DRUG INDUSTRY EFFORTS TO COMMUNICATE WITH PATIENTS SHOULD FOCUS ON EDUCATION AFTER PRESCRIPTION IS DISPENSED, FDA COMMISSIONER KESSLER TELLS NACDS

The pharmaceutical industry should focus its efforts to communicate with patients on information after a prescription product is dispensed, not on promotion before it is prescribed, FDA Commissioner Kessler urged the industry at an Aug. 31 session of the National Association of Chain Drug Stores pharmacy conference in Chicago. "There's a world of difference between a pharmacist counseling a patient about a drug and a pharmaceutical firm 'pitching' a product. One is patient education, and the other is promotion," Kessler said. "It would be useful if people with a stake in this issue would shift their attention -- shift their focus from what happens before a drug is prescribed and pay more attention to what happens after." The commissioner urged companies to transform their promotional efforts "aimed primarily at increasing the number of prescriptions written" into cooperative efforts "with pharmacists to help patients derive the greatest benefit from their medications." Kessler credited Upjohn's recent repackaging for the benzodiazepine hypnotic Halcion as "one innovative approach" to informing patients about their drugs. "My guess is that such efforts, including unit-of-use packaging and information leaflets, will grow." FDA asked Upjohn and all other makers of benzodiazepines in November to put their products into unit-of-use packages, relabel the drugs and provide patient package inserts to emphasize short- term use of the sleep aids and proper dosing ("The Pink Sheet" Nov. 25, 1991, p. 11). Similarly, FDA is currently discussing a promotional effort with Marion Merrell Dow to spread information directly to the consumer about the potential interaction of Seldane with erythromycin or ketoconazole ("The Pink Sheet" July 13, p. 9). Turning to the pharmacy profession and its role in patient education, the commissioner praised the pharmacy chain Revco for its practice of dispensing computer-generated, personalized patient information leaflets with its prescriptions. Citing the Revco program as an exemplary use of creative technology to educate patients about their prescription drugs, Kessler said the Youngstown, Ohio-based chain's system is "amazing; it really is the state of the art." Revco's pharmacy computers print out leaflets that are "tailored to the patient in conjunction with counseling," he said. Launched in May 1991 in all Revco stores, the program provides the leaflets free with about 2,200 prescription products. The chain uses IBM hardware, but the software was designed by Revco and uses information from the U.S. Pharmacopoeia's USP/DI compendium of dispensing information for the patient. When a prescription is submitted by a patient and the pharmacist enters it in the electronic patient files, the computer automatically prints out the leaflet on the store's laser printer. The leaflet includes the names of the patient, prescriber, and pharmacist, the pharmacy's telephone number and information on the drug, with specific instructions on the dosage prescribed. More than one year after the launch, Revco says it is still the only large chain that offers such a program. Kessler predicted that such counseling innovations will change the practice of community pharmacies "by the end of this decade," as pharmacists look to improve business, "compete with mail-order" pharmacy, improve patient compliance and "reduce health care costs." FDA, under Kessler, clearly has pharmacy counseling and increased patient information as one of its long-term objectives. Nine months ago, the agency was indicating that it would make a big publicity effort to get more drug use information to the patients. At the New Orleans mid-year meeting of the American Society of Hospital Pharmacy last year, one of Kessler's top aides committed the agency to an "initiative" to promote the distribution of more information to the patient about the appropriate use of medications. While that initiative has not materialized, the agency has been pursuing the objective in a low-key way. It is using praise for programs such as the Revco computer labeling and behind-the- scenes efforts with individual manufacturers to expand patient labeling. When incidences of new major adverse reactions have arisen, the agency has turned to patient labeling and information as a way to correct them. One of the reasons that the agency is being careful about how hard it pushes for patient labeling is the memory of the dispute created by the attempt to require across-the-board patient labeling for prescription drugs in 1979-1980. The agency does not have much to offer pharmacy other than praise and encouragement for taking a lead role in patient information. Kessler told NACDS, for example, that the agency is looking at ways to recognize "the more innovative, state-of-the- art" strategies for patient counseling. As one approach, the agency plans to solicit "nominations for the Harvey Wiley Award specifically to recognize innovations in patient information." The award is named for one of the early FDA commissioners. Asked whether mail-order pharmacies can provide prescription drug information "tailored" to specific patients, Kessler suggested that the quality of service depends on the provider, not the setting. "There are mail-orders and there are mail-orders," just as "there are retailers and there are retailers; they run the gamut," he said. However, Kessler added: "It's one thing to know the pharmacist in your community, and it's another thing to know who's stuffing something in an envelope."