BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the adoption of New Rule I, the amendment of ARM 37.106.2401, 37.106.2404, 37.106.2405, 37.106.2407, 37.106.2411, 37.106.2412, 37.106.2415, 37.106.2416, 37.106.2420, 37.106.2422, 37.106.2423, 37.106.2430, 37.106.2431, 37.106.2432, and 37.106.2433, and the repeal of ARM 37.106.2406 and 37.106.2426 pertaining to home infusion therapy (HIT)

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION, AMENDMENT, AND REPEAL

 

TO:  All Concerned Persons

 

            1.  On June 17, 2009, at 1:30 p.m., the Department of Public Health and Human Services will hold a public hearing in the auditorium of the Department of Public Health and Human Services Building, 111 North Sanders, Helena, Montana, to consider the proposed adoption, amendment, and repeal of the above-stated rules.

 

            2.  The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice.  If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on June 8, 2009, to advise us of the nature of the accommodation that you need.  Please contact Rhonda Lesofski, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

 

            3.  The rule as proposed to be adopted provides as follows:

 

            RULE I  INCORPORATION BY REFERENCE  (1)  The department adopts and incorporates by reference United States Pharmacopoeia (USP) 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations, June 1, 2008, which sets practice standards to help ensure that compounded sterile preparations are of high quality.  A copy of USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations may be obtained from USP Headquarters, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, telephone (800) 227-8772 or http://www.usp.org/products/797Guidebook.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, MCA

 

            4.  The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

 

            37.106.2401  HOME INFUSION THERAPY AGENCY:  DEFINITIONS  In addition to the definitions in 50-5-101, MCA, the following definitions apply to this subchapter:

            (1) remains the same.

            (2)  "Biological safety cabinet" means a containment unit suitable for the preparation of low to moderate risk agents where there is a need, according to national sanitation foundation standard 49 for class II biohazard cabinetry, as revised May 1992, for protection of the product, personnel, and environment.  The department hereby adopts and incorporates by reference national sanitation foundation standard 49 for class II biohazard cabinetry, as revised May 1992, promulgated by the National Sanitation Foundation International, 3475 Plymouth Road, P.O. Box 1468, Ann Arbor, MI 48113.  A copy of national sanitation foundation standard 49 may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

            (3)  "Class 100 environment" means an atmospheric environment which contains less than 100 particles 0.5 microns in diameter per cubic foot of air.

            (4) remains the same but is renumbered (3).

            (5) (4)  "Enteral" means a preparation compounded in a class 100 an ISO Class 5 environment, and dispensed by a pharmacist, and administered within or by way of the intestine.

            (5)  "Home infusion therapy (HIT) services" means the preparation, administration, or furnishing of parenteral medications, or parenteral or enteral nutritional services to an individual in that individual's residence.  The services include an educational component for the patient, the patient's caregiver, or the patient's family member.

            (6)  "ISO Class 5" means a classification of air cleanliness as defined in USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations.

            (6) remains the same but is renumbered (7).

            (7) (8)  "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin with infusion administration time equal to or greater than 15 minutes determined by the recommendation of the pharmaceutical manufacturer.

            (8) (9)  "Pharmacist" means a natural person licensed by the Montana department of labor and industry to prepare, compound, dispense, and sell drugs, medicines, chemicals, and poisons state to engage in the practice of pharmacy and who may affix to the person's name the term "R.Ph."

            (9) (10)  "Pharmacist-in-charge or their designee" means a licensed pharmacist licensed by the Montana department of labor and industry who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally in full and actual charge of such pharmacy.

            (10) (11)  "Pharmacy" means an established place location, either physical or electronic, registered by the Montana department of labor and industry in which prescriptions, drugs requiring a prescription, medicines, chemicals, and poisons are compounded, dispensed, vended, or sold Board of Pharmacy where drugs or devices are dispensed with pharmaceutical care or where pharmaceutical care is provided.

            (11) (12)  "Prescribing practitioner" means a practitioner authorized to prescribe by the jurisdiction in which he or she is licensed to practice the profession and acting with the scope of this authorization licensed health care professional authorized by state statute or federal law to prescribe pharmaceuticals and/or treatments.

