13.4 Automated Pharmacy Systems, Quality Assurance & Pharmacy Audits
Key Takeaways
Utah requires a pharmacist to review each prescription or medication order before a drug is removed from an automated system, unless a licensed independent practitioner controls ordering and administration or an urgent delay would harm the patient (R156-17b-620(2)).
A Utah automated pharmacy system must electronically record every event involving its contents, and the pharmacy must keep those records five years (R156-17b-620(5)).
Utah requires automated systems to be filled and stocked by qualified licensed health care personnel under a pharmacist's supervision, with a five-year record of who filled, stocked, and checked each medication.
The PIC must run an ongoing quality assurance program for any automated pharmacy system, evidenced by written policies (R156-17b-603(3)(n)–(o)).
A Utah on-site PBM audit requires 10 days' written notice, may not occur in the first five business days of a month without the pharmacy's consent, and generally covers claims no older than 18 months (Utah Code § 58-17b-622).
13.4 Automated Pharmacy Systems, Quality Assurance & Pharmacy Audits
Automated pharmacy systems
Statute (§ 58-17b-621): automated pharmacy systems may be used in licensed pharmacies, remote locations under the board's jurisdiction, and licensed health care facilities where legally permitted, as DOPL approves with the board and describes by rule.
Operating standards (R156-17b-620)
| Topic | Requirement |
|---|---|
| On-site documentation | Equipment type, serial numbers, contents, location, and policies, including the pharmacy or facility name and address, manufacturer and model, how the device is used, quality assurance procedures, and policies for operation, safety, security, accuracy, confidentiality, access, and malfunction |
| Pharmacist review | Use only where a pharmaceutical care program ensures that a pharmacist reviews every prescription or medication order before dispensing or removal. Exceptions: a licensed independent practitioner controls ordering, preparation, and administration, or an urgent situation in which delay would harm the patient (for example, a sudden change in clinical status). |
| Policies location | Kept in the responsible pharmacy, and at the system's location if it is elsewhere |
| Security | Prevents unauthorized access, complies with law, and protects PHI. Written policies must be in place before installation. |
| Records | Every event involving the contents is recorded electronically. Records are kept five years and must show the system accessed, the person accessing it, the transaction type, drug name, strength, dosage form, quantity, patient, and anything else the PIC requires. |
| Access | Defined by policy. The PIC or a pharmacist designee assigns, changes, and ends user access based on employment status and credentials. |
| Stocking | Filled and stocked by qualified licensed health care personnel under a pharmacist's supervision. A five-year record identifies who filled, stocked, and checked for accuracy. |
| Packaging | Medications in the system are packaged and labeled according to law |
| Controlled substances | All handling meets state and federal law |
| Returns and waste | The system must secure and account for medications removed and returned, and for wasted or discarded medications, under written policies |
The PIC must ensure the system works properly and accurately dispenses the correct strength, dosage form, and quantity, with appropriate records and security, and must run an ongoing quality assurance program, evidenced by written policies (R156-17b-603(3)(n)–(o)). Automated system stock is included in controlled-substance inventories (R156-17b-605).
Quality assurance elsewhere in Utah rules
- Central processing: the P&P manual must include a continuous quality improvement program that objectively monitors and evaluates care, pursues improvements, and resolves problems (R156-17b-614f(2)(e)).
- Hospital tech-check-tech: requires a medication error reporting system with documentation that it is used, plus training and competency records kept during employment and three years after (R156-17b-601(1)(m)).
- Remote dispensing: monthly documented inspections, kept five years (R156-17b-614g(10)).
- Pharmacist identification: each dispensing pharmacist has unique initials or an ID code, recorded and kept five years, so errors can be traced (R156-17b-614a(8)).
- Drug therapy problems: failing to take appropriate steps to resolve problems found in DUR is unprofessional conduct (R156-17b-502(18)).
Utah's pharmacy rules do not set a fixed deadline for investigating a dispensing error. Candidates should know the structural requirements above rather than an invented timeline.
PBM and payer audits (§ 58-17b-622)
Utah limits how payers and pharmacy benefit managers audit pharmacy records. The limits apply to audits under contracts entered, amended, or renewed on or after July 1, 2012. They do not apply to federally funded programs (Medicaid, Medicare Part D, DoD, VA) or to audits based on evidence of fraud.
- An audit involving clinical or professional judgment must be done by, or in consultation with, a licensed pharmacist.
- An on-site audit requires 10 days' advance written notice of the audit and of the prescription number and date ranges. It may not take place during the first five business days of the month unless the pharmacy agrees.
- Claims submitted more than 18 months earlier may not be audited, unless federal law requires it or the originating prescription is dated within the preceding six months. No more than 200 selected claims may be audited per year, except in fraud, waste, or abuse investigations.
- Dispensing fees may not be included in overpayment calculations unless the prescription was a misfill. Funds may not be recouped for clerical or recordkeeping errors (typographical, scrivener's, or computer errors) unless fraud or willful misrepresentation is alleged.
Scenario
A hospital installs automated dispensing cabinets on each unit. Before installation, the PIC must have written policies on access, security, and confidentiality. Nurses may remove medications only after a pharmacist has reviewed the order, except in urgent situations or when a licensed independent practitioner controls the process. Every access and stocking event is logged and kept five years. Technicians who restock must be licensed and work under a pharmacist's supervision.
A hospital wants nurses to remove scheduled medications from automated dispensing cabinets without pharmacist review of the orders. Under R156-17b-620(2), when is removal before pharmacist review permitted?
Whenever the pharmacy is closed overnight
Whenever the nurse has completed ADC training
Only when a licensed independent practitioner controls ordering, preparation, and administration, or in an urgent situation where delay would harm the patient
For any medication not in Schedule II
How long must a Utah pharmacy keep the electronic records of events involving an automated pharmacy system's contents?
Five years
One year
Three years
Two years
Who may fill and stock a Utah automated pharmacy system?
Only the pharmacist-in-charge personally
Qualified licensed health care personnel under a pharmacist's supervision, with a five-year record of who filled, stocked, and checked each medication
Any hospital employee who has a badge for the cabinet
Unlicensed supportive personnel, if a nurse witnesses the stocking
A commercial PBM schedules an on-site audit of a Utah pharmacy for the second business day of the month, with three days' notice, and plans to recoup money for a typographical error on a prescription record. Which statement is correct under Utah Code § 58-17b-622?
The audit is valid because it is limited to 200 claims
Utah law does not regulate PBM audits
The PBM may audit at any time with 24 hours' notice and recoup for any error
The PBM must give 10 days' written notice, may not audit during the first five business days of the month without the pharmacy's consent, and may not recoup for clerical errors absent alleged fraud
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