The thalidomide tragedy of the late 1950s demonstrated the importance of pharmacovigilance. Pharmacovigilance is the monitoring of medications post-marketing to identify adverse drug reactions. It aims to improve patient safety and assess medication risks and benefits. The thalidomide birth defects showed that not all adverse effects are found in clinical trials. Healthcare professionals and patients can report any serious or non-serious adverse reactions to their nearest monitoring center. Reported reactions are analyzed for new safety signals and to continuously evaluate medications' risk-benefit profiles. Ongoing pharmacovigilance is important for patient safety and optimal drug use.

1. PHARMACOVIGILANCE
Dr.S.S.Shiva
Pharmacovigilance Associate
ADR monitoring centre
Department of Pharmacology
AIIMS, Patna
an overview

2. HISTORY - THALIDOMIDE TRAGEDY * PHOCOMELIA*
Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter.When first released, thalidomide
was promoted for anxiety, trouble sleeping, "tension", and morning sickness.While it was initially thought to be safe in pregnancy,
concerns regarding birth defects arose until the medication was removed from the market in Europe in 1961.The total number of
infants affected by use during pregnancy is estimated at 10,000, of which about 40% died around the time of birth.Those who
survived had limb, eye, urinary tract, and heart problems.

3. What is Pharmacovigilance?
Pharmacovigilance is the pharmaceutical science relating to the collection, detection, assessment,
monitoring, and prevention of adverse effects with pharmaceutical products.
Pre-Marketing : Phase 0
Phase 1
Phase 2
Phase 3
Post-Marketing : Phase 4
pharmakon (Greek for drug) and vigilare (Latin for to keep watch)
Two types:

4. 1
Improve patient care and
public safety for medical and
paramedical interventions.
3
Assess benefit, harm,
effectiveness and risk of
medicines
5
Encourage safe, rational and
(cost-)effective use of
medicines
2
Effectively communicate
surveillance results to the
public..
4
Promote understanding,
education and clinical
training in PV.
Aims of Pharmacovigilance

5. What is an Adverse Drug Reaction ?
“A response which is noxious and unintended, and which occurs at doses normally used in humans for the
prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”
steven johnson syndrome
phocomelia
Maculopapular drug eruptions Hypoxia Fast Heart rate

6. Classification of ADRs
OTHERS
TYPE OF REACTION
SEVERITY
ONSET OF ACTION
Acute : <60mins
Sub-acute : 1-24hours
latent : > 2days
Minor
Moderate
Severe
lethal
Type A, B, C,
D, E, F
Side effects, Secondary effects
Toxic effects, Intolerance
Idiosyncrasy, Drug allergy
Photosensitivity, Drug dependance
Drug withdrawal reactions
Teratogenicity,Mutagenicity
Carcinogenicity, Drug induced
disease(latrogenic)

7. 80%
10%
Type of Reaction (Mnemonic) Features
A: Dose related (Augmented) Common
Related to the pharmacologic action of the drug – exaggerated pharmacologic response
Predictable Low mortality
B: Non–dose related (Bizarre) Uncommon
Not related to the pharmacologic action of the drug Unpredictable High mortality
C: Dose related and time related
(Chemical)
Uncommon
Related to the cumulative dose
D: Time related (Delayed) Uncommon
Usually dose related Occurs or becomes apparent sometime after use of the drug
E: Withdrawal (End of use) Uncommon
Occurs soon after withdrawal of the drug
F: Unexpected failure of therapy (Failure) Common
Dose related Often caused by drug interactions

8. Anticoagulants Nitrates Beta blockers
A: Dose related (Augmented) B: Non–dose related (Bizarre)
Penicillins Anticonvulsants
C: Dose related and time
related (Chemical)
Paracetamol
D: Time related (Delayed)
TARDIVE DYSKINESIA
TERATOGENECITY
HYPERSENSITIVITY
Phenytoin Antipsychotics Analgesics
E: Withdrawal (End of use)
Phenytoin
withdrawal
steroid
withdrawal
seizures
90%
10%

9. company adherence
to regulations
Why is pharmacovigilance important?
Patient safety and
continuous vigilance
Power and authority Keeping it moving

10. What does pharmacovigilance do?
Benefits of a drug outweigh the risks Ongoing monitoring of drugs
Clinical trials may not uncover every
possible side effect.
Elderly may not be involved in the
clinical trial

11. WHAT to report ? ● Serious or Non-serious ADR
● Known or Unknown ADR
● Frequent or Rare
WHO can report ?
All healthcare professionals (clinicians, dentists, pharmacists, nurses)
Patient/consumers
The pharmaceutical companies can also send individual case safety reports for their product to NCC.

12. Nearest ADR Monitoring Center (AMC) - AIIMS Patna
● Cug no : 8544423488
● Email id : pharmacology@aiimspatna.org
● You can submit the filled ADR form to AMC, Department of pharmacology,
Admin block, AIIMS, patna or can send the details on whatsapp
HOW to report adverse drug reactions ?
Directly to NCC, IPC Ghaziabad
● pvpi.ipcindia@gmail.com, pvpi@ipcindia.net
● Toll free no. – 1800 180 3024
● ADR Reporting Android app

14. What happens to ADR reports ?
● The obtained information is
entered in the drug safety
database, analyzed, and assessed
by the experts to identify new
signals.
● Signal: Reported information on a
possible causal relationship
between an adverse event and a
drug, of which the relationship is
unknown or incompletely
documented
previously.
● The information generated on the
basis of these reports helps in
continuous assessment of the
benefit-risk ratio of the
medicines.

15. WHO–UMC CAUSALITY ASSESSMENT SCALE

16. The following points are considered to prevent ADR :
LABORATORY
MONITORING

17. Thank you