1. Any pharmacist practicing in an
Arkansas Hospital, must so notify the Board of Pharmacy and ascertain that a
Hospital Pharmaceutical Services Permit has been issued. The Hospital
Pharmaceutical Services Permit shall be issued in the name of the Hospital,
showing a pharmacist in charge.
2.
Any hospital holding a retail pharmacy permit as of February 15, 1975, upon
application for renewal must separate the facilities, stocks, records, etc., in
compliance with A.C.A.
17-92-403
-
17-92-405.
All hospitals shall have adequate provisions for pharmaceutical
services regarding the procurement, storage, distribution, and control of all
medications. All federal and state regulations shall be complied with.
A. DEFINITIONS:
1.
"Hospital
Pharmacy" means the place or places in which drugs, chemicals,
medicines, prescriptions, or poisons are prepared for distribution and
administration for the use and/or benefit of patients in a hospital licensed by
the Arkansas Department of Health.
The Hospital Pharmacy shall also mean the place or places in which
drugs, chemicals, medicines, prescriptions or poisons are compounded for the
dispensing to hospital employees, members of the immediate families of hospital
employees, patients being discharged, and other persons in emergency
situations.
Hospital Pharmacy shall also mean the provision of pharmaceutical
services as defined in the Pharmacy Practice Act by a pharmacist to a patient
of the hospital.
2.
"Hospital Employee" means any individual employed by
the hospital whose compensation for services or labor actually performed for a
hospital is reflected on the payroll records of a hospital.
3.
"Qualified Hospital
Personnel" means persons other than Licensed Pharmacists who
perform duties in conjunction with the overall hospital pharmaceutical services
for inpatients.
4.
"Licensed Pharmacist" means any person licensed to
practice pharmacy by the Arkansas State Board of Pharmacy who provides
pharmaceutical services as defined in the Pharmacy Practice Act to patients of
the hospital.
5.
"Unit
Dose Distribution System" is a pharmacy-coordinated method of
dispensing and controlling medications in hospitals in which medication are
dispensed in single unit packages for a specific patient on orders of a
physician where not more than 24-hour supply of said medications is dispensed,
delivered, or available to the patient.
6.
"Unit Dose Distribution
System" is a system that meets the requirement of a "Unit Dose
Distribution System," provided that up to a 72-hour supply may be sent to the
floor once a week if the system has been reviewed and approved administratively
by the Board of Pharmacy.
B. COMPOUNDING, DISPENSING, AND DISTRIBUTING
1. Compounding-The act of selecting, mixing,
combining, measuring, counting, or otherwise preparing a drug or
medication.
2. Dispensing--A
function restricted to licensed pharmacists which involves the issuance of:
(a) one or more doses of a medication in
containers other than the original, with such new containers being properly
labeled by the dispenser as to content and/or directions for use as directed by
the prescriber;
(b) medication in
its original container with a pharmacy prepared label that carries to the
patient the directions of the prescriber as well as other vital
information;
(c) a package carrying
a label prepared for nursing station use. The contents of the container may be
for one patient (individual prescription) or for several patients (such as a
nursing station medication container).
3. Distributing-Distributing, in the context
of this regulation, refers to the movement of a medication from a central point
to a nursing station medication center. The medication must be in the original
labeled manufacturer's container or in a prepackaged container labeled
according to Federal and State statutes and regulations, by a pharmacist or
under his direct and immediate supervision.
C. ADMINISTERING
An act, restricted to nursing personnel as defined in Nurses Practice
Act 43 of 1971, in which a single dose of a prescribed drug or biological is
given a patient. This activity includes the removal of the dose from a
previously dispensed, properly labeled container, verifying it with the
prescriber's orders, giving the individual dose to the proper patient and
recording the time and dose given.
D. PHARMACY AND THERAPEUTICS COMMITTEE
There is a committee of the medical staff to confer with the Pharmacist
in the formulation of policies, explained as follows:
1. A pharmacy and therapeutics committee (P
& T Committee), composed of a least one physician, the administrator or
representative, the director of nursing service or representative, and the
pharmacist is established in the hospital. It represents the organizational
line of communication and the liaison between the medical staff and the
pharmacist.
2. The committee
assists in the formation of broad professional policies regarding the
evaluation, appraisal, selection, procurement, storage, distribution, use, and
safety procedures, and all other matters relating to drugs in
hospitals.
3. The committee
performs the following specific functions:
a.
Serves as an advisory group to the hospital medical staff and the pharmacist on
matters pertaining to the choice drugs.
b. Develops and reviews periodically a
formulary or drug list for use in the hospital;
c. Establishes standards concerning the use
and control of investigational drugs and research in the use of recognized
drugs;
d. Evaluates clinical data
concerning new drugs or preparations requested for use in the
hospital;
e. Makes recommendations
concerning drugs to be stocked on the nursing unit floors and emergency drug
stocks;
f. Prevents unnecessary
duplication in stocking drugs and drugs in combination having identical amounts
of the same therapeutic ingredients.
