HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED . HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.

1. PHARMACOVIGILANCE
BY
K.SURABHI,
16DU1R0026,
B. PHARMACY.

3. CONTENTS
 INTRODUCTION
 AIMS AND SCOPE
 RESPONSIBILITIES
 NEED OF PHARMACOVIGILANCE
 HISTORY OF PHARMACOVIGILANCE
 TERMINOLOGY IN PHARMACOVIGILANCE
 CLASSIFICATION AND SEVERITY OF ADR
 METHODS IN PHARMACOVIGILANCE
 APPLICATIONS
 REFERENCES

4. INTRODUCTION
The science and activities relating to the detection, assessment,
understanding, and prevention of adverse effects or any other drug-
related problems.
 DRUG SAFETY
 PHARMAKON ( GREEK) = MEDICINAL SUBSTANCES
 VIGILARE ( LATIN) = TO KEEP WATCH
 Ultimately, pharmacovigilance is concerned with identifying the hazards
associated with pharmaceutical products and with minimizing the risk of
any harm that may come to patients.

6. AIMS AND SCOPE
 Early detection of unknown safety problems.
 Identification of risk factors.
 Quantifying risks.
 Preventing patients from being affected unnecessarily.
 Rational and safe use of medicines.
SCOPE
 Herbal medicines and dietary supplements.
 Traditional and complementary medicines.
 Blood products.

7. RESPONSIBILITIES
 Timely collection of data, recording and notification.
 Monitoring the effectiveness and any adverse effects or
side effects of pharmaceutical products.
 Create appropriate structure for communication.
 Periodical reporting of data.

8. NEED OF PHARMACOVIGILANCE
 Insufficient evidence of safety from clinical trials.
 Medicines are supposed to save lives. It has been suggested
that ADRs may cause 5700 deaths per year in UK.
 To KEEP products on the market.
 To protect patients from unnecessary harm.
 To reduce healthcare expenses.
 Because any medicine can be implicated.
‘’DYING FROM A DISEASE IS SOMETIMES UNAVOIDABLE. BUT DYING FROM AN
ADVERSE DRUG REACTION IS UNACCEPTABLE.”

9. HISTORICAL EXAMPLES
 1880: Chloroform: Cardiac depression
 1922: Arsenical: Hepatic necrosis
 1923: Cinchofen: Hepatotoxicity
 1933: Aminopurine: Agranulocytosis
 1938: Sulfanilamide: Acute renal insufficiency
 1950: Chloramphenicol: Gray baby Syndrome
 1953: Phenacetin: Nephrotoxicity
 1961: Thalidomide: Phocomelia
 1972: Diethyl-stilbestrol: Vaginal adenocarcinoma
 2004: Rofecoxib: Thrombophilia

10. HISTORY OF PHARMACOVIGILANCE
IN INDIA
 IN 1986, FIRST PROPOSAL TO SETUP REGIONAL CENTRES.
 IN 1997, CGI AND WHO ESTABLISHED 3 ADR MONITORING
CENTRES.
 IN 2004, NPP WAS INITIATED.
 IN 2010, PHARMACOVIGILANCE PROGRAMME OF INDIA
WAS INTRODUCED.

11. TERMINOLOGY IN PHARMACOVIGILANCE
 ADVERSE DRUG REACTIONS(ADR)
A response to a medicine which is noxious and unintended, which
occurs at the doses normally used in man.
 ADVERSE DRUG EVENT(ADE)
Any untoward medical occurrence that may present during treatment
with a medicine but which doesn't necessarily have casual relationship with
this treatment.
 SIDE EFFECTS
An unintended effect of a pharmaceutical product occurring at
doses normally used by a patient which is related to the pharmacological
properties of the drug.

12.  SERIOUS ADR/ADE
Any adverse event which is fatal, life threatening,
permanently disabling or which results in hospitalisation.
 UNEXPECTED ADVERSE DRUG REACTION
An adverse reaction, the nature or severity of which is not
consistent with the domestic labelling or market authorisation or
expected from characteristics of the drug.

