Monitoring of Adverse Drug Events: Guidelines and Requirements


Adverse drug events are among the leading causes of death from approved pharmaceuticals, and illnesses and deaths from these events cost the healthcare system billions of dollars each year.

As such, the Food and Drug Administration has regulations regarding the monitoring and reporting of them. Keeping track of these events is important because the full adverse drug event profile may not be known when a pharmaceutical is approved.

The consequences of failing to report adverse drug events or reporting them late are severe. The Food and Drug Administration has issued warning letters and prosecuted pharmaceutical companies that have failed to comply.

Pharmaceutical executives should understand regulations and responsibilities regarding monitoring and reporting these events.

The Guidelines Governing Adverse Drug Event Management

The guidelines that govern adverse drug event management include Title 21 Code of Federal Regulations 310.305, Title 21 Code of Federal Regulations 314.80, and Title 21 Code of Federal Regulations 314.98.

These regulations cover approved prescription medications, unapproved prescription medications and approved over-the-counter medications, and prescription medications subject to approval under abbreviated applications, respectively.

Requirements for Reporting Adverse Drug Events

The Food and Drug Administration requires pharmaceutical companies to monitor adverse events and report them before and after a drug is approved. Domestic and foreign pharmaceutical companies must report serious and unexpected adverse drug events to the Food and Drug Administration within fifteen working days of learning of the experience.

They must also provide follow-up information after they provide the initial report. For drugs that are under development, study site should notify a pharmaceutical company within five working days of learning of the experience.

Reports should include the following information:

• Severity and seriousness of the event
• Signs and symptoms associated with the event
• Treatments given for the event
• Outcome of the event
• status of the patient before the event
• Relationship of the event to the drug
• Information on whether the symptoms stopped when (or if) the patient stopped taking the drug
• Information on whether the event recurred after the patient resumed taking the drug
• Information on other drugs that the patient was taking or other medical conditions that could affect the results

Pharmaceutical companies must also provide quarterly and annual reports to the Food and Drug Administration. In these reports they provide updates on adverse events, including those that are serious and expected.

The Responsibilities of Pharmaceutical Executives

In order to assure that adverse drug events are reported in a timely fashion, pharmaceutical executives must ensure that mechanisms to capture the events, such as MedWatch and Council for International Organizations of Medical Sciences forms, are in place and that they capture the appropriate information. They should ensure that standard operating procedures that conform to the regulations are in place.

They must also make certain that personnel involved in capturing and reporting the adverse drug events are trained in these standard operating procedures and regulations. As such, they should work with members of upper management to recruit and train appropriate professionals.

Pharmaceutical executives should also ensure that the quarterly and annual reports are compiled. This could include enlisting the help of professionals to compile the reports, such as medical writers. They should work to ensure that these reports are submitted in a timely fashion. Working with members of upper management and members other departments is critical.


By understanding the guidelines and the responsibilities of personnel regarding the reporting of adverse drug events, pharmaceutical executives can ensure that adverse drug events are monitored and compiled according to the regulations.

This will enable the Food and Drug Administration to monitor the safety of pharmaceuticals more effectively.

Learn more:!po=0.381679

Topics: Process, Regulations, Compliance Consulting