4. The committee meets at least quarterly and
reports to the medical staff by written report.
E. PHARMACY OPERATIONS
The hospital has a pharmacy directed by a licensed pharmacist. The
Pharmacy is administered in accordance with accepted professional principles.
1. Pharmacy Supervision
There is a pharmacy directed by a licensed pharmacist, defined as
follows:
a. The Director of Pharmacy
is trained in the specialized functions of hospital pharmacy.
b. The Director of Pharmacy is responsible to
the administration of the hospital and the Board of Pharmacy for developing,
supervising, and coordinating all the activities of the pharmacy department and
all pharmacists providing professional services in the Hospital.
c. All licensed pharmacists who provide
pharmaceutical services as defined by the Pharmacy Practice Act shall practice
under policies, procedures, and protocols approved by the Director of Pharmacy.
These policies, procedures, and protocols shall be subject to review and
approval by the Board of Pharmacy.
F. PHYSICAL FACILITIES
Facilities are provided for the storage, safeguarding, preparation, and
dispensing of drugs, defined as follows:
1. Drugs are issued to floor units in
accordance with approved policies and procedures.
2. Drug cabinets on the nursing units are
routinely checked by the pharmacist. All floor stocks are properly
controlled.
3. A careful
determination of the functions of a department will regulate he space to be
allocated, the equipment necessary to carry out the functions, and the number
of personnel required to utilize the equipment and to render a given volume of
service, as these functions relate to the frequency or intensity of each
function or activity. Adequate equipment should specifically relate to services
rendered and functions performed by the hospital pharmacy. Equipment lists will
relate to the following services and functions:
a. Medication preparation;
b. Library reference facilities;
c. Record and office procedures;
d. Sterile product manufacturing;
e. Bulk compounding
(manufacturing);
f. Product control
(assay, sterility testing, etc.);
g. Product development and special
formulations for medical staff.
4. Equipment and supplies necessary to the
hospital pharmacy's safe, efficient and economical operation shall include but
not be limited to:
a. Graduates capable of
measuring from 0.1 ml. up to at least 500ml.
b. Mortars and pestles.
c. Hot and cold running water.
d. Spatulas (steel and
non-metallic).
e.
Funnels.
f. Stirring
rods.
g. Class A balance and
appropriate weights.
h. Typewriter,
or other label printer.
i. Suitable
apparatus for production of small-volume sterile
k. Suitable containers and labels.
I. Adequate reference library to include at
least the following:
1) American Hospital
Formulary Service.
2) Pharmacology
text.
3) Each hospital pharmacy
shall have available for personal and patient use a current copy of the U.S.P.
Dl 3 book set including "Drug Information for the Healthcare Professional" (2
volumes) and "Advice for the Patient" (1 volume), or the two volume set "Facts
and Comparisons" (1 volume) and "Patient Drug Facts" (1 volume).
4) Text on compatibility of parenteral
products.
5) Current professional
journals, such as:
(a) Drug Intelligence and
Clinical Pharmacy
(b) Hospital
Pharmacy.
(c) Journal of
ASHP.
5. Special locked storage space is provided
to meet the legal requirements for storage of controlled drugs, alcohol, and
other prescribed drugs.
G. PERSONNEL
Personnel competent in their respective duties are provided in Keeping
with size and activity of the department, explained as follows:
1. The Director of Pharmacy is assisted by an
adequate number of additional licensed pharmacists and such other personnel as
the activities of the pharmacy may require to insure quality pharmaceutical
services.
2. The pharmacy,
depending upon the size and scope of its operations, is staffed by the
following categories of personnel:
a. Chief
Pharmacist (Director of Pharmacy).
b. One or more assistant chief pharmacists
(Assistant Director of Pharmacy).
c. Staff pharmacists.
d. Pharmacy residents (where program has been
activated).
e. Trained
non-professional pharmacy helpers (qualified hospital personnel).
f. Clerical help.
H. EMERGENCY PHARMACEUTICAL
SERVICES
Through the administrator of the hospital, the P & T Committee
shall establish policies and procedures that include, but are not limited to
the following:
1. Upon admission to
the Emergency Room on an outpatient basis and when examined by the physician
where medications are prescribed to be administered, a record must be kept on
file in the Emergency Room admission book or a copy of the Emergency Room
medication order must be kept by the pharmacist to be readily accessible, for
control and other purposes, as required by these regulations.
2. If the physician wishes the patient to
have medication to be taken with them from the Emergency Room Supplies, the
amounts to be taken shall be sufficient to last until medication may be
obtained by local pharmacies, in any case not to exceed a 48-hour supply. All
State and Federal laws must be observed concerning all records, labeling, and
outpatient dispensing requirement.