            (12) (13)  "Sterile pharmaceutical or product" means a an aseptic dosage form free from living micro-organisms (aseptic).

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

            37.106.2404  HOME INFUSION THERAPY AGENCY:  RESPONSIBILITY FOR SERVICES  (1)  Where a home infusion therapy agency directly provides either the home infusion therapy services or skilled nursing services and arranges for the provision of the other services, the parties must enter into a written contract defining the nature and scope of the services to be provided by each party.  The contract must:

            (a)  describe the services to be provided by each party; and

            (b)  specify the responsibilities of each party of the parties in the provision, coordination, supervision, and evaluation of the care or services provided; and.  This must include each party's role in:

            (c)  specify the role of the parties in:

            (i)  the patient admission process;

            (ii)  the patient assessment process;

            (iii)  the patient education process;

            (iv)  the development, review, and revision of the patient plan of care;

            (v)  the development, review, and revision of the patient home care medical record;

            (vi)  the provision of clinical services;

            (vii)  the timely reporting of adverse reactions to treatment, medical symptoms, or abnormal lab values;

            (viii)  the timely reporting of the patient failing to comply with the home infusion regiment;

            (vii) (ix)  the patient care conferences; and

            (viii) (x)  discharge planning.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2405  HOME INFUSION THERAPY AGENCY:  ADMINISTRATOR AND PERSONNEL  (1)  Each home infusion therapy agency must employ an administrator who shall:

            (a) remains the same.

            (b)  be responsible for ongoing oversight of the agency's quality assessment system, including the establishment of policies and procedures which address the safe control, accountability, and distribution, and administration of infusion products;

            (c) and (d) remain the same.

            (2)  For a pharmacy which is licensed as a home infusion therapy agency, the pharmacist-in-charge may be serve as the administrator.

            (3)  All services provided by the home infusion therapy agency and its employees must be provided in accordance with state laws, regulations, and home infusion therapy agency policies and procedures.

            (4)  The home infusion therapy agency must maintain, at all times, a pharmacist-in-charge (or designee) and a Montana licensed nurse that are both accessible and physically able to respond 24 hours a day, seven days per week.

            (5)  The home infusion therapy agency shall document in the employee record:

            (a)  all professional employee orientation;

            (b)  competency assessments;

            (c)  specialized training required within the respective professions; and

              (d)  a current license.

            (6)  The pharmacist-in-charge may be assisted by supportive personnel.  Supportive personnel must work under the immediate supervision of a licensed pharmacist and have specialized training in the field of home infusion therapy.  The duties and responsibilities of these personnel must be consistent with their training and experience.

            (7)  The licensed health care professional providing skilled nursing services shall:

            (a)  provide those services in accordance with the plan of care;

            (b)  dictate or write clinical notes at the time of service.  Clinical notes must be signed, recorded, and incorporated into the patient's medical record within three working days of providing the service;

            (c)  assist in coordinating all services provided; and

            (d)  notify the pharmacist, the prescribing practitioner, and the home infusion therapy agency's personnel responsible for the care of the patient, of any significant changes in the patient's condition.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2407  HOME INFUSION THERAPY AGENCY:  QUALITY ASSESSMENT  (1)  Each home infusion therapy agency, in consultation with any contracted parties, if applicable, shall prepare and maintain on file an annual report of improvements made as a result of a quality assessment program. develop and implement a system of reviewing and evaluating the appropriateness and effectiveness of patient services and the correction of deficiencies.  At a minimum, the quality assessment system must:

            (a)  consist of an annual review of overall provider functions and a semiannual review of selected patient clinical records; and

            (b)  be reviewed and evaluated by a team composed of, at a minimum, a pharmacist-in-charge, a licensed health care professional, and a licensed health care professional not affiliated with the home infusion therapy agency.  The evaluation will be ongoing, including sampling not initiated solely in response to a problem.

            (2)  The annual review of provider function must be an organized, effective and documented evaluation.  At a minimum, the evaluation must include a review of the:

            (a)  administrative policies and procedures;

            (b)  personnel policies;

            (c)  safety management;

            (d)  emergency preparedness policies;

            (e)  clinical program policies and procedures; and

            (f)  durable medical equipment maintenance and procedures.

