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How to fill adr reporitng form
- 1. How to fill ADRReporting Form Dr. Kopal Sharma Senior Demonstrator SMS Medical College, Jaipur
- 2. ADRReportingForms • SuspectedAdverseDrugReactionReportingForm • (Forvoluntary reporting of AdverseDrugReactionsbyHealthcareProfessionals) • ADRReporting Form forConsumer • Transfusion Reaction Reporting Form(TRRF) • (Haemovigilance ProgramofIndia) • MedicalDeviceAdverseEventReporting Form • (Materiovigilance ProgramofIndia)
- 4. • Nearest ADRMonitoringCenter (AMC) – Dept. of Pharmacology – SMSMC,Jaipur • Directly to NCC,IPCGhaziabad • pvpi.ipcindia@gmail.com pvpi@ipcindia.net • Toll free no. –18001803024 • ADRReporting Androidapp Wheretoreport
- 5. • Serious or Non-seriousADR • Known or UnknownADR • Frequent orRare – Related to medicine, vaccine, herbal products What toreport?
- 8. A. PatientInformation 1 Patient Initials 2 Age at the time of Event or Date of Birth 3 Sex Male Female Other 4 Weight (kg)
- 9. B. SuspectedAdverse Reaction 5 Date of Reaction started (dd/mm/yyyy) 6 Date ofrecovery (dd/mm/yyyy) 7 Describe reaction orproblem
- 10. C. SuspectedMedication 8 Name (Brand and/orGeneric) Manufacturer (ifknown) Batch No. /LotNo. Exp. Date (ifknown) Doseused Route used Frequency (OD, BD,etc) Therapy dates Date Started Date Stopped Indication CausalityAssessment
- 11. C. SuspectedMedication 9 Action Taken (Pleasetick) Drug Withdrawn Dose increased Dose reduced Dosenot changed Not applicable Unknown i ii iii iv
- 12. C. SuspectedMedication 10 Reaction reappeared afterreintroduction (pleasetick) Yes No Effect unknown Dose (if reintroduced) i ii iii iv
- 13. C. SuspectedMedication 11 Concomitant medicalproducts Including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction) Name (Brand/ Generic ) Dos e used Rout e Used Frequenc y (OD, BD, etc.) Therapydates IndicationDate Started Date Stoppe d i ii iii iv
- 14. 12 Relevanttests/laboratory data with dates 13 Relevant medical / medication history (e.g. allergies, race,pregnancy, smoking, alcohol use,hepatic/renal dysfunction etc.)
- 15. 14 Seriousness of thereaction: No If Yes (Pleasetick anyone) Death (dd/mm/yyyy) Life threatening Hospitalization(initial or prolonged) Disability Congenitalanomaly Requiredintervention to prevent permanent impairment / damage Other (specify)
- 16. 15 Outcomes Recovered Recovering Not recovered Fatal Recovered with sequelae Unknown
- 17. D. ReporterDetails 16 Name and Professional Address Pin Email Tel. No. (with STDCode) Occupation Signature 17 Date of this report (dd/mm/yyyy)
- 18. Mandatory FieldsforSuspectedADR ReportingForm Patient initials Age at onset of reaction Date of onset of reaction Reaction term(s) Suspected medication Reporter information 1 2 5 7 8 16,17
- 21. ADRCase–1
- 22. MadanLal,a65-yearsoldmalepatientadmittedto hospitalon12.01.2016with chief complaints of pain in upper abdomen andnauseasincelast 5days.Onphysical examination, hehadyellowish discoloration of palm, conjunctiva andnail bed. His weight was72kg. Hehad few episodesof psychoticattacks, for which he wason Chlorpromazine therapy sincelast 4 weeks.Onenquiry, he told that he wastakingTab. Largactil (Chlorpromazine)100mg, 4 tablets at bed time. He was also taking Tab. Diclofenac 50 mg twice-a-day (self-medication) for abdominalpain for three daysbefore admitting to hospital. Hewasinvestigatedon the day of admissionfor laboratory parameters which areasfollows: – Alkaline Phosphatase = 180 U/L (Normal range: 25 – 100 U/L) – ALT = 205 U/L (Normal range: 10 – 40 Units/L) – Total Bilirubin = 5.0 mg/dL (Normal range: 0.8 – 1.2 mg/dL) On admission,Chlorpromazineand Diclofenactherapy wasstopped.After 7daysof stopping the medications, the intensity of pain decreased.Also, he was re investigatedfor aboveparameters which are asfollows: – Alkaline Phosphatase = 110 IU/L – ALT = 98 Units/L – Total Bilirubin = 1.8 mg/dL • Note: Tab Chlorpromazine Brand Name: LARGACTIL, Batch number:LGL0881, Manufacturer: Wedleylabs Expiry date: Dec2018
- 23. A. PatientInformation 1 Patient Initials –ML 2 Age at the time of Event or Date of Birth –65years 3 Sex Male Female Other 4 Weight (kg) –72 kg ✓3
- 24. MadanLal,a65-yearsold male patient admitted to hospitalon 12.01.2016with chief complaints of pain in upper abdomen and nauseasince last 5days. On physical examination, he had yellowish discoloration of palm, conjunctiva and nail bed. He had few episodes of psychotic attacks, for which he was on Chlorpromazine therapy since last 4 weeks. On enquiry, he told that he was taking Tab. Largactil (Chlorpromazine) 100 mg, 4 tablets at bed time.
