PHARMACOVIGILANCE AN OVERVIEW
“Role of pharmacovigilance” in medicines regulation”
Robust regulatory arrangements provide the foundation for a national method of medicine safety, and for public confidence in medicines. To be effective the remit of drug regulatory authorities needs to go further than the approval of new medicines, to encompass a wider range of issues relating to the safety of medicines, namely:
Ø Clinical trials;
Ø The safety of complementary and traditional medicines, vaccines and biological medicines;
Ø The development of lines of communication between all parties which have an interest in medicine safety, ensuring that they are able to function efficiently and ethically, particularly at times of crisis.
In order to achieve their respective objectives pharmacovigilance programmes and drug regulatory authorities must be mutually supporting. On the one hand, pharmacovigilance programmes need to maintain strong links with the drug regulatory authorities to ensure that the latter are well briefed on safety issues in everyday clinical practice, whether these issues are relevant to future regulatory action or to concerns that emerge in the public domain. On the other, regulators need to understand the specialized and pivotal role that pharmacovigilance plays in ensuring the ongoing safety of medicinal products.
Partners in pharmacovigilance
The management of the risks associated with the use of medicines demands close and effective collaboration between the key players in the pharmacovigilance7. Sustained commitment to such collaboration is vital if the future challenges in pharmacovigilance are to be met, and if the discipline is to continue to develop and flourish.
Those responsible must jointly anticipate, describe and respond to the continually increasing demands and expectations of the public, health administrator policy officials, politicians and health professionals However, there is little prospect of this happening in the absence of sound and comprehensive systems which make such collaboration possible. The constraints typically include lack of training, resources, political support, and most especially scientific infrastructure. Understanding and tackling these are an essential prerequisite for future development of the science and practice of pharmacovigilance.
Monitoring the safety of medicines: key partners
Ø Hospitals and academia
Ø Medical and pharmaceutical associations
Ø Poisons and medicines information centres
Ø Health professionals
Ø The media
Ø World Health Organization
NATIONAL PROGRAMME OF PHARMACOVIGILANCE
Before a product is marketed, experience of its safety and efficacy is limited to its use in clinical trials, which are not reflective of practice conditions as they are limited by the patient numbers and duration of trial as well as by the highly controlled conditions in which Clinical Trials are conducted. The conditions under which patients are studied during the pre-marketing phase do not necessarily reflect the way the medicine will be used in the hospital or in general practice once it is marketed.
Information about rare but serious adverse drug reactions, chronic toxicity, use in special groups (e.g. pregnant women, children, elderly) and drug interactions is often incomplete or not available. Certain adverse drug reactions may not be detected until a very large number of people have received the medicine.
Pharmacovigilance is therefore one of the important post-marketing tools in ensuring the safety of pharmaceutical and related health products.
• Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use
• Providing information to users to optimise safe and effective use of medicines
• Monitoring the impact of any action taken
Pharmacovigilance in national drug policy
The provision of good quality, safe and effective medicines and their appropriate use is the responsibility of national governments. The establishment of a national medicine regulatory agency and a designated centre for the study of adverse reactions are central to the achievement of these functions.
Multidisciplinary collaboration is of great importance; in particular, links need to be forged between various departments of the ministry of health and also with other stakeholders, such as the pharmaceutical industry, universities, nongovernmental organizations (NGOs) and those professional associations having responsibility for education on rational use of medicines and pharmacotherapy monitoring.
Key elements of pharmacovigilance in national drug policy
Ø Establishment of national pharmacovigilance systems for the reporting of adverse events, including national and, if appropriate, regional pharmacovigilance centres.
Ø Development of legislation/regulation for medicine monitoring.
Ø National policy development (to include costing, budgeting and financing).
Ø Continuing education of health-care providers on safe and effective pharmacotherapy.
Ø Provision of up-to-date information on adverse reactions to professionals and consumers.
Ø Monitoring the impact of pharmacovigilance through process indicators and outcome
The purpose of the programme is to collate data, analyse it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public.
Milestones of the Programme:
Ø Short-term objectives: To foster a culture of notification
Ø Medium-term objectives: To engage several healthcare professionals and NGOs in the drug
Ø Monitoring and information dissemination processes.
