Introduction of Pharmacovigilance systems at District Hospitals, Community Health Centres & Primary Health Centres 

INTRODUCTION

Pharmacovigilance (PV) is the science and activities relating to the detection, monitoring, assessment, understanding and prevention of adverse effects or any other drug-related problem from any pharmaceutical products. The core purpose of pharmacovigilance is to enhance patient care and generate the evidence based information on safety of medicines. It is increasingly gaining significance in pursuit of safe-guarding public health by monitoring and prevention of adverse drug reactions. Adverse drug reactions (ADRs) represent the leading cause of death after cancer and cardiac disease in USA. ADRs account for 4.2-30% of hospital admissions in USA and Canada, 5.7-18.8% in Australia, and 2.5-10.6% in Europe . A study in India reported overall incidence of 9.8% ADRs including 3.4% of total hospital admissions and 3.7% ADRs developed during hospital stay. 

Pharmacovigilance Programme of India The Pharmacovigilance Programme of India (PvPI) was initiated in July 2010 by Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health & Family Welfare (MoHFW) to safeguard health of Indian population. On 15 April 2011, Indian Pharmacopoeia Commission (IPC) took over as NCC. The MoHFW has constituted five committees and Panels to guide the conduction of Pharmacovigilance activities in the

country. These are the Steering Committee and the Working Group and three panels for

Signal Review, Quality Review and Core Training.

NCC-PvPI started with 22 ADR Monitoring Centres (AMCs) in the initial phase and currently has 250 centres across the country. Of these, 17 receive information from the Revised National Tuberculosis Control Programme (RNTCP), 20 from the HIV control programme on Anti-retroviral therapy (ART) and 6 are designated Bedaquiline centres (now scaled up to 19 sites- with appropriate capacity).

Pharmacovigilance Programme of India (PvPI) has established procedures and tools for collection, assessment, and interpretation of safety issues. Suspected ADR reporting formats are standardized for the reporting of adverse events. Communication of information includes a PvPI website, e-mails, Short Message Service and a dedicated toll free helpline. In addition the PvPI publishes a periodic newsletter with updates on activities and information which is widely disseminated. The PvPI also conducts regular interactive meetings and weekly teleconferences with all stakeholders providing feedback and recognizing performance with appreciation certificates and awards.

Pharmacovigilance Programme of India (PvPI) is also collaborating with WHO-UMC, Sweden, for international Drug Monitoring Program by exchange of scientific information through different software tools (VigiFlow, VigiBase, VigiMine, VigiMed, VigiSearch, VigiLyze). 

                                                           

Pharmacovigilance is an integral part of every public health programme (PHP) that uses medicines & thus optimizing their safety is paramount. The issue of safeguarding public health in India fully aligns with one of the three pillars of Universal Health Coverage; ensuring access to safe and quality medicines and vaccines in the country. Therefore, PvPI recognized monitoring safety of medicines used in national health programmes as a matter of concern. Multi drug regimens enhance safety issues for the treatment of tuberculosis, HIV, malaria and other vector borne diseases.

NCC-PvPI is collaborating with various National Health Programmes to promote vigilance activities and for monitoring adverse events due to drugs used in the treatment regimen, these include Revised National Tuberculosis Control Programme (RNTCP), National AIDS Control Organization (NACO), National Vector Borne Disease Control programme (NVBDCP) and Universal Immunization Programme (UIP) [details of existing collaborations in Annexure I). The recent PvPI focus on Bedaquilline safety monitoring is a classic example of a response to drugs of national importance. In addition, advocacy for active participation in the ADR is extended to Teaching and Corporate Hospitals to monitor Adverse Events through collaborations with National Accreditation Board of Hospitals (NABH), Indian Medical Association (IMA) and Indian Council of Medical Research (ICMR) for optimizing drug safety through research-based Pharmacovigilance. WHO India has been engaged in providing pivotal strategic and technical support to the PvPI during the last few years,

including setting up of pharmacovigilance systems in Tuberculosis, HIV-AIDS and vector-borne disease public health programmes. 

Early identification and prevention of ADRs will lead to optimal use of medicines. Better adherence within the target population will reassure that monitoring and good communication on risks and benefits provide favorable implications for decisions on medicine procurement. Adverse drug reactions (ADR) continue to remain an important public health issue in India and are among the ten leading causes of mortality. Safety monitoring of medicines is thus a vital and crucial element of any health system. Pharmacovigilance programme, jointly with current PHPs, address the special needs of the vulnerable population (such as pediatric, geriatric, pregnant & breast feeding women and patients with other diseases, e.g. renal, cardiac or hepatic disease).

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