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Contraceptive access issues highlight pharmacists’ role
Requirements for birth control dispensing, decision on nonprescription emergency contraception pending even as more states allow pharmacists to prescribe EC.

Women’s access to hormonal contraception continues to be a hot political issue, and the role of the pharmacist in providing this access is at the center of much of the debate and, sometimes ill-considered, actions. The questions of whether pharmacists will be required to dispense prescriptions for contraceptives regardless of personal moral or religious objections or medical appropriateness and whether a product for emergency contraception (EC) will become available without a prescription in the United States remain unsettled. At the same time, pharmacists are increasingly gaining the authority to provide EC.

On April 1, Illinois Gov. Rod Blagojevich responded to two alleged incidents of women being unable to have prescriptions for EC dispensed at a pharmacy in Chicago by issuing an emergency order requiring “pharmacies that sell contraceptives to fill prescriptions for birth control without delay.” As originally written, the order did not even permit pharmacists to consider contraindications to hormonal contraception or to exercise their rights of conscience, stating only that “if the contraceptive, or a suitable alternative, is not in stock, the pharmacy must order or obtain the contraceptive or … transfer the prescription to another local pharmacy of the patient’s choice or return it to the patient.”

The order, which will be in effect through August, was modified several days later to allow pharmacists to continue to rely on their professional judgment in determining whether a birth control prescription was appropriate. The revision was prompted, in part, by a letter the Illinois Pharmacists Association, APhA, and the American Society of Health-System Pharmacists sent to the governor in which the groups noted that “the order creates a professional dilemma for pharmacists: the requirement to dispense a valid, lawful prescription ‘without delay’ could require a pharmacist to dispense a valid, lawful—but clinically inappropriate—medication ‘without delay’. This requirement conflicts with the responsibilities outlined in the Illinois Practice Act, specifically requiring pharmacists to conduct prospective drug utilization review.”

Following Blagojevich’s lead, a group of federal legislators led by Rep. Carolyn Maloney (D-N.Y.) in the House of Representatives and Sen. Frank Lautenberg (D-N.J.) in the Senate introduced the Access to Legal Pharmaceuticals Act (H.R. 1652/S. 809) on April 14. The language of the federal bills is similar to that of the Illinois emergency order. However, H.R. 1652 explicitly states that pharmacies that employ a pharmacist who “refuses on the basis of a personal belief to fill a valid prescription” is subject to civil fines of up to $500,000 if another pharmacist is not found to dispense the prescription.

In a press release issued as part of June 7 media briefing, Maloney and other bill sponsors noted the proposal is intended to “protect an individual’s access to legal contraception by requiring that if a pharmacist has a personal objection to filling a legal prescription for a drug or device, the pharmacy will be required to ensure that the prescription is filled by another pharmacist employed by the pharmacy who does not have a personal objection.”

The federal proposal attempts to support APhA’s policy regarding balancing pharmacists’ rights of conscience with patients’ rights of access to appropriate therapy. The Association supports pharmacists who choose to “step away” but not those who choose to “step in the way.” This two-part policy supports the ability of pharmacists to choose not to dispense certain prescriptions and the creation of systems to make sure patients are served.

However, as much as the sponsors believe they are balancing the needs of pharmacists and patients, as written, the federal proposal creates a single system that may not work in every situation. The result may be the establishment of a duty to fill.

As clouded as issues relating to prescription birth control are, those surrounding EC are even more unclear. Despite Health Canada’s April decision to grant the single-ingredient EC product Plan B (levonorgestrel) nonprescription status and a long-past deadline to make a final determination regarding an Rx-to-OTC switch here in the United States, FDA has yet to say whether women 16 years or older can get EC without a prescription.

In contrast to FDA’s foot-dragging, several states have made it possible for pharmacists to provide EC under collaborative arrangements with prescribers. Women in Alaska, California, Hawaii, Maine, New Hampshire, New Mexico, and Washington are currently able to get EC directly from pharmacists. This is likely to become the case in several other states before the end of this year. In each state that authorizes pharmacist-provided EC, an opt-in system is in place. No pharmacist is required to dispense EC. Also, in each state, pharmacists must screen patients to ensure that they are appropriate candidates for EC, counsel the women on proper use of the medication, and inform them of the necessity for a follow-up visit to a health care provider.

APhA Director for Federal Government Affairs Kristina E. Lunner shared this information with legislators and family planning advocates during a panel discussion on Capitol Hill on June 8. Lunner’s message to attendees was that “pharmacists are important collaborators when working to advance appropriate patient access to medications. The success of the pharmacist prescriptive authority programs, which authorize pharmacists to prescribe emergency contraception, is evidence of the important role pharmacists can play in helping patients gain access to and make the best use of medications.”

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Contact the writer: Ed Lamb (elamb@aphanet.org), Pharmacy Today

Posted June 9, 2005, 3:45 pm EDT