Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.07-010 - Regulation 05 - Long Term Care Facilities
Universal Citation: AR Admin Rules 070.00.07-010
Current through Register Vol. 49, No. 9, September, 2024
REGULATION 5 - LONG-TERM-CARE FACILITIES
05-00
-NURSING HOME
CONSULTANTS
05-00-0001
-DEFINITIONS
(a) Consultant
pharmacist in charge
A nursing home pharmacist in charge, hereinafter referred to as a consultant pharmacist in charge, means a pharmacist who assumes the ultimate responsibility to ensure adherence to all laws and regulations concerning pharmacy services in the nursing home permitted in his or her name.
The consultant pharmacist in charge is required to perform a majority of the consultative services provided in the nursing home and must ensure that other consultant pharmacists at large assisting him or her in the nursing home are aware of, and abide by, pharmacy law and regulations, and the policy and procedures of the nursing home.
(b) Consultant pharmacist at large
A nursing home consultant pharmacist at large is a pharmacist who practices as a consultant in one or more homes to assist the consultant pharmacist in charge.
(c)
Consultant pharmacist shall mean consultant pharmacist in charge and consultant
pharmacist at large collectively. (Reg. Revised 02/11/2003)
05-00-0002
-GENERAL
REQUIREMENTS
(a)
(1) Any pharmacist desiring to serve as a
consultant pharmacist in charge for a nursing home shall submit an application
on a form provided by the Board of Pharmacy and secure a nursing home
consultant permit which shall designate the home for which he or she is
responsible within five days of assuming responsibility for that nursing home.
a. If the consultant pharmacist in charge
stops providing nursing home consulting services to a nursing home, the
consultant pharmacist in charge shall notify the Arkansas State Board of
Pharmacy in writing of such change within five days after discontinuing
consultant pharmacist in charge services to a nursing home.
b. The consultant pharmacist in charge, in
conjunction with the nursing home administrator, shall be responsible for the
issuance of the nursing home permit and the timely renewal of the nursing home
permit.
(2) Any
pharmacist desiring to serve as a consultant pharmacist at large shall submit
an application on a form approved by the Board of Pharmacy and secure a
consultant pharmacist at large permit.
(b) Before a pharmacist can be licensed as a
consultant pharmacist, he or she must satisfactorily complete a test on
requirements developed by the Board to measure the knowledge of pharmaceutical
duties and responsibilities in a nursing home and certify that he or she has
read and understands these regulations and will abide by them.
(c) For renewal of a nursing home consultant
pharmacist permit, it is required that, in addition to the continuing education
required for all pharmacists, consultant pharmacists shall annually obtain
three (3) hours of continuing education specifically related to his/her role as
a consultant in a nursing home. Each consultant pharmacist shall report this
continuing education on the renewal form approved by the Board. (Reg. Revised
02/11/2003 and 11/1/2007)
05-00-0003
-RESPONSIBILITIES
Consultant pharmacists in a nursing home are involved in the following areas of pharmaceutical care which include drug storage, distribution and utilization in that nursing home:
(a) Supervision of Services
(1) The consultant pharmacist(s) shall
develop, coordinate, and supervise all pharmaceutical services. The consultant
pharmacist in charge for the nursing home 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 nursing home 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 nursing home 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 nursing homes and shall
communicate with the state agencies involved with enforcement and regulation of
nursing homes.
(5) The consultant
pharmacist(s) shall spend sufficient time to evaluate discontinued or other
unused medication for destruction or donation, destroy unused medication not
intended for donation, check entries in a bound, numbered controlled drugs
book, process unused medication for donation as provided in AC A §
17-92-1101 et
seq. and Board Regulation 04-07-0006, and make general observations at the
nursing stations.
(6) An
individualized resident record 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 in charge
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. The consultant pharmacist shall cause a designated nurse to record
all discontinued and outdated non-controlled legend drugs in a bound and
numbered drug destruction book when the drug is discontinued or becomes
outdated. The consultant pharmacist(s) and a designated nurse shall jointly
inventory and destroy the drugs and each shall sign the drug destruction book
to document the destruction of these drugs.
