§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 review of facility policy and clinical records, and staff interview, it was determined that the facility failed to provide a clinical rationale for the continued use of a PRN (as needed) psychotropic (affecting the mind) medication beyond 14-days and failed to provide evidence that non-pharmacological interventions (interventions attempted to calm a resident other than medication) were attempted prior to the administration of a PRN psychotropic medication for four of 22 residents reviewed (Residents R81, R41, R43, and R2).
Findings include:
A facility policy entitled "Psychotropic Medication Use" dated 2/12/24, revealed that "Non-pharmacological approaches are used (unless contraindicated) to minimize the need for medications, permit the lowest possible dose, and allow for discontinuation of medications when possible ....For psychotropic medications that are NOT antipsychotics: If the prescriber or attending physician believes it is appropriate to extend the PRN order beyond 14 days, he or she will document the rationale for extending the use and include the duration of the PRN order."
Resident R81's clinical record revealed an admission date of 1/21/24, with diagnoses that included vitamin D deficiency, major depressive disorder, and pneumonia. A physician's order dated 3/4/24, identified to administer Lorazepam (anti-anxiety) 0.5 milligrams (mg) by mouth every 6 hours as needed for aggression and combativeness, and lacked the required stop date within 14 days or a clinical rationale for continued use beyond 14 days.
Review of the March 2024 and April 2024 medication administration record (MAR) for Resident R81 revealed that the PRN Lorazepam was used on 3/5/24, 3/7/24, 3/8/24, 3/9/24, 3/11/24, 3/12/24, 3/14/24, 3/16/24, 3/17/24, 3/19/24, 3/20/24, 3/22/24, 3/23/24, 3/24/24, 3/25/24, 3/26/24, 4/20/24, 4/23/24, 4/24/24, 4/25/24, 4/26/24, and 4/30/24. Review of the March and April 2024 MARs, and clinical record progress notes revealed that there was no evidence of non-pharmacological interventions attempted prior to the administration of the PRN Lorazepam for the 16 administrations of Lorazepam in March 2024 and six administrations of Lorazepam in April 2024.
Resident R41's clinical record revealed an admission date of 3/29/24, with diagnoses that included anxiety, dysphagia (difficulty swallowing), pain in left shoulder, and muscle weakness. A physician's order dated 3/29/24, identified to administer Lorazepam 0.5 mg by mouth as needed for anxiety, and lacked the required stop date within 14 days or a clinical rationale for continued use beyond 14 days.
Review of the March and April 2024 MARs for Resident R41 revealed that the PRN Lorazepam was used on 3/31/24, 4/5/24, 4/9/24, 4/13/24, 4/23/24, 4/24/24, 4/27/24, 4/29/24, and 4/30/24. Review of the March and April 2024 MARs, and clinical record progress notes revealed that there was no evidence of non-pharmacological interventions attempted prior to the administration of the PRN Lorazepam for the one administration of Lorazepam in March 2024 and three of eight administrations of Lorazepam in April 2024 (4/13/24, 4/23/24, and 4/29/24).
Review of Resident R43's clinical record revealed an admission date of 11/21/17, with diagnoses that included dementia, chronic obstructive pulmonary disease (a disease that obstructs air flow from the lungs), and peripheral vascular disease (a disease where your veins have trouble sending blood from your limbs back to your heart). A physician's order dated 3/26/24 to administer Lorazepam, 0.5 mg by mouth every six hours as needed for anxiety and lacked the required stop date within 14 days or a clinical rationale for continued use beyond 14 days.
Review of Resident R2's clinical record revealed an admission date of 1/12/21, with diagnoses that included dementia, weakness, and anxiety. A physician's order dated 5/1/24, to administer Lorazepam, 0.5 mg by mouth every four hours as needed for anxiety and lacked the required stop date within 14 days or a clinical rationale for continued use beyond 14 days.
During an interview on 5/2/24, at 2:35 p.m. the Assistant Director of Nursing confirmed that all the residents listed above had Lorazepam orders that lacked the required stop date within 14 days or a clinical rationale for continued use beyond 14 days and that R41's and R81's clinical record lacked evidence that non-pharmacological interventions were being attempted prior to administering Lorazepam.
28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
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1. Resident R2, R41, R43, and R81, orders were reviewed for a PRN psychotropic medication, received an order for a stop date placed within 14 days. All current residents who have a physician's order for a PRN psychotropic medication received an order for a stop date placed within 14 days per the regulation. Prior to any psychotropic medication is given, a non-pharmacologic intervention must be attempted and a failed attempt to be documented prior to the use of the physician ordered psychotropic medication. 2. The Director of Nursing and Assistant Director of Nursing educated the professional nursing staff on non-pharmacologic approach prior to the use of physician ordered medication. The professional nursing staff were educated on the regulation of "Stop Dates" being applied to all PRN psychotropic medications. The Assistant Director of Nursing completed an audit of all current in-house residents to identify anyone on PRN psychotropic medication. New orders be reviewed to ensue a stop date or clinical rationale to continue beyond the 14-days 3. The Director of Nursing and/or Assistant Director of Nursing will audit all residents on PRN psychotropics to ensure a non-pharmacological intervention was attempted prior to medication given. The Director of Nursing and/or Assistant Director of Nursing will audit all residents on PRN psychotropics to ensure a 14 day stop date for three (3) times per week for two (2) weeks, then one (1) time per week for two weeks depending on audit outcomes and results. 4. The Psychotropic Audits will be submitted by the Director of Nursing to the QAPI Committee for review and recommendation at the monthly meeting.
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