Arkansas Administrative Code › Agency 007 - ARKANSAS DEPARTMENT OF HEALTH › Division 33 - Division of Health Related Boards and Commissions › Rule 007.33.21-009 - RULE 5 - LONG TERM-CARE FACILITIES

Current through Register Vol. 49, No. 6, June, 2024
05-00
-CONSULTANTS
05-00-0001
-DEFINITIONS
Consultant pharmacist
A consultant pharmacist means a pharmacist who assumes the
				ultimate responsibility to ensure adherence to all laws and regulations
				concerning pharmacy services for a nursing home or other facility requiring
				consultant pharmacist services. The consultant pharmacist is required to
				perform the consultative services provided in the nursing home or other
				facility and must abide by, pharmacy law and rules, and the policy and
				procedures of the facility.
(Amended 2/14/2022)
05-00-0002
-GENERAL REQUIREMENTS
(a) Any pharmacist desiring to serve as a
			 consultant pharmacist for a nursing home or other facility must post a copy of
			 their Arkansas Pharmacist License in the facility for which he or she is
			 consulting.
(Amended 02/11/2003, 11/1/2007, 7/10/2009, and
				2/14/2022)
05-00-0003
-RESPONSIBILITIES
Consultant pharmacists in a facility are involved in the
				following areas of pharmaceutical care which include drug storage, distribution
				and utilization in that facility:
(a)
			 Supervision of Services
(1) The consultant
			 pharmacist(s) shall develop, coordinate, and supervise all pharmaceutical
			 services. The consultant pharmacist for the facility must ensure that
			 pharmacist consultation is available on a 24-hours-per-day, 7-days-per-week
			 basis. Consultant pharmacists shall devote a sufficient number of hours based
			 upon the needs of the facility, during regularly scheduled visits to carry out
			 these responsibilities.
(2)
			 Consultant pharmacists shall assist the facility in developing procedures to
			 ensure the provision of emergency drugs, and shall report to the Board of
			 Pharmacy any pharmacy refusing to provide medication for the pharmacy's regular
			 patients in the facility on a 24-hours-per-day, 7-days-per-week
			 basis.
(3) The consultant
			 pharmacist(s) shall provide written consultation on compliance with federal and
			 state laws governing legend drugs (including controlled substances).
(4) The consultant pharmacist(s) shall be
			 knowledgeable of all laws and regulations pertaining to the facility and shall
			 communicate with the state agencies involved with enforcement and regulation of
			 the facility.
(5) The consultant
			 pharmacist(s) shall spend sufficient time to evaluate discontinued or other
			 unused medication for destruction or donation, check entries in a bound,
			 numbered controlled drugs book, process unused medication for donation as
			 provided in ACA § 1792-1101 et seq. and Board Regulation 04-07-0006, and
			 make general observations at the nursing stations.
(6) Records shall indicate the day the
			 consultant pharmacist(s) visited the home, a brief statement of purpose,
			 finding, and actions.
(b) Control and accountability of all legend
			 drugs (including controlled substance)
(1) The
			 consultant pharmacist develops written procedures for control and
			 accountability of all drugs and biologicals throughout the facility and
			 supervises the implementation of these procedures.
(2) Only approved drugs and biologicals are
			 used in the facility and shall be dispensed in compliance with federal and
			 state laws. Records of receipt and disposition of all controlled drugs shall be
			 maintained in sufficient detail to enable an accurate reconciliation. The
			 consultant pharmacist shall determine that drug records are in order and that
			 an account of all controlled drugs is maintained and reconciled.
(3) The consultant pharmacist(s) shall
			 establish procedures to ensure that:
(A) All
			 legend drugs and controlled substances must be stored in a secured location and
			 appropriately locked.
(B) Proper
			 records of receipt and administration of controlled drugs must be maintained
			 for review by the consultant pharmacist.
(C) Non-controlled legend drugs.
(i) Drugs to be destroyed shall be handled in
			 accordance with state and federal requirements.
