Policies of the University of North Texas Health Science Center
14.315 Physician Delegation to Pharmacists under a Drug Therapy
Management Protocol
Chapter 14 –
UNT Health
Policy Statement.
UNTHSC shall require pharmacists and physicians to sign a delegated drug therapy
management protocol before pharmacists may provide drug therapy management to patients
in a UNT Health practice site.
Application of Policy.
This policy shall apply to all employed or contracted UNT Health physicians and pharmacists
who are providing patient care under a Delegated Drug Therapy Management Protocol.
Definitions
1. “Supervising Physician” means an employed or contracted UNT Health credentialed
physician who is authorized to prescribe drugs and who is responsible for the
delegation of drug therapy management to a Pharmacist pursuant to a Protocol.
2. “Pharmacist” means an employed or contracted UNT Health credentialed
pharmacist who is authorized to dispense drugs and to engage in Drug Therapy
Management as delegated by the Supervising Physician under a Delegated Drug
Therapy Management Protocol.
3. “Dangerous Drug” means a drug or device that is unsafe for self medication and is
not included in Chapter 481 of Texas Health and Safety Code’s Schedules I-V or
Penalty Groups I-IV. It includes a drug or device that bears or is required to bear the
legend: “Caution: federal law prohibits dispensing without prescription” or “Rx only”
or another legend that complies with federal law.
4. “Drug Therapy Management” means the performance of specific acts, including the
authority to sign a prescription drug order for dangerous drugs, by a Pharmacist as
authorized by the Supervising Physician through a Protocol. It does not include the
selection of drug products not prescribed by the Supervising Physician unless the
drug product is named in the Protocol or the Supervising Physician initiated a
written record allowing a deviation from the Protocol.
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5. “Delegated Drug Therapy Management Protocol” or “Protocol” means the
document in which the Supervising Physician delegates Drug Therapy Management
to a Pharmacist and which meets the requirements of a “written protocol” under
the Texas Medical Practice Act and the Texas Pharmacy Act.
Procedures and Responsibilities.
A. Protocol
1. A Pharmacist may provide Drug Therapy Management under the supervision of a
Supervising Physician pursuant to a Protocol. The Supervising Physician shall
formulate or approve the Protocol and any patient deviation from the Protocol.
Responsible Party: Supervising Physician and Pharmacist
2. The Protocol shall contain, at a minimum, the following information:
a. A statement identifying the Supervising Physician authorized to prescribe
drugs and responsible for the delegation of Drug Therapy Management.
b. A statement identifying the Pharmacist authorized to dispense drugs and
to engage in Drug Therapy Management as delegated by the Supervising
Physician.
c. A statement identifying the types of drug therapy management decisions
that the Pharmacist is authorized to make which shall include:
i.
A statement of the ailments or diseases involved, drugs, and types
of drug therapy management authorized, and
ii.
A specific statement of the procedures, decision criteria or plan the
Pharmacist shall follow when exercising drug management therapy
authority.
d.
A statement of the activities the Pharmacist shall follow in the course of
exercising Drug Therapy Management authority including the method for
documenting decisions made and a plan for communication of feedback
to the Supervising Physician concerning specific decisions made.
e.
A statement that documentation shall be recorded in the patient’s
medical record within a reasonable time of each intervention.
f.
A statement that describes appropriate mechanisms and time schedule
for the Pharmacist to report to the Supervising Physician and the results of
Drug Therapy Management.
g.
The expiration date of the Protocol.
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Responsible Party: Supervising Physician and Pharmacist
3. The Credentialing Office shall maintain a copy of the Protocol in the Pharmacist’s
and Supervising Physician’s credentialing files.
Responsible Party: Credentialing Office
B. Responsibilities of Supervising Physician
1. The Supervising Physician shall:
a. Establish and maintain a physician-patient relationship with each patient
provided Drug Therapy Management by a Pharmacist and inform the
patient that drug therapy will be managed by a Pharmacist under a written
Protocol.
b. Verify that the Pharmacist establishes and maintains a pharmacist-patient
relationship with each patient provided Drug Therapy Management.
c. Diagnose and perform an initial assessment of the patient and initiate drug
therapy orders for the patient.
d. Provide a summary to the Pharmacist of the patient’s medical condition,
medication needs and any other information or specific instructions
necessary to assist the Pharmacist in making decisions.
e.
