Generic drug safety labels often contain incorrect information, study finds
INDIANAPOLIS — More than two-thirds of generic drugs carry safety warning labels different from those of their branded equivalents, according to a new study.
Researchers at the Regenstrief Institute, a research organization supported by the Regenstrief Foundation and located on the campus of Indiana University Purdue University Indianapolis, reviewed 9,105 product labels for more than 1,500 drugs available on the Food and Drug Administration’s and National Library of Medicine’s online labeling information repository DailyMed. Of more than 1,040 drugs with more than one manufacturer’s label, 68% had discrepancies within their safety information.
Using a software program they developed, the researchers found that most of the generic showed relatively small differences, but 9% showed differences of more than 10 side effects, and other errors included out-of-date information, incomplete data and one that had information for the wrong drug. The study was published online in the journal Pharmacoepidemiology and Drug Safety and will be published in the print edition as well.
"Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions," lead study investigator and Indiana University professor of medicine Jon Duke said. "They need to know about side effects, drug interactions and other safety issues. We found that generic drug labels may contain incomplete or incorrect safety information. Until this problem is resolved, physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug."
Most prescribers would pick biosimilar RA drugs
BURLINGTON, Mass. — A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.
Market research firm Decision Resources found that about 80% of current prescribers of Johnson & Johnson’s and Merck’s Remicade (infliximab) and Rituxan (rituximab), made by Biogen Idec and Roche, would prescribe biosimilar versions, but about half of them said they would prescribe biosimilar versions only if a patient requests it or insurance plans demand it, and most do not plan to prescribe the branded versions to patients who fail treatment with the biosimilars.
At the same time, half of commercial plans that cover the branded drugs will not likely cover biosimilar versions of either drug by 2015, while only one-third of Medicare Part D plans that cover Remicade and Rituxan would exclude biosimilars.
Seeing the real value of pharmacists and NPs
Beyond those in the health professions, forward-thinking healthcare advocates and pharmacists themselves, who in this country believes in the power of pharmacy to improve access to patient care, lower health costs and help Americans prevent or better manage diseases? Add the editors of the New York Times to the growing list of believers.
On Saturday, the New York Times ran a lengthy editorial touting the obvious benefits that pharmacists, nurse practitioners and retail clinicians can bring to an overstretched healthcare system facing an acute shortage of primary care physicians. The article pointed out that the shortage will become even more critical once the Patient Protection and Affordable Care Act expands health coverage to millions of currently uninsured patients.
“Expanding medical schools and residency programs could help in the long run,” the New York Times noted. “But a sensible solution to this crisis — particularly to address the short supply of primary care doctors — is to rely much more on nurse practitioners, physician assistants, pharmacists, community members and even the patients themselves to do many of the routine tasks traditionally reserved for doctors.”
It’s the kind of long-overdue recognition from a nationally respected news source that retail pharmacy advocates like the National Association of Chain Drug Stores, the National Community Pharmacists Association and Drug Store News have long sought. Even better, the editorial noted an opinion issued last year by the United States Public Health Service: that “pharmacists are ‘remarkably underutilized’ given their education, training and closeness to the community.”
The editorial in the nation’s premier “newspaper of record” signals the kind of sea change going on nationally in Americans’ perception of the pharmacy profession and its role in a smarter, more connected and more cost-effective health delivery system. But has the message truly filtered down into local communities across the United States? What about your community? Are local physicians’ practices, hospitals and patients themselves looking to the community pharmacist to help relieve the doctor shortage, cut health costs and improve access to care? Comment below to let us know.