|(a) Definitions. The following words and terms when
used in this chapter shall have the following meanings unless the
context clearly indicates otherwise:
(1) Controlled substance (also referred to as scheduled
drugs)--A substance, including a drug, adulterant, and dilutant, listed
in Schedules I through V or Penalty Groups 1, 1-A, or 2 through 4
of Chapter 481, Health and Safety Code (Texas Controlled Substances
Act). The term includes the aggregate weight of any mixture, solution,
or other substance containing a controlled substance.
(2) Dangerous drug--A device or drug that is unsafe
for self-medication and that is not included in Schedules I through
V or Penalty Groups 1 through 4 of Chapter 481, Health and Safety
Code. The term includes a device or drug 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
(3) Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article, including a component part or accessory, that is required
under federal or state law to be ordered or prescribed by a practitioner.
The term includes durable medical equipment.
(4) Medication--A dangerous drug, controlled substance,
non-prescription drug, or device. For purposes of this chapter, the
term also includes herbal and naturopathic remedies.
(5) Non-prescription drug--A non-narcotic drug or device
that may be sold without a prescription and that is labeled and packaged
in compliance with state or federal law.
(6) Pain management clinic--As defined in Chapter 168,
(b) Purpose. This section sets forth the minimum standards
of nursing practice for an advanced practice registered nurse (APRN)
who provides pain management services.
(1) The goal of pain management is to therapeutically
treat the patient's pain in relation to overall health, including
physical function, psychological, social and work-related factors.
(2) Medications must be prescribed in a therapeutic
manner that helps, rather than harms, the patient. Medications must
be recognized to be pharmacologically appropriate and safe for the
diagnosis for which the medication is being used.
(3) Proper treatment of pain must be based on careful
and complete patient assessment and sound clinical judgment. Harm
can result from failure to use sound clinical judgment, particularly
in drug therapy. The APRN shall provide treatment of pain that is
within the current standard of care and is supported by evidence based
(4) Documentation in patient records shall be legible,
complete, and accurate. All consultations and referrals with the delegating
physician and other health care providers shall be documented.
(5) Any treatment plan should be mutually agreed upon
by the patient and the provider. Treatment of pain requires a reasonably
detailed and documented plan of care to ensure that the patient's
treatment is appropriately monitored. A documented explanation of
the rationale for the particular treatment plan is required for cases
in which treatment with scheduled drugs is difficult to relate to
the patient's objective physical, radiographic, or laboratory findings.
Ongoing consultation and referral to the delegating physician and
other health care providers shall be documented.
(c) Evaluation of the Patient Seeking Treatment for
(1) The APRN shall ensure that a current and complete
health history is documented in the patient record. The APRN shall
per-form and document a physical assessment that includes a problem
focused exam specific to the chief presenting complaint of the patient.
At a minimum, this assessment must be performed and documented when
prescribing and/or ordering a new medication or a refill of a medication
for the patient.
(2) Pain assessment and documentation in the patient
record shall include, as appropriate:
(A) The nature and intensity of the pain;
(B) All current and past treatments for pain, including
relevant patient records from prior treating providers as available;
(C) Underlying conditions and co-existing physical
and psychiatric disorders;
(D) The effect of pain on physical and psychological
(E) History and potential for substance misuse, abuse,
dependence, addiction or other substance use disorder, including relevant
validated, objective testing and risk stratification tools; and
(F) One or more recognized clinical indications for
the use of a medication, if prescribed.
(d) Treatment Plan and Outcomes for Patients with Pain.
The APRN who treats patients with pain shall ensure that there is
a written treatment plan documented in the patient record. Information
in the patient record shall include, as appropriate:
(1) A written explanation of how the medication(s)
ordered/prescribed relate(s) to the chief presenting complaint and
treatment of pain;
(2) The name, dosage, frequency, and quantity of any
medication prescribed and number of refills authorized;
(3) Laboratory testing and diagnostic evaluations ordered;
(4) All other treatment options that are planned or
(5) Plans for ongoing monitoring of the treatment plan
(6) Subjective and objective measures that will be
used to determine treatment outcomes, such as pain relief and improved
physical and psychosocial function;
(7) Any and all consultations and referrals, including
the date the consultation and/or referral was made; to whom the consultation
and/or referral was made; the time frame for completion of the consultation
and/or referral; and the results of the consultation and/or referral;
(8) Documentation of informed consent, as required
by subsection (e) of this section.
