5.3 Patient Counseling & Prospective Drug Utilization Review (DUR)

Patient Counseling & Prospective Drug Utilization Review (DUR)

The delivery of pharmaceutical care in New Jersey is anchored by two mandatory professional safeguards: Prospective Drug Utilization Review (DUR) and Patient Counseling. Rooted historically in the federal Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (42 U.S.C. § 1396r-8) and codified comprehensively in state regulation under N.J.A.C. 13:39-7.20 and 13:39-7.21, these provisions transform the pharmacist's role from a mechanical purveyor of drug containers into a clinical gatekeeper of medication safety.

Under New Jersey law, every prescription presented for dispensing—whether in a high-volume community retail chain, an independent pharmacy, an institutional outpatient dispensary, or a mail-order facility—must undergo rigorous prospective clinical screening and an affirmative offer to counsel. Candidates preparing for the NJ MPJE must understand the mandatory clinical elements of prospective DUR, the legal standards governing oral offers to counsel, the requirements for delivery/mail pharmacies, the strict prohibitions placed on non-pharmacist personnel, and the rules surrounding patient refusals.

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Mandatory Prospective Drug Utilization Review (DUR)

Under N.J.A.C. 13:39-7.20 and 13:39-7.21(a), a licensed pharmacist must perform a Prospective Drug Utilization Review prior to dispensing each prescription medication or device, whether the order is an initial fill or a refill. Unlike retrospective DUR (which analyzes historical claims data after dispensing), prospective DUR is an immediate, real-time safety intervention designed to intercept medication errors and clinical hazards before the medication leaves the pharmacy's physical control.

                             Prospective DUR Screening
                                         │
        ┌────────────────────────────────┼────────────────────────────────┐
        ▼                                ▼                                ▼
  1. Therapeutic Duplication       3. Drug-Drug Interactions        5. Drug-Allergy Alerts
  2. Drug-Disease Conflicts        4. Incorrect Dose / Duration     6. Clinical Abuse / Misuse

The Six Mandatory Clinical DUR Screening Categories

The prospective DUR requires the pharmacist to scrutinize the patient's comprehensive profile, medication history, and clinical documentation to detect:

1. Therapeutic Duplication: The concurrent prescribing of two or more medications containing identical active ingredients or belonging to identical pharmacological classes without documented clinical rationale.
2. Drug-Disease Contraindications: Situations where a prescribed drug is known to adversely affect or worsen a pre-existing medical condition or comorbidity documented in the patient profile (e.g., non-selective beta-blockers in severe asthma, NSAIDs in advanced chronic kidney disease or active peptic ulcer disease).
3. Drug-Drug Interactions: Clinically significant pharmacological, pharmacokinetic, or pharmacodynamic interactions between the prescribed agent and other medications, over-the-counter (OTC) drugs, or nutritional/herbal supplements currently taken by the patient.
4. Incorrect Dosage or Duration of Treatment: Dosing regimens that deviate from established clinical guidelines, manufacturer labeling, or pediatric/geriatric safety parameters, including subtherapeutic dosing, excessive dosing, inappropriate dosage forms, or prolonged durations of therapy.
5. Drug-Allergy Interactions: Potential adverse hypersensitivity reactions between the prescribed agent and known patient allergies or cross-reactive drug classes documented in the pharmacy profile (e.g., prescribing cephalosporins to a patient with a documented history of severe anaphylactic penicillin allergy).
6. Clinical Abuse, Misuse, or Underutilization: Patterns indicating potential drug diversion, excessive consumption, doctor shopping, early refill requests for controlled dangerous substances, or conversely, severe non-adherence and underutilization of critical maintenance therapies.

Pharmacist Intervention & Clinical Resolution

When a prospective DUR screening flags a potential clinical problem, the automated warning cannot simply be overridden without clinical evaluation. The dispensing pharmacist must exercise professional judgment, contact the prescriber or patient when clinically indicated, resolve the conflict, and document the clinical resolution and rationale in the pharmacy computer system.

