7.3 Patient Counseling, Profiles & Drug Utilization Review
Key Takeaways
- The offer to counsel is anchored in M.G.L. c. 94C, § 21A and 247 CMR 9.07(3), and must be extended on all prescriptions dispensed, new and refill alike.
- While pharmacy technicians, cashiers, and support staff are legally permitted to extend the initial offer to counsel, actual patient counseling MUST be performed directly by a licensed pharmacist or a registered pharmacy intern under direct supervision.
- Prospective Drug Utilization Review (DUR) is a mandatory clinical screening performed by the pharmacist PRIOR to dispensing each prescription, evaluating therapeutic duplication, drug-disease contraindications, drug interactions, incorrect dose/duration, allergies, and clinical abuse/misuse.
- Pharmacy records, including patient profiles and counselling documentation, must be retained for at least two years under 247 CMR 9.05, 105 CMR 700.006 and 21 CFR 1304.21.
7.3 Patient Counseling, Profiles & Drug Utilization Review
MPJE Core Concept: Patient safety standards under 247 CMR 9.00 require a multi-tiered duty of care: prospective Drug Utilization Review (DUR) prior to dispensing, a mandatory offer to counsel on every fill, and maintenance of complete patient profile records retained for at least 2 years.
Originally established federally under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) for Medicaid beneficiaries, the duty is anchored in Massachusetts by M.G.L. c. 94C, § 21A and the Board's standards at 247 CMR 9.07(3), and it extends to all patients across outpatient retail, mail-order and delivery settings.
[!IMPORTANT] Who may make the offer, and who may counsel, are different questions — and the regulation answers both. 247 CMR 8.02(6)(b) and 8.04(4)(b) expressly permit a pharmacy technician and a certified pharmacy technician to relay the pharmacist's offer to counsel, citing M.G.L. c. 94C, § 21A and 247 CMR 9.07(3). The same regulations prohibit both from providing patient counselling. Relaying an offer is a message; counselling is professional judgement.
Massachusetts Patient Counseling Regulations (247 CMR 9.00)
Mandatory Offer to Counsel
In Massachusetts, a pharmacy must make a mandatory offer to counsel the patient or caregiver on EVERY prescription filled—this encompasses both NEW prescriptions and REFILLS.
- Personnel Authorized to Make the Offer: Pharmacy technicians, certified technicians, cashiers, and administrative support staff are legally permitted to extend the initial offer to counsel at the pharmacy counter.
- In-Person Offer Standard: For prescriptions picked up in person, the offer must be extended verbally directly to the patient or caregiver.
- Delivery & Mail-Order Offer Standard: For prescriptions delivered or shipped via mail, a written offer to counsel must accompany the medication. This written notice MUST provide a toll-free telephone number allowing the patient direct access to a licensed pharmacist during normal business hours.
Conducting Actual Patient Counseling
If the patient or caregiver accepts the offer to counsel, ONLY a licensed pharmacist or a registered pharmacy intern acting under the direct supervision of a pharmacist may perform the actual counseling.
- Prohibited Personnel: Pharmacy technicians, certified technicians, trainees, and cashiers are strictly prohibited from providing clinical drug information, interpreting drug usage, or conducting counseling.
Core Elements of Counseling
When conducting counseling, the pharmacist or intern must communicate matters that, in their professional judgment, are significant, including:
- Name and description of the medication (brand, generic, therapeutic class).
- Dosage form, dosage, route of administration, and duration of therapy.
- Special directions and precautions for preparation, administration, and patient use.
- Common severe side effects, adverse interactions, and therapeutic contraindications (including strategies to prevent adverse events and necessary action if they occur).
- Techniques for self-monitoring drug therapy.
- Proper storage requirements.
- Refill authorization information.
- Action to be taken in the event of a missed dose.
Prospective Drug Utilization Review (DUR)
Before any prescription is released to a patient, the dispensing pharmacist MUST perform a prospective Drug Utilization Review (DUR). Prospective DUR involves evaluating the prescription order against the patient's existing profile data to screen for potential drug therapy problems.
