ACR Stresses Pharmacovigilance and Postmarket Monitoring in the Biosimilar Era

This week, the American College of Rheumatology (ACR) released a new position statement on the importance of pharmacovigilance and the critical need to continue monitoring new drugs after they reach the market.

In a statement, the organization stressed that, with the development and introduction of biosimilars in the rheumatology clinic, the need for both the detection and reporting of adverse events (AEs) is vital. This fact is particularly due to the complex manufacturing process of biosimilars, and the difference in AEs that could theoretically be possible between the biosimilar or reference product.

To ensure the continued monitoring of drugs, ACR supports 5 key positions:

• Thorough pharmacovigilance to support the safety of medications in rheumatology
• Ongoing development of the FDA’s Sentinel System
• Active monitoring and reporting of any serious AEs experienced by patients through MedWatch
• Inclusion of full product information, including the biosimilar suffix, lot information, and indication the drug was being used for in an AE report
• Ready availability of pharmacovigilance systems for patients for spontaneous reporting of AEs

ACR stresses the importance of pharmacovigilance not only at the national level, but the international level as well. The United States participates in a pharmacovigilance program developed by the World Health Organization called the Program for International Drug Monitoring. As of 2016, 127 countries were included in the program.

“Most new medications are approved for marketing after only a limited period of testing on a relatively small group of patients,” said Donald Miller, PharmD, FASHP, co-author of the position statement, in a prepared comment.

“This statement puts us on record of supporting prompt reporting of new and unexpected side effects to the FDA and advocating for more comprehensive systems to observe drug safety in practice.”