adverse drug reactions management

1. MANAGEMENT OF ADVERSE REACTIONS Presented By C h. Deepthi

2. INTRODUCTION It describes the procedure for identifying, recording and reporting of Adverse Reactions(AE) and Serious Adverse R eactions (SARs) It also describes the procedure for reporting Suspected Unexpected Serious Adverse Reactions(SUSARs)

3. ABBREVATIONS AE/AR Adverse Event/Reaction SAE/SAR Serious Adverse Event/Reaction SUSAR Suspected Unexpected Serious Adverse Reactions CTIMP Clinical Trail of an Investigational Manufacturing Product NIMP Non Investigational Medicinal Product

4. DEFINITIONS ADVERSE EVENTS Any Untowarded medical occurance in a patient or a clinical trail participant administered an investigational product , and which does not necessarily have a causal relationship with the drug. ADVERSE REACTIONS All untowarded and unintended responses to the IMP related to any dose administered to that participant.

5. DEFINITIONS SERIOUS ADVERSE REACTIONS Any untowarded medical occurance that at any dose Results in death Is life-threatening Requires hospitalisation,or prolongation of existing hospitalisation Results in persistent or significant disability or incapacity Is a congenital anomaly.

6. DEFINITIONS SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS The trail protocol or IB should include a list of known side effects for each drug in the study. This should be consulted when a SAR occurs, to determine expectedness. If the event is not listed, or has occurred in a more serious form,or more frequently than expected, it should be considered to be a SUSAR

7. Identifying of Adverse Events The trial protocol should define how AEs will be recorded, and states that all SAEs will be reported to the Sponsor. AEs may also be identified by support documents, for example clinical biochemistry, hematology, and radiology.

8. Identifying of Adverse Events The protocol should state whether any NIMPs are to be supplied to participants in the trail. The procedure for notifying such adverse events to the CI or PI must be clearly documented in the trail protocol.

9. Assessment of Adverse Event AEs must be assessed for seriousness, causality, expectedness, and severity It is the responsibility of the CI or PI to assess each AE for seriousness, causality, expectedness, and severity The sponsor should review if a SAR reported to them is expected or not. If the event is not expected it will be considered as a SUSAR.

10. Assessment of Severity The CI or PI or delegated medically qualified research team member should make an assessment of severity for each AR. The assessment should be recorded on the SAE form and reported to the sponsor according to the following categories: Mild : A reaction that is easily tolerated by the subject. Moderate : A reaction that is sufficiently discomforting to interfere with normal everyday activities. Severe : A reaction that prevents normal everyday activities

11. Reporting of Adverse reactions Patient details Initials Gender Age and date of birth Weight Height Suspected drugs Generic name of the drug *. Indication(s) for which suspect drug was prescribed or tested. Dosage form and strength.

12. Reporting of Adverse Reactions Daily dose and regimen (specify units - e.g., mg, ml, mg/kg) .. Route of administration. Starting date and time of day. Stopping date and time, or duration of treatment Other Treatment(s) Provide the same information for concomitant drugs

13. Reporting of Adverse Reactions Details of Suspected Adverse Drug Reaction(s) Full description of reaction(s) including body site and severity, as well as the criteria for regarding the report as serious,whenever possible, describe a specific diagnosis for the reaction. * Start date (and time) of onset of reaction. Stop date (and time) or duration of reaction.

14. Reporting of Adverse Reactions Outcome Information on recovery; results of specific tests and/or treatment. For a fatal outcome, cause of death and its possible relationship to the suspected reaction; any post-mortem findings. Any Other information relevant to facilitate assessment of the case, such as medical history of allergy, drug or alcohol abuse; family history; findings from special investigations etc.

15. Reporting of Adverse Reactions Details about the Investigator* Name Address Telephone number Profession (speciality) Date of reporting the event to Licensing Authority: Date of reporting the event to Ethics Committee overseeing the site: Signature of the Investigator

16. Responsibilities . Responsibilities of Sponsor SAE should be reported to the licensing authority with in 14 calendar days. Submit status report to the licensing authority periodically Responsibilities of Investigator Ensure adequate medical care is provided to the subject SAE and unexpected AE should be reported to the sponsor within 24 hrs To the EC within 7 working days

17. Responsibilities Regular reporting of adverse events is done through data collection in case report forms. Adverse events are already known as potential risks when participating in a research study with a specific investigational product. It is important to have a documented baseline assessment that is detailed with health history and current health issues prior to exposure to the investigational product.

18. Responsibilities As the participant is exposed to the investigational product, the research team must document any changes in health that may be due to the research study product and report these adverse events through normal data collection tools provided by the sponsor.

19. Responsibilities Most reports require a brief history of the event. Key information that is helpful to the reviewers of the reports are: participant demographic information, when the participant started the research study, what research intervention the participant was receiving, previous medical history, concomitant medications

20. Responsibilities last exposure to investigational product, abnormal labs or diagnostic tests, when the study team was notified of the event, description of the actual event, relationship of the AE to the investigational product, whether the participant was hospitalized, the event has resolved or not, whether the participant will be removed from the research study or continue to receive the research product .

21. IDENTIFYING OF ADVERSE REACTIONS yes no This is a SAR/SAE Is this IMP Related ? This is a AE This is a SAR This is a SAE yes no

22. IDENTIFYING OF ADVERSE REACTIONS AE Is it Serious ? Yes No It is a SAE. It is AE. Is the event related to the IMP? Yes No Is the event Expected It is SAE. No Action Required. (listed in IB,Protocol) Yes No It is SAR. It is a SUSAR