Medicinal Side Effects Reporting Form – East India Pharmaceutical Works Limited

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Medicinal Side Effects Reporting Form

Medicinal Side Effects Reporting Form (by all) East India Pharma P-Vig ICSR Form 2550 F1 (version 1.2)

(based on ADR Reporting Form, Pharmacovigilance Programme of India, Ministry of Health & Family Welfare, Govt of India, CDSCO, CIOMS & ICH E2B Formats)

REPORTING DATE

Company Reference Number

A. PATIENT:

1. Initials only

2. Sex

3. Body Wt (kg)

4. Residing at (Locality, Village, City / Town, District, Country only)

5. Date of Birth

6. Age at time of event

D. ANY OTHER SIMULTANEOUS MEDICATION(s): (Including herbal & self-medications, except those used to treat side-effects)

	(i)	(ii)	(iii)	(iv)
1. Indication
2. Brand, Route & Form, Strength
3. Composition
4. Dose Amount/Frequency
5. START DATE
6. STOP DATE (write CONT if continuing)
7. Expiry Date

E. REPORTER:

1. Relation to patient

2. DATE

3. Initials

4. Age

5. Sex

6. Educational Qualification

7. Mobile Number

8. Whatsapp Number

9. Full Name

10. Email

11. Professional Address (Designation, Dept / Unit / Bldg / Branch / Headquarters, Institution, Regn No, Seal, Signature, etc)

12. Residential Address (Locality, Village, City / Town, PO, PS, Block, District, State, PIN code, Landmark)

If filled up (on behalf of reporter) by company representative / anybody else:

13. Full Name

14. Age .

15. Sex .

16. Mobile Number

17. Whatsapp Number

18. Professional Address (Designation, Dept / Unit / Bldg / Branch / Headquarters, Institution, Regn No, Seal, Signature, etc)

19. Residential Address (Locality, Village, City / Town, PO, PS, Block, District, State, PIN code, Landmark)

REPORT ADRs (adverse drug reactions / side effects of medicines) – Just a Few Min could Save Many :

WHY : ADRs are the 4th-6th major cause of deaths worldwide. Filling out this form could help us ensure safer medicines, as the data generated will help in continual risk-benefit analysis of medicinal drugs.

WHO : Anybody can report : • Laymen / General Public : Patients (consumer), their friends / relatives, etc.

Specially • Health care professionals : Doctors, Dentists, Nurses, Paramedics, Pharmacists, etc. whose participation is vital.

WHEN : Even if you • don’t have all details • are not certain that reactions have been caused by that product only

WHAT : Any adverse experience : • Adverse Drug Reactions • Adverse Events • Product Problems

WHERE & HOW : Please report as completely as possible, in the specific FORMAT provided , either online or offline by downloading it first, filling-up & then submitting hard / soft / scanned copies TO :

reportsideeffects@eastindiapharma.org by e-mail
any of our company’s Medical Representatives
Pharmacovigilance Officer-in-Charge, East India Pharmaceutical Works Ltd., 119 Biren Roy Road (West), Kolkata 700061, India.

Disclaimer : Patient’s identity will be kept Strictly Confidential & protected to the fullest extent, at all times & circumstances. Reporter’s identity too is not for public disclosure. Reporting is purely voluntary & aimed at patient safety only. Merely its compilation / submission DOES NOT amount to an admission of causality / contribution by the physician, manufacturer or product, towards the reported untoward incident or adverse outcome. Neither does it have any legal binding / implications.

Strictly Confidential

Pharmacovigilance Individual Case Safety Report (version date 16-Sept-2020)