NACDS lauds prevention of ‘personal importation’ of prescription medications
ALEXANDRIA, Va. — Following the Senate’s defeat of a proposal that would have permitted “personal importation” of prescription drug medications, the National Association of Chain Drug Stores lauded the Senate’s decision to support patient safety.
During debate of the Prescription Drug User Fee Act on Thursday, Sen. John McCain, R-Ariz., proposed an amendment that would have allowed an individual — not in the business of importing a prescription drug — to import prescription drugs from Canada. NACDS warned that such action would lead to the sale of reimported drugs on websites not associated with licensed pharmacies, further jeopardizing patient safety.
“We thank the Senate for its leadership in protecting patients,” NACDS president and CEO Steve Anderson said. “NACDS shares the goal of reducing the cost of prescription drugs. However, we do not believe that patient safety can be ensured under a prescription drug reimportation system.
"In addition to questions concerning the safety and effectiveness of imported drugs, individuals who obtain medications through personal importation are less likely to benefit from the professional services of their local, licensed community pharmacist,” Anderson said. “Community pharmacy offers various patient services including screenings, health education and wellness programs, vaccinations, and medication therapy management services to help patients understand the importance of taking medications as prescribed — all of which can help patients live healthier and reduce overall healthcare costs.”
Following Senate passage of the bill this week, the House will vote on their version of PDUFA as early as next week. The Senate and House will work to reconcile their respective versions next month. NACDS stated that, throughout this process, it will continue to work with lawmakers to ensure the health and safety of patients served by community pharmacy.
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.