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What’s New in the Patient Safety World

February 2020


·       NICU: Decolonize the Parents

·       The FDA and Long-Acting Opioids

·       DVT and Behavioral Health

·       The Older Physician: A Practical Approach?




NICU: Decolonize the Parents



Staph aureus has long been a leading cause of nosocomial infections in neonatal intensive care units (NICU’s). Attempts to reduce transmission of Staph aureus from any source would be welcome. Parents of neonates are one of those potential sources. The TREAT PARENTS (Treating Parents to Reduce Neonatal Transmission of Staphylococcus aureus) trial (Milstone 2019) has now demonstrated that treatment of parents colonized with Staph aureus with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an Staph aureus strain concordant with a parental baseline strain. This was a double-blinded randomized clinical trial conducted in 2 NICU’s.


Colonization with parental strains of Staph aureus strain occurred in 14.6% of neonates in the intervention group versus 28.7% in the control group.


Minor adverse events that occurred in treated parents were mostly mild skin irritation or nasal congestion and no major adverse events occurred in treated parents.


The study is considered to be preliminary and should seek replication in other settings. Also, because of low numbers of patients, the study was not able to demonstrate that their findings translate to a reduction in symptomatic Staph aureus infections in the neonates. Nor was it powered enough to show that mortality or NICU length of stay (LOS) were impacted by the intervention. The cost effectiveness was not noted but the cost of the intervention was likely low. Those are good questions for larger, multicenter studies. But, certainly, the results of TREAT PARENTS are encouraging and should lead to further investigation.






Milstone AM, Voskertchian A, Koontz DW, et al. Effect of Treating Parents Colonized with Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial. JAMA 2019; Published online December 30, 2019





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The FDA and Long-Acting Opioids



In multiple columns we have highlighted the dangers of long-acting and/or extended-release opioids (see especially our Patient Safety Tips of the Week for June 28, 2011 “Long-Acting and Extended-Release Opioid Dangers”, July 24, 2012 “FDA and Extended-Release/Long-Acting Opioids” and February 24, 2015 “More Risks with Long-Acting Opioids”, and our February 2017 What's New in the Patient Safety World column “FDA Approves Even More Long-Acting Opioids”).


These long-acting and extended-release opioid formulations are not intended for use as first-line agents in opioid-naοve patients. The newer opiate formulations are either more potent or designed to produce a longer peak action, two characteristics that lead to some of the greatest dangers. These have been designed to be used in patients who are opioid-tolerant and have pain of a chronic nature that has not been controlled with more conventional opiates. They were not intended to be used for treatment of acute pain nor to be used as first line agents in patients with pain. But in practice they are often being (mis)used in that way. And, unfortunately, these preparations became a prime driver of the opioid epidemic in the US.


Recognizing that ER/LA opioids were associated with greater risk of addiction, unintentional overdose and death than their immediate-release counterparts, the FDA in 2012 developed the concept of Risk Evaluation and Mitigation Strategy (REMS) programs. These were intended to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics.


So how did these REMS do? Not so good, according to a new study (Heyward 2019). Heyward et al. reviewed 9739 pages of FDA documents obtained through a Freedom of Information Act request. Their aim was to investigate whether the FDA and ER/LA manufacturers were able to assess the effectiveness of the ER/LA Risk Evaluation and Mitigation Strategy (REMS) program by evaluating manufacturer REMS assessments and FDA oversight of these assessments.


The documents show that the FDA’s REMS program was largely implemented as planned, and that tens of thousands of physicians took CE courses approved through the REMS, and that the courses generally included the content sought by the FDA.


The FDA’s goal was for 60% of ER/LA prescribers to take REMS-adherent continuing education (CE) between 2012 and 2016; Only 27.6% of prescribers had done so by 2016. Nonrepresentative cross-sectional surveys of self-selected prescribers suggested modestly greater ER/LA knowledge among CE completers than noncompleters, and claims-based surveillance indicated slowly declining ER/LA prescribing, although the contribution of the REMS to these trends could not be assessed.


The effectiveness of the REMS program for reducing adverse outcomes also could not be assessed because the analyses used nonrepresentative samples, lacked adequate controls for confounding, and did not link prescribing or clinical outcomes to prescribers’ receipt of CE training. Although the FDA had requested studies tracking adverse outcomes as a function of CE training, the FDA concluded that these studies had not been performed as of the 60-month report in 2017.