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The Mandatory Offer to Counsel: Legal Standards & Delivery

Under N.J.A.C. 13:39-7.20 and 13:39-7.21(b), the pharmacist must ensure that a meaningful offer of oral consultation is extended to every patient or caregiver.

                               The Offer to Counsel
                                         │
        ┌────────────────────────────────┴────────────────────────────────┐
        ▼                                                                 ▼
  New Prescriptions                                                 Refill Prescriptions
 • Mandatory ORAL offer to counsel                                 • Guided by professional judgment
 • Must be made by Pharmacist or Intern                           • Offered when clinically indicated
 • Technicians CANNOT make the offer                              • Mandatory if requested by patient

1. New Prescriptions: Mandatory Oral Offer

For every new prescription, the pharmacist—or a registered pharmacy intern acting under the direct personal supervision of a licensed pharmacist—must make an oral offer to counsel the patient or their caregiver. The offer must be communicated verbally whenever the patient or caregiver presents in person at the pharmacy practice site.

2. Refill Prescriptions: Professional Judgment

For refill prescriptions, the pharmacist must exercise professional judgment regarding the necessity of counseling. Counseling must be provided if the patient requests it, if changes in dosage or directions have occurred, if a new clinical warning has emerged, or if the pharmacist identifies an adherence or safety concern during the prospective DUR.

3. Face-to-Face Setting & Patient Privacy

In community retail pharmacies, patient counseling should occur in an area that affords reasonable visual and auditory privacy. While a separate enclosed room is not statutorily mandated for every pharmacy, the facility layout must prevent casual eavesdropping by third parties, consistent with both state practice rules and federal Health Insurance Portability and Accountability Act (HIPAA) privacy mandates.

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Mail-Order, Delivery & Remote Dispensing Requirements

When a medication is not handed directly to the patient in a community pharmacy (such as prescriptions fulfilled by mail-order pharmacies, central fill facilities, or local delivery drivers), the pharmacy must implement specialized communication mechanisms under N.J.A.C. 13:39-7.20 and 13:39-7.21(e):

[!IMPORTANT] MPJE Memory Anchor: Mail-order / delivery counseling standard = Written patient literature + Toll-free number on package + Pharmacist available minimum 6 days/week and 40 hours/week.

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Core Elements of Comprehensive Patient Counseling

When conducting oral patient counseling pursuant to N.J.A.C. 13:39-7.20 and 13:39-7.21(c) and OBRA '90, the pharmacist or intern should cover all clinically significant points, tailored to the patient's individual needs. These core elements include:

1. Medication Identity & Purpose: The proprietary (brand) and non-proprietary (generic) names of the drug, its therapeutic intent, and expected clinical benefits.
2. Dosage & Administration: The dosage form, prescribed dose, anatomical route of administration, and expected duration of therapy.
3. Special Instructions & Precautions: Techniques for preparation or administration (e.g., priming an inhaler, shaking suspensions, subcutaneous injection technique), food interactions, and lifestyle modifications (e.g., avoiding sun exposure or alcohol).
4. Common Severe Adverse Effects & Interactions: Significant adverse reactions, potential drug-drug or food-drug interactions, known contraindications, and actions required to prevent or mitigate them.
5. Self-Monitoring Techniques: Methods for monitoring therapeutic progress at home (e.g., blood glucose tracking, blood pressure logs, peak flow readings, monitoring for signs of bleeding or infection).
6. Proper Storage Conditions: Environmental requirements necessary to preserve drug stability (e.g., refrigeration between 36°F–46°F, room temperature storage, protection from light and moisture, child-resistant storage).
7. Refill Information: Authorization status, remaining refill counts, and procedure for requesting subsequent renewals.
8. Missed Dose Protocol: Specific clinical actions to take if a scheduled dose is omitted (e.g., whether to take the dose immediately or skip to the next scheduled interval, avoiding doubling up doses).

