| (a) A limited services rural hospital (LSRH) shall
provide pharmaceutical services that meet the needs of the patients.
The LSRH shall provide a pharmacy that is licensed, as required, by
the Texas State Board of Pharmacy. Pharmacy services shall comply
with all applicable statutes and rules.
(b) The LSRH pharmacy shall be directed by a licensed
pharmacist.
(c) The LSRH medical staff shall develop policies and
procedures that minimize drug errors. This function may be delegated
to the LSRH's organized pharmaceutical services.
(d) The LSRH pharmacy or drug storage area shall be
administered in accordance with accepted professional principles.
(e) Standards of practice as defined by state law shall
be followed regarding the provision of pharmacy services.
(f) The pharmaceutical services shall have an adequate
number of personnel to ensure quality pharmaceutical services, including
emergency services.
(1) The staff shall be sufficient in number and training
to respond to the pharmaceutical needs of the patient population being
served. There shall be an arrangement for emergency services.
(2) Employees shall provide pharmaceutical services
within the scope of their license and education.
(g) Drugs and biologicals shall be properly stored
to ensure ventilation, light, security, and temperature controls.
(h) Records shall have sufficient detail to follow
the flow of drugs from entry through dispensation.
(i) There shall be adequate controls over all drugs
and medications, including the floor stock. Drug storage areas shall
be approved by the pharmacist, and floor stock lists shall be established.
(j) Inspections of drug storage areas shall be conducted
throughout the LSRH under pharmacist supervision.
(k) The LSRH shall have a drug recall procedure.
(l) A full-time, part-time, or consulting pharmacist
shall be responsible for developing, supervising, and coordinating
all the activities of the pharmacy services.
(1) Direction of pharmaceutical services may not require
on-premises supervision but may be accomplished through regularly
scheduled visits in accordance with state law.
(2) A job description or other written agreement shall
clearly define the responsibilities of the pharmacist.
(m) The LSRH shall keep current and accurate records
of the receipt and disposition of all scheduled drugs.
(1) There shall be a record system in place that provides
the information on controlled substances in a readily retrievable
manner that is separate from the patient record.
(2) Records shall trace the movement of scheduled drugs
throughout the services, documenting utilization or wastage.
(3) The pharmacist shall be responsible for determining
that all drug records are in order and that an account of all scheduled
drugs is maintained and reconciled with written orders.
(n) In order to provide patient safety, drugs and biologicals
shall be controlled and distributed in accordance with applicable
standards of practice, consistent with federal and state laws.
(o) All compounding, packaging, and dispensing of drugs
and biologicals shall be under the supervision of a pharmacist and
performed consistent with federal and state laws.
(p) All drugs and biologicals shall be kept in a secure
area and locked when appropriate.
(1) The LSRH shall adopt, implement, and enforce a
policy to ensure the safeguarding, transferring, and availability
of keys to the locked storage area.
(2) Drugs listed in Schedules II, III, IV, and V of
the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub.
L. 91-513, 84 Stat. 1236 (21 USC Ch. 13 § 801 et seq.), shall
be kept locked within a secure area.
(q) Outdated, mislabeled, or otherwise unusable drugs
and biologicals shall not be available for patient use.
(r) When a pharmacist is not available, drugs and biologicals
shall be removed from the pharmacy or storage area only by personnel
designated in the policies of the medical staff and pharmaceutical
service, in accordance with federal and state laws.
(1) There shall be a current list of individuals identified
by name and qualifications who are designated to remove drugs from
the pharmacy.
(2) Only amounts sufficient for immediate therapeutic
needs shall be removed.
(s) Drugs and biologicals not specifically prescribed
as to time or number of doses shall automatically be stopped after
a reasonable time that is predetermined by the medical staff.
(1) Stop order policies and procedures shall be consistent
with those of the nursing staff and the medical staff rules and regulations.
(2) A protocol shall be established by the medical
staff for the implementation of the stop order policy, in order that
drugs shall be reviewed and renewed, or automatically stopped.
(3) A system shall be in place to determine compliance
with the stop order policy.
(t) Drug administration errors, adverse drug reactions,
and incompatibilities shall be immediately reported to the attending
physician and, if appropriate, to the LSRH-wide quality assessment
and performance improvement program. There shall be a mechanism in
place for capturing, reviewing, and tracking medication errors and
adverse drug reactions.
(u) Abuses and losses of controlled substances shall
be reported, in accordance with applicable federal and state laws,
to the individual responsible for the pharmaceutical services, and
to the chief executive officer, as appropriate.
(v) Information relating to drug interactions and information
on drug therapy, side effects, toxicology, dosage, indications for
use, and routes of administration shall be immediately available to
the professional staff.
(1) A pharmacist shall be readily accessible by telephone
or other means to discuss drug therapy, interactions, side effects,
dosage, assist in drug selection, and assist in the identification
of drug induced problems.
(2) There shall be staff development programs on drug
therapy available to facility staff to cover such topics as new drugs
added to the formulary, how to resolve drug therapy problems, and
other general information as the need arises.
(3) The medical staff shall establish a formulary system
to ensure quality pharmaceuticals at reasonable costs.
(w) Blood transfusions, blood products, and intravenous
medications must be administered in accordance with state law and
approved medical staff policies and procedures.
(x) Orders given orally for drugs and biologicals must
be followed by a written order, signed by the prescribing physician
or other authorized prescriber.
(y) The LSRH shall have a procedure for reporting transfusion
reactions, adverse drug reactions, and errors in administration of
drugs.
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