THE IMPORTANCE OF REPORTING ADVERSE EVENTS RELATED TO DRUGS AND MEDICAL DEVICES
When a drug or medical device is initially registered and approved for marketing to the general public, information about its safety and efficacy is available only from clinical trials. Clinical trials provide information about many of the possible adverse effects, but they do not include all possible adverse effects because:
� Clinical trials do not continue long enough to detect adverse events which will take a long time to develop,
� Clinical trials include a limited number of patients to detect adverse events that occur rarely, and
� Clinical trials do not include all different types of people who might use the medicine and who might be more susceptible to some adverse events, such as older people, children, pregnant women, or people with other medical conditions. Every person is unique and different in the way of reaction to medicine and until we have personalized medicine available to the general public, reporting adverse events is crucial to insure public safety
Regulatory agencies around the world monitor the safety of therapeutic goods and document their possible adverse effects when they are used outside the controlled conditions of clinical trials. This information is then made available to all relevant interested parties like patients, physicians, hospitals and clinics, manufacturers of drugs and medical devices…
Who can report: Anybody can report adverse events, whether it is the patient or family member, care giver like nurse or physician, community and hospital pharmacists. If you are exposed to an adverse event and not sure if it is expected or not, serious or not � it is better to report. Let the professionals do the analysis and make the decision. Reporting adverse events should be encouraged and supported by training and education to the general public and the medical community.