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Report of the Second Meeting of the 2005-2006 Task Force on Telepharmacy and the Implementation of the Medicare Drug Benefit Medication Therapy

Management Provisions

Members Present:

Susan Ksiazek (NY), Chair; Monica K. Franklin (TN); Dan Luce (Walgreens); Michael A. Podgurski (PA); Mary Ryan (Medco); and Hal Wand (AZ). Members Not Present:

Stephen R. Statz (SD); and Woodrow Storey (NM).

Others Present:

Gary A. Schnabel, Executive Committee Liaison; Oren M. Peacock, Representative from the 2005-2006 Committee on Law Enforcement/Legislation, Carmen Catizone, Melissa Madigan, and Chris Siwik, NABP staff.

Introduction:

The second meeting of the 2005-2006 Task Force on Telepharmacy and the Implementation of the Medicare Drug Benefit Medication Therapy Management Provisions (Task Force) took place May 18-19, 2006. The Task Force requested this second meeting at the conclusion of its first meeting since it was unable to complete its charge due to the magnitude of the topic and time limitations. Review of the Task Force Charge:

Task Force members reviewed their charge and accepted it as follows:

The Task Force will review its work to date1, review existing state regulations relating to the practice of telepharmacy, and develop model legislation/regulations to address the provision of pharmacist care across state borders considering the medication management therapy provisions of the Medicare Drug Benefit. Overview of Presentations:

Melissa Madigan, NABP staff member, provided an overview of the report of the first Task Force meeting and reviewed relevant recommendations of the 2005-2006 Committee on Law Enforcement/Legislation.

Recommendations:

After significant discussion, the Task Force made the following recommendations to the NABP Executive Committee.

1 See attached APPENDIX A: Report of the 2005-2006 Task Force on Telepharmacy and the Implementation of the Medicare Drug Benefit Medication Therapy Management Provisions (First Report)

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Recommendation 1: The Task Force recommends the following amendments to the Definitions section of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act). These recommendations are made in the context of the evolving practice of pharmacy, including pharmacist care and medication therapy management services, and the evolving practice of telepharmacy.

The revisions recommended by the initial Task Force are denoted by single underlined text and single strikethrough text and revisions recommended at the second meeting of the Task Force are denoted by double underlined text and double strikethrough text.

Article I

Title, Purpose, and Definitions …

Section 104. Practice of Pharmacy. The “Practice of Pharmacy” means the interpretation, evaluation, and implementation of Medical Orders; the Dispensing of Prescription Drug Orders; participation in Drug and Device selection; Drug Administration; Drug Regimen Reviews; the Practice of Telepharmacy within and across state lines; Drug or Drug-related research; the provision of Patient Counseling; and the provision of those acts or services necessary to provide Pharmaceutical Pharmacist Care in all areas of patient care, including Primary Care and Collaborative Pharmacy Practice; and the responsibility for Compounding and Labeling of Drugs and Devices (except Labeling by a Manufacturer, Repackager, or Distributor of Non-Prescription Drugs and commercially packaged Legend Drugs and Devices), proper and safe storage of Drugs and Devices, and maintenance of proper required records for them.

Section 105. Definitions.

“Centralized Prescription Filling” means the filling by a Pharmacy of a request from another Pharmacy to fill or refill a Prescription Drug Order. “Centralized Prescription Processing” means the functions performed processing by a Pharmacy or Pharmacist of a at the request from of another Pharmacy to fill or refill a Prescription Drug Order or to perform processing functions such as Dispensing, Drug Regimen Review, claims adjudication, refill authorizations, and therapeutic interventions. “Collaborative Pharmacy Practice Agreement” is a written and signed agreement between one or more Pharmacists and one or more Practitioners that provides for Collaborative Pharmacy Practice for the purpose of conducting Medication Drug Therapy Management of patients activities, as defined by law and the Rules of the Board. “Central Coordinating Pharmacy” is a Pharmacy responsible for the Practice of Telepharmacy performed at Remote Pharmacies and Remote Dispensing Sites.

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“Drug Regimen Review” includes but is not limited to the following activities:

(1) Evaluation of the Prescription Drug Order(s) and patient record(s) for:

(i) known allergies;

(ii) rational therapy- contraindications;

(iii) reasonable dose, duration of use, and route of Administration, considering age, gender, and other patient factors; and

(iv) reasonable directions for use;

(v) potential or actual adverse Drug reactions;

(vi) Drug-Drug interactions;

(vii) Drug-food interactions;

(viii) Drug-disease contraindications;

(ix) Therapeutic duplication;

(x) Proper utilization (including over- or under-utilization), and optimum therapeutic outcomes; and

(xi) abuse/misuse.

(2) Evaluation of the Prescription Drug Order(s) and patient record(s) for duplication of therapy.

(3) Evaluation of the Prescription Drug Order(s) and patient record(s) for interactions:

(i) Drug-Drug;

(ii) Drug-food;

(iii) Drug-disease; and

(iv) Adverse Drug reactions..

(4) Evaluation of the Prescription Drug Order(s) and patient record(s) for proper utilization (including over- or under-utilization), and optimum therapeutic outcomes.

“Drug Therapy Management” means the review of Drug therapy regimen(s) of patients by one or more Pharmacists for the purpose of evaluating and rendering advice to one or more Practitioners regarding adjustment of the regimen. Decisions involving Drug Therapy Management shall be made in the best interest of the patient. “Drug Therapy Management” may include:

(1) Implementing, modifying, and managing Drug therapy according to the terms of the Collaborative Pharmacy Practice Agreement;

(2) Collecting and reviewing patient histories;

(3) Obtaining and checking vital signs, including pulse, temperature, blood pressure, and respiration;

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(4) Ordering and evaluating the results of laboratory tests directly to Drug therapy, when performed in accordance with approved protocols applicable to the practice setting; and

(5) Such other patient care services as may be allowed by law. “Medication Therapy Management” is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication or a medical device. Medication Therapy Management encompasses a broad range of professional activities and responsibilities within the licensed Pharmacist’s scope of practice. These services may include but are not limited to the following, according to the individual needs of the patient:

(1) Performing or obtaining necessary assessments of the patient’s health status;

(2) Formulating a medication treatment plan; (3) Selecting, initiating, modifying, or administering medication therapy; (4) Monitoring and evaluating the patient’s response to therapy, including

safety and effectiveness; (5) Performing a comprehensive medication review to identify, resolve, and

prevent medication-related problems, including adverse drug events; (6) Documenting the care delivered and communicating essential information

to the patient’s other primary care providers; (7) Providing verbal education and training designed to enhance patient

understanding and appropriate use of his/her medications; (8) Providing information, support services and resources designed to enhance

patient adherence with his/her therapeutic regimens; (9) Coordinating and integrating Medication Therapy Management services

within the broader health care-management services being provided to the patient; and

(10) Such other patient care services as may be allowed by law.

“Pharmaceutical Pharmacist Care” is the provision by a Pharmacist of Drug therapy and other patient care services Medication Therapy Management Services, with or without the Dispensing of Drugs or Devices, 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.

“Pharmacist” means an individual currently licensed by this State to engage in the Practice of Pharmacy. A Pharmacist is entitled to engage in the Practice of Pharmacy, as defined by this chapter, within or outside of a licensed Pharmacy as defined in the Rules of the Board.

“Pharmacy” means any place within this State where Drugs are Dispensed and Pharmaceutical Pharmacist Care is provided and any place outside of this State where

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Drugs are Dispensed and Pharmaceutical Pharmacist Care is provided to residents of this State. “Practice of Telepharmacy” means the provision of Pharmaceutical Pharmacist Care by registered Pharmacies and Pharmacists located within US jurisdictions through the use of telecommunications or and other technologies to patients or their agents at a distance that are located within US jurisdictions.

“Practice of Telepharmacy Across State Lines” means the Practice of Telepharmacy when the patient is located within a US jurisdiction and the Pharmacist is located in a different US jurisdiction.

“Primary Care” is the first level of contact of individuals, the family, and the community with the health care delivery system, bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care process. (Areas of Primary Care where Pharmacists provide Pharmaceutical Pharmacist Care include, but are not limited to, the following: chronic disease management; smoking cessation; maternal and child health; immunizations; family planning; self-care consulting; Drug selection under protocol; treatment of common diseases and injuries; nutrition; and general health education and promotion.) “Remote Dispensing Site” is a site located within an Institutional Facility or outpatient a clinic that utilizes an Automated Pharmacy System and that is electronically linked to the Central Coordinating Pharmacy via a computer system and/or a video/auditory communication system approved by the Board.

“Remote Pharmacy” is a Pharmacy staffed by a Pharmacist, Pharmacy Intern, or Certified Pharmacy Technician that is electronically linked to the Central Coordinating Pharmacy via a computer system and/or a video/auditory communication system approved by the Board.

Comments Section 104. Comment. The definition of the “Practice of Pharmacy” is one of the most important, and perhaps one of the most discussed, clauses in the NABP Model Act. The definition is purposely expressed in broad terms to provide substantial latitude to the Board of Pharmacy in the adoption of implementing rules. Additionally, the definition limits certain activities to performance by Pharmacists only, while allowing qualified personnel to assist Pharmacists in practice. That distinction is noted by listing activities that must be performed by the Pharmacist, such as the interpretation, evaluation, and implementation of Medical Orders; the Dispensing of Prescription Drug Orders; participation in Drug and Device selection; Drug Administration; Drug Regimen Reviews; the Practice of Telepharmacy within and across state lines; Drug or Drug-related research; the provision of Patient Counseling; and the provision of those acts or services necessary to provide Pharmaceutical Pharmacist Care in all areas of patient care, including Primary Care and

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Collaborative Pharmacy Practice,; and other tasks that the Pharmacist has responsibility for, such as Compounding and Labeling of Drugs and Devices (except Labeling by a Manufacturer, Repackager, or Distributor of Non-Prescription Drugs and commercially packaged Legend Drugs and Devices),; the proper and safe storage of Drugs and Devices, and maintenance of proper records for them. The deliberate distinction between the terms “must perform” and “is responsible for” intends to allow delegation of tasks to Certified Pharmacy Technicians or Pharmacy Technicians.

