Arizona State Profile
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EC PHARMACY UPDATE
In the 2002 legislative session, Arizona passed contraceptive equity using a broad-based coalition (HB 2234 health care insurance; contraceptive coverage). The coalition also introduced a bill to provide emergency contraception for victims of sexual assault (SB 1334 sexual assault victims, emergency services), but the bill failed to get a hearing. For the 2003 session, former Senator Virginia Yrun pulled together the sexual assault community, the Arizona Nurses Association, the Arizona Hospital and Healthcare Association and representatives of the Family Planning Coalition to work out revisions. Senator Linda Binder sponsored SB 1087 sexual assault; emergency medical services, which required hospital emergency rooms to provide victims of sexual assault information about emergency contraceptives as well as provide EC to victims upon request. This EC bill passed through the Senate, amended to include a conscience clause with a duty to refer, but was never scheduled for a House hearing. It has not been determined whether it will be introduced again at the next session. The Arizona Pharmacy Association hopes to have a dialogue with Senator Binder before the 2004 session to get pharmacists recognized in the ER legislation.
Arizona has a Family Planning Coalition which includes: AZ Public Health Association, County Health Departments, Planned Parenthood affiliates, AZ Family Planning Council, AZ NOW (National Organization for Women), BPW (Business and Professional Women) Arizona, Health Plans, ACLU (American Civil Liberties Union), and League of Women Voters.
Advocates have been in dialogue with pharmacists around vaccination provisions. There is interest in modifying the pharmacy practice act to make collaborative practice agreements a useful mechanism to provide EC pharmacy access.
Trainings on EC for family planning providers are conducted by the Center for Health Training.
CONTACTS
Mindy Rasmussen
Director
Arizona Pharmacy Alliance
1845 East Southern Avenue
Tempe, Arizona 85282-5831
480-838-3385
Fax: 480-838-3557
director@azpharmacy.org
www.azpharmacy.org
Ginger Yrun
Director
University of AZ Health Policy and Law Initiative
4001 N. 3rd Street, Suite 415
Phoenix, AZ 85012-2085
520-626-9640
Fax: 520-626-7382
vyrun@email.arizona.edu
Charlotte Harrison
Executive Director
Arizona Family Planning Council
2920 N. 24th Avenue, Suite 26
Phoenix, AZ 85015
602-258-5777
Fax: 602-252-3708
charrison@azfpc.org
www.azfpc.org
Amy Kobeta
Director of Public Affairs
Planned Parenthood of Central and Northern Arizona
5651 North 7th Street
Phoenix, AZ 85014
602-263-4223
Fax: 602-277-5243
akobeta@ppcna.org
www.ppcna.org
Patti Caldwell
President/CEO
Planned Parenthood of Southern Arizona
2255 N. Wyatt
Tucson, AZ 85712
520-624-1761 x211
520-784-5811 (direct line)
Fax: 520-622-8743
Patti_Caldwell@ppfa.org
Jonathan Pinkney-Baird
Vice President of External Affairs
Planned Parenthood of Southern Arizona
2255 North Wyatt Dr.
Tucson, AZ 85712
520-784-5809
Jonathan.Pinkney-Baird@ppfa.org
www.ppsaz.org
USEFUL LINKS
Arizona State Board of Pharmacy
www.pharmacy.state.az.us
Arizona Pharmacy Association
www.azpharmacy.org
Arizona State Legislature
www.azleg.state.az.us
Arizona Family Planning Council
www.azfpc.org
Planned Parenthood of Southern Arizona
www.ppsaz.org
Planned Parenthood of Central and Northern Arizona
www.ppcna.org
PROTOCOL ENVIRONMENT
Possible 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 on a practical basis would require:
- Revising statute to authorize collaborative practice agreements in any pharmacy setting. (Current authority is limited to hospitals, staff model of a health care services organization, nursing care institution with an on-site pharmacy, contractual relationship with a pharmacy service, or long-term care consultant pharmacist, qualifying community health care center with an on-site pharmacy.)
