2. What is Pharmacovigilance (PV)?
The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
medicine-related problem
– World Health Organization
3. Pharmaco - Vigilance
Pharmaco = medicine
Vigilare = to watch
alert watchfulness
wakefulness
watchfulness in respect of danger; care; caution; circumspection
the process of paying close and continuous attention
4. Definition
Adverse Drug Reaction
"A response to a drug which is noxious and unintended, and which occurs at
doses normally used in man for the prophylaxis, diagnosis, or therapy of disease,
or for the modification of physiological function."
Adverse Event
Any untoward medical occurrence that may present during treatment with a
pharmaceutical product but which does not necessarily have a causal relationship
with this treatment
Side Effect
Any unintended effect of a pharmaceutical product occurring at doses normally
used in man which is related to the pharmacological properties of the drug
5. The 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 medicines
To promote understanding, education and clinical training
6. What to Report?
SERIOUS ADRS
A serious adverse event (experience) or reaction is any
untoward medical occurrence that at any dose:
results in death,
is life-threatening,
requires inpatient hospitalization of prolongation of existing
hospitalization,
is a congenital anomaly/birth defect.
NOTE: The term “life-threatening” in the definition of “serious” refers to an event
in which the patient was at risk of death at the time of the event; it does not
refer to an event which hypothetically might have caused death if it was more
severe.
7. Adverse Reactions:Possible Causes
Intrinsic factors of the drug
Pharmacological
Idiosyncratic
Carcinogenicity, Mutagenicity
Teratogenicity
Extrinsic factors
Adulterants
Contamination
Underlying medical conditions
Interactions
Wrong usage
8. What Should be Reported
New drugs
Report all suspected reactions including minor ones
For established or well known drugs
All serious, unexpected, unusual ADRs
Change in frequency of a given reaction
ADRs to generics not seen with innovator products
ADRs to traditional medicines
9. What Should be Reported
All suspected drug-drug, drug-food, drug-food supplement
interactions
Statement highlighting marine source of supplements such
as glucosamine so that can be avoided by those with allergy
to sea food
ADRs associated with drug withdrawals
ADRs due to medication errors
eg vincristine given IT
ADRs due to lack of efficacy or suspected pharmaceutical
defects
10. Why ADRs are important ?
5% of hospital admissions
Death of 1 in 1000 medical inpatients
Complicates drug therapy
Decrease compliance
11. Why ADRs are important ?
30 – 50% of all ADRs are preventable
13. Why do we need
pharmacovigilance?
Reason 1:
Humanitarian concern –
Insufficient evidence of safety from clinical trials
Animal experiments
Phase 1 – 3 studies prior to marketing authorization
14. Why do we need
pharmacovigilance?
Reason 2
Medicines are supposed to save lives
Dying from a disease is sometimes unavoidable; dying from a
medicine is unacceptable.
WHO. Geneva 2005
15. Why do we need
pharmacovigilance?
Reason 3: ADRs are expensive !!
6.5% of admissions are due to ADRs
Seven 800-bed hospitals are occupied by ADR patients
16. Cost of ADRs ?
ADR related cost to the country exceeds the cost of the
medications themselves
17. Why do we need
pharmacovigilance?
Reason 4:
Promoting rational use of medicines and adherence
18. Pharmacovigilance system
Records medication related errors
Analyses those errors
Implements interventions
Promotes patient safety
Prevent 'preventable errors'
Actionable learning system
ARGUS – ARIS Global – Phase Forward (Empirica)
19. Passive - Proactive
Future Pro-Active State
Risk
Management
Aggregate
Reporting
Signal Detection
Adverse Case
Management
