2. PHARMACOVIGILANCE
The Need of The Hour!
Way towards a safe
medical practice………….
PRESENTED BY
NILESH.S.JAWALKAR
(M.PHARM IInd Semister )
SKB COLLEGE OF PHARMACY NEW
KAMPTEE , NAGPUR
2012-2013

3. CONTENT
 INTRODUCTION
 AIM AND OBJECTIVE
 ADVERSE EFFECT
 IMPORTANCE
 PARTENERS IN PHARMACOVIGILANCE
 PHARMACOVIGILANCE IN DRUG REGULATION
 PHARMACOVIGILANCE IN CLINICAL PRACTICE
 THE RaPID
 CONCLUSION AND CONSIDARATION FOR FUTURE.
 REFERANCES

4. INTRODUCTION
 Pharmacovigilance (PV) is the pharmacological
science relating to the detection , assessment
,understanding and prevention of adverse
effects, particularly long term and short term side
effect of medicines.
 All medicines (pharmaceutical and vaccines) have side
effect some are known many are still unknown even
this medicine has been in clinical use. The important
to monitor both known and unknown side effects of
medicines in order to determine any new information
in relation to their safety profile .

5. • Pharmacovigilance looks at all available
information to assess the safety profile of a drug
• Pharmacovigilance should also take the benefit of
the drug in account
• Spontaneous reporting depends on the health
professional – YOU.

6. ADR
Suspicion
1 2 3
How Pharmacovigilance
works
4
ADR
Reporting
ADR
Analysis
Sharing
of Findings

7. Aim And Objectives of
Pharmacovigilance
 Aim:-
 To identifying new information about hazards as
associated with medicines
Objective:-
 Improve patient care and safety
 Improve public health and safety
 Encourage safe, rational and appropriate use of drugs
 Promote understanding, education and clinical
training in pharmacovigilance

8. Adverse drug reaction
 which is noxious ,unintended and which occurs A
response at doses normally used in humans for
Prophylaxis, Diagnosis or Therapy of disease , or for
modification of physiological function…..(WHO 1972)
Type A(Augmented) Type B(Bizarre)
Pharmacologically predictable Yes No
Dose dependent Yes No
Frequency Common Rarer
Incidence High Low
Mortality Low High
Treatment Adjust Dose Stop the Drug
Adverse Drug Reactions Classifications

9. Adverse drug reaction(ADR)
a)Serious adverse reaction.
b) Unexpected adverse reaction.
Data Analysis
Response

10. Side effect
 Any unintended effect of a pharmaceutical product
occurring at normal dosage which is related to the
pharmacological properties of the drug. e.g.
antihistamines producing sedation , anticholinergics
producing dryness ..

11. 1 approved5 enter trials
5,000
compounds
evaluated
Success
Rate
Verify
effectiveness, mo
nitor adverse
reactions from
long-term use
Evaluate
effectiveness, lo
ok for side
effects
Determine
safety and
dosage
Assess safety
and biological
activity
Purpose
Review
process /
Approval
1000 to 3000
patient
volunteers
100 to 300
patient
volunteers
20 to 80
healthy
volunteers
Laboratory and
animal studies
Test
Population
Additional
Post
marketing
testing
required by
FDA
12
Total
2.53213.5Years
Phase IVFDA
File NDA
at FDA
Phase IIIPhase IIPhase I
File IND
at FDA
Preclinical
Testing
Clinical Trials
Phases of Product Development
 It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in
5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in
people is approved.

12. Pharmacovigilance And India
India is is a hub of Global Clinical trials & a destination
for Drug Discovery & Development. However, whether
patients in India receive safe drugs or not is still very
muchin question
Rapid induction of NCEs and high tech Pharma
products in the market throw up the Challenges of
monitoring Adverse Drug Reactions (ADRs) over
large multiethnic population base...

13. Who Should Report Safety Data
 Physicians
 Pharmacists
 Pharmaceutical companies qualified persons –
(Pharmacovigilance/Regulatory manager)
 Investigational products (clinical trials)
 Post-approval reporting – Individual Case Safety Report
(ICSR), Periodic Safety Update Report (PSUR)
 In many countries patients are encouraged (but not
obligated) to report side effects

14. What to Report
 It is important to report serious unexpected ADRs.
 Most cases of unexpected ADRs are associated with
medicines newly introduced on the market.
 All suspected adverse reactions.
 Every single problem related to the use of a drug.
 ADRs associated with radiology contrast
media, vaccines, diagnostics, drugs used in traditional
medicine, herbal remedies, cosmetics, medical devices
and equipment.