- Modifying the requirement for a patient-specific protocol
- Modifying the current training and education requirements
- Promulgation, review and adoption of implementing regulations by both the Board of Pharmacy and the allopathic board of medical examiners and the board of osteopathic examiners in medicine and surgery
PHARMACY PRACTICE ACT
Pharmacy 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.
ARIZONA
Under current law, only pharmacists in the following health care facilities may initiate drug therapy under a collaborative agreement that is: 1) written for an individual patient by the diagnosing physician; 2) approved annually by the Board after review by the Board’s Drug Therapy Management Advisory Committee, and 3) complies with newly promulgated regulations:
- hospital,
- staff model of a health care services organization,
- nursing care institution that has an on site pharmacy or contractual relationship with a pharmacy service or long-term care consultant pharmacist, or
- a qualifying community health care center with an on-site pharmacy.
On November 9, 2002 the Board adopted regulations implementing this statutory section after approval by the state medical board and the state board of osteopathic examiners. Under those rules, the pharmacist’s scope of practice is defined by the drug therapy management agreement which must include, most notably:
- the specific drug therapy (and modifications) authorized and the criteria for implementing (or modifying) it;
- patient assessment criteria to be used at each patient visit;
- the provision of written status reports to the supervisory physician; and
- designation of an alternate physician covering for the supervisory physician.
The pharmacist must also submit a comprehensive application form with the proposed collaborative agreement, including proof of completion of at least one of four enumerated residencies or certificate programs and annual completion of 0.6 CEU’s.
The pharmacist must file in the patient’s record the collaborative agreement, physician’s order and patient consent form for review by the patient’s other health care providers. He must also document all activities pursuant to the agreement, implement a quality assurance program, and provide a “private and distinct” area for drug therapy management. Pharmacists and physicians explicitly remain liable for a range of negligent acts.
According to the Board’s latest newsletter (April 2003), “drug therapy management opportunities remain an unfulfilled expectation. At the time this Newsletter was written, one participant remains to be named to serve on the review panel.”
Current law does not explicitly authorize pharmacists to administer medications, such as immunizations or an emergency contraceptive.
Statutory Authority: Provided in the sections of the “Pharmacy” chapter governing Definitions and “Implementing, Monitoring and Modifying Drug Therapy and Use,” Ariz. Rvsd. Stats. §§ 32-1901 and 1970 (April 11, 2002)
Regulatory Authority: Provided in the Board’s regulations governing “Definitions” and “Drug Therapy Management”, Arizona Administrative Code, Title 4, Chapter 23 Board of Pharmacy, Section R4 23-110 and (new) Sections R4 23-421-429 (effective Nov. 9, 2002).
ARIZONA STATUTE
TITLE 32: Professions and Occupations
CHAPTER 18: Pharmacy
CHAPTER 18 - PHARMACY
Article 1 - Board of Pharmacy
32-1901. Definitions
In this chapter, unless the context otherwise requires:
1. “Administer” means the direct application of a controlled substance, prescription-only drug, dangerous drug or narcotic drug, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by a practitioner or by his authorized agent or the patient or research subject at the direction of the practitioner.
. . .
21. “Dispense” means to deliver to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling or compounding necessary to prepare for that delivery.
…
25. “Drug” means:
(a) Articles recognized, or for which standards or specifications are prescribed, in the official compendium.
(b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in the human body or other animals.
(c) Articles other than food intended to affect the structure or any function of the human body or other animals.
(d) Articles intended for use as a component of any articles specified in subdivision (a), (b) or (c) of this paragraph but does not include devices or their components, parts or accessories.
32-1970. Implementing, monitoring and modifying drug therapy and use; conditions; definitions
A. A pharmacist licensed pursuant to this chapter may implement, monitor and modify drug therapy and use only under the following circumstances:
- 1. The patient's drug therapy and use are pursuant to a diagnosis by a physician licensed pursuant to chapter 13 or 17 of this title in an inpatient setting except for health care provided pursuant to paragraph 4, subdivisions (b) and (d) of this subsection.
- 2. The pharmacist complies with rules adopted by the state board of pharmacy that have been approved by the allopathic board of medical examiners and the board of osteopathic examiners in medicine and surgery.
