Suspected Adverse Drug Reaction Reporting Form PDF

Version 1.4 SUSPECTED ADVERSE DRUG REACTION REPORTING FORM For VOLUNTARY reporting of ADRs by Healthcare Professionals INDIAN PHARMACOPOEIA COMMISSION (National Co...

Version 1.4 SUSPECTED ADVERSE DRUG REACTION REPORTING FORM For VOLUNTARY reporting of ADRs by Healthcare Professionals INDIAN PHARMACOPOEIA COMMISSION (National Coordination Centre-Pharmacovigilance Programme of India) Ministry of Health & Family Welfare, Government of India, Sector-23, Raj Nagar, Ghaziabad-201002 PvPI Helpline (Toll Free) :1800-180-3024 (9:00 AM to 5:30 PM, Monday-Friday) Initial Case  Follow-up Case  FOR AMC / NCC USE ONLY A. PATIENT INFORMATION * Reg. No. / IPD No. / OPD No. / CR No. : 1. Patient Initials: 2. Age or date of birth: AMC Report No. : 3. Gender: M  F  Other  4.Weight (in Kg.) Worldwide Unique No. : 12. Relevant investigations with dates : B. SUSPECTED ADVERSE REACTION * 5. Event / Reaction start date (dd/mm/yyyy) 6. Event / Reaction stop date (dd/mm/yyyy) 7. Describe Event/Reaction management with details , if any 13. Relevant medical / medication history (e.g. allergies, pregnancy, addiction, hepatic, renal dysfunction etc.) 14. Seriousness of the reaction : No  if Yes  (please tick anyone)  Death (dd/mm/yyyy)  Congenital-anomaly  Life threatening  Disability  Hospitalization-Initial/Prolonged  Other Medically important 15. Outcome:  Recovered  Recovering  Not Recovered  Fatal  Recovered with sequelae  Unknown C. SUSPECTED MEDICATION(S) * S. 8. Manufactu Batch No. Expiry Dose Route Frequency Therapy Dates Indication Causality No. Name rer / Date Date Date Assessment (Brand/ (if known) Lot (if Started Stopped Generic) No. known) i ii iii iv # 10. Reaction reappeared after reintroduction of 9. Action taken after reaction (please tick) suspected medication (please tick) S. Drug Dose Dose Dose not Not Unknown Yes No Effect Dose No. withdrawn increased reduced changed applicable unknown (if re- as introduced) per C i ii iii iv 11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction) Name Dose Route Frequency (OD, Therapy Dates Indication S. No. (Brand / Generic) BD, etc.) Date Started Date Stopped i ii iii # Additional Information : D. REPORTER DETAILS * 16. Name & Address : __________________ __________________________ ______________________________________ __________________________ Pin : __________ Email : ___________________________________________ Contact No- : _______________________________ Occupation : _______________________Signature : ___________________ 17. Date of this report (dd/mm/yyyy) : Signature and Name of Receiving Personnel : Confidentiality : The patient’s identity is held in strict confidence and protected to the fullest extent. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction. Submiss ion of an ADR report does not have any legal implication on the reporter. # Use separate page for more information * Mandatory Fields for suspected ADR Reporting Form  ADVICE ABOUT REPORTING A. What to report? All adverse events should be reported Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines, Vaccines & Herbal Products. Report every serious adverse drug reactions. A reaction is serious when the patient outcome is :  Death  Life-threatening  Hospitalization (initial or prolonged)  Disability (significant, persistent or permanent)  Congenital anomaly  Report intervention to prevent permanent impairment or damage NOTE : Serious/Adverse Event following immunization can also be reported in Serious AEFI case Notification Form available on http://www.ipc.gov.in B. Who can report? All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurse etc.) can report adverse drug reactions C. Where to report? Duly filled in Suspected Adverse Drug Reaction Reporting Form can be sent to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC) for PvPI. Call on Helpline (Toll Free) 1800 180 3024 to report ADRs or directly mail this filled form to [email protected] A list of nationwide AMCs is available at : http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html D.What happens to the 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 analyzed forms are forwarded to the NCC -PvPI through ADR database. Finally the data is analyzed and forwarded to the 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 the benefit-risk ratio of medicines.  The Signal Review Panel of PvPI reviews the data and suggests any interventions that may be required. E. Mandatory fields for suspected ADR Reporting Form ( *) Patient initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected medication(s) & reporter information. For Adverse Drug Reaction Reporting Tools  E-mail : [email protected]  PvPI Helpline (Toll Free) : 1800 180 3024 (9:00 AM to 5:30 PM, Monday-Friday)  ADR Mobile App : “ADRPvPI”