Reporting of ADRs, Management of, Definition, aim, and scope of Pharmacovigilance, Role of pharmacist in pharmacovigilance

1. REPORTING Of ADR
Dr. Ramesh Bhandari
Asst. Professor
Department of Pharmacy Practice
KLE College of Pharmacy, Belagavi

2. ADR Reporting Process
Health Care Professionals
Peripheral Centre
Regional Centre
Zonal Centre
NPC/CDSCO
WHO-UMC

3.  All Types of suspected ADR
irrespective of serious and
non-serious, known or
unknown and frequent or
rare
 ADR by prescription or non
prescription drugs.
 Unexpected reactions
What to Report ?
 All Health Care Professionals
(Physician, Dentist, Pharmacist,
Nurses and others).
 Pharmaceutical Manufacturing
Companies
Who can Report ?
 To the ADR Monitoring
Centre (AMC) or to the
nearest AMC or to the
National Coordination
Centre.
Whom to Report ?

4. ADR Reporting forms
India – ‘Suspected Adverse Drug Reaction Reporting form’
UK – “Yellow Card”
Australia – “Blue Card”
US – “Med watch”

5. Information Required for an ADR Reporting
1)Patient information
2)Adverse Reaction description
3)Suspected drug information
4)Management of the adverse reaction
5)Reporter information

6. Information Required for an ADR Reporting
Patient information:

7. Information Required for an ADR Reporting
Adverse Reaction description

8. Information Required for an ADR Reporting
Suspected drug information

9. Information Required for an ADR Reporting
Reporter information

10. Management of ADRs
 Decide - seriousness or severity of ADRs, Risk-Benefit and seriousness of the disease
 If Reaction is serious – Withdraw the culprit drug and treat the reactions.
 If the reaction is mild –
 Stop unnecessary drugs
 Consider dose reduction
 Symptomatic treatment if needed
 If the disease is serious – Consider alternative if possible otherwise Consider treatment
and treat symptoms of reactions.

11. Role of pharmacist in the Management of ADR
 Monitoring patient who are at greater risk of developing ADRs.
 Monitoring patients who are prescribed with drugs likely to cause ADRs.
 Assessing patient previous allergic status, patient’s drug therapy, possible drug interactions.
 Assisting health care professionals in the detection and assessment of ADRs.
 Documentation of all suspected reported reactions
 Follow up patient to assess the outcome of the reaction and management.
 Educating the health care professionals about the importance of reporting an ADR
 Creating awareness about ADRs amongst healthcare professionals, patients and the public.

12. PHARMACOVIGILANCE

13.  Started in 2010, in AIIMS, New Delhi as National Coordination Centre (NCC)
 Later Shifted to Indian Pharmacopoeia Commissiona (IPC), Ghaziabad functioning as a National
Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).

14. Pharmacovigilance
Greek, Pharmacon – ‘Drug’
Latin, Vigilare – ‘to watch’ or ‘to be alert/awake’
According to WHO, Pharmacovigilance is the science and
activities relating to the detection, assessment,
understanding and prevention of adverse effects and other
possible drug related problems.

15. Aim of Pharmacovigilance
 Early detection of unknown drug related problems
 Assess risk-benefit, effectiveness of pharmaceutical product
 Identification of risk factors
 Quantification of risks
 Encourage safe and rational use of pharmaceutical products
 Improve patient and public health and safety

16. Scope of Pharmacovigilance
Pre-Clinical safety pharmacology area
Post marketing area
 Riches source of safety experience
 Challenging to analyse