- 3. The pharmacist follows the written drug therapy management protocols prescribed by the physician who made the diagnosis.
- 4. The pharmacist implements, monitors or modifies a person's drug therapy and use only in the following health care institutions:
- (a) A hospital as defined in section 32-1901.
- (b) A staff model of a health care services organization.
- (c) A nursing care institution that has a contractual relationship between a limited service pharmacy or a long-term care consultant pharmacist or has an on-site pharmacy.
- (d) A qualifying community health center as defined in section 32-1921 that has an on-site pharmacy.
- 5. The pharmacist includes the approved guidelines and protocols in the patient's chart or file and makes the chart or file available for review by the patient's other health care providers.
B. A licensee who violates this section commits an act of unprofessional conduct.
C. A pharmacist is responsible for the pharmacist's negligent acts that are the result of the pharmacist's change of medication or that relate to patient drug usage pursuant to drug therapy management protocols. This subsection does not limit a physician's liability for negligent acts that are not related to a pharmacist's change of medication pursuant to the protocols.
D. For the purposes of this section:
- 1. “Implement, monitor and modify” means that a pharmacist may perform specific acts as authorized by a physician pursuant to written guidelines and protocols. This does not include the selection of drug products not prescribed by the physician unless selection of the specific drug product is authorized by the written guidelines and protocols.
- 2. “Long-term care consultant pharmacist” means a pharmacist providing consulting services to a long-term care facility.
- 3. “Protocol” means a physician's written order, written standing medical order or other written order of protocol as defined by rules adopted by the Arizona board of medical examiners and the Arizona board of osteopathic examiners in medicine and surgery and that are patient, physician and pharmacist specific for prescriptions or orders given by the physician authorizing the written protocol.
- 4. “Staff model of a health care services organization” means an organization that is licensed pursuant to title 20 and that employs its health care providers.
ARIZONA REGULATIONS
Arizona State Board of Pharmacy
Title 4. Professions and Occupations
CHAPTER 23. BOARD OF PHARMACY
ARTICLE 1. ADMINISTRATION
R4-23-110. Definitions
“Alternate physician” means a physician licensed under A.R.S. Title 32 Chapter 13 or 17 who signs a drug therapy management agreement to temporarily assume responsibility for supervision and evaluation of the drug therapy management performed by a pharmacist when the supervisory physician is unavailable by direct telecommunication or physical presence at the practice site.
…
“Drug therapy management” means any act or service provided by a pharmacist in compliance with a Board-approved drug therapy management agreement.
“Drug therapy management agreement” means a written protocol, approved and signed by a supervisory physician, alternate physician, and pharmacist that specifies the conditions under which a pharmacist:
- [-] Assesses patient status;
- [-] Orders and interprets laboratory tests; and
- [-] Modifies, implements, or monitors patient drug therapy.
…
“Supervisory physician” means a physician licensed under A.R.S. Title 32 Chapter 13 or 17 who:
- [-] Writes an order in a patient's medical record and signs a drug therapy management agreement authorizing a pharmacist to provide patient-specific drug therapy management, and
- [-] Assumes responsibility for the on-going supervision and evaluation of the drug therapy management performed by the pharmacist.
Historical Note: Adopted effective August 24, 1992 (Supp. 92-2). . . Amended by final rulemaking at 8 A.A.R. 4052, effective November 9, 2002 (Supp. 02-3). Amended by final rulemaking at 8 A.A.R. 4898 and 8 A.A.R. 4902, effective January 5, 2003 (Supp. 02-4). Amended by final rulemaking at 9 A.A.R. 1064, effective May 4, 2003 (Supp. 03-1).
ARTICLE 4. PROFESSIONAL PRACTICES
R4-23-421. Drug Therapy Management
A. A pharmacist qualified under R4-23-424 may provide drug therapy management under A.R.S. § 32-1970 after a physician's initial diagnosis of a patient if drug therapy management:
- 1. Is guided by a Board-approved drug therapy management agreement; and
- 2. Occurs in one of the following pharmacy practice sites:
- a. An acute care hospital,
- b. A nursing care institution,
- c. A staff model HMO, or
- d. A community health center as defined in A.R.S. § 32-1921 and A.R.S. § 36-2907.06.
