12.2 Prospective Drug Utilization Review

Why prospective DUR is not optional software

Quick Answer: OBRA ’90 (42 U.S.C. § 1396r-8(g)) requires prospective drug utilization review (DUR) before a Medicaid outpatient fill. CGS § 20-620 implements it in Connecticut: review drugs this pharmacy dispensed to that recipient in the previous 180 days, and screen for therapeutic duplication, drug–disease contraindication, drug–drug interaction, incorrect dose or duration, drug–allergy, clinical abuse or misuse, and other significant clinical issues. CGS § 20-635 is the quality-assurance overlay: a written program to detect, identify, and prevent prescription errors, with immediate patient-and-prescriber notice and a review starting no later than two business days. Counseling’s offer-to-discuss rule is CGS § 20-614 (Chapter 11).

NABP Competency 3.3 (DUR) and the public-health/QA slice of 2.5.1 sit together because a missed interaction is both a clinical screen failure and, if it reaches the patient, a prescription error under § 20-635. Candidates lose items by treating DUR as “whatever the claims switch hard-stop said,” by assuming cash patients have no review duty of any kind, or by inventing a statute that makes the pharmacy file every error with DCP. Open the federal floor, then the Connecticut Medicaid statute, then the QA regulations.

OBRA ’90 — the federal Medicaid floor

Section 4401 of the Omnibus Budget Reconciliation Act of 1990 required each state, as a condition of Medicaid funding, to run a drug-use review program. The pharmacist-facing pieces are:

• A patient record that makes review possible
• Prospective DUR before dispensing
• An offer to counsel the Medicaid patient or caregiver
• A state retrospective DUR board (not a bench task)

The prospective screens in 42 U.S.C. § 1396r-8(g) and 42 CFR Part 456, Subpart K are the list the exam quotes: therapeutic duplication, drug–disease contraindication, drug–drug interaction, incorrect dosage or duration, drug–allergy interactions, and clinical abuse or misuse. Over- and under-utilization show up as dose, duration, and abuse/misuse problems. Appropriateness is the point of the whole screen, not a seventh unlabeled statute.

OBRA is a Medicaid floor. It is not a statement that cash-pay patients may swallow unreviewed warfarin. Connecticut’s statutory prospective-DUR sentence is § 20-620 and is written for individuals eligible under the listed Medicaid sections. CGS § 20-614 already extends the offer to counsel to patients generally (Chapter 11). Corresponding responsibility (section 12.1) and § 20-579(a)(16) negligent work still attach if a pharmacist releases a documented, lethal interaction to a cash patient because “OBRA is Medicaid-only.” Teach the citation correctly: quote § 20-620 on a Medicaid-statute item; do not invent a second DUR statute that Chapter 400j has not published for cash patients.

CGS § 20-620 — 180 days in this pharmacy

CGS § 20-620 is Connecticut’s OBRA implementation for Medicaid recipients. Before or simultaneously with dispensing, the pharmacist must:

• Obtain, record, and maintain pertinent patient information about the recipient
• Review drugs previously dispensed to that individual by that pharmacy during the previous 180 days
• Screen for potential drug-therapy problems due to therapeutic duplication, a contraindication between a drug and a disease, the interaction of one drug with another, incorrect drug dosage or duration, the interaction of a drug and an allergy, clinical abuse or misuse, and any other significant clinical issues relating to appropriate use
• Offer, whenever practicable, to discuss the drugs and counsel on correct usage (in person, with a written-offer exception when the person at the counter is not the patient or the pharmacist determines a written offer is appropriate)

The 180-day lookback is this pharmacy’s fills, not a promise that the statute downloaded every other store’s profile. That is why CPMRS still matters for controlled substances and why a new-to-store Medicaid patient can have a thin local profile. The screen is still mandatory.

Software alerts are a tool. § 20-620 assigns the review to a pharmacist. A technician clicking “override – doctor aware” on every warfarin alert is not prospective DUR. The pharmacist who never looks at the queue is not reviewing.

CGS § 20-635 — quality assurance, not an auto-report to DCP

CGS § 20-635 is captioned prescription error reporting. Read it as three duties, not one.

