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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEThere is currently no known activity promoting direct pharmacy access to EC. There are no strong coalitions around reproductive health issues in North Dakota. In 2003, House Bill 1247 (PDF-6K), which related to health insurance coverage for contraceptives including EC, was introduced and failed. Clinics funded by federal grants are authorized to offer EC, but some clinic staff continue to refer clients to other locations due to opposition by clinic physicians.
CONTACTSMichael Schwab Deb Arnold Carol Moen
USEFUL LINKSNorth Dakota Board of Pharmacy North Dakota Pharmaceutical Association North Dakota Legislative Branch
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. NORTH DAKOTA Only pharmacists working in a hospital, health care institution setting or in a physician setting may enter into patient-specific collaborative drug therapy agreements with the treating physician. Participating pharmacists who have a Doctor of Science, Doctor of Philosophy in Clinical Pharmacy, Master of Science, or Doctor of Pharmacy degree, are a certified fellow from the Board of Pharmaceutical Specialties, or have completed an accredited pharmacy fellowship or residency may initiate therapy; all other participating pharmacists may only modify the drug regime. The Boards of Pharmacy and Medicine must approve the protocols and authorize a physician to supervise more than three pharmacists, or a pharmacist to collaborate with multiple physicians. Pharmacists must provide immediate notification to the physician when initiating drug therapy. Patient medical records must be accessible to the pharmacist and the physician within the facility setting. Modification of drug therapy must be documented in a timely manner. The scope of practice is outlined in the protocol or collaborative agreement which must indicate the scope and authority to be exercised by the pharmacist, the disease state(s) and types or class of drugs or drug therapy to be utilized or prohibited, and provide for contingencies in case of adverse reaction. Pharmacists may not initiate Schedule II drugs or continue care if the patient is discharged. Protocols must be renewed every two years. Statutory authority: Provided for immunization authority in section governing Injections of Drugs and related definitions, N.D. Cent. Code §§ 43-15-01, §43-15-31.5, and for “limited prescriptive practices” at N.D. Cent. Code §43-15-31.4. Regulatory authority: Provided at “administration of medications and immunizations,” N.D. Admin. Code §§ 61-04-11 et seq, and for collaborative practice at N.D. Admin. Code § 61-04-08-01 through -07.
NORTH DAKOTA STATUTE TITLE 43 - OCCUPATIONS AND PROFESSIONS CHAPTER 43-15 - PHARMACISTS 43-15-01. Definitions. In this chapter, unless the context or subject matter otherwise requires: 1. “Administration” means the direct application of a drug to the body of a patient.
… 19. “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 the rules of the board. … 23. “Practice of pharmacy” means the interpretation, evaluation, and monitoring of prescription orders and patient drug therapy; the compounding, dispensing, labeling of drugs and devices except labeling by a manufacturer, packer, or distributor of nonprescription drugs and commercially packaged legend drugs and devices; the participation in drug selection, drug monitoring, drug administration, drug regimen review, the provision of these acts or services necessary as a primary health care provider of pharmaceutical care, and drug utilization evaluations; the proper and safe storage of drugs and devices and the maintenance of proper records for this storage; the responsibility for advising, consulting, and educating if necessary or if regulated, patients, public, and other health care providers on the rational, safe, and cost-effective use of drugs including therapeutic values, content, hazards, and appropriate use of drugs and devices; the participation in interpreting and applying pharmacokinetic data and other pertinent laboratory data to design safe and effective drug dosage regimens; if appropriate and if regulated, the participation in drug research either scientific or clinical as investigator or in collaboration with other investigators for the purposes of studying the effects of drugs on animals or human subjects, with other drugs or chemicals, and with drug delivery devices; emergency pharmacy practice; prescriptive practices as limited under this chapter; the performance of laboratory tests to provide pharmaceutical care services which are waived under the Federal Clinical Laboratory Improvement Act of 1988 [Pub. L. 100-578, section 2; 102 Stat. 2903; 42 U.S.C. 263a et seq.], as amended; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy. 43-15-31.4. Limited prescriptive practices. 1. A licensed pharmacist in an institutional setting has limited prescriptive practices to initiate or modify drug therapy following diagnosis and initial patient assessment by a licensed physician, under the supervision of the same licensed physician, in accordance with this section. An institutional setting, for the purpose of this section, is a hospital, a physician clinic, a skilled nursing facility, or a swing bed facility in which a patient's medical records are readily available to the licensed physician and the licensed pharmacist. 2. The licensed physician and the licensed pharmacist shall prepare a collaborative agreement concerning the scope of the pharmacist's prescriptive practices and shall update the agreement at least every two years or when they modify the scope of the pharmacist's prescriptive practices. The collaborative agreement, or an amendment to the agreement, is effective when approved by the board of medical examiners and the board of pharmacy. 