Drug Safety and AE Reporting – How Far Have We Come?

It’s not something we care to think about, but it’s a well-known fact that drugs, which are supposed to save lives, end up taking them as well. The reasons are varied – the drugs are not safe, patients don’t follow instructions and overdose on them, spurious drugs enter the market and are sold along with the genuine variety, and worst of all, sometimes doctors and other healthcare providers goof up when treating patients and writing prescriptions.

Again, we’d rather sweep the issue under the carpet than acknowledge the fact that the medical fraternity is prone to errors that take lives. Healthcare practitioners make mistakes because:

  • They are negligent in checking patient history and the drugs that they’re already taking. This may cause a fatality if the drugs they prescribe react adversely to the ones they’re already on.
  • Patients mislead them or fail to inform them of the drugs they’re taking, not deliberately but because they may not know that they’re supposed to be open with their doctors.
  • They don’t have the time or/and the inclination to check with patients and find out if they’re allergic to certain drugs or if they’re on any prior medication.
  • They’re overworked and tend to make mistakes.

If there is one good thing about mistakes, it’s that we can use them as examples to learn from and to ensure that they do not happen again. This is what Adverse Event (AE) reporting is all about; as a part of the MedWatch initiative that was set up almost two decades ago by the then FDA Commissioner David Kessler, AE reporting involves the identification and evaluation of adverse events and product quality issues regarding the use of drugs and medical devices and appliances. The success of this endeavor depends largely on the willingness of doctors, nurses and pharmacists to provide adequate support and timely feedback so that errors can be rectified and prevented from happening again. It’s a voluntary process, but one that is apparently quite successful as the FDA receives as many as 40,000 AE reports directly from doctors, clinicians and patients and many more indirectly from reports that are sent to manufacturers by clinicians.