Definition. A prescription error is an act or omission of clinical significance relating to the dispensing of a drug. Wrong drug, wrong strength, wrong patient, missed contraindication that reached the patient, and a quantity so wrong it is clinically significant all fit. A purely clerical bag-sticker miss that never affected the drug may or may not be “of clinical significance”—when in doubt, treat it as an error and review it.

Consumer-facing reporting. The pharmacy must display an informational statement, in lettering readable at the prescription counter, telling patients they may contact DCP Drug Control if they think an error occurred. UConn’s published signage checklist quotes the required idea: “If you have a concern that an error may have occurred in the dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling 1-800-842-2649.” That is how the public reports. It is not a statute that says the pharmacy must itself file every harm event with DCP.

Internal QA program. § 20-635(d) directs the Commissioner, with the Commission’s advice, to require each pharmacy to implement a written quality-assurance program designed to detect, identify, and prevent prescription errors. The policies must include how to communicate the error to the prescribing practitioner and to the patient (or caregiver or appropriate family member if the patient is deceased or cannot comprehend), including methods of correcting the error or reducing its negative impact. Records of reported errors must be kept ready for inspection for at least three years and produced to the Commissioner within 48 hours when DCP is investigating a report of a prescription error.

RCSA §§ 20-635-1 through 20-635-6 fill in the operations:

• 20-635-2 — implement the program; document and assess errors to find cause and an appropriate system response; use findings to change workflow
• 20-635-3 — unless the prescriber or patient already informed the pharmacy, a pharmacist who discovers or is told of an error shall immediately notify the patient and the prescribing practitioner, and shall communicate how to correct it and reduce harm
• 20-635-4 — a quality-assurance review for each error starts as soon as reasonably possible, no later than two business days from discovery, and the record names reviewers, facts, patient/prescriber contact, findings, and recommended system changes
• 20-635-5 — keep a written copy of the program on the premises; keep review records three years, filed by date, producible within 48 hours even if stored off-site
• 20-635-6 — give each pharmacist a copy of the program; tell all pharmacy personnel to relay a discovered error immediately to a pharmacist on duty; tell staff about system changes that came out of reviews

§ 20-635(e) then protects the QA file: those records need not be disclosed under FOIA (CGS § 1-210(a)) for six months after creation, and they shall not be subject to subpoena or discovery or introduced into evidence in a judicial proceeding except as otherwise specifically provided by law. The QA program is for prevention, not for a plaintiff’s fishing expedition. It is still available to DCP on the 48-hour clock when Drug Control is investigating.

What the statute does not require. Open 20-635 and the six regulations: there is no sentence that says “the pharmacy shall report every harm event to DCP within X hours.” Consumers may call the posted number. DCP may then investigate and demand the QA record. Inventing a 24-hour mandatory board report because another state has one is a wrong answer on the Connecticut MPJE.

Scenario: two alerts, one missed error

A Medicaid patient in Stamford is due for warfarin. The profile, looking back 180 days in this pharmacy, already lists metronidazole from last week and a documented penicillin anaphylaxis. The claims switch fires a warfarin interaction. The pharmacist who documents the INR plan with the prescriber and does not release metronidazole blindly has done § 20-620 prospective DUR. The same afternoon a technician dispenses the penicillin-allergic patient’s amoxicillin. That release is a prescription error. RCSA § 20-635-3 requires immediate notice to the patient and the prescriber, with instructions to stop the amoxicillin and reduce harm. The QA review must start within two business days. Posting the Drug Control number does not replace that notice, and failing to call DCP the same night is not itself a § 20-635 violation—failing to notify the patient, failing to review, and leaving recalled or wrong-drug stock in the bay are.

CT may be stricter; more-restrictive wins.

Official anchors

• 42 U.S.C. § 1396r-8(g) — OBRA ’90 prospective DUR.
• CGS § 20-620 — Medicaid 180-day review and listed screens.
• CGS § 20-635 — prescription-error definition, QA program, three-year records, 48-hour DCP production, six-month FOIA delay.
• RCSA §§ 20-635-1 to 20-635-6 — immediate notice, two-business-day review, on-site program copy, staff relay duty.