describe about what is pharmacovigilance and methods.

1. METHODS OF
PHARMACOVIGILANCE
PRAVEEN KUMAR.S
M.PHARM 2ND SEMESTER
DEPARTMENT OF PHARMACOLOGY
PSG COLLEGE OF PHARMACY

2. CONTENTS
• Introduction about pharmacovigilance
• Methods of pharmacovigilance
• Passive surveillance
• Stimulated reporting
• Active surveillance
• Comparative observational study
• Descriptive studies

3. PHARMACOVIGILANCE
• Pharmacovigilance is science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other possible drug
related problems.
Pharmacovigilance: The present status:
• The WHO international drug monitoring program was laid in 1971.the current
international system of PV Is based on report published in 1972 and accordingly
national PV centers were established.
• WHO collaborating centre for international drug monitoring is based in Uppsala,
Sweden.

4. The role of Pharmacovigilance can be divided into three main areas;
1. To identify, quantify and document drug-related problems.
2. To contribute to reduce the risk of drug related problems in health care systems
3. To increase knowledge and understanding of factors and mechanism, which are
responsible for drug related injury.

5. METHODS OF PHARMACOVIGILANCE
• As per ICH E2E guidelines the pharmacovigilance method can be categorized as:
1. Passive surveillance:
• Spontaneous reporting
• Case series
2. Stimulated reporting
3. Active surveillance
• Sentinel sites
• Drug event monitoring
• Registries.

6. CONT..
4.Comparative observational studies
• Cross sectional study
• Cohort study
• Case control study
• Targeted clinical investigation
5.Descriptive studies
• Natural history of disease
• Drug utilisation study

7. PASSIVE SURVEILLANCE:
• Passive surveillance: a system by which a health jurisdiction receives reports submitted from
hospitals, clinics, public health units, or other sources.

8. A) SPONTANEOUS REPORTS:
• Is an unsolicited communication by healthcare professionals or consumers to a
company,regulatory authority or other organisations (eg,WHO,Regional centres,
poison control centre).
• Spontaneous reports play a major role in the identification of safety signals once a
drug is marketed.
• Doctors need to fill the ADR experienced by patient and all details like dose interval
diagnosis symptoms in a form,these form generated by regulatory authority.these
filled form Notified to central authority.

9. • In USA 'MedWatch form is used in two different categories,
1. Form FDA 3500 voluntary reporting:used By health professionals and
consumers and patients.
2. Form FDA 3500A Mandatory reporting:used for IND reporters, manufacturer,
distributors,importers.
• Data mining techniques facilitate the evaluation of spontaneous reports by
using statistical method to detect potential signals for further evaluation.

10. CASE SERIES
• Series of case reports can provide evidence of an association between a drug and an
adverse event,but they are generally more useful for generating hypothesis than for
verifying an association between drug exposure and outcome.
• There are certain distinct adverse events known to be associated more frequently with drug
therapy,such as anaphylaxis,aplastic anemia,toxic epidermal necrolysis and Stevens-
johnson syndrome.

11. 2.STIMULATED REPORTING
• Several methods have been used to encourage and facilitate reporting by
health professionals in specific situations (eg, in hospital settings)for new
products or for limited time periods.
• During the early post-marketing phase, companies might actively provide
health professionals with safety information and at the same time encourage
cautious use of new products and submission of spontaneous reports when an
adverse event is identified,A plan can be developed before the product is
launched.

12. ACTIVE SURVEILLANCE
• Is in contrast to passive surveillance,seeks to ascertain completely the number
of adverse events via continuous pre-organized process.an example of active
surveillance is the follow up of patients treated with a particular drug through
a risk management program.
• Patients who fill a prescription for this drug may be asked to complete a brief
survey form and give permission for later contact.
• It is more feasible to get comprehensive data on individual adverse event
reports.

13. A) SENTINEL SITES
• Active surveillance can be achieved by reviewing medical records or interviewing patients or
physicians in a sample of sentinel sites to ensure complete and accurate data on reported adverse
events from these sites.
• Information on the use of drug,such as abuse, can be targeted at selected sentinel sites.
• Some of the major weakneses of sentinel sites are problems with selection bias, small numbers of
patients and increased costs.
• Intensive monitoring of sentinel sites can also be helpful in identifying risks among patients
taking orphan drugs.

14. B)DRUG EVENT MONITORING
• Drug event monitoring is a method of active pharmacovigilance surveillance.patients might be
identified from electronic prescription data.
• A follow-up questionnaire can then be sent to each prescribing physician or patient at pre-
specified intervals to obtain outcome information.
• Information on patient demographics, indication for treatment, duration of therapy (including
start dates),dosage, clinical events and reason for discontinuation can be included in
questionnaire.

15. C)REGISTRIES
• A registry is a list of patients presenting with the same characteristics, characteristic can be a disease
(disease registry)or a specific exposure (drug registry).
• Both types of registries, which only differ by the type of patient data of interest,can collect
information using standardized questionnaires in prospective fashion.
• Disease registeries,such as registries for blood dyscrasias,severe cutaneous reaction or congenital
malformations can help collect data on drug exposure and other factors associated with clinical
conditions.
• A disease registeries might Also be used as a base for case control studies.

16. COMPARATIVE OBSERVATIONAL STUDIES
1. Cohort study
2. Case control
3. Cross sectional study.

17. COHORT STUDY
• A population at risk for the disease event is followed over time for the occurrence
of disease and events.
• This study used to estimate how often disease or life events happen in a certain
population.
• Best method for determining the incidence and natural history of a condition.

19. CROSS SECTIONAL STUDY
• Is a type of observational study that are primarily used to determinePrevelance.
• Prevalence equals the number of cases in a population at a given point in time
• All the measurements on each person are made at one point in time.
Prevelence = case/Total population.

21. CASE CONTROL STUDY
• An observational study that compares patients who have a disease or outcome of interest
(cases) with patients who do not have disease.
• Or outcome (controls) , and looks back retrospectively to compare how.
• Frequently the exposure to a risk factor is present in each group.

23. DESCRIPTIVE STUDIES
An important component of pharmacovigilance, although not for the detection or
verification of adverse events associated with drug exposures.
A) Natural history of Disease:
The science of Epidemiology originally focused on the natural history of disease, including
characteristics of diseased patients and distribution of disease in selected population, as
well as estimating the incidence and prevalence of potential outcomes of interest.

24. B)DRUG UTILIZATION STUDY:
• Describe how a drug is marketed,prescribed, and used in a population, and how these factors
influence outcomes , including clinical,social and economic outcomes.
• These studies provide data on specific populations ,such as elderly, children or patients with
hepatic or renal dysfunction,often stratified by age,gender, concomitant medication.
• DUS used to determine if a product is being used in these populations.
• DUS used to describe the effect of regulatory actions and media attention on the use of drugs,as
well as develop estimates of the economic burden of the cost of drugs.

25. Thank you