PHARMACOVIGILANCE AN OVERVIEW
THE NATIONAL PHARMACOVIGILANCE CENTRES
At present, post-marketing surveillance of medicines is mainly co-ordinated by national pharmacovigilance centres. In collaboration withthe Uppsala Monitoring Centre (UMC) the National Centres have achieved a great deal in:
Ø Collecting and analysing case reports of ADRs
Ø Distinguishing signals from background ‘noise’
Ø Making regulatory decisions based on strengthened signals
Ø Alerting prescribers, manufacturers and the public to new risks of adverse reactions.
Ø The number of National Centres participating in the WHO International Drug Monitoring Programme has increased from 10 in 1968 when the Programme started to 67 in 2002. The centres vary considerably in size, resources, support structure, and scope of activities. Collecting spontaneous reports of suspected ADRs remains their core activity.
National pharmacovigilance centres are responsible for:
Ø Promoting the reporting of adverse reactions;
Ø Collecting case reports of adverse reactions;
Ø Clinically evaluating case reports;
Ø Collating, analyzing and evaluating patterns of adverse reactions;
Ø Distinguishing signals of adverse reactions from “noise”;
Ø Recommending or taking regulatory action in response to findings supported by good evidence;
Ø Initiating studies to investigate significant suspect reactions;
Ø Alerting prescribers, manufacturers and the public to new risks of adverse reactions; and
Ø Sharing their reports with the WHO Programme for International Drug Monitoring.
National centres have played a significant role in increasing public awareness of issues relevant to the safety of medicines. As a result, in some countries, pharmacovigilance is increasingly being seen as much more than a regulatory activity as it also has a major part to play in clinical practice and the development of public health policy. This development is partly attributable to the fact that many national and regional centres are housed within hospitals, medical schools or poison and medicine information centres and is in collaboration with a Medicines Regulatory Authority (MRA). The scope of activities of national centres has expanded to include communication of information about the benefits, harm and effectiveness of medicines to practitioners, patients and the public.
The Central Drugs Standard Control Organization (CDSCO) is initiating a country-wide pharmacovigilance programme under the aegis of DGHS, Ministry of Health & Family Welfare, and Government of India. The programme shall be coordinated by the National Pharmacovigilance Centre at CDSCO. The National Centre will operate under the supervision of the National Pharmacovigilance Advisory Committee to recommend procedures and guidelines for regulatory interventions.
RESOURCES FOR PHARMACOVIGILANCE CENTRES
The following books shall be provided to various centres as identified by the NPAC: Current editions of:
Ø Meyler’s Side Effects
Ø AHFS Drug Information hand book
Ø Davies Text Book of ADR
Ø Physician’s Desk reference
Ø British National Formulary
Each ZPC will be provided funds to deploy a pharmacologist and a data manager. Each RPC will be provided funds to deploy a pharmacologist. Training programmes be arranged for those healthcare professionals who are participating in NPP. All centre coordinators’ will be provided training on the following issues:
Ø Skills to foster notification culture.
Ø Communications skills – for complete and meticulous collection of data.
Ø Methodology of filling up the forms
Terms of Reference for engagement of Regional Pharmacovigilance Centre under the National Pharmacovigilance Programme
With the number of new drugs being regularly approved for marketing in India, there is a need for a vibrant pharmacovigilance system in the country to protect our population from the potential harms that may be caused by some of these new drugs. Besides, with the patent regime coming in force from 2005, it is widely believed that India would become the global hub for new drug trials6.These situations make it pertinent for the Indian central drugs regulatory authority to have a vibrant pharmacovigilance system in the country.
The programme shall be coordinated by CDSCO under the supervision of a National Pharmacovigilance Advisory Committee which would monitor the program and also recommend regulatory interventions based on the generated Adverse Drug Reaction (ADR) data.
Objective of the Assignment
The overall objective as per the National Pharmacovigilance Programme will be:
Ø To monitor safety of the drugs and provide structured inputs for appropriate regulatory interventions
Ø To create awareness about ADR monitoring in India
Regional centres will be the secondary pharmacovigilance centres under the National Pharmacovigilance Programme.
To carry out the functions as envisaged in the “Protocol for the National Pharmacovigilance Programme” a Coordinator will have to be designated who will be in-charge of the pharmacovigilance activities at the designated regional centre.
