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Information for Doctors, Nurses, and Pharmacists

Reporting of suspected adverse drug reaction for doctors, nurses, and pharmacists

 

National pharmacovigilance system relies heavily on spontaneous reporting of adverse drug reactions by health professionals, manufacturers, or the patients. Health professionals, such as doctors, nurses, and pharmacists, may be able to detect and identify suspected adverse reactions to a medicine or vaccine. It is essential that these reports are captured and submitted to the appropriate institution or authorities. Such reports are vital in the detection of potential risk and in continuous monitoring of the benefit/risk profile of medicines prescribed, administered, and/or dispensed. While health professionals may report directly to the pharmaceutical supplier companies, they also have the option to report it to the FDA. They should only choose one option to avoid duplication of reports. 

 

Health care professionals are advised to report with complete details as possible with the following points:  

  • The description of the adverse drug reactions with symptoms and findings as precise as possible
  • The temporal relationship between the administration of medicine and the onset of the reaction
  • The outcome of the reaction whether the symptoms resolved or improved after stopping the therapy (this will give dechallenge or rechallenge information) 
  • Details of all medicines administered, including start and stop date 
  • Details of other possible factors that may influence the clinical picture such as diagnosis or other non-drug related factors
  • If the adverse reaction is suspected to be due to a quality of the vaccine or medicinal products, lot or batch number will be very useful

 

To facilitate reporting of adverse drug reactions, the doctors, nurses or pharmacists have various options in reporting. Note that all information provided is treated with utmost confidentiality. Reporting health professional may select any of the following:

Step 1: Visit the Online Adverse Drug Reaction Reporting.

Step 2: Fill in all available information and be as complete as possible.

Step 3: Review the information then click Send report.

Step 4: A prompt will appear that your report has been sent. You have the option to download your report.

Note: You may receive a follow-up if we need more information

Step 1: Download the FDA Suspected Side Effects Reporting Form.

Step 2: Fill in all available information and be as complete as possible.

Step 3: Save, print or scan the accomplished form.

Step 4: Send to [email protected]

Step 5: An acknowledgement email will be sent to you once the report is received.

Note: A follow-up email will be sent if additional information is needed.

Step 1: Download the FDA Suspected Side Effects Reporting Form.

Step 2: Fill in all information available. Information shall be as complete as possible.

Step 3: Save and print the accomplished form.

Step 4: Mail to the following address:

Pharmacovigilance Section
Product Research and Standards Development Division
Center for Drug Regulation and Research
FOOD AND DRUG ADMINISTRATION
Civic Drive, Filinvest City, Alabang, Muntinlupa City 1781

or

FDA Regional Field Office near you. Click here for the directory.

Step 5: An acknowledgement email will be sent to you once the report is received.

Note: It is also possible to report walk-ins to our FDA Action Center (FDAC).

Step 1: Call us at (02) 8809 5596.

Step 2: Somebody will receive your call and ask you for all the needed information with reference to the FDA Suspected Side Effects Reporting Form.

Note: You may receive a follow-up call if we need more information.

Last updated: 19 August 2022

 

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