Utilizing usage data for postmarketing studies has become an area of active growth in the United States and other countries. Medical and health care data also exist in large databases. With these databases, you can generate or test hypotheses about drug safety. For example, there are large publicly financed insurance systems in the United States; Medicare for people over 65 and Medicaid for younger people or older people who meet certain income eligibility criteria. OSE is using these data to conduct drug safety analyses.
Private health insurers are interested in these data because they want to understand what's happening to patients whose care they are funding. Pharmaceutical companies contract with independent companies, research organizations or the research arm of a health insurance company to do epidemiologic studies. OSE reviews the protocols and findings of these studies to see if regulatory action needs to be taken. The adjustments can include a label change, instituting or modifying a risk management plan or in rare cases, removing the product from the market.