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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEWashington was the first state in the U.S. to directly distribute EC through pharmacies, and has since served as a model for later states including California, Alaska, New Mexico and Hawaii. Washington launched its EC pharmacy program in 1997 with a two-year pilot project led by PATH (Program for Appropriate Technology in Health) and supported by the Packard Foundation. Similar to other states with an optimal protocol environment, Washington did not need to make regulatory or statutory changes to allow pharmacists to initiate EC for the general community. For more information about how services were started, see the Washington model for EC pharmacies. Washington state continues to be a leader in promoting EC access nationwide. In January 2006, Senator Karen Keiser (D) along with Senators Franklin, Kohl-Welles and Thibadeau, sponsored a Senate Joint Memorial (SJM 8032 2005-2006) to ask that over-the-counter access status be granted to “Plan B”. The state has enjoyed strong support for its EC pharmacy access from organizations including the Board of Pharmacy, the Washington State Pharmacy Association (WSPA), medical groups and state and local departments of health and social services. Many of these groups and organizations were involved in the initial media campaign associated with implementation and several provided OP-ED letters and press interviews. Like Hawaii, Washington used CDC PRAMS data to support EC pharmacy access as a public health issue. The State Department of Health, Family Planning and Reproductive Health Section has worked hard to frame the ‘Unintended Pregnancy’ message as an issue of broad appeal, with both social and economic implications. Placing the need for EC in this context, rather than as a ‘choice’ issue has helped generate greater support, while minimizing confrontation. A strong coalition of local family planning providers in Washington has met quarterly for the last 25 years and the state has a high degree of interagency collaboration around reproductive health issues. Until 1989, the Department of Social & Health Services (DSHS) and Department of Health (DOH) were one organization. When the pilot project began in 1997, DOH and DSHS already had a strategic initiative in place to reduce unintended pregnancy by 3% over a six-year period. Key leaders in both Departments have continued to be actively involved in generating greater public awareness of EC and in facilitating supportive policies around implementation. DOH and DSHS have successfully worked together at the local level and have jointly trained staff at Community Services Offices (welfare centers) about EC, unintended pregnancy and how staff can help increase awareness about pharmacy access to EC. DSHS houses the state’s Medicaid program, and Washington is the only state thus far that allows government MAA reimbursement (PDF-24K) for pharmacist initiation of EC. Pharmacists are paid $13.50 per encounter for the counseling portion of EC service and must bill using a HCFA claim form. Washington’s EC pharmacy program contributed to state savings of nearly $22 million in Medicaid dollars from 1999 to 2000 (Downing D. Pharmaceutical care in emergency contraception. Supplement to the Journal of the American Pharmaceutical Association 2002; 42: S38-S39.) Pharmacists became more aware of patient need for not only EC, but other OTC contraceptives such as contraceptive foam and condoms. Emergency contraception is now provided by pharmacies as a matter of course, and the system has been successfully integrated into key Washington institutions. Approximately 2,000 women per month access EC directly in pharmacies. Washington started with 90 EC pharmacies in the first 3 months of the 1997 pilot project and has steadily grown to about 300 pharmacies as of August 2003. Approximately 1900 pharmacists have been trained to provide EC service. The Washington State Pharmacist Association (WSPA) has incorporated EC training into their Continuing Education Program for all licensed pharmacists and both Schools of Pharmacy in the state (Washington State and University of Washington) have incorporated EC training into their student curricula. In addition, the Washington State Board of Pharmacy has an established system for reviewing and overseeing EC collaborative protocols. The program is in the process of switching to a new type of protocol. Initially, the protocol was specific to a pharmacy, and any pharmacist working there could provide service. However, to increase the renewal of protocols, the program will switch to a pharmacist-specific protocol. The State Board of Pharmacy sent a letter to all the EC pharmacies in July 2003, asking them which pharmacists provided service under the protocol. The switch began in August 2003, and the difficulty in the transition has been changing the filing system at the Board of Pharmacy. If a pharmacist is providing service under a pharmacy protocol, he or she will be grandfathered into the new system. But once that protocol expires, the pharmacist will have to obtain a pharmacist-specific protocol. The following service documents and tools are used in Washington State:
WSPA has created an email address for all pharmacists in the state and has maintained a pharmacy forum on EC to share the latest news and encourage questions. To increase awareness, the program has conducted outreach to school nurses and college campuses.
