Failure to Follow FDA Fentanyl Patch Dosing Guidelines Resulting in Opioid Overdose
Summary
The deficiency involves the facility’s failure to follow FDA Black Box Warnings and manufacturer dosing specifications for a fentanyl transdermal patch in an elderly resident with COPD and multiple comorbidities. The resident, in her late 70s, had diagnoses including dementia, chronic pain, vertebral compression fractures, bipolar disorder, anxiety disorder, COPD, and cerebral infarction. Prior to fentanyl initiation, the resident was receiving hydrocodone-acetaminophen (Norco) 5-325 mg on a scheduled basis, with a regimen that allowed for up to five tablets per day, but the MAR showed multiple instances where doses were refused or held due to sedation. Based on the consultant pharmacist’s review and morphine equivalent (ME) calculations, the resident’s actual opioid exposure at the time fentanyl was started was approximately 20–25 mg ME per day, below the FDA-defined threshold of at least 60 mg oral morphine daily for at least one week to qualify as opioid-tolerant. The record contained no documented justification for switching from Norco to a fentanyl patch or any risk assessment addressing the resident’s advanced age, COPD, and sub-threshold opioid exposure in relation to the FDA Black Box Warning and manufacturer guidance. On 11/26/25, an order was written for a fentanyl (Duragesic) 25 mcg/hr transdermal patch to be applied every 72 hours for chronic pain, and Norco was changed to PRN two days later. The consultant pharmacist later confirmed that, according to the Duragesic dosing guidelines, a 25 mcg/hr starting dose should only be used in patients already receiving at least 60 mg oral morphine equivalents daily for a minimum of seven days, which this resident did not meet. The facility’s own pain management policy stated that pain medications should be selected based on pertinent treatment guidelines, that the lowest possible effective opioid dose should be used with ongoing monitoring, and that combining opioids and benzodiazepines should be avoided or closely monitored for respiratory depression. Despite these standards and the resident’s COPD and geriatric status, the fentanyl patch was initiated without documentation that the resident was opioid-tolerant as defined by the FDA labeling, and without a documented risk assessment. Subsequently, the resident’s fentanyl dose was increased from 25 mcg/hr to 50 mcg/hr on 1/30/26, after a period in late January when the 25 mcg/hr patch had been removed and not replaced for several days due to unavailability. During January, the resident’s PRN Norco use ranged from one to three tablets per day, with nine days of no Norco administration, and pain scores varied from 0 to 9. On 1/29/26, nursing documentation showed the resident was restless and unable to be consoled, leading to a new order for lorazepam 0.5 mg for anxiety, which was administered at 5:20 p.m., following a Norco dose at 4:00 p.m. The next day, the fentanyl patch dose was doubled to 50 mcg/hr. The consultant pharmacist verified that, at the time of this dose increase, the resident was receiving only 5–15 mg of supplementary morphine equivalents per day, far below the 45 mg ME per day that the manufacturer’s titration guidelines associate with a 12.5 mcg/hr increase, and that lorazepam and Norco had been administered shortly before the fentanyl dose escalation, creating a potential for respiratory depression. On 2/1/26, nursing notes documented that the resident began screaming for help and reported, “I can’t breathe, I can’t talk, I can’t swallow.” The nurse applied supplemental oxygen, but the resident’s oxygen saturation dropped to 77%, and her temperature was 100.1°F. The medical director was notified and ordered transfer to the emergency department. ED triage documentation indicated shortness of breath, slow shallow respirations, pinpoint pupils, and a positive response to naloxone administered by EMS, with the fentanyl patch removed by EMS. The ED history and physical described somnolence presumed due to opioid overdose and shortness of breath, and the ED physician’s note characterized the event as an iatrogenic occurrence requiring re-evaluation of the resident’s pain management strategy. The ED diagnoses included accidental or unintentional opiate overdose and hypoxia. Throughout interviews, the consultant pharmacist confirmed that both the initial fentanyl dose and the subsequent dose increase did not meet FDA and manufacturer criteria for opioid tolerance and dose titration, while the medical director stated he believed he had followed fentanyl dosing guidelines but could not identify the cause of the resident’s respiratory distress.