            (3)  The semiannual review of patient clinical records must be:

            (a)  both concurrent and retrospective; and

            (b)  performed against preset criteria of practice for each discipline providing care.  Criteria of practice must include:

            (i)  the appropriateness of the level of care provided to protect the health and safety of patients;

            (ii)  the timeliness of the provision of care;

            (iii)  the adequacy of the care to meet the patient's needs; and

            (iv)  the appropriateness of the specific services provided.

            (4)  Each home infusion therapy agency, in consultation with any contracted parties, if applicable, shall develop and implement a quality assessment plan.  The plan must include:

            (a)  a method for reporting results and a mechanism for taking follow up action;

            (b)  patient and caregiver and licensed health care professional satisfaction surveys; and

            (c)  methods to document medication errors and incident reporting and adverse drug reactions.

            (5)  Each home infusion therapy agency, in consultation with any contracted parties, if applicable, shall establish, document, and audit at regular, planned intervals, quality control procedures.  Quality control procedures must be  evaluated on an ongoing basis.  At a minimum, quality control procedures must include:

            (a)  drug or product recall procedures;

            (b)  documentation of storage, stability, and expiration dates;

            (c)  documentation of equipment functioning and maintenance (such as daily refrigerator temperature logs, records for cleaning, maintenance and calibration of infusion devices);

            (d)  certification of laminar flow hoods and biological safety cabinets by an independent contractor, according to national sanitation foundation standard 49, for operational efficiency at least every 12 months.  Appropriate records must be maintained to document certification;

            (e)  documentation of assessment of sterile technique performed by pharmacy personnel; and

            (f)  procedures for suspected microbial contamination of sterile products.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2411  HOME INFUSION THERAPY AGENCY:  EDUCATION SERVICES  (1)  Each home infusion therapy agency, and any contracted party providing services to the patient, together, shall:

            (a)  provide the patient or the patient's caregiver with education and counseling on proper storage, scheduling, and risks associated with specific drugs and infusion therapy in general, the proper disposal of unused or outdated medications, and document the counseling sessions in the patient's home care medical record; and

            (b)  provide to the patient and/or patient caregiver written educational material which must include at a minimum:

            (i)  drug information sheets for prescribed therapy;

            (ii)  compounding, admix technique, adding medications to solutions, and withdrawing medications from vials;

            (iii)  function, operation, and troubleshooting durable medical equipment when prescribed; and

            (iv)  supplies and training for safe and proper handling and disposal of antineoplastic, infectious, and hazardous waste.

            (b) (c)  reassess on an ongoing basis, the patient's competency or the patient's caregiver's competency, in managing home infusion therapy in the home environment and document the reassessment process in the patient's home care medical record.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2412  HOME INFUSION THERAPY AGENCY:  HOME CARE MEDICAL RECORD  (1)  Each home infusion therapy agency, and any contracted party providing services to the patient, together, shall establish and maintain for each patient accepted for care, a home care medical record which must be accessible to home infusion therapy personnel and which must include the following information:

            (a)  admission data, including the:

            (i) through (v) remain the same.

            (vi)  name, address and telephone number and contact information of the patient's caregiver or family member; and

            (vii)  name, address and telephone number and contact information of the pharmacist-in-charge and the prescribing practitioner; and.

            (viii)  admission diagnosis or pertinent health information.

            (b)  a notation of patient conditions and diagnoses which are admission diagnosis and pertinent health information relevant to the plan of care;

            (c) remains the same.

            (d)  laboratory reports, if applicable; and;

            (e)  documentation that a list of patient rights and responsibilities have been made available to each patient or the patient's caregiver.;

            (f)  the plan of care;

            (g)  clinical assessments and services documentation;

            (h)  the prescribing practitioner's order for home infusion therapy;

            (i)  a monthly clinical therapy summary for any patient receiving services 30 days or longer; and

            (j)  a discharge summary of therapy at the end of treatment.

            (2)  The responsibilities of the patient, and the home infusion therapy agency, including any contracted parties, and the prescribing practitioner, in the areas of delivery of care and monitoring of the patient, must be clearly documented in the patient's home care medical record.

            (3) through (3)(k) remain the same.

