Pharmacists can help dispel patient confusion about drug safety, efficacy
WHAT IT MEANS AND WHY IT’S IMPORTANT — The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don’t take their drugs as prescribed, or don’t take them at all.
(THE NEWS: CVS Caremark-sponsored research finds FDA drug warnings can fuel medication nonadherence. For the full story, click here.)
It doesn’t help that Food and Drug Administration advisories and warnings, while usually mentioning specifically whether patients should or shouldn’t continue using a drug based on new study findings, often get enough play in the news media to sow doubt about the drugs people take.
Comedian Jeff Foxworthy has a routine in which he advertises a fictional drug called Flora-Flor, for itchy, watery eyes. Flora-Flor, he says, imitating the reading off of possible side effects required by law in drug advertisements, can cause everything from nausea and vomiting to low resale value on your home and feline leukemia. Well, he concludes, it would probably be better to just have itchy, watery eyes. While the CVS Caremark study focused on FDA communications regarding drug efficacy in which safety issues were not mentioned, Foxworthy’s routine shows how pervasive fears of side effects can be among consumers.
While news media reporting on FDA communications have a responsibility to disseminate them to the public accurately, and the FDA itself has a responsibility to make its communications clear and understandable, pharmacists also can step in and ensure that patients have all the information they need. When the FDA reports that a drug may not be effective in certain patients, may interact in adverse ways with other medications or may cause serious side effects according to data submitted through its warning system or found in a clinical trial, pharmacists can take the initiative to talk to their patients and ensure they have a complete understanding of the issue and know what their options are if they become uncomfortable taking their current therapies.
Bayer HealthCare submits approval application for colorectal cancer drug
SOUTH SAN FRANCISCO, Calif. — Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.
Onyx Pharmaceuticals announced that Bayer HealthCare had submitted a regulatory approval application to the Food and Drug Administration for regorafenib in patients with metastatic colorectal cancer.
The drug is a Bayer compound, and Onyx will receive a royalty based on global net sales of the drug for cancer. The regulatory submission was based on a 760-patient, phase-3 study conducted in North America, Europe, China, Japan and Australia, results of which were presented in January at a symposium of the American Society of Clinical Oncology and will be presented at ASCO’s annual meeting in Chicago next month.
FDA panel declines to recommend new approval for J&J anticlotting drug
RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.
J&J subsidiary Janssen Research & Development said the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.
The FDA is not required to follow the recommendations of advisory committees, but usually does. Xarelto already is approved for reducing the risk of blood clots in patients who have had knee or hip replacement surgery and for reducing the risk of strokes and other blood clots in certain people with atrial fibrillation.