NACDS Cautiously Backs ‘New Paradigm’ for 3rd Class of Drugs

The National Association of Chain Drug Stores (NACDS) has submitted comments to the Food and Drug Administration (FDA) regarding its position on the “new paradigm” for a third class of drugs. The comments were submitted in conjunction with the agency’s hearing, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription.”

In its comments, NACDS emphasized the value of community pharmacies as high-quality, accessible health-and-wellness centers. The Arlington, Va.-based trade association, which represents traditional drug stores, supermarkets, and mass merchants with pharmacies, also stressed the importance of current and future collaboration among health care professionals for the ultimate benefit of patient care and to lower health care costs.

“In recent years, retail community pharmacies have played an increasingly important role in providing patient care,” NACDS said in its comments. “Activities such as the increased number of health screenings provided by pharmacists help educate patients and give them a better understanding of their health status and potential needs. Pharmacists also provide vital patient care through their participating in collaborative practice agreements and their expanding role in providing immunizations. Pharmacists are uniquely positioned and qualified to take on these expanded roles.”

The organization noted that 34 states allow pharmacists to take part in collaborative practice agreements with physicians. These written agreements foster cooperation between a pharmacist or pharmacy and a physician or group of physicians to manage patients’ drug therapy. Under this type of arrangement, pharmacists serve as physician extenders and help to monitor and execute physicians’ drug therapy plans for patients.

Overall, NACDS expressed cautious optimism about the creation of the “new paradigm,” saying it would work with FDA to prevent any unintended consequences of its adoption.

“Structured properly, this new paradigm has the potential to increase access, improve patient compliance, and reduce health care costs,” the association said. “However, a flawed structure could result in a group of drugs with limited access, reduced compliance, and lacking in a clear compensation policy for pharmacies, despite the additional clinical and administrative responsibilities that it would impose.”

One of the most important unintended consequences is the effect on consumers -- and their wallets -- with regard to what may happen when prescription-only medications become over-the-counter medications, and potentially may not be covered by insurance or other third-party payers.

“Costs for some of their medications that were previously covered by their third-party payer might no longer be covered if dispensed under this new paradigm and would therefore be an out-of-pocket cost to them,” explained NACDS. “This may be viewed as a positive for decreasing costs to health care system, but if the patient no longer can afford the product and adherence decreases, the costs associated with poor outcomes and increased hospitalizations and emergency room visits could increase.”

The association also noted the importance of clear guidance on what types of drugs would qualify for the new status, so that medication regimens for patients continue without interruption, as well as medication management counseling between pharmacists and patients for these regimens.

“Consistency and predictability are needed to train pharmacists and other pharmacy staff, determine formulary placement and reimbursement policy, and ensure uninterrupted availability for patient,” said NACDS. “Consequently, NACDS advocates that this new paradigm should be a permanent class for drugs that require special counseling, monitoring, screening, lab testing or other clinical intervention.”

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