            (4)  All records of dispensed sterile pharmaceuticals must be a part of the patient's medical record.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2415  HOME INFUSION THERAPY AGENCY:  ADMINISTRATION OF MEDICATION AND TREATMENT  (1)  All medications and treatments administered by the home infusion therapy agency's personnel or contracted parties must be administered by a Montana licensed health care professionals.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2416  HOME INFUSION THERAPY AGENCY:  PARENTERAL OR ENTERAL SOLUTIONS  (1)  In addition to the minimum requirements for a pharmacist and a pharmacy established by Title 37, chapter 7, MCA, and ARM Title 24, chapter 174, any parenteral or enteral solution provided by the home infusion therapy agency or obtained through contract with a third party pharmacy and provided to patients of the home infusion therapy agency must be dispensed by a licensed pharmacist in a Montana licensed pharmacy, whom and which are in compliance with the requirements of ARM 37.106.2420, 37.106.2404, 37.106.2407, 37.106.2422, 37.106.2423, 37.106.2426, and 37.106.2430 through 37.106.2433 in this subchapter.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2420  HOME INFUSION THERAPY AGENCY:  PHARMACY POLICY AND PROCEDURE MANUAL  (1)  The pharmacy home infusion therapy agency shall develop a policy and procedure manual relating to sterile products and home infusion therapy.  The for the organization and operation of the agency.  A copy of the manual must be kept current at all times, and be readily available at all times, and to all who request it for inspection at the pharmacy.

            (2)  The pharmacist-in-charge shall review and revise the manual on an annual basis.  The manual must include an organizational chart delineating the lines of authority, responsibility, and accountability for the administration and patient care services of the agency.

            (3)  The manual must specifically detail the storage, stability, handling, compounding, labeling, dispensing, and delivery of all sterile pharmaceuticals and address requirements relating to:

            (a) through (g) remain the same.

            (h)  the administration of parenteral therapy to include infusion devices, drug delivery systems, and first dose monitoring;

            (i) through (l) remain the same.

            (m)  24-hour emergency access to a pharmacist;

            (n)  the handling of antineoplastic agents, a description of which must include protective apparel to be worn by compounding personnel;

            (o) through (x) remain the same.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2422  HOME INFUSION THERAPY AGENCY:  PHYSICAL REQUIREMENTS FOR PHARMACIES  (1)  The pharmacy must have a designated area with entry restricted to designated personnel for preparing sterile products.  This area must be:

            (a)  a separate room with a closed door, isolated from other areas with restricted entry or access, and designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled facility as required by USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations;

            (b) and (c) remain the same.

            (d)  one with cleanable work surfaces, walls, and floors.

            (2)  The pharmacy preparing the sterile products must have:

            (a)  appropriate environmental control devices capable of

maintaining at least a class 100 environment an ISO Class 5 in the workplace where critical activities are performed.  The devices must be capable of maintaining class 100 conditions this condition during normal activity.  Examples of appropriate devices include vertical and horizontal laminar airflow hoods and zonal laminar flow of high efficiency particulate air filtered air.  All airflow hoods used by the home infusion therapy agency must be certified as able to maintain an ISO Class 5 environment as required by USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations;

            (b) and (c) remain the same.

            (d)  temperature controlled delivery containers, when appropriate necessary;

            (e)  infusion devices, when appropriate necessary;

            (f) through (3) remain the same.

            (4)  The pharmacy shall maintain sufficient current reference materials relating to sterile products to meet the needs of the pharmacy personnel.  Reference materials must contain information on stability, incompatibilities, mixing guidelines, and the handling of antineoplastic products.

            (5)  The pharmacy shall document a chain of possession for all controlled substances including return or disposal of unused controlled substances.

            (6)  All pharmacies utilized by or part of a home infusion therapy agency must be able to deliver to the home infusion therapy agency patient any needed medications and therapies within 24 hours of the need being recognized.  If a pharmacy is not able to ensure a 24-hour response time, a current contract with a pharmacy that is able to ensure a 24-hour response time is required, and must be kept at the home infusion therapy agency.

