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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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In May 2006, Pharmacy Access Partnership and the California Family Health Council co-launched the first ever state EC network. Learn more about EC advocacy in California through the California EC Network. EC PHARMACY UPDATELegislation permitting pharmacists to offer direct access to EC took effect January 1, 2002. The 70 pharmacies that were providing EC through a demonstration project quickly converted to the new system, and with strong foundation support, pharmacist training, pharmacist and physician recruitment, and a public awareness campaign were launched. The Pharmacy Access Partnership, a center of the private nonprofit Public Health Institute, coordinated most of these activities. One of the most critical factors shaping implementation was development of a multidisciplinary team of consultants and advisors. The group represented the pharmacy community, public health, OB/GYN leaders and reproductive rights advocates. This team served as the Circle of Advisors to the Pharmacy Access Partnership and provided input on major issues. Family PACT and Medi-Cal enrollees who obtain Plan B from a pharmacy are eligible to receive one pack of Plan B per visit, for a maximum of up to six packs in a 12-month timeframe from any Medi-Cal contracted pharmacy. This applies to women presenting a doctor’s prescription and those seeking EC through a pharmacist-initiated prescription (without first getting a prescription from a doctor or clinic). The FDA decided on August 24, 2006, to make Plan B available without a prescription for consumers 18 and older by the end of 2006. Family PACT and Medi-Cal require a prescription in order to pay for drugs and supplies in pharmacies, and therefore will not cover Plan B obtained over-the-counter. Read more about Medi-Cal’s continued coverage of Plan B as a prescription product. New Legislation In August 2003, two bills relating to pharmacist provision of EC were passed by the California state legislature and signed by the Governor. SB490, sponsored by the Public Health Institute, simplifies pharmacist participation in the EC pharmacy program. The bill authorizes the State Pharmacy and Medical Boards to develop a standardized protocol under which trained pharmacists may initiate EC. Like many state-level advancements in deregulating EC, California’s proposed policy change is modeled after another state — New Mexico. Trained pharmacists will be able to download the protocol and provide services. The system requires no formal notification or enrollment process by pharmacists. The bill requires pharmacists to have a minimum of 1 hour of CE training and does not specify provider type or training format. SB 490 had the support of organized medicine, women’s groups and the pharmacy community. SB545, sponsored by the American College of Obstetricians and Gynecologists, sets a $10 price cap on the amount pharmacists may charge for the assessment and counseling component of the service. This “administrative” fee is independent of charges for the drug or the traditional dispensing fee. To address the equity issue, the bill also prohibits physicians from charging patients more than $10 for EC (non drug costs) that is prescribed as a result of contact made by telephone or electronic means. SB 545 had the strong support of organized medicine and women’s groups, but is opposed by pharmacy groups. Prior to the approval of Plan B for OTC use, the maximum fee allowed was $10, and applied to in-person, telephone and internet-based consultations. Since Plan B became an OTC product, there is no longer a maximum on how much a pharmacist can charge for consultation before providing Plan B via pharmacy access. Pharmacy Participation More than 900 pharmacies currently provide EC service in California. About half of these are independent community pharmacies and half represent large chain stores. Most chain stores in California participate in this program, although not all retail outlets provide EC service. EC pharmacies are located in 52 of the 58 counties in California and can be found in about 60% of California’s rural counties. Click here for a map (DOC-76K) of CA counties with EC pharmacies. Non-participating counties are rural or remote and have few, if any, pharmacies. Pharmacies have informally developed networks in many communities in which they refer women seeking EC to the designated local EC pharmacy. The Partnership provides technical support to pharmacists through a website www.pharmacyaccess.org. At this site pharmacists can download documents, customize materials for their own purposes, register their pharmacy for public listing, and obtain training information. EC Hotline and Website To increase public awareness and help women find pharmacies that provide EC, the Partnership developed a website (www.EC-Help.org) and hotline (1-888-Not-2-Late). In the first two years of implementation, they received over 60,000 visitors and calls. The website and hotline were extremely important in the initial implementation phase when some women knew about the law change permitting pharmacy access, but were uncertain which