22 Tex. Admin. Code § 228.1 - Standards of Practice
(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 law.
(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, Occupations Code.
(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 research.
(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 Pain.
(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 function;
(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 considered;
(5) Plans
for ongoing monitoring of the treatment plan and outcomes;
(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; and
(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:
(1) Diagnosis;
(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 to:
(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 refills;
(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 providers.
(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 patient record
(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 ensure that s/he
is in compliance with all other requirements for delegation of prescriptive
authority for medications as set forth in Board rule and the Occupations Code
Chapter 157.
(2) APRNs shall not
own or operate a pain management clinic, as that term is defined by the
Occupations Code Chapter 168 and any applicable rules promulgated by the Texas
Medical Board.
Notes
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