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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEPRAMS data gathered in the late 1990’s showed that 42 percent of all pregnancies in Alaska were unintended. A loose coalition, led by an OB/GYN in Anchorage, formed to increase public awareness of and access to emergency contraception. Representatives included members of the State Health Department, Planned Parenthood and other local organizations. Out of this coalition, the Alaska Emergency Contraception Project (AKECP) was created with the mission to improve EC education and access. In April 2001, the Alaska State Board of Pharmacy adopted general regulations permitting pharmacists to establish collaborative practice agreements with prescribers. In Alaska, both physicians and advance practice nurses have prescriptive authority and can sign protocols with pharmacists. The new regulations allowed pharmacists to initiate, modify and discontinue drug therapy under protocol with a prescriber. In the same year, to help promote awareness of EC in the pharmacy community, AKECP arranged for Don Downing, a pharmacist trainer from Washington State, to provide EC training. In April 25, 2002, the Board of Pharmacy approved the first collaborative protocols enabling pharmacists to dispense EC in collaboration with a licensed prescriber. AKECP developed support documents for pharmacists to use including:
In 2003, AKECP began working with Dr. Terry Babb, the President of the Alaska Pharmacists Association and a well-known figure in Alaska’s pharmacy community. His professional work and involvement are essential for pharmacist recruitment and technical support. Early public awareness efforts consisted of various radio public service announcements, and booths at the Alaska Women’s Show, the state fair and other locations. The media also announced that local pharmacies would start dispensing EC after the first protocol was approved. Alaska’s remote, and often extremely isolated, communities present special logistical problems not shared by most states. For example, pharmacists generally receive their EC training through an American Pharmacists Association distant learning program on EC. Parts of Alaska are also deeply conservative which has slowed pharmacist recruitment. Some pharmacists may be hesitant due to real or perceived community backlash and internal pressure. On March 12, 2003 new legislation (SB138) was introduced that would annul pharmacy regulations that allow for collaborative practice. The bill has support from anti-choice legislators. Some physicians are concerned they will be removed from the EC process, and that their concerns were not addressed when the Board of Pharmacy adopted new collaborative drug therapy management regulations. Due to the collaborative efforts of the Alaska Pharmacists Association and the AKECP, the Senate Health and Social Services Committee heard broad opposition from pharmacists and physicians. The bill was only heard once in Spring 2003 and died upon adjournment in 2004. On August 19, 2003, the Alaska State Medical Association (ASMA) filed a lawsuit against the State of Alaska, Division of Occupational Licensing and the Board of Pharmacy for the regulations regarding collaborative protocols. Although ASMA requested an injunction to halt any activity until the suit was heard, a hearing on this is not expected until late 2004. In the meantime, the EC Project is moving ahead: recruiting pharmacies, and gathering data and support for their case. The Alaska Pharmacists Association is currently working to increase awareness among legislators, physicians, and the public on the benefits of collaborative drug therapy management. The advocacy and public education efforts of the Alaska Pharmacists Association and the AKECP appear to be working on multiple levels. Not only is the unfriendly legislation stalled in the Senate, but in February 2004, three additional EC collaborative agreements were approved, bringing the total number of participating pharmacies to fourteen. Seven of these pharmacies are in Anchorage, where half the state's population lives within a fifty-mile radius. Other pharmacies are in Fairbanks, Kenai, North Pole, Sitka, Soldotna and Wasilla. Fourteen may seem like a small number, but only nineteen Alaskan communities have commercial pharmacies. Pharmacies offering this service in Alaska are independents, two large retail chains and a Native Medical Center. At least two additional pharmacies in underserved communities are working on protocols to submit to the Pharmacy Board this spring. In October 2005, the Alaska State Medical Board rejected 4-2 a proposal that would have required women seeking EC to see a physician before obtaining it from a pharmacist. For press coverage in this state, click here.
