Drug Regimen Review (DRR)
A complete F-755 §483.45(c)(1)–(4) Drug Regimen Review policy plus survey-ready documentation tools for skilled nursing facilities. This template covers the monthly pharmacist-conducted drug regimen review for every resident, the identification and reporting of clinically significant medication irregularities to the attending physician and the Director of Nursing, the documented follow-up that closes the loop between the pharmacist's report and the physician's response, and the surveyor-encounter workflow CMS uses during F-755 investigations.
F-755 is the F-tag surveyors cite when the monthly drug regimen review is treated as a checkbox on a calendar instead of a clinically meaningful review of every resident's medication regimen. Under §483.45(c)(1), the facility must ensure that a licensed pharmacist performs a drug regimen review for each resident at least once a month, with additional review after any clinically significant change in the resident's condition or medication regimen. Under §483.45(c)(2), the pharmacist must report any clinically significant irregularities to the attending physician and the Director of Nursing, and under §483.45(c)(3), the attending physician must act on the report. Surveyors test all three legs: did the pharmacist actually perform the review, was the report generated and routed, and did the physician respond. A break at any leg is a citation.
The most common citation patterns surveyors document include: monthly reviews not performed for every resident, reviews not performed in any meaningful clinical depth (signature-only documentation), clinically significant irregularities identified but not routed to the physician or the DON, physician responses missing or delayed beyond facility-defined turnaround, action taken on the physician response not closed back to the next month's review cycle, and pharmacy vendor change-of-service interruptions that produce gaps in monthly reviews with no documented bridging plan. This template gives the consultant pharmacist, the DON, the attending physicians, and the unit nurse manager a single shared paper trail so that the drug regimen review sequence — perform, identify, report, respond, close — survives the F-755 chart review.
CMS guidance (State Operations Manual Appendix PP, F-755) treats the drug regimen review as a substantive clinical obligation, not a documentation obligation. A signature-only review with no documented findings is presumptively inadequate regardless of how regularly it is performed. Surveyors pull the monthly review log, the irregularity reports, the physician responses, the care plan updates that flow from the irregularities, and the medication regimen changes between sequential review months when investigating F-755. Surveyors also interview the consultant pharmacist, the DON, and at least one attending physician during the F-755 investigation to confirm that the reviews are operating as a closed clinical loop rather than as a paper exercise.
This template is intended for use by the consultant pharmacist, the Director of Nursing, the attending physicians, the Staff Development Coordinator, and the unit nurse manager. The DON retains facility accountability for ensuring the review loop closes; the consultant pharmacist retains professional accountability for performing each individual review and for routing reports within facility-defined timeframes; the attending physician retains professional accountability for acting on each report; and the Staff Development Coordinator retains accountability for in-service education on the review process for any new nursing or pharmacy staff. The included surveyor-encounter sheet shall be walked at minimum 30 days before any anticipated survey window.
Purpose
The purpose of this policy is to establish a single, defensible, surveyor-reviewable workflow for monthly Drug Regimen Review under 42 CFR §483.45(c)(1)–(4). It defines the review cycle, the format and content of the monthly review, the routing and turnaround for clinically significant irregularities, the physician response cycle, the care-plan update cycle, and the documentation chain required to demonstrate that the facility meets all three legs of the regulatory requirement — perform, identify, respond — across the entire resident population every month.
Policy
The facility shall ensure that a licensed pharmacist performs a drug regimen review for every resident at least once a month, in accordance with 42 CFR §483.45(c)(1)–(4). The pharmacist shall be a consultant pharmacist under contract with the facility who meets state licensure requirements, who has documented access to each resident's full medical record, and who is not the dispensing pharmacist for the same resident in a way that would create a self-review conflict. Each monthly review shall be conducted at the clinical level required to identify clinically significant medication irregularities as defined at §483.45(c)(2). The pharmacist shall report any identified irregularity to the attending physician and the Director of Nursing within facility-defined timeframes. The attending physician shall respond to each report, and the response shall be documented and folded into the resident's care plan. Any change in pharmacy vendor or interruption in consultant pharmacist coverage shall be documented with a bridging plan that keeps the monthly review cycle current for the duration of any gap.
Scope
This policy applies to all residents admitted to the facility for skilled nursing or long-term care, regardless of payer source, length of stay, or medication regimen complexity. It applies to the consultant pharmacist performing monthly reviews, to the Director of Nursing receiving and acting on pharmacist reports, to all attending physicians and qualified practitioners receiving reports for their assigned residents, to the Staff Development Coordinator orienting new staff to the review process, and to the unit nurse managers supporting the routing and follow-up cycle. It applies during routine monthly cycles, during transitions of care (admission, readmission, post-hospitalization), during episodes of acute clinical change, and during any documented interruption in pharmacy vendor or consultant pharmacist coverage. It does not replace individualized clinical judgment by the attending physician.
