This document discusses pharmacovigilance, which refers to monitoring drugs for adverse effects after they reach the market. It defines pharmacovigilance and notes that the WHO recommends every country establish a pharmacovigilance center to share adverse drug reaction data globally. Clinical trials involve fewer patients over a short time, whereas drugs are used by many more people long-term in clinical practice. Reporting adverse drug reactions helps prevent future harm and improve drug safety. Causality assessment methods like the Naranjo algorithm determine the likelihood a drug caused a reaction in a patient. India has established a national pharmacovigilance program to monitor adverse reactions and ensure drug safety.

1. PHARMACOVIGILANCE
Dr. Varun Gupta (MBBS MD)
Govt. Medical College Bharatpur
Rajasthan

2. INTRODUCTION
 ( pharmaco= medicine , vigilare = to watch)
 Pharmacovigilance means continuous monitoring for unwanted effects and other safety
related aspects of marketed drugs.
WHO DEFINITION-
 It is the science and activity related to Detection, Assessment, Understanding and
Prevention (DAUP) of adverse effects or any other drug related problems.
 The WHO suggests that every country should set up a Pharmacovigilance center and the
adverse drug reaction data of any new drug even of old drug should be shared with global
health care community through WHO-Uppsala monitoring center located in Sweden.

4. CLINICAL TRIALS CLINICAL PRACTICE
NO OF PATIENTS FEW 100 TO FEW 1000 1000 TO MILLIONS
DURATION SHORT DURATION OF FEW
YEARS
LONG DURATION OF MANY
YEARS
POPULATION PREGNANT,CHILDREN,
ELDERLY EXCLUDED
ALL
CONCOMITANT
MEDICATION & ILLNESS
AVOIDED NORMALLY USUALLY PRESENT
DOSE NORMALLY FIXED VARIAABLE
(COMPLIANCE)

5. Why it is important?
• Adverse Drug Reactions are the 4th to 6th largest cause of mortality in the USA
• The percentage of hospital admissions due to drug related events in some countries is about or
more than 10%
• Approximately 5.3% of hospital admissions associated with ADRs
• Higher rates found in elderly patients who are likely to be receiving multiple medications for
long-term illnesses
• Nearly 10–20% of acute geriatric hospital admissions are related to ADRs
– Find out pharmacodynamic and pharmacokinetic drug interaction
– observe Long-term efficacy, Resistance
– Find Risk factors
– Cost assessment

11. AIMS & OBJECTIVES
• Early detection of unknown safety problems.
• To improve patient care and safety.
• To improve public health and safety.
• Detection of increases in frequency of ADR
• To monitor benefit-risk profile of medicines
• Promote rational and safe use of medicines.
• Assessment of benefit, harm, effectiveness and risk of medicines.
• Create a national centre of excellence at par with global drug safety
monitoring standards.

12. Who can reported ADR
Dentist
Doctors
Nurses &
Paramedics
patients
Pharmacists

13. How to prevent ADR
1. Avoid inappropriate use of drugs
2. Use appropriate dose, dosage form, route & frequency of drug
3. Take H/O drug allergy
4. H/O allergic ds.
5. Rule out any possible drug interaction
6. Correct drug administration technique
7. Laboratory drug monitoring for drugs with low safety margin

14. Actions taken from the PV findings include
1. Restriction in use
2. Changes in the specified dose of the medicine
3. Introduction of specific warnings in the product information
4. Changing the legal status of a medicine, e.g., from over-the-counter to
prescription only
5. Product recall: In rare cases, removal of the medicine from the market, if the
risks of a medicine are found to outweigh the benefits

15. PHARMCOVIGILANCE PROGRAMME IN INDIA
(PVPI)
 The Central Drugs Standard Control Organization (CDSCO), New Delhi
has initiated a nation–wide Pharmacovigilance programme under the Drugs
controller general of India , Ministry of Health & Family welfare,
Government of India.
 The programme is coordinated by the Indian Pharmacopoeia
Commission (IPC) located at Ghaziabad.
 The National coordinating centre is operating under the supervision of
steering committee to recommend procedures and guidelines for
regulatory interventions.

