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 othermedicine-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 atdoses 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 apharmaceutical
product but which does not necessarily have a causal
relationshipwith this treatment Side Effect Any unintended effect
of a pharmaceutical product occurring at doses normallyused 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 anyuntoward medical occurrence that at any dose:
results in death, is life-threatening, requires inpatient
hospitalization of prolongation of existinghospitalization, 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 supplementinteractions
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 pharmaceuticaldefects 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
needpharmacovigilance? 13. Why do we needpharmacovigilance?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 needpharmacovigilance?Reason
2 Medicines are supposed to save lives Dying from a disease is
sometimes unavoidable; dying from amedicine 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 themedications
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 errorsActionable learning system ARGUS ARIS Global
Phase Forward (Empirica) 19. Passive - ProactiveFuture Pro-Active
StateRiskManagementAggregateReportingSignal DetectionAdverse
CaseManagement 20. Passive - ProactiveCurrent Passive State Risk
Management Signal Detection Aggregate Reporting 21. What can we do?
22. What can we do? Develop procedures for the identification,
reporting andfollow up of adverse drug events 23. What can we do?
Assess the current technology used in the drug safety processand
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
trainingprograms 27. What can we do? Reconcile internal processes
for recording safety data receivedfrom multiple sources 28. For
more information:Monica Dema, Manager New Business Development
973.658.3133Or [email protected]@MonicaDema
