The pharma aspirants can read the important information provided in this presentation about Pharmacovigilance which is necessary to qualify the interviews of the same field

1. PHARMACOVIGILANCE REPORTING
METHODS
SUBMITTED BY –MR. Swapnil Bade
STUDENT OF ELITE INSTITUTE OF PHARMA
SKILLS
Guided By Mrs. Archana Gawade
www.elite-pharmaskills.com

2.  INTRODUCTION TO PHARMACOVIGILANCE
 Pharamcovigilance is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effect.
 Aims Of Pharmacovigilance
1. To improve patient care and safety
2. To improve public health and safety.
3. To contribute to the assessment, harm, effectiveness and risk of medicines.
4. To promote education and clinical trails.
5. To promote rational and safe use of medicines.

3.  METHODS OF PHARMACOVIFILANCE
 Passive surveillance
1. Spontaneous reporting
2. Stimulated reporting
3. Intensified reporting
4. Targeted spontaneous reporting
 Active surveillance
 Comparative observational studies
 Clinical studies
 OBJECTIVES
1. To established a functional reporting system to monitor the safety of all medicines.
2. To learn more about the safety profile of new medicines in early post marketing
phase.
3. To learn more about the ADR profile of a specific medicines in your population.

4.  PASSIVE SURVILLANCE
1. Spontaneous reporting
 A functional ADR system to monitor the safety of all medicines
 Reports are submitted voluntarily by health care professionals, pharmaceutical
companies or patients to the pharmacovigilance centre
 Reporting systems are based on suspected ADRs
 Data are collected in a central or regional data base
 Reporting form contains- reporter details, patient details, suspected product details
and the description of suspected reaction
 This reporting is based on suspected adverse drug reactions
 Cases are not collected systematically
 These methods includes calculations of a proportional reporting ratio, as well as the
use of Bayesian and other techniques for signal detection.
 Data techniques should always be used to examine drug drug interactions

5. 2.Stimulated reporting
 A method used to encouraged and facilitate reporting by health professionals for new
products or for limited time period.
 Methods- on line reporting of AE, systematic stimulation of reporting of AE.
 Stimulated adverse event reporting in the early post-marketing phase can lead
companies to notify healthcare professionals of new therapies and provide safety in
the use by the general population.
 Data are often incomplete.
 Not useful to generate accurate incidence rates.

6. 3.Intensified reporting
 This is an extension of spontaneous reporting program
 It aims to enhance ADR reporting of specific medicines in early post marketing phase
 The procedure is usually followed for new drugs, biological medicines and for medicines that
require additional studies
 Example: Antiretroviral medicines under a separate program
4.Targeted spontaneous reporting
 This method is used to learn more about ADR profile of a specific medicine in the population
 To estimate the incidences of a known ADR for a specific medicine in a population
 Example: Monitoring renal toxicities related to the use of tenofovir based regimen in antiretroviral
therapy

7.  Active Surveillance
 Sentinal sites: It involves the collection of AE data from only part of the total population
to learn something about the larger population.
 Example: to study the trends in a disease.
 Drug event monitoring: The patients are identified from electronic prescription data or
automated health insurance claims. Patients will fill the survey form. Follow up
questionnaire is then sent to prescribing physician.
 Registries: A registry is a list of patients with the same characteristics. The registries
may be disease specific (disease registry) or drug specific (drug registry) or type of
exposure during a specific life event (pregnancy exposure registry). The information is
collected using standardized questionaries.

8.  Comparative observational studies
 Cross sectional study: The data collected from a population of patients can be attributed at a
single point of time/time interval regardless of exposure or disease status.
 Case control study: Cases/patients of AEs are identified from an existing data baseor using data
collected specifically for the purpose of the study.
 Cohort studies.
I. Cohort means a group of people who share a common characteristic such as exposure to a drug
within a defined time period.
II. It is a prospective observational cohort study of adverse events associated with one or more
medicines.
III. The study is planned prior to beginning of the treatment with the medication.
IV. Every patient is followed up for adverse events since the time of treatment.
V. All adverse events are recorded.

9. Cross-sectional study
 Data collected on a population of patient at a single point in time regardless of exposure or disease status
constitute a cross secyional study.
 These type of study primarily used gather data for survey.
 These studies re best used to examine disease at one time point or to examine trends over time.
 These are best utilized when exposure do not change over time.
 Case control study
I. In this study,case of disease are identified.
II. Case control studies are particularly useful when the goal is to investigate whether there is an association
between a drug and one specific rare adverse event as well as to identify risk factors for adverse events.
III. Risk factors includes conditions such as renal and hepatic dysfunction.

10.  Clinical studies
 When significant risk are identified from pre approval clinical trials further clinical studies
might be called for evaluate the mechanism of action for the adverse reaction
 In some instances pharmacodynamic and pharmacokinetic studies might be conducted to
determine whether a particular dosing instruction can put patient at an increased risk of
adverse event based on the pharmacological properties and expected use of drug in
general practice conducting specific studies to investigate potential drug drug interaction
and food drug interaction might be called for.
 These studies can include population pharmacokinetics studies and drug concentration
monitoring in patient and normal volunteers these population might include the elderly or
children of patient with renal or hepatic disorder.

11.  Descriptive studies
 These studies are primarily used to obtain the background rate of outcome event or establish the prevalence
of the use of drug in specified population and it is not used for the detection or verification of adverse event
I. Natural history of disease
 the science of epidemiology originally focused on the natural history of disease including the characteristics
of disease patient and the distribution of disease in selected population
 these outcomes of interest now include a description of disease treatment pattern and adverse event
 studies that examine specific aspect of adverse event such as background incidence rate of risk factor for the
advance event of interest can be used to assist in putting spontaneous reports into perspective
Drug utilisation study
 This study describes how a drug is marketed prescribed and used in a population and how these factors
influence outcomes including clinical social and economic studies
 from these studies denominator data can be developed for use in determining rates of adverse event reactions

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