8.3 Prospective DUR & the I-STOP PMP Registry

Prospective Drug Utilization Review

Before any prescription is dispensed or delivered to a patient (or the patient's authorized representative), 8 NYCRR § 63.6(b)(7) requires the pharmacist or a supervised pharmacy intern to conduct a prospective Drug Utilization Review (DUR). This is a clinical screen — not a paperwork formality — covering:

• Therapeutic duplication
• Drug–drug interactions, including clinically significant interactions with over-the-counter (OTC) products
• Incorrect drug dosage or duration of treatment
• Drug–allergy interactions
• Clinical abuse or misuse

The screen depends on an accurate patient medication profile, which the same regulation requires the pharmacy to maintain: name, address, telephone number, gender, date of birth or age, known allergies and drug reactions, chronic disease states, and a comprehensive medication list. Profiles — like transfer and dispensing records — are retained for five years. Unlike federal OBRA '90, which requires prospective DUR only for Medicaid recipients, New York's Part 63 duty applies to every dispensed prescription, regardless of payer — a frequently tested contrast on the MPJE.

I-STOP and the PMP Registry: Who Must Query

New York's Internet System for Tracking Over-Prescribing (I-STOP) Act, codified at Public Health Law § 3343-a (Article 33), took effect August 27, 2013. Its centerpiece is a real-time Prescription Monitoring Program (PMP) Registry that collects controlled-substance dispensing data from every New York pharmacy. The single most testable distinction about I-STOP is who has a duty to consult the registry and who has only authority to do so:

• Practitioners (prescribers) — mandatory duty. Under § 3343-a(2), every practitioner shall consult the PMP Registry before prescribing or dispensing any Schedule II, III, or IV controlled substance, to review the patient's controlled-substance history. The duty attaches to the prescriber, not to the dispensing pharmacist.
• Pharmacists — permissive authority, not a duty. Under § 3343-a(3), a pharmacist may consult the PMP Registry to review the controlled-substance history of a patient who presents a controlled-substance prescription. The Department of Health and the Board of Pharmacy encourage pharmacists to query before dispensing, but pharmacists are not required to consult the registry. A pharmacist who declines to query has not violated I-STOP, even for a Schedule II opioid.

This practitioner/pharmacist split is a favorite MPJE trap: candidates often assume I-STOP imposes the same mandatory query on both sides of the counter. It does not — the mandate runs to the prescriber; the pharmacist's access is a tool made available by law, not a command.

Access and Designation

To access the PMP Registry, a pharmacist must hold an individual account on the Department of Health's Health Commerce System (HCS) — the credential is personal to the pharmacist, not shared at the pharmacy level. A pharmacist who chooses to query may designate another licensed pharmacist or a licensed pharmacy intern (employed by or under contract with the same pharmacy) to query the registry on their behalf; pharmacy technicians and other unlicensed staff may not be designated, no matter how routine the lookup. (Practitioners have a parallel designee rule under § 3343-a(2)(b), limited to employees of the same professional practice.)

Exceptions to the Practitioner's Mandatory Query Duty

The practitioner's duty to consult the PMP Registry does not apply in several defined circumstances set out in § 3343-a(2)(a). The most testable:

Two structural points about these exceptions: (1) they excuse the practitioner's duty — they do not create or modify any pharmacist duty, because pharmacists have no query duty to begin with; and (2) several are quantity-capped at a 5-day supply (ED prescribing and the combined timely-access/no-designee exception), so a 30-day Schedule III opioid prescription cannot slip through the "timely access" exception. Schedule V is not covered by the practitioner duty at all, because § 3343-a(2) reaches only Schedule II, III, and IV substances.

What the Query Accomplishes at the Counter

Although a PMP query is not mandatory for pharmacists, it is their most powerful voluntary tool for resolving the red flags discussed in § 8.1: multiple prescribers, early refills, and overlapping opioid/benzodiazepine therapy all surface in the patient's PMP history. A query that shows no conflicting fills does not end the pharmacist's professional judgment — it resolves one specific red flag (diversion via multiple sources), not every red flag; an implausible dose still needs prescriber contact. A pharmacist who routinely queries before dispensing controlled substances builds both a stronger corresponding-responsibility record and a better defense if a filled prescription is later questioned.

The 24-Hour BNE Reporting Duty

Separately from the PMP query, every pharmacy that dispenses a Schedule II–V controlled substance must electronically submit the dispensing data to the DOH Bureau of Narcotic Enforcement (BNE) no later than 24 hours after the substance is delivered to the patient. Prescriptions delivered by mail or licensed express-delivery service get an extended window — data must be submitted no later than 72 hours after the substance is shipped from the pharmacy. Errors in submitted data must be corrected within three days of discovery, and it is the dispenser's responsibility — not the state's — to check daily that submissions actually went through, regardless of which submission method or software vendor the pharmacy uses. This BNE feed is what populates the PMP Registry other prescribers and pharmacists query; a pharmacy that reports late or inaccurately degrades the entire system's real-time reliability.

Common MPJE traps

• "I-STOP imposes a mandatory PMP query on pharmacists before dispensing." False — the mandatory query duty runs to practitioners (prescribers) under § 3343-a(2); pharmacists have permissive authority to query under § 3343-a(3) and are encouraged, but not required, to do so.
• "A pharmacy technician can run the PMP query if I'm busy." No — a pharmacist's designees are limited to other licensed pharmacists and licensed pharmacy interns employed by the same pharmacy.
• "Prospective DUR in New York only applies to Medicaid claims." No — unlike federal OBRA '90, New York's Part 63 DUR duty applies to every prescription dispensed, regardless of payer.
• "I have 24 hours to report to BNE no matter how the drug was delivered." Not quite — mail and licensed express-delivery dispensing get a 72-hour reporting window instead of the standard 24 hours.
• "Schedule V requires the same PMP query as Schedule IV." No — the practitioner's mandatory query duty covers only Schedule II, III, and IV; Schedule V is outside it entirely.