Even in developed countries, which have, relatively speaking, stringent regulatory authorities, several drugs have been withdrawn from the market in the past few years, including: Alosetron (then returned to market with restrictions and a label warning), Troglitazone, propulsid, cerivastatin, rofecoxib, valdecoxib, Several other products such as antidepressant and NSAIDs have received additional warnings and restrictions based on data captured from drug safety activities. In developing countries, where several million people are taking drugs for chronic diseases such as HIV/AIDS and tuberculosis, many of which are known to have serious side effects and a narrow therapeutic window, gathering safety data is imperative.
It is also important to emphasize that clinical trials for new drugs are almost never conducted on patients with co-infections, or on children and pregnant women; whereas in the real world, all these groups of people will likely take the drugs at one time or another. For example, even in the United States, with almost a 100% literacy rate and well-informed health professionals and a patients, it was noted that groups contraindicated to use specific medicines were using them frequently (as much as 20% in some instances) . The situation in developing countries is likely to be much worse, but this data is not being captured.
To gather this type of safety data, country-based systems for pharmacovigilance must be established. RaPID will help national program establish these and will also develop registries for children, pregnant women, people with co-infections, etc.
Further, the data from developed countries can not be extrapolated to developing countries for several reasons |