REPORT OF ADVERSE REACTIONS TO MEDICINES VACCINES DEVICES TRADITIONAL

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REPORT OF ADVERSE REACTIONS TO MEDICINES, VACCINES, DEVICES, TRADITIONAL REMEDIES & COSMETICS

(Identities of Reporter, Patient and Institution will remain confidential)

PATIENT DETAILS:

BHT/ Record no.

Name & address (optional)

Age

Ethnicity

Sex

REPORT OF ADVERSE REACTIONS TO MEDICINES VACCINES DEVICES TRADITIONAL

ALL MEDICINES IN USE:

Suspected Drug-generic & trade name (batch no. if available)	Dose & frequency	Route	Date Begun	Date stopped	Reason for Use

Other Drugs in use:

DESCRIPTION OF ADVERSE REACTION

Date of Onset: System involved

RESP	CVS	GIT	CNS	GUT	SKIN	OTHER

Description of the event: Lab investigations if any:

Out come: tick “” or circle “o”

Recovered

Continuing

Hospitalized

Severity

Date of death

Birth defect

Specify:

mild

Moderate

severe

fatal

Result on discontinuation of suspect drug: Result on reintroduction of drug Alternative diagnosis

Improved

Disappeared

Persisted

Not Known

Reappeared: Yes / No / Not known

Risk factors present: 

Renal dysfunction	Cardiac Dysfunction	Hepatic Dysfunction	Previous Allergies		Smoking		Alcohol		Drug addict	Other (name)
REPORT ON MEDICAL DEVICE/ COSMETIC/ QUALITY PROBLEM
Name (Brand & Generic):				Device		Cosmetic		Drug	Date of expiry:
Manufacturer (Name & Address):									Model/Serial/Batch/Other number:
Description of the problem:

REPORTING DOCTOR/ PHARMACIST/ NURSE/DENTIST/ OTHER

N REPORT OF ADVERSE REACTIONS TO MEDICINES VACCINES DEVICES TRADITIONAL ame & Designation:…………………………………………………………………………………………………….

Address:…………………………………………………………………………………………………………………..

Telephone number:………………………………………. Hospital & Ward No:……………………………………

Signature:…………………………………………………. Date of reporting: …… / ……/….

For assistance contact: INFO-VIG Dept of Pharmacology Faculty of Medicine, P O Box 271 Kynsey Rd, Colombo 08; Telephone 2695300 Ext 194-198 or Direct line 5677244 or 2697483; Fax:2697483. Photocopies of the above are accepted, or forms could be obtained from the department.

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Tags: adverse reactions, of adverse, adverse, report, reactions, medicines, devices, traditional, vaccines