3. Take home prescriptions for
anti-infectives issued to patients at the time of discharge from the emergency
room, filled by a pharmacist, shall be quantities consistent with the medical
needs of the patient.
I.
PHARMACY RECORDS AND LABELING
Records are kept of the transactions of the pharmacy and correlated
with other hospital records where indicated. All medication shall be properly
labeled. Such record and labeling requirements are as follows:
1. The pharmacy establishes and maintains, in
cooperation with the accounting department, a satisfactory system of records
and bookkeeping in accordance with the policies of the hospital for:
a. Maintaining adequate control over the
requisitioning and dispensing of all drugs and pharmaceutical supplies, and
b. Charging patients for drugs and
pharmaceutical supplies.
2. A record of procurement and dispersement
of all controlled drugs is maintained in such a manner that the disposition of
any particular item may be readily traced.
3. The pharmacist shall receive and provide
service pursuant to the perusal of the physician's original order or a direct
copy thereof, except in emergency situations wherein the pharmacist may provide
service pursuant to a verbal order or to an oral or written transcription of
the physician's order provided that the pharmacist shall receive and review the
original or direct copy within twenty-four (24) hours of the time the service
is provided.
4. A record shall be
maintained by the pharmacy and stored separately from other hospital records
for each patient (inpatient or outpatient) containing the name of the patient,
the prescribing physician, the name and strength of drugs prescribed, the name
and manufacturer (or trademark) of medication dispensed.
5. The label of each medication container
prepared for administration to inpatients, shall bear the name and strength of
the medication, the expiration date, and the lot and control number. The label
on the medication, or the container into which the labeled medication is placed
must bear the name of the patient.
6. The label of each outpatient's individual
prescription medication container bears the name of the patient, prescribing
physician, directions for use, the name and strength of the medication
dispensed (unless directed otherwise by the physician).
J. CONTROL OF TOXIC OR DANGEROUS DRUGS
Policies are established to control the administration of toxic or
dangerous drugs with specific reference to the duration of the order and the
dosage, explained as follows:
1. The
medical staff has established a written policy that all toxic or dangerous
medications not specifically prescribed as to time or number of doses, will be
automatically stopped after a reasonable time limit set by the staff.
2. The classifications ordinarily thought of
as toxic or dangerous drugs are controlled sub-stances, anticoagulants,
antibiotics, oxytocics, and cortisone products.
3. All deteriorated non-sterile, non-labeled
or damaged medication shall be destroyed by the pharmacist, except on
controlled drugs, as defined below.
a. All
controlled drugs (Schedule II, III, IV, and V) should be listed and a copy
sent, along with drugs to the Arkansas Department of Health by registered mail
or delivered in person for disposition.
K. DRUGS TO BE DISPENSED
Therapeutic ingredients of medications dispensed are included (or
approved for inclusion) in the United States Pharmacopoeia, N.F. and U.S.
Homeopathic Pharmacopoeia, or Accepted Dental Remedies (except for any drugs
unfavorably evaluated therein) and drugs approved by provisions of the Arkansas
Act 436 of 1975, or are approved for use by the P & T Committee of the
hospital staff, explained as follows:
1. The pharmacist, with the advice and
guidance of the P & T Committee, is responsible for specifications as to
quality, quantity, and source of supply of all drugs.
2. There is available a formulary or list of
drugs accepted for use in the hospital which is developed and amended at
regular intervals by the P & T Committee with the cooperation of the
pharmacist and the administration.
L. POLICY AND PROCEDURE MANUAL
1. A Policy and Procedure Manual pertaining
to the operations of the Hospital Pharmacy with updated revisions adopted by
the P & T Committee of each hospital shall be prepared and maintained at
the hospital.
2. The Policy and
Procedure Manual should include at a minimum the following:
a. Provisions for procurement, storage,
distribution and drug control for all aspects of pharmaceutical services in the
hospital.
b. Specialized areas such
as surgery, delivery, ICU and CCU units and emergency room stock and usage of
medication shall be specifically outlined.
c. A system of requisitioning supplies and
medications for nurses stations stock shall be in written procedural form as to
limits of medications to be stocked in each nursing unit.
d. Detailed job descriptions and duties of
each employee by job title working in the Pharmacy Department must be developed
and made a part of these policies and procedures.
e. The Pharmacy Policy and Procedure Manual
shall be subject to review and approval by the Board of Pharmacy on request
from the Board.
M. EMPLOYEE PRESCRIPTION MEDICATION
1. There will be a prescription on file for
all prescription drugs dispensed to hospital employees and their immediate
families. These records will be kept separate from all inpatient
records.
