MAHESECO MPC DOC. NO.

PROCEDURE MANUAL
Hospital MH-AD-PG-43

TITLE: REV: 00

“ REPORTING OF ADVERSE DRUG DATE: 6/27/2015

REACTION / EVENTS (ADR / E)”
Page 1 of 3

I. PURPOSE

To set the standard operating procedures in pharmacy department in compliance with the
requirement of FDA and DOH.

II. SCOPE/ COVERAGE

This covers the hospital pharmacy of MAHESECO.

III. RESPONSIBILITY

The hospital Adverse Drug Reaction Reporting Program involves a multidisciplinary team,

coordinated by the pharmacy department. The team aims to identify any adverse drug
events occurring within the hospital. A copy of each ADR report is kept in the Pharmacy
Department. A second copy is also forwarded to Therapeutic Committee.

1. Doctors/ Nurses – responsible in reporting suspicious adverse reaction of

medicines to Chief Pharmacist.
2. Chief Pharmacist – receives and collects adverse reaction reports for
endorsement to therapeutic committee.
3. Therapeutic Committee – investigate the case and will submit report to
ADR unit of FDA.

IV. DEFINITION

An ADR is any undesired or unintended effect of drug treatment.

Examples of reported ADRs

 Common reports
o rash caused by amoxycillin
o red face, fever secondary to vancomycin
o serum sickness reactions to cefaclor
 Uncommon reports
o hair loss due to low molecular weight heparin
o neuroleptic malignant syndrome with risperidone

Detection of ADRs requires the vigilance of all health care professionals.

V. PROCEDURE DETAILS

 How are ARs detected once a health product is available for sale?
Prepared by: Reviewed by: Reviewed and Approved by:
Nira O. Gacutan Carmie Mae R. Ramos Luz A. Velasco, MD
Chief Pharmacist Administrative Officer Medical Director
Signature: Date: Signature: Date: Signature: Date:
MAHESECO MPC DOC. NO.
PROCEDURE MANUAL
Hospital MH-AD-PG-43

TITLE: REV: 00

“ REPORTING OF ADVERSE DRUG DATE: 6/27/2015

REACTION / EVENTS (ADR / E)”
Page 2 of 3

Patients, health professionals, manufacturers and health product regulatory authorities

worked together to monitor ARs. Voluntary reporting by health professionals and
consumers of suspected reactions is the most common way to monitor the safety and
effectiveness of marketed health products to obtain information regarding ARs. These
individual reports may be the only source of information concerning previously undetected
ARs or changes in product safety and effectiveness profiles to marketed health products.

 What to report

ALL suspected ADRs to drugs and other medicinal substances are encouraged to be
reported. It is also important to report ADRs to complementary medicines.

Reporting seemingly insignificant or common ADRs is useful and may highlight a

widespread prescribing problem and assist in determining the incidence of ADRs.

 How to report an ADR in the hospital

A hospital ADR report form should be completed by the person reporting the reaction and
sent to the pharmacy. The form is also available on all wards, from your ward pharmacist or
from the Pharmacy Department

 Review of ADRs
1. Data from all reports are kept centrally in the pharmacy.
2. The form is reviewed by a pharmacist to ensure that all relevant information is
recorded on both the form and in the medical record.
3. The report is then reviewed by the Therapeutic (ADR) committee.
4. The report will be submitted then to ADR unit of FDA.

 Why are ARs monitored?

All health products have risks and benefits. Before a product is marketed, safety and
efficacy experience is limited to its use in clinical trials. However, these initial clinical trials
mostly detect common and frequent ARs. Some important reactions may take an extremely
long time to develop or occur infrequently. In addition, the controlled conditions under
which patients use health products in clinical trials (e.g., under direct medical supervision
without necessarily significant exposure to other products and or underlying diseases), do
not necessarily reflect the way the product will be used in real life conditions once it is
marketed. Continued monitoring of ARs is thus essential to maintain a comprehensive
safety and effectiveness profile of health products made available.

 What type of information is collected in AR reports?

Prepared by: Reviewed by: Reviewed and Approved by:

Nira O. Gacutan Carmie Mae R. Ramos Luz A. Velasco, MD
Chief Pharmacist Administrative Officer Medical Director
Signature: Date: Signature: Date: Signature: Date:
MAHESECO MPC DOC. NO.
PROCEDURE MANUAL
Hospital MH-AD-PG-43

TITLE: REV: 00

“ REPORTING OF ADVERSE DRUG DATE: 6/27/2015

REACTION / EVENTS (ADR / E)”
Page 3 of 3

Reports contain relevant information about the patient characteristics and details about the
reaction(s) suspected to be associated with the health product(s), the general finding(s), the
treatment and final outcome(s). Information about the identity of the patient and the health
care provider is kept confidential. Disclosure of data is only done in accordance with the
provisions of Patient’s Rights & Responsibilities..

 How is the information processed?

AR reports are analyzed to discover potential health product safety signals. A signal is
considered to be the preliminary indication of a product-related issue. The identification of
a signal is not by itself the proof of the association of an AR to a health product, but it
triggers the need to further investigate a potential association. Signals must be carefully
evaluated in order to confirm or to disprove the potential association between the product
and the AR.

V. RELATED DOCUMENTS

 Adverse Drug Reaction Report Form (MH Form 2011-019 Rev. 00)

- END OF DOCUMENT -

Prepared by: Reviewed by: Reviewed and Approved by:

Nira O. Gacutan Carmie Mae R. Ramos Luz A. Velasco, MD
Chief Pharmacist Administrative Officer Medical Director
Signature: Date: Signature: Date: Signature: Date: