Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.96-006 - Reg. 60 - Pharmacy Technicians
Universal Citation: AR Admin Rules 070.00.96-006
Current through Register Vol. 49, No. 9, September, 2024
REGULATION 60 - PHARMACY TECHNICIANS
I.
DEFINITIONS:
A.
PHARMACY
TECHNICIAN: This term refers to those individuals identified as
Pharmacist Assistants in Arkansas Code §
17-92-801.
Pharmacy Technicians are those pharmacy personnel, exclusive of pharmacy
interns, who are regular paid employees of the pharmacy or hospital and assist
the pharmacist in pharmaceutical services.
B.
SUPERVISION:
Supervision means that the responsible pharmacist must be physically present to
observe, direct, and supervise the pharmacy technician at all times when the
pharmacy technician performs acts specified in this regulation. The supervising
pharmacist is totally and absolutely responsible for the actions of the
pharmacy technician.
II.
REGISTRATION REQUIRED
A. A
pharmacy technician shall register annually with the Board of Pharmacy on a
form approved by the Board; and said registration shall expire on December 31
of each year.
B. The registration
fee for a pharmacy technician shall be defined in regulation 59.
C. The Board will issue a permit for the
pharmacy technician applicable to a specified pharmacy location; said permit
cannot be transferred to any other pharmacy location. The permit shall be
prominently displayed for public perusal in said pharmacy.
D. Prior to a person beginning work as a
pharmacy technician the pharmacy technician shall submit an application to the
Board office which shall issue a certificate of registration to the pharmacy
technician and a permit for the pharmacy technician to work at the pharmacy
designated on the application.
E.
When a pharmacy technician leaves the employment of a pharmacy, the
pharmacist-in-charge shall notify the Board, in writing, within fourteen (14)
days thereof.
F. Any concurrent or
subsequent employment at a pharmacy other than the pharmacy identified on the
current permit, issued by the Board of Pharmacy, the pharmacist in charge of
the pharmacy where the pharmacy technician will be working must notify the
Board of pharmacy, in writing, of the exact date when the pharmacy technician
will begin working. The pharmacy technician shall not work at that location
until a permit has been received from the Board of Pharmacy for that pharmacy
location.
G. A pharmacy technician
shall identify himself as such in any telephone conversation regarding the
functions of a pharmacy technician while on duty in the pharmacy.
H. If the pharmacy technician is suspected to
have or evidence exists that a pharmacy technician may have violated any law or
regulation regarding the practice of pharmacy, legend drugs or controlled
substances, the pharmacist-in-charge shall notify the Board, in writing, within
ten days or immediately if any danger to the public health or safety may exist.
Any other pharmacist, whether or not practicing in the same pharmacy, who has
such knowledge or suspicion, shall notify the Board in a like manner.
I.
(1) The
Board may, after notice and hearing, suspend or revoke the permit of a pharmacy
technician upon a finding of the following:
(a) Violation of this regulation.
(b) Violation of any law or regulation
regarding the practice of pharmacy.
(c) Violation of any law or regulation
related to legend drugs or controlled substances.
(2) The Board shall follow the same
procedures for hearings for pharmacy technicians as applicable to hearings for
pharmacists as set forth in A.C.A. §
17-92-101
et seq. and Board Regulations.
J. A Pharmacy technician shall:
(1) Conduct himself professionally in
conformity with all applicable federal, state, and municipal laws and
regulations in his relationship with the public, health care professions, and
pharmacists.
(2) Hold to the
strictest confidences all knowledge concerning patrons, their prescriptions,
and other confidence entrusted or acquired by him; divulging in the interest of
the patron, only by proper release forms, or where required for proper
compliance with legal authority.
(3) Provide valid and sufficient checks in
payment for licenses or renewals.
III.
QUALIFICATIONS
A. A high school graduate or a recognized
graduate equivalency degree (G.E.D.).
B. Of good moral character and temperate
habits.
C. If the pharmacy
technician has a past record of alcohol or drug addiction or past record of
violation of any law related to controlled substances, employment must be prior
approved by the Board of Pharmacy.
