Pharmacovigilance in Indian Population

Introduction Governing Bodies Need for Pharmacovigilance

Pharmacovigilance is the science and
activities relating to the detection,
assessment, understanding and
prevention of adverse effects or any
other medicine/vaccine related
problem.
(ADR recognition and monitoring)
PHARMACO = Medicine
VIGILARE = To Watch
Aim Of Pharmacovigilance
✓ To monitor safety of natural remedies
✓ Effectiveness and risk of medicine.
Collect data of ADR reports
✓ Rational and Safe use of medicine
✓ Humanitarian Concern
❖ World Health Organization (WHO) ✓ Safe use of medicines.
(Geneva) ✓ Promoting rational use of medicine
❖ Council for international organization Adherence.
of medical science-(CIOMS). (Geneva) ✓ Ensuring public confidence.
❖ UPPSALA Monitoring Centre (UMC) ✓ Ethical concern.
(Switzerland).
❖ Central Drug Standard Control
Organization (CDSCO) (New Delhi). What To Report ?
❖ National Pharmacovigilance Advisory
Council (NPAC) (Kolkata) ✓ All suspected adverse reactions
❖ International Society of ✓ Drug interactions
Pharmacovigilance (ISOP) (Geneva). ✓ Patient Information
❖ Indian Pharmacopoeia Commission ✓ Route of Administration
ADRs occurring from overdose
(Ghaziabad). ✓
medication error.

Objective Pharmacovigilance

Who Can Report ?

✓ To Create a national-wide system
for patient safety reporting.
✓ To identify and analyze new signal
from the report cases. • ASU Doctors
✓ To analyze the benefit-risk ratio of • Dentists
marketed medication. • Pharmacists
✓ To generate evidence based
information on safety of medicine. • Nurses
✓ To support regulatory agency in
the decision making process on
use of medication.

Short Terms Goals Mission What To Report ?

✓ To develop & implement Safeguard the Health of the Indian Population by ensuring
pharmacovigilance system in that the benefits of use of medicine outweigh the risk
Manufacturer
India associated with its use.
Peripheral
✓ To enroll, initially all MCI Centre
approved medical colleges in Communication under PvPI
the program covering north,
south, east and west of India
Uppsala Monitoring
✓ To encourage healthcare CDSCO Regional
Centre, Sweden
professionals in reporting of Short Terms Goals
Headquarter Patient
Hospital Centre
adverse reaction to drugs,
vaccines, medical devices and National Coordination New Delhi
Centre, IPC,
biological products Ghaziabad National
Centre
Long Terms Goals ADRs Monitoring
CDSCO Zonal
Offices
Centre South Zone, Chennai Health
✓ To expand the PvPI to all hospitals West Zone, Mumbai Professionals
(govt. & private), public heath East Zone, Kolkata NCC MERP WHO
programs located across India Healthcare
North Zone,
✓ To develop & implement Professionals Ghaziabad
e-reporting system Conclusion
✓ To make ADR reporting ✓ To National Coordinating Council for
mandatory for HCPs Medication Error Reporting and
Prevention (NCC MERP) or Addiction ✓ Providers of medicines, such as physicians,
Role of Pharmacist in Medicine Care (AMCs). nurses, and pharmacists, often have little
✓ The pharmaceutical companies can also training in and understanding of how
Monitoring ADRs send individual case safety reports for herbal medicines affect the health of their
their product to NCC. patients. Many of them are also poorly
✓ Patient counseling on ADRs. informed about these products and how
Identification and documentation in
✓
the patient’s medical record.
References they are being used.
✓ Pharmacists involvement in daily rounds,
✓ Adjusting doses in appropriate
✓ Pharmacovigilance Programme of may be with the team of Doctors can be a
patients (e.g., patients with impaired
India. significant contribution.
renal or hepatic function).
Ipc.gov.in. 2018 ✓ Companies must conduct a comprehensive
✓ Taking into consideration intensity and
seriousness of the reaction, ✓ https://pubmed.ncbi.nlm.nih.gov/3026 drug safety and pharmacovigilance audit
pharmacist can advice if immediate 9244 to assess their compliance with worldwide
discontinuation of therapy is required. ✓ Textbook Of Pharmacovigilance: laws, regulations, and guidance.
Pharmacist must know risk/benefit Ensuring The Safe Use Of Medicine: ✓ By incorporating PV one will be able to
ratio of the continued administration Ensuring the Safe Use of Medicines by prepare medicine with good efficacy, safety
of the drug against the availability of S.K.Gupta and minimum side effects.
the other drugs ✓ Pharmacovigilance by Dr. Triphati