B. A drug therapy management agreement shall contain the following:
- 1. The criteria and medical conditions under which the pharmacist may modify the patient's drug therapy;
- 2. The specific modifications of drug therapy that a pharmacist may make including drug, dose, and dosage form;
- 3. The criteria and medical conditions under which a pharmacist may implement a patient’s drug therapy;
- 4. The specific drug therapy that a pharmacist may implement including drug, dose, and dosage form;
- 5. The subjective and objective patient assessment parameters that a pharmacist uses to evaluate a patient's drug therapy at each patient visit, including ordering and interpreting a patient's laboratory tests;
- 6. The subjective and objective patient assessment criteria that indicate when a pharmacist shall consult with a supervisory physician or if unavailable, an alternate physician, including the timing and nature of a consultation with or referral to a supervisory or alternate physician and the specific procedures for a consultation with or referral to a supervisory or alternate physician;
- 7. The content and frequency of the periodic status report on a patient that a pharmacist shall provide in writing to or in a meeting with the supervisory physician;
- 8. The procedure for terminating the drug therapy management agreement;
- 9. The names of the supervisory physician, the alternate physician, and the pharmacist authorized to provide services under the agreement; and
- 10. The signature of all persons named in subsection (B)(9).
R4-23-422. Drug Therapy Management - Duties of the Board
A. The Board shall:
- 1. Appoint a Drug Therapy Management Advisory Committee;
- 2. In consultation with Board staff and the Drug Therapy Management Advisory Committee, approve or deny an initial drug therapy management agreement and the annual renewal of an existing drug therapy management agreement;
- 3. Terminate a pharmacist's drug therapy management agreement if the pharmacist:
- a. Does not renew the agreement on or before the approval date anniversary; or
- b. Is found by the Board to lack the qualifications required in R4-23-424; and
- 4. In processing a drug therapy management agreement application, comply with the application process established in R4-23-602 [note: this section governs Permit Application Process and Time-frames], except the substantive review time-frame is 180 days and the overall time-frame is 200 days.
B. The Board may terminate a pharmacist's drug therapy management agreement if the Board determines that the pharmacist is violating the requirements of the drug therapy management agreement or federal or state drug laws.
R4-23-423. Drug Therapy Management Advisory Committee
A. The Drug Therapy Management Advisory Committee shall:
- 1. Consist of an osteopathic physician, an allopathic physician, and two pharmacists with prior or current experience in drug therapy management;
- 2. Serve at the pleasure of the Board;
- 3. Serve for a term of two years unless removed or reappointed by the Board;
- 4. Review initial and renewal drug therapy management agreement applications; and
- 5. Advise the Board regarding the approval or denial of reviewed drug therapy management agreement applications.
B. The Drug Therapy Management Advisory Committee members are not eligible for compensation from the Board.
R4-23-424. Drug Therapy Management - Pharmacist and Physician Qualifications
A. Pharmacist qualifications.
- 1. Before initiating a drug therapy management agreement with a supervisory physician, a pharmacist shall have:
- a. A current, unrestricted license issued by the Board; and
- b. Proof of one of the following:
- i. Completion of a pharmacy practice residency accredited by the American Society of Health Systems Pharmacists or the American Pharmaceutical Association;
ii. Current board specialty certification from the Board of Pharmaceutical Specialists or current certification as a Certified Geriatric Pharmacist;
- iii. A Doctor of Pharmacy degree and completion of an American Council on Pharmaceutical Education approved certificate program in each area of practice covered in the drug therapy management agreement; or
- iv. A Bachelor's degree in Pharmacy, satisfactory completion of an American Council on Pharmaceutical Education approved certificate program in each area of practice covered in the drug therapy management agreement, and appropriate credentialing issued by the governing body of a qualifying Arizona practice site described in A.R.S. § 32-1970.
- 2. To ensure that a pharmacist who provides drug therapy management is competent to continue providing the services delineated in a drug therapy management agreement, a pharmacist shall annually complete six contact hours (0.6 CEU's) of continuing education for each area of practice covered by the pharmacist's drug therapy management agreement. The continuing education hours may be used to satisfy the continuing education requirements for licensure as a pharmacist.
