Pharmacists can manage drug therapy under a physician’s protocols if they observe certain rules. Failure to adhere to these rules can lead to disciplinary proceedings against your pharmacist license.
Obtaining experienced legal counsel to represent your interests in disciplinary proceedings before the Texas State Board of Pharmacy (TSBP) can be a substantial step in reaching a positive outcome in your case. Therefore, if you are facing disciplinary investigations, complaints, or formal proceedings, you should consult a pharmacist license defense attorney for help.
Authorization Under the Texas Medical Practice Act
Tex. Occ. Code §157.001 authorizes physicians to “delegate to a properly qualified and trained pharmacist acting under adequate physician supervision the performance of specific acts of drug therapy management authorized by the physician through the physician’s order, standing medical order, standing delegation order, or other order or protocol as defined by board rule.” A delegation under the Medical Practice Act may include the implementation or modification of a patient’s drug therapy under a protocol if:
- The delegation follows a diagnosis, initial patient assessment, and drug therapy order by the physician; and
- The pharmacist maintains a copy of the protocol for inspection until at least the seventh anniversary of the expiration date of the protocol.
Under this section, physician supervision is adequate if a delegating physician:
- Formulates or approves the physician’s order, standing medical order, standing delegation order, or other order or protocol and periodically reviews the order or protocol and the services provided to a patient under the order or protocol;
- Establishes a physician-patient relationship with each patient who is provided drug therapy management by a delegated pharmacist;
- Is geographically located so as to be able to be physically present daily to provide medical care and supervision;
- Receives, as appropriate, a periodic status report on each patient, including any problem or complication encountered; and
- Remains available through direct telecommunication for consultation, assistance, and direction.
Standards for Pharmacists Engaged in Drug Therapy Management
22 Tex. Admin. Code §295.13 outlines the standards that pharmacists must follow to maintain records when engaged in the provision of drug therapy management. This section defines drug therapy management as:
The performance of specific acts by pharmacists as authorized by a physician through written protocol. Drug therapy management does not include selecting drug products not prescribed by the physician unless the drug product is named in the physician-initiated protocol or the physician-initiated record of deviation from a standing protocol.
Drug therapy management may include the following:
- Collecting and reviewing patient drug use histories;
- Ordering or performing routine drug therapy-related patient assessment procedures, including temperature, pulse, and respiration;
- Ordering drug therapy-related laboratory tests;
- Implementing or modifying drug therapy following diagnosis, initial patient assessment, and ordering of drug therapy by a physician as detailed in the protocol; or
- Any other drug therapy-related act delegated by a physician.
All drug therapy management by a pharmacist must occur under a written protocol from a physician’s order. A written protocol must include:
- A statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of drug therapy management;
- A statement identifying the individual pharmacist authorized to dispense drugs and to engage in drug therapy management as delegated by the physician;
- A statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make, which shall include:
- The ailments or diseases involved, drugs, and types of drug therapy management authorized; and
- The procedures, decision criteria, or plan the pharmacist shall follow when exercising drug therapy management authority;
- A statement of the activities the pharmacist shall follow while exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation shall be recorded within a reasonable time of each intervention and may be performed on the patient medication record, patient medical chart, or in a separate logbook; and
- A statement that describes appropriate mechanisms and a schedule for the pharmacist to report to the monitoring physician the pharmacist’s exercise of delegated drug therapy management and the results of the drug therapy management.
Physicians may use a standard drug therapy management protocol or a separate protocol for each patient. If a physician uses a standard protocol, they must record any deviations from the standard protocol ordered for an individual patient.
A delegation from physician to pharmacist may include:
- The implementation or modification of a patient’s drug therapy under a protocol if:
- The delegation follows a diagnosis, initial patient assessment, and drug therapy order by the physician; and
- The pharmacist maintains a copy of the protocol for inspection until at least the seventh anniversary of the expiration date of the protocol.
Pharmacist Training Requirements
Pharmacists must undergo certain training requirements to engage in drug therapy management under a delegation from a physician. First, the pharmacist must maintain and provide a statement to the TSBP within 24 hours of a request attesting that they have completed the following training within the last year:
- At least six hours of continuing education related to drug therapy offered by a provider approved by the Accreditation Council for Pharmacy Education (ACPE); or
- Engaged in drug therapy management as allowed under previous laws or rules. A statement from the physician supervising the acts shall be sufficient documentation.
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Additionally, pharmacists are subject to continuing training requirements. More specifically, they shall complete at least six hours of continuing education on drug therapy offered by a provider approved by the Accreditation Council for Pharmacy Education (ACPE). These hours will also apply toward the hours required to renew their pharmacist license.
Standards for Physician Supervision
22 Tex. Admin. Code §295.13(e) also sets standards for when physician supervision is adequate. These standards mirror the standards in the Texas Medical Practice Act, Chapter 157, but expand on them. Under these standards, delegating physicians must:
- Formulate or approve the written protocol and any patient-specific deviations from the protocol, review the written protocol and any patient-specific deviations at least annually, and review the services provided to a patient as per the protocol’s schedule;
- Establish and maintain a physician-patient relationship with each patient receiving drug therapy management and inform the patient of the pharmacist’s management;
- Maintain a geographical location so as to be physically present daily to provide medical care and supervision;
- Receive periodic status reports on patients, as per the protocol, including any problems or complications;
- Provide direct telecommunication access for consultation, assistance, and direction; and
- Determine that the pharmacist establishes and maintains a pharmacist-patient relationship.
Standards for Maintaining Records
Pharmacists shall keep certain records for at least two years for inspection and copying by the TSBP or other authorized law enforcement or regulatory agencies when engaging in drug therapy management. Pharmacists may maintain records in a data processing or direct imaging system as long as:
- the records contain all the information required on the manual record; and
- the data processing system can produce a hard record copy upon request.
Pharmacists also must maintain a copy of the written protocol and any patient-specific deviations from that protocol. They must document all interventions taken under the protocol within a reasonable time, whether maintained in the patient medication record, patient medical chart, or a separate log.
The physician may use a standard protocol or one specific to an individual patient. If the physician uses a standard protocol, the physician must record any deviations ordered for a patient and maintain a copy of those deviations. The physician and pharmacist must review and revise all protocols and deviations at least annually and all services provided to the patient per the protocol’s schedule. The pharmacist must document all reviews in their records.
Confidentiality Requirements
In addition to the normal confidentiality requirements outlined in §291.27, a pharmacist must follow other confidentiality requirements when providing drug therapy management. Under 22 Tex. Admin. Code §295.13(g), pharmacists shall comply with the following:
- HIPAA privacy provisions and any rules adopted under HIPAA;
- Medical records privacy requirements in Tex. Health and Safety Code, Chapter 181;
- Privacy of health information requirements in Tex. Insurance Code, Chapter 28B; and
- Any other confidentiality provisions of federal or state laws.
We Can Advocate for Your Interests in Disciplinary Proceedings Before TSBP
The pharmacist license defense lawyers of Bertolino LLP can help guide you through the disciplinary complaint process. Regardless of the allegations you face, we are here to represent your interests and work to minimize the negative effects of a complaint on your pharmacist license and career. We can help resolve the case against you and maintain your licensure or certification. Call us today at (512) 980-3751 to reach the offices of Bertolino LLP or contact us online.
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