Section 9.2: Patient Counseling and Drug Utilization Review Requirements

Section 9.2: Patient Counseling and Drug Utilization Review Requirements

To ensure patient safety and promote optimal therapeutic outcomes, Texas pharmacy law establishes strict mandates for drug utilization reviews (DURs) and patient counseling. These regulations are primarily governed by the Texas State Board of Pharmacy (TSBP) Rules under 22 TAC §291.33(c). Pharmacists are positioned as the final clinical gatekeepers, and a failure to conduct a proper DUR or offer counseling is one of the most common grounds for disciplinary action by the TSBP.

Prospective Drug Utilization Review (DUR)

Before dispensing or delivering any prescription (whether it is a new prescription or a refill), a pharmacist must conduct a prospective Drug Utilization Review. The DUR is a clinical review of the patient's drug therapy record and the prescription being filled to identify potential drug-related problems.

Under TSBP rules, the pharmacist must screen for the following clinical issues:

1. Clinical Abuse or Misuse: Identifying patterns of over-utilization, early refills, or inappropriate combinations of controlled substances.
2. Therapeutic Duplication: Ensuring the patient is not taking multiple medications from the same therapeutic class (e.g., two different ACE inhibitors) unless clinically indicated.
3. Drug-Disease Contraindications: Verifying that a prescribed drug will not exacerbate an existing medical condition (e.g., avoiding NSAIDs in a patient with severe chronic kidney disease).
4. Drug-Drug Interactions: Screening for clinically significant interactions between the newly prescribed medication and other drugs in the patient's profile.
5. Incorrect Drug Dosage or Duration: Checking that the prescribed dose, frequency, and duration of therapy are appropriate for the patient's age, weight, and clinical status.
6. Drug-Allergy Interactions: Reviewing the patient’s recorded allergies to prevent allergic reactions or cross-sensitivity.
7. Correlation of Prescription with Patient Profile: Cross-referencing the prescription with the patient's medical history, age, gender, and other diagnostic information.

If a pharmacist identifies any potential problem during the prospective DUR, they must take appropriate steps to resolve it. This may involve reviewing clinical literature, consulting the patient, or contacting the prescribing practitioner. The pharmacist must document any clinical interventions and resolutions in the pharmacy's computer system.

Patient Counseling Requirements

In Texas, the rules distinguish between new prescriptions and refills regarding the obligation to provide patient counseling.

1. New Prescriptions: Mandatory Counseling

Counseling is mandatory for all new prescriptions. A prescription is legally considered "new" if:

• The medication has not been previously dispensed to the patient by the pharmacy.
• The medication was previously dispensed, but in a different strength or dosage form.
• The medication was previously dispensed in the same strength and dosage form, but more than one year (12 months) has elapsed since the patient last filled it at that pharmacy.

For new prescriptions, the pharmacist (or a pharmacist intern under direct supervision) must provide oral counseling. The pharmacist must initiate the counseling session. It is legally insufficient to wait for the patient to ask questions or to simply ask, "Do you have any questions for the pharmacist?"

2. Refill Prescriptions: Mandatory Offer to Counsel

For refill prescriptions, counseling is not automatically mandatory, but the pharmacy must make a mandatory offer to counsel.

• Who can make the offer: A pharmacist, pharmacist intern, or pharmacy technician can make the offer to counsel when dispensing a refill.
• Patient Request: If the patient accepts the offer or has questions, a pharmacist (or intern under direct supervision) must provide the counseling. Pharmacy technicians are legally prohibited from performing the actual counseling.

Professional Roles: Who Can Counsel?

A critical distinction on the MPJE is the division of labor between pharmacists, interns, and technicians.

• Pharmacist: Can perform DURs, make counseling offers, and conduct patient counseling.
• Pharmacist Intern: Under the direct, one-on-one supervision of a preceptor (pharmacist), an intern can perform all duties of a pharmacist, including DURs and patient counseling. The supervising pharmacist remains responsible for the accuracy and legality of the transaction.
• Pharmacy Technician / Trainee: Technicians can perform administrative and technical tasks. They can make the initial offer to counsel on refills or ask a patient picking up a new prescription to wait for the pharmacist. However, they cannot conduct a DUR, interpret patient profiles, or provide clinical information to the patient.

Essential Content of a Counseling Session

When counseling a patient, the pharmacist must provide information that, in their professional judgment, is necessary for the safe and effective use of the drug. The counseling session should cover:

• The name and description of the drug.
• The dosage form, dosage, route of administration, and duration of drug therapy.
• Special directions and precautions for preparation, administration, and use by the patient.
• Common severe side effects, adverse effects, or therapeutic contraindications, including how to avoid them and what action to take if they occur.
• Techniques for self-monitoring drug therapy.
• Proper storage requirements.
• Prescription refill information.
• Action to be taken in the event of a missed dose.

Counseling for Delivery and Mail Order Prescriptions

If a prescription is delivered to a patient outside the physical location of the pharmacy (via courier, delivery driver, or mail), the pharmacy must implement alternative counseling procedures:

1. Written Information: The pharmacy must provide written information (e.g., a patient medication guide or information sheet) that explains the key counseling points.
2. Toll-Free Telephone Number: The pharmacy must provide a toll-free telephone number where the patient can contact a pharmacist. This toll-free number must be printed on the prescription label or included in the written materials accompanying the medication.
3. Availability: The pharmacy must ensure that a pharmacist is available to answer calls during the pharmacy's regular business hours (which must be at least 40 hours per week, 6 days per week).

Patient Refusal of Counseling

A patient or the patient's agent has the right to refuse (waive) counseling.

• Documentation: If a patient refuses counseling, the pharmacist or pharmacy staff must document the refusal in the pharmacy's records (often via an electronic signature pad or a signed logbook).
• No Passive Waivers: Pharmacies are strictly prohibited from utilizing "passive waivers." For example, a pharmacy cannot use a signature pad that automatically checks a box waiving counseling, nor can they ask the patient to "sign here to skip counseling" without first making a clear, active offer to counsel. The patient must actively choose to decline.

Common Exam Traps and Legal Nuances

• The "One-Year" Rule for New Prescriptions: A common trap is assuming a drug is a "refill" because the patient has taken it before. If a patient took amoxicillin 500mg last year and receives a new prescription for amoxicillin 500mg today, it is legally a "new" prescription requiring mandatory counseling if it has been more than 12 months since the last fill.
• Technicians Transmitting Clinical Information: Even if a technician knows the answer to a patient's simple question (e.g., "Should I take this with food?"), they cannot answer it. Any response that involves clinical knowledge or advice must be referred to the pharmacist.
• Discharge Medications in Class C Pharmacies: Inpatients do not receive counseling under these community rules because nursing or medical staff administer the medications and monitor the patient. However, if a Class C pharmacy dispenses discharge medications for the patient to take home, those medications are subject to the same DUR and mandatory counseling rules as Class A community pharmacies.