4.6 Mandatory Patient Counseling & Drug Utilization Review (OBRA 90 & GA Rules)

Patient Counseling & Drug Utilization Review (DUR)

The landscape of pharmacy practice fundamentally shifted with the passage of the federal Omnibus Budget Reconciliation Act of 1990, universally known as OBRA '90. Prior to this legislation, pharmacists were primarily viewed as dispensers of medication. OBRA '90 legally transformed the pharmacist's role into a clinical care provider responsible for ensuring that medication therapy is both safe and effective.

While OBRA '90 originally tied these requirements only to states receiving federal Medicaid funding, virtually all states, including Georgia, subsequently adopted these standards into their state pharmacy practice acts, applying them to all patients, not just Medicaid recipients. In Georgia, these requirements are rigorously enforced under State Board of Pharmacy rules.

The OBRA '90 framework rests on three primary pillars:

1. Prospective Drug Utilization Review (DUR)
2. Patient Counseling
3. Patient Record Maintenance (Patient Profiles)

Let's explore each of these pillars in the context of Georgia pharmacy law.

1. Prospective Drug Utilization Review (DUR)

Before dispensing any prescription, a pharmacist must review the patient's medication profile to identify any potential problems. This "look ahead" is called a Prospective Drug Utilization Review (Prospective DUR).

According to Georgia Board of Pharmacy rules, the pharmacist must review the patient record and each prescription drug order presented for dispensing for the purpose of identifying:

• Therapeutic Duplication: Is the patient already taking a drug in the same therapeutic class? (e.g., receiving a prescription for lisinopril when they already have an active prescription for ramipril).
• Drug-Disease Contraindications: Does the patient have a medical condition that makes this drug dangerous? (e.g., prescribing a non-selective beta-blocker to a patient with severe asthma).
• Drug-Drug Interactions: Will the new drug interact adversely with an existing medication on the patient's profile? (e.g., combining sildenafil with nitrates).
• Incorrect Drug Dosage or Duration of Treatment: Is the dose too high, too low, or prescribed for an inappropriate length of time?
• Drug-Allergy Interactions: Is the patient allergic to the prescribed medication or its excipients?
• Clinical Abuse or Misuse: Is there evidence that the patient is overusing, underusing, or otherwise abusing the medication? (e.g., seeking early refills on controlled substances).

If the prospective DUR triggers an alert in any of these categories, the pharmacist cannot simply ignore it or clear the alert blindly. The pharmacist must use their professional judgment to evaluate the clinical significance of the issue. Often, this requires contacting the prescribing practitioner to resolve the problem before dispensing the medication. The pharmacist's intervention is a critical safety net that prevents countless adverse drug events every day.

2. Mandatory Patient Counseling

Perhaps the most visible aspect of OBRA '90 is the requirement for patient counseling. Georgia Board of Pharmacy Rule 480-31 strictly governs patient counseling standards.

The Offer to Counsel

In Georgia, upon receipt of a new prescription drug order, the pharmacist or pharmacy intern must personally offer to discuss matters that will enhance or optimize the patient's drug therapy.

CRITICAL EXAM POINT: The offer to counsel must be made personally by the pharmacist or the pharmacy intern (under direct supervision). In Georgia, pharmacy technicians, cashiers, or delivery drivers are strictly prohibited from making the offer to counsel. Simply having a sign on the wall or a printed statement on the receipt does not satisfy the requirement for an oral offer. The pharmacist or intern must verbally communicate the offer to the patient or their caregiver.

Required Counseling Topics

If the patient accepts the offer to counsel, the pharmacist (or intern) should discuss elements deemed clinically significant based on their professional judgment. These elements typically include:

• The name and description of the drug (brand and generic).
• The dosage form, dose, route of administration, and duration of drug therapy.
• The intended use of the drug and expected action.
• Special directions and precautions for preparation, administration, and use by the patient.
• Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur.
• Techniques for self-monitoring drug therapy.
• Proper storage and handling requirements.
• Prescription refill information.
• Action to be taken in the event of a missed dose.

Exemptions to the Counseling Rule

The mandatory offer to counsel does not apply in every single dispensing scenario. Georgia law provides specific exemptions where the rule does not apply:

1. Inpatients of a Hospital or Institution: When medications are administered to inpatients by other licensed healthcare professionals (like nurses), the dispensing pharmacist is not required to provide counseling to the patient directly.
2. Inmates: Medications dispensed to inmates of correctional institutions where healthcare staff administers the drugs.
3. Patients Receiving Drugs from the Department of Public Health: Under certain specific public health programs.
4. Patient Refusal: The most common exemption. A patient (or caregiver) has the absolute right to refuse consultation.

Documenting Refusals

If a patient refuses counseling, the pharmacist must document this refusal. While federal and state rules don't strictly mandate exactly how a refusal must be documented in every scenario, standard practice and Board expectations require a tangible record (e.g., an electronic signature log where the patient explicitly signs "Refused Counseling"). If the record shows no documented refusal, the legal assumption is that counseling was provided.

Refills and Counseling

For refill prescriptions, the mandatory offer to counsel is not absolute in the same way it is for new prescriptions. However, the pharmacist should exercise professional judgment and offer counseling on refills if they deem it necessary (e.g., if there has been a change in dosage, if the patient hasn't filled it in a long time, or if a DUR alert fires indicating a potential problem).

3. Patient Record Maintenance (Patient Profiles)

To conduct a meaningful prospective DUR and provide accurate counseling, the pharmacist must have access to the patient's medical history. OBRA '90 and Georgia rules require pharmacies to make a reasonable effort to obtain, record, and maintain patient profiles.

A complete patient profile should include:

• The patient's full name, address, and telephone number.
• The patient's date of birth (or age) and gender.
• A comprehensive list of all prescription drug orders obtained by the patient at the pharmacy.
• Known allergies, drug reactions, and idiosyncrasies.
• Chronic conditions or disease states.
• Any pharmacist comments relevant to the individual's drug therapy.

Pharmacists must make a "reasonable effort" to collect this data. If a patient refuses to provide their date of birth or their allergy information, the pharmacist cannot force them. However, the pharmacist should document that the patient refused to provide the information so that the pharmacy cannot be cited for failing to collect it. The profile serves as the foundational database upon which clinical pharmacy practice is built.