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Section 105(___). Comment. A “reasonable” dose, duration of use, and route of administration under “Drug Regimen Review” would be determined by taking into consideration patient-specific factors, including but not limited to age, gender, and other patient factors, but dependent upon the information about the patient known to the pharmacist.

Section 105(uuu). Comment. “Pharmaceutical Care” encompasses the process through which Pharmacists, in cooperation with the patient and other professionals, design, implement, and monitor a therapeutic plan for the purpose of improving a patient’s quality of life. Objectives of Pharmacist Care include cure of a disease, elimination or reduction of a patient’s symptomatology, arresting or slowing of a disease process, or prevention of a disease or symptomatology. The process includes three primary functions: (1) identifying potential and actual Drug-related problems; (2) resolving actual Drug-related problems; and (3) preventing potential Drug-related problems. Pharmaceutical Pharmacist Care should be provided by all Pharmacists to the extent of their abilities regardless of the practice setting. …

Section 105(eeee). Comment. When the The “Practice of Telepharmacy“ is deemed to occurs within the jurisdiction in which the patient is located and the jurisdiction(s) in which the pharmacist and, if applicable, pharmacy are located, therefore, then such practice should will be subject to the Pharmacy practice regulations of that all jurisdiction’s’ Boards of Pharmacy.

Section 105(___). Comment. The Board may want to consider allowing only Institutional Facilities that are licensed by the State to utilize a “Remote Dispensing Site.”

Background:

This Task Force agreed in concept to the addition of “Central Pharmacy,” “Remote Pharmacy,” and “Remote Dispensing Site” to the Model Act, as recommended by the Task Force at their first meeting, so as to provide a regulatory framework for a variety of models of telepharmacy practice via remote pharmacies and remote dispensing sites, as illustrated in states like North Dakota, Texas, and Missouri. In an effort to distinguish this

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practice from that of Central Filling, the Task Force, at its second meeting, felt a change in the term “Central Pharmacy” was in order and agreed to replace it with “Coordinating Pharmacy.” To further distinguish these practices, the Task Force felt it was important to distinguish centralized prescription processing activities from centralized prescription filling activities, thus the new term “Centralized Prescription Filling” was recommended for incorporation. Next, the Task Force agreed that the term “Pharmaceutical Care” in the Model Act should be changed to “Pharmacist Care” in an effort to reflect current and future pharmacy practice activities, and to recognize that the term “pharmaceutical care” has a currently accepted definition within the profession. (Note that the term “Pharmaceutical Care” would be replaced by “Pharmacist Care” throughout the Model Act, as each of these replacements may not be indicated in this report.) Additionally, the Task Force recommended the incorporation of the profession-wide accepted definition of “Medication Therapy Management,” also in an effort to reflect current and future pharmacy practice activities. In addition, the Task Force discussed the practice of telepharmacy across state lines. Recognizing that this practice is growing, especially with the advent of Medicare reimbursing for medication therapy management services, the Task Force felt it was appropriate to recognize by incorporating a definition for the “Practice of Telepharmacy Across State Lines” into the Model Act, with the goal of regulating it by various suggested mechanisms discussed later in the meeting and in this report. All other edits to the Definitions section were made to incorporate as necessary the amendments previously discussed, to clarify vague or ambiguous language, to remove excess, unnecessary, or inconsistent wording, or for grammatical purposes or other issues with wording consistency.

Recommendation 2: The Task Force recommends that the Model Act’s “Model Rules for Pharmaceutical Care” be renamed “Model Rules for the Practice of Pharmacy” to reflect their true scope.

The revisions recommended at the second meeting of the Task Force are denoted by double underlined text and double strikethrough text.

Model Rules for Pharmaceutical Care the Practice of Pharmacy

Background:

With the term “Pharmacist Care” recommended for incorporation into the Model Act and the term “Pharmaceutical Care” recommended for deletion, the Task Force felt it important to look at the title of the “Model Rules for Pharmaceutical Care” for appropriateness. The Task Force found these Model Rules to regulate many more activities than just pharmaceutical or pharmacist care activities, agreeing that it covered

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the vast majority of the practice of pharmacy, thus the recommendation that the title be changed to “Model Rules for the Practice of Pharmacy.”

Recommendation 3: The Task Force recommends that Model Act language pertaining to remote pharmacy services developed at its first meeting be amended to reflect the discussions that took place at its second meeting.

The Task Force recommends the following amendments to the Model Act. The revisions recommended by the initial Task Force are denoted by single underlined text and single strikethrough text and revisions recommended at the second meeting of the Task Force are denoted by double underlined text and double strikethrough text.


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Section 2. Personnel.

A. Duties and Responsibilities of the Pharmacist-in-Charge

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(3) The Pharmacist-in-Charge shall be assisted by a sufficient number of Pharmacists, Certified Pharmacy Technicians, and Pharmacy Technicians as may be required to competently and safely provide Pharmacy services.

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(b) The Pharmacist-in-Charge shall develop and implement written policies and procedures to specify the duties to be performed by Certified Pharmacy Technicians and Pharmacy Technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience and shall address the method and level of necessary supervision specific to the practice site. These policies and procedures shall, at a minimum, specify that Certified Pharmacy Technicians and Pharmacy Technicians are to be personally and directly supervised by a Pharmacist stationed within the same work area who has the ability to control and who is responsible for the activities of Certified Pharmacy Technicians and Pharmacy Technicians, and that Certified Pharmacy Technicians and Pharmacy Technicians are not assigned duties that may be performed only by a Pharmacist. Such policies and procedures shall also specify that Pharmacy Technicians shall not be assigned duties that may be performed only by Certified Pharmacy Technicians.

Section 3. Pharmacy Practice.

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O. Remote Pharmacy Services

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(1) General Requirements

(a) The Pharmacist-in-Charge of the Central Coordinating Pharmacy shall apply to the Board for a permit prior to engaging in the Practice of Telepharmacy via the Remote Pharmacies and Remote Dispensing Sites.

(b) A Central Coordinating Pharmacy shall demonstrate to the Board that there is limited access to pharmacy services in the community prior to engaging in the Practice of Telepharmacy via the Remote Pharmacies and Remote Dispensing Sites.

(c) One Pharmacist shall not operate more than three simultaneously-open Remote Pharmacies or Remote Dispensing Sites. An exception to this limit may be granted by the Board in situations where the Central Coordinating Pharmacy has documented a need to supervise additional Remote Pharmacies or Remote Dispensing Sites and has demonstrated that appropriate safeguards are in place to assure proper supervision of each.

(d) Remote Pharmacies that are principally staffed by Certified Pharmacy Technicians or Pharmacy Interns shall be under the continuous supervision of a Pharmacist at the Central Coordinating Pharmacy at all times that it is open to provide pharmacy services. To qualify as continuous supervision, the Pharmacist is not required to be physically present at the Remote Pharmacy, but shall supervise operations electronically through the use of a video/auditory communication system.

(e) A Central Coordinating Pharmacy shall comply with appropriate federal and state controlled substance registrations for each Remote Pharmacy or Remote Dispensing Site if controlled substances are maintained.

(f) A Central Coordinating Pharmacy shall notify the Board in writing within ten days of a change of location, discontinuance of service or closure of a Remote Pharmacy or Remote Dispensing Site operated by the Central Coordinating Pharmacy.

(2) Remote Pharmacy

A Remote Pharmacy may have a limited Drug inventory consisting of suitable unit-of-use containers Prepackaged by the Central Coordinating Pharmacy or a registered Repackager or as provided in the original Manufacturer’s container. A Remote Pharmacy may utilize an Automated Pharmacy System.

(3) Remote Dispensing Site

A Remote Dispensing Site shall utilize an Automated Pharmacy System located in an area accessible only to authorized personnel.

(4) Personnel

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(a) The Pharmacist-in-Charge of the Central Coordinating Pharmacy:

(i) is responsible for the Practice of Telepharmacy performed at Remote Pharmacies and Remote Dispensing Sites, including the supervision of any Automated Pharmacy System and compliance with these Rules;

(ii) is responsible for ensuring that the Central Coordinating Pharmacy and the Remote Pharmacy and Remote Dispensing Site have entered into a written agreement that outlines the services to be provided and the responsibilities and accountability of each party in fulfilling the terms of the agreement in compliance with federal and state laws and regulations. Such contract or agreement is not required if the Remote Pharmacy or Remote Dispensing Site are under common control or ownership of the Central Coordinating Pharmacy;

(iii) shall ensure the Central Coordinating Pharmacy has sufficient Pharmacists on duty for the safe operation and supervision of all Remote Pharmacies and Remote Dispensing Sites; and

(iv) shall ensure that the Automated Pharmacy System is in good working order and accurately Dispenses the correct strength, dosage form, and quantity of the Drug prescribed while maintaining appropriate recordkeeping and security safeguards.

(b) Pharmacists, Pharmacy Interns, and Certified Pharmacy Technicians at Remote Pharmacies shall be registered with the Board and be trained in the operation of the video/auditory communication system used for Dispensing and Patient Counseling.

(5) Operations

(a) Remote Pharmacies:

(i) that are principally staffed by Certified Pharmacy Technicians or Pharmacy Interns shall be under the personal and direct continuous supervision of a Pharmacist;

(ii) may receive Prescription Drug Orders or refill requests by the patient or the patient’s agent in accordance with the policies and procedures designated by the Pharmacist-in-Charge. The Certified Pharmacy Technician or Pharmacy Intern shall either transmit the Prescription Drug Order or refill request to the Central Coordinating Pharmacy or process the Prescription Drug Order or refill request so that the Pharmacist at the Central Coordinating Pharmacy may perform a Prospective Drug Regimen Review prior to Dispensing;

(iii) shall contain an appropriate area for Patient Counseling by the Pharmacist, if required;

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(iv) may employ Certified Pharmacy Technicians or Pharmacy Interns, whom of which shall be under the continuous supervision of a Pharmacist at the Central Coordinating Pharmacy, to assist in the Dispensing process and maintain appropriate video/auditory communication with the Central Coordinating Pharmacy; and

(v) may contain an Automated Pharmacy System or a limited Drug inventory for the purposes of preparing medications for Dispensing. The Pharmacist at the Central Coordinating Pharmacy shall have access to the Remote Pharmacy’s automated data processing system to perform a Prospective Drug Regimen Review prior to Dispensing. The Pharmacist shall ensure, through the use of the video/auditory communication system, that the Certified Pharmacy Technician or Pharmacy Intern has accurately and correctly prepared the Drug for Dispensing according to the Prescription Drug Order.

