Plans to Increase Safety of Patients Prescribed Dangerous Medicines

By February 24, 2013Product Liability

Five years ago, the Food and Drug Administration was given the legal authority to require pharmaceutical companies to develop safety plans for their most risky medicines. The goal was to better mitigate the risks for patients who were prescribed the drugs. Unfortunately, a recent federal review indicates that many of these plans aren’t being properly implemented.

These plans are formally known as Risk Evaluation and Mitigation Strategies (REMS), and their origins go back to the late 1990s. Then, pharmaceutical companies voluntarily agreed to develop plans for drugs that posed severe but avoidable dangers. By 2008, Congress authorized that REMS be a required part of the FDA’s approval process for drugs that pose potentially dangerous side effects, such as birth defects and blindness.

Steps to Help Increase Safety of Risky Medicines

Today’s REMS feature a variety of components designed to educate prescribing physicians and increase patient safety, including:

• Specific training for doctors

• Brochures that outline potential dangerous side effects

• Testing of patients before a medicine can be prescribed

• Limiting the distribution of dangerous drugs

• Reporting of adverse reactions in patients

Report Indicates How Few Drug Safety Plans are Effective

Just last week, the U.S. Department of Health and Human Services issued a report of its first review of the REMS programs. The report indicated that very few are meeting their goals of increasing patient safety:

• Only seven out of the 49 drug safety plans reviewed were deemed to be meeting all their goals

• Only one out the 19 most dangerous drugs subject to the REMS plan was meeting all of its goals

According to the report, in the majority of these cases the pharmaceutical companies aren’t doing a good enough job on following through with components of the plan. And currently, the FDA has no authority to impose penalties on pharmaceutical companies that submit an insufficient amount of information to determine if the REMS are working.

Just another reminder that patients can suffer great harm from dangerous pharmaceuticals, and many times these dangers could have – and should have – been avoided.