RESUMO
Adverse drug reaction is defined by the WHO as a response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, therapy of disease or for the modification of physiologic function. The term Pharmacovigilance was coined by a French group of pharmacologist and toxicologist in the 1970s, which implied strategy promoting detection and assessment of side effects and adverse drug reaction. The first endeavor made to resolve the problem of drug safety was announced in 1961 promptly after the disaster caused by thalidomide treatment in pregnant women. The World Health Organization center for adverse drug reaction monitoring is known as the Uppsala Monitoring Centre. It is an International establishment with the responsibility of coordinating the program based on an agreement made in 1978. The major challenges of Pharmacovigilance program are underreporting, and the best solution is to resolve the problem from the grassroots. This claim could be justified as the outcome of previous knowledge, attitude and practice studies on adverse drug reactions and Pharmacovigilance among medical students was inadequate. Also, the curriculum of teaching and training of medical students was insufficient. The aim of this review was to discuss the current challenges facing adverse drug reactions reporting system and to highlight the gap left in the training of medical students.
RESUMO
Background: Adverse drug reactions (ADRs) have been making headlines because of life threatening issues. ADRs are always underreported and still the major public health problem. Spontaneous reporting system has remained the most significant method for safeguarding patients’ lives. Objectives: Is to examine and analyse the various pharmacovigilance (PV) studies conducted among doctors and to make recommendations for future research. Study Selection: 32 studies covered from 2004 to 2014 were selected. Data Sources: Four electronic data-bases including Science-Direct, Springer-Link, PubMed and MEDLINE were used to obtain 129 relevant publications using HotBot, FreeFullPDF, and Google Scholar as search engines. Data Extraction: Studies conducted on doctors were selected covering research from ten countries. Inclusion Criteria: Only studies done from 2004 to 2014 were included, KAP studies done on ADRs and pharmacovigilance among doctors were selected. Exclusion criteria: All studies done before 2004 and studies done on general public KAP were excluded; similarly, studies conducted on healthcare professionals in general were excluded; also studies done on adverse drug event (ADE) reporting were excluded. The study was conducted from April to August, 2014. Data Synthesis: Knowledge, attitude and practice (KAP) regarding ADRs reporting by doctors were poor. Longitudinal study involving educational intervention and training through workshops and seminars were found to be effective in improving doctors’ knowledge and attitude. Conclusion: There is urgent need to improve knowledge, awareness and practice of doctors on pharmacovigilance. It is imperative for WHO and national pharmacovigilance centres to take proactive measures to curve the menace of ADRs in order to safeguard the patients’ lives. The curriculum of all health and health related schools should be restructured with respect to pharmacovigilance without any delay and hesitation.