CHPA joins anti-BTC camp
WASHINGTON The Consumer Healthcare Products Association on Wednesday released a statement advocating increased access to over-the-counter medicines and noted that a third-class of drugs did not need to be created to expand access to appropriate medicines.
The flexibility to accomplish that expanded access exists in the two-drug system, today, commented Linda Suydam, president of CHPA. “The last several years have seen a significant number of successful Rx-to-OTC switches across a wide range of therapeutic categories, which have benefited millions of patients with such conditions as migraines, frequent recurring heartburn, vaginal yeast infections and hair loss,” Suydam stated. “Most importantly, flexibility is built in to the existing framework, with sponsors having the opportunity to work with the [Food and Drug Administration] and to design the appropriate tools to address any challenges to that particular medicine,” she said. “Examples of this include informational and support strategies to support the Rx-to-OTC switches of nicotine replacement therapy, orlistat and levonorgestrel.”
CHPA was one of several organizations presenting information Wednesday on a possible behind-the-counter class of drugs during a meeting hosted by the FDA.
“As reflected in our presentation today, CHPA has always advocated for expanded access to nonprescription medicines, and we have made every effort to empower consumers with the additional tools and information needed to make appropriate decisions on OTC use,” Suydam said.
NACDS and NCPA speak out at FDA hearing in favor of BTC classification
WASHINGTON Both the National Association of Chain Drug Stores and the National Community Pharmacists Association are heavily in favor of the creation of a third class of drugs, according to testimony provided by both associations before a Food and Drug Administration panel on the matter here this afternoon, provided that the increased pharmacist-patient interaction a behind-the-counter class of drugs would generate would be duly compensated.
NCPA president Stephen Giroux suggested three reasons behind retail pharmacy’s strong support of a BTC class of drugs—reduced health costs, increased consumer convenience and the potential utilization of BTC as a vehicle in creating a comprehensive post-marketing tool with pharmacist oversight. “Not only are pharmacists the most accessible healthcare provider [out there], pharmacists have the training and the knowledge to [provide drug] interactions,” he said.
“Pharmacists are uniquely qualified to take on this new role,” testified NACDS’ Mary Ann Wagner, but if an appropriate reimbursement model is not included in that new rule, a BTC class of drugs could evolve into a medicine class that limits access to consumers, and similarly has the potential to increase healthcare costs.
As for concerns raised earlier in the day pertaining to the potential draining a BTC class of drugs would have on pharmacy workflow (see “FDA panel hears arguments in BTC debate“), Giroux suggested pharmacists would take that new challenge in stride. And pharmacists may not have a problem accessing comprehensive patient records, Giroux said, especially as e-prescribing capabilities continue to evolve through association backed partnerships such as SureScripts.
Wagner suggested that a BTC class of drugs not be used as a reverse-switch option. “This class should not be used to enforce age” or any other restrictions, she said. The recently legislated migration of pseudoephedrine to behind the pharmacy counter could serve as an example of an inappropriate use of a BTC model—PSE was first BTC because of concerns over diversion, not concerns over product safety.
Likewise, Wagner opined that the BTC class of drugs should not be a layover for a prescription medicine en route to over-the-counter status. Rather, it should be a permanent class of drugs because of the necessity of pharmacist intervention.
Giroux, however, suggested that BTC might indeed become a new waypoint for drug switching from Rx-to-OTC, and appropriately so.
And while Wagner acknowledged that the FDA had little to do by way of establishing a reimbursement-based business model around the proposed BTC class of drugs, that issue could very well be the most crucial question for pharmacy operators. It is possible, she said, that moving drugs from prescription-only to BTC could prompt maintenance care operators to drop those medicines from their drug formularies. “The additional clinical role [of the pharmacist] must be recognized and compensated,” she said.
Liability is another concern for drug store operators, Wagner said, noting that product liability in a BTC model should not necessarily pass from manufacturer to retailer.
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.