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An update on the Pharmacovigilance Programme of India.

Lihite RJ, Lahkar M - Front Pharmacol (2015)

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, ADR Monitoring Centre (Pharmacovigilance Programme of India), Gauhati Medical College and Hospital Guwahati, India.

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It has been observed that a medication that is proven efficacious in large patient population often fails to work in some other patients of different ancestry... Recognizing the need for improved ADR monitoring in the country, in July, 2010, under the aegis of Health Ministry, a nation-wide revised ADR monitoring programme was launched and named as Pharmacovigilance Programme of India (PvPI) (Kalaiselvan et al., )... These drug safety information/Individual Case Safety Reports (ICSRs) are collected in predesigned suspected ADR reporting form, broadly consist of 4 sections i.e., patient's information, suspected adverse reaction, suspected medication(s), and reporter's information... These ICSRs are then reported to NCC for Quality & Signal Review via Vigiflow after causality assessments of ADRs performed using the WHO-UMC causality assessment system (Figure 1)... The purpose of this programme is to collect, collate and analyze this reported data to arrive at an inference to recommend regulatory interventions for safeguarding the health of Indian population by ensuring that benefit outweighs the risks associated with the use of medicines... At present there are 150 AMCs under this programme and categorized into four zones i.e., North, South, East and West (Pharmacovigilance Programme of India (PvPI) newsletter, 2013)... Based upon PvPI database, this year Drugs Controller of India has instructed manufacturers to include Steven Johnson Syndrome (SJS) in package insert of product containing carbamazepine and advised to the physicians to screen the patients for HLA-B1502 allele before initiating treatment with carbamazepine... Therefore, for sufficient database on ADRs, awareness among the healthcare providers of government and corporate hospitals including rural areas are needed to be created... The other healthcare institutes like dental, pharmacy, nursing, paramedical etc. associated with patients care by providing safe and effective medication should be encouraged for ADR reporting... It was observed that the percentage of ADR reporting by physicians was higher as compare to pharmacists and other healthcare providers (Kalaiselvan et al., )... In India, system of distribution does not leave much scope for pharmacists, nurses, and other healthcare providers to be a significant source of ADR reporting... In year 2013, India's contribution to WHO–UMC's global drug safety database (Vigibase) was 2%... India was 7th in position among top 10 counties contributing to global drug safety database... Thus, from this completeness score it can be predicted that AMCs of PvPI are collecting all the necessary information required for ADR reporting via Vigiflow... In conclusion, awareness about the ADR reporting among the healthcare providers can improve the rate of reporting across the country.

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Programme Communication & flow of ADR reports.
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Figure 1: Programme Communication & flow of ADR reports.

Mentions: Recognizing the need for improved ADR monitoring in the country, in July, 2010, under the aegis of Health Ministry, a nation-wide revised ADR monitoring programme was launched and named as Pharmacovigilance Programme of India (PvPI) (Kalaiselvan et al., 2014a). Initially, under this National programme, All India Institute of Medical Sciences, New Delhi was the National Coordination Centre (NCC) and in April, 2011, it was shifted to Indian Pharmacopoeia Commission (IPC), Ghaziabad. Dr. G. N. Singh, Scientific Director of IPC was designated as a National Coordinator of PvPI for ADR monitoring in the country (Rehan, 2013). Under PvPI, ADRs are being identified and spontaneously reported by the healthcare professional of Adverse Drug Reaction Monitoring Centres (AMC). These AMCs are set up across the country in medical colleges approved by Medical Council of India (MCI) (Rehan, 2013). These AMCs are responsible for collecting adverse event as per Standard Operating Procedure (SOP), performing follow up if require for the completeness of ADR reports and uploading these reports in net-based software used for ADR reporting called as Vigiflow (Kalaiselvan et al., 2014b). These drug safety information/Individual Case Safety Reports (ICSRs) are collected in predesigned suspected ADR reporting form, broadly consist of 4 sections i.e., patient's information, suspected adverse reaction, suspected medication(s), and reporter's information. These ICSRs are then reported to NCC for Quality & Signal Review via Vigiflow after causality assessments of ADRs performed using the WHO-UMC causality assessment system (Figure 1). The purpose of this programme is to collect, collate and analyze this reported data to arrive at an inference to recommend regulatory interventions for safeguarding the health of Indian population by ensuring that benefit outweighs the risks associated with the use of medicines. Under PvPI, AMC plays a vital role in collection and follow-up of ADR reports from healthcare professionals. Initially there were 22 AMCs in the country. At present there are 150 AMCs under this programme and categorized into four zones i.e., North, South, East and West (Pharmacovigilance Programme of India (PvPI) newsletter, 2013)1. In coming year, there will be 350 AMCs across the country to make this programme one of the largest Pharmacovigilance Programme in the world.