            (7)  If the home infusion therapy agency utilizes a pharmacy located outside the state of Montana, documentation must be maintained at the home infusion therapy agency site that the pharmacy utilized has a current Montana pharmacy license per Board of Pharmacy requirements, and that it meets the requirements of this rule.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2423  HOME INFUSION THERAPY AGENCY:  DISPENSING OF STERILE PHARMACEUTICALS  (1) through (1)(h) remain the same.

            (2)  All records of dispensed sterile pharmaceuticals must be made a part of the patient's home care record.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2430  HOME INFUSION THERAPY AGENCY:  LABELING

            (1)  Parenteral pharmaceuticals dispensed to patients must have a permanent label with the following information:

            (a)  the name, address, and phone number and contact information of the pharmacy including a phone number which provides access to a pharmacist 24 hours per day, seven days per week;

            (b) through (f) remain the same.

            (g)  the name of each component, its strength, and amount;

            (h) through (j) remain the same.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2431  HOME INFUSION THERAPY AGENCY:  ANTINEOPLASTIC DRUGS  (1)  The following requirements must be met by those pharmacies that prepare antineoplastic drugs to ensure the protection of the personnel involved:

            (a)  All antineoplastic drugs must be compounded in a vertical flow, Class II, biological safety cabinet;.

            (b)  Protective apparel must be worn by personnel compounding antineoplastic drugs according to the home infusion agency's policies and procedures.  This must include gloves, gowns with tight cuffs, and appropriate equipment as necessary;

            (c)  Appropriate safety and containment techniques for compounding antineoplastic drugs must be used in conjunction with the aseptic techniques required for preparing sterile pharmaceuticals;.

            (d)  Written procedures for handling both major and minor spills of antineoplastic agents must be included in the policy and procedure manual; and.

            (e) remains the same.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2432  HOME INFUSION THERAPY AGENCY:  DISPOSAL OF ANTINEOPLASTIC, INFECTIOUS, AND HAZARDOUS WASTES  (1)  Disposal of antineoplastic, infectious, and hazardous waste is governed by the Infectious Waste Management Act, Title 75, chapter 10, part 10, MCA. 

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2433  HOME INFUSION THERAPY AGENCY:  DELIVERY OF MEDICATIONS  (1)  The pharmacist-in-charge home infusion therapy agency shall ensure that medications are timely delivered according to the prescribed start of therapy  so that the prescription for sterile pharmaceuticals can be implemented as ordered without undue delay.  Once therapy has been initiated, the pharmacy home infusion therapy agency shall continue to provide sterile pharmaceuticals in a timely fashion so as not to interrupt ongoing therapy.

            (2)  The pharmacist-in-charge shall ensure the environmental control of all products shipped.  All compounded, sterile pharmaceuticals must be shipped or delivered, other than those compounded in an institutional setting, to a patient in appropriate, temperature-controlled (as defined by the United States Pharmacopeia/National Formulary) delivery containers and stored appropriately in the patient's therapy setting.  If the start of therapy is to be delayed for more than two hours from the prescribed start time, the home infusion agency shall notify both the patient and the prescribing practitioner.

            (3) and (4) remain the same.

            (5)  The home infusion therapy agency shall ensure the environmental control of all products shipped.  All compounded, sterile pharmaceuticals must be shipped or delivered to a patient in appropriate, temperature-controlled delivery containers as defined by the United States Pharmacopeia/National Formulary and stored appropriately in the patient's therapy setting.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            5.  The department proposes to repeal the following rules:

 

            37.106.2406  HOME INFUSION THERAPY:  CLINICAL SERVICES, is found on page 37-26465 of the Administrative Rules of Montana.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            37.106.2426  HOME INFUSION THERAPY:  PHARMACY PERSONNEL, is found on page 37-26487 of the Administrative Rules of Montana.

 

AUTH:  50-5-103, MCA

IMP:  50-5-103, 50-5-213, MCA

 

            6.  The Department of Public Health and Human Services (the department) is proposing the adoption of new Rule I, the amendment of ARM 37.106.2401, 37.106.2404, 37.106.2405, 37.106.2407, 37.106.2411, 37.106.2412, 37.106.2415, 37.106.2416, 37.106.2420, 37.106.2422, 37.106.2423, 37.106.2430, 37.106.2431, 37.106.2432, and 37.106.2433, and the repeal of ARM 37.106.2406 and 37.106.2426, pertaining to home infusion.  The proposed changes are necessary to reflect the evolving changes in the home infusion therapy (HIT) industry.