CONTACTSNancy Davis Elizabeth Smaha, ANP
USEFUL LINKSAlaska Board of Pharmacy Alaska Emergency Contraception Project Alaska Pharmacist’s Association Alaska Legislature Planned Parenthood of Alaska
PROTOCOL ENVIRONMENTOptimal Environment: No Revision to Authority Necessary Existing statutes and regulations would accommodate pharmacists’ initiation of emergency contraception, generally under a collaborative practice agreement (protocol) with a prescriber. Pharmacist initiation of EC requires:
PHARMACY PRACTICE ACTPharmacy Practice Act Regulatory and Statutory Authority Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003. ALASKA Under regulations recently promulgated by the Board of Pharmacy, one or more pharmacists in any practice setting may initiate drug therapy or administer drugs to individual patients or defined classes of patients under a written protocol with one or more active prescribers, if their agreement has been approved by the Board of Pharmacy. The pharmacist is required to show “adequate training” or the Board will require training. The protocol is valid for up to two years, and the authorizing practitioner must review the pharmacist’s decisions at least every three months. The written protocol must identify:
On April 26, 2002 the Board approved the first-ever collaborative therapy agreements: five for emergency contraception, one for pain management, and one for an anticoagulation clinic. In its June 2003 Newsletter, the Board outlined the conditions under which additional agreements can be approved.
A review of the emergency contraception protocols approved by the Board showed that these additional conditions apply:
As of early 2003, the Board had five additional collaborative agreements for emergency contraception pending. Legislation introduced in early 2003 to eliminate collaborative practice authority has not passed. Statutory Authority: Granted in the statutory definitions of “drug,” “pharmaceutical care,” “practice of pharmacy,” “practitioner,” and “administer” in the Pharmacy Act, Alaska Stat. § 08.80 (2002) (Feb., 2003 Board edition) Regulatory Authority: Provided in the section of the Board’s regulations on “Pharmacists Collaborative Practice Authority,” Alaska Admin. Code Title 12, § 52.240 (Feb., 2003 Board edition)
ALASKA STATUTE Pharmacy Act Article 5. General Provisions. Sec. 08.80.480. DEFINITIONS. In this chapter, unless the context otherwise requires (1) “administer” means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or other means; … (9) “drug” means an article recognized as a drug in an official compendium, or supplement to an official compendium; an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; an article other than food, intended to affect the structure or function of the body of man or animal; and an article intended for use as a component of an article specified in this paragraph but does not include devices or their components, parts, or accessories; … (21) “pharmaceutical care” is the provision of drug therapy and other pharmaceutical patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms, or arresting or slowing of a disease process as defined in regulations of the board; … (27) “practice of pharmacy” means the interpretation, evaluation, and dispensing of prescription drug orders in the patient’s best interest; participation in drug and device selection, drug administration, drug regimen reviews, and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for: compounding and labeling of drugs and devices except labeling by a manufacturer, repackager, or distributor of nonprescription drugs and commercially packaged legend drugs and devices; proper and safe storage of drugs and devices; and maintenance of proper records for them.
ALASKA REGULATIONS CHAPTER 52. BOARD OF PHARMACY. 12 AAC 52.240. PHARMACIST COLLABORATIVE PRACTICE AUTHORITY. (a) A pharmacist planning to exercise collaborative practice authority in the pharmacist’s practice by initiating or modifying drug therapy in accordance with a written protocol established and approved for the pharmacist’s practice by a practitioner authorized to prescribe drugs under AS 08 must submit the completed written protocol to the board and be approved by the board before implementation. (b) A written protocol must include
(c) To enter into a written protocol under this section, practitioners authorized to prescribe must be in active practice, and the authority granted must be within the scope of the practitioners’ practice. (d) Unless the board is satisfied that the pharmacist has been adequately trained in the procedures outlined in the written protocol, the board will specify and require completion of additional training that covers those procedures before issuing approval of the protocol. (e) Documentation related to the written protocol must be maintained for at least two years. (f) The written protocol may be terminated upon written notice by the authorizing practitioners or pharmacists. The pharmacists shall notify the board in writing within 30 days after a written protocol is terminated. (g) Any modification to the written protocol must be approved by the board as required by this section for a new written protocol.
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