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)