 

References are made throughout the rules to the United States Pharmacopoeia (USP) 31 797 Guidebook to Pharmaceutical Compounding - Sterile Preparations (USP 797).  The USP is a nongovernmental, standards-setting organization for all prescription and over the counter medications and other health care products manufactured or sold in the United States.  Use of USP 797 requirements place in rule the standards of practice that are used by pharmacies when filling home infusion therapy and other orders.

 

The word "agency" has been added after "home infusion therapy" in all rule catchphrases.  This change is necessary to clarify that the rules pertain to agencies and not to the process of home infusion therapy, which is a pharmacological process.

 

"Home care record" is being replaced with the words "medical record" for accuracy in what is required to be maintained in a home infusion therapy (HIT) patient medical record.  This change is necessary to broaden and improve the scope of patient care documentation enabling practitioners to provide a full continuum of care.

 

General amendments include reorganizing information, deleting redundancies, correcting punctuation, formatting requirements, and clarifying the process of home infusion therapy from the home infusion therapy agency providing the service.

 

RULE I

 

The department proposes new Rule I to incorporate USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations by reference.  Locating the incorporated by reference material in an individual rule instead of in several rules that refer to USP 797 makes the rules more user friendly while providing the necessary information for material incorporated by reference.

 

ARM 37.106.2401

 

ARM 37.106.2401 is amended to include and update the definitions used in the subchapter that, except for "home infusion therapy services", are not defined in 50-5-101, MCA.  To avoid confusion, the definition of home infusion therapy services is defined in both this rule and 50-5-101(26), MCA so providers and the public have easy access in determining regulatory compliance.

 

The reference to the National Sanitation Foundation Standard 49 is deleted and replaced by the USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations which is a widely recognized industry standard.  Also, outdated reference language to class 100 environment is deleted and a new ISO Class 5 definition is added. 

 

It is necessary to amend the definition of parenteral so that the infusion time required to administer drugs for injection is determined by the recommendation of the pharmaceutical manufacturer in order to obtain the maximum benefits from the drug.

 

To maintain consistency and continuity with the Board of Pharmacy regulations it is necessary to revise the definitions for "pharmacist" and "pharmacy" to reflect the language found at 37-7-101, MCA.

 

It is necessary to amend the definition of pharmacist-in-charge for clarity and to identify a specific member of the pharmacy team responsible for the operation of the pharmacy.  This designation enables members of the home infusion therapy agency, as well as others, a point of contact in the event of unforeseen issues regarding home infusion therapy.

 

It is necessary to amend the definition of prescribing practitioner to more specifically address the authorization of the scope of practice of the prescribing practitioner.  "Sterile pharmaceutical or product" is amended to more clearly identify that the pharmaceutical or product referred to is aseptic.

 

ARM 37.106.2404

 

ARM 37.106.2404 is amended to improve the language structure, make provisions more specific, and require timely reporting of critical events and/or patient conditions in order to provide quality patient care.

 

ARM 37.106.2405

 

ARM 37.106.2405 amendments consolidate language from ARM 37.106.2405, 37.106.2406, and 37.106.2426 dealing with personnel requirements.  The department is proposing to repeal ARM 37.106.2406 and 37.106.2426 in this notice.  The consolidation is necessary to make the rules more user-friendly, delete repetitive and excessive information, and more accurately and clearly express the requirements for all home infusion therapy agency personnel.  It is also necessary to ensure that home infusion therapy does not end with the distribution of the infusion product but includes the administration of the pharmaceutical or product since administration of drugs is included in the home infusion therapy services definition.  The amendments ensure the safety, welfare, and health of the patients under the agency's care.

 

ARM 37.106.2406

 

The department is proposing to repeal ARM 37.106.2406 and incorporate existing text into ARM 37.106.2405 as explained regarding the amendment of ARM 37.106.2405.

