MAULDIN, S.C. — By September of last year, a new category of drug had emerged: over-the-counter medicines that do not require a prescription but still call for the intervention of a pharmacist or other retail employee. With the passage of the federal Combat Methamphetamine Act, part of the Patriot Act renewal in March 2006, retail sales restrictions on the ingredient pseudoephedrine were enacted, limiting the amount that can be purchased. On Sept. 30, 2006, final provisions of the act went into effect. Retailers now must place products containing PSE behind the pharmacy counter or in a locked case, request identification of the customer wishing to buy the product, and maintain a log of customer purchases of PSE. In the same month, the emergency contraceptive drug, Plan B, from Barr Pharmaceuticals, Woodcliff Lake, N.J., began hitting shelves as an OTC product for women at least 18 years old. Still, the U.S. Food and Drug Administration mandated that it be sold from behind the pharmacy counter and remain prescription-only for women 17 and under. As a result, retail pharmacists were faced with added duties as well as increased chances to connect with their customers. SN asked Curtis Hartin, senior director of pharmacy at Bi-Lo here, about how these drugs are contributing to the changing role of retail pharmacists and the possibility that more medications may be distributed this way in the future.
SN: What drug characteristics require retail involvement for the sale, although not necessarily a prescription from a doctor?
CH: There are two major reasons for limiting sales of over-the-counter products to pharmacies: prevention of abuse and requirement of professional consultation by a pharmacist prior to the sale to ensure proper use of the product. At this time, in the markets we serve in the Southeast, pseudoephedrine products and Plan B are the only OTC products required to be sold in the pharmacy. However, I expect that this list will grow in the future. For example, dextromethorphan, a cough suppressant found in many OTC cough remedies, is under legislative scrutiny because of its abuse. It is likely these products will fall under sales rules similar to pseudoephedrine.
SN: Are there any other products that seem to be strong candidates for behind-the-counter sales?
CH: Other products that could require professional consultation prior to sale would be cholesterol-lowering statins [under consideration for OTC switches]. This restriction would ensure that patients understand appropriate use of the products and the importance of regular monitoring for proper dosing. Conceivably, the pharmacist could be in a position to order blood tests or require the patient to present test results prior to selling the medication. Also, a new weight-loss product scheduled for the market this summer is Alli [from GlaxoSmithKline, Philadelphia]. This product, while not requiring a prescription or to be sold in a pharmacy, presents another opportunity for pharmacists to counsel patients on its proper use, discuss expected outcomes and offer support to improve the likelihood of successful outcomes. We will stock this product in our pharmacies to provide our pharmacists and patients those opportunities.
SN: Retail pharmacists have recently taken a more active role in the health care of patients. On one hand, for-profit counseling can offset money lost from lowered Medicaid drug reimbursement rates. On the other, Medicare has made it possible for insurers to reimburse pharmacists counseling Medicare patients. Do these drugs contribute to that effort?
CH: Recently, the pharmacy profession has found it necessary to demonstrate its value as a service provider, as opposed to a product provider, in order to augment its revenue streams. While the payer community [employers, PBMs, government] appears to be slowly gaining acceptance of this concept, the public has been insulated from the argument. Sales of selected OTC products at a pharmacy provide tremendous opportunities for pharmacists to further engage their patients and thus demonstrate the value of their expertise in achieving valuable positive outcomes of medication therapy. Savvy pharmacists already understand this concept and use these “pharmacy only” transactions as engagement opportunities to gain and retain pharmacy customers. The challenge for the profession remains, however, in progressing from proving the value of its role in providing services to receiving payment commensurate with that value.
SN: Is there still marketing potential for PSE products because of the relative ineffectiveness of their replacements, or are regulatory requirements too daunting for consumers?
CH: Although not nearly what they used to be, sales of these products continue because they are effective.