(ii) Drugs to be donated. The consultant
			 pharmacist shall cause all drugs that are designated for donation to charitable
			 clinics licensed by the Board under Regulation 0403-0004 and ACA §
													17-92-1101 et
			 seq., to be processed in accordance with Board Regulation 04-07-0006.
(D) Controlled drugs shall be
			 handled in accordance with state and federal requirements.
(c) Patient Drug Regimen Review
(1) The primary duty of the consultant
			 pharmacist(s) to the patients' concerns is to apply his or her expertise on
			 drugs to the patient's specific situation.
(2) State and federal regulations shall be
			 the minimum standards for an adequate drug regimen review.
(3) Additionally, the consultant pharmacist
			 shall routinely review each patient's medical records and:
(A) Ascertain that patient history and drug
			 utilization is being properly recorded.
(B) Review drug usage (including O.T.C. and
			 prescriptions).
(C) Review patient
			 compliance with drug regimen.
(D)
			 Review drug allergies or sensitivities.
(E) Determine whether the patient is
			 predisposed to side effects due to disease, illness, or age.
(F) Determine whether potential exists for
			 significant drug interaction.
(G)
			 Develop procedures to monitor patients' records for signs that indicate abuse
			 or misuse of drugs by the patient or individuals.
(H) Make recommendations regarding drug
			 therapy to the physician, nurse or other persons involved in the patient's
			 care.
(I) Communicate to the
			 facility, procedures that ensure adequate pharmacy services are available for
			 emergencies that might develop in the facility for a specific
			 patient.
(J) Promote pharmacists'
			 ability and knowledge to all persons involved in patient care and to offer
			 assistance in solving specific problems relating to patient drug
			 regimen.
(4) A
			 consultant pharmacist(s) shall quarterly in ICF/MR and assisted living (level
			 II) facilities and monthly in nursing homes, review each patient's medication
			 record, consult with and provide a written report of findings to the director
			 of nursing or the patient's physician
(d) Labeling of drugs and biologicals and
			 proper storage
(1) All legend drugs (including
			 controlled substances) on the premises of a nursing home except for the
			 emergency kit maintained pursuant to Board regulations 05-00-0004 and
			 05-000005, shall be stored under lock pursuant to Arkansas Department of Health
			 regulations, and always be in a properly labeled container as dispensed upon a
			 prescription by the pharmacy of the patient's choice.
(2) It is the duty of the consultant
			 pharmacist(s) to ascertain that medications are properly labeled, properly
			 stored, refrigerated when needed, expiration dates routinely checked, and that
			 appropriate accessory and cautionary instructions are on all medications when
			 required.
(e) Quality
			 assurance and patient assessment committee
(1)
			 A consultant pharmacist(s) shall be a member of the quality assurance and
			 patient assessment committee (or its equivalent) and make official reports to
			 this committee as often as needed to ensure quality pharmaceutical
			 care.
(2) The consultant pharmacist
			 shall ensure that there are written policies and procedures for safe and
			 effective drug therapy, distribution, control, and use.
(3) The policies and procedures shall include
			 and are not limited to:
(A) Stop order
			 policies or other methods to ensure appropriateness of continued drug
			 therapy.
(B) Maintaining the
			 contents of the emergency kit in compliance with Board regulation
			 0500-0005.
(C) Policies for the
			 safe procurement, storage, distribution, and use of drugs and biologicals.
			 (10/9/80, Amended 2/17/82, 6/25/83, 10/12/93, 02/11/2003, 6/23/05, 7/10/2009,
			 8/1/2018, and 2/14/2022)
05-00-0004
-EMERGENCY KITS FOR
			 LONG-TERM-CARE AND OTHER APPROVED INSTITUTIONAL FACILITIES
(a) With recognition of D.E.A.'s statement of
			 policy regarding emergency kits for long- termcare facilities and other law
			 applicable to non-controlled legend drugs, the following regulation is adopted
			 to permit controlled substances and non-controlled legend drugs to be stored in
			 emergency kits in long-term-care facilities in Arkansas.
Requirements
(1) All
			 contents of the emergency kit will be provided by one pharmacy designated by
			 the longterm-care facility. This pharmacy must be properly registered with
			 D.E.A.