An update on the Pharmacovigilance Programme of India.

Lihite RJ, Lahkar M - Front Pharmacol (2015)

Programme Communication & flow of ADR reports.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4585088&req=5

Figure 1: Programme Communication & flow of ADR reports.
Mentions: Recognizing the need for improved ADR monitoring in the country, in July, 2010, under the aegis of Health Ministry, a nation-wide revised ADR monitoring programme was launched and named as Pharmacovigilance Programme of India (PvPI) (Kalaiselvan et al., 2014a). Initially, under this National programme, All India Institute of Medical Sciences, New Delhi was the National Coordination Centre (NCC) and in April, 2011, it was shifted to Indian Pharmacopoeia Commission (IPC), Ghaziabad. Dr. G. N. Singh, Scientific Director of IPC was designated as a National Coordinator of PvPI for ADR monitoring in the country (Rehan, 2013). Under PvPI, ADRs are being identified and spontaneously reported by the healthcare professional of Adverse Drug Reaction Monitoring Centres (AMC). These AMCs are set up across the country in medical colleges approved by Medical Council of India (MCI) (Rehan, 2013). These AMCs are responsible for collecting adverse event as per Standard Operating Procedure (SOP), performing follow up if require for the completeness of ADR reports and uploading these reports in net-based software used for ADR reporting called as Vigiflow (Kalaiselvan et al., 2014b). These drug safety information/Individual Case Safety Reports (ICSRs) are collected in predesigned suspected ADR reporting form, broadly consist of 4 sections i.e., patient's information, suspected adverse reaction, suspected medication(s), and reporter's information. These ICSRs are then reported to NCC for Quality & Signal Review via Vigiflow after causality assessments of ADRs performed using the WHO-UMC causality assessment system (Figure 1). The purpose of this programme is to collect, collate and analyze this reported data to arrive at an inference to recommend regulatory interventions for safeguarding the health of Indian population by ensuring that benefit outweighs the risks associated with the use of medicines. Under PvPI, AMC plays a vital role in collection and follow-up of ADR reports from healthcare professionals. Initially there were 22 AMCs in the country. At present there are 150 AMCs under this programme and categorized into four zones i.e., North, South, East and West (Pharmacovigilance Programme of India (PvPI) newsletter, 2013)1. In coming year, there will be 350 AMCs across the country to make this programme one of the largest Pharmacovigilance Programme in the world.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, ADR Monitoring Centre (Pharmacovigilance Programme of India), Gauhati Medical College and Hospital Guwahati, India.

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

It has been observed that a medication that is proven efficacious in large patient population often fails to work in some other patients of different ancestry... Recognizing the need for improved ADR monitoring in the country, in July, 2010, under the aegis of Health Ministry, a nation-wide revised ADR monitoring programme was launched and named as Pharmacovigilance Programme of India (PvPI) (Kalaiselvan et al., )... These drug safety information/Individual Case Safety Reports (ICSRs) are collected in predesigned suspected ADR reporting form, broadly consist of 4 sections i.e., patient's information, suspected adverse reaction, suspected medication(s), and reporter's information... These ICSRs are then reported to NCC for Quality & Signal Review via Vigiflow after causality assessments of ADRs performed using the WHO-UMC causality assessment system (Figure 1)... The purpose of this programme is to collect, collate and analyze this reported data to arrive at an inference to recommend regulatory interventions for safeguarding the health of Indian population by ensuring that benefit outweighs the risks associated with the use of medicines... At present there are 150 AMCs under this programme and categorized into four zones i.e., North, South, East and West (Pharmacovigilance Programme of India (PvPI) newsletter, 2013)... Based upon PvPI database, this year Drugs Controller of India has instructed manufacturers to include Steven Johnson Syndrome (SJS) in package insert of product containing carbamazepine and advised to the physicians to screen the patients for HLA-B1502 allele before initiating treatment with carbamazepine... Therefore, for sufficient database on ADRs, awareness among the healthcare providers of government and corporate hospitals including rural areas are needed to be created... The other healthcare institutes like dental, pharmacy, nursing, paramedical etc. associated with patients care by providing safe and effective medication should be encouraged for ADR reporting... It was observed that the percentage of ADR reporting by physicians was higher as compare to pharmacists and other healthcare providers (Kalaiselvan et al., )... In India, system of distribution does not leave much scope for pharmacists, nurses, and other healthcare providers to be a significant source of ADR reporting... In year 2013, India's contribution to WHO–UMC's global drug safety database (Vigibase) was 2%... India was 7th in position among top 10 counties contributing to global drug safety database... Thus, from this completeness score it can be predicted that AMCs of PvPI are collecting all the necessary information required for ADR reporting via Vigiflow... In conclusion, awareness about the ADR reporting among the healthcare providers can improve the rate of reporting across the country.

No MeSH data available.