Ø Long-term objectives: To achieve such operational efficiencies that would make Indian
Ø National Pharmacovigilance Programme a benchmark for global drug monitoring
OUTLINE OF THE NATIONAL PHARMACOVIGILANCE PROGRAMME
The National Pharmacovigilance Programme aims to provide adverse drug reaction data related to various drugs available in the country to the central drugs regulatory authority i.e. Central Drugs Standard Control Organisation (CDSCO). The programme will be coordinated by the National Pharmacovigilance Advisory Committee [NPAC] constituted by the Ministry of Health & Family Welfare. The Programme would comprise of the following steps:
Step 1 Identifying various centres across the country for capturing ADR related data
Ø Set-up 2 Zonal Pharmacovigilance Centres [ZPC] to coordinate the nationwide programme. [AIIMS for North and East and KEM-Mumbai for South and West]. Zonal Centres shall provide a room and other requisite infrastructure, e.g. a PC with internet facility, access to fax, telecom, etc.
Ø Identify 5 Regional Pharmacovigilance Centres [RPC] across the country
· Ideally medical colleges with interested and initiated pharmacologists
· Can provide a small area (approx. 100 sq. feet)
· Can deploy a pharmacologist for the Programme
Ø Identify Peripheral Pharmacovigilance Centres [PPC]: At least oneteaching hospital in each state and union-territory, and some other leading medical institutions, clinics or pharmacies in the area under each RPC.
· Ideally, centres that have internet facility
· Manned by doctors / pharmacists who are enthusiastic about carrying out research activities e.g. monitoring ADRs
· Visited by not less than a total of 50 patients daily in any/all of the following departments: Medicine, Gynaecology, Paediatrics, Orthopaedics, Cardiology, Oncology
Step 2 Training and Coordination
To ensure harmonized implementation of the Programme efforts shall be made to arrive at a uniform understanding of the operational systems, along with standardized formats to document and analyse ADRs. An induction training programme shall be arranged for healthcare professionals participating in the NPP.
Intensive interaction / training sessions will be organized for all participants to:
Ø i. Clearly define their individual and team roles and responsibilities
Ø ii. Set operational benchmarks e.g.
Each PPC to record at least 30 AEs each month (statistically speaking 30 AEs in about 1500 patients who visit each month would be quite easy to record). Completed AE forms shall be forwarded to the concerned RPC at the end of each month.
Ø Each RPC
· To collate and scrutinize the data received
· To perform the causality analysis of all 120 to 150 forms received every month.
· To submit a monthly report – prepared in a specific form to be forwarded to National Pharmacovigilance Centre (NPC) every month.
· To report any alarming or critical ADRs to NPC along with supporting evidence.
Ø Each ZPC
· To collate the data (approx. 1000-1200 forms) received from RPCs.
· To verify / validate the causality analysis.
· To prepare MIS reports for NPC in a specified format.
· To pass on the final data to WHO Uppsala Centre for their global data pool.
· To publish a periodic newsletter.
Ø iii. Evolve SOPs for generating and forwarding ADR data and for general conduct of the Programme (Zonal centres to prepare SOPs which must ensure that the Programme is conducted in compliance with this Protocol).
Ø iv. Impart relevant skills for carrying out ADR data capture namely
· Appropriate communication skills to elicit ADR related information
· For recording ADR information through hands-on training
· For meticulous collation and completeness of data
· For fostering notification culture.
These training programs and interaction meetings shall be held every 6 months after the initial training. Besides, continuous communication through emails, carrying relevant information related to ADR monitoring methods shall be maintained among the participating centres.
Broad objectives of the Programme
Ø To foster the culture of AE notification and reporting To establish a viable and broad-based ADR monitoring program in India
Ø Specific objectives of the Programme
Ø To create an ADR database for the Indian population To create awareness of ADR monitoring among people To ensure optimum safety of drug products in Indian market To create infrastructure for ongoing regulatory review of PSURs
Coordinator’s eligibility at different tiers of NPP
Ø PPC – Any physician (primary-care or specialist), pharmacist
Ø RPC – A pharmacologist, preferably not below the rank of an assistant professor, attached to a medical college
Ø ZPC – A pharmacologist, not below the rank of a professor, attached to a medical college
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