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WHAT IS PHARMACOVIGILANCE ?  
   
 

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.

- Source : Importance Of Pharmacovigilance, WHO 2002      

 
   
current reporting of pharmacovigilance  
 
 
IN MOST DEVELOPING COUNTRIES, THERE IS PRACTICALLY NO CULTURE OF PHARMACOVIGILANCE AND DRUG SAFETY.
 
AS A RESULT, THERE IS ALMOST NO EVIDENCE ON THE SAFETY OF DRUGS IN PUBLIC HEALTH PROGRAMS.
 
 
 
Current Status of ADR Reporting
           Top Ten Contributors to WHO Database
     
     
  Less than 2% of all Adverse Drug Reaction (ADR) data is captured in Africa and Asia
  Some developing countries collect less than 100 ADRs per year < 1% of their target
     
     
- From Uppsala Monitoring Center
 

 

 
   
WHY PHARMACOVIGILANCE IS IMPORTANT ?  
 


Even in developed countries, which have, relatively speaking, stringent regulatory authorities, several drugs have been withdrawn from the market in the past few years, including: Alosetron (then returned to market with restrictions and a label warning), Troglitazone, propulsid,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
     
  the type of drug use in different (developed countries) do not use the co-formulated ARVs and minimally use anti-TB, anti-malarial and anti-diarrheal drugs.
 
  Patient genotype and phenotype are markedly distinct than in developed countries, with a large number of malnourished patients and patients with concomitant diseases in developing countries relative to developed countries.
 
  The need to establish pharmacovigilance capability needs to be accelerated given that:
  New drugs are reaching developing countries in greater numbers and more quickly because of new funding from several donors, including the Bill and Melinda Gates Foundation.
 
  Faster scale up of public health programs due to availability of new funding from major donors such as the Global Fund, World Bank, PEPFAR, PMI and other major bilaterals.