Direct-to-consumer advertising affects provider/patient relationship
Patients more aware of prescription drugs — Are they better educated?
A young woman enters your office, clutching an ad torn from a popular magazine. She asks for an oral contraceptive (OC) by name. What do you do?
If you are seeing more of those types of requests, you are not alone. Kathy Zubik, CRNP, a nurse practitioner in the student health services facility at Elizabethtown (PA) College, reports an increase in requests for Ortho Tri-Cyclen (Ortho-McNeil Pharmaceuticals, Raritan, NJ). The company received approval in 1997 for use of the drug as a treatment for moderate acne from the U.S. Food and Drug Administration (FDA), and it has marketed the indication.
"I never have had requests as often for a particular brand of OC as with this," Zubik says. "We are a small liberal arts college [1,500 students] and are limited in the number of OCs we can carry here for distribution to students, but I did add Tri-Cyclen to our formulary. It now is the No. 1 choice of mine for new starts.’"
Cynthia Waldron, PA-C, manager of gynecologic services for Planned Parenthood/Preterm of Greater Boston, also notes an upturn in requests, the majority of which are generated by magazine advertising aimed at young women. The effects are troubling, she says. "I have found brand-specific requests difficult to deal with. I do not view OCs in the same manner as choosing a brand of toothpaste, for example."
The ideal scenario is one in which prescribing clinicians choose what they feel is best for patients, she says. "On the other hand, it usually is fine and makes the patient feel satisfied if we can prescribe the pill she requests. It is important to inform each patient, however, that they may not have the favorable experience promoted in the advertisement and that any low-dose OC will give the majority of women a favorable outcome."
Ad dollars redirected
Direct-to-consumer ads have spurred the recent increase in brand-specific requests for prescription drugs. While print consumer pitches for Rx drugs have been on the scene for some time, proposed guidance issued by the FDA in August 1997 allows pharmaceutical companies to more easily broadcast product claim commercials on TV and radio.
That move has caused a dramatic result: Half of all direct-to-consumer advertising dollars spent by pharmaceutical companies during January and February 1998 were directed to television ads, nearly twice the share spent on television last year, according to Scott-Levin of Newton, PA, a marketing information firm.1 Total spending for such advertising reached $139 million during that two months. Last year, pharmaceutical companies spent more than $1 billion on direct-to-consumer advertising, the firm estimates.
The change is making its presence known in providers’ offices. Prior to the FDA guidance, 41% of physicians participating in a national survey observed an increase in patients’ requests for brand name drugs, according to IMS Health, a Westport, CT, pharmaceutical information firm.2 Since the change, 65% surveyed to date have observed an increase in such requests.
With the increase in advertising comes potential for violations of the U.S. Food, Drug, and Cosmetic Act, which regulates provider and consumer prescription drug advertising. According to information posted by the FDA’s Freedom of Electronic Information Office, 125 companies have been cited for violations in 1998. Six were cited specifically for violations connected with contraceptive information they disseminated. (Be sure to read the January Contraceptive Technology Update for an overview of the violations.)
Before the change in FDA guidance, most of the commercials seen on TV were "reminder" ads, says Norman Drezin, RPh, JD, deputy director of the FDA’s division of drug marketing, advertising, and communications in Rockville, MD. Reminder ads are allowed to mention a drug’s name but cannot specifically state its use.3 Another form of advertising, the "help-seeking ad," does not give a brand name but only mentions that treatments are available. Those types of commercials, which Drezin characterizes as "see your doctor" ads, cannot state or imply the name of a product but are allowed to mention the manufacturer’s name.
By federal law, prescription drug ads that make product claims must contain certain information about the drug’s side effects, contraindications, and effectiveness. Known as the "brief summary," such information has been addressed in print ads by including the risk-related sections of drug labeling along with the advertising copy. Providing the same level of information in a 30- to 60-second broadcast advertisement, however, can be a daunting task, given the time and format constraints.
As consumers have become more involved in their health care, they have sought increased information on prescription drugs. Due to the confusion caused by broadcast ads held to such statements as "There’s treatment for [fill in the blank] — see your doctor," the FDA issued a draft guidance for public comment in August 1997.
The proposed guidance, which companies are now using to produce broadcast advertising, call for the manufacturer to ensure easy access to full product labeling in lieu of the brief summary.4 Companies can provide access through a variety of means, such as offering a toll-free number for consumers to get product information by mail, fax, or phone; referring to print ads or a Web address that carry the brief summary of the product labeling; or referring consumers to health care providers for more information.
In a product claim ad, fair balance of information is important because of its impact on a consumer, stresses Drezin. "Prescription drugs are not magic bullets; they do have side effects, and they are not for everyone. Consumers need to understand that these are drugs, and they do have effects. Some of them you want, and on the other hand, there are some you may not want. Checking with their provider is the most important point."
While a national survey of physicians shows 71% believe consumer ads pressure providers to use medications they may not ordinarily, 60% agree it encourages patients to take a more active role in their health care.5
How can providers handle brand-specific requests if their formularies don’t include the drug in question, or patients’ insurance only covers certain brands?
In Hawaii, the major insurance carrier covers just four OCs, says Rick Williams, MD, medical director of the Women’s Clinic in Pearl City. The choices usually are Loestrin 1/20 (Parke-Davis, Morris Plains, NJ), Tri-Levlen (Berlex, Wayne, NJ), Desogen (Organon, West Orange, NJ), and one other. If patients come in with a specific request for the "acne pill" or Ortho Tri-Cyclen, he uses this strategy: "Since the promotion talks about acne, I tell them that Deso gen is just as good as any Ortho product. For patients without insurance, I prescribe Zovia 1/35 [Watson Laboratories, Corona, CA], which is kind of like generic Demulen."
Direct marketing can be classified as neither "good" nor "bad" in that it has aspects of both, observes Constance Songer, CRNP, RNC, a nurse practitioner at Gettysburg (PA) College’s Health Center. As a health care provider, Songer says she likes using the teaching opportunities to point out the pros and cons of the advertising in question, as well as why a particular drug may or may not be appropriate for an individual patient. There are pitfalls as well, she points out.
"There are those few patients who are convinced that the marketing information is indisputably accurate and that providers are uninformed if they disagree with the patients’ requests," Songer says. "These patients would probably be difficult anyway, but direct marketing has added to their confusion and fear and our stress level. It is important to me to dredge up that last iota of patience and diffuse both."
Williams uses patients’ questions on specific pills to educate women on the non-contraceptive benefits of oral contraceptives. (See his patient handout on OCs, enclosed in this issue, or visit his Web site: http://www.rickmd.com.) He says consumer advertising can only bode well for providers. "Informed consumers are ultimately better for the provider. It does take more time, but that is time well spent."
References
1. Petersen C. Television ads grab lion’s share. DTC Times. July 1, 1998:10.
2. IMS Health press release. IMS Health forecast direct- to-consumer advertising of pharmaceuticals to rise 50%. Westport, CT; July 9, 1998.
3. Nordenberg T. Direct to you: TV drug ads that make sense. FDA Consumer 1998; January-February.
4. U.S. Food and Drug Administration press release. FDA to review standards for all direct-to-consumer Rx drug promotion: New guidance for prescription drug TV and radio ads first step. Rockville, MD; Aug. 8, 1997.
5. Lipsky MS, Taylor CA. The opinions and experiences of family physicians regarding direct-to-consumer advertising. J Fam Pract 1997; 45:495-9.
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