The American College of Rheumatology (ACR) has issued a position statement on pharmacovigilance, underlining its support for continued monitoring of new drugs and their side effects after they have been approved by the US Food and Drug Administration (FDA). This is especially important in the area of biosimilar development, which affects the treatment of several rheumatic diseases.
The statement comprises the following 5 points that the ACR supports related to postmarket surveillance of new drugs approved by the FDA to treat patients with rheumatic diseases:
- Robust pharmacovigilance to support the safety of medications used in rheumatology
- Ongoing development of the Sentinel System by the FDA
- The vital role of healthcare providers in actively monitoring patients for adverse events, and reporting any serious adverse events through MedWatch
- Reporting of full product information, including biosimilar suffix, lot information, and indication for drugs when reporting adverse events
- Pharmacovigilance systems that are readily available and easy to use given the current partial reliance on patients for spontaneous reporting of adverse events.
The Sentinel System refers to the FDA’s Sentinel Initiative, which was launched in 2008. This initiative allows the FDA to electronically monitor postmarket safety events through the agency’s Adverse Event Reporting System. MedWatch is the FDA’s safety information and adverse event reporting program where interested stakeholders can research safety information, report serious problems with human medical products, and receive future safety updates.
“Most new medications are approved for marketing after only a limited period of testing on a relatively small group of patients. 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,” said Donald R. Miller, PharmD, FASHP, member of the ACR’s Committee on Rheumatologic Care and co-author of the position statement.
Biosimilar Does Not Equal Identical
The ACR’s point of emphasis in releasing the position statement appears to center around the reporting of adverse events when patients with rheumatic diseases are treated with FDA-approved biosimilars. The ACR has requested the additional reporting step of including the manufacturer’s lot number in a patient’s medical records for postmarket tracking of any adverse events associated with the use of a biosimilar product, in addition to documenting the specific indication for the drug.
“Due to the complex manufacturing processes of biopharmaceuticals, biosimilars are not identical to their reference products or even between two different biosimilar manufacturers. This may result in differences in adverse events and/or immunogenicity between originator and biosimilar products,” the ACR noted in the position paper.
Given this fact, the organization is recommending that the FDA-required, unique 4-letter suffix be included in the medical record of all patients treated with biologics. It also is advocating for the inclusion of lot numbers for each medication.
Source: American College of Rheumatology website. American College of Rheumatology issues position statement on pharmacovigilance. www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/917/American-College-of-Rheumatology-Issues-Position-Statement-on-Pharmacovigilance. Accessed August 8, 2018.