3. The agreement must include a provision that requires the licensed pharmacist to immediately notify the licensed physician when the licensed pharmacist initiates or modifies a drug therapy. 4. The board of medical examiners and the board of pharmacy shall jointly establish a prescriptive practices committee consisting of two physicians appointed by the board of medical examiners, one physician appointed by the North Dakota medical association, one pharmacist appointed by the board of pharmacy, and one pharmacist appointed by the North Dakota pharmaceutical association. The prescriptive practices committee shall develop and submit proposed rules concerning the implementation of this section to the board of medical examiners and the board of pharmacy. Any rules to implement this section must be jointly adopted by the board of medical examiners and the board of pharmacy. 43-15-31.5. Injection of drugs - Rules. Any pharmacist who administers drugs by injection must have a certificate of authority from the board. The authority to administer a drug by injection may not be delegated. The board shall adopt rules to establish educational and operational requirements for a pharmacist to obtain and maintain a certificate of authority to administer drugs by injection. Rules adopted by the board under this section must include:
NORTH DAKOTA REGULATIONS TITLE 61 – STATE BOARD OF PHARMACY Chapter 61-04-08 LIMITED PRESCRIPTIVE PRACTICES 61-04-08-01 - Purpose. The purpose of these rules is to implement limited prescriptive practices provisions of the North Dakota Century Code. History: Effective December 1, 1998. General Authority: NDCC 28-32-02, 43-15-10(9)(12)(14), 43-15-31.4 Law Implemented: NDCC 28-32-02, 43-15-10(9)(12)(14), 43-15-31.4 61-04-08-02.- Definitions. For purposes of this chapter: 1. “Collaborative agreement” means the written document signed by a physician and a pharmacist which describes the limited prescribing authority granted the pharmacist under North Dakota Century Code section 43-15-31.4. 2. “Immediate notification” means interactive two-way communication between the pharmacist and physician within twenty-four hours of the initiation or modification of drug therapy, unless specific reference is made in the collaborative agreement to situations in which a notification time limit of up to seventy-two hours is appropriate. 3. “Initiate drug therapy” means to begin administering for the first time a prescribed drug therapy for treating a patient with an existing diagnosis. A licensed physician shall make any diagnosis required. 4. “Medical record” means a written record of clinical care developed and maintained by a patient's physician which contains information and data about a patient's condition sufficient to justify the diagnosis and subsequent treatment. The record must contain further appropriate information as described in section 33-07-01.1-20. 5. “Modify drug therapy” means to change, within the same therapeutic class of drugs, a specific drug, the dosage, or route of delivery of a drug currently being administered for an existing diagnosis. 6. “Pharmacist in an institutional setting” means a pharmacist who:
7. “Supervision” means the active role taken by the physician to oversee the pharmacist throughout the provision of drug therapy to patients under the terms of a collaborative agreement. 61-04-08-03.- Eligibility and approval. 1. A physician and a pharmacist who are licensed and practicing their respective professions in this state are eligible, provided the conditions of this section and any applicable statutes are met, to enter into the collaborative agreement allowing the pharmacist to provide prescription drug therapy to patients in an institutional setting on a limited basis. 2. A physician may have a collaborative agreement with no more than three eligible pharmacists unless the physician's licensing board specifies otherwise based on individual circumstances. A pharmacist may have a collaborative agreement with one or more physicians, the number of which may be limited by the board based on individual circumstances. 3. The collaborative agreement serves as a formal arrangement between an individual pharmacist and an individual collaborative supervising physician and is operative only within the institutional setting identified on the collaborative agreement form. 4. Each individual collaborative agreement must be reviewed by the board of medical examiners and the board of pharmacy, and will not become effective until both boards grant approval and notify the parties. Each agreement must be reviewed at least every two years or when modifications are proposed by the parties, and must receive continued approval from both boards in order to remain in effect. 5. A collaborative agreement may be terminated by either board for good cause, including adverse action taken against either licensee. Noncompliance with the terms of these rules or of a collaborative agreement may be considered evidence of unprofessional conduct by either board. 6. Either party of a collaborative agreement may terminate the agreement at will by notifying either board of their desire to do so. 7. Neither party to a collaborative agreement may seek to gain personal financial benefit by participating in any incentive-based program that influences or encourages therapeutic or product changes. 61-04-08-04.