The authors conclude that, five years after initiation of the REMS program, the FDA and ER/LA manufacturers could not conclude whether the ER/LA REMS had reduced inappropriate prescribing or improved patient outcomes.


Retired FDA senior executive William Hubbard wrote the editorial accompanying the Heyward study (Hubbard 2019). He notes that actions at the federal level to combat the opioid epidemic have been “underwhelming”. He notes that more effective interventions are available, pointing to Florida’s restriction on prescribing. Florida had become known for its “pill mills”. In banned pain management clinics from dispensing drugs and established requirements for medical examinations and follow-ups before and after prescribing opioids for chronic pain. That resulted in a two-thirds reduction in pain clinics. Johnson et al. (Johnson 2014) described the multiple events that took place in Florida in response to a proliferation of pain clinics and a 61% increase in overdose death from 2003 to 2009. Pain clinic regulations were further expanded later in 2010. In February 2011, law enforcement conducted statewide raids, resulting in numerous arrests, seizures of assets, and pain clinic closures. In July of that year, coinciding with a public health emergency declaration by the Florida Surgeon General, the state legislature prohibited physician dispensing of schedule II or III drugs from their offices and activated regional strike forces to address the emergency. Mandatory dispenser reporting to the newly established prescription drug monitoring program began in September 2011. Finally, in 2012, the legislature expanded regulation of wholesale drug distributors and created the Statewide Task Force on Prescription Drug Abuse and Newborns.


Many states have implemented restrictions on prescriptions for opioids, for example, limiting initial prescriptions of opioids to a specified time period (eg seven days) for treatment of acute pain.


Long-acting and extended-release opioid preparations have clearly played a role in the opioid epidemic that has plagued the US. The crisis has been fed not only by an oversupply of opioids that often gets them into the wrong hands, but also by opioids being prescribed by healthcare professionals. Much of the FDA’s approach has been to focus on abuse-deterrent formulations to discourage abuse (see our February 2017 What's New in the Patient Safety World column “FDA Approves Even More Long-Acting Opioids”).


But our concerns over ER/LA opioid preparations extend well beyond just the issues of abuse, illicit use, and addiction. One significant factor related to the association between long-acting opioids and overdoses is dosage equipotency. The amount of morphine equivalents in these preparations is typically higher than that found in most short-acting formulations and many prescribers are not appreciative of this. Of course, the issue of dose is not unique to the long-acting opioids. We’ve highlighted the same problem with HYDROmorphone in our September 21, 2010 Patient Safety Tip of the Week “Dilaudid Dangers” and the other columns on HYDROmorphone safety issues listed below. It is also problematic that when switching from short-acting opioids to long-acting or extended-release opioids it is very common to see misunderstandings of the relative potencies of the various opiate preparations.


We’ve also seen patients develop delayed-onset coma after attempting suicide. If the specific formulation they took is unknown, they may be evaluated in an ER prior to admission to a behavioral health unit, at which time they lack clinical signs of opioid intoxication and may have very low toxicology levels. They are given “medical clearance” and admitted to the behavioral health unit. Overnight they get further release of the opioid into their bloodstream and the following morning they may be comatose.


Another important issue for these long-acting and extended release opioids is the phenomenon of re-narcotization. The effect of the reversal agent naloxone may wear off long before the effect of the opioid wears off, raising the danger of recurrence of respiratory depression.


We’ve also seen rare cases in which patients on these long-acting opioid formulations have developed acute opioid withdrawal symptoms following naloxone injections.


Note that long-acting opioid formulations (particularly those in transdermal patches) are also now frequent causes of accidental overdoses, including those for whom they were not prescribed such as children and pets (see our September 13, 2011  Patient Safety Tip of the Week “Do You Use Fentanyl Transdermal Patches Safely?” and our May 2012 What’s New in the Patient Safety World column “Another Fentanyl Patch Warning from FDA”).


These are all issues that should be addressed in the ER/LA REMS programs, but not all of them are. We find it particularly bothersome that the Heyward study has shown that, five years after initiation of the REMS program, the FDA and ER/LA manufacturers could not conclude whether the ER/LA REMS had reduced inappropriate prescribing or improved patient outcomes.