pharmacies were providing service. Public Awareness Because of the high costs for paid media in California’s major markets, the Partnership has relied on alternative strategies to promote awareness about pharmacy access to EC. One key strategy has been the development and distribution of printed materials for consumers through mass mailings. This central strategy supplemented other efforts including presentations at regional and statewide conferences, seminars and public events and a very limited amount of paid media. Ogilvy Public Relations Worldwide designed and produced a line of consumer informational and promotional materials that promoted pharmacy access to EC, and featured the EC-Help hotline and website. Materials were field tested for readability and design approval and include panel cards, wallet cards, brochures, flyers and posters for pharmacies. To view materials click here. The Partnership developed a mailing list of approximately 2,000 community-based organizations (CBOs) including Title X and other family planning clinics, primary care clinics, Maternal and Child Health and WIC Directors, local health departments and other community-based organizations. With the help of CBOs, these materials were publicly distributed. The CBO database was compiled to ensure that all counties, including urban, rural and remote locations, were represented. Initially mass mailings of consumer materials were shipped to organizations on a county-by-county basis to coincide with start up of local EC pharmacies. Additionally consumer materials have been provided free of charge to each pharmacy that has signed up on the EC-Help hotline and website. There has been a limited amount of paid media in Spanish, Korean and Vietnamese newspapers. This advertising provided an avenue for diverse communities to learn about pharmacy access to EC. In spring 2003, the Partnership ran a radio ad (DOC-24K) on two popular stations in the Los Angeles and San Francisco Bay areas. Ogilvy also developed a line of professional materials to target pharmacists, physicians, lawmakers and other professionals interested in EC. All materials are available for viewing at PharmacyAccess.org. These materials were mass mailed and distributed through professional organizations including the California Pharmacists Association and ACOG District IX. Combined efforts for all aspects of the campaign are estimated to have reached almost 10 million consumers and professionals in California. This includes:
Training The California Pharmacists Association provided the majority of live EC training programs in the state under contract with the Pharmacy Access Partnership. The University of Southern California and Washington State Pharmacy Association also provided accredited EC training programs in California during the start up demonstration phase. Together these groups provided about 55 live trainings in the first year and a half. Group size averaged 28, but varied from 5 to 110 pharmacists. Training programs were initially 20 hours – 8 hours of home study and 12 hours of live programming. After a year, these programs were shortened to 2 hours of home study and 4 hours of live program. Approximately half of the program is devoted to clinical issues and half to promoting effective communication skills and managing sensitive situations such as minor’s right to confidential service, abuse, etc. Most live trainings in California have had two trainers — a pharmacist and a family planning health educator. All trainings stress the important role pharmacists can play in getting women into care for ongoing contraception, STD/HIV screening etc. A respected family planning training organization, the Center for Health Training helped develop the materials and curriculum for the non-clinical component of the training. Trainings were offered throughout the state, including rural and remote areas (e.g., Bishop, California) during the first 18 months of implementation. This was a strategic decision to promote statewide participation in California’s widely diverse communities. Costs to participants were kept at a relatively affordable $45 for a four-hour live CE program. Several chains also launched their own programs. The UCSF School of Pharmacy developed a self-study program to serve one chain. This decentralized approach makes it difficult to know the total number of pharmacists trained. However, estimates vary from 2,500 - 3,000 pharmacists. As of 2004, a minimum of 1 hour (.1 CEU) is required by California law. In May 2004, Pharmacy Access Partnership launched a 1 hour online training program. Pharmacy Access Partnership occasionally offers 2-hour live training programs, in collaboration with partnering organizations. HMO Coverage In 2002, then Governor Gray Davis issued a directive mandating all HMOs in California to provide full coverage of EC for women. The Governor instructed HMOs to cover the costs for EC when dispensed from participating pharmacists within the HMO's network or, in emergency situations, from pharmacists that don't have a contract with his or her HMO. View the letter (PDF-110K) from the California Department of Managed Health Care. For press coverage in this state, click here. For outreach materials in this state, click here.