Penalty
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A resident on warfarin for a mechanical heart valve had critically elevated PT/INR values documented, yet nursing staff continued to administer warfarin, including during a period when the drug was ordered to be held. The MAR shows doses given on days when INRs were elevated, with no evidence that the physician was notified before administration. After a critically high INR, the provider ordered vitamin K and daily PT/INR labs for two days, but the ordered labs were not drawn as scheduled, and the next INR was not obtained until after the resident became nonresponsive and stopped eating. The DON later confirmed that the labs were missed and that there was no documentation of timely physician contact regarding the elevated INRs.
A resident with heart failure and stage 3 CKD had a standing midodrine order changed to a PRN order for 10 mg every eight hours based on SBP parameters. After this change, the MAR showed no administrations of midodrine, and there were no documented BP readings in the MAR or vital signs section for this resident. During interview, the DON confirmed that no BPs had been recorded since the PRN order was initiated and could not explain why monitoring was not performed, resulting in a deficiency related to failure to monitor BP for a PRN antihypotensive medication.
Surveyors found that two residents had duplicate PRN medication orders without clear instructions on which route to use first. One resident with severe dementia and constipation had multiple bisacodyl orders (scheduled oral tablets, PRN oral tablets, and a PRN suppository) on the MAR, with no indication of sequencing, while the care plan referenced prune juice and PRN Dulcolax use. Another resident with dementia, a sacral fracture, and chronic pain had both PRN rectal acetaminophen and scheduled oral acetaminophen ordered, again without guidance on which to administer first. The DON stated that the least invasive or oral options should be used first and acknowledged that the rectal PRN orders were likely unnecessary, but they remained active in the residents’ drug regimens.
A resident receiving multiple psychotropic medications, including an antipsychotic and antidepressants for depression and anxiety, did not have required behavior monitoring documented to support the ongoing use and effectiveness of these drugs. The DON in training reported that behavior monitoring should be recorded on the treatment administration record but could not locate any such documentation for this resident. This was inconsistent with the facility’s psychotropic medication policy, which requires monitoring and documentation of the resident’s response to demonstrate that the medications are appropriate and beneficial.
A resident with a diagnosis of constipation and moderately impaired cognition had PRN orders for docusate sodium and Glycolax but went multiple five-day periods without a documented BM, and staff did not administer the ordered PRN bowel medications. Documentation showed the resident was always bowel incontinent and used disposable briefs, and a triggered CAA lacked analysis. A CNA confirmed the resident experienced constipation and that BMs were recorded in the EMR, while a nurse verified the absence of BMs on the noted days and the lack of PRN medication use. An administrative nurse stated nurses were expected to give PRN bowel meds after three or more days without a BM, and no bowel management policy was provided.
A resident with HTN, atrial fibrillation, CAD, HF, and ESRD received Metoprolol Tartrate with hold parameters for SBP and pulse, but staff did not obtain or document BP or pulse before administration as ordered. Interviews with a TMA, LPN, ADON, DON, and consultant nurse confirmed that vital sign monitoring was not being completed prior to giving medications with parameters, despite the physician order requiring it.
Failure to Hold Warfarin and Complete Ordered INR Monitoring
Penalty
Summary
The deficiency involves the facility’s failure to ensure a resident’s anticoagulation drug regimen was free from unnecessary drugs and was adequately monitored. The resident was admitted on warfarin for a mechanical heart valve, with physician orders for 5 mg dosing and ongoing PT/INR monitoring. Laboratory results showed critically elevated PT/INR values, including a PT of 94.9 seconds with an INR of 9.12 and later a PT of 180 seconds with an INR of 17.63. Despite these elevated results, the clinical record shows that warfarin was administered, and there is no evidence that nursing staff consistently contacted the physician for guidance prior to giving the medication when the INR was elevated. Physician orders were in place to hold warfarin pending INR results and later to adjust the dose to 2.5 mg on one day and resume 5 mg daily thereafter, with associated INR monitoring. The Medication Administration Record indicates that nurses initialed administration of 2.5 mg on the ordered day and 5 mg on subsequent days, including days when the INR was documented as 3.38 and 9.12. The record further shows that warfarin 5 mg was documented as administered during a period when the order indicated the medication was on hold. There is no documentation that the physician was notified when the INR values were elevated prior to these administrations. After the INR reached a critically high value of 17.63, the physician ordered vitamin K and daily PT/INR labs for two days; however, the lab results provide no evidence that these ordered labs were drawn on the specified days. The next PT/INR was not completed until a later date, by which time the resident had experienced a change in condition, including being nonresponsive and not eating. Progress notes from an advanced registered nurse practitioner and another practitioner describe the resident as drowsy, less responsive, and exhibiting an overall decline. The DON confirmed in interview that the ordered labs were not drawn on the specified days and that there is no evidence nurses contacted the physician before administering warfarin when the INR was elevated.
