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 and vaccines 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 or vaccine 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