Active and Passive Surveillance of pharmacovigillance

detail information about active and passive surveillance

1. Active and passive surveillance Presented By : Sejal Agrawal

2. CONTENT Introduction to surveillance Basic Surveillance Process Types of Surveillance Benefits Limitations Applications

3. What is Public Health Surveillance ? The ongoing, systematic collection , analysis and interpretation of health-related data essential to planning, implementation , and evaluation of public health practice , closely integrated with the timely dissemination of these data to those responsible for prevention and control . GOAL: the primary goal of surveillance in pharmacovigilance is to monitor and evaluate the safety of pharmaceutical product, detecting and assessing adverse effects, and minimizing risks to public health. It involves collection, analyzing, and interpreting data on adverse drug reaction and other drug-related problems to ensure the safe and effective use of medications.

4. Basic Surveillances Process

5. Types of Surveillances Passive Surveillance Active Surveillance Diseases are reported by health care providers. Health agencies contact health provider seeking reports. Simple and inexpensive Ensure more complete reporting of conditions. Limited by incompleteness of reporting and variability of quality. Used in conjuction with specific epidemiologic investigation.

6. Passive Surveillance Passive surveillance for adverse drug reaction (ADR) reporting in pharmacovigilance involves the spontaneous reporting of ADRs by healthcare professionals, patients, and sometimes pharmaceutical companies. For reporting diseases, risk factor or health-related events. Health practioners report events as they come to their attention. This is the more common type of surveillance. Ex: A physician sees a patient, diagnoses , and then initiates a case report by contacting the local health department and providing the details as required for a case of measles(contagious illness).

7. Types of passive surveillance

8. Spontaneous Surveillance Spontaneous surveillance entails the unplanned and informal monitoring of individuals, locations, or events. Voluntary communication by healthcare professionals or consumers to a company, regulatory authority or other organization. Define one or more adverse drug reaction (ADRs) in a patient who was given one or more medicinal products. Identification of safety signals once a medicine is marketed. Can vigilant a company to rare adverse event that were not noticed in early clinical trials or other pre-marketing studies.

9. It can also deliver important information on at-risk groups, risk factor and clinical features of know serious ADRs. Unlike organized surveillance efforts, which involve systematic planning and authorization, spontaneous surveillance arises spontaneously from individual or collective actions. It is a high sensitivity and low specificity of the method .

10. Case Series: A case series is a type of medical or scientific study that involves the detailed analysis of multiple cases of suspected adverse drug reaction to identify pattern or trends in drug safety. A series of case-reports can deliver sign of an association between a medicine and an adverse event. But they are normally more valuable for producing theories then for confirming a relationship between medicine exposure and outcome.

11. Targeted spontaneous report Target spontaneous report could be interpreted as a directive to focus on specific types of adverse events or issues when soliciting spontaneous reports from healthcare professionals and consumers. For example, a pharmaceutical company might focus on obtaining reports from healthcare providers specializing in a particular medical field or prescribing a specific medication. Similarly, during a public health crisis, authorities might target spontaneous reports related to symptoms or complications associated with the outbreak. In essence, "targeting" spontaneous reports involves directing efforts towards specific areas of interest or concern to gather relevant data and address potential safety issues more effectively.

12. Active Surveillance It refer to a proactive approach in monitoring for adverse event or disease outbreaks by actively seeking out and collecting data often through regular and systematic methods. The primary goal of active surveillance in pharmacovigilance is to detect, assess, and report adverse drug reactions (ADRs) that may occur after a drug is approved and marketed.

13. Types of active surveillance

14. Sentinel Site These are strategically chosen location where surveillance systems are established to monitor specific health indicators, diseases or events providing early warning signals and representative data . EX – hospital or clinics in a region to monitoring the spread of infections diseases. Purpose to serve as early warning systems by monitoring specific health indicators or diseases. Selection of sentinel site based on factors like geographical representation , population density and healthcare infrastructure. Data collection collect standardized data on predetermined health indicators or disease. Sentinel sites helps health authorities detect outbreak asses disease trends.

15. Cohort Event Monitoring In a cohort study, a population at risk for the disease is monitored over time to record the occurrence of the disease or event. Information on exposure status is accessible during the follow-up period for each patient. A patient might be exposed to a medicine at one time during follow up, but not exposed at another time. In many cohort studies concerning medicine exposure, appraisal cohort of interest are selected on the basis of medicine use and monitored over time.

16. Medicine Event Monitoring It involves systematic collection and analysis of data on adverse drug reaction occurring in patients following the administration of medication. For medication event monitoring, patients can be acknowledged from electronic or automated health insurance claims. A single prescription or a series might be composed monitoring. A follow-up questionnaire can then be sent to each prescribing physician or patient at prespecified intervals to acquire outcome data. Requests for data on patient demorgraphics , indication for treatment , duration of therapy, dosage ,clinical event, reasons for termination and applicable past history can be involved in the questionnaires.

17. Registries These are structural database that gather comprehensive information about patients medical histories treatments and outcomes, aiding in the systematic monitoring and analysis drug safety. This representative can be a disease or a specific exposure(medicine registry) A registry may be a disease registry or exposure registry. Disease registries such as registries for the blood dyscrasias, severe reactions, or congenital malformations can helps to gather data on medicine exposure. Exposure medicine registries address populations exposed to the medicine of interest to govern if a medicine has a distinct influence on this group patient. Patients can be followed over time and included in a cohort study to collect data on adverse event using standardized questionnaires. This registries can be vary valuable when examination the safety of an orphan medicine indication for a specific condition.

18. Benefits of surveillances

19. Limitation

20. Applications