Pharmacy and Law: Women's Issues
If one mentions women's health, people think of hormone replacement therapy, mammography, osteoporosis, cardiovascular risk, and so on. If one mentions litigation and women's health, the transformed list focuses almost exclusively on reproductive health: pregnancy, birth complications, emergency contraception (EC), abortion, and minors' treatment access and decision rights.
Social, religious, and political perspectives often overshadow medical safety concerns when elected representatives promulgate laws and statutes affecting women's health. Changing political landscapes often invite legal challenges and amendments, creating increasingly complex demands on health care providers. In any given year, several states are likely to mandate additional informed consent, counseling, and drug utilization review requirements, many directed at pharmacists. Some of the most salient examples are seen in laws affecting women's reproductive choices.
RU-486's 1988 approval in France generated unprecedented controversy. Although its manufacturer attempted to withdraw RU-486 from the market, France's minister of health insisted that it remain as "the moral property of women." The United States banned this abortifacient's importation until 1996, and in September 2000 the FDA approved mifepristone (Mifeprex; Danco Laboratories). Americans concerned about its adverse events, contraindications, and indications threatened to boycott pharmacies and companies associated with RU-486. One state's legislature attempted to exempt pharmacists from dispensing RU-486 if they invoked a conscience clause.1 Today this is a moot point; pharmacists must refer patients who have questions to physicians who have a signed provider agreement with the manufacturer, because mifepristone is not available in pharmacies.
The deregulation of EC (the "morning-after pill") is second only to that of RU-486 in terms of debate (see also "Emergency Contraception: Just the Facts," page 60). Plan B (Women's Capital Corp) and Preven (Barr Laboratories) are the only 2 FDA-approved EC agents. Most oral contraceptives taken in specific doses also are effective, but their EC use is off-label, causing prescriber reluctance to employ them.2
Women's knowledge of postcoital pregnancy prevention has increased from 41% in 1997 to 68% in 2003, and so too have demands for easy EC access.3 In 2003, an FDA advisory panel recommended OTC status for Plan B, including its sale to females older than age 16. Supporters of OTC status cite the need to use EC within 72 hours of intercourse? which can be a challenge on weekends or in rural settings. The FDA had been expected to rule on this question in February 2004, but it delayed action for 90 days to review additional information regarding access by minors.4
Under debate was the potential impact on minors' sexual behavior. On May 6, 2004, the FDA ruled that the manufacturer of EC (Barr Pharmaceuticals) must either prove in additional studies that young women can understand the product without physician advice or ensure that young women cannot get the product from the shelves.
Five states (Alaska, California, Hawaii, New Mexico, and Washington) allow women access to EC without a prescription through collaborative agreements. Their dispensing, counseling, and documentation procedures differ. Most restrict men's access to EC, limiting it to women. Access usually occurs "at the counter" with an authorized pharmacist. Because some women confuse RU-486 (an abortive agent) with EC (a preventive process), detailed counseling requirements often accompany informed consent.
Pharmacists who fail to meet dispensing and counseling requirements may face litigation. The Table presents several legal requirements existing in 1 or more of the states that allow EC access. As other states consider legislation, similar requirements will follow.
Attorneys actively solicit people who may have been harmed by teratogenic agents, such as thalidomide (Thalomid; Celgene) or isotretinoin (Accutane; Roche Laboratories). In lawsuits, they target inadequate patient counseling, noncompliance with manufacturer's dispensing requirements, and/or lack of informed consent. Although the media have publicized extremely potent teratogenic agents, informed consent and counseling are critical for any possible teratogen.
Isotretinoin's complex informed consent is a well-planned example. Isotretinoin's association with birth defects, depression, and suicide prompted revised inflexible dispensing guidelines in April 2002. Pharmacists must do the following:
- Fill only prescriptions affixed with a yellow self-adhesive Accutane Qualification Sticker
- Dispense a maximum 30-day supply
- Refuse refills
- Consider prescriptions for females unfilled after 7 days expired
- Honor only prescriptions written by physicians authorized by Roche Laboratories
Additionally, the patient or a guardian must complete a 3-page informed consent document, initialing understanding of 12 issues. Female patients must have 2 negative urine pregnancy tests before treatment, as well as additional pregnancy tests with subsequent prescriptions. Women also must sign an informed consent form containing a warning about the risks of birth defects, should pregnancy occur.7
Equally stringent informed consent and counseling guidelines apply to thalidomide, approved for Hansen's disease but used for other disorders (eg, AIDS-related wasting, cancer). Female patients must not be pregnant, and, beginning 1 month before the first dose and continuing until 30 days after the last, they must use 2 effective birth control methods. Pharmacists must counsel men who can father a child to use condoms.8
HIPAA and Minors
The general principle of the Health Insurance Portability and Accountability Act (HIPAA) for minors appears simple: people having a right to make health care decisions also have the right to control access to information associated with that decision.9 Many states permit minors over age 13 to access pregnancy-related services, mental health services, and sexually transmitted disease treatment. Minors hence control information release. HIPAA, however, allows state laws on parents' access to information to preempt federal laws.9
More than 1 pharmacist has been approached by an irate parent who finds a prescription for oral contraceptives and demands answers. Pharmacists need a familiarity with state law before releasing or withholding a minor's information. Some state laws permit providers to withhold information if they believe that information release would endanger the minor (ie, knowledge that the parent has physically abused children). Similarly, most states mandate that providers notify appropriate authorities if they suspect abuse and neglect. Finally, pharmacists should warn minors who use an insurance card that parents may have access to information if the parent is the cardholder.
Most experts believe, for example, that EC is safe and that its accessibility over the counter or "at the counter" will steadily increase, including accessibility to some minors. Pharmacists must keep themselves updated about women's health issues and never assume that last year's laws are current today.
Dr. Zanni is a health systems consultant. Ms. Wick is a senior clinical research pharmacist at the National Cancer Institute, National Institutes of Health. The views expressed are those of the authors and not those of the National Cancer Institute.
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