By accepting to participate in the National Pharmacovigilance Programme all centres explicitly agree that all pharmacovigilance activities at their institutions shall be performed in strict consonance with the National Pharmacovigilance Programme appended here (Coordinators of the centres and heads of the institutions are advised to carefully go through the Protocol prior to joining the programme).
Outline of tasks to be carried out
The National Pharmacovigilance Programme encourages the reporting of all suspected adverse reaction to drugs and other medicinal substances including herbal, traditional or alternative remedies. The reporting of seemingly insignificant or common adverse reactions would be important since it may highlight a wide spread prescribing problem.
Regional Centre is expected to carry out the following tasks:
Ø To maintain a log of all ADE notification forms received and forwarded To receive blank ADE forms and acknowledge receipt To fill or get filled the ADE forms Collect & collate Adverse Drug notifications from Peripheral as well as own centres Receive Adverse Drug Events (ADE) forms and maintain log of all ADE forms received and forwarded.
Ø Correspond with Peripheral Centres, provide them with general technical support, coordinate and monitor their functioning.
Ø Identify and delegate a pharmacologist for management of pharmacovigilance tasks.
Ø Carry out (and/or review) data causality analysis of all ADEs
Ø To forward all duly-filled ADE forms [those generated at the same centre and those received from immediate lower-level centre] as per pre-determined time line
Ø Forward periodic reports to the CDSCO centre as per Sl. No. 9
Ø Liaise with health care professionals in order to inculcate / foster the culture of ADE reporting / notification by acknowledging the cooperation by the notifier and share with the notifier relevant feedback from higher centre.
Ø Organize and attend training programmes / interactive meetings for all peripheral centres falling under the respective regional pharmacovigilance centres
Ø To provide updates, reports and such other information as may be required by the National Pharmacovigilance Advisory Committee and to attend their meetings
Ø To conduct special pharmacovigilance projects on various drugs which may be of special concern or interest to CDSCO / Government of India
Ø To maintain account of the funds provided under this program as per your institution’s systems; to review the account statement received from peripheral centres, and provide a consolidated statement to the zonal centre. Carryout audits to ensure compliance with the program, enlist non-compliance, establish corrective measures and implement them at regional centres and oversee their implications at peripheral centres
In line with the size & patient intake of the institutions where it is based, the regional centre shall ensure a minimum 50 adverse event reporting’s every month and this number must be increased periodically. This number will be in addition to the number of reports generated by the peripheral centres falling under respective regional centres.
What to report
The National Pharmacovigilance Programme (NPP) shall encourage reporting of all suspected drug related adverse events, including those suspected to have been caused by herbal, traditional or alternative remedies. The reporting of seemingly insignificant or common adverse reactions would be important since it may highlight a widespread prescribing problem.
The programme particularly solicits reports of:
Ø All adverse events suspected to have been caused by new drugs and ‘Drugs of current interest’ (List to be published by CDSCO from time to time)
Ø All suspected drug interactions
Ø Reactions to any other drugs which are suspected of significantly affecting a patient's management,
Ø including reactions suspected of causing:
Ø Life-threatening (real risk of dying)
Ø Hospitalisation (initial or prolonged)
Ø Disability (significant, persistent or permanent)
Ø Congenital anomaly
Ø Required intervention to prevent permanent impairment or damage
Who can report
Any health care professionals (Doctors including Dentists, Nurses, and Pharmacists) may report suspected adverse drug events. The Programme shall not accept reports from lay members of the public or anyone else who is not a health care professional.
Where to report
After completion the form shall be returned/forwarded to the same pharmacovigilance Centre from where it was received. Reporting can be done to any one of the country vide pharmacovigilance Centres nearest to the reporter. (Complete list of pharmacovigilance Centres is available at www.cdsco.nic.in) In case of doubt the form may be sent to the national pharmacovigilanc
Centre at:Central Drugs Standard Control Organisation, New Delhi.
What happens to the information submitted
The information in the form shall be handled in strict confidence. Peripheral Pharmacovigilance Centres shall forward the form to the respective Regional Pharmacovigilance Centres who will carry out the causality analysis. This information shall be forwarded to the Zonal Pharmacovigilance Centres. The data will be statistically analysed and forwarded to the global Pharmacovigilance Database managed by WHO Uppsala Monitoring Centre in Sweden. The final report based on the analysed data will be periodically reviewed by the National Pharmacovigilance Advisory Committee constituted by the Ministry of Health and Family Welfare. The Committee is entrusted with the responsibility to review data and suggest any regulatory interventions that may be required with respect to the drug/drugs or class of drugs.
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