(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.       
     Source Note:        The provisions of this §228.1 adopted to be effective February 23, 2014, 39 TexReg 989; amended to be effective May 19, 2022, 47 TexReg 2861