Merck Global Safety manages a global system for the collection, management and reporting of adverse experience (AE) reports received by Merck worldwide.

Regulations vary by country; however, most countries require drug manufacturers to promptly review AE information they receive from any source, domestic or foreign, relating to their products. In addition, regulations require that manufacturers adopt written procedures for managing and reporting post-marketing adverse experiences. Merck has a custom-designed, computer-based system that stores information received for AEs with Merck products.

REPORTING AN ADVERSE EXPERIENCE IN THE U.S.

To speak with a Merck healthcare professional about Merck products, or to report an adverse experience with a specific Merck product, please call the Merck National Service Center at 800-444-2080. The Merck National Service Center can assist you Monday through Friday from 8 AM to 7 PM ET. Adverse experiences and product-related emergencies can be reported at any time by dialing 800-444-2080.

In accordance with these regulatory requirements, Merck has developed a written procedure to provide personnel worldwide—including all contractors—with a consistent and thorough process for identifying, reporting and processing AEs occurring while patients are using Merck products (but not necessarily due to their use). These procedures cover the reporting of AEs originating in clinical studies and those associated with the use of marketed products. Adherence to these procedures ensures the timely and accurate monitoring of the safety profile of Merck's investigational and marketed products globally.

To report an adverse experience to regulatory authorities, we need minimal information: the name of the Merck medicine involved, an adverse experience, an identifiable patient and an identifiable reporter. In addition to submission of individual adverse experience reports to regulatory authorities, either within 15 days or periodically, we also file aggregate reports (quarterly, twice a year, annually) for as long as we market a medicine or vaccine.

Our Risk Management Safety Teams review all pharmacovigilance data and determine what actions need to be taken with reference to the evolving safety profile of our products. These teams include physicians and epidemiologists who are trained to review this type of data.

It can be difficult to determine the exact cause of an adverse experience because many patients have more than one condition and may be taking multiple medicines. Our pharmacovigilance staff takes great care to make sure that AE reporting is as accurate as possible. We consolidate the data to determine if there are any patterns or signs of problems that need additional surveillance.

Another major safety focus is the ongoing oversight and monitoring of our product labels. Our label-review teams monitor information on our products and work with our product safety teams to develop or update product labeling. Information is then communicated to regulatory agencies worldwide.

Employees responsible for monitoring and reporting adverse experiences undergo rigorous training every other year. New MRL employees — including all contract personnel — working in areas related to clinical research undergo training on Merck's adverse experience policies and procedures when they join the company. All other MRL employees are encouraged to complete the training.