(b) Remote Dispensing Sites:

(i) that are located within an Institutional Facility shall utilize an Automated Pharmacy System for the purposes of Dispensing. The Pharmacist at the Central Coordinating Pharmacy shall have the necessary patient information to perform a Prospective Drug Regimen Review prior to Dispensing; and

(ii) that are located in outpatient clinics shall utilize an Automated Pharmacy System. Such Automated Pharmacy Systems shall be located in an area that will provide for Patient Counseling and must be installed within the same area utilized by the Practitioner for the provision of clinical services.

(6) Security

(a) Drugs shall be stored in compliance with state and federal laws and in accordance with these Rules, including those addressing temperature, proper containers, and the handling of outdated drugs.

(b) Drugs stored at Remote Dispensing Sites shall be stored in an area that is:

(i) separate from any other Drugs used by the health care facility; and

(ii) locked by key or combination, so as to prevent access by unauthorized personnel.

(c) Access to the area where Drugs are stored at the Remote Pharmacy or Remote Dispensing Site must be limited to:

(i) Pharmacists, Certified Pharmacy Technicians, Pharmacy Technicians, or Pharmacy Interns who are employed by the Central Coordinating Pharmacy; or

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(ii) Personnel employed at the Institutional Facility or clinic where the Remote Dispensing Site is located who:

(a) are licensed health care providers;

(b) are designated in writing by the Pharmacist-in-Charge or the Person responsible for the supervision and on-site operation of the facility where the Automated Pharmacy System is located; and

(c) have completed documented training concerning their duties associated with the remote site.

(d) Remote Pharmacies and Remote Dispensing Sites shall have adequate security to:

(i) comply with federal and state laws and regulations; and

(ii) maintain patient confidentiality;

(e) The Central Coordinating Pharmacy shall have procedures that specify that Drugs may only be Delivered to the Remote Pharmacy or Remote Dispensing Site by the Central Pharmacy and shall be: in accordance with the policies and procedures of the Coordinating Pharmacy.

(i) shipped in a sealed container with a list of Drugs Delivered; and

(ii) checked by personnel designated by the Pharmacist-in-Charge to verify that Drugs sent by the Central Pharmacy were actually received. The designated Person who checks the order shall document the verification by signing and dating the list of Drugs Delivered.

(7) Policies and Procedures

(a) The Central Coordinating Pharmacy, Remote Pharmacy, and Remote Dispensing Site shall operate in compliance with according to written policies and procedures that are established by the Central Coordinating Pharmacy. The policy and procedure manual shall include, but not be limited to, the following:

(i) a current list containing the name and business address of the Pharmacist-in-Charge and personnel designated by the Pharmacist-in-Charge to have access to the area where Drugs are stored at the Remote Pharmacy or Remote Dispensing Site;

(ii) duties that may only be performed by a Pharmacist;

(iii) a copy of the written agreement between the Central Coordinating Pharmacy and the Remote Pharmacy or between the Central Coordinating Pharmacy and the Institutional Facility or outpatient clinic where the Remote Dispensing Site is located. Such contract or agreement is not required if the Remote Pharmacy or Remote Dispensing Site are under common control or ownership of the Central Coordinating Pharmacy;

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(iv) date of last review and revision of policy and procedure manual; and

(v) policies and procedures for:

a. operation of the video/auditory communication system;,

b. security;,

c. sanitation;,

d. storage of Drugs;,

e. Dispensing;,

f. supervision;,

g. Drug procurement, receipt ving of Drugs, and Delivery of Drugs;,

i. Drugs may only be Delivered to the Remote Pharmacy or Remote Dispensing Site in a sealed container with a list of Drugs Delivered;

ii. Drugs Delivered to the Remote Pharmacy or Remote Dispensing Site must be checked by personnel designated by the Pharmacist-in-Charge to verify that the Drugs sent were actually received. The designated Person who checks the order shall document the verification by signing and dating the list of Drugs Delivered; and

h. Recordkeeping.

(b) A Central Coordinating Pharmacy providing pharmacy services at a Remote Pharmacy or Remote Dispensing Site shall, at least annually, review and revise as necessary its written policies and procedures, and document such review.

(c) A Central Coordinating Pharmacy providing pharmacy services at a Remote Pharmacy or Remote Dispensing Site shall maintain a written plan for recovery from an event that interrupts the ability of a Pharmacist to electronically supervise the Dispensing of Drugs at the Remote Pharmacy or Remote Dispensing Site. The written plan for recovery shall include:

(i) a statement that Drugs shall not be Dispensed at the Remote Pharmacy or Remote Dispensing Site if a Pharmacist is not able to electronically supervise such Dispensing;

(ii) procedures for response when the video/auditory communication system is experiencing downtime; and

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(iii) procedures for the maintenance and testing of the written plan for recovery.

(d) All policies and procedures must be maintained and made available for inspection by the Board in the Central Coordinating Pharmacy responsible for the Automated Pharmacy System and at the Remote Pharmacy or Remote Dispensing Site where the Automated Pharmacy System is being used.

(8) Quality Assurance

(a) A Central Coordinating Pharmacy that provides pharmacy services via a Remote Pharmacy or Remote Dispensing Site shall operate according to a written program for quality assurance that:

(i) requires continuous supervision of the Remote Pharmacy at all times the site is open to provide pharmacy services;

(ii) requires a Pharmacist of the Central Coordinating Pharmacy to be accessible to respond to inquiries or requests pertaining to Drugs Dispensed from the Remote Pharmacy or from the Automated Pharmacy System located at the Remote Dispensing Site; and

(iii) establishes procedures to test the operation of all Automated Pharmacy Systems and all video/auditory communication systems at a minimum of every six months and whenever any upgrade or change is made to the system and document the testing of each such system.

(9) Recordkeeping

(a) Required Records

(i) A Central Coordinating Pharmacy shall keep a record of all Drugs received, Dispensed, and Distributed from the Central Coordinating Pharmacy.

(ii) A Central Coordinating Pharmacy shall keep a record of all Drugs received, Dispensed, and Distributed from each Remote Pharmacy or Remote Dispensing Site.

(iii) All records of receipt, Dispensing, and Distribution shall be kept at the Central Coordinating Pharmacy. Central Coordinating Pharmacy, Remote Pharmacy, and Remote Dispensing Site records must be kept separate from each other.

(b) Inventory

(i) A Central Coordinating Pharmacy shall keep a perpetual inventory of controlled substances, and other Drugs required to be inventoried according to state and federal law, that are held in the Central Coordinating Pharmacy, each Remote Pharmacy, and each Remote Dispensing Site;

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(ii) A Central Coordinating Pharmacy shall conduct an annual non-controlled substance Drug inventory at the Central Coordinating Pharmacy and at each Remote Pharmacy or Remote Dispensing Site; and

(iii) All inventory records shall be kept at the Central Coordinating Pharmacy. The Central Coordinating Pharmacy, Remote Pharmacy, and Remote Dispensing Site inventory records must be kept separate from each other.

Comments Section 2A(3)(b). Comment

The method of and level of pharmacist supervision over technicians may vary depending on practice site. For example, supervision of technicians in a Remote Pharmacy or Remote Dispensing Site will be different than that of technicians in a retail Pharmacy setting.

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Section 3O(1). Comment. The Board may want to consider the extent to which this General Requirements section is applicable to institutional-based Remote Dispensing Sites, as such application may be subject to interpretation of existing state and federal law governing Institutional Facilities.

Section 3O(1)(a). Comment. Often the terms “licensure,” “registration,” and “permit” are used interchangeably throughout the Model Act. In the case of Remote Dispensing Sites that utilize Automated Pharmacy Systems, boards may determine that it is appropriate to issue a permit for the Automated Pharmacy System but not for the physical site where the Automated Pharmacy System is located.

Section 3O(1)(b). Comment. States will need to determine what constitutes limited access to pharmacy services in the community. For example, states may consider using parameters such as mileage or census tracts to assist in measuring the availability of pharmacies within a defined area or community. States may also consider waiving this requirement for remote pharmacy services used within an institutional system.

Section 3O(5)(b). Comment. Automated Pharmacy Systems may be operated through a variety of settings such as clinics, Institutional Facilities, and retail Pharmacies.

Background:

Substantive suggested amendments to this new language include the following:

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1. Clarifying that any clinic, not just an outpatient clinic, may be classified as a Remote Dispensing Site and, thus, may use an Automated Dispensing System;

2. Removing the requirement that pharmacist supervision of pharmacy interns and technicians be “personal and direct” and that it be described as “continuous,” finding it might be construed as too difficult, if not impossible, to personally and directly supervise someone via electronic technologies; and

3. Moving the wording addressing the delivery of pharmaceutical products to Remote Pharmacies and Remote Dispensing Sites to the “policies and procedures” section and removing the requirement that deliveries to these entities be routed through the coordinating pharmacy, recognizing current practices and that there is no added benefit to routing such shipments through the coordinating pharmacy.

Additionally, as was indicated earlier in this report, appropriate edits were made to change “Central Pharmacy” to “Coordinating Pharmacy.”

Recommendation 4: The Task Force recommends that the section on Automated Pharmacy Systems found in the Model Rules for the Practice of Pharmacy (formerly the Model Rules for Pharmaceutical Care) be amended to include the language on remote pharmacy systems developed by the Task Force at its first meeting and to reflect the discussions that took place at the second meeting.



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N. Automated Pharmacy Systems

Automated Pharmacy Systems can be utilized in licensed Pharmacies, remote locations under the jurisdiction of the Board of Pharmacy Remote Pharmacies, and Remote Dispensing Sites located within an Institutional Facility or outpatient clinic and licensed health care facilities where legally permissible and. A Pharmacist is not required to be physically present at the site of the Automated Pharmacy System if the system is supervised electronically by a Pharmacist. Automated Pharmacy Systems shall comply with the following provisions.