15. Withdrawn Drugs From the Market
Drug Year Reason
Lumiracoxib 2008 Hepatotoxicity
Aprotinin 2008 Kidney and cardiovascular toxicity
Tegaserod 2007 Cardiovascular ischemic events
Ximelagatran 2006 Hepatotoxicity
Valdecoxib 2005 Dermatology adverse events
Pemoline 2005 Hepatotoxicity
Rofecoxib 2004 Thrombotic cardiovascular events
Levomethadyl 2003 Fatal Arrhytmia
Rapacuronium 2001 Risk of fatal bronchospasm
Cerivastatin 2001 Rhabdomyolosis
Trovafloxacin 2001 Hepatotoxicity
Amineptine 2000 Hepatotoxicity, dermatological side effects, abuse potential
Cisapride 2000 Cardiac arrhythmias
Troglitazone 2000 Hepatotoxicity

16. Four common drug banned in
other countries but not in India

17. IMPORTANCE OF PHARMACOVIGILANCE
 Complete safety data (especially for unexpected and
serious adverse events) can only be captured through
pharmacovigilance
 It cannot be captured through clinical trials which are
conducted in an “artificial environment.”
 In clinical trials
 patients are not taking any other medications
 do not have concomitant diseases
 are taking the drug short-term (during the duration of the trials
only) and
 are not part of vulnerable groups (e.g., children, pregnant
women, elderly, etc.)

18. PATNERS IN
PHARMACOVIGILANCE
 The WHO Quality Assurance and Safety : Medicines
team
 The Uppsala Monitoring Centre (UMC)
 The National Pharmacovigilance Centers
 Hospitals And Academia
 Health Professionals
 Patients
 Other Partners

19. System of Safety Data Gathering
Pharmaceutical
Companies
Patients National Regulatory
Authority
International Safety
Databases
Healthcare
Professionals
Clinical Trials
Pre-Approval
Post-Approval

20. PHARMACOVIGILANCE IN DRUG
REGULATION
 Clinical Trial Regulation
i) Collection of ADR
ii)monitoring clinical data
iii)reporting of clinical data
 Post Marketing safety Monitoring

21. THE RaPID
 The RaPID is a PV program it conduct public health
program.
 It provide support to focal point.
 Focus on RaPID HIV, T.B, Malaria and other program.
 It is important to encourage and ensure reporting of
ADR.
 It consist of various department for working various
type of diseases

24. I964 :U. K. starts "Yellow Card"
system
..

25.  The Yellow Card Scheme is the main ADR reporting
scheme in the UK and was introduced in 1964 after the
thalidomide tragedy highlighted the urgent need for
routine monitoring of medicines. It receives more than
20,000 reports of possible side effects each year.

26. What should be our contribution……

27. True challenge lies in….
 In recognising at the earliest possible stage, the
adverse effects that a drug may induce , so that the
risk (unfavourable results) never becomes
disproportionate to benefit (Favourable results)

28. At the level of Clinicians …..
My Doctor is a good doctor, He made me no iller than I was…….
Willem Hussem (The Netherlands)1900 -1974
Translation: Peter Raven
There are no really safe biologically active drugs . There are only
safe physicians…. Harold A. kaminetzsky1963

29.  1.Active reporting of ADVERSE DRUG REACTIONS as
forms are available freely e.g. Nimusulide
 European Medicine Evaluation Agency Bans
NIMESULIDE

30. Avoid Prescription errors
Articles highlighting the rise in prescription errors

31. Illegible prescriptions? Who is to
blame……

32. At the level of Pharmacists &
Pharmacologists

33. To train Pharmacists in drug
interactions, side effects ,drug dosages

34.  11. Students can start Pharmacy bulletins with help of
Respected Principal sir & coordinators…..
 ( Australian Prescriber, USPDI)

35. Student involvement
. Students can start Pharmacy bulletins with help of
Respected Principal sir & coordinators…..
( Australian Prescriber, USPDI)

36. Aims of Drug Alerts….
 The information resources should be designed to
assist the health provider in their clinical choice of
drugs, in an effort to reduce the incidence and
severity of adverse effects & medication errors .

37. Student involved in making Drug
alerts

38. Presenting Drug Alerts

39. Drug Alert Leaflets
 FDA pulls antiparkinsonism drug of Pergolide
from market
 EMEA bans Nimesulide
 Petitions to remove Cox2 inhibitors
 Cisapride under strict scrutiny
 Phenylpropanolamine risk of Hemorragic
stroke

40. Animation of Pharmacovigilance: Students
have presented & posted on Google images

41. conclusion
Think less about drug safety: more about
patient safety
Use and react to concerns
Think less about regulating (incl. withdrawal)
and automating data input: more about useful
information output
Think more about impact and consequences of
decisions and non-decisions
It is expected that 50 – 75 % of medical errors are
preventable.