Vivekanandan Kalaiselvan

Pharmacovigilance Programme of India: Recent developments and future perspectives

Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions.

Helpline facility to assist reporting of adverse drug reactions in India

Address for correspondence: Dr Vivekanandan Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Sector 23, Rajnagar, Ghaziabad, Uttar Pradesh 201002, India Email: vivekarts@rediffmail.com We wish to draw colleagues’ attention to the launch of a helpline facility for health-care professionals and the public – especially those in rural areas – to report adverse drug reactions to the Indian Pharmacopoeia Commission (IPC). In 2010, the Ministry of Health and Family Welfare, Government of India, launched the nationwide Pharmacovigilance Programme of India (PvPI) to monitor the safety of medicine. IPC, an autonomous institution, established under the Ministry of Health and Family Welfare, Government of India, Ghaziabad, has been functioning as the National Coordination Centre (NCC) for PvPI since April 15th 2011.1 The main responsibility of the NCC is to monitor adverse reactions to medicines observed in the Indian population and to develop and maintain its own pharmacovigilance database.2 Adverse drug reaction monitoring centres (AMCs) have been set up across the country by the PvPI; there are currently 150 of these centres, which monitor the adverse drug reactions and report to the NCC. This system allows health-care professionals to report any adverse drug reactions in their areas of work, but may not bridge the gap between general public and NCC.

Risk of Intussusception with Rotavirus Vaccine

ObjectiveTo study the case series for intussusception associated with the vaccination of rotavirus vaccine in children.MethodsThe study of spontaneous adverse event monitoring such as intussusception due to rotavirus vaccine was carried out from the year 2011 through 2015. The individual case safety reports (ICSRs) of this event were collated, assessed and recorded as per the requirement of Suspected Adverse Drug Reactions Reporting form of Pharmacovigilance Programme of India (PvPI).ResultsIn the present study, 10 ICSRs of intussussception due to rotavirus vaccine were reported to PvPI. Of which 3 ICSRs were found to be causal relationship with rotavirus vaccine, as evidenced by the adequate information provided in ICSRs.ConclusionsSince intussusception, the emerging safety as one of the important safety concern, healthcare professionals are advised to monitor and report to the concerned authority for appropriate action.

Best Practices for Improving the Quality of Individual Case Safety Reports in Pharmacovigilance

Background: The quality of individual case safety reports (ICSRs) plays a vital role in identifying new safety signals in pharmacovigilance. This article focuses on establishing a method for ensuring the quality data. Objective: To develop an in-house method for assessing the documentation grading and completeness score of ICSRs. Methods: In the proposed method, 16 parameters, from report title to case narrative, are adopted to assess the quality of ICSRs. The in-house method ensures the completeness of the data and enhances the quality of ICSRs. Results: The in-house method was found effective in calculating the completeness score of ICSR ranges from 0.05 to 1. Indian ICSR completeness scores significantly improved after the implementation of the proposed method in the third quarter of 2013. In 2014 and until the third quarter of 2015, the score was found to be 0.91 and 0.93 out of 1, respectively. Conclusion: The higher quality ICSRs aids in more effective identification of new drug safety alerts and provides evidence-based information for regulating the drug safety.

Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India

A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

System of adverse drug reactions reporting: What, where, how, and whom to report?

Sir, The continuous progress in medical and pharmaceutical sciences has made the availability of pharmaceutical products in the Indian market to prevent and control of several disease conditions. Irrespective of the benefits associated with the use of medicines adverse effects associated with them has emerged the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. World Health Organization (WHO) defined ADR as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”[1] To improve public health, the safe use of medicine must be monitored through an effective pharmacovigilance (PV) system. PV is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects, or any other possible drug-related problems.[2] Indian Pharmacopoeia Commission (IPC), Ghaziabad is functioning as a National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI). One Hundred and fifty ADR monitoring centres (AMCs) were established in various medical institutions/hospitals across India to monitor and collect ADR reports under NCC-PvPI.[3]

Statistical Signal Process in R Language in the Pharmacovigilance Programme of India

Background: The Ministry of Health & Family Welfare, Government of India, initiated the Pharmacovigilance Programme of India (PvPI) in July 2010. The purpose of the PvPI is to collect data on adverse reactions due to medications, analyze it, and use the reference to recommend informed regulatory intervention, besides communicating the risk to health care professionals and the public. The goal of the present study was to apply statistical tools to find the relationship between drugs and ADRs for signal detection by R programming. Methods: Four statistical parameters were proposed for quantitative signal detection. These 4 parameters are IC025, PRR and PRRlb, chi-square, and N11; we calculated these 4 values using R programming. We analyzed 78,983 drug-ADR combinations, and the total count of drug-ADR combination was 4,20,060. During the calculation of the statistical parameter, we use 3 variables: (1) N11 (number of counts), (2) N1. (Drug margin), and (3) N.1 (ADR margin). Results: The structure and calculation of these 4 statistical parameters in R language are easily understandable. On the basis of the IC value (IC value >0), out of the 78,983 drug-ADR combination (drug-ADR combination), we found the 8,667 combinations to be significantly associated. Conclusions: The calculation of statistical parameters in R language is time saving and allows to easily identify new signals in the Indian ICSR (Individual Case Safety Reports) database.

Topical Corticosteroids: The Pharmacovigilance Perspective

Pharmacovigilance is the need of hour for use of topical steroids because the irrational use of topical steroids may harm the patients in long and short term; the outcome of such treatments can be assessed by using pharmacovigilance as a scientific tool to assess safety of medicine. Pharmacovigilance system of some developed countries is very strong, while in developing and poor countries, it is still in infancy state. The role of international bodies like ICH, CIOMS, WHO-UMC is very significant for harmonising the process of pharmacovigilance across the world. In this chapter, authors tries to establish the need of pharmacovigilance to ascertain frequency of rarely reported cases due to steroids and other drugs; an analysis of International ADR database is presented to show the culture of reporting across the world.

Pharmacovigilance in drugs used in the treatment of drug dependence

Indian Journal of Psychiatry Volume 59, Issue 3, July-September 2017 393 adverse drug reactions (ADRs) and alerting physicians to the plausibility and degree of such events, thereby protecting the user population from unnecessary harm.[2,3] Different classes of psychotropic medications and medications used for the treatment of substance-use disorders have different ADR profile. In addition, polypharmacy, i.e., prescribing more than one drug to the single person of the same chemical class (such as antipsychotics), can result in serious adverse reactions and exacerbate side effects and can lead to early death. PvPI encourages all types of suspected ADRs reporting whether they are known, unknown, serious, nonserious, frequent, or rare regardless of an established causal relationship between a drug and the reaction. ADRs related to the use of allopathic medicines, vaccines, traditional medicines, medical devices, contrast media, etc., can be reported to the PvPI. Regular and informed reporting practices can result in strengthened database about ADR, especially those which have late onset, or vary by genetic stock. Specific forms, endorsed by the PvPI, are available for Sir,

Veterinary pharmacovigilance in India: A need of hour

Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.