Our prior articles pertaining to long-acting and/or extended release preparations of opioids:



Our prior columns on patient safety issues related to Dilaudid/HYDROmorphone:



Some of our other Patient Safety Tips of the Week regarding fentanyl and fentanyl patches:








Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review. JAMA Intern Med 2019; Published online December 30, 2019



Hubbard WK. Getting Serious About Opioid Regulation. JAMA Intern Med 2019; Published online December 30, 2019

(Hubbard 2019)



Johnson H, Paulozzi L, Porucznik C, et al. Decline in Drug Overdose Deaths After State Policy Changes — Florida, 2010–2012. MMWR Morb Mortal Wkly Rep 2014; 63(26): 569-574; Published online July 4, 2014.

(Johnson 2014)






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DVT and Behavioral Health



In our February 6, 2018 Patient Safety Tip of the Week “Adverse Events in Inpatient Psychiatry”  we noted that, although deep venous thrombosis (DVT) is relatively rare on behavioral health units, every year state incident reporting systems receive reports of DVT or even fatal pulmonary embolism in patients on behavioral health units. This most often occurs in patients with severe behavioral health problems that leave them bedridden. We’ve seen DVT in one patient who had laid in bed at home several weeks prior to admission. Therefore, it is essential that every patient admitted to behavioral health units received an assessment for DVT risk factors just as if they had been admitted to a med/surg unit.


But, just as your risk of falling may change during a hospital stay, your risk for DVT may also change due to events that happen during a hospital stay. One of those events on a behavioral health unit is the use of restraints. A recent study (Funayama 2020) found that use of physical restraints was associated with a 6-fold higher risk of DVT. The researchers analyzed medical records of over 1300 psychiatric inpatients and compared a physical restraint group (those who had been subjected to physical restraint while hospitalized) to a non-physical restraint group. The physical restraint group had a higher risk for deep vein thrombosis (OR = 6.0). Even after controlling for potentially confounding factors, physical restraints substantially raised the risk of deep vein thrombosis. The physical restraint group had a higher risk for aspiration pneumonia (OR = 4.1) when compared with the non-physical restraint group.


Immobility, of course, is probably the most important risk factor for DVT and venous thromboembolism. And, patients on behavioral health units are not immune from the comorbidities that may predispose to DVT in the general population.


But there are other risk factors for DVT that occur in the behavioral health population. A recent study from Taiwan (Lin 2019) found that patients with depressive, bipolar, and schizophrenic disorders had a roughly 3-fold higher risk of DVT and 2.5-fold higher risk of pulmonary embolism than the general population. One possible contributing factor may be the use of certain medications. In our October 2010 What's New in the Patient Safety World column “Antipsychotic Drugs and Venous Thrombembolism” we noted a large population-based case-control study (Parker 2010) showed a 32% increased risk for VTE in patients prescribed antipsychotic medications within the past 24 months. The risk was almost double in patients newly prescribed antipsychotics (within the past 3 months) and was higher for atypical antipsychotics and for low rather than high potency drugs. The overall absolute risk, however, was low. The estimated number of excess cases per 10,000 patients was 4 for all ages and 10 for patients aged 65 or older.


Therefore, it is essential that every patient admitted to behavioral health units receive an assessment for DVT risk factors just as if they had been admitted to a med/surg unit. And that risk assessment should be updated when certain events occur during a hospitalization. Perhaps your restraint protocol should include an item reminding you to update that DVT risk assessment. We’re not advocating that you put such patients on pharmacoprophylaxis. Administration of injections of prophylactic agents might even be detrimental to a patient with a mental state that merits restraint use. But that DVT risk assessment should remind you to be on the lookout for signs or symptoms of DVT or pulmonary embolism. It also emphasizes the need for frequent release of restraints, and perhaps active or passive range-of-motion exercises of the limbs. And, of course, any decision about possible use of DVT prophylaxis should also take into account any other medical conditions that might increase the risk of DVT.



Some of our past columns on DVT risk in behavioral health settings:




Some of our past columns on issues related to behavioral health:







Funayama M, Takata T. Psychiatric inpatients subjected to physical restraint have a higher risk of deep vein thrombosis and aspiration pneumonia. General Hospital Psychiatry 2020; 62: 1-5



Parker C, Coupland C, Hippisley-Cox J. Antipsychotic drugs and risk of venous thromboembolism: nested case-control study. BMJ 2010; 341:c4245



Lin C-E, Chung C-H, Chengh L-F, Chen W-C. Increased risk for venous thromboembolism among patients with concurrent depressive, bipolar, and schizophrenic disorders. General Hospital Psychiatry 2019; 61: 34-40






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The Older Physician: A Practical Approach?



