Pharmacovigilance: Ensuring safe use of medicines
Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects- particularly concerned with long term and short term side effects of medicines. It is essential to improve public health and safety in relation to the use of medicines. In order to assessment of benefit, harm, effectiveness and risk of medicines, analysing the safety index, rational and more effective (including cost-effective) use of medicine, pharmacovilgilance has been the principal basis of World Health Organisation (WHO)'s International Drug Monitoring Programme. After the disaster caused by drug-Thalidomide in 1961 which was responsible for the birth of thousands of malformed infants, the first systematic international efforts were initiated to address drug safety issues. Events such as the Thalidomide tragedy highlight the extreme importance of effective drug monitoring systems for all medicine. Medicine used by patients for one indication might have other different diseases, who might be using several other drugs and who might have different lifestyle and diets which may affect the way in which they react to a medicine. Different brands of medicine may differ in the manner in which they are produced and the ingredients that are used. The adverse drug reactions and poisonings associated with traditional and herbal remedies also need to be monitored in each country. To prevent unnecessary suffering by the patients and to decrease the financial loss sustained by the patients due to the inappropriate or unsafe use of medicine, it is essential that a monitoring system for the safety of medicines is supported by doctors, pharmacists, nurses and other health professionals in the country. In regard to safety and efficacy of drugs, particularly those concern Adverse Drug Reactions (ADR), in Bangladesh are left unanswered mainly due to lack of a systematic mechanism of monitoring. Under the guidance of WHO, a cell has been established in Directorate General of Drug Administration (DGDA) in 1996. When adverse drug effects associated with a drug's use are identified, a report should be submitted to either the pharmaceutical manufacturer or the government entity in charge of pharmacovigilance. Regulatory body with the collaboration of drug manufacturers can play a vital role to have a robust pharmacovigilance system in place.
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