Source: https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=15&ch=291&rl=29
Timestamp: 2019-02-23 01:36:12
Document Index: 149876104

Matched Legal Cases: ['§291', '§190', '§190', '§170', '§195', '§291']

SUBCHAPTER A ALL CLASSES OF PHARMACIES
RULE §291.29 Professional Responsibility of Pharmacists
(a) A pharmacist shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription drug order dispensed. If the pharmacist questions the accuracy or authenticity of a prescription drug order, the pharmacist shall verify the order with the practitioner prior to dispensing.
<?Pub Caret -2> (b) A pharmacist shall make every reasonable effort to ensure that any prescription drug order, regardless of the means of transmission, has been issued for a legitimate medical purpose by a practitioner in the course of medical practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued without a valid pre-existing patient-practitioner relationship as defined by the Texas Medical Board in 22 Texas Administrative Code (TAC) §190.8 (relating to Violation Guidelines) or without a valid prescription drug order.
(1) A prescription drug order may not be dispensed or delivered by means of the Internet unless pursuant to a valid prescription that was issued for a legitimate medical purpose in the course of medical practice by a practitioner, or practitioner covering for another practitioner.
(2) A prescription drug order may not be dispensed or delivered if the pharmacist has reason to suspect that the prescription drug order may have been authorized in the absence of a valid patient-practitioner relationship, or otherwise in violation of the practitioner's standard of practice to include that the practitioner:
(A) did not establish a diagnosis through the use of acceptable medical practices for the treatment of patient's condition;
(B) prescribed prescription drugs that were not necessary for the patient due to a lack of a valid medical need or the lack of a therapeutic purpose for the prescription drugs; or
(C) issued the prescriptions outside the usual course of medical practice.
(3) Notwithstanding the provisions of this subsection and as authorized by the Texas Medical Board in 22 TAC §190.8, a pharmacist may dispense a prescription when a physician has not established a professional relationship with a patient if the prescription is for medications for:
(A) sexually transmitted diseases for partners of the physician's established patient; or
(B) a patient's family members if the patient has an illness determined by the Centers for Disease Control and Prevention, the World Health Organization, or the Governor's office to be pandemic.
(c) If a pharmacist has reasons to suspect that a prescription was authorized solely based on the results of a questionnaire and/or in the absence of a documented patient evaluation including a physical examination, the pharmacist shall ascertain if that practitioner's standard of practice allows that practitioner to authorize a prescription under such circumstances. Reasons to suspect that a prescription may have been authorized in the absence of a valid patient-practitioner relationship or in violation of the practitioner's standard of practice include:
(1) the number of prescriptions authorized on a daily basis by the practitioner;
(2) a disproportionate number of patients of the practitioner receive controlled substances;
(3) the manner in which the prescriptions are authorized by the practitioner or received by the pharmacy;
(4) the geographical distance between the practitioner and the patient or between the pharmacy and the patient;
(5) knowledge by the pharmacist that the prescription was issued solely based on answers to a questionnaire;
(6) knowledge by the pharmacist that the pharmacy he/she works for directly or indirectly participates in or is otherwise associated with an Internet site that markets prescription drugs to the public without requiring the patient to provide a valid prescription order from the patients practitioner; or
(7) knowledge by the pharmacist that the patient has exhibited doctor-shopping or pharmacy-shopping tendencies.
(d) A pharmacist shall ensure that prescription drug orders for the treatment of chronic pain have been issued in accordance with the guidelines set forth by the Texas Medical Board in 22 TAC §170.3 (relating to Guidelines), prior to dispensing or delivering such prescriptions.
(e) A prescription drug order may not be dispensed or delivered if issued by a practitioner practicing at a pain management clinic that is not in compliance with the rules of the Texas Medical Board in 22 TAC §§195.1 - 195.4 (relating to Pain Management Clinics). A prescription drug order from a practitioner practicing at a certified pain management clinic is not automatically valid and does not negate a pharmacist's responsibility to determine that the prescription is valid and has been issued for a legitimate or appropriate medical purpose.