(2) The emergency kit shall
			 be properly sealed, stored, and accessible only to authorized
			 personnel.
(3) The emergency kit
			 contents shall only be administered by authorized personnel acting on order of
			 a physician in compliance with
			 21 CFR
			 1306.11 and 21 CFR 1306.21.
(4) The categories of drugs that may be
			 contained in an emergency kit are identified in Board regulation 05-00-0005.
			 The contents of the kit shall be determined by the medical director, director
			 of nurses and consultant pharmacist at the long-term-care facility. Any
			 exceptions to the established standard categories must be approved by the Board
			 of Pharmacy. A list of contents shall be kept in the kit.
(5) The facility's licensed consultant
			 pharmacist shall be responsible for maintaining the nursing home's emergency
			 kit contents in compliance with Board regulation 05-00-0005 and the facility's
			 licensed consultant pharmacist shall check the kit monthly for outdated drugs,
			 etc.
(6) All drugs administered
			 from the kit will be replaced within 72 hours by the designated provider
			 pharmacy based on a prescription for the patient to whom the drugs were
			 administered.
(7) Violation of this
			 regulation 05-00-0001 through 05-00-0005 shall be just cause for the Board to
			 impose appropriate disciplinary action.
(8) Emergency kit drugs shall be of such a
			 nature that the absence of such drugs would detrimentally affect the health of
			 the patient.
(9) Before an out of
			 state pharmacy may supply an emergency kit to an Arkansas long-term care
			 facility, it must provide an affidavit on a form supplied by the Board that it
			 will comply with Arkansas law regarding emergency kits. If applicable, an out
			 of state pharmacy will also be subject to reciprocal restrictions as are
			 imposed by its home state on out of state pharmacies. (10/14/1981 and
			 7/27/2011)
(b)
			 Recognizing the emergency and or unanticipated need for certain legend
			 (non-controlled) drugs to be available to nurses employed by Arkansas licensed
			 home health agencies, an Arkansas licensed pharmacy may provide certain
			 medications under the following conditions:
(1) A written contract must exist between the
			 Arkansas licensed home health agency and the Arkansas licensed pharmacy, and
			 this must be available for review by the Board of Pharmacy upon
			 request.
(2) The legend drugs
			 remain the property of, and under the responsibility of, the Arkansas licensed
			 pharmacy.
(3) All medications shall
			 be administered only on physician's orders and any medication administered from
			 the nurse's supply must be recorded as a prescription by the pharmacy prior to
			 the pharmacy's replacement of the drug in the emergency supply.
(4) All medication records must be maintained
			 as required by law, and out of date drugs must be properly destroyed by the
			 pharmacy.
(5) The emergency supply
			 may be carried by each nurse or an emergency kit may be provided for each
			 patient's home.
(6) Careful patient
			 planning shall be a cooperative effort between the pharmacy and the nursing
			 agency to make all medications available and this emergency supply shall only
			 be used for emergency or unanticipated needs and shall not become a routine
			 source or supply.
(7) Only the
			 following medications can be supplied for emergency use by licensed home health
			 agencies under this paragraph by the pharmacy in sufficient but limited
			 quantities:
(A) Heparin flush: pediatric (one
			 strength)
(B) Heparin flush: adult
			 (one strength)
(C) Sterile water
			 for injection: small volume
(D)
			 Sodium chloride for injection: small volume
(E) Adrenalin (epinephrine) injection: single
			 dose only
(F) Benadryl
			 (diphenhydramine) injection : single dose only
Note: For heparin, adrenaline and benadryl, all patients shall
				have a precalculated dose.
(G) If a container is opened and partially
			 used, the unused portion shall be immediately discarded.
(8) The pharmacy is responsible to ensure
			 compliance with this regulation, and any abuse or misuse of the intent of this
			 regulation shall be immediately reported to the Board of Pharmacy.
(9) The pharmacy and the agency shall develop
			 policy and procedures to address storage conditions for medications.