2. The only person(s)
entitled to have employee prescriptions filled will be the employee listed on
the hospital payroll and members of their immediate family.
N. PATIENT DISCHARGE MEDICATION
Any take-home prescription dispensed to patients at time of discharge
from the hospital shall be for drugs and quantities consistent with the
immediate medical needs of the patient.
O. LICENSED PHARMACIST PERSONNEL REQUIREMENTS
1. The minimum requirements for licensed
pharmacists in hospitals is:
a. A general
hospital, surgery and general medical care maternal and general medical care
hospital, chronic disease hospitals, psychiatric hospitals, and rehabilitative
facilities licensed for greater than 50 beds, as determined by the
institution's license issued by the Arkansas Department of Health, shall
require the services of one (1) pharmacist on the basis of 40 hours per week,
with such additional pharmacists as are necessary, in the opinion of the
Arkansas State Board of Pharmacy, to perform required pharmacy duties as are
necessary in keeping with the size and scope of the services of the hospital
pharmacy's safe and efficient operation. Hospitals, providing specialized or
unique patient care services, may request approval from the Arkansas State
Board of Pharmacy to be exempt from the requirement of a pharmacist on duty 40
hours per week. The request for exemption must provide adequate written
documentation to justify the services of a pharmacist such hours as are
necessary to perform required pharmacy services, followed by an appearance
before the Board for final approval of the request.
b. The above classified hospitals, licensed
for 50 beds or less, as determined by the institution's license issued by the
Arkansas Department of Health, shall require the services of a pharmacist such
hours as, in the opinion of the Arkansas State Board of Pharmacy and the
Arkansas State Board of Health, are necessary to perform required pharmacy
duties in keeping with the size and scope of the services of the hospital
pharmacy's safe and efficient operation. The pharmacist shall be on site at
least 5 days per week to perform and review pharmacy dispensing, drug
utilization, and drug distribution activities. A pharmacist shall be available
to provide emergency services to the staff when the pharmacy is
closed.
c. Recuperative Centers,
Outpatient Surgery Centers, and Infirmaries.
1) If the infirmary, recuperative center or
outpatient surgery center has a pharmacy department, a licensed pharmacist must
be employed to administer the pharmacy in accordance with all state and federal
laws regarding drugs and drug control.
2) If the infirmary, recuperative center, or
outpatient surgery center does not have a pharmacy department, it has
provisions for promptly and conveniently obtaining prescribed drugs and
biologicals from a community or institutional pharmacy.
3) If the infirmary, recuperative center, or
outpatient surgery center does not have a pharmacy department, but does
maintain a supply of drugs, a licensed pharmacist shall be responsible for the
control of all bulk drugs and maintain records of their receipt and
disposition. The pharmacist shall dispense drugs from the drug supply, properly
labeled, and make them available to appropriate nursing personnel.
4) All medication for patients shall be on
individual prescription basis.
d. A pharmacist in charge, who is employed at
any facility permitted by the Arkansas State Board of Pharmacy where a 40 hour
work week is required, may also be the pharmacist in charge at a hospital
licensed for 50 beds or less by the Arkansas Department of Health.
P. RESPONSIBILITY OF A
PHARMACIST IN HOSPITAL PHARMACY
1. The
pharmacist is responsible for the control of all medications distributed in the
hospital where he practices, and for the proper provision of all pharmaceutical
services.
2. The following aspects
of medication distribution and pharmaceutical service are functions involving
professional evaluations of judgments and may not be performed by supportive
personnel:
a. Selection of the brand and
supplier of medication.
b.
Interpretation and certification of the medication order. This involves a
number of professional responsibilities such as the determination of:
1) Accuracy and appropriateness of dose and
dosage schedule.
2) Such items as
possible drug interactions, medication sensitivities of the patient and
chemical and therapeutic incompatibilities.
3) Accuracy of entry of medication order to
patient's medication profile.
c. Final certification of the prepared
medication.
Q.
OPERATION OF PHARMACY DEPARTMENT WITHOUT A PHARMACIST
At no time will the hospital pharmacy be open and in operation unless a
licensed pharmacist is physically present except:
a. Entrance may be obtained for emergency
medication as set forth in the Pharmacy Policy and Procedure Manual when the
pharmacy is closed outside its normal operation hours.
b. When the pharmacist is summoned away from
the pharmacy and there are other qualified personnel left in the pharmacy, the
personnel left in the pharmacy could perform only those functions authorized
within this regulation.
R. THE AMERICAN SOCIETY OF HEALTH-SYSTEM
PHARMACISTS, GUIDELINES
The American Society of Health-System Pharmacists' most recent
statement on hospital drug control systems and Guidelines for Institutional Use
of Controlled Substances shall be required reading by hospital pharmacists.
(Revised 6/25/83,4/7/89,6/15/95)