Be geographically located so as to be able to be physically present daily to
provide medical care and supervision and be available through direct
telecommunication for consultation, assistance, direction and feedback
about the patient’s condition.
f. Receive, as specified in the Protocol, periodic status reports from the
Pharmacist on patients including any services provided to a patient or
problems or complications encountered.
g. On a monthly basis, review the medical record documentation of all services
provided to patients by the Pharmacist.
h. At least annually, review the Protocol, services provided to the patient
under the Protocol or any patient specific deviations from the Protocol with
the Pharmacist and revise the Protocol as necessary.
Responsible Party: Supervising Physician
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C. Responsibilities of Pharmacist
1. The Pharmacist shall:
a. Prior to signing a prescription for a Dangerous Drug or instituting Drug
Therapy Management, sign a Protocol, and notify the Texas State Board of
Pharmacy, on an application provided by the Texas State Board of Pharmacy,
that the Supervising Physician has delegated the authority to sign a prescription
for Dangerous Drugs. The Pharmacist shall provide the Texas State Board of
Pharmacy with a copy of the Protocol.
b. Include the name, address and telephone number of the Pharmacist and
Supervising Physician on each prescription signed by the Pharmacist.
c. Complete required continuing education related to Drug Therapy
Management by a provider approved by the Accreditation Council for
Pharmacy Education or have engaged in Drug Therapy Management as
allowed under previous laws or rules. Thereafter, the Pharmacist shall
annually complete required hours of continuing education in Drug Therapy
Management as required by the Texas State Board of Pharmacy.
d. Establish and maintain a pharmacist-patient relationship with each patient.
e. Document patient care activities in the patient’s medical record within a
reasonable time frame of each activity or intervention.
f. As required by the Protocol, provide a status report of the patient to the
Supervising Physician including any problem or complication encountered,
results of Drug Therapy Management and decisions made.
g. Maintain a copy of the Protocol and any deviations from the Protocol ordered
by the Supervising Physician for at least 2 years from the date of the
record(s).
h. At least annually, review the Protocol, services provided to the patient under
the Protocol or any patient specific deviations from the Protocol with the
Supervising Physician and provide the Texas State Board of Pharmacy with
an updated Protocol. Such review shall be documented by the Pharmacist
and maintained by the Pharmacist for at least 2 years from the date of the
review.
Responsible Party: Pharmacist
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References and Cross-references
Texas Occupations Code, The Texas Medical Practice Act, Chapter 157
Texas Occupations Code, The Texas Pharmacy Act, Chapters 551 and 554
Texas Administrative Code, Title 22, Chapter 193 – “Standing Delegation Orders”
Texas Administrative Code, Title 22, Chapter 295 – “Drug Therapy Management by a Pharmacist
under Written Protocol of a Physician”
Forms and Tools
Delegated Drug Therapy Management Protocol for Pharmacists
Approved: May 13, 2014
Effective: May 13, 2014
Revised:
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DELEGATED DRUG THERAPY MANAGEMENT PROTOCOL FOR PHARMACISTS
A. PURPOSE
The purpose of the Delegated Drug Therapy Management Protocol (“Protocol”) is to describe the delegation of
drug therapy management by the physician to the pharmacist pursuant to the Texas Medical Practice Act and the
Texas Medical Board rules.
The following physician is authorized to prescribe drugs and is responsible for the delegation of drug therapy
management under this Protocol:
Name of supervising physician: ________________________________________________.
The following pharmacist is authorized to dispense drugs and to engage in drug therapy management as
delegated by the supervising physician under this Protocol:
Name of pharmacist: ________________________________________________.
B.
SCOPE OF DELEGATION
The pharmacist may provide the following drug therapy management in the supervising physician’s UNTHealth
Practice site:
1. collecting and reviewing patient drug histories,
2. ordering or performing routine drug therapy related patient assessment procedures i ncluding
temperature, pulse and respiration,
3. ordering drug therapy related laboratory tests,
4. implementing or modifying drug therapy, including the authority to sign a prescription drug order for the
dangerous drugs listed in this Protocol following the di agnosis, initial patient assessment and ordering of
drug therapy by a physician,
5. generically equivalent drug selection if the physician’s signature does not clearly indicate that the
prescription be dispensed as written, or
6. any other drug therapy related act delegated in this Protocol.
