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Pharmacovigilance and the Importance of Reporting Adverse Events
Drugs that are approved by the national regulatory authorities for marketing are required and expected to be safe. However, given the limitations in the conduct of clinical trials such as small numbers of subjects; restricted population in terms of age, gender and ethnicity; restricted co-morbidity; restricted co-medication; restricted conditions of use; relatively short duration of exposure and followup; and the statistical problems associated with looking at multiple outcomes; knowledge regarding the safety profile of any drug is also limited and cannot be considered complete and accurate. Thus, during the post-marketing phase, patients are exposed to the risk of side effects (adverse drug reactions or ADRs) which could either be an expected event known to occur from the use of the drug or an unexpected event. Several studies conducted in developed countries have confirmed the contribution of ADRs to mortality and morbidity. A meta-analysis of 39 prospective studies from hospitals in the United States indicated that adverse drug reactions ranked from the fourth to sixth leading cause of death. Management of this risk should essentially be aimed at ensuring a balance in the benefit-risk ratio by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk. This has led to the development of post marketing surveillance or pharmacovigilance, which has been defined by the World Health Organisation (WHO) as the science and activities related to detection, assessment, understanding and prevention of adverse effects or any other possible drug related problems. The need for an effective risk management strategy was recognized by FDA as early as 1993 when MedWatch, the safety information and adverse event reporting program of FDA was established. Currently the evaluation and risk assessment of drugs is taken care by a separate division of FDA, the Pharmacovigilance and Epidemiology Division of CDER (Center for Drug Evaluation and Research). EMEA has created a centralized computerized database of ADRs in December 2001 which contains ADR reports to medicines licensed across EU. These reports are received both from the EU regulatory agencies and the pharmaceutical companies. In India, pharmacovigilance is still in its infancy and is yet to gain the momentum needed to cope up with the demands of a country that is already under the pressure of overpopulation, malnutrition and high disease burden. A major step in this direction has been the establishment of National Pharmacovigilance Program in 2005 by India’s Drug Control Department within the Ministry of Health and Family Welfare. This program is being sponsored by the WHO, funded by World Bank and coordinated by the Central Drugs Standard Control Organization (CDSCO) with scientific advice from the National Pharmacovigilance Advisory committee. Pharmacovigilance involves detection of the risk of ADRs following usage of a drug, assessment of this risk, minimization of risk and communication and this is possible through the various functional components of pharmacovigilance:
The success or failure of pharmacovigilance depends on the reporting of suspected ADRs by medical professionals, pharmaceutical companies or consumers to the national pharmacovigilance centers. Reports made by a health professional are an interpretation of information originally provided by a patient who has experienced the actual benefit or harm of a medicine taken. It may also be the result of a direct observation of the effect of a medicine. Patients who suspect they have been affected by a reaction to a medicine are normally encouraged to inform their health professionals to enable them to report to the pharmacovigilance centre. In a few countries, the national reporting system provides some opportunity for patient reporting, especially when there are disease specific control programs in operation. The culture of reporting varies greatly between countries in terms of the quantity, quality and source of reports. In the UK and Sweden, most doctors report directly to the national regulatory authority rather than pharmaceutical companies, although some report to both. In other countries such as Germany and the USA, the majority of reports go initially to companies who then report to the authority in that country. The proportion of reports received by companies directly from patients also varies considerably between countries and is highest in the USA. Under reporting could occur due to several reasons: lack of an effective pharmacovigilance program, failure on the part of the health professionals to report an adverse event, or failure to recognize a previously unknown adverse event and hence not thought to be an ADR. WHO has established International Drug Monitoring Programs that coordinate with and support the national pharmacovigilance programs and 78 countries all over the world are participants in this program. Good pharmacovigilance practice has been developed with guidelines and standards that describe the practical details of the intended information flow. Lack of awareness is one of the reasons for under-reporting from healthcare professionals. This must be addressed through adequate training aimed at all stakeholders involved in this activity such as doctors, dentists, nurses, pharmacists, healthcare administrators, academic institutions, health insurance companies, and pharmaceutical companies. While the magnitude of under-reporting in pharmacovigilance has not been accurately estimated, it is known to be a major area of concern and no efforts are to be spared to address this key activity. References 2. Pharmacovigilance in the pharmaceutical industry; J C C Talbot and B S Nilsson; Br J Clin Pharmacol; 1998 May; 45(5): 427–431. 3. Guidelines on Pharmacovigilance for Medicinal Products for Human Use at ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9A_2007-01.pdf
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