(1) Documentation as to type of equipment, serial numbers, content, policies and procedures, and Remote Pharmacy or Remote Dispensing Site location shall be maintained on site in the Pharmacy (or Central

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Coordinating Pharmacy) for review by the Board of Pharmacy. Such documentation shall include, but is not limited to:

(a) name and address of the Pharmacy (or Central Coordinating Pharmacy) and/or the licensed health care facility the Remote Pharmacy or Remote Dispensing Site where the Automated Pharmacy System(s) is being used;

(b) Manufacturer’s name and model;

(c) description of how the Device is used;

(d) quality assurance procedures to determine continued appropriate use of the automated Device; and

(e) policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, and malfunction; and

(f) documentation evidencing that the Automated Pharmacy System has been tested prior to initial use and on a periodic basis at each at all locations to ensure that the Automated Pharmacy System is operating properly.

(2) Automated Pharmacy Systems should be used only in settings where there is an established program of Pharmaceutical Pharmacist Care that ensures medication orders are reviewed by a Pharmacist in accordance with established policies and procedures and good Pharmacy practice.

(a) A Pharmacist shall be accessible to respond to inquiries or requests pertaining to Drugs Dispensed from the Automated Pharmacy System.

(b) Any Pharmacy (or Central Coordinating Pharmacy) that maintains an Automated Pharmacy System for the purposes of remote Dispensing to outpatients shall maintain a video/auditory communication system to provide for effective communication between the Remote Pharmacy or Remote Dispensing Site and the Pharmacist; the video/auditory communication system shall allow for the appropriate exchange of oral and written communication and Patient Counseling; if the video/auditory communication system malfunctions, then all operations of the Automated Pharmacy System at the Remote Pharmacy or Remote Dispensing Site shall cease until the system is fully functional.

(3) All policies and procedures must be maintained in the Pharmacy (or Central Coordinating Pharmacy) responsible for the system and, if the system is not located within the facility where the Pharmacy is located, at the location where the system Automated Pharmacy System and at the Remote Pharmacy or Remote Dispensing Site where the Automated Pharmacy System is being used.

Comments

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Section 3N(2)(a). Comment.

In order to facilitate communication between the Central Coordinating Pharmacy and the site where the Automated Pharmacy System is located, a Pharmacy should provide a toll-free telephone number so that the Pharmacist is accessible at all times the Automated Pharmacy System is operational.

Section 3N(2)(b). Comment.

Although an “outpatient” generally refers to a Person who receives Drugs for use outside of an Institutional Facility, the definition of “outpatient” must be defined by each state. For example, although the Model Act classifies penal institutions as a type of Institutional Facility and therefore its inmates as inpatients, the Pharmacist is exempt from providing Patient Counseling. However, some states may consider inmates of penal institutions as outpatients and therefore should decide if a video/audio communication system is required in such facilities so that the Pharmacist is able to provide Patient Counseling.

Background:

These changes reflect the Task Force’s recommendation to change the term “Central Pharmacy” to “Coordinating Pharmacy.” In addition, the Task Force clarified that automated pharmacy systems should be tested prior to initial use and on a periodic basis to ensure they are working correctly.

Recommendation 5: The Task Force recommends that NABP recognize the independent practice of pharmacy outside of a pharmacy setting by incorporating the following language into the Model Rules for the Practice of Pharmacy (formerly the Model Rules for Pharmaceutical Care).



Section 4. Privacy of Individually Identifiable Health Information Independent Practice of Pharmacists A. A Pharmacist may provide Pharmacist Care services outside of a licensed

Pharmacy if all the following conditions are met: (1) The Pharmacist has access to prescription records, patient profiles, or

other relevant medical information for purposes of Pharmacist Care services and appropriately reviews such information before performing any such functions;

(2) Access to the information described in paragraph (1) of this section is secure from unauthorized access and use, and all access by Pharmacists is documented; and

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(3) A Pharmacist providing Pharmacist Care services outside the premises of a licensed Pharmacy shall maintain the records or other patient-specific information used in such activities in a readily retrievable form in a system that is secured and managed by the pharmacy with whom the pharmacist is providing such services or, if acting independent of a pharmacy, a secure system maintained by the pharmacist. Such records or information shall:

(a) provide accountability and an audit trail; (b) be provided to the Board upon request; and (c) be preserved for a period of at least five years from the date relied

upon or consulted for the purposes of performing any such function.

Background:

With this new section, Task Force members recognized the provision of pharmacist care services outside the pharmacy setting. Acknowledging that such activities are on the rise as a result of medication therapy management services now being offered as a benefit to some Medicare recipients, members felt regulation of these activities was necessary. Of utmost concern was the protection of patient information. In a licensed pharmacy setting, current laws and rules sufficiently protect patient information. Outside a pharmacy setting, however, those protections may be lost. The Task Force felt this language remedied the issue by providing documentation, accountability, and audit trail requirements sufficient to protect patient information outside a pharmacy setting.

Recommendation 6: The Task Force recommends that NABP, in an effort to regulate the practice of telepharmacy across state lines, explore a multistate licensure approach that encompasses mutual state pharmacist licensure recognition and the current non-resident pharmacy license structure.

Background:

Currently, the Model Act requires full licensure in the state where the patient is located for pharmacists practicing telepharmacy across state lines. Although the Task Force agreed that the objective of this requirement, which is for each jurisdiction to have a record of who is providing services to their citizens, is a good one, members felt that the reality of such a requirement, with pharmacists maintaining multiple separate licenses in various states, is overly burdensome and may not necessarily provide protection to the public above and beyond single state licensure. There are no states that have adopted this model language, although a few do require the pharmacist-in-charge or a single pharmacist working for registered non-resident pharmacy obtain full licensure in those states.

Members agreed that the current method by which the majority of states regulate non-resident pharmacists, through non-resident pharmacy registration, as opposed to non-resident pharmacist licensure, is effective. Through this mechanism, boards have authority over pharmacists via their employers. With the advent of the independent practice of pharmacy, however, this is not the case. Members felt it necessary for boards

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to adopt some sort of framework that allows for the regulation of non-resident pharmacists who are not employed by registered non-resident pharmacies, but that is not overly burdensome.

Members reviewed the multistate licensure models implemented by the nursing and medical professions and found that the nurse licensure compact model, with some modification, could be a workable solution. The Task Force felt NABP should evaluate a model that allows independently practicing pharmacists to use the one license obtained in their state of residency for traditional pharmacy practice in that state, and electronic, but not physical, practice, in any other state that enters into the compact. Such compact could be administered by NABP.

Recommendation 7: The Task Force recommends NABP, should it find the multistate licensure recommendation to be difficult or impossible to implement at this time, consider incorporating the following language into the Model Act that describes a registration, as opposed to a full licensure, process for pharmacists who practice telepharmacy across state lines, as a means by which to regulate this practice.

If necessary, the Task Force recommends the following amendments to the Model Act. The revisions recommended by the initial Task Force are denoted by single underlined text and single strikethrough text and revisions recommended at the second meeting of the Task Force are denoted by double underlined text and double strikethrough text.

Article I

Title, Purpose, and Definitions …

Section 104. Practice of Pharmacy. …

Comments Section 104. Comment. … NABP recognizes that protection of the public health should extend across state borders. Accordingly, the NABP Model Act incorporates the Practice of Telepharmacy Across State Lines within the scope of the “Practice of Pharmacy.” and requires full licensure for all pharmacists practicing within a particular jurisdiction by any means. Alternatively, states may choose to implement a nonresident pharmacist “registration” rather than require full licensure for pharmacists providing Pharmaceutical Care services from outside the state to patients within the state.

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Article III

Licensing Introductory Comment to Article III Article III of the Model Act specifies the requirements for initial licensure of Pharmacists, transfer of licensure, registration to engage in the Practice of Telepharmacy Across State Lines, and renewal of licenses and registrations. In each of these areas, the Act sets forth basic Criteria and delegates to the Board the authority for implementing those Criteria. The Board does this by utilizing appropriate administrative enforcement mechanisms and by the issuance of specific rules. Section 301 establishes the basis for this Article by making it unlawful for any unlicensed Person to engage in the Practice of Pharmacy, and by enabling the Board to exact penalties for unlawful practice. In the area of initial licensure (Section 302), the Board must implement the Act by approving degree programs of Pharmacy, by specifying the examination to be employed (Section 302[b]), by establishing internship standards (Section 302[c]), and by ensuring that all other prerequisites are met by each applicant to whom it issues a license. The Act also reflects the efforts of NABP to continue uniform standards for transfer of licensure (Section 303).

Section 301. Unlawful Practice.

(a) Except as otherwise provided in this Act, it shall be unlawful for any individual, whether located in or outside this State, to engage in the Practice of Pharmacy in this State unless currently licensed to practice under any facet of the provisions of this Act.

(b) The provision of Pharmaceutical Pharmacist Care services to an individual in this State, through the use of telecommunications or other electronic communications technologies telephonic, electronic, or other means, regardless of the location of the pharmacist, shall constitute the Practice of Pharmacy and shall be subject to regulation.

(1) Licensed Pharmacies located outside this State that provide Pharmacist Care services to individuals in this State must be licensed within this State under Article V of this Act.

(2) Pharmacists located outside this state who are providing Pharmacist Care services outside of a licensed Pharmacy to individuals located in this state must register with this state to engage in the Practice of Telepharmacy Across State Lines.

…

Section 304. Qualifications for Registration to Engage in the Practice of Telepharmacy Across State Lines.

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(a) An applicant applying for registration to engage in the Practice of Telepharmacy Across State Lines shall:

(1) present to the Board proof of licensure in another State and proof that such license is in good standing;

(2) submit an application in the form prescribed by the Board; (3) pay the fee(s) specified by the Board for the issuance of the Registration;

and (4) comply with all other requirements of the Board.

