8.5 Patient Counseling, Patient Profiles & Drug Regimen Review
Key Takeaways
- Tennessee is a face-to-face counseling state: Rule 1140-03-.01(1)(a) requires the pharmacist to personally counsel the patient or caregiver face-to-face when they are present, which is stricter than OBRA '90's offer to counsel.
- When the patient or caregiver is not present, the pharmacist must make a reasonable effort to counsel through alternative means; printed leaflets may supplement but never replace face-to-face counseling.
- Counseling is required for outpatients of hospitals and for discharge medications, is not required for inpatients of an institutional or long-term care facility, and is not required where the patient or caregiver refuses it.
- On a refill request, Rule 1140-03-.01(1)(f) requires only that the pharmacist or a designee offer for the pharmacist to counsel; full counseling follows if the patient asks or the pharmacist's professional judgment calls for it.
- Rule 1140-03-.01(3) requires a drug regimen review of the patient's record before dispensing each order against seven criteria, and Rule 1140-02-.01(13) makes counseling and certification of orders non-delegable pharmacist functions.
8.5 Patient Counseling, Patient Profiles & Drug Regimen Review
Quick Answer: Tennessee's counseling standard lives in Tenn. Comp. R. & Regs. 1140-03-.01, titled Responsibilities for Pharmaceutical Care. It is stricter than federal law. Where OBRA '90 requires only an offer to counsel Medicaid patients, Rule 1140-03-.01(1)(a) provides that upon receipt of an order and following a review of the patient's record, "a pharmacist shall personally counsel the patient or caregiver 'face-to-face' if the patient or caregiver is present." If they are not present, the pharmacist "shall make a reasonable effort to counsel through alternative means." Written leaflets may supplement but not replace face-to-face counseling. The same rule requires a patient record system with immediate retrieval (paragraph 2) and a drug regimen review before dispensing each order (paragraph 3).
1. Why This Rule Anchors Area 2 and Area 3 of the Blueprint
The NABP Competency Statements devote a full competency to counseling requirements and documentation (2.3) inside the 33%-weighted Pharmacist Practice area, and a further competency to prospective drug utilization review (3.3) inside Dispensing Requirements. In Tennessee both live in one short rule. Candidates who study only the federal OBRA '90 framework will answer Tennessee counseling items incorrectly, because the state rule replaces the federal floor with a materially higher duty.
| Element | Federal OBRA '90 (42 U.S.C. § 1396r-8) | Tennessee Rule 1140-03-.01 | Which controls in Tennessee? |
|---|---|---|---|
| Who is covered | Medicaid outpatients (adopted by most states for all patients) | All patients for whom orders are dispensed | Tennessee — no payer limitation |
| Nature of the duty | Make an offer to counsel | Personally counsel face-to-face when the patient or caregiver is present | Tennessee — counseling, not merely an offer |
| Who may perform it | State law determines | Pharmacist, or intern in the presence of and under the personal supervision of a pharmacist (Rule 1140-02-.01(13)(d)) | Tennessee |
| Patient absent | Offer may be documented | Reasonable effort through alternative means | Tennessee |
| Refills | Offer required | Offer for the pharmacist to counsel; full counseling if requested or professionally indicated | Tennessee |
| Refusal | Patient may decline | No counseling required where the patient or caregiver refuses | Same result |
2. The Counseling Duty, Clause by Clause
Rule 1140-03-.01(1) has seven lettered subparagraphs. Each is a discrete testable point.
- (a) Face-to-face when present; reasonable effort when not. The trigger is receipt of an order and a review of the patient's record — counseling is downstream of the profile review, not independent of it.
- (b) Supplement, never substitute. "Alternative forms of patient information may be used to supplement, but not replace, face-to-face patient counseling." A printed monograph stapled to the bag does not discharge the duty.
- (c) Hospital outpatients and discharge medications are covered. Counseling "shall also be required for outpatients of hospitals or other institutional facilities dispensing medical and prescription orders and for patients when medications are dispensed on discharge."
- (d) Inpatients are excluded. Counseling as described in the rule "shall not be required for inpatients of an institutional or long-term care facility." This is the mirror image of the labeling carve-out in Rule 1140-03-.06.
- (e) Eight content elements (see below), each filtered through the pharmacist's professional judgment about what is significant.
- (f) Refills get an offer. On a refill request, "a pharmacist or a person designated by the pharmacist" shall offer for the pharmacist to counsel. Note that the offer may be relayed by a technician; the counseling itself may not be.
- (g) Refusal ends the duty. "A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such counseling."
The Eight Counseling Content Elements — Rule 1140-03-.01(1)(e)
┌─────────────────────────────────────────────────────────────────────────────┐
│ 1. The name and description of the medication. │
│ 2. Dosage form, dose, route of administration, and duration of therapy. │
│ 3. Special directions and precautions for preparation, administration, │
│ and use by the patient. │
│ 4. Common side effects or adverse effects or interactions and therapeutic │
│ contraindications, including avoidance and the action required. │
│ 5. Techniques for self-monitoring drug therapy. │
│ 6. Proper storage. │
│ 7. Prescription refill information. │
│ 8. Action to be taken in the event of a missed dose. │
└─────────────────────────────────────────────────────────────────────────────┘
The list is introduced by "shall cover matters, which in the exercise of the pharmacist's professional judgement, the pharmacist deems significant." An examiner may test either half of that sentence: the eight enumerated topics, or the professional-judgment filter that lets a pharmacist prioritize among them.
