Advocating to Ensure Safety

Postmarketing Assessment of New Medications Essential

The Committee on Rheumatologic Care of the American College of Rheumatology has released a position statement calling for “robust pharmacovigilance” to ensure the safety of medications used to treat rheumatologic conditions. Pharmacovigilance is defined by the Committee as “…the science of detection and assessment of adverse effects from drugs, with particular emphasis on effects not recognized prior to licensing.” It is important because new medications like biosimilars are often approved for marketing after only a limited period and scope of patient testing, and the safety profile of the drug may be incomplete. Pharmacovigilance also aids in the identification of bad lots of medication or in detecting other changes to the drug’s safety profile. Coauthor Donald Miller, PharmD, FASHP, commented, “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 advocates for 5 positions including: continued development for the Sentinel System by the FDA to monitor reported adverse events in real time; the use of MedWatch by clinicians to communicate to the FDA’s Adverse Event Reporting System; supplying full product information when reporting adverse effects from biologics, to aid in identifying at-risk patient groups for specific events; furnishing user-friendly reporting systems to patients to ensure their participation in reporting adverse events that occur; and ACR support for robust pharmacovigilance to ensure the safety of rheumatologic treatments.

Read about the ACR initiative.

The position statement may be read here.


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