16.  The pharmacovigilance programme of India was initiated by the
Government of India on 14.7.2010 with the All India Institute of
Medical Sciences (AIIMS), New Delhi as the National co-ordination
centre for monitoring adverse drug reactions (ADR) in the country for
safe guarding public health.
 In year 2010, 22 ADR monitoring centers including AIIMS, New
Delhi had been set up under this programme.
 To ensure implementation of this programme in a more effective way,
the national coordination centre has been shifted from the all India
institute of Medical Sciences (AIIMS), New Delhi to the Indian
Pharmacopoeia Commission, Ghaziabad, (U.P.) on 15.4.11.

17. National Pharmacovigilance center is linked downward with two zonal, four regional, 28
peripheral Pharmacovigilance centers.
 Information fed to any of the peripheral centers is forwarded to regional centers which
in turn pass on this data to zonal centers.
 Zonal centers are supposed to analyze these data and submit the consolidated report to
the national pharmacovigilance center .
 This center has a national advisory committee which would evaluate these data and
would recommend appropriate regulatory intervention.
 The generated data will then be forwarded to the global pharmacovigilance database at
the WHO-Uppsala monitoring center in Sweden, under the safety data exchange
agreements.

18. National Pharmacovigilance center is linked downward with two zonal, four regional,
28 peripheral Pharmacovigilance centers.

19. The ADR reports will be collected from the following centers:-
Pre-marketing safety data
pharmaceutical industry- Animal Experiments:Relevant?
Clinical Trials: Complete?
Post-marketing data-
i. MCI approved Medical Colleges and Hospitals
ii Private Hospitals
iii Public Health Programmes
Iv Autonomous Institutions (ICMR etc)

21.  Developing systems & procedures
 Enroll 40 medical colleges
 Start Data Collection from AEFI (Adverse event
following immunization)

22.  Development & establishment of training centers
 Training of Pharmacovigilance human resource
 linkage with Uppsala monitoring center, Sweden,
WHO
 Initiate software development for national drug
safety database.
 Zonal workshop for public awareness of drug safety
 Publication of drug safety newsletter.

23.  Enroll additional 60 medical colleges
 Training of pharmacovigilance human resources
 Identify gaps & address through appropriate training
 Training in pharmacovigilance software provided by Uppsala Monitoring
Center Sweden, WHO
 Software development and validation
 Zonal workshop for public awareness of drug safety
 Publication of drug safety newsletter

24. Enroll additional 100 medical colleges
 Training of Pharmacovigilance human resources
 Zonal workshop for public awareness of drug safety
 Publication of drug safety newsletter.

25. Enroll additional 100 medical colleges
 Training with international Pharmacovigilance bodies
 Training of pharmacovigilance human resources
 Publication of drug safety newsletter.

26. Create center of excellence for pharmacovigilance in Asia
pacific.

28. Causality assessment
How likely is this medication the cause of this
problem in this particular patient?

29. The Naranjo algorithm
This is a questionnaire for determining the likelihood of whether an ADR is
actually due to the drug rather than the result of other factors.
Probability is assigned by a score (definite, probable, possible or doubtful).
LIMITATION- it explains causality only with individual drug, it doesn’t explains
the causality occurs due to drug interactions.

30. The ADR Probability Scale
• The ADR Probability Scale consists of 10 questions that are answered as either Yes, No, or “Do not
know”. Different point values (-1, 0, +1 or +2) are assigned to each answer.
• A simplified version of the 10 questions is provided below:
1. Are there previous conclusive reports of this reaction?
2. Did the adverse event appear after the drug was given?
3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was
given?
4. Did the adverse reaction reappear upon re-administering the drug?
5. Were there other possible causes for the reaction?
6. Did the adverse reaction reappear upon administration of placebo?

31. The ADR Probability Scale
7. Was the drug detected in the blood or other fluids in toxic
concentrations?
8. Was the reaction worsened upon increasing the dose? Or,
was the reaction lessened upon decreasing the dose?
9. Did the patient have a similar reaction to the drug or a
related agent in the past?
10. Was the adverse event confirmed by any other objective
evidence?

32. Naranjo scoring system

38. Categories of causality (Scoring)
Definite ADR > 9
Probable ADR 5-8
Possible ADR 1-4
Doubtful ADR 0

53. THANK YOU