Adverse Drug Reactions Monitoring Center
Since 2013 this Department is one of the Adverse Drug Reactions Monitoring Centers under the aegis of Pharmacovigilance Programme of India, IPC, Ghaziabad, UP. The Adverse Drug Reaction Monitoring Centre, under the Pharmacovigilance Programme of India (PvPI), started functioning in the department of Pharmacology, Government Medical College Srinagar from 2013. ADR Monitoring Centres (AMCs) under PvPI play a vital role of collection and follow-up of ADR reports from the patients. They are set up across India to collect the adverse event information from patients. These AMCs are the Medical Council of India (MCI) approved medical colleges & hospitals, medical/central/autonomous institutes, public health programmes or corporate hospitals. They are responsible for collecting the adverse event information from the patients, performing follow up with them to check the completeness of the ADR reports as per Standard Operating Procedures (SOPs), entering information in the prescribed software (Vigiflow) and sending them to NCC via the same software. Some AMCs are also responsible for providing training and technical support at regional level. The education which is an integral part of the Pharmacovigilance Programme of India (PvPI) aimed to create awareness related to patient safety and improving Adverse Drug Reactions (ADRs) reporting culture in India. Doctors, Pharmacists, Nurses of state health and medical education departments apart from other healthcare professionals who are engaged in playing a vital role in reporting of suspected ADRs are targeted audience for the Continuing Medical Education (CME’s).
PHARMACOVIGILANCE
GENESIS
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), at the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) to safeguard health of Indian population. On 15th April 2011, the NCC was shifted from AIIMS to Indian Pharmacopoeia Commission (IPC). IPC is an autonomous institution of the MoHFW, Government of India (GoI) and functioning as NCC for PvPI. Within a short time span NCC-PvPI leaped from 22 ADR Monitoring Centres (AMCs) to 202 centres (upto March 2016) as a consequence of phase wise addition of AMCs. Among these 202 centres, 17 Revised National Tuberculosis Control Programme (RNTCP), 20 Anti retroviral therapy (ART) and 6 Bedaquiline centres are also functioning under the umbrella of PvPI.
VISION
To improve patient safety and welfare of Indian population by monitoring the drug safety and thereby reducing the risk associated with use of medicines.
MISSION
To safeguard the health of the Indian population by ensuring that the benefits of use of medicine outweighs the risks associated with its use.
SCOPE AND OBJECTIVES
- To create a nation-wide system for patient safety reporting.
- To identify and analyze new signals from the reported cases.
- To analyze the benefit-risk ratio of marketed medications.
- To generate evidence based information on safety of medicines.
- To support regulatory agencies in the decision-making process on use of medications.
- To communicate the safety information on use of medicines to various stakeholders ton prevent/ minimize the risk.
- To emerge as a National Centre of Excellence for Pharmacovigilance activities.
- To collaborate with other national centers for the exchange of information and data management.
- To provide training and consultancy support to other National Pharmacovigilance Centers across the
ADR REPORTING IN PvPI
Who can Report?
All healthcare professionals and others including consumers may report a suspected adverse drug reaction. Pharmaceutical companies may send report on adverse drug reaction for their product directly to the NCC-PvPI
Why to Report?
The health and safety of Indian population is a matter of national concern. Occurrence of ADR constitutes a significant economic burden on the patient and the government. As prudent and vigilant healthcare professionals (HCPs), it is the responsibility of HCPs to report adverse drug reactions associated with use of medicines to safeguard the health of patients. India has a vast population that exhibits genetic and ethnic variability; there also exists a vast variation in disease prevalence. The data so generated will help to make vital policy decisions regarding safe use of medicines in Indian population.
What to Report?
In order to foster the culture of reporting, PvPI encourages reporting of all types of suspected ADRs- irrespective of whether they are known or unknown, serious or nonserious, frequent or rare and regardless of an established causal relationship to PvPI. Although Pharmacovigilance is primarily concerned with pharmaceutical medicines and vaccines, adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies), medical devices, contrast media and other pharmaceuticals are also monitored. Special areas of interest include outcomes associated with the drug use during pregnancy, lactation period, and in paediatric and geriatric populations. In addition, reporting of lack of efficacy of medicines and suspected pharmaceutical defects are also recommended to report. Reporting of ADRs encountered with overdose, abuse, off-label use, misuse or occupational exposure is not currently included in the purview of PvPI.
Whom to Report?
All healthcare professionals (clinicians, dentists, pharmacists, nurses, etc.) can report adverse drug reactions using the ‘Suspected Adverse Drug Reaction Reporting Form’ and can call on Toll Free no 1800-180-3024 or 9797299710. The form is available on the official website of IPC (http://www.ipc.gov.in) or the CDSCO (
http://www.cdsco.nic.in
).
CHANNELS OF ADR REPORTING
Suspected ADR form
Reporters may fill the ‘Suspected Adverse Drug Reaction Reporting Form’ available on the official website of IPC (www.ipc.gov.in) or the CDSCO (www.cdsco.nic.in) to report any ADR. Reporters may submit the ADR form to Adverse Drug Reaction Monitoring Centre, Department of Pharmacology, Government Medical College Srinagar.
Helpline (1800-180-3024)
Pa t i e n t s / C o n s u m e r s / H e a l t h c a r e Professionals may report suspected ADRs associated with the use of medicinal products to NCC-PvPI via toll-free helpline 1800-180-3024 from 9:00 A.M. to 5:30 P.M. on working days or they may call 9797299710.
Mobile Application
An android mobile application for Adverse Drug Reaction (ADR) reporting was launched on 22nd May 2015. It is a joint venture of IPC (NCC) and NSCB Medical College, Jabalpur. It is expected that this application will provide a platform for the private healthcare professionals to report ADRs. The mobile application includes inbuilt functions and features for reporting ADRs such as customization of reporter details, auto-entry of drug details and WHO algorithm based causality assessment.
Medicines Side Effect Reporting Form (For Consumers)
The form ensures direct participation of patients/ consumers in PvPI and this in turn helps in safeguarding the health of Indian population. The form is now available in ten local languages i.e. Hindi, Bengali, Gujarati, Kannada, Malayalam, Marathi, Assamese, Oriya, Tamil and Telugu. This channel of reporting ADR may be regarded as a mechanism for consumer empowerment in healthcare sector.
Adverse Drug Reaction Monitoring Centre (AMC)
Department of Pharmacology, Government Medical College Srinagar was designated as an Adverse Drug Reaction Monitoring Centre of Pharmacovigilance Programme of India (PvPI) on 24 Jan 2014. The center performs following functions.
- Collection of ADR reports.
- Perform follow up with the complainant to check completeness as per SOPs.
- Data entry into Vigiflow.
- Reporting to PvPI National Coordinating Centre (PvPI NCC) through Vigiflow with the source data (original) attached with each ADR case.
- Training/ sensitization/ feedback to physicians through newsletters circulated by the PvPI NCC.
CONTACT USDr. Zubair Ashai Lecturer cum Coordinator Adverse Drug Reaction Monitoring Centre.Department of Pharmacology, Govt. Medical College, SrinagarEmail: zubairashai@yahoo.co.uk Cell: 9419467514. Mr. Urfan NabiPharmacovigilance Associate Adverse Drug Reaction Monitoring Centre.Department of Pharmacology, Govt. Medical College, SrinagarEmail: amcgmcsrinagar@gmail.comCell: 9797299710For updates join our Facebook Group: https://www.facebook.com/groups/843219529136821/