1. Basic concept of Pharmacovigilance & 2. Detecting and reporting ADR’s

1. PHARMACOVIGILANCE
Presented By
Md Raihanul Islam

2. Basic concept of
PHARMACOVIGILANCE
PATIENTS
DOCTOR/
PHARMACISTcomplaints MAH’s
Reports
CENTER FOR
MONITORING
ADR’s
REGULATORY
BODY
Reviews
TAKES
APPROPRIATE
MEASURES/
ACTIONS
DOCTOR/
PHARMACIST Informs
Advises

3. What is pharmacovigilance
Drug safety monitoring

4. Why do you need Pharmacovigilance
Humanitarian concern
ADR May cause sudden death
Promoting rational use of
medicine & adherence
Ethics
To know something that is harmful to another
person who does not know.
PHARMACOVIGILANCE

5. The
pharmaceutical
industry
CIOMS (Council for
International
Organization of
Medical Sciences )
WHO collaborating
center for international
drug monitoring
Regulatory
authorities
GOVERNING
BODIES

6. ADVERSE DRUG
REACTION (ADR)
• A response to a medicine which is noxious and unintended, and which occurs at doses
normally used in man.
ADVERSE DRUG
EVENT (ADE)
• Any unwanted medical occurrence that may present during treatment with a medicine but
which dose not necessarily have a causal relationship with this treatment.
UNEXPECTED
ADVERSE DRUG
REACTION
• An adverse reaction, the nature or severity of which is not consistent with domestic labelling
or market authorization, or expected from characteristics of the drug.
SERIOUS
ADVERSE DRUG
EVENT/ REACTION
• Results in death
• Require inpatient hospitalization or prolongation of existing hospitalization
• Result in persistent or significant disability
• Is life-threatening
Common terminologies of Pharmacovigilance

7. Detecting and reporting
ADR’s
Other methods for
collecting ADR
Spontaneous
reporting
Mandatory
reporting
Comparable observational studies Active surveillance

8. Types of reportable information
Adverse drug
reaction

9. Reports of Abuse, Off-
Label Use, Misuse, or
Occupational Exposure

10. Reporting overdose

11. Drug withdrawal
symptoms

12. Drug
interaction

13. Lack of efficacy

14. Product Quality
Complaint

15. Medication
Error
Supply Error
Stock: inadequate/expired
Drug information problem
Labelling error
Dispensing error
Administration
Error
Dose omission/delay
Incorrect dose given
Incorrect administration
- technique/rate
Prescribing
Error
Name/weight/age/sex missing
Incorrect dose/frequency
unsigned
Drug interaction

16. Minimum Criteria for Reporting
An identifiable reporter
An identifiable patient
An adverse reaction
A suspect drug

17. ADR’s reporting Form

18. References
 Global Pharmacovigilance
- UMC & WHO programs for international drug monitoring
 ICH E2E Guideline
 Pharmacovigilance Wikipedia
 pharmacovigilance program in Bangladesh