Plan Of Correction
Preparation and/or execution of this plan does not constitute admission or agreement by the provider of the truth of the facts alleged or conclusions set forth in the Statement of Deficiencies. This plan of correction is prepared and/or executed solely because it is required (1) What corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice? A. On [R] , resident #1 was discharged from facility to Lawnwood Regional Medical Center. B. As of [R] , there are no residents on [R] . No additional residents were identified as negatively [R] . (2) How you will identify other residents having potential to be affected by the same practice and what corrective actions will be taken; A. On [R] , the Director of Nursing/Designee identified and reviewed current residents receiving [R] . The review included verification of current physician orders, review of [R] INR results and therapeutic ranges, confirmation of timely laboratory draws, and verification of appropriate medication and documentation. At the time of review, there were no residents in the facility receiving [R] , however, all other [R] therapies were reviewed. Any discrepancies identified during the review were immediately corrected, including physician notification and clarification of orders. (2) (3) What measures will be put into place or what systematic changes you will make to ensure A. By [R] , License Nursing staff will have been educated by the Director of Nursing/Designee on the components of F757, including the use of the [R] management protocol, documentation of indication and monitoring, appropriate response to laboratory results, and timely physician notification, with an emphasis on avoidance of unnecessary drugs and compliance with monitoring requirements for [R] .B. Newly hired license nursing staff will receive education by the Director of Nursing/Designee on the components of F757, including the use of the management protocol, documentation standards, critical lab value reporting and escalation processes, and physician communication expectations during orientation as part of the facility's systematic changes.(3) (4) How the corrective action(s) will be monitored to ensure the practice will not recur, ie., what quality assurance program will be put in place:A. The Director of Nursing/designee will conduct [R] monitoring audits weekly for 4 weeks, then biweekly for 4 weeks, and monthly x 1 month. Audits will review appropriate drug use, compliance with laboratory monitoring, timely physician notification, and accuracy of documentation.The findings of these quality monitoring is to be reported to the Quality Assurance/Performance Improvement Committee monthly until the committee determines substantial compliance has been met.
Failure to Monitor BP for PRN Midodrine Order
Penalty
Summary
The facility failed to ensure appropriate monitoring for a PRN blood pressure medication, resulting in a deficiency related to unnecessary drugs for one resident. Resident 5, who had diagnoses including heart failure and stage 3 chronic kidney disease, had an order dated 11/16/25 for midodrine 10 mg three times daily for hypotension, to be held if systolic blood pressure (SBP) was greater than 120; this order was discontinued on 3/23/26. On 3/23/26, a new PRN order was written for midodrine 10 mg every eight hours as needed if SBP was less than 120. The March 2026 MAR showed no administrations of midodrine after the order change on 3/23/26, and the April and May 2026 MARs indicated the medication was never administered. There were no blood pressure readings documented in the MAR or in the vital signs section of the medical record after 3/23/26, and during interview the DON confirmed there were no blood pressures recorded since that date for the PRN midodrine and was unsure why they had not been checked when the new order was initiated. This lack of documented blood pressure monitoring and absence of vital sign entries following the initiation of a PRN midodrine order formed the basis of the cited deficiency under 410 IAC 16.2-3.1-48(a)(6).
