FDA panel hears arguments in BTC debate
WASHINGTON Pharmacists representing several pharmacy organizations all advocated the creation of a third class of drugs Wednesday morning before a panel of Food and Drug Administration executives chairing a meeting to consider what issues ought to be addressed in considering a behind-the-counter class of drugs.
Opposed to a third class of drugs were the American Medical Association and the Consumer Healthcare Products Association.
Increased access to comprehensive patient medical records was one need identified by pharmacy if pharmacists were to be intimately involved in the dispensing of a BTC class of drugs.
Much of pharmacy’s support of BTC was centered on the increased access to medication that a BTC class of drugs would create. For example, vaccines could be administered by pharmacists in some 46 states, testified Michael Hogue, speaking for the Institute for Public Health and Pharmacy, but those pharmacists cannot prescribe those vaccines. A BTC class of drugs that included vaccinations would therefore increase access to those vaccines and convenience to the consumer.
Some of the pharmacy organizations expressed a concern that over-the-counter medicines might be inappropriately moved to BPC, limiting access. BTC should be a clinical encounter as opposed to a “policed” dispensing of certain medicines, noted Ed Webb, speaking on behalf of the American College of Clinical Pharmacy, setting the stage for an argument that those clinical consultations ought to be reimbursed, whether by third-party payers or by the patients themselves. That consultation is of some considerable value—increasing compliance and thereby decreasing future hospital expenditures—and should be reimbursed as such.
The American Medical Association was also concerned over the potential reimbursement of those clinical consultations with pharmacists, worrying that managed care might incentivize patients to pursue a cheaper BPC treatment regimen before consulting their general practitioner, a factor that may delay treatment of an undiagnosed condition.
Along those lines, AMA challenged the notion that the pharmacists would even be capable of adequately consulting with their patients on BTC medicines on account of their expertise and training in medicines and lack of expertise and training in the diagnosis of disease. “When a drug is not safe for use without supervision,” AMA’s Joseph Cranston said, “then a physician … should be responsible for the administration of that drug.”
The relationship between a patient’s pharmacists and a patient’s physician ought to be collaborative rather than adversarial, countered Bill Soller of the UCSF School of Pharmacy. “The pharmacist is a coach” in the healthcare paradigm, he said. “This [role] is something doctors should support, rather than oppose.”
AMA also stated emphatically that the whole question of a BTC class of drugs was moot without a change in the Federal Food, Drug and Cosmetic Act. “It is somewhat perplexing to the AMA that the FDA is even holding this meeting,” Cranston said.
CHPA stated its belief that a BTC class of drugs might, in fact, restrict access and increase costs—the current OTC market system helps keep costs down through competition, reported CHPA’s David Spangler. The switch of cough-cold products in the 1970s and 1980s resulted in 100,000 fewer doctor visits per year by the end of the 1980s, Spangler said. When nicotine-replacement therapies switched, use of those products increased three- to fourfold, he added.
And if a BTC class of drugs were created, CHPA charged, that class may both become the default channel into which prescription-only drugs may switch and the channel into which any OTCs with a hint of controversy may be pushed. Indeed, Maria Sulli of the St. John’s University College of Pharmacy suggested that kids’ cough-cold medicines, indicated for children under the age of 6, may be ideal candidates for BTC placement.
Eileen Harley, speaking on behalf of the Food Marketing Institute, advised the FDA panel that the creation of a BTC class of drugs would necessitate considerable capital costs throughout retail pharmacy. Retail pharmacy would need to expand their pharmacy shelf space to incorporate this new class of drugs and, in many cases, would also need to reorganize the overall pharmacy layout in order to incorporate private screening areas where pharmacists could consult with their patients.
The National Association of Chain Drug Stores and the National Pharmacists Association are scheduled to testify before the panel Wednesday afternoon.
CRN study finds many healthcare professionals recommend dietary supplements
WASHINGTON The Council for Responsible Nutrition on Tuesday released the results of its “Life…supplemented” Healthcare Professionals Impact Study, finding that more than three quarters of U.S. physicians (79 percent) and nurses (82 percent) recommend dietary supplements to their patients. The study also found that an almost equal number—72 percent of physicians and 89 percent of nurses—personally use vitamin, mineral herbal and other supplements either regularly, occasionally or seasonally, which is a higher percentage than the 68 percent of adults who report they take nutritional or dietary supplements, the Council noted.
“This survey, which is a first for our industry, shows that healthcare professionals believe that dietary supplements are part of a healthy lifestyle,” stated Steve Mister, president and chief executive officer of CRN. “Not only are they taking supplements for their own benefit, but they’re also recommending them to their patients. The approval of our products from reputable, respectable healthcare professionals, such as doctors and nurses, should be encouraging to consumers who already incorporate supplements into their wellness routine, and a wake-up call to those who haven’t yet started to do so.”
Of the 72 percent of physicians who use supplements, 85 percent also recommend them to their patients; and of the 28 percent of physicians who do not use supplements, three out of five (62 percent) still recommend them.
“It is common sense that physicians who personally take supplements also recommend them to their patients,” stated Donnica Moore, president of the Sapphire Women’s Health Group and a member of the study’s physician advisor team. “It’s interesting that the majority of physicians who don’t use supplements still recognize their patients may benefit from them. Although the study doesn’t provide an explanation, it may simply be that physicians recommend supplements to their patients for specific conditions that don’t apply to the physician’s own personal health.”
The number of physicians recommending dietary supplements to their patients is highest among obstetrician/gynecologists (91 percent), followed by primary care physicians (84 percent). Primary care physicians, OB/GYNs and nurses recommend supplements as often for “general well-being/prevention” as they do for special conditions, while other specialists recommend supplements more often for special conditions.
Almost three quarters of physicians (72 percent) and even more nurses (87 percent) reported they personally ask their patients about their use of dietary supplements. Also, 40 percent of physicians and 43 percent of nurses report that when discussing supplements with their patients, they, not their patients, are the ones who bring up the subject most often.
“Our industry needs to continue this type of research,” noted Judy Blatman, vice president, communications, CRN. “It’s important that we use this as benchmark data, continuing to do these types of surveys to see what trends develop in the upcoming years. … Healthcare professionals are an important audience for our industry and for our consumers and we must continue to be proactive in this area.”
Diabetes is focus of Indiana, Nevada initiatives
INDIANAPOLIS and LAS VEGAS Eli Lilly and the Indiana Health Industry Forum will hold a summit on Nov. 13 called, “Building on Indiana’s Strength in Diabetes Research, Diagnostics, and Therapeutics,” to focus on the development of better therapies and diagnostic technologies for the prevention and management of diabetes.
The IHIF is a not-for-profit organization that works to define factors that can lead to economic development success in healthcare for Indiana and then build programs that support the future of the industry in the state.
The summit will be used to connect Indiana resources for the development of diabetes treatments and diagnostics, as well as identify business collaborations. In addition to attendees from academia and pharmaceutical and biotechnology industries, representatives from Indiana state government, venture capital concerns, clinical research organizations, research service companies and advocacy groups will attend.
Also, today in Nevada, Health Innovations, the Nevada Health Care Coalition and Sanofi-Aventis released a new report on the demographics, costs and quality of care for people with Type 2 diabetes.
The Nevada Type 2 Diabetes Report for 2007 gives an overview of patient demographics, hospital and provider charges, and utilization of clinical services and drug therapy for people with Type 2 Diabetes in key local markets in the state of Nevada. The report also provides benchmarks from Phoenix as well as national benchmarks that can help employers and providers better identify opportunities to serve the needs of people with Type 2 diabetes.