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Patient Refusal of Counseling & Non-Pharmacist Boundaries

New Jersey law strictly balances mandatory patient protection with individual patient autonomy:

                             Patient Refusal Protocols
                                         │
        ┌────────────────────────────────┼────────────────────────────────┐
        ▼                                ▼                                ▼
   Patient Autonomy                Technician Boundary              Mandatory Documentation
 • Patient may freely decline    • Technicians CANNOT counsel     • Must record in pharmacy file
 • Cannot be coerced or steered   • Technicians CANNOT assess need • Electronic or signature log
 • Must be fully voluntary       • Must not solicit refusals      • Retain records for 5 YEARS

1. The Right of Refusal

A patient or their authorized caregiver has the uncompromised statutory right to decline counseling. However, to be legally valid, the refusal must be spontaneous and fully voluntary. A pharmacy cannot coerce, solicit, or steer a patient into refusing counseling.

2. Strict Prohibition on Pharmacy Technicians

Under N.J.A.C. 13:39-7.20 and 13:39-7.21(d), pharmacy technicians, technician applicants, cashiers, and clerical personnel are strictly prohibited from conducting patient counseling, answering clinical drug questions, or evaluating whether counseling is warranted.

• A pharmacy cashier or technician cannot ask a patient: "Do you have any questions for the pharmacist, or do you want to decline?"
• A pharmacy management system cannot use pre-selected, default "waiver of counseling" checkboxes or automated prompts that encourage technicians or patients to bypass consultation.
• Only the licensed pharmacist or registered intern may evaluate patient understanding or clarify prescription instructions.

3. Mandatory Documentation: 5-Year Retention

Whenever a patient or caregiver refuses the oral offer to counsel, the pharmacy must document the refusal in its permanent records. The documentation may be captured via an electronic signature pad, a paper signature log, or an entry directly into the computerized patient profile. Under N.J.A.C. 13:39-7.6, all patient counseling records and documented refusals must be retained by the pharmacy for at least five (5) years and made readily retrievable for Board inspection.

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Practical Legal Scenario: The Drive-Thru Counseling Breakdown

Scenario: A patient arrives at a community pharmacy drive-thru window to pick up a new prescription for ciprofloxacin 500 mg tablets prescribed for an acute urinary tract infection. The pharmacy technician rings up the copay, hands the medication bag to the patient, and asks: "Sign here to waive consultation unless you feel like waiting for the pharmacist." The patient signs the electronic signature pad, and the technician hands over the receipt. The pharmacist on duty was in the dispensary verifying other orders and never spoke with the patient.

Legal Analysis:

1. Prospective DUR Compliance: The pharmacist must ensure prospective DUR occurred prior to dispensing ciprofloxacin (e.g., checking for concurrent antacid/divalent cation use, QT-prolonging drugs, or tendon disorder history).
2. Offer to Counsel Violation: Because this is a new prescription, New Jersey law mandates an oral offer to counsel communicated directly by the pharmacist or pharmacy intern. Allowing a pharmacy technician to handle the pick-up without an oral offer from the pharmacist constitutes a direct violation of N.J.A.C. 13:39-7.20 and 13:39-7.21(b).
3. Coercive Solicitation: The technician's leading question ("Sign here to waive consultation...") violates the legal requirement that refusals be uncoerced and voluntary.
4. Professional Disciplinary Exposure: The dispensing pharmacist, the Pharmacist-in-Charge (RPIC), and the permit holder are subject to administrative disciplinary sanctions and civil monetary penalties under the Uniform Enforcement Act (N.J.S.A. 45:1-25).

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Getting the Citation Right

Subchapter 7 of N.J.A.C. 13:39 is dense, and several of its rules are routinely mis-cited in secondary study material. Because MPJE items frequently anchor a fact to a rule number, it is worth memorizing the neighborhood around counseling and DUR:

The three that matter for this section form a sequence: the profile (7.19) supplies the data, the DUR (7.20) is the screen you run against that data before dispensing a new or refill prescription, and counseling (7.21) is how the result reaches the patient. A question that cites 13:39-7.14 in a counseling fact pattern is citing the advertising rule.