1. Dr. Jannatul Ferdoush
Assistant Professor
Department Of Pharmacology

2. Objectives:
Importance & needs of pharmacovigilance.
Monitoring Adverse drug reaction.
Adverse drug reaction reporting.

3. What is Pharmacovigilance?
The science and activities
relating to the detection,
assessment, understanding
and prevention of adverse
effects or any other drug-
related problem.

4.  Insufficient evidence of safety from clinical trials
1959-61 thalidomide disaster ( 4000-100000 case)
Why do we need pharmacovigilance?

5. Cont’d…
 Medicines are supposed to save lives
Dying from a disease is sometimes unavoidable; dying from a
medicine is unacceptable. Lepakhin V. Geneva 2005
 Promoting rational use of medicines and adherence.

6. Cont’d…
Among the Leading cause of death-

7. Cont’d…
 ADRs are expensive !!
Cost of ADRs in the US:
Cost of drug related morbidity and mortality exceeded
$177.4 billion in 2000 (Ernst FR & Grizzle AJ, 2001: J American
Pharm. Assoc)
ADR related cost to the country exceeds the cost of the
medications themselves.

8. Cont’d…
 Ethics:
To know of something that is harmful to another
person who does not know, and not telling, is unethical.
 No medicine is risk free, vigilant
assessment of the risks and benefits
of medicine promote safety.

9. Aims of pharmacovigilance
To improve patient care and safety
To improve public health and safety
To contribute to the assessment of benefit, harm,
effectiveness and risk of medicine.

10. Adverse drug reactions[ADRs] monitoring
 Monitoring centre:
- WHO collaborating centre for international drug
monitoring , Uppsala Monitoring Centre, Sweden.
- Established in1968.
In Bangladesh:
- Directorate General of Drug Administration.

11. Cont’d…
 Monitoring of ADRs:
- Clinical trial monitoring
- Prescription event monitoring
- Yellow card system

12. ADRs reporting:
 Who to report:
- All health care professionals.
 What to report:
- Any suspected ADRs.

13. Cont’d…
 How to report:
- ADRs form
- Assessment tool: Naranjo scale
 Where to report:
- National body

14. Pharmacovigilance is Essential

15. Thank You!