Adverse Drug Reactions (ADR) Online Reporting
Drug Office, Department of Health
Complaint Phone No.: 2572 2068
Email Address:
pharmgeneral@dh.gov.hk
Frequently Asked Questions
Drug Office, Department of Health
Complaint Phone No.: 2572 2068
Email Address:
pharmgeneral@dh.gov.hk
Frequently Asked Questions
Section (A): Patient Information
Patient initials or ref. no. (Please read instruction 5 below)
Sex
M
F
Pregnant?
No
Yes
Unknown
Weight (if known)
kg
Date of birth
/
/
(dd/mm/yyyy)
Or age (at last birthday)
Ethnic group
Chinese
Asian
African
Caucasian
Eurasian
Unknown
Others
Section (B): About the Adverse Drug Reaction
Date of onset of ADR
/
/
(dd/mm/yyyy)
Description
ADR category (for vaccine related ADR only)
Allergic reaction
Local reaction
Systemic reaction
Neurological disorders
Severity (can tick more than 1 box if appropriate)
Life threatening
Prolonged Hospitalization
Hospitalised on
/
/
(dd/mm/yyyy)
Hospitalisation NOT required
Laboratory result (if applicable)
All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)
Daily Dosage (dose number for vaccines e.g. 1st DTP)
Route
Date Begun
Date Stopped
Reason for Use
All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)
Daily Dosage (dose number for vaccines e.g. 1st DTP)
Route
Date Begun
Date Stopped
Reason for Use
All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)
Daily Dosage (dose number for vaccines e.g. 1st DTP)
Route
Date Begun
Date Stopped
Reason for Use
All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)
Daily Dosage (dose number for vaccines e.g. 1st DTP)
Route
Date Begun
Date Stopped
Reason for Use
All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)
Daily Dosage (dose number for vaccines e.g. 1st DTP)
Route
Date Begun
Date Stopped
Reason for Use
All Drug Therapies/Vaccines Prior to ADR (Please use trade names and, for vaccine, indicate batch number. Please mark the suspected drug with asterisk*.)
Daily Dosage (dose number for vaccines e.g. 1st DTP)
Route
Date Begun
Date Stopped
Reason for Use
Section (C): Treatment & Outcome
Treatment of ADR
No
Yes.
Details (including dosage, frequency, route, duration)
Laboratory result (if applicable)
Outcome
Recovered on
/
/
(dd/mm/yyyy)
Not yet recovered
Unknown
Died on
/
/
(dd/mm/yyyy)
Sequelae
No
Yes
Persistent disability
Birth defect
Medically significant events
Details
Allergies or other relevant history (including medical history, liver / kidney problems, smoking, alcohol use etc)
Other Information
Section (D): Reporter Details (Please read instruction 6 below)
Name
Sector of service
Private
Public
Occupation
Doctor
Chinese medicine practitioner
Dentist
Pharmacist
Nurse
Others
Correspondence Address
Tel. no.
Fax. no.
Email
Confirmed Email
Also report to
Manufacturer
Distributor / Importer
Others
Date of this report
Please read the following instructions
1.
Please read the Guidance for Healthcare Professionals (http://www.drugoffice.gov.hk/adr.html); and Guidance for Pharmaceutical Industry (http://www.drugoffice.gov.hk/adr_industry.html) before completing the ADR report form.
2.
ADR can be briefly described as a noxious and unintended response to a pharmaceutical product (i.e. drug or vaccine).
3.
If the ADR of a newborn/child may be related to the mother, please submit a separate report for the mother.
4.
Please provide information to every section.
5.
Full name and any kind of personal identifier of the patient
, such as identity card number and hospital admission number,
should not be
provided on the report form.
6.
Information of individual reporter will be treated in strict confidence. Please read the
Statement of Purposes
in respect of the collection of your personal data.
7.
As limited space is provided, please use another page for additional information if necessary.
8.
For further enquires, please contact the Clinical Trials and Pharmacovigilance Unit of Drug Office of the DH at 2319 2920.
Please enter the five letters as shown above.
Mandatory fields
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Revised 01/2024