 

ARM 37.106.2407

 

The proposed amendment to ARM 37.106.2407 replaces existing text with the requirement of an annual report of improvements made as a result of a quality assessment program.  This amendment is necessary to simplify the rule, shift the responsibility for the quality assessment from the state to the actual home infusion therapy agency itself, and in doing so provides the home infusion therapy agency the flexibility to address specific quality assurance needs unique to the agency thereby benefiting the agency's patients.

 

ARM 37.106.2411

 

It is necessary to amend this rule to more accurately reflect educational process requirements that a home infusion therapy agency must provide to patients.  Educating patients on proper disposal of unused or outdated medications is necessary for the patient's benefit.  The storing of unused or outdated medications could result in harm to the patient or others.  The language in ARM 37.106.2411(1)(b) was taken from ARM 37.106.2426 which deals with pharmacy personnel.  Moving these provisions consolidates the educational process requirements into one rule thereby making the rules easier to use.

 

ARM 37.106.2412

 

It is necessary to amend ARM 37.106.2412 because it is the responsibility of the home infusion therapy agency to establish and maintain for each patient a medical record.  While contracted parties may indeed contribute to that record, setting policies that establish what is required to be in that record, and maintaining that record, is the responsibility of the home infusion therapy agency.  This is a necessary change in order to ensure that it is clear that the home infusion therapy agency is the body that the state will hold accountable in maintaining a patient medical record.

 

During the survey process, it has been found that if the pharmacy and the nursing staff are operated from separate locations, the individual entities do not have access to the full patient medical record.  Therefore, it is necessary to amend the rule to ensure continuum of care and adequate communication between professionals providing care to the patient.

 

It is also necessary to amend the rule to reflect changes in contact information encountered among patients, providers, etc.  Since 1996, when the original rule was written, communication methods have advanced and contact information has evolved beyond address and phone numbers to include such information as fax, cell phone, or pager numbers, and e-mail addresses.  Allowing additional methods of contact information makes it more convenient for providers and those to be contacted resulting in improved customer service.  Also, it is necessary to amend the rule to separate admission data from additional admission documentation criteria, establish that all laboratory reports are to be made a part of the medical record, indicate that "clinical assessments and services documentation" are also an essential part of the medical record, and require that the prescribing practitioners' orders, authorizing the home infusion treatment, be included to complete the medical record.  These requirements broaden and improve the scope of patient medical record documentation thereby improving the patient's continuum of care.

 

Several sections were previously parts of other rules but are proposed to be included in ARM 37.106.2412 because they are clearly and more accurately medical record requirements.  It is necessary to include these sections in the medical records rule so all medical record requirements are located in one rule for ease of use.  The section requiring records of dispensed sterile pharmaceuticals to be a part of the patient's medical record is necessary to ensure tracking of all medications.

 

ARM 37.106.2415

 

It is necessary to amend ARM 37.106.2415 to indicate that those administering medications within a home infusion therapy agency be licensed by the state of Montana in order to protect the patient by assuring the medication administrator is qualified to perform this duty.  Through Montana's health care professional licensing laws and rules, licensees must meet these requirements thereby protecting the patient.

 

ARM 37.106.2416

 

It is necessary to amend ARM 37.106.2416 to protect patients by requiring that pharmacies hold a Montana pharmacy license.  Through Montana's health care professional licensing laws and rules, licensees must meet these requirements thereby protecting the patient.

 

ARM 37.106.2420

 

It is necessary to amend ARM 37.106.2420 to indicate that home infusion therapy entails more than just pharmaceutical related policies and procedures.  Nursing is a large component of home infusion therapy and the current rule does not indicate the requirements for nursing policies and procedures.  The proposed amendments enable the incorporation of policies and procedures for pharmacy and nursing, in addition to other services the agency may provide.  Requiring current policy and procedure manuals protects patients, employees, and the agency by detailing responsibilities.  The current rule limits the scope of the home infusion policy and procedure manual to sterile products and home infusion therapy without regard to the various professional roles involved with the operation of the agency and delivery of services.  The proposed amendments are necessary to broaden the scope and application of the agency's policies and procedures and encompass the goal of the agency's policies and procedures.