CONTACTS
USEFUL LINKSCalifornia State Board of Pharmacy California Pharmacists Association California Legislature Six Rivers Planned Parenthood California Family Health Council Planned Parenthood of Los Angeles Planned Parenthood of Pasadena Planned Parenthood of San Diego and Riverside Counties Planned Parenthood Mar Monte Planned Parenthood Golden Gate Planned Parenthood of Orange and San Bernardino Counties Planned Parenthood of Santa Barbara, Ventura, and San Luis Obispo Counties Planned Parenthood: Shasta-Diablo Planned Parenthood Affiliates of California NARAL Pro-Choice California
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. CALIFORNIA Pharmacists in any setting, including community pharmacies, may prescribe and administer emergency contraception in accordance with standardized procedures or protocols (that need not be patient-specific) developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice. Pharmacists must first complete an emergency contraception training program, and must provide a fact sheet to each patient. They may also administer immunizations by any route of delivery, and any other drug or biological orally or topically, but not by injection, pursuant to a prescriber’s order. Only pharmacists working in a licensed health care facility, home health agency, clinic in which there is physician oversight, or working for licensed health care service plan, may implement collaborative practice agreements. The agreements must be granted through policies, procedures, or protocol developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the facility administrator. Except for emergency contraception, protocols must be patient-specific. There is no external board review required for these agreements. Pharmacists may initiate or adjust the drug regimen of a patient pursuant to an order or authorization by the patient’s prescriber and requires that the pharmacist function as part of a multidisciplinary group where physician will help determine appropriate functions of the pharmacists and direct care registered nurse. The scope of practice must be outlined in the protocol and must include statements regarding:
Any disease state listed in the protocol is allowed, including immunizations and emergency contraception. The patient medical record and protocol must be made available to the prescriber and pharmacist and any change or modification in drug therapy must be provided in writing to physician within 24 hours. The pharmacist is required to have clinical residency training or demonstration of direct patient clinical care delivery. Authorization for collaborative practice and the specific emergency contraceptive language lies within the Pharmacy Practice Act statutory language detailing authorized pharmacist activities. Statutory Authority: Cal. Bus & Prof. Code §§ 4016, 4025, and 4050 – 4052 Regulatory Authority: N/A
CALIFORNIA STATUTE CALIFORNIA CODES BUSINESS AND PROFESSIONS CODE CA PracAct 4016. “Administer” means the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion, or other means CA Prac Act 4025 Drug
CA PracAct 4050-52 Legislative Declaration Conduct Limited to Pharmacist; Conduct Authorized by Pharmacist Furnishing to Prescriber; Permissible Procedures by Pharmacist in Health Care Facility or Clinic or for Other Health Care Provider 4050. (a) In recognition of and consistent with the decisions of the appellate courts of this state, the Legislature hereby declares the practice of pharmacy to be a profession. (b) Pharmacy practice is a dynamic patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes. 4051. (a) Except as otherwise provided in this chapter, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense any dangerous drug or dangerous device, or to dispense or compound any prescription pursuant to Section 4040 of a prescriber unless he or she is a pharmacist under this chapter. (b) Notwithstanding any other law, a pharmacist may authorize the initiation of a prescription, pursuant to Section 4052, and otherwise provide clinical advice or information or patient consultation if all of the following conditions are met: (1) The clinical advice or information or patient consultation is provided to a health care professional or to a patient. (2) The pharmacist has access to prescription, patient profile, or other relevant medical information for purposes of patient and clinical consultation and advice. (3) Access to the information described in paragraph (2) is secure from unauthorized access and use. 4052. (a) Notwithstanding any other provision of law, a pharmacist may:
4052.1. Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform skin puncture in the course of performing routine patient assessment procedures or in the course of performing any procedure authorized under Section 1206.5. For purposes of this section, “routine patient assessment procedures” means: (a) procedures that a patient could, with or without a prescription, perform for himself or herself, or (b) clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by paragraph (11) of subdivision (a) of Section 1206.5. A pharmacist performing these functions shall report the results obtained from a test to the patient and any physician designated by the patient. Any pharmacist who performs the service authorized by this section shall not be in violation of Section 2052.
CALIFORNIA REGULATIONS None promulgated as of June 15, 2003.
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