(b) The application required under Section 304(a)(2) shall request of the applicant, at a minimum, the following information:

(1) Name, address, and current Pharmacist licensure information in all other States, including State(s) of licensure and license number(s);

(2) Name, address, phone number, and, if applicable, State of licensure and license number of the site where the Practice of Telepharmacy will originate;

(3) A statement of the scope of patient services that will be provided; (4) A description of the protocol or framework by which patient care will be

provided; (5) If applicable, any Collaborative Practice Agreements with other health

care Practitioners; and (6) A statement attesting that the applicant will abide by the Pharmacy laws

and regulations of the State in which the patient is located.

Section 304305. Renewal of Licenses and Registrations.

(a) Each Pharmacist and Pharmacy Intern shall apply for renewal of his license annually [or at such interval determined by the Board], no later than the first day of ___________. A Pharmacist or Pharmacy Intern who desires to continue in the Practice of Pharmacy in this State shall file with the Board an application in such form and containing such data as the Board may require for renewal of the license. If the Board finds that the applicant has been licensed, and that such license has not been Revoked or placed under Suspension, that the applicant has paid the renewal fee, has continued his or her Pharmacy education in accordance with the rules of the Board, and is entitled to continue in the Practice of Pharmacy, the Board shall issue a license to the applicant.

(b) If a Pharmacist fails to make application to the State Board of Pharmacy for renewal of his or her license within a period of three years from the expiration of his or her license, he or she must pass an examination for license renewal; except that a Person who has been licensed under the laws of this State and after the expiration of his or her license, has continually practiced Pharmacy in another State under a license issued by the authority of such State, may renew his or her license upon payment of the designated fee.

(c) A Pharmacist shall apply for renewal of his or her registration to Practice Telepharmacy Across State Lines annually [or at such interval determined by the Board], no later than the first day of (month). A Pharmacist who desires to

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continue in the Practice of Telepharmacy Across State Lines shall file with the Board an application in such form and containing such data as the Board may require for renewal of the registration. If the Board finds that the applicant has been licensed to Practice Pharmacy in another State and registered to Practice Telepharmacy Across State Lines in this State, that such license and registration have not been Revoked or placed under Suspension, and that the applicant has paid the renewal fee and is entitled to continue to engage in the Practice of Telepharmacy Across State Lines, the Board shall issue a registration to the applicant.

…

Comments Section 301(a)(b). Comment. NABP recognizes that protection of the public health should extend across state borders. Accordingly, the NABP Model Act incorporates the Practice of Telepharmacy aAcross sState lLines within the scope of the “Practice of Pharmacy” and requires full licensure for all pharmacists practicing within a particular jurisdiction by any means. Alternatively, states may choose to implement an nonresident independently-practicing pharmacist located outside this state to register “registration” to Practice Telepharmacy Across State Lines, rather than obtain require full licensure, for pharmacists providing pharmaceutical Pharmacist Ccare services from outside the State to patients within the State. Pharmacists located outside this state who are providing Pharmacist Care services from a Pharmacy or non-resident Pharmacy licensed in this State need not register with this State to Practice Telepharmacy Across State Lines.

Section 304. Comment. The Registration to Practice Telepharmacy Across State Lines would not allow the Pharmacist to enter the State for the purpose of engaging in the Practice of Pharmacy. In addition, this section does not apply to Pharmacists who are practicing in any licensed Pharmacy setting, including a “central processing” Pharmacy setting, as long as that location is licensed or registered as a Pharmacy or non-resident Pharmacy as required by state laws and regulations. …

Model Rules for Pharmaceutical Care the Practice of Pharmacy …


…

H. Patient Counseling

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(1) Upon receipt of a Prescription Drug Order and following a review of the patient’s record, a Pharmacist shall personally initiate discussion of matters which will enhance or optimize Drug therapy with each patient or caregiver of such patient. Such discussion shall be in Person, whenever practicable, or by telephone and shall include appropriate elements of Patient Counseling. Such elements may include the following:

(a) the name and description of the Drug;

(b) the dosage form, dose, route of Administration, and duration of Drug therapy;

(c) intended use of the Drug and expected action;

(d) special directions and precautions for preparation, Administration, and use by the patient;

(e) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(f) techniques for self-monitoring Drug therapy;

(g) proper storage;

(h) prescription refill information;

(i) action to be taken in the event of a missed dose; and

(j) Pharmacist comments relevant to the individual’s Drug therapy, including any other information peculiar to the specific patient or Drug.

(2) Alternative forms of patient information shall be used to supplement Patient Counseling when appropriate. Examples include written information leaflets, pictogram labels, video programs, etc.

(3) A Pharmacist providing Telepharmacy services across state lines shall:

(a) identify himself or herself to patients as a “licensed Pharmacist;” and

(b) notify patients of the State in which he or she is currently licensed to Practice Pharmacy and registered to Practice Telepharmacy Across State Lines.

(4) Patient Counseling, as described above and defined in this Act, shall not be required for inpatients of a hospital or institution where other licensed health care professionals are authorized to Administer the Drug(s).

(5) A Pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation.

…

Comments Section 3H(3). Comment.

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The intent of this section is to provide a means of protection for the patient, so that he or she knows with whom he or she is communicating and where to report a problem or complaint.

Background:

The Task Force voiced concern that a multistate compact project may be difficult or impossible to implement at this time. Should this be the case, members agreed that a less burdensome telepharmacy registration process for pharmacists, as opposed to having to obtain full licensure, would be a good alternative for states to regulate telepharmacy practice across state lines.

Recommendation 8: The Task Force recommends the following edits to the Model Rules for the Practice of Pharmacy (formerly the Model Rules for Pharmaceutical Care) so this section is consistent with the recommended amendments to the Definitions section of the Model Act made in Recommendation 1.

The revisions recommended by the initial Task Force are denoted by single underlined text and single strikethrough text and revisions recommended at the second meeting of the Task Force are denoted by double underlined text and double strikethrough text.

Model Rules for Pharmaceutical Care the Practice of Pharmacy …


…

G. Prospective Drug Regimen Review

A Pharmacist shall review the patient record and each Prescription Drug Order presented for Dispensing for purposes of promoting therapeutic appropriateness by identifying for:

(1) known allergies;

(2) rational therapy contraindications;

(3) reasonable dose, duration of use, and route of Administration, considering age, gender, and other patient factors;

(4) reasonable directions for use;

(5) potential or actual adverse Drug reactions;

(6) Drug-Drug interactions;

(7) Drug-food interactions;

(8) Drug-disease contraindications;

(9) Therapeutic duplication;

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(10) Proper utilization (including over- or under-utilization), and optimum therapeutic outcomes; and

(11) abuse/misuse.

(1) over-utilization or under-utilization;

(2) therapeutic duplication;

(3) Drug-disease contraindications;

(4) Drug-Drug interactions;

(5) incorrect Drug dosage, or duration of Drug treatment;

(6) Drug-allergy interactions; and

(7) abuse/misuse.

Upon recognizing any of the above, the Pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the Practitioner.

…

J. Collaborative Pharmacy Practice

(1) Collaborative Pharmacy Practice Agreement.

A Pharmacist planning to engage in Collaborative Pharmacy Practice shall have on file at his or her place of practice the written Collaborative Pharmacy Practice Agreement. The initial existence and subsequent termination of any such agreement and any additional information the Board may require concerning the Collaborative Pharmacy Practice Agreement, including the agreement itself, shall be made available to the Board for review upon request. The Agreement may allow the Pharmacist, within the Pharmacist’s Scope of Practice Pursuant to the Collaborative Pharmacy Practice Agreement, to conduct Medication Drug Therapy Management activities approved by the Practitioner, and as defined by law and by the Rules of the Board. The collaboration that the Practitioner agrees to conduct with the Pharmacist must be within the scope of the Practitioner’s current practice. Patients or caregivers shall be advised of such agreement.

(2) Contents.

The Collaborative Pharmacy Practice Agreement shall include:

(a) Identification of the Practitioner(s) and Pharmacist(s) who are parties to the Agreement;

(b) The types of Drug Medication Therapy Management decisions that the Pharmacist is allowed to make, which may include:

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(i) A detailed description of the types of diseases, Drugs, or Drug categories involved, and the type of Drug Therapy Management activities allowed in each case;

(ii) A detailed description of the methods, procedures, decision Criteria, and plan the Pharmacist is to follow when conducting allowed activities Drug Therapy Management; and

(iii) A detailed description of the activities the Pharmacist is to follow in the course of conducting Drug Therapy Management, including documentation of decisions made and a plan or appropriate mechanism for communication, feedback, and reporting to the Practitioner concerning specific decisions made. In addition to the Agreement, documentation shall occur on the prescription record, patient profile, a separate log book, or in some other appropriate system;

(c) A method for the Practitioner to monitor compliance with the Agreement and clinical outcomes where Drug Therapy Management by the Pharmacist has occurred and to intercede where necessary;

(d) A description of the Continuous Quality Improvement Program used to evaluate effectiveness of patient care and ensure positive patient outcomes.

(e) A provision that allows the Practitioner to override a Collaborative Practice decision made by the Pharmacist whenever he or she deems it necessary or appropriate;

(f) A provision that allows either party to cancel the Agreement by written notification;

(g) An effective date; and

(h) Signatures of all collaborating Pharmacists and Practitioners who are party to the agreement, as well as dates of signing.

Amendments to a Collaborative Pharmacy Practice Agreement must be documented, signed, and dated.

(3) Initiation of the Collaborative Pharmacy Practice Agreement

The Collaborative Pharmacy Practice Agreement must be coupled with a medical order from the Practitioner to initiate Drug Therapy Management allowed activities for any particular patient.

(4) Documentation of Pharmacist activities Drug Therapy Management.

Documentation of Drug Therapy Management allowed activities must be kept as part of the patient’s permanent record and be readily available to other health care professionals providing care to that patient and who are authorized to receive it. Documentation of Drug Therapy Management allowed activities shall be considered Protected Health Information.

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(5) Review.

At a minimum, the written agreement shall be reviewed and renewed and, if necessary, revised every year.

…

O. Centralized Prescription Processing and Filling

(1) A Pharmacy may perform or outsource Centralized Prescription Filling or Centralized Prescription Processing services provided the parties:

(a) have the same owner; or

(b) have a written contract outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of said contract in compliance with federal and state laws and regulations; and

(c) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to fill or refill a Prescription Drug Order.