13. CLASSIFICATION OF ADR
 A:Dose-related reactions- Salbutamol - Tachycardia.
 B: Non-dose-related reactions- Penicillin rash.
 C: Dose and time-related reactions- NSAIDS included
nephropathy.
 D:Time related reactions- Thalidomide - Phocomelia.
 E:Withdrawal reactions- Addisonian crisis after steroid
withdrawal.
 F:Unexpected failure of therapy- prescription, diagnosis, missed
selection of the medicine or doses.

14. SEVERITY OF ADR
 MINOR: No need of therapy, antidote or hospitalization.
 MODERATE : Require drug change specific treatment,
hospitalization.
 SEVERE : Potentially life threating, permanent damage and
prolonged hospitalization.
 LETHAL : Directly or indirectly leads to death.

15. METHODS IN PHARMACOVIGILANCE
 INDIVIDUAL CASE SAFETY REPORTS.
 CLINICAL REVIEW OF CASE REPORTS.
 COHORT-EVENT MONITORING.
 LONGITUDINAL ELECTRONIC PATIENT RECORDS.
 SPONTANEOUS REPORTING.
 PERIODICAL SAFETY UPDATE REPORTS(PSUR).
 EXPEDITED REPORT.
 RECORD LINKAGE.

16. Individual case safety reports
ICSR captures information necessary to support reporting of suspected
adverse reaction(s) due to use of a medicinal product by a patient at a
specific point of time.
 Early warnings of potential ADRs are possible in the absence of convincing
index cases if there is no plausible explanation for an apparently excessive
reporting rate of an event.
Clinical review of case reports
 Collections of individual case reports are complex and heterogeneous.
 Not all reports are submitted to pharmacovigilance systems by health
professionals even if each report could be reviewed, important reporting
patterns would be missed in the vast amounts so computational methods
are being used.

17. Cohort-event monitoring
 CEM systems for intensified follow-up of selected medicinal products.
 The main limitations of CEM are its restriction to a small subset of
medicinal products, the relatively small fraction (globally) of the
population covered.
Longitudinal electronic patient records
 Extremely valuable but underused.
 They cover large populations, provide detailed information on extended
parts of medical histories and include information on both exposed and
unexposed patients.
 Information is extracted directly from the computer systems in which
physicians store patients’ data.
 Privacy protection for patients and physicians is of the utmost importance.

18. Spontaneous reporting
 The reporting might be directly to the regulatory authority.
 Main limitation is under reporting.
 Main purpose is to identify the signals but not to quantify.
Periodical safety update reports(PSUR)
 Premarketing clinical trails may not be sufficient to reflect the
product safety profile.
 Licence holders shall proactively collect post marketing safety
data, prepare PSUR and submit them to the healthy authority.

19. Expedited report
 If there has been spontaneous reporting of a suspected ADR to
a pharmaceutical company to the report serious reactions
within a specified time frame to the regulatory authority.
 Based on the results of drug safety assessment, license holders
shall report to the health authorities in the expedited manner.
Record linkage
 Less expensive.
 Time consuming.
 Involves binding records of various patients together.

21. APPLICATIONS OF PHARMACOVIGILANCE
 In National drug policy.
 In the regulation of medicines.
 In clinical practice.
 In Disease control public health programmes.

22. REFERENCES
 Source: The Importance of Pharmacovigilance, WHO 2002.
 “DIRECTIVE 2010/84/EU, Article 101" (PDF). ec.europa.eu.
Retrieved October 26,2015.
 Current Challenges in Pharmacovigilance: Pragmatic
Approaches (Report of CIOMS Working Group V), 2001 Geneva.
 Joshi SR, Sapatnekar SM. “Pharmacovigilance in India: how safe are the
new drugs? How sure are we?”. J Assoc Physicians Ind 2008;56:933-4.
 Olsson S. Pharmacovigilance training with focus on India. Ind J
Pharmacol 2008;40: S28-S30.
 Edwards IR, Lindquist M, Wiholm BE, Napke E. Quality criteria for early
signals of possible adverse drug reactions. Lancet 1990;336:156–
8.10.1016/0140-6736(90)91669-2.

23. ANY QUERIES

24. THANK YOU