pharmacovigilance programme of india (pvpi)
TRANSCRIPT
Pharmacovigilance Programme of India (PvPI)- Role of MAMC
Jamshed Ahmad
04/14/23
In Safety do not forget danger; in peace, do not forget disorder
Pharmacovigilance?Pharmacovigilance: science and activities relating to the Detection Assessment Understanding
& Prevention
of adverse drug reactions or any other possible drug related problems
WHO 2002
Cont…• 1962
USA revised law requiring to prove safety and efficacy before issuing marketing authorization
• 1963
British Committee on Safety of drug monitoring• 1964
UK starts “yellow cards” system
Cont…• 1964-65
National ADR reporting system UK, Australia, New Zealand, Canada, West Germany, Sweden.
Uppsala Monitoring Centre• 1968 - WHO Collaborating Centre for
International Drug Monitoring, Geneva• 1978 - Moved to Uppsala after agreement between
Sweden and WHO• Non-profit foundation with
international administrative board• WHO Headquarters responsible for policy• Self-financing• Global Pharmacovigilance
India?
Pharmacovigilance in India
1986
ADR monitoring system for India proposed with 12 regional centres
Oversaw areas with population sizes of approximately 50 million each
Cont…1997
India joined WHO-ADR reporting program based in Uppsala, Sweden
3 centres viz, AIIMS, KEM and AMU
National Pharmacovigilance Program (NPP)
2004 The National Pharmacovigilance Program (NPP)
officially inaugurated by the Central Health Minister at New Delhi
Cont…2005
The Ministry of Health and Family Welfare in India initiated the NPP, coordinated by the Central Drugs Standard Control Organization (CDSCO)
Programme was started with 2 zonal, 5 regional and 24 peripheral centres
Pharmacovigilance Programme of India (PvPI)
July 2010 The Pharmacovigilance Programme of India
(PvPI) initiated with AIIMS, New Delhi as National Coordination Centre (NCC) for monitoring ADRs in the country
Cont…15th April 2011
The NCC shifted from AIIMS, New Delhi to Indian Pharmacopoeia Commission (IPC), Ghaziabad
MissionSafeguard the health of the Indian population by ensuring that the benefits of use of medicine outweigh the risks associated with its use
Objectives• To create a national-wide system for patient safety
reporting• To identify and analyze new signal from the report
cases• To analyze the benefit-risk ratio of marketed
medications• To generate evidence based information on safety
of medicines• To support regulatory agency in the decision-
making process on use of medications• To promote rational use of medicine
Short term goals• To develop & implement pharmacovigilance
system in India
• To enroll, initially all MCI approved medical colleges in the program covering north, south, east and west of India
• To encourage healthcare professionals in reporting of adverse reaction to drugs, vaccines, medical devices and biological products
• Collection of case reports and data
Long term goals• To expand the PvPI to all hospitals (govt. &
private), public heath programs located across India
• To develop & implement e-reporting system
• To develop reporting culture amongst HCPs
• To make ADR reporting mandatory for HCPs
Committees under NCC Steering Committee Working Group Quality Review Panel Signal Review Panel Core Training Panel
Communication under PvPIUppsala Monitoring
Centre, Sweden
National Coordination Centre, IPC, Ghaziabad
ADRs Monitoring Centre
Healthcare Professionals
CDSCO Zonal OfficesSouth Zone, ChennaiWest Zone, MumbaiEast Zone, Kolkata
North Zone, Ghaziabad
CDSCO Headquarter,
New Delhi
CDSCO HeadquarterThe CDSCO HQ is responsible for:
• Taking appropriate regulatory decision and action regarding drug safety
• Propagating medicine safety related decisions to stakeholders
• Provide administrative and Technical support to run PvPI
Regional Centres under PvPIThese regional centres are recognized as Regional Resource Centre.