(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 04-03-0004 and ACA §
17-92-1101 et
seq., to be processed in accordance with Board Regulation 04-07-0006.
(D) Controlled drugs. All
discontinued and outdated controlled drugs shall be signed out of narcotic
inventory at the time of discontinuation or at the point of becoming outdated
and shall be entered on the Arkansas Department of Health's Report of
Drugs Surrendered form by a designated nurse and the director of
nurses. Said outdated or discontinued drugs shall be secured in the office of
the director of nurses pursuant to paragraph 3(A) of this section until sent to
the Department of Health. The consultant pharmacist shall confirm the quantity
of drugs segregated for shipment to the Arkansas Department of Health is
accurately entered on the inventory of controlled substances recorded on the
Report of Drugs Surrendered form.
(E) The controlled drugs shall be sent to the
Arkansas Department of Health by licensed facility personnel, to be designated
by the administrator, at least quarterly. The Arkansas Department of Health's
receipt of drugs destroyed shall be reconciled with the nurse/pharmacist
inventory. The consultant pharmacist in charge shall make recommendations
ensuring that the facility conforms to the polices and procedures established
by the Division of Pharmacy Services and Drug Control, Arkansas Department of
Health.
(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 chart 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 nursing home 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 05-00-0005, 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
in charge 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
05-00-0005.
(C) Policies for the
safe procurement, storage, distribution, and use of drugs and biologicals.
(10/9/80, Reg. Revised 2/17/82 & 6/25/83 & 10/12/93 & 02/11/2003
& 6/23/05)
05-00-0004
-EMERGENCY KITS FOR
LONG-TERM-CARE FACILITIES
(a) With
recognition of D.E.A.'s statement of policy regarding emergency kits for long-
term-care 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 long-term-care facility. This pharmacy must be properly registered with
D.EA.
(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 in charge 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. 10/14/81
(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. (Revised
10/12/93, Revised 10/14/97, Revised 02/11/2003 & 6/23/05)
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. In every instance where injectables are indicated, only single-dose injectables are acceptable.
(a) Analgesics, controlled
drugs
(1) Schedule 2: injectable-
Limit: one (1)
Maximum quantity: two (2)
(2) Schedule 3, 4 or 5
Limit: three (3)
Maximum quantity: if oral: six (6);
if injectable: two (2)
(b) Antibiotics
(1) Oral doses:
Limit: five (5)
Maximum quantity: five (5)
(2) Parenteral doses:
Limit: three (3)
Maximum quantity: one (1)
(c) Anticoagulant
Limit: one (1)
Maximum quantity: three (3)
(d) Antidiarrheals
Limit: one (1)
Maximum quantity: ten (10)
(e) Antihistamine Injectables
Limit: two (2)
Maximum quantity: four (4)
(f) Antinauseants
Limit: three (3)
Maximum quantity: four (4)
(g) Antipsychotic injectables
Limit: two (2)
Maximum quantity: four (4)
(h) Anxiolytics
Limit: one (1)
Maximum quantity: four (4)
(i) Cardiac life support medications
(1) Injectables:
The content and quantity of injectable cardiac life support medications is to be recommended by the quality assurance and patient assessment committee at the long-term-care facility and approved by the Executive Director of the Arkansas State Board of Pharmacy.
(2) Hypertensive crisis oral medications:
Limit: three (3)
Maximum quantity: eight (8)*
*When nitroglycerine sublingual is used: quantity -1 bottle of 25
(j) Coagulants
Limit: one (1)
Maximum quantity: one (1)
(k) Hypoglycemics
Limit: three (3)
Maximum quantity: two (2)
(l) Injectable seizure control medications
Limit: two (2)
Maximum quantity: four (4)
(m) Large volume parenterals
Limit: three (3)
Maximum quantity: two (2)
(n) Poison control
Limit: two (2)
Maximum quantity: two (2)
(o) Breathing Medication
Limit (1)
Maximum quantity: two (2)
(p) Corticosteroid
Limit (1)
Maximum quantity: two (2)
(Revised 02/11/2003 and 11/1/2007)
Disclaimer: These regulations may not be the most recent version. Arkansas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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