| (6) Discharge Prescriptions. Discharge prescriptions
must be dispensed and labeled in accordance with §291.33 of this
title (relating to Operational Standards) except that certain medications
packaged in unit-of-use containers, such as metered-dose inhalers,
insulin pens, topical creams or ointments, or ophthalmic or otic preparation
that are administered to the patient during the time the patient was
a patient in the hospital, may be provided to the patient upon discharge
provided the pharmacy receives a discharge order and the product bears
a label containing the following information:
(A) name of the patient;
(B) name and strength of the medication;
(C) name of the prescribing or attending practitioner;
(D) directions for use;
(E) duration of therapy (if applicable); and
(F) name and telephone number of the pharmacy.
(7) Redistribution of Donated Prepackaged Prescription
Drugs.
(A) A participating provider may dispense to a recipient
donated prescription drugs that are prepackaged and labeled in accordance
with §442.0515, Health and Safety Code, and this paragraph.
(B) Drugs may be prepackaged in quantities suitable
for distribution to a recipient only by a pharmacist or by pharmacy
technicians or pharmacy technician trainees under the direction and
direct supervision of a pharmacist.
(C) The label of a prepackaged prescription drug a
participating provider dispenses to a recipient shall indicate:
(i) brand name and strength of the drug; or if no brand
name, then the generic name, strength, and name of the manufacturer
or distributor;
(ii) participating provider's lot number;
(iii) participating provider's beyond use date; and
(iv) quantity of the drug, if the quantity is greater
than one.
(D) Records of prepackaged prescription drugs dispensed
to a recipient shall be maintained to show:
(i) name of the drug, strength, and dosage form;
(ii) participating provider's lot number;
(iii) manufacturer or distributor;
(iv) manufacturer's lot number;
(v) manufacturer's expiration date;
(vi) quantity per prepackaged unit;
(vii) number of prepackaged units;
(viii) date packaged;
(ix) name, initials, or written or electronic signature
of the prepacker; and
(x) written or electronic signature of the responsible
pharmacist.
(E) Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(g) Pharmaceutical care services.
(1) The pharmacist-in-charge shall assure that at least
the following pharmaceutical care services are provided to patients
of the facility:
(A) Drug utilization review. A systematic ongoing process
of drug utilization review shall be developed in conjunction with
the medical staff to increase the probability of desired patient outcomes
and decrease the probability of undesired outcomes from drug therapy.
(B) Drug regimen review.
(i) For the purpose of promoting therapeutic appropriateness,
a pharmacist shall evaluate medication orders and patient medication
records for:
(I) known allergies;
(II) rational therapy--contraindications;
(III) reasonable dose and route of administration;
(IV) reasonable directions for use;
(V) duplication of therapy;
(VI) drug-drug interactions;
(VII) drug-food interactions;
(VIII) drug-disease interactions;
(IX) adverse drug reactions;
(X) proper utilization, including overutilization or
underutilization; and
(XI) clinical laboratory or clinical monitoring methods
to monitor and evaluate drug effectiveness, side effects, toxicity,
or adverse effects, and appropriateness to continued use of the drug
in its current regimen.
(ii) The drug regimen review shall be conducted on
a prospective basis when a pharmacist is on duty, except for an emergency
order, and on a retrospective basis as specified in subsection (e)(1)
or (e)(3) of this section when a pharmacist is not on duty.
(iii) Any questions regarding the order must be resolved
with the prescriber and a written notation of these discussions made
and maintained.
(iv) The drug regimen review may be conducted by remotely
accessing the pharmacy's electronic data base from outside the pharmacy
by an individual Texas licensed pharmacist employee of the pharmacy,
provided the pharmacy establishes controls to protect the privacy
of the patient and the security of confidential records.
(C) Education. The pharmacist-in-charge in cooperation
with appropriate multi-disciplinary staff of the facility shall develop
policies that assure that:
(i) the patient and/or patient's caregiver receives
information regarding drugs and their safe and appropriate use; and
(ii) health care providers are provided with patient
specific drug information.
(D) Patient monitoring. The pharmacist-in-charge in
cooperation with appropriate multi-disciplinary staff of the facility
shall develop policies to ensure that the patient's response to drug
therapy is monitored and conveyed to the appropriate health care provider.
(2) Other pharmaceutical care services which may be
provided by pharmacists in the facility include, but are not limited
to, the following:
(A) managing drug therapy as delegated by a practitioner
as allowed under the provisions of the Medical Practice Act;
(B) administering immunizations and vaccinations under
written protocol of a physician;
(C) managing patient compliance programs;
(D) providing preventative health care services; and
(E) providing case management of patients who are being
treated with high-risk or high-cost drugs, or who are considered "high
risk" due to their age, medical condition, family history, or related
concern.
(h) Emergency rooms.
(1) During the times a pharmacist is on duty in the
facility any prescription drugs supplied to an outpatient, including
emergency department patients, may only be dispensed by a pharmacist.
(2) When a pharmacist is not on duty in the facility,
the following is applicable for supplying prescription drugs to be
taken home by the patient for self-administration from the emergency
room. If the patient has been admitted to the emergency room and assessed
by a practitioner at the hospital, the following procedures shall
be observed in supplying prescription drugs from the emergency room.
(A) Dangerous drugs and/or controlled substances may
only be supplied in accordance with the system of control and accountability
for dangerous drugs and/or controlled substances administered or supplied
from the emergency room; such system shall be developed and supervised
by the pharmacist-in-charge or staff pharmacist designated by the
pharmacist-in-charge.
(B) Only dangerous drugs and/or controlled substances
listed on the emergency room drug list may be supplied; such list
shall be developed by the pharmacist-in-charge and the facility's
emergency department committee (or like group or person responsible
for policy in that department) and shall consist of dangerous drugs
and/or controlled substances of the nature and type to meet the immediate
needs of emergency room patients.
(C) Dangerous drugs and/or controlled substances may
only be supplied in prepackaged quantities not to exceed a 72-hour
supply in suitable containers and appropriately prelabeled (including
necessary auxiliary labels) by the institutional pharmacy.
(D) At the time of delivery of the dangerous drugs
and/or controlled substances, the practitioner or licensed nurse under
the supervision of a practitioner shall appropriately complete the
label with at least the following information:
(i) name, address, and phone number of the facility;
(ii) date supplied;
(iii) name of practitioner;
(iv) name of patient;
(v) directions for use;
(vi) brand name and strength of the dangerous drug
or controlled substance; or if no brand name, then the generic name,
strength, and the name of the manufacturer or distributor of the dangerous
drug or controlled substance;
(vii) quantity supplied; and
Cont'd... |