Procedure
Monthly review cycle
The consultant pharmacist shall perform a drug regimen review for each resident at least once a month. The review shall be conducted against the resident's complete current medication regimen, including prescription medications, over-the-counter medications, dietary supplements, and topical preparations. The review shall consider each medication's indication, dose, route, frequency, duration, duplication, drug-drug interactions, drug-disease interactions, lab monitoring completeness, and clinical response. The review shall be documented per resident with the date, the pharmacist of record, the medications reviewed, and any findings of clinically significant irregularities.
Identification of clinically significant irregularities
A clinically significant irregularity is any issue that, if not addressed, presents a foreseeable risk of clinically meaningful harm to the resident. Examples include but are not limited to: unnecessary medications persisting beyond the medical justification, dose outside the therapeutic window, duplications not justified clinically, drug-drug interactions not being monitored or mitigated, missing lab monitoring for high-risk medications (anticoagulants, anticonvulsants, hypoglycemics, nephrotoxics), adverse drug reaction patterns, and medications continued past an indication without re-justification. The consultant pharmacist shall document any identified irregularity with sufficient clinical detail that the attending physician and DON can act on the report without reconstruction.
Reporting to physician and DON
The consultant pharmacist shall report any clinically significant irregularity to the attending physician and the Director of Nursing within facility-defined timeframes. Urgent irregularities (foreseeable risk of imminent harm) shall be reported within the same business day. Non-urgent but clinically significant irregularities shall be reported in writing within facility-defined turnaround (commonly 24–72 hours) and shall be acknowledged by the DON. The report shall include the resident identifier, the medications involved, the nature of the irregularity, and the pharmacist's recommended action.
Physician response
The attending physician shall respond to each pharmacist report in writing. Responses shall include one of: a documented action the physician is taking (medication change, lab order, observation order, consultation referral), a documented rationale for not acting (clinical reasoning specific to the resident), or a documented acknowledgment for follow-up at the next appropriate clinical touchpoint. Original handwritten or e-signed responses are acceptable; verbal responses shall be documented by the nurse receiving the verbal order per facility protocol. The physician's response shall be retained in the resident's medical record with the original pharmacist report so that the report-response chain is reproducible from the chart alone.
Care plan integration
Any medication regimen change arising from a pharmacist report and physician response shall be reflected in the resident's care plan within facility-defined turnaround (commonly the next care plan review cycle or sooner when clinically indicated). The care plan entry shall reference the source pharmacist report and physician response to maintain the audit chain. The unit nurse manager and DON are jointly accountable for confirming that the care plan entry has been made.
Operational elements
Bridging plan during vendor changes
Any interruption in consultant pharmacist coverage — pharmacy vendor change, consultant on leave, coverage gap during contract transition — shall be documented with a bridging plan that preserves the monthly review cycle for the duration of the interruption. The bridging plan shall identify the covering consultant pharmacist, define the start and expected end date of the gap, and confirm that no review cycle is missed for any resident. The bridging plan shall be retained in the survey binder.
Quality assurance review
The DON and the consultant pharmacist shall jointly conduct a quarterly quality assurance review covering: review compliance rate per resident (target 100%), turnaround from finding to physician response, care plan currency following physician response, and any documented bridging events. Findings shall be summarized for the QAPI committee and incorporated into the in-service program for nursing and pharmacy staff.
Documentation
Documentation generated under this policy shall include: monthly per-resident drug regimen review notes; pharmacist reports of clinically significant irregularities; physician responses; care-plan updates tied to each response; bridging plans during any coverage gap; the quarterly quality assurance summary; and the policy and procedure document itself. Documentation shall be retained per facility policy (commonly a minimum of one year for monthly reviews and indefinitely for the policy itself) and shall be retrievable within surveyor timeframes. Documentation shall identify the staff member completing the entry and the date and time of completion.
Survey prep checklist
The DON and the consultant pharmacist shall complete a 30-day pre-survey audit covering: monthly review currency for every resident for the trailing 90 days, completeness of irregularity reports, physician response completeness, care-plan currency following physician response, bridging plan documentation for any vendor or coverage gaps, in-service attendance for staff on the DRR process, and corrective action for any identified gap. Audit findings and corrective action documentation shall be retained in the survey binder for the trailing 12 months.
References
Primary regulatory authority: 42 CFR §483.45(c)(1)–(4) — Drug Regimen Review. CMS State Operations Manual, Appendix PP — Guidance to Surveyors for Long Term Care Facilities, F-755. American Society of Consultant Pharmacists (ASCP) guidance on monthly drug regimen review. State-specific regulations on consultant pharmacy services in skilled nursing facilities. Facility pharmacy vendor contract and any addenda covering consultant pharmacy scope.