Spontaneous ADR reporting system and reporting to regulatory authorities

Introduction
Spontaneous ADR reporting process
ADR reporting system in different countries
Suspected ADR Reporting Form
Parts of Suspected ADR Reporting Form
Advice about reporting
References

1. A Presentation on the Topic SPONTANEOUS REPORTING SYSTEM OF ADR & REPORTING TO REGULATORY AUTHORITIES Presented by AJAY KM YADAV M.PHARM DEPARTMENT OF PHARMACOLOGY 1 AJ MPL 2023-25

2. CONTENTS Introduction Spontaneous ADR reporting process ADR reporting system in different countries Suspected ADR Reporting Form Parts of Suspected ADR Reporting Form Advice about reporting References 2 AJ MPL 2023-25

3. INTRODUCTION A spontaneous report is an unsolicited communication by healthcare professionals or consumers, pharmaceutical companies to national pharmacovigilance center (NPC) or other organizations (CDSCOs, AMC) that describes one or more suspected ADR in a patient given a medicinal product that dose not derive from study or any organized data collection scheme. Passive surveillance system. Health professionals are encouraged to report adverse reactions which they believe to drug related to the regulatory authority. 3 AJ MPL 2023-25

4. SPONTENOUS ADR REPORTING PROCESS Data acquisition Data assessment Data interpretation 1. DATA ACQUISITION Which Depends largely on input of information derived from reports submitted by health professionals who have encountered what they suspected an ADR. 4 AJ MPL 2023-25

5. 2. DATA ASSESMENT Which involve assessment of individual case reports and assessment of pooled data obtained from various sources such as international database of the WHO. 3. DATA INTERPRETATION Data interpretation based on available data and assessment made a signal related to the adverse reaction may be generated. 5 AJ MPL 2023-25

6. ADR REPORTING SYSTEM IN DIFFERENT COUNTRIES India – ‘suspected adverse drug reaction reporting form’ UK - ‘Yellow card since; 1964 Australia – ‘Blue card since; 1964 US – ‘Med Watch’ 6 AJ MPL 2023-25

7. 7 INDIA ‘Suspected Adverse Drug Reaction Reporting Form’ Indian pharmacopeia commission (IPC), Ghaziabad is functioning as national coordination center (NCC) for pharmacovigilance program of India (PvPI). 150 ADR monitoring centers (AMCs) where stablished is in the various medical institutions/hospital across India to monitor and collect ADR reports under NCC- PvPI. AJ MPL 2023-25

8. SUSPECTED ADR REPORTING FORM The NCC has designed a ‘Suspected Adverse Drug Reaction Reporting Form’ to record adverse reaction related to drug. Separate forms are available to record adverse reaction associated with transfusion of blood and blood related product and A dverse E vent F ollowing I mmunization (AEFI). 8 AJ MPL 2023-25

9. PARTS OF SUSPECTED ADR REPORTING FORM Patient Information Suspected Adverse Reaction Suspected Medications Reporter Details 9 AJ MPL 2023-25

10. 10 PATIENT INFORMATION 1. Patient initials: write only the initials a patient instead of full name. For e.g. Madhu Gupta as MG. 2. Age: Age at time of event or date of birth. 3. Sex: Mention the gender of the patient. 4. Weight: Mention the weight of patient. B. SUSPECTED ADVERSE REACTION 5. Date of reaction started 6. Date of recovery 7. Describe reaction: Provide the description of the reaction in terms of nature, localization. AJ MPL 2023-25

11. C. SUSPECTED MEDICATION 8. Details of suspected medication Drug name (brand or generic) Manufacturer Batch no. and expiry date Dose and route used Date of therapy started and stopped Indication of use must be provided by reporter. 11 AJ MPL 2023-25

12. 9. Dechallenge details Fill the outcome of dechallenge: Yes- if reaction abate after dechallenge No- if reaction did not abate after dechallenge Unknown- if effect of dechallenge is not known Not Applicable (NA)– where single dose is given (Ex. vaccines, anesthesia) or death Reduced dose- if dose at which reaction occurred is reduced Note: Also mention the reduced dose and date. 12 AJ MPL 2023-25

13. 10 . Rechallenge details Fill the outcome of the rechallenge Yes- if reaction appear after rechallenge No- if reaction does not appear after rechallenge Unknown- if effect of rechallenge not confirmed Not Applicable- if rechallenge is not applicable as in case of anaphylaxis Note: Mention the dose and date of rechallenge 13 AJ MPL 2023-25

14. 11 .Concomitant drugs Including self medication (OTC), herbal remedies with therapy date 12. Relevant test/ laboratory data Mention all laboratory data (if available) relevant to the reaction occurred 13 . Other relevant history Pre existing medical conditions (allergies, pregnancy, smoking/alcohol use, hepatic/renal disfunction) 14 AJ MPL 2023-25

15. 14 . Seriousness of the reaction If any reaction is serious in nature tick the appropriate reason for seriousness as: Death Hospitalisation/prolonged Disability Congenital anomaly Other medically important 15 AJ MPL 2023-25

16. 15. Outcomes Tick the outcome of the event as: Fatal – if the patient dies Continuing- if the patients continuing to experience the reaction Recovering- if the patient is recovering from the reaction Recovered- if the patient completely recovered from reaction (date of recovery). Unknown- if outcome is not known 16 AJ MPL 2023-25

17. D. REPORTER DETAILS Name Address Pin, Email and contact No. Occupation Signature and date of this report 17 AJ 2023-25

18. ADVICE ABOUT REPORTING what to report? All adverse event to be reported Reporting non-serious , known or unknown frequent or rare ADR due to medicine, vaccine and herbal product. Reporting every serious adverse drug reaction 18 AJ MPL 2023-25

19. B. Who can report? All healthcare professionals (clinician, dentists, pharmacist nurses etc.) and non healthcare professionals including consumers can report suspected ADR. C. Where to report? Duly filled in ‘Suspected ADR Reporting Form’ can be sent to the nearest Adverse Drug Monitoring Centre (AMC) or directly to the National Coordination Center (NCC) for PvPI. By Email: [email protected] PvPI Helpline: 18001803024 (9:00 to 5;30 PM, Monday-Friday) ADR Mob. App : “ADRPvPI” 19 AJ MPL 2023-25

20. D. What happens to submitted information? Information provided in this form is handled in strict confidence. The causality assessment is carried out at AMCs by using WHO-UMC scale. The analysed forms are forwarded to the NCC-PvPI through ADR database. Finally the data is analysed and forwarded to Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Centre in Sweden. The reports are periodically reviewed by the NCC-PvPI. The information generated on the basis of these reports helps in continuous assessment of benefit–risk ratio of medicines. Panel of PvPI reviews the data and suggests any interventions that may be required. 20 AJ MPL 2023-25

21. E. Mandatory field for suspected ADR Reporting Form (*) Patients initials Age at onset of reaction Reaction term(s) Date of onset of reaction Suspected Medication(s) Reporter information 21 AJ MPL 2023-25

22. References “Guidance Document for Spontaneous Adverse Drug Reaction Reporting” Spontaneous Reporting, Published by Indian Pharmacopoeia Commission, NCC-PvPI, 2014, Peg No. 10-17. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODQ5MA== “Suspected Adverse Drug Reaction Reporting Form” , Peg No. 1-2. https://www.slideshare.net/slideshow/spontenous-adr-reporting/140582426 Spontaneous Reporting by Sonal Vijay pande 22 AJ MPL 2023-25

23. THANK YOU [email protected]