Mandatory Prospective DUR Screening Categories
| DUR Category | Clinical Objective & Screening Focus |
|---|---|
| Therapeutic Duplication | Identifying concurrent use of two or more drugs from the same therapeutic class without clinical justification. |
| Drug-Disease Contraindications | Screening prescribed drugs against documented patient medical conditions (e.g., prescribing beta-blockers to a severe asthmatic). |
| Drug-Drug Interactions | Evaluating potential adverse pharmacological interactions between prescribed drugs or known OTC medications. |
| Incorrect Dosage or Duration | Verifying that drug dosage, frequency, and treatment duration fall within safe clinical guidelines (avoiding subtherapeutic or toxic doses). |
| Drug-Allergy Interactions | Cross-referencing prescribed medications against recorded drug allergies or cross-sensitivities (e.g., cephalosporins in severe penicillin allergy). |
| Clinical Abuse / Misuse | Detecting patterns of overutilization, early refills, or multi-prescriber controlled substance acquisition. |
[!IMPORTANT] Pharmacist Professional Obligation on DUR Alerts: When a computer system generates a DUR alert (e.g., major drug interaction or allergy conflict), the pharmacist cannot simply bypass the system without clinical evaluation. The pharmacist must exercise professional judgment, document the clinical resolution in the patient profile, and contact the prescriber whenever necessary to modify therapy.
Patient Profile Requirements in Massachusetts
Under 247 CMR 9.00, a registered pharmacy must maintain a computerized or manual patient profile system for all patients for whom prescriptions are dispensed at that location.
Mandatory Profile Data Elements
- Demographic Data: Full patient name, address, telephone number, age or date of birth, and gender.
- Individual History: Known drug allergies, adverse drug reactions, idiosyncratic history, and documented chronic disease states.
- Comprehensive Medication History: A complete 2-year record of all prescriptions filled at the pharmacy, including prescription number, drug name, strength, quantity, date filled, and prescribing practitioner name.
- Pharmacist Clinical Notes: Comments regarding DUR resolution, clinical interventions, or special patient preferences.
Retention Period Mandate
Pharmacy records, including patient profiles, must be maintained and readily retrievable for a minimum of two years (247 CMR 9.05; 105 CMR 700.006; 21 CFR 1304.21). Third-party payers and other agencies may require longer retention, and the Board's own guidance says so.
Counseling Refusal & Mandatory Recordkeeping
Patients or their caregivers possess the legal right to refuse counseling.
- Handling Counseling Refusals: If a patient or caregiver declines the offer to counsel, the pharmacist is not required to force counseling. However, the refusal MUST be documented.
- Documentation Protocols: The pharmacy must record the refusal either in the electronic data processing system or on a physical prescription signature log.
- Retention of Refusal Logs: All records of counseling refusals must be retained by the pharmacy for a minimum of 2 years.
Summary of Patient Care Standards
| Regulatory Standard | Mandated Requirement | Authorized Personnel | Mandatory Retention |
|---|---|---|---|
| Offer to Counsel | Required on ALL new scripts and refills | Pharmacists, Interns, Certified Techs, Techs, Cashiers | N/A |
| Actual Counseling | Required whenever offer is accepted | Pharmacists and Pharmacy Interns ONLY | N/A |
| Prospective DUR | Required prior to dispensing each script | Licensed Pharmacist ONLY | Captured in dispensing audit log |
| Patient Profiles | Comprehensive demographic & medication file | Pharmacy Staff | 2 years from date of LAST entry |
| Counseling Refusal | Documented upon patient declination | Pharmacy Staff | 2 years |
Under 247 CMR 9.00, which pharmacy personnel are legally authorized to conduct actual clinical patient counseling when an offer to counsel is accepted by a patient?
Under Massachusetts pharmacy regulations, what is the minimum statutory retention period for patient profile records calculated from the date of the last entry?
Regarding the mandatory offer to counsel under Massachusetts pharmacy law (247 CMR 9.00), for which prescription fills must an offer to counsel be extended?