B. Supervisory physician qualifications. Before initiating a drug therapy management agreement with a pharmacist, a supervisory physician shall:
- 1. Have a current, unrestricted license from the Allopathic Board of Medical Examiners or the Board of Osteopathic Examiners in Medicine and Surgery; and
- 2. Not be a resident in a post-graduate medical training program.
C. Alternate physician qualifications. Before initiating a drug therapy management agreement with a pharmacist, an alternate physician shall:
- 1. Have a current, unrestricted license from the Allopathic Board of Medical Examiners or the Board of Osteopathic Examiners in Medicine and Surgery; and
- 2. Not be a resident in a post-graduate medical training program.
R4-23-425. Drug Therapy Management - Pharmacist Duties
A. To obtain initial approval for a drug therapy management agreement, a pharmacist shall submit a completed application, on a form furnished by the Board, that includes:
- 1. Pharmacist name and Arizona pharmacist license number;
- 2. Documentation of a pharmacist's qualifications as specified in R4-23-424;
- 3. Practice site name, address, mailing address, if different, telephone number, and facsimile number;
- 4. Documentation of practice site qualification under A.R.S. § 32-1970;
- 5. Supervisory physician name, office address, mailing address, if different, telephone number, and facsimile number;
- 6. Documentation of a supervisory physician's qualifications as specified in R4-23-424;
- 7. Alternate physician name, office address, mailing address, if different, telephone number, and facsimile number;
- 8. Documentation of an alternate physician's qualifications as specified in R4-23-424;
- 9. Description of the pharmacist's practice area or areas for which approval is sought;
- 10. An original and 11 copies of the drug therapy management agreement covering each practice area for which Board approval is sought;
- 11. Dated and signed affirmation of the supervisory physician’s acceptance of the responsibility for oversight of the pharmacist's drug therapy management;
- 12. Dated and signed affirmation of an alternate physician's acceptance of the responsibility for temporary oversight of the pharmacist's drug therapy management; and
- 13. Dated and signed affirmation of the pharmacist's acceptance of the responsibility to provide drug therapy management as described in the drug therapy management agreement.
B. To renew an existing drug therapy management agreement, a pharmacist shall submit a completed renewal application, on a form furnished by the Board, that includes, in addition to the requirements of subsection (A), the following:
- a. Documentation that the supervisory physician, alternate physician, and participating pharmacist reviewed the protocols contained in the agreement;
- b. Documentation that the participating pharmacist completed the continuing education requirements specified in R4-23-424; and
- c. An original and 11 copies of the drug therapy management agreement covering each practice area for which renewal is sought, including highlighting any requested modifications to the agreement.
C. A pharmacist who participates in a Board-approved drug therapy management agreement shall:
- 1. Renew the agreement annually on or before the initial approval date anniversary;
- 2. Before submitting the application to renew the agreement, participate with the supervisory physician in reviewing the agreement;
- 3. Notify the Board within ten days of termination of the drug therapy management agreement.
- 4. During the first appointment with a patient under a Board-approved drug therapy management agreement:
- a. Verify that a copy of the drug therapy management agreement which includes the signature of the supervisory physician, alternate physician, and pharmacist, is placed in the patient’s record;
- b. Verify that a copy of the supervisory physician's written order, which authorizes the pharmacist to collaboratively manage the patient's drug therapy, is placed in the patient's medical record;
- c. Verify that a copy of the patient's written consent, which shows that the patient understands the pharmacist's role in the patient's care, the nature of the relationship with the supervisory physician, and the procedure for revoking consent, is placed in the patient’s record;
- 5. Ensure compliance with the documentation requirements of R4-23-427;
- 6. Ensure compliance with quality assurance program required in R4-23-428;
- 7. Ensure compliance with the privacy requirements of R4-23-429; and
- 8. Comply with the Board-approved drug therapy management agreement.