Referrals to the pharmacist may be made by providers at any UNT Health practice site who recognize a patient
meeting the following criteria:
1. Has multiple medications, disease states, or healthcare providers in numerous locations
2. Has difficulty in self-management of medications
3. Has difficulty in adherence to chronic medications or use of devices
4. Has difficulty with access to medications
5. Has significant lack of understanding or knowledge of chronic drug therapy or disease states
6. Is not able to attain goals of therapy (i.e. HgA1c or lipid levels)
7. Other– Assess medication therapy management issues including potential drug – drug & drug -food
interactions.
The pharmacist may provide drug therapy management for the following diseas es and ailments and is authorized
to prescribe or modify the following medications:
PLEASE CROSS OUT ANY (DISEASES/AILMENTS AND LAB TESTS) THAT DO NOT APPLY
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Diseases/Ailments
Type 1 Diabetes
Type 2 Diabetes
Gestational Diabetes
Pre-Diabetes
Medications and Devices
Sulfonylureas
Thiazolidinediones
Biguanides
alpha-Glucosidase Inhibitors
DPP-4 Inhibitors
GLP-1 Agonists and SGLT2
Insulins and Insulin Syringes
Glucometers and Supplies
Gabapentin
Asthma
COPD
Metered Dose Inhalers
Inhaled Beta Agonists
Inhaled/PO Corticosteroids
Leukotriene Modifiers
Methylxanthines
Dyslipidemia
HMG-CoA Reductase Inhibitors
Fibrates
Niacin
Bile Acid Resins
Ezetimbe
Hypertension
ARB’s and ACE inhibitors,
Antiadrenergic Agents
Beta Blockers and Diuretics
Calcium Channel Blockers
Direct Renin Inhibitors
Vasodilators
Depression
Obesity
Antidepressants
Phentermine-Topiramate
5HT2C Receptor Agonists
Hypothyroidism
Thyroid USP, Levothyroxine
Liothyronine
Cardiovascular Disorders
Digoxin and Oral Direct Thrombin Inhibitors
Wafarin and Other Anticoagulants
LMWHs and Factor Xa Inhibitors
Nicotine Addiction
Bupropion and OTC Products
The pharmacist is authorized to order the following tests for drug therapy management:
Lab Tests:
Chem 14
Lipid Panel
Hemoglobin A1c
Triiodothryronine (T3)
International Normalized Ratio (INR)
Thyroid Stimulating Hormone (TSH)
Urine Microalbumin/Creatinine Ratio
Urine Microalbumin
CBC with differential
Thyroxine (T4) Total
Prothrombin Time (PT)
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C.
PHYSICIAN SUPERVISION, DECISION-MAKING AND DOCUMENTATION
The supervising physician must have a patient physician relationship with all patients before delegating drug
therapy management and shall inform the patient that drug therapy will be managed by a pharmacist under a
Protocol. Before the pharmacist may initiate any drug therapy management on any patient, the supervising
physician shall provide a summary of the patient’s medical condition and medication needs to the pharmacist
and any other information or specific instructions the physician deems appropriate to assist the pharmacist in
making decisions. The supervising physician shall be geographically located so as to be able to be physically
present daily to provide medical care and supervision and shall be available through direct telecommunication
for consultation, assistance, direction and feedback about the patient’s condition. Every 6 months, or more
frequently as required by a patient’s medical status, the pharmacist shall provide a status report of the
patients to the supervising physician including any problem or complications encountered, results of drug
therapy management and decisions made by the pharmacist under this Protocol. The supervising physician
and pharmacist shall document patient care activities in the UNT Health EMR within a reasonable time of each
intervention.
D.
EMERGENCIES
In the event of an emergency, the pharmacist or supervising physician will provide appropriate care for persons
commensurate with their training, experience and level of expertise and resource s available at the site. 911
emergency services will be utilized as appropriate.
E.
QUALITY IMPROVEMENT:
This protocol will be reviewed yearly by the pharmacist and the supervising physician, and revised as necessary.
The supervising physician shall review the medical record documentation of all services provided to patients by the
pharmacist on a monthly basis.
F.
EXPIRATION DATE
This protocol shall expire on (DATE).
___________________________
Signature of supervising physician
____________________________
Signature of pharmacist
_____________
Date
____________
Date