CONTACTSDon Downing, R.Ph. Jackie Gardner, PhD Jeff Rochon, Pharm D Rod Shafer, R.Ph. Jane Hutchings
USEFUL LINKSWashington State Board of Pharmacy Washington State Pharmacy Association Washington State Legislature Mt. Baker Planned Parenthood Planned Parenthood of Western Washington Planned Parenthood of Central Washington NARAL Pro-Choice Washington
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. WASHINGTON STATE Pharmacists practicing in any setting may initiate, modify and administer drug therapy in accordance with patient specific written guidelines or protocols previously established and approved by a practitioner authorized to prescribe drugs. The Board must have prior notification and have the written guidelines or protocol on file. The pharmacist must also keep the protocol agreement on file. Pharmacists may also pursue DEA registration. The scope of practice is defined within protocol and includes:
There is no limitation on disease state management opportunities. The Board has protocols on file for more than 570 pharmacists participating in collaborative practice agreements that cover emergency contraception and a wide range of other therapies including: smoking cessation, anti-emetic chemotherapy plans, asthma, prenatal, post pregnancy comfort kits, palliative care/hospice, pre-dental antibiotics, rhinitis, motion sickness, malaria, burns, refill authorization, folic acid, hormone replacement therapy, herpes, strep management, meningococcal prophylaxis for college students, hypertension, anticoagulant therapy, aminoglycosides, methadone, psychiatric management, fluoride, total parenteral nutrition, vaginal yeast infections, theophylline, and Relenza.™ In Washington, pharmacists administer injectable hormonal contraceptives through a referral system with medical providers, and pharmacies are starting to directly provide ongoing contraception through a project funded by the National Institutes of Health. Pharmacists and physicians taking part in this project are using collaborative agreements to provide women with oral contraceptives when they need effective, long-term contraception and they come to pharmacies requesting emergency supplies or seeking contraceptive assistance. Women initiating contraception through the program have access to medical collaborators for physical exams, but these exams are not required for contraception initiation. A self-administered screening tool has been developed to ensure that the pill is provided to women for whom it is appropriate. Statutory authority: Wash. Rev. Code18.64 Regulatory authority: Wash. Admin. Code § 246-863-100
WASHINGTON STATUTE Chapter 18.64 RCW PHARMACISTS RCW 18.64.011 Definitions. (9) “Practitioner” means a physician, dentist, veterinarian, nurse, or other person duly authorized by law or rule in the state of Washington to prescribe drugs. (10) “Pharmacist” means a person duly licensed by the Washington state board of pharmacy to engage in the practice of pharmacy. (11) “Practice of pharmacy” includes the practice of and responsibility for: Interpreting prescription orders; the compounding, dispensing, labeling, administering, and distributing of drugs and devices; the monitoring of drug therapy and use; the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs; the participating in drug utilization reviews and drug product selection; the proper and safe storing and distributing of drugs and devices and maintenance of proper records thereof; the providing of information on legend drugs which may include, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices. … (23) “Administer” means the direct application of a drug or device, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject.
WASHINGTON REGULATIONS Washington State Chapter 246-863 WAC PHARMACISTS-LICENSING WAC 246-863-100 Pharmacist prescriptive authority-Prior board notification of written guideline or protocol required. (1) A pharmacist planning to exercise prescriptive authority in his or her practice (see RCW 18.64.011(11)) by initiating or modifying drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs must have on file at his/her place of practice a properly prepared written guideline or protocol indicating approval has been granted by a practitioner authorized to prescribe. A copy of the written guideline or protocol must also be on file with the board of pharmacy. 2) For purposes of pharmacist prescriptive authority under RCW 18.64.011(11), a written guideline or protocol is defined as an agreement in which any practitioner authorized to prescribe legend drugs delegates to a pharmacist or group of pharmacists authority to conduct specified prescribing functions. Any modification of the written guideline or protocol shall be treated as a new protocol. It shall include:
WAC 246-863-110 Monitoring of drug therapy by pharmacists. The term “monitoring drug therapy” used in RCW 18.64.011(11) shall mean a review of the drug therapy regimen of patients by a pharmacist for the purpose of evaluating and rendering advice to the prescribing practitioner regarding adjustment of the regimen. Monitoring of drug therapy shall include, but not be limited to: (1) Collecting and reviewing patient drug use histories;
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