(e) Informed consent includes a discussion with the
patient, a person(s) designated by the patient, or with the patient's
surrogate or guardian, if the patient is without medical decision-making
capacity, of the risks and benefits of the use of medications for
the treatment of pain. As appropriate, this discussion should be documented
by either a written, signed document maintained in the patient record
or a contemporaneous notation included in the patient record. Discussion
of risks and benefits should include an explanation of the following:
(2) Treatment plan;
(3) Expected therapeutic outcomes, including the realistic
expectations for sustained pain relief, and possibilities for lack
of pain relief;
(4) Non-pharmacological therapies;
(5) Potential side effects of treatments and drug therapy
and how to manage common side effects;
(6) Adverse effects of medication use, including the
potential for dependence, addiction, tolerance, and withdrawal; and
(7) Potential for impaired judgment and motor skills.
(f) If the treatment plan includes drug therapy beyond
90 days, the use of a written pain management agreement should be
included, as appropriate. The written pain management agreement should
outline patient responsibilities that, at a minimum require the patient
(1) Submit to laboratory testing for drug confirmation
upon request of the APRN, the delegating physician, and/or any other
health care providers;
(2) Adhere to the number and frequency of prescription
(3) Use only one provider to prescribe controlled substances
related to pain management, and to make consultations and referrals;
(4) Use only one pharmacy for all prescriptions for
controlled substances related to pain management;
(5) Acknowledge potential consequences of non-compliance
with the agreement; and
(6) Acknowledge processes following successful completion
of treatment goals, including weaning of medications.
(g) Ongoing monitoring of the treatment of pain.
(1) The APRN shall see the patient for periodic review
of the treatment plan at reasonable intervals.
(2) The periodic review shall include an assessment
of the patient's progress toward reaching treatment plan goals, taking
into consideration the history of medication usage, as well as any
new information about the pain, and the patient's compliance with
the pain management agreement.
(3) Each periodic review of the treatment plan shall
be documented in the patient record.
(4) Any adjustment in the treatment plan based on individual
needs of the patient shall be documented.
(5) Continuation or modification of the use of medications
for pain management shall be based on an evaluation of progress toward
treatment plan goals, as well as evaluation and consideration of any
new factors that may influence the treatment plan.
(A) Progress or lack of progress in relieving pain
and meeting treatment objectives shall be documented in the patient
record. Progress may be indicated by the patient's decreased pain,
increased level of function, and/or improved quality of life.
(B) Objective evidence of improved or diminished function
shall be monitored. Information from the patient, family members,
or other caregivers should be considered in determining the patient's
response to treatment.
(C) If the patient's progress is unsatisfactory, the
current treatment plan should be reevaluated, with consideration given
to the use of other therapeutic modalities and/or services of other
(6) Continuation of the use of scheduled drugs shall
include consultation with the delegating physician and documentation
of such consultation in the patient record, as required for delegation
of prescriptive authority for controlled substances pursuant to §157.0511
and §168.201, Occupations Code.
(h) Consultation and Referral. In certain situations,
further evaluation and treatment may be indicated.
(1) Patients who are at risk for substance use disorders
or addiction require special attention. Consideration should be given
to consultation with and/or referral to a provider who is an expert
in the treatment of patients with substance use disorders.
(2) Patients with chronic pain and histories of substance
use disorders or with co-existing psychological and/or psychiatric
disorders may require consultation with and/or referral to an expert
in the treatment of such patients. Consideration should be given to
consultation with and/or referral to a provider who is an expert in
the treatment of patients with these histories and/or disorders.
(3) Information regarding the consideration of consultation
and/or referral under this subsection should be documented in the
(i) Pain management clinics in the state of Texas.
Prior to providing pain management services in these settings, APRNs
who practice in pain management clinics shall verify that the clinic
has been properly certified as a pain management clinic by the Texas
Medical Board and that the certification is current.
(1) The APRN shall be available on site with the physician
at least 33 percent of a pain management clinic's total operating
(2) The APRN shall comply with the requirements of §168.201,
Occupations Code for review of 33 percent of patient charts in pain
(3) The APRN shall ensure that s/he is in compliance
with all other requirements for delegation of prescriptive authority
for medications as set forth in Board rule.
(4) An APRN who owns or operates a clinic in this state
that meets the definition of a pain management clinic under this section
is exempt from the certification requirements of the Occupations Code
Chapter 168 and the Texas Medical Board if:
(A) the APRN is treating patients in the APRN's area
of specialty; and
(B) the APRN personally uses other forms of treatment
with the issuance of a prescription to the majority of the APRN's
patients. A treatment under this subparagraph must be within the current
standard of care, supported by evidence based research, and consistent
with the treatment plan.
(5) APRNs shall not own or operate a pain management
clinic. This prohibition does not apply to an APRN who owns or operates
a clinic in this state that is exempt from the certification requirements
of the Occupations Code Chapter 168 and the Texas Medical Board.