D. Be a paid employee of a
pharmacy.
IV.
TASKS, RESPONSIBILITIES, AND DUTIES OF THE PHARMACY TECHNICIAN
A pharmacy technician may assist the pharmacist in performing the following specific tasks in accordance with specified Policy and Procedures covering the areas described in this section. If the pharmacy technician performs any other task that is defined as the practice of pharmacy, it will be considered a violation.
A. Approved
tasks:
(1) Placing, packing, pouring, or
putting in a container for dispensing, sale, distribution, transfer possession
of, vending, or barter any drug, medicine, poison, or chemical which, under the
laws of the United States or the State of Arkansas, may be sold or dispensed
only on the prescription of a practitioner authorized by law to prescribe
drugs, medicines, poisons, or chemicals. This shall also include the adding of
water for reconstitution of oral antibiotic liquids.
(2) Placing in or affixing upon any container
described in Section
III(A) (1) of this
Regulation a label required to be placed upon drugs, medicines, poisons, or
chemicals sold or dispensed upon prescription of a practitioner authorized by
law to prescribe those drugs, medicines, poisons, or chemicals.
(3) Selecting, taking from, and replacing
upon shelves in the prescription department of a pharmacy or apothecary drugs,
medicines, chemicals, or poisons which are required by the law of the United
States or the State of Arkansas to be sold or dispensed only on prescription of
a practitioner authorized by law to prescribe them.
(4) In a manual system - preparing, typing,
or writing labels to be placed or affixed on any container described in ACA
§
17-92-101(14)
(A), which a label is required to be placed
upon drugs, medicines, poisons, or chemicals sold or dispensed upon
prescription of a practitioner authorized by law to prescribe those drugs,
medicines, poisons, or chemicals.
In a computer system - a pharmacy technician may enter information into the pharmacy computer. The pharmacy technician shall not make any judgement decisions which could affect patient care. The final verification of prescription information, entered into the computer, shall be made by the supervising pharmacist who is then totally responsible for all aspects of the data and data entry.
(5) A
pharmacy technician may obtain prescriber authorization for prescription
refills provided that nothing about the prescription is changed.
(6) Prepackaging and labeling of multi-dose
and unit-dose packages of medication. The pharmacist must establish the
procedures, including selection of containers, labels and lot numbers, and must
check the finished task.
(7) Dose
picking for unit dose cart fill for a hospital or for a nursing home
patient.
(8) Nursing unit checks in
a hospital or nursing home: Pharmacy technicians may check nursing units for
proper medication storage and other related floor stock medication issues. Any
related medication storage problems or concerns shall be documented and
initialed by a pharmacist.
(9)
Patient and medication records.
The recording of patient or medication information in manual or electronic system for later validation by the pharmacist may be performed by pharmacy technicians.
(10)
The pharmacy technician shall not make any judgement decisions which could
effect patient care.
B.
Additional tasks which can be performed in a Hospital setting:
(1) Bulk reconsitution of prefabricated
non-injectable medication
(2) Bulk
compounding. This category may include such items as sterile bulk solutions for
small-volume injectables, sterile irrigating solutions, products prepared in
relatively large volume for internal or external use by patients, and reagents
or other products for the pharmacy or other departments of a
hospital.
(3) Preparation of
parenteral products.
a. The pharmacy
technician must follow guidelines established by the pharmacist as directed in
Section
V of
this regulation.
b. Pharmacy
technicians may (1) perform functions involving reconstitution of single or
multiple dosage units that are to be administered to a given patient as a unit
and (2) perform functions involving the addition of one manufacturer's single
dose or multiple unit doses of the same product to another manufacturer's
prepared unit to be administered to a patient. Pharmacy technicians shall not
add multiple ingredients in preparing parenteral products but may draw up or
prepare the ingredients. The pharmacist must check the preparations and make
the final addition.
V.
