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ACR Releases Position Statement on Pharmacovigilance
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The American College of Rheumatology has recently issued a position statement on pharmacovigilance, highlighting the importance of monitoring new drugs for the treatment of rheumatic diseases once they are on the market, according to a press release.
To demonstrate the ACR’s support for the safe use of medications by both clinicians and patients, the statement consists of five specific positions, according to the release. These include:
- an emphasis on pharmacovigilance;
- further development by the FDA of the Sentinel System, an interconnected system that uses information from a variety of databases to monitor reports of adverse events as they occur;
- the need for health care providers to actively monitor and use the reporting system MedWatch;
- the need for full product information to be submitted when reporting adverse events related to biologics so that at-risk populations; and
- an increase in the availability of user-friendly patient reporting systems so that patients can immediately report adverse effects.
It is especially important to continue to use the FDA’s naming guidance to provide the most detailed drug information possible and to track information — the ACR suggests using lot numbers — regarding medications frequently given approval for the treatment of rheumatic diseases, such as new biosimilars, according to the release.
“Most new medications are approved for marketing after only a limited period of testing on a relatively small group of patients,” Donald R. Miller, PharmD, FASHP, member of the ACR’s Committee on Rheumatologic Care and co-author of the position statement, said in the release. “This statement puts us on the 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.”