Eastern Region: IPGMER, Kolkata Western Region: KEM Hospital, Mumbai Northern Region: PGIMER, Chandigarh Southern Region: JSS Hospital, Mysore
Whom to Report? Use the ‘Suspected Adverse Drug Reaction Reporting
Form’ to report any ADR
Form available in all AMCs or download from www.ipc.gov.in or www.cdsco.nic.in
The filled reporting form can be submitted to the AMC or directly to the NCC
A reporter can also mail the form at [email protected]
Toll free number 1800-180-3024 for reporting ADR
Current status of NCC-PvPITill 31st Jan 2015-
Total number of ADR monitoring centres: 90 Total number of proposed ADR monitoring centres: 60 Number of ADRs committed by NCC to WHO-UMC:
75,663 Number of ADRs under assessment of NCC: 6421 Number of reports reverted back to AMCs: 705 Total number of Individual Case Safety Reports
(ICSRs) in PvPI database: 84,470
ADRs Reporting Status ADR reporting rate in India has gradually
increased as compared to previous year
PvPI in-house assessment shows that; 64.66% of ICSRs reported by Clinicians• 14.75% by Pharmacists• 18.83% by Nurses and Dentists
India’s contribution to WHO-UMC, 2013
117 countries participating in the WHO programme for International Drug Monitoring
India stood at 7th position in contributing to global ICSRs safety database for the year 2013
EXPANSION OF PvPI
Medical Council of India (MCI)
Mandatory for every medical college in India to have a Pharmacovigilance committee, as per regulations of Medical Council of India, 2010
HaemovigilanceCOLLABORATION BETWEEN NIB AND PvPI
IPC in collaboration with National Institute of Biologicals (NIB) has launched Haemovigilance Program of India on 10th Dec 2012 as an integral part of PvPI
Revised National TB Control Programme (RNTCP)
COLLABORATION BETWEEN RNTCP AND PvPI
In order to improve patient care and safety in relation to the use of anti-tubercular drugs. RNTCP formally collaborated with PvPI on October 11th, 2013
Participation of Nursing Professionals
NCC-PvPI oraganized a meeting with president Nursing Coumcil of India (NCI), on July 16, 2014, New Delhi to initiate the participation of nursing professionals in PvPI.
National AIDS Control Organization (NACO)
COLLABORATION BETWEEN NACO & PvPITo ensure the safety of ARV medicines used in the programme, the Indian Pharmacopoeia Commission and the National AIDS Control Organization (NACO) formally agreed on 15 September 2014.
ADR Monitoring Centres (AMCs) All MCI approved teaching hospitals established
as AMCs under the PvPI. Total number of AMCs in India till now is 150 Department of Pharmacology, MAMC has been
established as an AMC under the PvPI.
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MAMC as AMC As per the MCI guideline, all Medical Colleges to
have a college pharmacovigilance committee.
MAMC has made a College Pharmacovigilance Committee involving 30 Departments of college and associated hospitals.
MAMC as AMC Total number of Individual Case Safety reports
(ICSRs) collected at AMC (Sep-2014 to Mar-2015): 198
Total number of ICSRs reported from MAMC to NCC : 135
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MAMC as AMCMajor ADR reported from MAMC
Thrombophlebitis: Ceftriaxone Lymphadenopathy: Dapsone Exfoliative dermatitis: Phenytoin Optic neuropathy: Ethambutol Oliguria: Amphotericin B Red man syndrome: Vancomycin Tongue protrusion: Trifluoperazine Hematuria: Cyclophosphamide Hand-foot syndrome: Capecitabine Peripheral neuropathy: Paclitaxel
MAMC as AMCDepartments actively involved in reporting of ADRs:
Radiotherapy HIV/ART Clinic Medicine TB & Chest Clinic Surgery Dermatology Obs & Gyn Psychiatry Radio-diagnosis
MAMC as AMCHow to report & Whom to report?
Pink colored ADR reporting form available at centre as well as all OPDs & Nursing stations
Through mobile number: 9560627611 Email: [email protected] Contact detail: ADR Monitoring Centre, Room
No. 176, Department of Pharmacology, Pathology Block, MAMC
MAMC as AMCPink-colored ADR reporting form
Recently banned drugs in India Dextropropoxyphene (23rd May, 2013) Serodiagnostic test kits for diagnosis of
tuberculosis (7th Jun, 2013) Fixed dose combination of Flupentixol+Melitracen
(18th Jun, 2013) Analgin (18th Jun, 2013) Pioglitazone (18th Jun, 2013)
04/14/23
A journey of thousand miles must begin with a single step
Lao-Tzu
Thank You