- 25. B. SuspectedAdverse Reaction 5 Date of Reaction started (dd/mm/yyyy):07.01.2016 6 Date ofrecovery (dd/mm/yyyy): 7 Describe reaction orproblem Patient was taking Chlorpromazine since 12.12.2015. He developed pain in abdomen and nausea since 07.01.2016. Examination revealed yellowish discoloration of conjunctiva, palm and nails. Pt. was admitted on 12.01.2016 and investigated. Liver function tests indicated raised serum bilirubin, ALT and alkaline phosphatase. Drugs were discontinued. On discontinuationof drug, reaction subsided in oneweek.
- 26. C. SuspectedMedication 8 Name (Brand and/or Generic):Tab. Chlorpromazine (Largactil) Manufacturer (if known): Wedley labs Batch No. /Lot No.: LGL0881 Exp.Date (if known): Dec. 2018 Dose used: 400mg Route used:Oral Frequency (OD, BD, etc):OD Therapy dates Date Started 12.12.2015 Date Stopped 12.01.2016 Indication: Psychosis Causality Assessment:Probable
- 27. C. SuspectedMedication 9 Action Taken (Pleasetick) Drug Withdraw n Dose increase d Dose reduce d Dosenot changed Not applicabl e Unknown i ✓f ii iii iv
- 28. C. SuspectedMedication 10 Reaction reappeared afterreintroduction (pleasetick) Yes No Effect unknow n Dose (if reintroduce d) i ii iii iv
- 29. C. SuspectedMedication 11 Concomitant medicalproducts Including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction) Name (Brand/ Generic ) Dos e used Rout e Used Frequenc y (OD, BD, etc.) Therapydates IndicationDate Starte d Date Stoppe d i Tab. Diclofenac 50mg Oral BD 09.01. 2016 12.01. 2016 Pain in abdome n ii iii
- 30. 12 Relevanttests/laboratory data with dates 12.01.2016 19.01.2016 Alkaline Phosphatase =180U/L Alkaline Phosphatase =110U/L ALT =205U/L ALT =98U/L Total Bilirubin =5.0 mg/dL Total Bilirubin=1.8 mg/dL 13 Relevantmedical / medication history (e.g. allergies, race, pregnancy, smoking, alcohol use, hepatic/renal dysfunctionetc.)
- 31. 14 Seriousnessof thereaction: No If Yes (Pleasetick anyone) Death (dd/mm/yyyy) Life threatening ✓f Hospitalization(Initial or prolonged) Disability Congenitalanomaly Requiredintervention to prevent permanent impairment / damage Other (specify) ✓h
- 32. 15 Outcomes Recovered ✓g Recovering Not recovered Fatal Recovered with sequelae Unknown
- 33. D. ReporterDetails 16 Name and ProfessionalAddress: Dr. K. Sharma, Dept. of Pharmacology, SMSMC, Jaipur Pin 302004 Email ksharrma@gmail.com Tel. No. (with STDCode): 0141-2563452 Occupation Doctor Signature 17 Date of this report (dd/mm/yyyy): 23.01.2016
- 34. Causality Assessment–ADRCase1 Categories Time sequenc e Otherdrug disease ruledout Dechallenge Rechallenge Certain Yes Yes Yes Yes Probable Yes Yes Yes No Possible Yes No No No Unlikely No No No No
- 35. ADRCase–2
- 36. • Mr SushantAGupta, a 30-years old male with 68 kg weight was diagnosed asa case of bacterial meningitis. • He was started empirically with: - Inj Ceftriaxone 1g IV BD and - Inj Vancomycin 500mg IVQID on 12.01.2016. First dose of Inj. Ceftriaxone was given at 8 am and Inj. Vancomycin was given at 9 am on 12.01.2016.
- 37. • After 10minutes of second drug administration, he started developing chills, rigors, fever, urticaria and intense flushing. • He was treated with Inj. Pheniramine 25mg IM, following which the reaction completely subsided. Inj. Ceftriaxone was continued. • However, next doses of Inj. Vancomycin scheduled on day 1were not given. • On day 2, the Inj Vancomycin was re-introduced at 9 am to the patient. Similar symptoms developed again and quickly resolved after Inj. Pheniramine25mg IM.
- 38. Note: • Inj Vancomycin – Brand Name: Vanzid – Manufacturer: SWACHHealthcare – Batch number: KKIL098 – Expiry date: Mar 2016 • Inj Ceftriaxone – Brand Name: Taximax – Manufacturer: Wedley Labs – Batch number: OPO659 – Expiry date: Dec2016
- 39. Thankyou…!