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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEThe Pharmacy Practice Act was updated in 1999 to include the ability of pharmacists to enter into “patient-specific” collaborative practice agreements with physicians. The Minnesota Pharmacy Association House of Delegates passed a resolution (PDF-8K) in 2000 that supports voluntary pharmacist involvement in EC. This has allowed the association to support EC bills that have been introduced (but failed) in the past. The first collaborative practice agreement for pharmacy access to EC was initiated in 2000 with the Family Tree Clinic and a local pharmacy. Approximately 12 EC agreements currently exist between clinics and pharmacists. Both retail chain and independent pharmacies are providing EC as needed to these patient populations. An article featured in the Minnesota Physician (May 2003), the Independent Medical Business Newspaper (DOC-32K), highlights the experience in Minnesota in using collaborative practice agreements. Unfortunately, the Family Tree Clinic’s patient-specific pharmacy access EC project ended in June 2004 when funding was expended. These 12 pharmacy collaborative agreements will continue to exist. Minnesota pharmacies were surveyed in as to whether they stocked EC and were interested in participating in a collaborative practice agreement with a physician. Of approximately 730 pharmacies in the state, almost 29% responded positively to stocking EC. The Family Tree Clinic sent these pharmacists a follow up packet of information with sample protocols and materials. A pharmacy graduate student also conducted a random mail survey with Minnesota pharmacists about their perceptions of emergency contraception and whether a correlation exists between a pharmacist’s understanding of EC’s mechanism of action and their comfort level in dispensing EC. Results show that reasons for not dispensing EC were mostly attributed to low demand for the product. A statewide conference, Improving Access to Emergency Contraception in Minnesota: Empowering Pharmacists & Providers for the Future, was held June 13, 2003 in Hinckley, MN. Family Tree Clinic’s EC Collaboration Project and the Minnesota Pharmacists Association jointly sponsored the conference and featured various speakers including Don Downing, pharmacist trainer from Washington State, who shared insight and technical assistance. The conference was attended by pharmacists, pharmacy students, and health care and community advocates. Pharmacists are not required to complete additional training to provide EC. The Family Tree Clinic provided professional training and consultation on emergency contraception to health care providers, community clinics and organizations. Most pharmacies and providers providing pharmacy access to EC are not advertising services to the community at large because of the “patient-specific” nature of the collaborative practice agreements in the state. However, there are efforts to increase EC awareness generally in the state through advertising and promotional activities. Radio spots reached an audience of over 28,000 people during broadcast from December 2002 to January 2003 on Clear Channel Communication Station 101.3 KDWB in Minneapolis/Saint Paul and another local radio station. Television ads were broadcast on Saint Paul’s WB affiliate (WB 23) in late prime and prime time slots targeting young adults ages 16-24. Spots ran from February 2003 to April 2003 with station coverage including the Twin Cities metropolitan area, Rochester, Mankato, Saint Cloud, much of South Eastern Minnesota and a portion of Western Wisconsin. They were also broadcast on Comcast Cable, MTV and BET networks, in all time slots from May 2003 to July 2003. The Family Tree Clinic has developed buttons, pre-printed prescription pads, telephone protocols, and office signs to increase physician involvement in increasing access to EC. An article in the May/June 2003 Minnesota Family Physician (PDF-20K), a newsletter of the Minnesota Academy of Family Physicians, encouraged providers to increase access to EC through pharmacies. Family Tree Clinic conducted outreach to college students directly, urging young adults to ask for EC and encouraging campus health centers to carry EC. At the campuses where the clinic did outreach, the requests for EC went up. The clinic hoped to show pharmacists that there was a great demand for EC and that dispensing it was an important service. In 2001, an EC pharmacy access program was developed at Hennepin County Medical Center. A collaborative agreement between the hospital’s pharmacy and therapeutics committee and the pharmacy allowed clinic patients to get EC directly from the hospital pharmacy without the first seeing a provider. Results show that EC use increased by almost 800% in the one-and-half year study. Approximately a quarter of EC was provided outside of clinic hours. Clinic Pharmacy Consultants at Brainerd Medical Center is looking at a collaborative agreement for pharmacists to dispense EC. For press coverage in this state, click here. For outreach materials in this state, click here.