(2) The parties performing or contracting for Centralized Prescription Filling or Centralized Prescription Processing services shall maintain a policy and procedures manual and documentation that implementation is occurring in a manner that shall be made available to the Board for review upon request and that includes, but is not limited to, the following:

(a) A description of how the parties will comply with federal and state laws and regulations;

(b) The maintenance of appropriate records to identify the responsible Pharmacist(s) in the Dispensing and counseling processes;

(c) The maintenance of a mechanism for tracking the Prescription Drug Order during each step in the Dispensing process;

(d) The maintenance of a mechanism to identify on the prescription label all Pharmacies involved in Dispensing the Prescription Drug Order;

(e) The provision of adequate security to protect the integrity and prevent the illegal use or disclosure of Protected Health Information;

(f) The maintenance of a Continuous Quality Improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

Background:

The amendments suggested to the definition of Drug Regimen Review, the removal of the term Drug Therapy Management, and the addition of the terms Medication Therapy Management and Centralized Prescription Filling all necessitate amendments to the sections of the Model Rules for the Practice of Pharmacy (formerly the Model Rules for Pharmaceutical Care) where these terms were used.

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APPENDIX A

Report of the 2005-2006 Task Force on Telepharmacy and the Implementation of the Medicare Drug Benefit Medication Therapy Management Provisions (First Report)

Members Present:

Karen Ryle (MA), Chair; Monica K. Franklin (TN); Susan Ksiazek (NY); Michael A. Podgurski (PA); Stephen R. Statz (SD); Woodrow Storey (NM); and Hal Wand (AZ). Ex-Officio Members Present:

Kim Caldwell (TX) and Stan Goldenberg (CA). Others Present:

Gary A. Schnabel, Executive Committee Liaison; Carmen Catizone, Charisse Johnson, Melissa Madigan, Chris Siwik, and Donald Talend, NABP staff; Tameka Houston, NABP pharmacy student intern.

Introduction:

The Task Force on Telepharmacy and the Implementation of the Medicare Drug Benefit Medication Therapy Management Provisions (Task Force) met on October 27, 2005. The appointment of this Task Force came at the direction of the NABP Executive Committee in response to a recommendation from the 2004-2005 NABP Committee on Law Enforcement/Legislation who proposed that a task force be commissioned to examine the evolving practices of telepharmacy in the context of the regulatory issues that the state boards of pharmacy are asked to define and address. Additionally, the NABP Executive Committee, pursuant to Resolution 101-8-05, Implementation of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, charged this Task Force with considering the need for developing model regulations to address the provision of pharmacist care across state borders that may result from the implementation of the medication therapy management services as a result of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Review of the Task Force Charge:

Task Force members reviewed their charge and accepted it as follows:

This Task Force will be reviewing existing state regulations in regard to the practice of telepharmacy and consider the need for developing model regulations to address the provision of pharmacist care across state borders that may result from the implementation of the medication management therapy provisions of the Medicare drug benefit. Overview of Presentations:

Charisse Johnson, NABP staff member, provided an overview of the various regulatory issues including the various factors, opportunities, and challenges involving the practice of telepharmacy. Dr. Johnson also provided an overview of the state telepharmacy regulations, various telepharmacy practice models, and reviewed the report of the 2004-2005 Committee on Law Enforcement/Legislation which contained a number of recommendations to serve as guidance for the Task Force as model language was proposed.

Kim Caldwell, member of the Texas State Board of Pharmacy and past Director of Division of Clinical and Economic Performance in the Centers for Beneficiary Choice for the Centers for Medicare and Medicaid Services, reviewed the federal regulatory provisions of Medication Therapy Management (MTM) services as a result of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA 2003). Mr Caldwell discussed the intended goals of MTM programs and criteria that Medicare beneficiaries must meet in order to qualify for MTM services. Additionally he reviewed the MTM submission requirements to be completed by plan sponsors and provided clarification on services that could qualify as MTM services.

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Stanley Goldenberg, president of the California State Board of Pharmacy, addressed the efforts of the California State Board of Pharmacy to allow pharmacists to provide the multitude of services reflective of MTM. Specifically, he reviewed the efforts of the Licensing Committee of the California State Board of Pharmacy to facilitate the provision of MTM through a new regulatory framework for the licensing and registration of pharmacies and pharmacists. In its deliberations, the Licensing Committee has discussed a revised regulatory framework, which addresses the licensing of entities that strictly provide cognitive services (not in conjunction with a pharmacy that dispenses drugs); and the licensure or registration of non-resident entities that provide such services. Mr Goldenberg also informed the Task Force that the Licensing Committee was also considering whether or not the scope of practice in existing California law allows pharmacists to provide MTM. He also discussed some of the concerns of the Licensing Committee with respect to cumbersome licensing fees for non-resident pharmacists who provide strictly cognitive services in a multitude of jurisdictions. Some of the solutions proposed by the Licensing Committee include a non-resident registration (which is presumably easier to obtain as opposed to a license); or a national license certification process that could be administered by NABP; or no additional requirements for non-resident pharmacists and the California Board would work collaboratively with the home licensure state for discipline and compliance (in addition to compliance with California standard of care requirements).

Task Force Recommendations to the NABP Executive Committee

Recommendation 1: The Task Force recommends that the terms “Central Pharmacy,” “Remote Pharmacy,” and “Remote Dispensing Site” be incorporated within the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in consideration of the evolving practices of telepharmacy. The Task Force also recommends revisions to the existing definition of “Practice of Telepharmacy.”

The Task Force recommends the following amendments to the Model Act. The revisions recommended by the Task Force are denoted by underlines and strikethroughs.

Article I

Title, Purpose, and Definitions

Section 105. Definitions.

“Central Pharmacy” is a Pharmacy responsible for the Practice of Telepharmacy performed at Remote Pharmacies and Remote Dispensing Sites.

“Remote Pharmacy” is a Pharmacy, staffed by a Pharmacist, Pharmacy Intern, or a Certified Pharmacy Technician, electronically linked to the Central Pharmacy via a computer system and a video/auditory communication system approved by the Board.

“Remote Dispensing Site” is a site located within an Institutional Facility or outpatient clinic that utilizes an Automated Pharmacy System and that is electronically linked to the Central Pharmacy via a computer system and/or a video/auditory communication system approved by the Board.

“Practice of Telepharmacy” means the provision of Pharmaceutical Care by registered Pharmacies and Pharmacists located within US jurisdictions through the use of telecommunications and technologies to patients or their agents at a distance who are located within US jurisdictions.

Background:

In consideration of the 2004-2005 Committee on Law Enforcement/Legislation recommendations and existing state regulations on the practice of telepharmacy, the Task Force members agreed that the terms “Central Pharmacy,” “Remote Pharmacy,” and “Remote Dispensing Site” and their definitions should be added to the Model Act. Collectively, the incorporation of these terms within the Model Act provides a regulatory framework to allow for various models of telepharmacy practice, as illustrated in states like North Dakota, Texas, and Missouri.

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In the Model Act, the central pharmacy is linked to the remote pharmacy via a video/audio communication system so that the central pharmacy can monitor operations at the remote pharmacy, assess the final product prior to dispensing, and provide patient counseling when required. In both community and institutional-based pharmacy practice settings, the remote pharmacy may be most analogous to a satellite pharmacy in that it contains a restricted drug inventory and is staffed by a limited number of staff (ie, pharmacist, pharmacy technician, or pharmacy intern). Prescription orders presented at a remote pharmacy require evaluation (drug regimen review) by a pharmacist at the central pharmacy (or remote pharmacy) prior to dispensing. This process is facilitated by a computer link between the central and remote pharmacy. Remote dispensing sites, located only in specific settings like hospitals (institutional facilities) and outpatient clinics, also receive pharmacy services remotely from a central pharmacy in conjunction with established policies and procedures that ensure the provision of pharmaceutical care. Ideally, health care professionals, such as nurses and physicians, at the remote dispensing site, would oversee the administration of medications and ensure that patients are provided with patient counseling from the pharmacist at the central pharmacy when required. Lastly, the Task Force members recommended that the “Practice of Telepharmacy” definition be amended to include the patient’s agent as a representative of the patient in the provision of pharmaceutical care.

Recommendation 2: The Task Force recommends that a section pertaining to remote pharmacy services be incorporated into the Model Rules for Pharmaceutical Care.


Model Rules for Pharmaceutical Care


O. Remote Pharmacy Services

(2) General Requirements

(a) The Pharmacist-in-Charge of the Central Pharmacy shall apply to the Board for a permit prior to engaging in the Practice of Telepharmacy via the Remote Pharmacies and Remote Dispensing Sites.

(b) A Central Pharmacy shall demonstrate to the Board that there is limited access to pharmacy services in the community prior to engaging in the Practice of Telepharmacy via the Remote Pharmacies and Remote Dispensing Sites.

(c) One Pharmacist shall not operate more than three simultaneously-open Remote Pharmacies or Remote Dispensing Sites. An exception to this limit may be granted by the Board in situations where the Central Pharmacy has documented a need to supervise additional Remote Pharmacies or Remote Dispensing Sites and has demonstrated that appropriate safeguards are in place to assure proper supervision of each.

(d) Remote Pharmacies that are principally staffed by Certified Pharmacy Technicians or Pharmacy Interns shall be under the continuous supervision of a Pharmacist at the Central Pharmacy at all times that it is open to provide pharmacy services. To qualify as continuous supervision, the Pharmacist is not required to be physically present at the Remote Pharmacy, but shall supervise operations electronically through the use of a video/auditory communication system.

(e) A Central Pharmacy shall comply with appropriate federal and state controlled substance registrations for each Remote Pharmacy or Remote Dispensing Site if controlled substances are maintained.

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(f) A Central Pharmacy shall notify the Board in writing within ten days of a change of location, discontinuance of service or closure of a Remote Pharmacy or Remote Dispensing Site operated by the Central Pharmacy.

(2) Remote Pharmacy

A Remote Pharmacy may have a limited Drug inventory consisting of suitable unit-of-use containers Prepackaged by the Central Pharmacy or a registered Repackager or as provided in the original Manufacturer’s container. A Remote Pharmacy may utilize an Automated Pharmacy System.

