How to fill adr reporitng form

For undergraduate students

1. HowtofillADRReportingForm
Dr. KopalSharma
Senior Demonstrator
SMS Medical College, Jaipur

2. ADR ReportingForms
•SuspectedAdverseDrugReactionReportingForm
•(ForvoluntaryreportingofAdverseDrugReactionsbyHealthcareProfessionals)
•ADR Reporting Form forConsumer
•Transfusion Reaction Reporting Form(TRRF)
•(Haemovigilance Program ofIndia)
•MedicalDeviceAdverseEventReportingForm
•(Materiovigilance Program ofIndia)

3. Who canreport?
Doctor Dentist
Pharmacist
Nurse
Patient

4. •Nearest ADR MonitoringCenter (AMC)
–Dept. of Pharmacology
–SMSMC,Jaipur
•Directly toNCC, IPC Ghaziabad
•[email protected]
[email protected]
•Tollfreeno.–18001803024
•ADR Reporting Androidapp
Where toreport

5. •Serious or Non-seriousADR
•Known or UnknownADR
•Frequent orRare
–Relatedtomedicine,vaccine,herbalproducts
What toreport?

8. A. PatientInformation
1PatientInitials
2AgeatthetimeofEventorDateofBirth
3
Sex
Male Female Other
4Weight(kg)

9. B. SuspectedAdverse Reaction
5DateofReactionstarted(dd/mm/yyyy)
6Date ofrecovery (dd/mm/yyyy)
7Describe reaction orproblem

10. C. SuspectedMedication
8Name (Brand and/orGeneric)
Manufacturer (ifknown)
Batch No. /LotNo.
Exp. Date (ifknown)
Doseused
Routeused
Frequency (OD, BD,etc)
Therapydates
DateStarted DateStopped
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Withdrawn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 Effectunknown
Dose (if
reintroduced)
i
ii
iii
iv

13. C. SuspectedMedication
11
Concomitant medicalproducts
Includingself-medicationandherbalremedieswiththerapydates
(Excludethoseusedtotreatreaction)
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. 12Relevanttests/laboratorydatawithdates
13
Relevant medical / medication history
(e.g.allergies,race,pregnancy,smoking,
alcoholuse,hepatic/renaldysfunctionetc.)

15. 14
Seriousness of thereaction:
No IfYes (Please tickanyone)
Death(dd/mm/yyyy)
Lifethreatening
Hospitalization(initialorprolonged)
Disability
Congenitalanomaly
Requiredinterventiontopreventpermanentimpairment/damage
Other(specify)

16. 15Outcomes
Recovered
Recovering
Notrecovered
Fatal
Recovered withsequelae
Unknown

17. D. ReporterDetails
16
Name and Professional
Address PinEmail
Tel. No. (with STD Code)
Occupation
Signature
17Dateofthisreport(dd/mm/yyyy)

18. Mandatory Fields forSuspected ADR ReportingForm
Patientinitials
Age at onset of reaction
Dateofonsetofreaction
Reaction term(s)
Suspected medication
Reporterinformation
1
2
5
7
8
16,17

19. •Vigiflowsoftware
SafetyDatabase

20. •Vigiflowsoftware
SafetyDatabase

21. ADR Case –1

22. MadanLal,a65-yearsoldmalepatientadmittedtohospitalon12.01.2016withchief
complaints of pain in upper abdomen and nausea since last 5 days. On physical
examination, he had yellowish discoloration of palm, conjunctiva and nail bed. His weight
was 72kg.
Hehadfewepisodesofpsychoticattacks,forwhichhewasonChlorpromazine
therapysincelast4weeks.Onenquiry,hetoldthathewastakingTab.Largactil
(Chlorpromazine)100mg,4tabletsatbedtime.
He was also taking Tab. Diclofenac 50 mg twice-a-day (self-medication) for
abdominalpainforthreedaysbeforeadmittingtohospital.Hewasinvestigatedon
thedayofadmissionforlaboratoryparameterswhichareasfollows:
–Alkaline Phosphatase = 180 U/L (Normal range: 25 –100U/L)
–ALT = 205 U/L (Normal range: 10 –40Units/L)
–Total Bilirubin = 5.0 mg/dL (Normal range: 0.8 –1.2mg/dL)
Onadmission,ChlorpromazineandDiclofenactherapywasstopped.After7daysof
stopping the medications, the intensity of pain decreased. Also, he was re
investigatedforaboveparameterswhichareasfollows:
–Alkaline Phosphatase = 110IU/L
–ALT = 98 Units/L
–Total Bilirubin = 1.8mg/dL
•Note:TabChlorpromazine
BrandName:LARGACTIL,
Batchnumber:LGL0881,
Manufacturer: Wedleylabs
Expiry date: Dec2018

23. A. PatientInformation
1Patient Initials –ML
2AgeatthetimeofEventorDateofBirth–65years
3
Sex
Male Female Other
4Weight (kg) –72kg
✓3

24. MadanLal,a65-yearsoldmalepatientadmittedto
hospitalon12.01.2016withchief complaints of pain in
upper abdomen and nausea since last 5 days. On physical
examination, he had yellowish discoloration of palm,
conjunctiva and nail bed.
Hehadfewepisodesofpsychoticattacks,forwhich
hewasonChlorpromazine therapysincelast4
weeks.Onenquiry,hetoldthathewastakingTab.
Largactil(Chlorpromazine)100mg,4tabletsatbed
time.

