Some Important Pharmacovigilance Questions "D"

FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE Obligations and Adverse Drug Reaction

Reporting Requirements

REPORTING ADRs to the Food and Drug Administration

Q1. What is Pharmacovigilance:

Pharmacovigilance, as defined by the World Health Organization, is the science and activities

relating to the detection, assessment, understanding and prevention of adverse events or any other

possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and

complementary medicines, blood products, biologicals, medical devices and vaccines.

Q2. What is an adverse event (AE)?

An adverse event is any untoward medical occurrence in a patient or clinical investigation

subject administered a pharmaceutical product and which does necessarily have to have a causal

relationship with this treatment (ICH E2A).

Q3. What is an adverse reaction (AR)?

An adverse reaction is a noxious and unintended response to a marketed product that occurs at

any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an

organic function.

Q4 What is an adverse drug reaction (ADR)?

It is a noxious response to a drug which is unintended and which occurs at doses normally used

in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

Q5. How does and AE differ from an AR?

An AR is characterized by the fact that a causal relationship between the drug and the event is

suspected. This implies that there is a suspected relatedness to the administered drug.

Q6. What is a serious ADR or a serious adverse event?

A serious adverse event or adverse reaction is any untoward medical occurrence that at any

dose:

· Results in death

· Is life-threatening

· Requires in patient hospitalization or prolongation of existing hospitalization

· Results in persistent or significant disability/incapacity or

· Is a congenital anomaly or birth defect

Serious reactions/events must be reported to FDA within 24-72 hours as stipulated in MC 009 s 2010.

Q7 How do we report to FDA?

If there is any suspicion that an adverse event or adverse reaction has occurred, the health care

professional attending to the patient or patient suspects that he has experienced an ADR, can fill up the

FDA ADR form and fax, mail or email it to FDA ADR Unit in Alabang, Muntinlupa.

Q8 Is there a prescribed form to be used in making reports?

There is a prescribed form that can be use in making reports to FDA which can be downloaded

from the FDA or DOH websites: http://www.fda.gov. ph or http://www.doh.gov.ph

Q9. What is ADORs?

ADOrs refers to the Adverse Drug Online Reporting system developed by DOH IMS to reinforce

the reporting of adverse drug reactions as required by the National Pharmacovigilance Center of the

Food and Drug Administration

Q10. Who can make use of ADORs?

The ADORs system is presently intended for the use of all government and private hospitals to

facilitate reporting and to promote confidentiality.

Hospitals who are interested to enroll in the program can write FDA to request for a user name

and password for their respective institutions. The user name and password shall be entrusted to the

Chief Pharmacist of the Hospital who then assigns a responsible staff to prepare the reports to ensure

that all reports submitted are official.

Q11. What are the minimum criteria for a valid ADR report?

The following minimum criteria must be met to make an ADR report valid:

· Patient identifier e.g., initials, or age or date of birth or sex

· Name of suspected medicinal product (s)

· Details of the suspected reaction

· An identifiable reporter (name, profession, institution, contact details)