Drug safety and pharmacovigilance need for internationally harmonized paper based spontaneous Adverse Drug Reactions Dr. Behrouz Mansouri Dr. Syed Ahmad Ali Shah Mr. Muhammad Tanvir Dr. Hafsa Hafeez Professor Peivand Pirouzi

1. Need for internationally harmonized
paper based Spontaneous ADR
Reporting forms
Behrouz Mansouri
Syed Ahmad Ali Shah
Muhammad Tanvir
Hafsa Hafeez
Research Director: Professor Peivand Pirouzi

2. HAZARDS OF ADRs
ADRs are one of the leading causes of morbidity and mortality
• 2.9–5.6% of all hospital admissions are caused by ADRs
• 35% of hospitalized patients experience an ADR during their hospital stay
• incidence of serious ADRs is 6.7% and
• fatal ADRs is 0.32% in hospitalized patients
• making these reactions between the fourth and sixth leading cause of death,
respectively

3. Methods of monitoring ADRs
• Intensified ADR Reporting: e.g.Black arrow scheme
• Spontaneous ADR reporting
• Targeted Spontaneous Reporting: e.g. in a specific Population
• Cohort Event Monitoring(CEM): early PM for new class; potential
class; Significant AEs in pre-& post Marketing
• Electronic Health record Mining:
Spontaneous ADR reporting is the most widely used. It is particularly
useful in identifying rare and delayed reactions

4. ADR Forms under study
● United States of America (US)
● Canada (CA)
● United Kingdom (UK)
● India (IN)
● Pakistan (PK)

5. Variation of reporting forms
• Patient
• Problem
• Suspect drug/product
• Concomitant medications
• Reporter

6. PATIENT (continued....)
• Patient Identifier: US, CA
• Patient initials: UK, IN
• Identification number (e.g. Practice or Hospital Ref.) UK
• Relationship of reporter with patient UK
• Age at the time of Event: US, CA (Years and Months), UK, IN

7. ● Date of Birth: US, IN
● Age: CA, UK (at time of reaction), PK, US ( at Time
of Event or Date of Birth)
● Sex: Male/Female US, CA, UK,PK, IN
• Weight: US (lb/Kg), CA (lb/Kg), UK (Kg), PK, IN
• Height CA (cm/feet),
PATIENT (…..continued....)

8. Health Information: CA {Allergies and other relevant information
(smoking, pregnancy,
alcohol use etc.)}
PK (Relevant Medical History)
Ethnicity/Race PK, UK(White, Mixed, Asian or Asian British, Black or
Black British)
Name of Patient: PK
Address: PK
Pregnancy status: PK (Yes/No/Not applicable)
Additional details: UK
Patient Reference number (If applicable) UK
PATIENT (…..continued)

9. PRODUCT (continued......)
Product Name:
US, CA, UK (Brand if known), PK
(commercial), IN (brand and /or generic name)
Generic Name: PK
Label Strength: US, CA
Manufacturer/Labeler: US, CA, PK, IN (if known)
Dose/Amount: US, CA, UK, IN

10. PRODUCT (…..continued.....)
Route: US, CA, UK, IN,
Frequency: US, CA, UK, IN
Lot/Batch Number: US, CA, UK(Batch), IN (if
known)
Drug License/Registration/NDC or Unique ID No.: US, CA (DIN/NPN #)
Dates of Use/start date: US, CA, UK, PK, IN

11. PRODUCT (…..continued.....)
• Is the product still being taken? CA
• End Date: CA, IN
• Expiration Date: US, CA, IN (if known)
• Diagnosis/Reason/indication for use/ Prescribed for: US, CA, UK, IN
• Event/Reaction Abated after use stopped or dose reduced? US, CA, IN

12. PRODUCT (…..continued.....)
Reaction/Event Reappeared After Reintroduction? US, CA, UK, IN
Do you still have the product in case we need to evaluate it? US
Treatment of reaction, including dates CA
Action taken with medicine (Stopped/dose reduced/ dose increased/Dose not changed/unknown) UK
Source of medicines (Prescription/bought in Pharmacy/ bought in other shop/Internet/mother took during
pregnancy/other) UK
Other source: UK

13. PROBLEM (continued......)
• What kind of Problem did you encounter?
• US (adverse event, product problem or product use error, Problem with Different
Manufacturer of Same Medicine)
• UK (Recovered/Recovering/Continuing/other)
• Outcomes Attributed to Adverse Event:
Death: US, CA, UK, PK, IN
Life Threatening US, CA, UK, PK, IN
Hospitalization-initial or prolonged US, CA, UK, PK, IN
Disability or Permanent Damage US, CA, UK, PK, IN
Congenital Anomaly/Birth defect US, CA, UK, PK, IN
Other Serious (Important Medical Events) US, CA, UK, PK, IN