(3) Remote Dispensing Site

A Remote Dispensing Site shall utilize an Automated Pharmacy System located in an area accessible only to authorized personnel.

(4) Personnel

(a) The Pharmacist-in-Charge of the Central Pharmacy:

(i) is responsible for the Practice of Telepharmacy performed at Remote Pharmacies and Remote Dispensing Sites, including the supervision of any Automated Pharmacy System and compliance with these Rules;

(ii) is responsible for ensuring that the Central Pharmacy and the Remote Pharmacy and Remote Dispensing Site have entered into a written agreement that outlines the services to be provided and the responsibilities and accountability of each party in fulfilling the terms of the agreement in compliance with federal and state laws and regulations. Such contract or agreement is not required if the Remote Pharmacy or Remote Dispensing Site are under common control or ownership of the Central Pharmacy;

(iii) shall ensure the Central Pharmacy has sufficient Pharmacists on duty for the safe operation and supervision of all Remote Pharmacies and Remote Dispensing Sites; and

(iv) shall ensure that the Automated Pharmacy System is in good working order and accurately Dispenses the correct strength, dosage form, and quantity of the Drug prescribed while maintaining appropriate recordkeeping and security safeguards.

(b) Pharmacists, Pharmacy Interns, and Certified Pharmacy Technicians at Remote Pharmacies shall be registered with the Board and be trained in the operation of the video/auditory communication system used for Dispensing and Patient Counseling.

(5) Operations

(a) Remote Pharmacies:

(i) that are principally staffed by Certified Pharmacy Technicians or Pharmacy Interns shall be under the personal and direct supervision of a Pharmacist;

(ii) may receive Prescription Drug Orders or refill requests by the patient or the patient’s agent in accordance with the policies and procedures designated by the Pharmacist-in-Charge. The Certified Pharmacy Technician or Pharmacy Intern shall either transmit the Prescription Drug Order or refill request to the Central Pharmacy or process the Prescription Drug Order or refill request so that the Pharmacist at the Central Pharmacy may perform a Prospective Drug Regimen Review prior to Dispensing;

(iii) shall contain an appropriate area for Patient Counseling by the Pharmacist, if required;

(iv) may employ Certified Pharmacy Technicians or Pharmacy Interns, whom of which shall be under the supervision of a Pharmacist at the Central Pharmacy, to

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assist in the Dispensing process and maintain appropriate video/auditory communication with the Central Pharmacy; and

(v) may contain an Automated Pharmacy System or a limited Drug inventory for the purposes of preparing medications for Dispensing. The Pharmacist at the Central Pharmacy shall have access to the Remote Pharmacy’s automated data processing system to perform a Prospective Drug Regimen Review prior to Dispensing. The Pharmacist shall ensure, through the use of the video/auditory communication system, that the Certified Pharmacy Technician or Pharmacy Intern has accurately and correctly prepared the Drug for Dispensing according to the Prescription Drug Order.

(b) Remote Dispensing Sites:

(i) that are located within an Institutional Facility shall utilize an Automated Pharmacy System for the purposes of Dispensing. The Pharmacist at the Central Pharmacy shall have the necessary patient information to perform a Prospective Drug Regimen Review prior to Dispensing; and

(ii) that are located in outpatient clinics shall utilize an Automated Pharmacy System. Such Automated Pharmacy Systems shall be located in an area that will provide for Patient Counseling and must be installed within the same area utilized by the Practitioner for the provision of clinical services.

(6) Security

(a) Drugs shall be stored in compliance with state and federal laws and in accordance with these Rules, including those addressing temperature, proper containers, and the handling of outdated drugs.

(b) Drugs stored at Remote Dispensing Sites shall be stored in an area that is:

(i) separate from any other Drugs used by the health care facility; and

(ii) locked by key or combination, so as to prevent access by unauthorized personnel.

(c) Access to the area where Drugs are stored at the Remote Pharmacy or Remote Dispensing Site must be limited to:

(i) Pharmacists, Certified Pharmacy Technicians, Pharmacy Technicians, or Pharmacy Interns who are employed by the Central Pharmacy; or

(ii) Personnel employed at the Institutional Facility or outpatient clinic where the Remote Dispensing Site is located who are:

(a) are licensed health care providers;

(b) are designated in writing by the Pharmacist-in-Charge or the Person responsible for the supervision and on-site operation of the facility where the Automated Pharmacy System is located; and

(c) have completed documented training concerning their duties associated with the remote site.

(d) Remote Pharmacies and Remote Dispensing Sites shall have adequate security to:

(i) comply with federal and state laws and regulations; and

(ii) maintain patient confidentiality;

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(e) The Central Pharmacy shall have procedures that specify that Drugs may only be Delivered to the Remote Pharmacy or Remote Dispensing Site by the Central Pharmacy and shall be:

(i) shipped in a sealed container with a list of Drugs Delivered; and

(ii) checked by personnel designated by the Pharmacist-in-Charge to verify that Drugs sent by the Central Pharmacy were actually received. The designated Person who checks the order shall document the verification by signing and dating the list of Drugs Delivered.

(7) Policies and Procedures

(a) The Central Pharmacy, Remote Pharmacy, and Remote Dispensing Site shall operate according to written policies and procedures that are established by the Central Pharmacy. The policy and procedure manual shall include, but not be limited to, the following:

(i) a current list containing the name and business address of the Pharmacist-in-Charge and personnel designated by the Pharmacist-in-Charge to have access to the area where Drugs are stored at the Remote Pharmacy or Remote Dispensing Site;

(ii) duties that may only be performed by a Pharmacist;

(iii) a copy of the written agreement between the Central Pharmacy and the Remote Pharmacy or between the Central Pharmacy and the Institutional Facility or outpatient clinic where the Remote Dispensing Site is located. Such contract or agreement is not required if the Remote Pharmacy or Remote Dispensing Site are under common control or ownership of the Central Pharmacy;

(iv) date of last review and revision of policy and procedure manual; and

(v) policies and procedures for operation of the video/auditory communication system, security, sanitation, storage of Drugs, Dispensing, supervision, Drug procurement, receiving of Drugs Delivery of Drugs, and recordkeeping.

(b) A Central Pharmacy providing pharmacy services at a Remote Pharmacy or Remote Dispensing Site shall, at least annually, review and revise as necessary its written policies and procedures, and document such review.

(c) A Central Pharmacy providing pharmacy services at a Remote Pharmacy or Remote Dispensing Site shall maintain a written plan for recovery from an event that interrupts the ability of a Pharmacist to electronically supervise the Dispensing of Drugs at the Remote Pharmacy or Remote Dispensing Site. The written plan for recovery shall include:

(i) a statement that Drugs shall not be Dispensed at the Remote Pharmacy or Remote Dispensing Site if a Pharmacist is not able to electronically supervise such Dispensing;

(ii) procedures for response when the video/auditory communication system is experiencing downtime; and

(iii) procedures for the maintenance and testing of the written plan for recovery.

(d) All policies and procedures must be maintained in the Central Pharmacy responsible for the Automated Pharmacy System and at the Remote Dispensing Site where the Automated Pharmacy System is being used.

(8) Quality Assurance

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(a) A Central Pharmacy that provides pharmacy services via a Remote Pharmacy or Remote Dispensing Site shall operate according to a written program for quality assurance that:

(i) requires continuous supervision of the Remote Pharmacy at all times the site is open to provide pharmacy services;

(ii) requires a Pharmacist of the Central Pharmacy to be accessible to respond to inquiries or requests pertaining to Drugs Dispensed from the Remote Pharmacy or from the Automated Pharmacy System located at the Remote Dispensing Site; and

(iii) establishes procedures to test the operation of all Automated Pharmacy Systems and all video/auditory communication systems at a minimum of every six months and whenever any upgrade or change is made to the system and document the testing of each such system.

(9) Recordkeeping

(a) Required Records

(i) A Central Pharmacy shall keep a record of all Drugs received, Dispensed, and Distributed from the Central Pharmacy.

(ii) A Central Pharmacy shall keep a record of all Drugs received, Dispensed, and Distributed from each Remote Pharmacy or Remote Dispensing Site.

(iii) All records of receipt, Dispensing, and Distribution shall be kept at the Central Pharmacy. Central Pharmacy, Remote Pharmacy, and Remote Dispensing Site records must be kept separate from each other.

(b) Inventory

(i) A Central Pharmacy shall keep a perpetual inventory of controlled substances, and other Drugs required to be inventoried according to state and federal law, that are held in the Central Pharmacy, each Remote Pharmacy, and each Remote Dispensing Site;

(ii) A Central Pharmacy shall conduct an annual non-controlled substance Drug inventory at the Central Pharmacy and at each Remote Pharmacy or Remote Dispensing Site; and

(iii) All inventory records shall be kept at the Central Pharmacy. The Central Pharmacy, Remote Pharmacy, and Remote Dispensing Site inventory records must be kept separate from each other.

Comments

Section 3O(1)(a). Comment. Often the terms “licensure,” “registration,” and “permit” are used interchangeably throughout the Model Act. In the case of Remote Dispensing Sites that utilize Automated Pharmacy Systems, boards may determine that it is appropriate to issue a permit for the Automated Pharmacy System but not for the physical site the Automated Pharmacy System is located.

Section 3O(1)(b). Comment. States will need to determine what constitutes limited access to pharmacy services in the community. For example, states may consider using parameters such as mileage or census tracts to assist in measuring the availability of pharmacies within a defined area or community.

Background:

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The 2004-2005 Committee on Law Enforcement/Legislation produced a number of recommendations to assist the Task Force members in developing model regulations pertaining to the remote provision of pharmacy services. Those recommendations suggested included sections addressing registration/licensure of remote site personnel, remote patient counseling, and restriction of remote sites to areas or communities that are underserved. In response to those specific recommendations, the Task Force members suggested rules on remote pharmacy services addressing general licensing requirements, personnel, operations, security, policies and procedures, quality assurance, and recordkeeping.

Recommendation 3: The Task Force recommends that the model language regarding automated pharmacy systems be amended in consideration of the proposed model language for remote pharmacy services.