 

Prior to the proposed amendments, the emphasis of the rule was the availability of the policy and procedure manual for inspection purposes.  The purpose of the policy and procedure manual is to provide the necessary guidance for the organization and operation of the agency.  In the survey process it has been found that manuals describing the operation of the agency are not kept at the home infusion therapy agency, but at remote locations such as corporate offices, etc.  This does not allow for patients, patient caregivers, employees, or contactors easy access to this information thereby creating the potential for negative consequences for those individuals.  The addition of the organizational chart requirements is necessary to make home infusion therapy agencies consistent with the requirements for other health care facilities licensed by the department.

 

ARM 37.106.2422

 

It is necessary to amend ARM 37.106.2422 to emphasize and add the requirements for pharmacies to protect Montana residents receiving home infusion therapy services from out-of-state and mail order pharmaceutical companies.  While it was determined to not be fair to place geographical restrictions on pharmacies, it was determined that to protect any patient receiving mail order or out-of-state therapies, a required time frame of response must be established to provide services within 24 hours, seven days a week.  Negative consequences can result if delays occur once home infusion therapy has been ordered.  While the department does not prohibit the use of out-of-state or mail order pharmacies for home infusion therapy agencies, it is proposed that if such a pharmacy cannot ensure a 24-hour response time that a contract with a pharmacy able to ensure such a response is maintained by the home infusion therapy agency.  Additionally, it is necessary for regulatory oversight to establish by rule a mechanism by which it can be determined that those outside pharmacies are held to the same physical requirements as those utilized in-state.  Additionally, the proposed amendment requires that the home infusion agency must maintain documentation of the out-of-state pharmacy's having a current Montana pharmacy license, which is required by the Montana Board of Pharmacy, in order to ensure patient safety.

 

It is proposed that all horizontal and laminar airflow hoods are required to be certified to the standards set by USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Compounding.  This is the current industry standard, and has been proposed to be incorporated by reference.

 

Other proposed amendments are necessary to update references to make rules within this subchapter consistent.  Also, it is necessary to provide physical requirements for the security of controlled substances to ensure documentation of all controlled substances in the possession of the home infusion therapy agency pharmacies for accountability purposes.

 

ARM 37.106.2423

 

The proposed amendment to ARM 37.106.2423 is necessary to move patient medical record requirements to ARM 37.106.1212 where it is more appropriate and to keep all medical record information in one rule for ease of use.

 

ARM 37.106.2430

 

The proposed amendment to ARM 37.106.2430 is necessary to address new technological communication methods.  Since 1996, when the original rule was written, communication methods have advanced and contact information has evolved beyond address and phone numbers to include such information as fax, cell phone, or pager numbers, and e-mail addresses.  Allowing additional methods of contact information makes it more convenient for providers and those to be contacted resulting in improved customer service.

 

ARM 37.106.2431

 

The proposed amendment to ARM 37.106.2431 requires that the protective apparel worn when working with antineoplastic drugs be consistent with the policies and procedures established by the home infusion therapy agency in accordance with ARM 37.106.2420.  This amendment is necessary to eliminate confusion and potential conflicts between rule requirements.

 

ARM 37.106.2433

 

It is necessary to amend ARM 37.106.2433 to identify that it is the home infusion therapy agency that is responsible for the delivery of therapy as prescribed, and that once therapy has started, the home infusion therapy agency must continue delivering the therapy in a manner that will not interrupt the ongoing therapy.  Confusion has resulted by the previous language indicating that the pharmacist-in-charge is responsible for therapy delivery.  It is also necessary to include new language to place accountability on the home infusion therapy agency to provide for continuity of care by requiring notice of start of therapy delays.

 

            7.  Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing.  Written data, views, or arguments may also be submitted to: Rhonda Lesofski, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., June 25, 2009.

 

8.  The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

9.  The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices.  Notices will be sent by e-mail unless a mailing preference is noted in the request.  Such written request may be mailed or delivered to the contact person in 7 above or may be made by completing a request form at any rules hearing held by the department.

 

10.  An electronic copy of this Proposal Notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the Notice conform to the official version of the Notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the Notice and the electronic version of the Notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

11.  The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

 

 

 

/s/  Lisa Swanson                                          /s/  Anna Whiting Sorrell                              

Rule Reviewer                                               Anna Whiting Sorrell, Director

                                                                        Public Health and Human Services

           

Certified to the Secretary of State May 18, 2009