Study Set Content:
are enjoined to report suspected adverse drug reactions experienced by their patients on the use of the products they prescribed, administered, or dispensed.
Doctors, nurses, and pharmacists
has the ultimate responsibility for the safety of their products. They are mandated to monitor the safety and efficacy of products approved for marketing by the FDA.
Pharmaceutical industry
ADR or safety reports are received and evaluated by FDA. The () receives the acknowledgement or notification that the report has been successfully submitted.
primary reporter
For reports with . incomplete information, there will be a () to the reporter to complete the minimum information necessary for the evaluation.
follow up
All valid reports are then entered into the national database:
PREP
PREP meaning
Patient, Reporter, Event, Product
The FDA forwards all the reports() to the global For reports with database.
anonymously
carefully screens all the reports for new risk.
The FDA Pharmacovigilance Team
If a new risk is identified, the need for an action is evaluated and () are taken into consideration.
appropriate measures
Reporting health professional may select any of the following:
Online reporting:
• Email:
• Direct mail to FDA
Telephone:
Online reporting:
https://vigiflow-eforms.who-umc.org/ph/fdaadr
: Fill out FDA Suspected Side Effects Reporting Form and send to pharmacovigilance@fda.gov.ph.
Telephone: Call FDA-PV at
(02) 8809 5596.
43.67
Various DOH programs
34.33
Pharmaceutical companies
17.88
Patients consumers
17.88
Hospitals
0.16
HCP
3.97
patients consumers
Of the total reports received, • 42.39% were
serious
