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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATECheck out Hawaii’s new dedicated EC website, www.echawaii.org The state Department of Health Services will begin to cover non-prescription Plan B for Medicaid recipients effective July 1, 2007. The Healthy Mothers Healthy Babies (HMHB) Coalition of Hawaii is working closely as community contacts/technical assistants with the state Medicaid office and the Director of Hawaii DHS to implement the OTC coverage for Medicaid recipients. HMHB is encouraging DHS to advertise the OTC coverage to all recipients when the change is implemented. HMHB has also recommended no payment caps on the amount of times a woman can obtain EC OTC. According to HMHB, a bill (HB 456) to address the same issue died in committee due to the recent DHS move. The bill would have required DHS to directly reimburse sellers of Plan B OTC to Medicaid enrollees. On June 24, 2003, Governor Lingle signed HB 123 into law (ACT 201), enabling pharmacists who have received appropriate training and who are working in collaboration with a physician, to initiate emergency contraception drug therapy. Hawaii’s successful effort had the backing of a diverse coalition of stakeholders, which was coordinated by the Healthy Mothers Healthy Babies (HMHB) Coalition of Hawaii. For a full account of Hawaii’s policy change click here. For an overview of Hawaii EC access through pharmacies, click here. Healthy Mothers Healthy Babies continues to assess women’s access to EC in pharmacies as well as pharmacists perspectives on stocking, filling and initiating prescriptions for EC. Click here to view the most recent versions of the confidential survey on women accessing EC in pharmacies (PDF-56K) and the survey of pharmacists regarding EC (PDF-48K). ACT 201 amends the definition of the “practice of pharmacy” to allow pharmacists to initiate emergency contraception drug therapy in accordance with a written collaborative agreement approved by the Hawaii Board of Pharmacy, between a licensed physician and a pharmacist who has received appropriate training. On July 17, 2003 the Hawaii Board of Pharmacy formed a working group to research, study and make recommendations to the Pharmacy Board regarding the collaborative agreement. The working group took additional time to solicit comments and recommendations from the public, and included these in the final draft of the collaborative agreement that was submitted to the Pharmacy Board for the Administrative Rules process in September 2003. The current Hawaii Administrative Rules process consists of 16 steps that include a lengthy review process by the Attorney General’s Office, Director’s Office, Legislative Reference Bureau, and scheduling public hearings etc. The proposed language for the Administrative Rules, regarding emergency contraception collaborative agreements, was approved by the Hawaii Board of Pharmacy on November 13, 2003. In early 2004 the rules were sent to the Director’s Office for review by the Director of DCCA. The Director mandated that the Hawaii Medical Association, Hawaii- ACOG Chapter, and the University of Hawaii School of Medicine (among others) review the collaborative agreement. Rulemaking had delayed implementation of the EC program, and the Women’s Legislative Caucus had urged the Department of Commerce and Consumer Affairs and the Board of Pharmacy for a quicker review. The proposed Administrative Rules were reviewed by the Director’s Office, and the Hawaii State Board of Pharmacy/DCCA scheduled a public hearing for Tuesday, September 28, 2004 to hear concerns from the public to determine if the Administrative Rules are to move forward towards implementing ACT 201, or start the process over. Shortly after public concerns were heard, the Hawaii State Board of Pharmacy/DCCA voted to approve the draft Administrative Rules on EC access. A meeting of the EC Policy Committee and EC Access and Awareness Committee was scheduled for December 16, 2004 to plan the implementation of the bill. The agenda includes pharmacist training, physician participation, educational materials, and public awareness strategies. The Governor gave final approval on the Administrative Rules on December 17, 2004, and effective 12/25/04 pharmacists could provide EC under collaborative protocol. There were over 15 individuals, local and national organizations that provided supportive testimony, and a few consumers who testified against the law being implemented. The Administrative Rules will now be forwarded onto the Attorney General and the Governor for signature. Once the final approval is given, Hawaii will begin to implement the new law, which will consist of training pharmacists and signing voluntary collaborative agreements between pharmacist and physicians, and continually building EC awareness and education. Currently the rules state that every protocol must be sent to the Department of Commerce and Consumer Affairs, permit a dispensing interval of 120 hours, and mandate a referral to another pharmacist if the EC pharmacist is not there. In 2002 HMHB formed an EC Workgroup to promote a greater understanding of EC and the public benefits of EC in preventing unintended pregnancy and reducing abortion, particularly in teens. The workgroup had broad representation and in addition to community