Model Rules for Pharmaceutical Care

Section 2. Personnel.

A. Duties and Responsibilities of the Pharmacist-in-Charge

(3) The Pharmacist-in-Charge shall be assisted by a sufficient number of Pharmacists, Certified Pharmacy Technicians, and Pharmacy Technicians as may be required to competently and safely provide Pharmacy services.

(a) The Pharmacist-in-Charge shall maintain and file with the Board of Pharmacy, on a form provided by the Board, a current list of all Certified Pharmacy Technicians and Pharmacy Technicians assisting in the provision of Pharmacy services.

(b) The Pharmacist-in-Charge shall develop and implement written policies and procedures to specify the duties to be performed by Certified Pharmacy Technicians and Pharmacy Technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience and shall address the method and level of necessary supervision specific to the practice site. These policies and procedures shall, at a minimum, specify that Certified Pharmacy Technicians and Pharmacy Technicians are to be personally and directly supervised by a Pharmacist stationed within the same work area who has the ability to control and who is responsible for the activities of Certified Pharmacy Technicians and Pharmacy Technicians, and that Certified Pharmacy Technicians and Pharmacy Technicians are not assigned duties that may be performed only by a Pharmacist. Such policies and procedures shall also specify that Pharmacy Technicians shall not be assigned duties that may be performed only by Certified Pharmacy Technicians.


N. Automated Pharmacy Systems

Automated Pharmacy Systems can be utilized in licensed Pharmacies, remote locations under the jurisdiction of the Board of Pharmacy Remote Pharmacies, and Remote Dispensing Sites located within an Institutional Facility or outpatient clinic and licensed health care facilities where legally permissible and. A Pharmacist is not required to be physically present at the site of the Automated Pharmacy System if the system is supervised electronically by a Pharmacist. Automated Pharmacy Systems shall comply with the following provisions.

(1) Documentation as to type of equipment, serial numbers, content, policies and procedures, and Remote Pharmacy or Remote Dispensing Site location shall be maintained on site in

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the Pharmacy (or Central Pharmacy) for review by the Board of Pharmacy. Such documentation shall include, but is not limited to:

(a) name and address of the Pharmacy (or Central Pharmacy) and/or the licensed health care facility the Remote Pharmacy or Remote Dispensing Site where the Automated Pharmacy System(s) is being used;

(b) Manufacturer’s name and model;

(c) description of how the Device is used;

(d) quality assurance procedures to determine continued appropriate use of the automated Device; and

(e) policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, and malfunction; and

(f) documentation evidencing that the Automated Pharmacy System has been tested at all locations to ensure that the Automated Pharmacy System is operating properly.

(2) Automated Pharmacy Systems should be used only in settings where there is an established program of Pharmaceutical Care that ensures medication orders are reviewed by a Pharmacist in accordance with established policies and procedures and good Pharmacy practice.

(a) A Pharmacist shall be accessible to respond to inquiries or requests pertaining to Drugs Dispensed from the Automated Pharmacy System.

(b) Any Pharmacy (or Central Pharmacy) that maintains an Automated Pharmacy System for the purposes of remote Dispensing to outpatients shall maintain a video/auditory communication system to provide for effective communication between the Remote Pharmacy or Remote Dispensing Site and the Pharmacist; the video/auditory communication system shall allow for the appropriate exchange of oral and written communication and Patient Counseling; if the video/auditory communication system malfunctions, then all operations of the Automated Pharmacy System at the Remote Pharmacy or Remote Dispensing Site shall cease until the system is fully functional.

(3) All policies and procedures must be maintained in the Pharmacy (or Central Pharmacy) responsible for the system and, if the system is not located within the facility where the Pharmacy is located, at the location where the system Automated Pharmacy System and at the Remote Pharmacy or Remote Dispensing Site where the Automated Pharmacy System is being used.

The method of and level of pharmacist supervision over technicians may vary depending on practice site. For example, supervision of technicians in a Remote Pharmacy or Remote Dispensing Site will be different than that of technicians in a retail Pharmacy setting.

…

Section 3N(2)(a). Comment.

In order to facilitate communication between the Central Pharmacy and the site where the Automated Pharmacy System is located, a Pharmacy should provide a toll-free telephone number so that the Pharmacist is accessible at all times the Automated Pharmacy System is operational.

Section 3N(2)(b). Comment.

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Although an “outpatient” generally refers to a Person who receives Drugs for use outside of an Institutional Facility, the definition of “outpatient” must be defined by each state. For example, although the Model Act classifies penal institutions as a type of Institutional Facility and therefore its inmates as inpatients, the Pharmacist is exempt from providing Patient Counseling. However, some states may consider inmates of penal institutions as outpatients and therefore should decide if a video/audio communication system is required in such facilities so that the Pharmacist is able to provide Patient Counseling.

Background:

According to the Model Act, automated pharmacy systems include, but are not limited to, mechanical systems that perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of medications, and which collect, control, and maintain all transaction information.

Although the existing Model Act contains model language on the regulation of automated pharmacy systems, the Task Force members agreed that it was necessary to include additional model language as a result of the revisions to the Model Act on remote pharmacy services.

Recognizing the use of automated pharmacy systems at remote sites, the Task Force members recommended that a pharmacist need not be physically present at the site of an automated pharmacy system if the pharmacist was able to supervise the system electronically. However, the Task Force members also stipulated that a pharmacist be accessible at all times to respond to inquiries or requests pertaining to the automated pharmacy system through a toll free phone number. Lastly, the Task Force members emphasized the use of a video/auditory communication system for the ensuring that outpatients received the appropriate patient counseling.

Recommendation 4: The Task Force recommends that the existing definition of “Pharmaceutical Care” within the NABP Model Act be amended in consideration of the MMA 2003 and MTM services. The Task Force further recommends that NABP encourage boards of pharmacy to review their pharmacy practice acts and regulations to determine whether or not pharmacists are able to legally provide MTM services as provided within the MMA 2003.


Article I

Title, Purpose, and Definitions

Section 105. Definitions. (uuu) “Pharmaceutical Care” is the provision by a Pharmacist of Drug therapy and other patient care

services, with or without the Dispensing of Drugs or Devices, 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.

Background:

The Task Force members were also charged with discussing the need for model regulations to address the provision of pharmacist care as a result of the MMA 2003. Per Resolution 101-8-05, Implementation of MMA 2003, NABP was directed to assess and revise, if necessary, the Model Act so that pharmacists could provide MTM. The Task Force members agreed that the Model Act appropriately enabled pharmacists to provide MTM as outlined in MMA 2003. Designed to ensure optimum therapeutic outcomes for targeted beneficiaries through improved medication use, reduce adverse events, and reduce drug-drug interactions, the goals of MTM and “Pharmaceutical Care,” as provided in the Model Act, are quite similar. According to the Task Force members, the Model Act realizes the achievement of pharmaceutical care through drug therapy

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management (the evaluation of drug therapy and the provision of specific patient care services) and drug regimen review (the evaluation of prescription drug orders and patient specific information). Furthermore, the “Practice of Pharmacy,” according to the Model Act, allows pharmacists to engage in traditional practices such as the evaluation and interpretation of prescription drug orders, as well as other patient care services necessary to achieve pharmaceutical care, including collaborative pharmacy practice. The Task Force members discussed the existing Model Act definition of “Pharmaceutical Care.” In consideration of MMA 2003 and its provisions pertaining to MTM, Task Force members felt that the definition of “Pharmaceutical Care” could potentially limit pharmacists who provide cognitive services apart from dispensing medication. “Pharmaceutical Care” includes the “provision of drug therapy and other patient care services…”, and although the Task Force members agreed that pharmaceutical care customarily occurs with the direct provision of drug therapy, the practice of pharmacy is evolving in that cognitive services, such as intensive patient education/training, often occur separate from the direct provision of drug therapy. Cognitive services such as formulating medication treatment plans and monitoring and evaluating responses to therapies, are increasingly becoming the sole array of services that pharmacists provide. Recommendation 5: The Task Force Recommends that NABP consider the feasibility of a national licensure/certification program for pharmacists.

Background:

In addition to assessing whether or not the Model Act permits pharmacists to provide MTM services as provided by the MMA 2003, the Task Force members were also charged with determining if the Model Act allows pharmacists to provide these services across multiple jurisdictions.

The Model Act recognizes that protection of the public health should extend across state borders and, therefore, the Model Act incorporates the “Practice of Telepharmacy” across state lines within the scope of the “Practice of Pharmacy” and currently requires full licensure for all pharmacists practicing within a particular jurisdiction by any means. Likewise, the Model Act requires registration of pharmacies that provide services to residents whether or not the pharmacy is located within or outside the state.

However, with the advent of MTM and the anticipated expansion of pharmacists providing cognitive services, states like California are considering whether it should now require the licensure of non-resident pharmacists and whether or not these cognitive-service-providing pharmacists should be required to be affiliated with (if not employed by) a pharmacy. Additionally, discussions regarding multiple licensing/registration fees for pharmacists wishing to practice in multiple jurisdictions may potentially hamper access by patients to pharmacists and especially those pharmacists that strictly provide cognitive services. For example, the California State Board of Pharmacy Licensing Committee has discussed a non-resident registration (which is presumably easier to obtain than a license), a national license/certification program that could be administered by NABP, and no additional requirements for non-resident pharmacists, with the California Board depending on the home licensure state for discipline and compliance (in addition to compliance with California standard of care requirements).

Considering the information presented by the California Board, Task Force members agreed that the NABP Executive Committee should consider the feasibility of a national licensure program for pharmacists. Other professions have considered and even adopted this measure. For example, the National Council of State Boards of Nursing and the Nurse Licensure Compact Administrators have developed a Nurse Licensure Compact, which allows a nurse to have one license (in the nurse’s state of residence) but practice in other states, as long as that individual acknowledges that he or she is subject to each state’s practice laws and discipline. Under the Nurse Licensure Compact, mutual recognition and practice across state lines is allowed, whether physical or electronic, unless the nurse is under discipline or a monitoring agreement that restricts practice across state lines. Currently, 18 states have implemented and adopted the Nurse Licensure Compact and three states are pending implementation.

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