3. Patient Profiling — Rule 1140-03-.01(2)
Every pharmacy practice site must maintain a patient record system for patients for whom orders are dispensed, and the system "shall provide for the immediate retrieval of information necessary for the pharmacist to identify previously dispensed orders at the time an order is presented." Retrieval that requires a call to a corporate data center the next business day does not satisfy the rule.
The pharmacist, or a person designated by the pharmacist, must make a reasonable effort to obtain, record, and maintain four categories of information through communication with the patient, caregiver, or agent:
| # | Required Profile Content |
|---|---|
| 1 | Name, address, telephone number |
| 2 | Date of birth (age), gender |
| 3 | An individual history where significant — disease states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices |
| 4 | The pharmacist's comments as deemed relevant |
The rule expressly permits the record to be kept "manually or by computer." Retention of a profile relied on for refill dispensing is governed separately by Rule 1140-03-.03(5)(d) — at least two years from the last dispensing recorded on it.
4. Drug Regimen Review — Rule 1140-03-.01(3)
Tennessee's prospective DUR is captioned Drug Regimen Review. The pharmacist "shall be responsible for a reasonable review of a patient's record prior to dispensing each medical or prescription order," evaluating seven screens:
- Over-utilization or under-utilization
- Therapeutic duplication
- Drug-disease contraindication
- Drug-drug interactions
- Incorrect drug dosage or duration of drug treatment
- Drug-allergy interactions
- Clinical abuse/misuse
Subparagraph (b) supplies the action clause that examiners love: "Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem." Silently clicking through a severe-interaction alert is a rule violation independent of any patient harm.
Where this shows up elsewhere. Rule 1140-13-.06 requires a pharmacist supervising technician activity in a federally qualified health center to perform "a drug utilization review in accordance with Tenn. Comp. R. & Regs. Rule 1140-03-.01(3)" and to perform patient counseling. Rule 1140-01-.08(3)(a)9 requires every out-of-state pharmacy practice site dispensing into Tennessee to comply with the Tennessee requirements for patient counseling, patient profiling, drug regimen review, and pharmaceutical care "as set forth at 1140-03-.01." Tennessee's counseling standard therefore follows the Tennessee patient across state lines.
5. Non-Delegable Functions — Rule 1140-02-.01(13)
Rule 1140-02-.01(13) lists nine functions that "must be performed personally by a pharmacist or by a pharmacy intern under the personal supervision and in the presence of a pharmacist":
| Function | Practical consequence |
|---|---|
| Certification of medical and prescription orders | No technician final check |
| Final verification of the product prior to dispensing | No release without pharmacist verification |
| Initialing orders with appropriate comments | Documentation is a pharmacist act |
| Providing patient counseling | A technician may relay the offer, never the counseling |
| Providing direct patient care services | Clinical services stay with the pharmacist |
| Providing drug information to patients, caregivers, and providers | Answering a drug question is counseling |
| Supervision of compounding | Compounding oversight is non-delegable |
| Evaluation and establishment of criteria for drug product and supplier selection | Formulary judgment is a pharmacist act |
| Daily opening and closing of a pharmacy practice site | Ties back to Rule 1140-01-.13(7) |
Structural Support: The Consultation Area
Rule 1140-01-.13(2) requires all new or relocated pharmacies opening after July 1, 1998 to provide "a consultation area which offers sufficient privacy to the patient before a license will be issued," with existing pharmacies compliant on or before January 1, 2000. The facility rule and the counseling rule are designed to be read together: Tennessee builds the private space and then requires the conversation to happen in it.
6. Practical Exam Scenarios
Scenario 1: The Bagged Leaflet
Case: A patient presents for a new prescription for apixaban. The technician staples a manufacturer leaflet to the bag, rings up the sale, and says, "Everything you need to know is in there — the pharmacist is swamped." Legal Analysis: This violates Rule 1140-03-.01(1)(a) and (b). The patient is present, so the pharmacist must personally counsel face-to-face; written materials may supplement but not replace that counseling. It separately violates Rule 1140-02-.01(13)(d) if the technician fields any medication question.
Scenario 2: Delivery to a Homebound Patient
Case: A pharmacy delivers a new prescription for tamsulosin to a homebound patient by courier. No pharmacist speaks to the patient. Legal Analysis: The patient is not present, so face-to-face counseling is impossible — but the duty does not evaporate. Rule 1140-03-.01(1)(a) requires a reasonable effort to counsel through alternative means, typically a documented telephone call. Rule 1140-03-.12(5) separately confirms that nothing prohibits delivery of a prescription to a patient's home or business by an agent of the pharmacy.
Scenario 3: Nursing Home Cart Fill vs. Discharge
Case: A long-term care pharmacy fills a monthly cycle for nursing home residents and, the same afternoon, dispenses a discharge supply of levofloxacin for a resident going home. Legal Analysis: Rule 1140-03-.01(1)(d) exempts the inpatient cart fill from the counseling requirement. The discharge medication is squarely covered by subparagraph (c), which extends counseling to patients when medications are dispensed on discharge from an institutional facility.
A patient is standing at the counter to pick up a new prescription for metformin. Under Tenn. Comp. R. & Regs. 1140-03-.01(1), what does Tennessee require of the pharmacist?
Which patient population is expressly excluded from the counseling requirement of Tenn. Comp. R. & Regs. 1140-03-.01(1)?
A pharmacy's software flags a severe drug-drug interaction between a newly presented order and a drug on the patient's profile. The pharmacist overrides the alert without documenting anything and dispenses. Which Tennessee provision has been violated?
A non-resident mail-order pharmacy licensed in Ohio dispenses maintenance medications to Tennessee residents. Which statement about its counseling and profiling obligations is correct?