based organizations, over time it included representatives of the State Department of Health, the Hawaii Women’s Legislative Caucus, Hawaii Planned Parenthood, the Hawaii Women's Coalition and the Hawaii Pharmacists Association. Members of the work group were instrumental in drafting, reviewing and editing HB 123, and this group is now addressing the larger issues of actual implementation. Hawaii developed a standardized EC collaborative agreement protocol that has agreement from major stakeholders, such as the Hawaii Medical Association, the John A. Burns School of Medicine at the University of Hawaii and the American College of Obstetricians and Gynecologists (ACOG) Hawaii Chapter. Once approved, the Board of Pharmacy will post the standardized protocol on a website. The Department of Health will compile signed collaborative agreements on an interim basis, so that information may be collected and used for evaluation/quality assurance purposes. The implementation workgroup is also addressing: pharmacist training, physician training, public awareness and education, as well as pharmacist reimbursement for patient counseling for EC. The University of Southern California conducted training on Maui and Oahu for over 100 pharmacists and other providers in August 2003, and future pharmacist trainings are expected to occur on all islands. The Department of Health, HMHB, and Hawaii Planned Parenthood and other organizations are also assisting in developing educational and promotional materials and referral resources. Both Planned Parenthood and Healthy Mothers Healthy Babies are actively seeking funds to support an integrated EC educational campaign. Meetings are planned to have the Hawaii Pharmacists Association and Department of Human Services as well as other a third party insurers to discuss pharmacist reimbursement for EC counseling. The Hawaii Pharmacists Association is also examining policies to accommodate pharmacist refusal to dispense EC. A variety of organizations, including the Hawaii Pharmacists Association, Department of Health, Kaiser Permanente Hawaii, Hawaii Planned Parenthood and Healthy Mothers Healthy Babies, also plan to be involved in promoting and supporting physicians and pharmacists signing collaborative agreements statewide. In August 2003, the Healthy Mothers Health Babies Coalition of Hawaii surveyed physicians regarding EC. Survey results (DOC-32K) indicated that 62% of providers surveyed are interested in entering into a collaborative practice agreement with a pharmacist. The largest pharmacy chain in Hawaii is Longs. In California, Longs has its own ACPE training program for emergency contraception. It is expected that Longs plans to be actively involved in implementing EC services into its Hawaii retail outlets. Kaiser Permanente Hawaii is also planning to implement EC access in its pharmacies statewide as well. Times, a chain supermarket, has also indicated interest in providing EC services. For press coverage in this state, click here.
CONTACTSCatherine Takauye Karen Mak, MPH, NP Barbara Kashiwabara Les Krenk, RPh Kari Wheeling
USEFUL LINKSHawaii’s Dedicated EC Website Hawaii Board of Pharmacy Hawaii State Legislature Planned Parenthood of Hawaii Healthy Mothers Healthy Babies Coalition of Hawaii
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. HAWAII Under a collaborate practice bill passed in 2002, pharmacists in virtually all clinical settings, health care facilities and community pharmacies were given the authority to provide a variety of patient-care services pursuant to patient-specific protocols developed collaboratively with prescribers, including physicians, surgeons, and registered nurses, and in concurrence with the facility administrator. The pharmacist must receive appropriate training and immunization certification as required by the policies, procedures, or protocols. Those patient care services included, most notably:
The scope of practice is outlined in the protocol, allowing for any drug therapy listed. Institutional pharmacies must identify the route of delivery for medications administered and maintain records for at least five years. On June 26, 2003, the Governor signed into law Act 201 (HB123/SB958) explicitly authorizing pharmacists to “initiat[e] emergency contraception oral drug therapy in accordance with a written collaborative agreement approved by the board [of pharmacy], between a licensed physician and a pharmacist who has received appropriate training that includes programs approved by the American Council of Pharmaceutical Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board of pharmacy.” The statute does not require the protocol to be patient-specific, and it defines “emergency contraception” broadly to include any FDA-approved drug “used post-coitally . . to prevent pregnancy. . .” Finally, the new law expanded the definition of contraceptive services by adding pharmacists to the list of authorized health care providers (including MDs, NPs, RNs, PAs, and nurse midwives) who can deliver contraceptive services. Statutory authority: Provided in the definition of “practice of pharmacy,” 25 Haw. Rev. Haw. Rev. Stat. § 461-1, and related definitions Haw.Rev.Stat. §431:10A-116.6-7, 19 Haw. Rev. Stat. §323D-2, and 24 Haw. Rev. Stat. §432E-1) Regulatory authority: No rules have been promulgated implementing these sections.
