What is an acceptable level of

1. Pharmacovigilance
Are you concerned enough?
December 2011

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

12. Why do we need
pharmacovigilance?

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

20. Passive - Proactive
Current Passive State
Risk
Management
Signal Detection
Aggregate
Reporting

21. What can we do?

22. What can we do?
 Develop procedures for the identification, reporting and
follow up of adverse drug events

23. What can we do?
 Assess the current technology used in the drug safety process
and assist in implementation of new systems

24. What can we do?
 Evaluate data quality and data integrity controls in place

25. What can we do?
 Prepare risk minimization action plan (RiskMAP)

26. What can we do?
 Assess current drug safety and pharmacovigilance training
programs

27. What can we do?
 Reconcile internal processes for recording safety data received
from multiple sources

28. For more information:
Monica Dema, Manager New
Business Development
973.658.3133
Or
Monica.Dema@RCMT.com
Or
@MonicaDema