| (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.
(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;
Cont'd... |