HAWAII STATUTE TITLE 25 – PROFESSIONS AND OCCUPATIONS CHAPTER 461 PHARMACISTS AND PHARMACY 19 Haw. Rev. Stat. §323D-2 Definitions. As used in this chapter: “Health care facility” and “health care service” include any program, institution, place, building, or agency, or portion thereof, private or public, other than federal facilities or services, whether organized for profit or not, used, operated, or designed to provide medical diagnosis, treatment, nursing, rehabilitative, or preventive care to any person or persons. The terms include, but are not limited to, health care facilities and health care services commonly referred to as hospitals, extended care and rehabilitation centers, nursing homes, skilled nursing facilities, intermediate care facilities, hospices for the terminally ill that require licensure or certification by the department of health, kidney disease treatment centers including freestanding hemodialysis units, outpatient clinics, organized ambulatory health care facilities, emergency care facilities and centers, home health agencies, health maintenance organizations, and others providing similarly organized services regardless of nomenclature. 19 Haw. Rev. Stat. §432E-1 Definitions. As used in this chapter, unless the context otherwise requires: “Managed care plan” means any plan, regardless of form, offered or administered by any person or entity, including but not limited to an insurer governed by chapter 431, a mutual benefit society governed by chapter 432, a health maintenance organization governed by chapter 432D, a preferred provider organization, a point of service organization, a health insurance issuer, a fiscal intermediary, a payor, a prepaid health care plan, and any other mixed model, that provides for the financing or delivery of health care services or benefits to enrollees through:
Report Title: Emergency Contraceptives; Collaborative Pharmacist-Physician Agreement Description: Allows pharmacists to dispense emergency contraceptives in accordance with approved procedures and protocols developed by a pharmacist and physician. (SD1) HOUSE OF REPRESENTATIVES H.B. NO. 123, H.D. 1, S.D. 1, TWENTY-SECOND LEGISLATURE, 2003 A BILL FOR AN ACT RELATING TO THE PRACTICE OF PHARMACY. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII: SECTION 1. In 2002, the legislature passed H.B. 1842, H.D. 1, S.D. 2, C.D. 1, which became Act 256, Session Laws of Hawaii 2002, to enable pharmacists to provide services in a broader range of clinical settings. The legislature noted that the increasing complexity of drug therapy required pharmacists to participate in the treatment of, and be the advocate for, the patient, in collaboration with other health care professionals. Unintended pregnancies are a major public health concern affecting individuals and society in general. Each year, about three million five hundred thousand unintended pregnancies occur in this country, half of which result from contraceptive failure or inadequate contraceptive technique. According to the department of health's office of health status monitoring, in 2000, fifty-three per cent of pregnancies were unintended for women of all ages in Hawaii, and seventy-eight per cent were unintended among women under twenty years of age. Emergency contraception is a highly cost-effective method of reducing unintended pregnancies, if taken within seventy-two hours after unprotected sex. However, in a statewide study conducted in early January of 2002, the Healthy Mothers, Healthy Babies Coalition of Hawaii learned that there are significant barriers to accessing emergency contraceptives in Hawaii within the recommended seventy-two hour time frame. The American College of Obstetricians and Gynecologists, American Academy of Pediatricians, American Public Health Association, and more than fifty other national organizations support increased access to emergency contraception. The purpose of this Act is to enable pharmacists with appropriate training and who are working in collaboration with a physician to initiate emergency contraception oral drug therapy. [Editor’s Note: Additions to existing law below are shown in bold; and deletions are in SECTION 2. Section 461-1, Hawaii Revised Statutes, is amended as follows: 1. By adding a new definition to be appropriately inserted and to read:
2. By amending the definition of “licensed medical doctor” and “practice of pharmacy” to read:
SECTION 3. Section 431:10A-116.6, Hawaii Revised Statutes, is amended by amending subsection (d) to read as follows:
SECTION 4. Section 431:10A-116.7, Hawaii Revised Statutes, is amended by amending subsection (g) to read as follows:
SECTION 5. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored (and bolded here--Editor’s Note.) SECTION 6. This Act shall take effect upon its approval. [Enacted as Act 201 on June 24, 2003 by signature of the Governor.]
HAWAII REGULATIONS HAWAII ADMINISTRATIVE RULES TITLE 16 - DEPARTMENT OF COMMERCE AND CONSUMER AFFAIRS CHAPTER 95 - PHARMACISTS AND PHARMACIES §16-95-82 Valid prescriptions. (a) A pharmacist may fill and dispense prescriptions provided the prescription is valid. A valid prescription shall be legibly written and contain, at the minimum, the following information: * * * (6) The room number and route of administration if the patient is in an institutional facility . . . [Eff and comp 12/24/92] (Auth: HRS 461-4.5) (Imp: HRS 461-11, 461-13) Historical note: 16-95-82 is based in part upon 16-95-9 and 16- 95-10. [Eff 5/16/64; am and ren 16-95-9, 16-95-10, 6/22/81; R 12/24/92] §16-95-93 Records of dispensing. (a) Records of dispensing for original and refill prescriptions are to be made and kept by pharmacies for five years and shall include, but not be limited to, the following: * * * (b) An institutional pharmacy will have fulfilled the requirements of this section if the information required by paragraphs (1) to (4) of subsection (a) is kept on accurate patient profiles or medication administration records showing all drugs administered to the patient for five years; and the institutional facility keeps the original patient charts evidencing the prescription orders and medication administration records in the institutional facility’s files for at least five years. [Eff and comp 12/24/92] (Auth: HRS §461-4.5) (Imp: HRS §§461-10, 461-11, 461-13)
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