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OTC ORAL CONTRACEPTIVE TELEPHONE AUTHORIZATION PROCESS RECOMMENDED

This article was originally published in The Tan Sheet

Executive Summary

OTC ORAL CONTRACEPTIVE TELEPHONE AUTHORIZATION PROCESS RECOMMENDED as a potential mechanism for dispensing over-the- counter oral contraceptives by James Trussell, Woodrow Wilson School of Public and International Affairs, et al. in the August issue of the American Journal of Public Health. Trussel et al. suggested that a toll-free number could be established with a "nurse available to administer a knowledge inventory and discuss the decision with a woman before authorizing a pharmacy to dispense oral contraceptives." The toll-free number is one of several options proposed by the authors to enable over-the-counter marketing of oral contraceptives. Trussell et al. suggested, for instance, that OTC OCs be "managed by pharmacists" who can "ensure that a woman understands contraindications and instructions for use before she is eligible to purchase oral contraceptives" without a prescription. Trussell et al. also proposed creating a "fax or mail-in order form requiring answers to a self-administered questionnaire" before women would be "licensed" to purchase OCs over-the-counter. In addition, the authors propounded that labeling could be developed to indicate that the OTC purchase of OCs is not intended for first-time users. Finally, "over-the-counter purchase of oral contraceptives could be allowed with no restriction," the authors concluded. Regarding packaging of potential over-the-counter versions of the Pill, the public health researchers suggested that all oral contraceptives could be packaged in an "identical 28-day format," thereby eliminating the confusion of having both 21- and 28-day packages. Also, "the most important rules for compliance and the chief danger signals [for OCs] could be stamped into the plastic packaging," Trussell et al. continued, "along with a reminder to conduct breast self-exams while taking the placebo pills." The article maintains that current prescription labeling for oral contraceptives "should be revised so that it is easily comprehensible and legible, and careful studies should be conducted to determine what women actually learn from" the labeling. The authors concluded that OC labeling should be available in English, Spanish and "other prevalent languages," and should include "toll-free telephone access to a nurse able to answer questions about safety and efficacy." Noting that many critics of allowing OCs over-the-counter cite various safety and efficacy issues when arguing against the idea, Trussell et al. declared that safety and efficacy "concerns are no longer sufficient to justify maintaining the current level of clinical control over a woman's contraceptive selection." While they acknowledged that Pill efficacy could decline if women are not required to have a clinical examination prior to obtaining OCs, Trussell et al. argued that "costly" physician visits and accompanying telephone calls for refills act as deterrents to obtaining "this inherently effective contraceptive." Moreover, Trussell et al. maintained that despite physical exams and their attendant counseling, improper use of OCs is widespread. Drug interactions, vomiting and missed pills are the most common problems affecting Pill efficacy, they noted. Trussell et al. acknowledged other common arguments against OTC OCs, such as that some women might have or develop conditions that would preclude the use of OCs but would nevertheless take the Pill because they would not be apprised of the risks normally discussed during regular gynecological exams. Trussell et al. asserted, however, that "the health benefits of increasing the availability of this highly effective method of contraception by distributing it over-the-counter outweigh the possible health costs." In general, the current contraindication screening process for prescription oral contraceptives consists of a medical history that the patient provides herself, measurement of blood pressure and a breast exam, Trussell et al. said. A Pap test is also commonly provided, although most clinicians prescribe OCs before the test results are received, they added. The authors cited a Mexican study that found that women are able to screen themselves for contraindications "just as accurately as clinicians screened them." Pharmacies also commonly provide blood pressure screening, Trussell et al. noted, and women can perform a breast self-exam with "appropriate instruction prior to using oral contraceptives." Acknowledging that oral contraceptives may never be available over-the-counter, Trussell et al. offered alternatives to current criteria that must be met before a woman can obtain a prescription for the Pill. They suggested, for example, that the pelvic exam could be eliminated or that only an initial exam could be required. Similarly, at a May meeting of FDA's Fertility and Maternal Health Drugs Advisory Committee, the committee recommended that prescription oral contraceptive labeling be changed to allow deferral of a physical examination at a patient's request and if judged appropriate by a physician ("The Tan Sheet" May 24, p. 5). If adopted by FDA, the advisory committee recommendation could remove one of the barriers to switching oral contraceptives to over-the-counter status. Although a meeting of the fertility/maternal health committee to discuss the possibility of OTC OCs was canceled earlier this year, FDAers have indicated that the idea is still being considered and may be the subject of a future joint meeting of FDA's Nonprescription Drugs and Fertility and Maternal Health Drugs Advisory Committees ("The Tan Sheet" March 29, p. 3). In addition to eliminating the physical exam, other ways to provide easier access to the Pill, Trussell et al. outlined, include "refill options" that would allow a "woman to refill her prescription when she is not near her pharmacy," and allowing an over-the-counter "emergency purchase of a miniature package" of OCs so that women could continue their contraception schedules if a clinician visit cannot be scheduled in time. In an accompanying editorial, David Grimes, MD, San Francisco General Hospital, echoed the argument of Trussell et al. that restricting oral contraceptives to prescription-only status does not improve the safety or efficacy of the Pill overall. "The hypothesis that the costs of 'medicalization' of oral contraceptives outweigh the benefits deserves to be tested in randomized controlled trials," Grimes asserted. "Until these trials have been performed," he said, "the distinction between protection and paternalism remain fuzzy."
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