National Database Proposed to Decrease Adverse Drug Events

Medicines are supposed to treat illnesses, not cause them. But every year dangerous pharmaceuticals cause over 770,000 deaths and injuries. The annual cost of treating the unfortunate victims in hospitals amounts to an estimated cost of up to $5.6 billion.

Delays in Notifications

What's especially alarming is that it can take time for consumers and medical professionals to become aware that a dangerous medication should not be administered.

The cholesterol drug Crestor is one such example. The potential hazards of the drug were reported but doctors were not yet aware of the drug's risks and continued to prescribe the drug to patients. Millions of people where therefore effected.

Advantages of a National Database

A national advocacy group, the Institute of Medicine, recommends that the U.S. Food and Drug Administration develop a public database that doctors and patients can access to find up-to-the-minute information about dangerous drug side effects and reactions.

The database would contain information about a drug from the time it is first marketed. Side effects that were known when the drug was introduced would be included, and as patients experience additional side effects, they would be added. If the FDA needs to take any action to regulate the drug, the action would be recorded in the database, too.

Patients and their caregivers would benefit, just like those in other countries that already have such public databases. They could look up a particular drug in the database and get information about the risks as well as benefits before taking or prescribing the drug.

The database would also help the FDA act more quickly to protect consumers. Currently, the FDA can recall a dangerous drug, but only after it receives a large number of reports about the drug causing harm to patients. Under the Institute of Medicine proposal, the national database would be a collection point where side effects and bad reactions could be reported promptly.

The cumulative effect of a number of timely complaints would work to put the FDA on notice that its action is required, faster than the system now allows.