are.
New England Journal of Medicine