R4-23-426. Drug Therapy Management - Physician Duties
A. Before referring a patient to a pharmacist, a supervisory physician who participates in a Board-approved drug therapy management agreement shall:
- 1. Have a physician-patient relationship with the patient and make a diagnosis of the patient;
- 2. Review the approved drug therapy management agreement with the patient;
- 3. Obtain the patient's consent to participate in the drug therapy management agreement;
- 4. Document the patient's consent to participate in the drug therapy management agreement by obtaining the patient's dated and signed consent that states that the patient has read, understood, and agreed to participate in the drug therapy management agreement. The dated and signed consent shall be placed in the patient's medical records;
- 5. Authorize a specific pharmacist to collaboratively manage a patient's drug therapy by placing a written order in the patient's medical record; and
- 6. Place a copy of the approved drug therapy management agreement in the patient's medical record to provide notice to other health care providers of the drug therapy management.
B. Physician supervision. A supervisory physician who supervises a pharmacist under a Board-approved drug therapy management agreement shall:
- 1. Before submitting the application to renew the agreement and in consultation with the participating alternate physician and pharmacist, review and approve the drug therapy management agreement;
- 2. Review and initial the pharmacist's documented care for appropriateness of care and compliance with the drug therapy management agreement when the patient visits the supervisory physician for follow-up or any other services;
- 3. Routinely evaluate the patient care provided by the pharmacist as specified in the drug therapy management agreement; and
- 4. Ensure that the supervisory physician or the alternate physician named in the drug therapy management agreement is readily available to the pharmacist for consultation, assistance, and direction by direct telecommunication or physical presence at the practice site.
C. Alternate physician duties. An alternate physician who participates in a Board-approved drug therapy management agreement shall ensure that the alternate physician is available to:
- 1. Temporarily assume responsibility for supervision and evaluation of the drug therapy management performed by the pharmacist;
- 2. Provide consultation, assistance, and direction to the pharmacist if the supervisory physician is unavailable; and
- 3. Before submitting the application to renew the agreement, participate with the supervisory physician and pharmacist in reviewing the agreement.
R4-23-427. Drug Therapy Management - Documentation
Documenting pharmacist-provided drug therapy management. A pharmacist who participates in drug therapy management under a Board-approved drug therapy management agreement shall:
1. After each patient-pharmacist appointment, document the drug therapy management for the patient in the patient's medical record at the practice site, including patient data, assessment of patient status, and treatment plan;
2. Date and sign the documentation required in subsection (1) in a patient's medical record with the pharmacist's first and last name, title, and Arizona pharmacist license number;
3. Document a consultation with or referral to the supervisory physician or the alternate physician; and
4. Document a consultation with a supervisory or alternate physician that results in a pharmacist's need to generate the physician's verbal prescription order for a drug not included in the drug therapy management agreement. The documentation shall include:
- a. The phrase “verbal order by Dr.” and the name of the supervisory physician or alternate physician authorizing the verbal prescription order,
- b. The signature of the pharmacist generating the verbal prescription order in the same manner described in subsection (2), and
- c. The countersignature of the supervisory physician or alternate physician authorizing the verbal prescription order within 72 hours of the pharmacist-generated verbal prescription order.
R4-23-428. Drug Therapy Management - Quality Assurance
A. A pharmacist who provides drug therapy management shall, in cooperation with the supervisory physician and the appropriate committee of the practice site, develop and implement a continuous quality assurance and improvement program that includes standards and procedures to identify, evaluate, and improve the quality of pharmacist-provided drug therapy management.
B. Periodic status reports or meetings between a pharmacist and supervisory physician regarding care of a patient under the drug therapy management agreement shall include evaluating and documenting patient status and the quality of care provided by the pharmacist.
R4-23-429. Drug Therapy Management - Privacy
1. A pharmacist who provides drug therapy management shall perform drug therapy management activities in a private and distinct area of the practice site.
2. In a practice site where a pharmacist provides drug therapy management under a drug therapy management agreement, a pharmacy permittee shall ensure that a private and distinct area of similar size and environment to those utilized by other primary care providers at the practice site is available for the performance of pharmacist-provided drug therapy management activities.
Historical Note: New Section[s 421-429] made final by rulemaking at 8 A.A.R. 4052, effective November 9, 2002 (Supp. 02-3).
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