Guidelines For Reporting Drug Reactions
Adverse reactions are an important part of the drug research process, revealing potential dangers with drugs that can be serious enough to end drug trials. For this reason, the FDA has created guidelines for reporting these reactions. There is always the risk of adverse events (AE) in the performance of clinical trials. These AEs are recorded and reported throughout the clinical trial. As a result of having to report AEs, a system of grading has been developed by the FDA in order to classify these events and properly report them (FDA, 2015). The FDA grading system for AEs are as follows:
Grade 1 Mild AE- Example: Dryness of Mouth
Grade 2 Moderate AE- Example: Irritated skin in small patches
Grade 3 Severe AE- Example: Blurred vision
Grade 4 Life-threatening or disabling AE- Example: Paralysis
Grade 5 Death related to AE- Example: Drug causes death or injury resulting in death (FDA, 2015).
This grading system works on the basis of having the researcher grade the AE as it occurs. It is the responsibility of the researcher to use his or her professional medical judgment to properly classify the AE. For example, a small amount of skin irritation would likely be categorized as a mild to moderate AE.
AEs must be reported to both the sponsor and the IRB. Grade 3–5 AEs should be reported immediately and the researcher should wait for direction as to whether the study should continue. If the danger of the AEs appears to be imminent the researcher can use his or her discretion to stop the study.
In cases of Grade 1–2 AEs, researchers can use their discretion and report these at a later time. No matter which country the trial is taking place all AEs must be reported to the country where the drug is registered. Failure to report AEs can have serious consequences.
FDA. (2015). FDA Adverse Events Reporting System (FAERS) Electronic Submissions. Retrieved from Food and Drug Administration: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm115894.htm