DUTIES OF THE PHARMACIST IN THE USE
OF PHARMACY TECHNICIANS
A. A pharmacy
which utilizes a pharmacy technician to enter information into the pharmacy
computer must develop and keep, on file at the pharmacy, written policy and
procedures which describe the procedures by which the supervising pharmacist
verifies the accuracy, validity, and appropriateness of the filled prescription
or medication order. Written procedures for training and utilization of
pharmacy technicians in the use of parenteral products and the check required
of the pharmacy technicians must be included in the procedures if the pharmacy
technician is performing these tasks.
B. The pharmacist shall include, in the
Policy and Procedure Manual, the specific scope of responsibilities for
pharmacy technicians or procedures delegated to pharmacy technicians.
C. The duties of pharmacy technicians in the
preparation or processing of medication shall be accomplished under the
immediate and direct supervision of the pharmacist who assumes the
responsibility. The final check and verification of the medication dispensed
shall be the responsibility of the pharmacist. The pharmacist is totally
responsible for all aspects of the data and data entry.
D. The supervising pharmacist shall assure
that the pharmacy technician maintains confidentiality of all patient
records.
VI.
PHARMACIST TO PHARMACY TECHNICIAN RATIO:
A.
RETAIL PHARMACY SETTING:
(1) A pharmacy, with one pharmacist on duty,
may utilize two pharmacy technicians to assist the pharmacist. Beyond two
pharmacists, the maximum number of technicians at any given time is limited to
a number equal to the number of pharmacists on duty in the pharmacy at that
specific time with a limit of four (4) pharmacy technicians.
(2) While supervising one or two
technician(s) the pharmacist shall not also supervise more than one student
intern. A Graduate intern will not affect the ratio.
B.
HOSPITAL SETTING:
(1) Pharmacy technicians used in assisting
the pharmacist in pharmaceutical services for inpatients of the hospital shall
be permitted to perform under direct supervision of a licensed pharmacist
within the following conditions:
a. The number
of supportive personnel employed by the Pharmacy Department shall not exceed a
ratio of one pharmacy technician directly involved in medication distribution
to each pharmacist on staff. The one to one ratio is governed by the number of
employees and is not shift dependent. If the pharmacist in charge desires to
use more than a one to one ratio on a certain shift, the hospital pharmacist in
charge shall notify the Board of Pharmacy that the ratio on that shift exceeds
one to one and include a brief summary of the duties now performed by the
pharmacist with emphasis on counseling, quality assurance, drug utilization
evaluation, education, and MD/RN interactions, etc.
The ratio shall not exceed two pharmacy technicians to one pharmacist on any one shift. This ratio shall not include pharmacy interns counted as either supportive personnel or pharmacists. Also excluded from the count of supportive personnel are those persons whose functions are not related to the preparation or distribution of medication. Such persons include clerks, secretaries, messengers, and delivery personnel.
9.
A.
HOSPITAL PHARHACEUTICAL SERVICES PERMIT (83 Revised)
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. 17-91-403 - 17-91-405.
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.
"Modified 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, AMD
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 Hurses 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 the 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 solutions.
j. Suitable containers and labels.
k. 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.
DI 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 fallowing:
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 AMD PROCEDURE HANUAL
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 stack 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 with average
annual occupied beds greater than 75, as determined by institution's patient
occupancy record, 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 necef-sary in keeping with the size and scope of the services of
the hospital pharmacy's safe, efficient, and economical operation.
b. The above classified hospitals, with
average annual occupied beds less than 75, as determined by institution's
patient occupancy records, 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, efficient, and economical operation.
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.
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 judgements 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 PHARHACISTS' 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)
9- A. HOSPITAL PHARMACEUTICAL SERVICES PERMIT (S3 Revised)
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. 17-91-403 --
17-91-405.
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.
"Modified 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 the space to be
allocated, the equipment necessary to carry out the functions, and the number
of personnel required to utilize the equipment arid 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 solutions.
j. Suitable containers and labels.
k. 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.
DI 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 far 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 with average
annual occupied beds greater than 75, as determined by institution's patient
occupancy record, 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, efficient, and economical operation.
b. The above classified hospitals, with
average annual occupied beds Less than 75, as determined by institution's
patient occupancy records, 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, efficient, and economical operation.
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.
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 judgements 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 Hanual 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)
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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