PHARMACOVIGILANCE

ADVERSE DRUG REACTIONS NEEDS TO BE REPORTED

1. PHARMACOVIGILANCE
SUDESHNA BANERJEE DUTTA
SAION

2. PHARMACOVIGILANCE
➢“Pharmacovigilance" Pharmakon(Greek for DRUG)
Vigilare(Latin for TO KEEP WATCH)
➢Pharmacovigilance is the same as ‘DRUG MONITORING ’.

3. DEFINITION
WHO: The science & activities relating to the detection, assessment,
understanding & preventionof adverse effects or any other medicine
related problem

4. BIRTH OF PHARMACOVIGILANCE
➢Collection of data of ADR dates back to early 19
th
century especially for vaccines
but systematic and stringent system for collection of ADR started only after the
Thalidomide Tragedy in 1960s.
➢It compelled health agencies and regulators worldwide to deliberate on drug safety
issues.

5. THALIDOMIDE TRAGEDY
Thalidomide was a widely used drug in the late 1950s and early 1960s for the
treatment of nausea in pregnant women. It became apparent in the 1960s that
thalidomide treatment resulted in severe birth defects in thousands of children.
In November 1961, thalidomide was taken off the market due to massive
pressure from the press and public. Experts estimate that thalidomide led
tothe death of approximately 2,000 children and serious birth defects in more
than 10,000 children.

6. Why is pharmacovigilance important?
➢To protect patients from unnecessary harm
➢Medicines are supposed to save lives
➢To reduce healthcare expenses
➢To improve patient care & safety

7. TERMINOLOGY
Adverse Drug Reaction
✓Aresponsewhichisnoxiousandunintendedeffectofdrugwhichoccursat
dosesnormallyusedinmanfortheprophylaxis,diagnosisortherapyof
diseaseorforthemodificationofphysiologicalfunctions.

8. INDIAN EXPERIENCE
3.7% of patients in hospitals experienced ADRs
0.7% of admissions occur due to ADRs
1.8% fatal ADRs

9. Serious ADRs
➢Death
➢Life-threatening
➢Hospitalization (prolonged)
➢Disability / Permanent Damage
➢Congenital Anomaly / Birth Defect

10. BASIC ELEMENTS : 4 D’S
1)Details of patient
2)Details of suspected drug/drugs
3)Details of ADR
4)Details of reporter

12. PHARMACOVIGILANCE PROGRAMME OF
INDIA(PVPI)
➢In 1986, PV activities were initiated with a proposal of a formal ADR monitoring system with 12
regional centres
➢In1989, 6 regional centreswere set up in Mumbai, New Delhi, Kolkata, Lucknow, Puducherry and
Chandigarh, under the supervision of the drug controller of India.
➢India joined the WHO Programmefor International Drug Monitoring in 1998, but was not
successful.
➢Later, the National Programmeof Pharmacovigilance was launched in 2005, and was renamed as the
Pharmacovigilance Programmeof India (PvPI) in14 July 2010, with AIIMS, New Delhi, as the
National Coordination Centre (NCC).

13. ➢The NCC was later shifted from AIIMS to the Indian Pharmacopoeia
Commission (IPC), Ghaziabad, on 15 April 2011, for effective implementation of
the programme.
➢MoHFW, Government of India through its two inter-collaborative Departments
Central Drug Standard Control Organization (CDSCO) New Delhi &
Indian Pharmacopeia commission(IPC), Ghaziabad
➢The culture of reporting of ADRs has achieved remarkable success, with 272
PvPI-established AMC all over India and provision of training to healthcare
professionals.

14. FUNCTIONS OF THE STAKEHOLDERS
ADRMonitoringCentre in Medical College(PvPIAMCs)
Collection of ADR reports
Check completenessas per SOPs
Data entry intoVigiflow
Reporting toPvPINational Coordinating Centre through Vigiflowwith the
source data (original) attached with each ADR case
Training/ sensitization/ feedback to physicians through newsletters circulated
by thePvPINCC

15. ADRMonitoringCentre other than medical colleges
Collection of ADR reports
Perform follow up with the complaint tocheck completenessas per SOP
Report the data to CDSCO HQ
NationalCoordinatingCentre (IPC GHAZIABAD)
Preparation of SOPs, guidance documents & training manuals
Data collection, Cross-check completeness etcas per SOPs
Conduct Training workshops of all enrolled centers
Publication ofMedicines Safety Newsletter
Reporting to CDSCO Headquarters

16. CDSCO, HQ, New Delhi
Take appropriate regulatory decision & actions on the basis of recommendations
ofPvPINCC at IPC Ghaziabad
Propagation of medicine safety related decisions to stakeholders
Collaboration with WHO-Uppsala Monitoring Center –Sweden
Provide for budgetary provisions & administrative support to run NationalPvPI

17. WHO Uppsala Monitoring Centre
➢WHO started International Drug Monitoring Programmein response to
Thalidomide Disaster
➢UMC which collects the data from all member countries and mines it to
generate the signal for decision –making on the fate of marketed drugs.
➢UMC providing tools for data entry, management, retrieval and research.

18. What to Report?
➢All known, expected and unexpected ADR (of any severity) with all new or old
drugs
➢All ADRs either serious or non serious.
➢Frequent/rare.
➢Drugs/vaccines/herbal medicines, medical devices, contrast media
➢Any abnormal laboratory investigation (known/unknown) following drug use.

19. Who can Report?
➢Any health care professionals( Doctors including Dentists, nurses
and Pharmacists) & even patient/consumers can report ADRs to
NCC or AMCs

21. Call on the PvPI
helpline No.
18001803024 (All
Working Days 9:00
AM to 5:30PM) &
report the suspected
ADR

22. REPORT ADRS
https://www.ipc.gov.in/PvPI/adr.html