passive_serviallance and responsibilities in pharmacovigilance pptx

Passive surveillance

1. Role and responsibilities of pharmacovigilance and passive surveillance Submitted by: Ayodhya Tanaji Paradhe Submitted to: Prof. Bang Ma’am M pharmacy 1 st year (Pharmacology) (Pharmacology Department) Sudhakar Rao Naik Institute Of Pharmacy Pusad

2. Contents Introduction Role and responsibility in pharmacovigilance Investigator Co-Ordinator Sponsor Monitor Contract research organization Passive surveillance Spontaneous reporting Case series Case reports Stimulated reporting References

3. Pharmacovigilance The science and activity relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems. pharmakon= Drug Vigilare= to watch; alert watchfulness; -watchfulness with respect to danger - the process of paying close and continuous attention So pharmacovigilance generally refers to continuous monitoring for unwanted effects and other safety-related aspects to marketed drugs.

4. Aim of Pharmacovigilance To improve public health and safety about medicines, cosmetics, herbal products To improve patient care and safety Early detection of unknown adverse reactions and interactions Identification of risk factors and possible mechanisms underlying adverse reaction To promote rational and safe use of medicines Estimation of quantitative aspects and benefits /risk analysis of information needed to improve drug prescribing and regulation To contribute to the assessment of benefits, harm, effectiveness, and risk of medicines To promote understanding, education, and clinical training in pharmacovigilance and its effective communication with health professionals in public

5. Role and responsibilities in pharmacovigilance The officers in pharmacovigilance such as specialist or management roles require extensive knowledge in areas, such as medical writing, medical affairs, or quality assurance. monitoring adverse drug reactions, they collect information on medical products and adverse events sourced from various studies This information is later submitted to regulatory authorities. The role of experts in this field is to process the drug safety reports and review trial-related documents to ensure the drug safety profile of medicines

6. This professional is responsible for medical case reviews and assessing product safety in clinical trials Timely collection of data, recording, and notification In pharmacovigilance roles and responsibilities of experts included Investigator Coordinator Sponsor Monitor Contract research organization

7. 1) investigator Role: Follow ethical principles and standard Interaction with applicable federal, state, and local regulatory authority Discipline in designing and conducting clinical trials for policies and procedure Refer to section GCP course for training requirements Responsibilities: Conducting the trial, statements, protocol, and applicable regulations Obtaining informed consent forms for all trial participants Maintaining proper records Managing all progress reports, safety reports,

8. 2) co-Ordinator Role: Conduct of research study Managing data and collecting biological specimens Preparing the institutional review board(IRB) submission Writing the informed consent document, recruiting and consenting participants Responsibilities: Provide regulatory, institutional, sponsor, and protocol requirements for the study Ensure all studies current IRB approval Complete with all IRB decisions, conditions, and requirements

9. 3) Sponsor Role: Financial Reputation Legal Responsibilities: Selecting and providing qualified investigators Ensuring proper monitoring of the investigation Ensuring conducted by plan and protocol Maintaining an effective respect for the investigation

10. 4) Monitor Role: Director monitoring Medical monitoring Management monitoring Scientific monitoring Responsibilities: Assist with pharmacovigilance activities Review protocol rules Advised protocol team on safety oversight Evaluate and review safety reports

11. 5) Contract research organization Role: Project management Database design and build Data entry and validation Clinical trial data management Responsibilities: Provide adequate, well managed staff Conduct study activities Manage process

12. Responsibilities of : Company- legally and morally responsible for monitoring their product Regulatory authorities- are responsible for the safety of newly licensed drugs Doctors- responsible for the prescription of safe drugs to patients Pharmacist and nurse- responsible for the monitoring of drug therapy given to patients and identification and reporting of ADRs

13. Passive surveillance Passive surveillance systems refer to systems that collect and analyse individual case report of adverse reactions that are sent to the system voluntarily by physician and patients Passive surveillance required for reporting diseases, risk factors or health-related events Health practitioners report events as they come to their attention This is more common type of surveillance Eg. A physician sees a patient, diagnoses measles, and then initiates a case report by contacting the local health department and providing the details as required for a case of measles, reports of death, disease registries, hospital record and physician billing systems within health insurance schemes.

14. Passive surveillance includes: Spontaneous reporting Case series Case reports Stimulated reporting 1. Spontaneous reporting Also called voluntary reporting An unsolicited report from healthcare professionals or consumers to a company, regulatory authorities, or other health organization that describes one or more ADRs in patients who were given one or more medicinal products is called spontaneous reporting Voluntary communication by healthcare professionals or consumers to company, regulatory authority, or other organization Reports are submitted voluntarily by healthcare professionals, pharmaceutical companies, or patients to the pharmacovigilance centres Reporting system based on suspected ADRs Reporting form contains- reporter details, patient details suspected product details, and description of suspected reactions This reporting based on suspected adverse drug reaction

15. Forms- are generated by regulatory authorities or by organizations under the aegis of regulatory authorities Forms- are circulated through the website or distributed to healthcare professionals through training programs conducted In India- the “suspected ADRs reporting form” is used for spontaneous reporting ( developed by CDSCO, working under the aegis of the directorate of health services), gov. of India. In the UK – a “yellow card” is used for spontaneous reporting of ADRs Yellow card- contains patient reporting form and healthcare professional reporting form 2. Case series: In case series is a descriptive study that allows a group of patients with common characteristics used to describe some clinical, pathophysiological or operational aspects of disease, treatment or diagnostic procedure.

16. Collection of reports that share some common characteristics such as being exposed to the same drug; and, in which the same outcome is observed A case series involves reports on two or more people with common exposure to drugs or a common outcome A series of case reports can provide evidence of an association between a drug and adverse events Used generally for generating a hypothesis rather than for verifying an association between drug exposure and outcomes. Eg. Certain distinct adverse events occur more frequently with drug therapy, such as anaphylaxis, aplastic anemia , toxic epidermal necrosis, and stevens- johnson syndrome

17. 3. Case reports: Case reports are descriptions of the history of a single patient who has been exposed to a medication and experienced a particular and unexpected effect whether the effect is beneficial or harmful. Case reports have a privileged place because they can be the first signal of an adverse drug events Eg. Adverse events – phocomelia associated with the use of thalidomide 4. Stimulated reporting: A method used to encourage and facilitate reporting by health professionals for new products Stimulated adverse event reporting in the early post-marketing phase can lead companies to notify healthcare professionals of new therapies and provide safety in their use by the general populations Information about patient, medication, ADRs, observed and reporter information

18. References Pinkston V. et al. Management of adverse drug reactions and adverse drug events data through collection, storage, and retrieval. 1998; 282 Goldmons SA. Limitations and strengths of spontaneous report data. Clinical therapeutics, 1998; c40-c44 S. K. Gupta textbook of pharmacovigilance. 2 nd edition.

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