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Safety of Medicines - A Guide to Detecting and Reporting Adverse Drug Reactions - Why Health Professionals Need to Take Action
(2002; 16 pages)
Table of Contents
View the documentIntroduction
View the documentGlossary
View the documentThe magnitude of the problem
View the documentWhy postmarketing surveillance and reporting ADR is needed
View the documentWhy pharmacovigilance is needed in every country
View the documentHow voluntary reporting on ADRs can prevent new medicine tragedies from developing
View the documentHow voluntary reporting on ADRs can influence labelling
View the documentWhy health professionals are in the best position to detect and report on ADRs
View the documentHow to recognize ADRs
View the documentWhat should be reported?
View the documentHow to report ADRs?
View the documentReferences
View the documentAcknowledgements

The magnitude of the problem

During the last decades it has been demonstrated by a number of studies that medicine morbidity and mortality is one of the major health problems which is beginning to be recognized by health professionals and the public. It has been estimated that such adverse drug reactions (ADRs) are the 4th to 6th largest cause for mortality in the USA2. They result in the death of several thousands of patients each year, and many more suffer from ADRs. The percentage of hospital admissions due to adverse drug reactions in some countries is about or more than 10%3, 4, 5.







In addition suitable services to treat ADRs impose a high financial burden on health care due to the hospital care of patients with drug related problems. Some countries spend up to 15-20% of their hospital budget dealing with drug complications6.

Beside ADRs, medicine-related problems include also - drug abuse, misuse, poisoning, therapeutic failure and medication errors.

There is very limited information available on ADRs in developing countries and countries in transition. However, one may expect that the situation is worse rather than better. This problem is also caused by a lack, in some countries, of legislation and proper drug regulations, including ADR reporting, a large number of substandard and counterfeit products circulating in their markets, a lack of independent information and the irrational use of drugs.

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