(Amended 10/12/93, 10/14/97, 02/11/2003, 6/23/05, 7/10/2009 and
				8/1/2018)
05-00-0005
-DRUG CATEGORIES FOR
			 EMERGENCY KITS IN LONG-TERM CARE FACILITIES
The following is a list of categories of drugs which are
				acceptable in emergency kits in long-term-care facilities in accordance with
				this regulation of the Arkansas State Board of Pharmacy. The Board shall set
				guidelines for specific quantities of approved medications which will be
				reviewed biennially or periodically as needed. The provision or presence of an
				emergency kit in long-term care facilities does not waive the requirements of
				board regulation 04-00-0006 which requires any pharmacy providing prescription
				drugs to one or more patients in a nursing home or other institution to provide
				emergency prescription services for those patients and to provide information
				to the nursing home or institution indicating how the pharmacists can be
				reached after pharmacy hours. In every instance where injectables are
				indicated, only singledose injectables are acceptable.
(a) Analgesics, controlled drugs
(b) Anti-Infectives
(c) Anticholinergics
(d) Anticoagulant
(e) Antidiarrheals
(f) Antihistamine Injectables
(g) Antinauseants
(h) Antipsychotic injectables
(i) Anti-hyperglycemics
(j) Anxiolytics
(k) Cardiac life support
			 medications
(l)
			 Coagulants
(m)
			 Corticosteroids
(n)
			 Hypoglycemics
(o) Seizure control
			 medications
(p) Large volume
			 parenterals
(q) Poison
			 control
(r) Respiratory
			 medications
(s) GI
			 Medications
(t) Other medications
			 as approved by the Board
(Amended 02/11/2003, 11/1/2007, 7/10/2009, 7/22/2015 and
				8/1/2018)
05-00-0006
-DRUG CATEGORIES FOR
			 EMERGENCY KITS IN HOSPICE CARE FACILITIES.
The following is a list of categories of drugs which are
				acceptable in emergency kits in licensed in-patient hospice facilities in
				accordance with this regulation of the Arkansas State Board of Pharmacy. The
				Board shall set guidelines for specific quantities of approved medications
				which will be reviewed periodically. The provision or presence of an emergency
				kit in an inpatient hospice facility does not waive the requirements of board
				regulation 04-00-0006 which requires any pharmacy providing prescription drugs
				to one or more patients in a nursing home or other institution to provide
				emergency prescription services for those patients and to provide information
				to the nursing home or institution indicating how the pharmacists can be
				reached after pharmacy hours.
(a)
			 Analgesics, controlled drugs
(b)
			 Antihistamine Injectables
(c)
			 Antinauseants
(d) Antipsychotic
			 Medications
(e)
			 Anxiolytics
(f) Seizure control
			 medications
(g)
			 Corticosteroids
(h) Anticholinergic
			 medications
(i) Opioid
			 antagonist
(j) Other medications as
			 approved by the Board (5/31/2014, Amended 7/22/2015)
05-00-0007
-DRUG CATEGORIES FOR
			 EMERGENCY KITS IN CRISIS STABILIZATION UNITS.
The following is a list of categories of drugs which are
				acceptable in emergency kits for facilities that are certified by the Arkansas
				Department of Human Services as a Crisis Stabilization Unit (CSU). The Board
				shall set guidelines for specific quantities of approved medications which will
				be reviewed periodically. The provision or presence of an emergency kit in a
				Crisis Stabilization Unit does not waive the requirements of board regulation
				04-00-0006 which requires any pharmacy providing prescription drugs to one or
				more patients in a nursing home or other institution to provide emergency
				prescription services for those patients and to provide information to the
				nursing home or institution indicating how the pharmacists can be reached after
				pharmacy hours.
(a) Analgesics,
			 controlled drugs
(b) Antihistamine
			 Injectables
(c)
			 Antinauseants
(d) Antipsychotic
			 Medications
(e)
			 Anxiolytics
(f) Cardiac life
			 support medications
(g) Injectable
			 seizure control medications
(h)
			 Anticholinergic medications
(i)
			 Opioid antagonist
(j) Other
			 medications as approved by the Board
(Adopted 8/1/2018)