14. PROBLEM (…...continued.....)
• Required Intervention to Prevent Permanent Impairment/Damage
(Devices) US, CA
• Overdose
PK
• Duration of event
PK
• Reaction Start Date
US (Date of event) , CA, UK(Date reaction(s) started), PK, IN
• Bad enough to affect everyday activities

15. • Report Date: US, CA
• Stop date of side effect CA, UK (Date reaction(s) stopped)
• Describe Reaction/Problem US, CA, UK, IN
• Product Use Error US
• Relevant Test/Laboratory Data, Including Dates: US, CA, IN
• Is side effect reported to manufacturer CA, UK
• Is the patient pregnant UK, PK
PROBLEM (…...continued.....)

16. Do you consider the reactions to be serious? UK
If yes, please indicate why the reaction is considered to be
serious (please tick all that apply):
Patient died due to reaction
Involved or prolonged inpatient hospitalisation
Life threatening
Involved persistent or significant disability or
incapacity
Congenital abnormality
Medically significant; please give details:________
PROBLEM (…...continued.....)

17. If the reactions were not serious according to the categories above, how
bad was the suspected reaction?
UK
Mild
Unpleasant, but did not affect everyday activities
PROBLEM (…...continued.....)

18. PROBLEM (…..continued.....)
• Other Relevant History, Including Pre-existing Medical Conditions:
Allergies US, IN, CA
Pregnancy US, IN, CA
Smoking US, IN, CA
Alcohol Use US, IN, CA
Hepatic/ Renal Dysfunction US, IN, CA
Other US, IN

19. PROBLEM (…..continued.....)
●Reaction occurred as a result of an unintentional error in the prescription,
dispensing or administration of the medication? UK
●Reason for reporting: PK (Requires or prolongs hospitalization /
Life threatening / Death / Permanently disabling
or incapacitating / Congenital anomaly /
Overdose / Other)

20. Date of recovery IN
Seriousness of the reaction: IN (Death (dd/mm/yyy)/Life threatening /
Hospitalization- initial or prolonged/ Disability/ Congenital anomaly /
Required intervention to prevent permanent impairment / damage/Other
(specify)
PROBLEM (…..continued.....)

21. REPORTER (continued.....)
Reporter type (Health professional? Yes/No): CA
Reporting only by Doctor/Pharmacist/Nurse: PK, IN
Institution of Reporter (Doctor/Pharmacist/Nurse): PK
Name: US, CA (First and last names),
UK, IN (only Doctor/Pharmacist/Nurse)
Address: US, CA, UK (Professional Address), IN
Post/Pin code: IN, UK
Phone: US, CA, UK, IN
E-mail Address: US, CA,UK, IN

22. REPORTER (continued.....)
Occupation: US, CA*, IN
Speciality: UK
Tell us who else you reported this adverse event to: US (Manufacturer/User Facility/Distributor/ Importer),
CA (Reported to manufacturer?)
Signature: UK, PK
Dates: UK, PK
Causality assessment: IN
I do NOT want my identity disclosed to the manufacturer: US
CLINICIAN (if not the reporter): UK
Name and Professional Address:
Postcode: Tel No:
Email:
Specialty:
Date:

23. CONCOMITANT MEDICATIONS
Did the patient take any other Medicines, Vaccines, complementary remedies in the last 3 months prior to the
reaction? Yes / No UK
If yes, please give the following information if known:
(Drug/Vaccine Name (Brand if known), Batch, Route, Dosage, Date Started, Date Stopped, Prescribed for)
UK
Concomitant health products, excluding treatment of reaction:
CA (name, dose, frequency, route used and therapy dates)
US (product names and therapy dates (or duration of use) and dose/frequency for any other medical
products (drugs, biologics, medical devices, etc.) that the patient was using at the time of the event)
IN (Concomitant medical product including self medication and herbal remedies with therapy dates
(exclude those used to treat reaction)

24. SUMMARY
• 89 different data elements were found in reporting forms of which
• 11 (12.36%) elements were common in all five forms.
• 14 (15.73%) data elements were common in four
• 10 (11.24%) in three
• 19 (21.34%) in two
• 35 (39.33%) in individual country forms

25. REFERENCES
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26. REFERENCES
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http://cdsco.nic.in/writereaddata/ADR%20form%20PvPI.pdf http://www.cdsco.nic.in .
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