CONTACTSJulie K. Johnson, R.Ph. Elizabeth Carpenter Nancy Ruhland Peg LaBore Joseph Unger Dr. Michele Van Vranken Dr. Michele Van Vranken Dr. Michele Van Vranken
USEFUL LINKSMinnesota Board of Pharmacy Minnesota Pharmacists Association Minnesota State Legislature Planned Parenthood of Minnesota and South Dakota NARAL Pro-Choice Minnesota The Family Tree Clinic Teen Health 411
PROTOCOL ENVIRONMENTPossible Environment: Revision to Existing Authority Required This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community. Pharmacist initiation of EC would require:
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. MINNESOTA Pharmacists practicing in any practice setting may participate in “managing and modifying drug therapy” if pursuant to a patient-specific protocol with an individual prescriber. Such collaborative agreements require no external review. The standards of practice must be outlined in the protocol; and any significant changes in drug therapy must be recorded by the pharmacist in the patient’s medical record. Minnesota authorizes pharmacists in any practice setting specifically to administer a drug if it is the “first dosage” or a “medical emergency.” State law imposes no explicit limitations on the types of drugs or routes of administration. Under legislation just passed and signed by the Governor, pharmacists may now also administer influenza and pneumococcal vaccine to individuals over 18 years of age pursuant to standing orders or a written protocol from a physician, provided that the pharmacist is trained (as defined) and the pharmacist reports the vaccination “to the patient's primary physician or clinic.” Under separate authority, it appears that hospital pharmacists can administer drugs, if pursuant to the hospital’s pharmaceutical care policy and a standing order which specifies the drug, dosage, route, frequency of administration, and duration. Statutory authority: Minn Stat §151 Regulatory authority: Minn. R. not specifically addressed
MINNESOTA STATUTE MINNESOTA PHARMACY PRACTICE ACT Chapter 151 - Pharmacy 151.01 Definitions Subdivision 27. Practice of Pharmacy. “Practice of pharmacy” means: (1) interpretation and evaluation of prescription drug orders; (2) compounding, labeling, and dispensing drugs and devices (except labeling by a manufacturer or packager of nonprescription drugs or commercially packaged legend drugs and devices); (3) participation in clinical interpretations and monitoring of drug therapy for assurance of safe and effective use of drugs; (4) participation in drug and therapeutic device selection; drug administration for first dosage and medical emergencies; drug regimen reviews; and drug or drug-related research; (5) participation in the practice of managing drug therapy and modifying drug therapy, according to section 151.21, subdivision 1, on a case-by-case basis according to a written protocol between the specific pharmacist and the individual dentist, optometrist, physician, podiatrist, or veterinarian who is responsible for the patient's care and authorized to independently prescribe drugs. Any significant changes in drug therapy must be reported by the pharmacist to the patient's medical record; (6) participation in the storage of drugs and the maintenance of records; (7) responsibility for participation in patient counseling on therapeutic values, content, hazards, and uses of drugs and devices; and (8) offering or performing those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a pharmacy. * * * HIST: (5808-1) 1937 c 354 s 1; 1961 c 394 s 1; 1967 c 377 s 1,2; 1969 c 933 s 1-7; 1973 c 639 s 1,2; 1975 c 101 s 1; 1985 c 247 s 25; 1985 c 248 s 70; 1986 c 444; 1988 c 550 s 1-5; 1990 c 412 s 1,2; 1990 c 526 s 2; 1991 c 213 s 1; 1993 c 121 s 10; 1994 c 389 s 3; 1994 c 632 art 2 s 36; 1995 c 205 art 2 s 5; 1997 c 132 s 1; 1999 c 62 s 1 S.F No. 574 83rd Legislative Session (2003-2004) A bill for an act relating to health occupations; modifying the scope of practice for pharmacists; amending Minnesota Statutes 2002, section 151.01, subdivision 27. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: Section 1. Minnesota Statutes 2002, section 151.01, subdivision 27, is amended to read: Subd. 27. [PRACTICE OF PHARMACY.] “Practice of pharmacy” means: * * * (5) participation in administration of influenza and pneumococcal vaccine to individuals over 18 years of age under standing orders from a physician licensed under chapter 147 or by written protocol with a physician provided that: (i) the pharmacist is trained in a program approved by the American Council of Pharmaceutical Education for the administration of immunizations or graduated from a college of pharmacy in 2001 or thereafter; and (ii) the pharmacist reports the administration of the immunization to the patient's primary physician or clinic; 151.21 Substitution Subdivision 1. Except as provided in this section, it shall be unlawful for any pharmacist, assistant pharmacist, or pharmacist intern who dispenses prescriptions, drugs, and medicines to substitute an article different from the one ordered, or deviate in any manner from the requirements of an order or prescription without the approval of the prescriber. HIST: (5808-22) 1937 c 354 s 22; 1969 c 933 s 10; 1975 c 101 s 2; 1986 c 444; 1993 c 345 art 5 s 10; 1994 c 625 art 8 s 48,49; 1997 c 202 art 2 s 40
MINNESOTA REGULATIONS CHAPTER 6800 Minnesota Board of Pharmacy Licensing and Operation Last updated 8/23/02 6800.0100 - Definitions Subpart 7. Pharmaceutical care. “Pharmaceutical care” means the responsible provision of drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve definite outcomes related to the cure or prevention of a disease, the elimination or reduction of a patient's symptoms, or the arresting or slowing of a disease process. 6800.7200 SCOPE. The provisions of parts 6800.7100 to 6800.7950 are applicable to pharmaceutical services provided to patients in hospitals, including state hospitals, provided, however, that parts 6800.0100 to 6800.5600 and 6800.8100 to 6800.9700 shall also be applicable to such pharmaceutical services, unless specifically exempted by parts 6800.7100 to 6800.8100 or unless in direct conflict therewith, in which case parts 6800.7100 to 6800.8100 shall apply. STAT AUTH: MS s 151.06 subd 1 6800.7510 PATIENT CARE. Pharmaceutical service policies shall cover at least the following: A. the providing of drug information to patients and health professionals; B. the limiting of drug administration; C. the immediate reporting of drug-related errors; D. the immediate reporting of adverse drug reactions; E. the self-administration of drugs by patients; F. the use of drugs brought into the hospital by or with the patient. If the drugs are not to be used while the patient is hospitalized, they shall be packaged, sealed, stored, and returned to the patient at the time of discharge; G. the use of investigational drugs; and H. the preparation, use, and disposal of chemotherapy drugs. STAT AUTH: MS s 151.06 HIST: 18 SR 1145 6800.7520 ADMINISTRATION. Subpart 1. Dispensing drugs. Pharmaceutical service policies shall cover at least the following measures related to the control, accessibility, dispensing, and administration of drugs: * * * M. Requiring authorization for a standing order to be noted on the patient's medical record. Standing orders shall specify the circumstances under which the drug is to be administered, the drug, dosage, route, frequency of administration, and duration. N. Assuring that when drug therapy is not renewed on an established regular basis the therapy is limited either by the prescriber's specific indication or by automatic stop orders. HIST: 18 SR 1145; 27 SR 260
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