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Background: Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding, and prevention of adverse effects associated with drugs. The objective of PV is to ensure the safety of the medicines and patients by monitoring and reporting all adverse drug reactions (ADRs) associated with prescribed medicine usage. Findings have indicated that about 0.2-24% of hospitalization cases are due to ADRs, of which 3.7% of patients have lethal ADRs. The reasons include the number of prescribed drugs, an increased number of new medicines in the market, an inadequate PV system for ADR monitoring, and a need for more awareness and knowledge about ADR reporting. Severe ADRs lead to enhanced hospital stays, increased treatment costs, risk of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance is essential to avoid further harmful effects of the prescribed drugs. In India, the rate of ADR reporting is less than 1%, whereas worldwide, it is 5% due to a need for more awareness about PV and ADR monitoring among healthcare providers and patients. Aim: The main objective of this review is to highlight the current scenario and possible futuristic ways of ADR reporting methods in rural areas of India. Method: We have searched the literature using PubMed, Google scholar, Indian citation index to retrieve the resources related to ADR monitoring and reporting in India's urban and rural areas. Results: Spontaneous reporting is the most commonly used PV method to report ADRs in India's urban and rural areas. Evidence revealed that no effective ADR reporting mechanisms developed in rural areas causing underreporting of ADR, thus increasing the threat to the rural population. Conclusion: Hence, PV and ADR reporting awareness among healthcare professionals and patients, telecommunication, telemedicine, use of social media and electronic medical records, and artificial intelligence are the potential approaches for prevention, monitoring, and reporting of ADR in rural areas.
Background: Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding, and prevention of adverse effects associated with drugs. The objective of PV is to ensure the safety of the medicines and patients by monitoring and reporting all adverse drug reactions (ADRs) associated with prescribed medicine usage. Findings have indicated that about 0.2-24% of hospitalization cases are due to ADRs, of which 3.7% of patients have lethal ADRs. The reasons include the number of prescribed drugs, an increased number of new medicines in the market, an inadequate PV system for ADR monitoring, and a need for more awareness and knowledge about ADR reporting. Severe ADRs lead to enhanced hospital stays, increased treatment costs, risk of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance is essential to avoid further harmful effects of the prescribed drugs. In India, the rate of ADR reporting is less than 1%, whereas worldwide, it is 5% due to a need for more awareness about PV and ADR monitoring among healthcare providers and patients. Aim: The main objective of this review is to highlight the current scenario and possible futuristic ways of ADR reporting methods in rural areas of India. Method: We have searched the literature using PubMed, Google scholar, Indian citation index to retrieve the resources related to ADR monitoring and reporting in India's urban and rural areas. Results: Spontaneous reporting is the most commonly used PV method to report ADRs in India's urban and rural areas. Evidence revealed that no effective ADR reporting mechanisms developed in rural areas causing underreporting of ADR, thus increasing the threat to the rural population. Conclusion: Hence, PV and ADR reporting awareness among healthcare professionals and patients, telecommunication, telemedicine, use of social media and electronic medical records, and artificial intelligence are the potential approaches for prevention, monitoring, and reporting of ADR in rural areas.
Introduction: Rise in the introduction of newer drugs in the market has increased the need to monitor the adverse drug reactions (ADRs) to ensure patient safety. To overcome this need, a nation-wide Pharmacovigilance Programme was initiated by the Government of India with an objective to assure drug safety. Even after a decade of its initiation, the program is in the stage of infancy. Aims and Objectives: To document knowledge, attitude, and practice (KAP) regarding pharmacovigilance among Primary Health Center/Community Health Centers (PHC/CHC) and private doctors. To document the opinion of PHC/CHC and private doctors with regard to reporting of ADRs. Materials and Methods: Doctors working in private setup, PHC and CHC in rural district and doctors willing to give written informed consent were included. A cross-sectional study design was used. KAP questionnaire was designed to assess the demographic details of doctors, their knowledge of pharmacovigilance, attitudes toward pharmacovigilance and practice on ADR reporting. Data entry and analysis was done using SPSS software. Results: 109 doctors of PHC/CHC and private set-up responded in the study. Out of 109 doctors, 52 were private practitioners. The mean age of participants was 43.09 ± 14.15 years. 56 (51.4%) of PHC/CHC and private set-up doctors were aware regarding the existence of a National Pharmacovigilance Programme in India. 107 (98.2%) doctors of PHC/CHC and private set up have the opinion that there is the necessity of reporting ADRs. Conclusion: This study will definitely act as a sensitizer toward ADR reporting among rural and private doctors. It is the need of the hour that doctors must spare time out of their busy schedule to report ADRs. Strong policy formation should be done to motivate them for reporting ADRs.
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