25. B. SuspectedAdverse Reaction
5Date of Reaction started (dd/mm/yyyy):07.01.2016
6Date ofrecovery (dd/mm/yyyy):
7
Describe reaction orproblem
PatientwastakingChlorpromazinesince12.12.2015.Hedevelopedpain
inabdomenandnauseasince07.01.2016.Examinationrevealedyellowish
discolorationofconjunctiva,palmandnails.Pt.wasadmittedon
12.01.2016andinvestigated.Liverfunctiontestsindicatedraisedserum
bilirubin,ALTandalkalinephosphatase.Drugswerediscontinued.On
discontinuationofdrug,reactionsubsidedinoneweek.

26. C. SuspectedMedication
8Name(Brandand/orGeneric):Tab.Chlorpromazine(Largactil)
Manufacturer(ifknown):Wedleylabs
BatchNo./LotNo.:LGL0881
Exp.Date(ifknown):Dec.2018
Dose used: 400mg
Route used:Oral
Frequency (OD, BD, etc):OD
Therapydates
DateStarted12.12.2015 Date Stopped12.01.2016
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
Includingself-medicationandherbalremedieswiththerapydates
(Excludethoseusedtotreatreaction)
Name
(Brand/
Generic
)
Dos
e
used
Rout
e
Used
Frequenc
y (OD,
BD,
etc.)
Therapydates
IndicationDate
Starte
d
Date
Stoppe
d
i
Tab.
Diclofenac
50mgOral BD
09.01.
2016
12.01.
2016
Pain in
abdome
n
ii
iii
iv

30. 12
Relevanttests/laboratorydatawithdates
12.01.2016 19.01.2016
Alkaline Phosphatase =180U/L Alkaline Phosphatase = 110U/L
ALT =205U/L ALT = 98U/L
Total Bilirubin =5.0mg/dL Total Bilirubin= 1.8 mg/dL
13
Relevantmedical/medicationhistory
(e.g.allergies,race,pregnancy,smoking,alcoholuse,
hepatic/renal dysfunctionetc.)

31. 14
Seriousness of thereaction:
No IfYes (Please tickanyone)
Death(dd/mm/yyyy)
Lifethreatening
✓f
Hospitalization(Initialorprolonged)
Disability
Congenitalanomaly
Requiredinterventiontopreventpermanentimpairment/damage
Other(specify)
✓h

32. 15Outcomes
Recovered
✓gRecovering
Notrecovered
Fatal
Recovered withsequelae
Unknown

33. D. ReporterDetails
16
NameandProfessionalAddress:Dr.K. Sharma,Dept.of
Pharmacology, SMSMC, Jaipur
Pin302004 [email protected]
Tel. No. (with STD Code): 0141-2563452
OccupationDoctor Signature
17Dateofthisreport(dd/mm/yyyy):23.01.2016

34. Causality Assessment –ADR Case1
Categories
Time
sequenc
e
Otherdrug
disease
ruledout
DechallengeRechallenge
CertainYes Yes Yes Yes
ProbableYes Yes Yes No
PossibleYes No No No
UnlikelyNo No No No

35. ADR Case –2

36. •Mr Sushant A Gupta, a 30-years old male with 68 kg weight
was diagnosed as a case of bacterial meningitis.
•He was started empirically with:
-Inj Ceftriaxone 1 g IV BD and
-InjVancomycin500mgIVQIDon12.01.2016.
FirstdoseofInj.Ceftriaxonewasgiven at 8 am and
Inj. Vancomycin was given at 9 am on 12.01.2016.

37. •After 10 minutes of second drug administration, he
started developing chills, rigors, fever, urticariaand
intenseflushing.
•HewastreatedwithInj.Pheniramine25mgIM,
followingwhichthe reactioncompletelysubsided.Inj.
Ceftriaxonewascontinued.
•However,nextdosesof Inj. Vancomycinscheduled on
day 1 were not given.
•On day 2, the InjVancomycinwas re-introduced at 9
am to the patient. Similar symptoms developed again
and quicklyresolvedafterInj.Pheniramine25mgIM.

38. Note:
•InjVancomycin
–Brand Name:Vanzid
–Manufacturer: SWACHHealthcare
–Batch number:KKIL098
–Expiry date: Mar2016
•InjCeftriaxone
–Brand Name:Taximax
–Manufacturer: WedleyLabs
–Batch number:OPO659
–Expiry date: Dec2016

39. Thankyou…!