Public Release: 

American College of Rheumatology issues position statement on pharmacovigilance

American College of Rheumatology

ATLANTA - The American College of Rheumatology has released a position statement (https://www.rheumatology.org/Portals/0/Files/Pharmacovigilance-Position-Statement.pdf) on pharmacovigilance emphasizing the need for the continued monitoring of new drugs once they are introduced to the market. As new medications like biosimilars are developed and approved for the treatment of rheumatic diseases, the ACR acknowledges the need for detecting and reporting adverse events, by both clinicians and patients.

"Most new medications are approved for marketing after only a limited period of testing on a relatively small group of patients," said Donald R. Miller, PharmD, FASHP, member of the ACR's Committee on Rheumatologic Care and co-author of the position statement. "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."

The statement contains five positions, including ACR support for:

  • Robust pharmacovigilance to ensure the safety of drugs used in rheumatologic treatments.

  • Continued development of the Sentinel System by the Food and Drug Administration (FDA), which is an interconnected system that relies on information from existing databases to monitor reported adverse events in real-time.

  • Active monitoring by healthcare providers and the use of MedWatch, a reporting system used by physicians and patients that communicates to the FDA's Adverse Event Reporting System (AERS).

  • Submitting full product information when reporting adverse events related to biologics, including biosimilar suffix, lot information and indication for using the drug. Complete reporting can help identify potential at-risk populations for specific effects.

  • Readily available and user-friendly patient reporting systems, making it easier for those taking medications to immediately report any spontaneous adverse effects that occur.

Through pharmacovigilance measures, the FDA extends testing into the post-marketing phase, which allows for individual adverse events to be recorded as well as aggregated data collected through connected databases.

Tracking information about new biosimilars is particularly crucial, as these medications continue to receive approval for treatment of rheumatic diseases. The ACR advocates for lot numbers to be used for tracking purposes, in addition to the FDA's naming guidance, providing the most detailed drug information available.

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About the American College of Rheumatology

The American College of Rheumatology is an international medical society representing over 9,600 rheumatologists and rheumatology health professionals with a mission to empower rheumatology professionals to excel in their specialty. In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit http://www.rheumatology.org.

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