§483.45(e) Psychotropic Drugs. §483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic
Based on a comprehensive assessment of a resident, the facility must ensure that---
§483.45(e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
§483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
§483.45(e)(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and
§483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident's medical record and indicate the duration for the PRN order. §483.45(e)(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.
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Observations:
Based on record review and staff interview, the facility failed to ensure that a PRN (as-needed) psychotropic medication was limited to 14 days without a documented physician rationale for extension and failed to document the use of non-pharmacological interventions prior to administering a PRN antianxiety medication, for Resident #39.
Findings include:
A review of Resident 39's clinical record revealed that the resident was admitted to the facility on January 30, 2025, with diagnoses that included malignant neoplasm of the bladder (another term for bladder cancer, is a common type of cancer that begins in the cells of the bladder), malnutrition (is the condition that develops when the body is deprived of vitamins, minerals and other nutrients it needs), and anxiety disorder (a mental health conditions that cause excessive fear and worry in response to situations).
A review of Resident 39's physician orders revealed an order dated February 6, 2025, at 11:50 AM, for Ativan (lorazepam a benzodiazepine that work by enhancing the activity of certain neurotransmitters in the brain and used to treat anxiety disorders) oral tablet 0.5 MG, give 0.5 mg by mouth every 8 hours as needed (PRN) for anxiety.
Review of Resident 39's electronic medication administration record (eMAR technology that automates data entry for the administration of medication to patients in healthcare settings and the digital records contain details about the prescribed medication regimen, dosage, timing, and administering staff) dated February 6, 2025, through March 26, 2025, revealed that Lorazepam was administered prior to licensed nursing staff attempting and documenting that non-pharmacological interventions were attempted prior to administering the antianxiety medication.
The following dates and times PRN Ativan was administered with no documentation found in the clinical record indicating that non-pharmacological interventions (such as redirection, reassurance, or other calming techniques) were attempted prior to each administration of the PRN Ativan during this period.
February 9, 2025, at 11:55 PM February 10, 2025, at 12:07 AM February 12, 2025, at 3:55 PM February 13, 2025, at 2:21 PM February 14, 2025, at 7:32 PM February 15, 2025, at 11:56 AM February 15, 2025, at 8:08 PM February 16, 2025, at 11:48 AM February 16, 2025, at 8:13 PM February 17, 2025, at 12:26 AM February 18, 2025, at 9:38 PM February 19, 2025, at 2:56 PM February 20, 2025, at 8:48 AM February 20, 2025, at 5:40 PM February 21, 2025, at 2:07 PM February 22, 2025, at 7:19 AM February 22, 2025, at 5:37 PM February 23, 2025, at 11:00 AM February 23, 2025, at 7:48 PM February 24, 2025, at 1:00 PM February 25, 2025, at 2:22 PM February 25, 2025, at 11:00 PM February 27, 2025, at 8:26 AM February 27, 2025, at 5:35 PM February 28, 2025, at 6:56 PM March 1, 2025, at 1:58 PM March 2, 2025, at 1:23 PM March 3, 2025, at 1:03 PM March 4, 2025, at 8:57 AM March 5, 2025, at 3:54 AM March 5, 2025, at 12:33 PM March 5, 2025, at 8:34 PM March 6, 2025, at 8:47 AM March 6, 2025, at 7:17 PM March 7, 2025, at 8:07 PM March 8, 2025, at 1:19 PM March 8, 2025, at 9:25 PM March 9, 2025, at 9:51 PM March 10, 2025, at 5:55 AM March 11, 2025, at 10:01 AM March 11, 2025, at 5:07 PM March 12, 2025, at 7:10 PM March 13, 2025, at 5:40 AM March 13, 2025, at 1:59 PM March 13, 2025, at 10:00 PM March 15, 2025, at 1:59 PM March 16, 2025, at 10:48 PM March 17, 2025, at 4:51 PM March 18, 2025, at 9:01 AM March 19, 2025, at 1:06 PM Mach 19, 2025, at 9:00 PM March 20, 2025, at 12:29 AM March 20, 2025, at 9:24 PM March 21, 2025, at 6:08 PM March 22, 2025, at 10:29 PM March 24, 2025, at 1:14 AM March 24, 2024, at 1:41 PM March 25, 2025, at 3:49 PM
Record review also showed that the PRN Ativan order dated February 6. 2025 remained active and in use beyond 14 days from its initiation without a documented rationale from the attending physician to justify extending the order Additionally, the facility failed to provide documented evidence that non-pharmacological interventions were attempted prior to administration of the PRN anxiety medication.
Interview with the Director of Nursing (DON) on April 4, 2025, at 2:00 PM confirmed that Resident 39 had a PRN order for Ativan that remained in effect longer than 14 days without the attending physician documenting a rationale for its continued use. The DON could not provide evidence of documentation of any non-pharmacological interventions attempted prior to administering the PRN Ativan for Resident 39's episodes of anxiety. She stated that it was the facility's expectation to utilize and document non-pharmacological approaches (such as diversion or comfort measures) before giving a PRN antianxiety medication and verified that in this case no such documentation was present in the resident's record. The lack of documented physician justification for extending the PRN psychotropic medication order beyond 14 days, combined with the absence of documented alternative interventions before each PRN dose, did not meet the required standard of practice and regulatory requirements for PRN psychotropic medication use.
28 Pa. Code 211.12 (c)(d)(1)(3)(5) Nursing Services
28 Pa. Code 211.9(a) (1) Pharmacy Services
28 Pa. Code 211.2(3) Medical Director
| | Plan of Correction - To be completed: 05/20/2025
1) Resident 39 order updated.
2) To identify other potential areas of concern, DON/designee quality monitored current residents as of 4/1/25 on PRN psychotropic medications for non-pharmacological interventions prior to administration medication. To identify other potential areas of concern, DON/ designee quality monitored current residents as of 4/1/25 on PRN psychotropic medications for 14 day stop dates To identify other potential areas of concern, DON/ designee quality monitored current residents as of 4/1/25 on PRN psychotropic medications for MD notification and documentation for continued usage of PRN psychotropic medication. 3) To prevent this from recurring, DON/designee re-educated licensed nursing staff on non-pharmacological interventions prior to administering PRN psychotropic medication.
To prevent this from recurring, DON/designee re-educated licensed nursing staff on 14 day stop dates for PRN medication.
To prevent this form recurring, DON/ designee re-educated licensed nursing staff on MDS notification and documentation for continued usage of PRN psychotropic medication.
4) To monitor and maintain compliance, DON/designee to quality monitor residents on PRN psychotropic medications have non-pharmacological interventions 5x weekly x 4 weeks then 1x weekly x 4 weeks. Findings will be forwarded to QA Committee for review and recommendations.
To monitor and maintain compliance, DON/designee to quality monitor residents on PRN psychotropic medications have 14 days stop dates 5x weekly x 4 weeks then 1x weekly x 4 weeks. Findings will be forwarded to QA Committee for review and recommendations.
To monitor and maintain compliance, DON/designee to quality monitor residents on PRN psychotropic medications have MDS notification and documentation for continued use 5x weekly x 4 weeks then 1x weekly x 4 weeks. Findings will be forwarded to QA Committee for review and recommendations.
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