(f) A pharmacist shall not dispense a prescription drug if the pharmacist knows or should know the prescription drug order is fraudulent or forged. A pharmacist shall make every reasonable effort to prevent inappropriate dispensing due to fraudulent, forged, invalid, or medically inappropriate prescriptions in violation of a pharmacist's corresponding responsibility. The following patterns (i.e., red flag factors) are relevant to preventing the non-therapeutic dispensing of controlled substances and shall be considered by evaluating the totality of the circumstances rather than any single factor:
(1) the pharmacy dispenses a reasonably discernible pattern of substantially identical prescriptions for the same controlled substances, potentially paired with other drugs, for numerous persons, indicating a lack of individual drug therapy in prescriptions issued by the practitioner;
(2) the pharmacy operates with a reasonably discernible pattern of overall low prescription dispensing volume, maintaining relatively consistent 1:1 ratio of controlled substances to dangerous drugs and/or over-the-counter products dispensed as prescriptions;
(3) prescriptions by a prescriber presented to the pharmacy are routinely for controlled substances commonly known to be abused drugs, including opioids, benzodiazepines, muscle relaxants, psychostimulants, and/or cough syrups containing codeine, or any combination of these drugs;
(4) prescriptions for controlled substances by a prescriber presented to the pharmacy contain nonspecific or no diagnoses, or lack the intended use of the drug;
(5) prescriptions for controlled substances are commonly for the highest strength of the drug and/or for large quantities (e.g., monthly supply), indicating a lack of individual drug therapy in prescriptions issued by the practitioner;
(6) dangerous drugs or over-the-counter products (e.g., multi-vitamins or laxatives) are consistently added by the prescriber to prescriptions for controlled substances presented to the pharmacy, indicating a lack of individual drug therapy in prescriptions issued by the practitioner;
(7) upon contacting the practitioner's office regarding a controlled substance prescription, the pharmacist is unable to engage in a discussion with the actual prescribing practitioner; the practitioner fails to appropriately address based on a reasonable pharmacist standard the pharmacist's concerns regarding the practitioner's prescribing practices with regard to the prescription; and/or the practitioner is unwilling to provide additional information, such as treatment goals and/or prognosis with prescribed drug therapy;
(8) the practitioner's clinic is not registered as, and not exempted from registration as, a pain management clinic by the Texas Medical Board, despite prescriptions by the practitioner presented to the pharmacy indicating that the practitioner is mostly prescribing opioids, benzodiazepines, barbiturates, or carisoprodol, but not including suboxone, or any combination of these drugs;
(9) the controlled substance(s) or the quantity of the controlled substance(s) prescribed are inconsistent with the practitioner's area of medical practice;
(10) the Texas Prescription Monitoring Program indicates the person presenting the prescriptions is obtaining similar drugs from multiple practitioners, and/or that the persons is being dispensed similar drugs at multiple pharmacies;
(11) multiple persons with the same address present substantially similar controlled substance prescriptions from the same practitioner;
(12) persons consistently pay for controlled substance prescriptions with cash or cash equivalents more often than through insurance;
(13) persons presenting controlled substance prescriptions are doing so in such a manner that varies from the manner in which persons routinely seek pharmacy services (e.g., persons arriving in the same vehicle with prescriptions from same practitioner; one person seeking to pick up prescriptions for multiple others; drugs referenced by street names;
(14) the pharmacy charges and persons are willing to pay significantly more for controlled substances relative to nearby pharmacies;
(15) the pharmacy routinely orders controlled substances from more than one drug supplier;
(16) the pharmacy has been discontinued by a drug supplier related to controlled substance orders;
(17) the pharmacy has a sporadic and inconsistent dispensing volume (including zero dispensing);
(18) the pharmacy does not maintain normal operational hours each week from Monday through Friday; and
(19) the pharmacy has been previously warned or disciplined by the Texas State Board of Pharmacy for inappropriate dispensing of controlled substances.
Source Note: The provisions of this §291.29 adopted to be effective May 30, 2010, 35 TexReg 4164; amended to be effective September 12, 2011, 36 TexReg 5846; amended to be effective September 16, 2018, 43 TexReg 5779