- Procedures. A physician who has signed an approved collaborative agreement with a pharmacist shall remain responsible for the care of the patient following initial diagnosis and assessment, and for the supervision of the pharmacist as prescriptive authority is exercised. The physician shall remain available to receive immediate notification from the pharmacist regarding prescriptive drug therapy being provided. The parties may modify as necessary, within the practice guidelines described in the collaborative agreement, their relationship in the joint provision of care to each patient as the requirements of the patient or drug therapy change. 61-04.08-05.- Initiation of drug therapy. To initiate drug therapy, a pharmacist must hold a valid North Dakota pharmacist license and have a collaborative agreement with the treating physician. A pharmacist may initiate drug therapy only if the pharmacist has obtained a Doctor of science, Doctor of philosophy in clinical pharmacy, Master of science, or Doctor of pharmacy degree, has been certified a fellow by the Board of pharmaceutical specialties, or has completed an accredited pharmacy fellowship or residency, and has been authorized to do so within the collaborative agreement. Verification of these credentials must be provided by the pharmacist. The pharmacist must provide immediate notification to the physician when the pharmacist initiates drug therapy. 61-04-08-06 - Modification of drug therapy. 1. To modify drug therapy, a pharmacist must hold a valid North Dakota pharmacist license and have a collaborative agreement with the treating physician. A pharmacist may modify drug therapy as warranted to assure an appropriate course of treatment for the patient. The pharmacist must provide immediate notification to the physician when the pharmacist modifies drug therapy. 2. The physician and pharmacist entering into a collaborative agreement must have indicated on the form the scope and authority to be exercised by the pharmacist and the type or class of drugs or drug therapy to be utilized or prohibited under the agreement. Authority to prescribe schedule II drugs may not be delegated to a pharmacist. The parties may also indicate the type of medical diagnosis to be included or excluded within the collaborative relationship. 3. The current medical record of each patient receiving drug therapy must be readily accessible to the pharmacist and physician within the facility setting. The pharmacist, unless physician or facility policy directs otherwise, shall provide timely documentation and indications for all drug therapies initiated or modified by the pharmacist as part of the medical record. 4. Contingency treatment should be addressed for treating allergic or acute adverse drug reactions. 61-04-08-07.- Form. 1. The collaborative agreement form utilized under this section is attached as an appendix to these rules as approved by the Board of Medical Examiners and Board of Pharmacy. Upon request, either board shall supply a copy of the rules and form to any interested party. 2. A copy of each collaborative agreement and subsequent amendments approved by the boards shall remain on file with the boards. Each party shall retain the original or a copy of the agreement and amendments, and either party shall provide a copy to the facility within which the agreement is operative. 3. Either board may disseminate a current listing of the individual parties who are practicing under an approved collaborative agreement. 4. More details may be provided. Further stipulations or details shall be supplied on a separate page. History: Effective Dec. 1, 1996 APPENDIX COLLABORATIVE AGREEMENT FORM The pharmacist and physician listed below are parties to this collaborative agreement, through which the pharmacist receives limited prescriptive authority under the supervision of the physician in accordance with North Dakota Century Code section 43.15-31.4 and administrative rules. Institution Pharmacist Name Physician Name Address Address Phone License Number Phone License Number [Please review the administrative rules governing collaborative agreements which accompany this form before proceeding.] 1. Describe the scope and authority to be exercised by the pharmacist. (If requesting authority to initiate drug therapy, pharmacist must include credential verification.) 2. Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies under this agreement. (Note: Schedule II drugs are excluded by these rules.) 3. If appropriate, indicate any diagnosis which are specifically included or excluded under this agreement. 4. Attach any protocols or guidelines to be used in decision making or other activities contemplated under this agreement. This must include a protocol for treating acute allergic or other adverse reactions related to drug therapy. 5. Describe approved situations, if any, in which the notification time limit may be extended beyond twenty-four hours (not to exceed seventy-two hours). Attach additional sheets if necessary. Pharmacist Signature Date Physician Signature Date Board of Pharmacy Approval Date Board of Medical Examiners Approval Date
CHAPTER 61-04-11. ADMINISTRATION OF MEDICATIONS AND IMMUNIZATIONS 61-04-11-01. Definitions. 61-04-11-02. Qualifications established to obtain certificate of authority. 61-04-11-03. Procedures to obtain certificate of authority. * * * 61-04-11-04. Requirements of physician or nurse practitioner order for a pharmacist to administer injections. 61-04-11-05. Requirements of written protocol. 61-04-11-06. Requirements of records and notifications. 61-04-11-07. Location of administration by injection. 61-04-11-08. Policy and procedural manual. History: Effective May 1, 2002.
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