Duplicate PRN Medication Orders Without Clear Administration Guidance
Penalty
Summary
The facility failed to ensure residents’ drug regimens were free from unnecessary duplicate medication orders, specifically for constipation and pain management. For one resident with severe dementia and constipation, the care plan directed staff to monitor for constipation and to use prune juice and consider PRN Dulcolax tablets if no bowel movement occurred by the third day. However, the Medication Administration Record (MAR) contained three separate bisacodyl (Dulcolax) orders: a PRN rectal suppository, scheduled oral tablets twice daily, and an additional PRN oral tablet, with no documentation indicating which medication should be administered first. During interview, the DON stated that the least invasive medication was always administered first and explained that prune juice and milk of magnesia had been used before a rectal suppository was given, and that the suppository was likely used because the resident already had scheduled oral bisacodyl tablets. Another resident with dementia, a right sacral fracture, and chronic pain had a care plan directing nurses to assess pain three times daily and as needed, and to monitor for non-verbal signs of pain. The MAR for this resident showed two acetaminophen orders: a PRN rectal suppository and scheduled oral tablets for chronic pain, again without any indication of which route should be used first. In interview, the DON stated that the oral tablet should be administered first and acknowledged that the suppository had not been used during a 90‑day look‑back period and was probably not necessary. The DON also confirmed that the resident had received oral PRN acetaminophen and that a subsequent assessment documented zero pain, indicating the medication was effective, yet the duplicate rectal PRN order remained active without clear guidance on its use.
Lack of Behavior Monitoring for Psychotropic Medications
Penalty
Summary
The facility failed to ensure that a resident’s drug regimen was free from unnecessary drugs by not providing adequate documented behavior monitoring for prescribed psychotropic medications. Physician orders for the resident showed ongoing use of Abilify 5 mg in the evening for depression, trazodone 50 mg at bedtime for depression/anxiety, and vilazodone 10 mg (two tablets) at bedtime for depression. During an interview, the DON in training stated that behavior monitoring is usually documented on the treatment administration record for nursing staff to monitor, but was unable to locate any behavior monitoring documentation related to the resident’s psychotropic medications. The facility’s policy on the use of psychotropic medications requires that such medications be used only when appropriate to treat a resident’s specific diagnoses and documented condition, and that their benefit be demonstrated by monitoring and documentation of the resident’s response, which was not found in this case. This lack of documented behavior monitoring for the resident’s antipsychotic and antidepressant medications resulted in a deficiency related to unnecessary medications, as the facility did not demonstrate through monitoring and documentation that the psychotropic medications were beneficial to the resident as required by its own policy.
Failure to Administer PRN Bowel Medications for Constipation
Penalty
Summary
The deficiency involves the facility’s failure to administer ordered PRN bowel medications for a resident with a diagnosis of constipation. The resident’s EMR documented constipation, and PRN orders were in place for docusate sodium 100 mg by mouth every 12 hours and Glycolax 17 g by mouth every 8 hours, both for constipation. The resident’s MDS assessments showed moderately impaired cognition with a BIMS score of 11 and documented that he was always bowel incontinent, with no constipation noted on one assessment. His care plan, revised in late February, addressed episodes of bowel incontinence and directed staff to use disposable briefs, but did not address constipation management. A CAA for urinary incontinence/indwelling catheter triggered but lacked an analysis of findings. The EMR task documentation showed the resident had no recorded bowel movement for two separate five-day periods in April, yet the April MAR contained no documentation that either PRN bowel medication was administered during those times. A CNA reported that the resident did have periods of constipation and that all bowel movements were documented in the EMR. A nurse confirmed that the resident did not have bowel movements on the identified dates and that staff had not administered PRN bowel medications. An administrative nurse stated that the expectation was for nurses to administer PRN medications when a resident had no bowel movement for three or more days. The facility did not provide a bowel management policy.
Failure to obtain required vital signs before administering Metoprolol
Penalty
Summary
The facility failed to ensure medications were administered in accordance with professional standards of practice for one resident who was reviewed for unnecessary medications. The resident had intact cognition and was independent with ADLs, and had diagnoses including hypertension, atrial fibrillation, coronary artery disease, heart failure, and end stage renal disease. A physician order dated 3/20/2026 directed Metoprolol Tartrate 50 mg by mouth twice daily for ESRD, with instructions to hold the medication if systolic blood pressure was less than 90 or pulse was less than 50. Review of the MAR from 3/20/2026 through 4/22/2026 showed Metoprolol Tartrate was administered as ordered, but there was no documentation that blood pressure or pulse were obtained before administration as required by the order. During interviews, a TMA stated blood pressure and pulse were not being obtained before giving the medication, and an LPN confirmed no vital signs were being obtained that morning related to medication administration. The ADON, LPN, DON, and consultant nurse all acknowledged that vital sign monitoring was not in place or was not being completed prior to administering medications with hold parameters, and the DON stated staff were expected to follow physician orders and obtain vital signs before giving medications with parameters.
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