No organization or individual wants to be accused of age discrimination. Yet, we have an obligation to our patients to police ourselves and ensure the competency of our clinicians to provide safe and effective care. The reality is that the incidence of both dementia and mild cognitive impairment (MCI) increase substantially after the age of 65. Prevalence rates for mild cognitive impairment and dementia in those ≥65 years old in the general population have been estimated to be up to 20% and 13%, respectively. While we know of no study that looked at such rates in the physician population, there is no reason to suspect that the rates in physicians differ from that of the general population. And the physician population over the age of 65 continues to increase.


In 2 of our previous columns we discussed some approaches to the issue of how to deal with the issue of credentialing and privileging of older physicians (see our Patient Safety Tips of the Week for July 7, 2015 “Medical Staff Risk Issues” and May 28, 2019 “The Older Physician”).


Recently, Yale New Haven Hospital developed a very practical process for dealing with this issue (Cooney 2020). In their process, physicians age 70 and older undergo a screening cognitive test developed by a neuropsychologist. The Cooney paper does not publish the actual test, noting that the test questions remain confidential so that prospective test takers cannot practice for it. But the article describes the general content of the test.


The screening battery used consisted of 16 brief tests including rudimentary information processing (2 tests), visual scanning and psychomotor efficiency (2 tests), processing speed and accuracy under decision load (1 test), concentration and working memory (1 test), visual analysis and reasoning (2 tests), verbal fluency (2 tests), memory (1 visual test and 1 verbal test), “prefrontal” self-regulation (1 test), and executive functioning (3 tests).


A Medical Staff Review Committee (MSRC) consisting of the previous and current chief medical officers of the hospital, a faculty geriatrician, and the neuropsychologist performing the examinations, review the results of this testing and make recommendations to the medical staff’s credentialing committee. Where concerns were raised, the committee reviews the case with the section chief or departmental chair. This review outlines the scope of the clinician’s practice and any concerns that his or her supervisor had about the candidate’s capabilities.


Practitioners with global scores considered within normal limits are allowed to proceed with the regular medical credentialing process. Those individuals are to be rescreened at subsequent recredentialing at 2-year intervals. Practitioners with somewhat lower global scores or who demonstrated relative weakness but not deficits in 1 or 2 abilities proceed with the credentialing process but are scheduled for rescreening in 1 year. Practitioners whose profiles indicate some weaknesses with possible implications for unsafe practices are requested to undergo a comprehensive neuropsychological examination, which involves an in-depth assessment of intellectual, memory, and executive function.


If, at the end of the review, the committee decides that an individual did not have adequate cognitive abilities to practice medicine, the chief medical officer, often with the assistance of another committee member, meets with the clinician to discuss options, including working in a highly structured proctored clinical environment or retirement from clinical practice. These individuals are offered assistance in evaluating medical conditions that may have contributed to their poor examination performance.


The Cooney paper described the results of the new process on a total of 141 clinicians aged 70 years or older. 88.7% were physicians, and the remainder included advanced practice registered nurses, dentists, psychologists, podiatrists, physician associates, and a midwife. 57.4% completed the screening test requirements and proceeded with the regular credentialing process. They were to be retested at 2 years at the time of the regular reappointment cycle. 24.1% proceeded with the credentialing process but were scheduled for rescreening in 1 year because of minor abnormalities on the screening test results. 5% had limitations in domains such as memory, executive function, processing speed, or constructional skills that could impair their capacity to practice medicine. These clinicians were asked to undergo a comprehensive assessment. At the completion of this assessment, 4 of the individuals were determined to be capable of continuing with the recredentialing process. Three clinicians were determined to have significant problems and either retired or resigned from the active medical staff.


Nineteen clinicians (13.4%) were identified as performing substantially less well than their colleagues on the global score of the screening neuropsychological assessment. Twelve of these had such substantial problems on their screening tests that discussions were undertaken with these clinicians to determine how to address these problems. Following those discussions, these clinicians either entered a proctored setting for their practice or retired from medical practice. The other 7 of these 19 clinicians were asked to undergo a full neuropsychological evaluation. At the conclusion of these tests, 4 individuals were allowed to proceed with the recredentialing process and 3 individuals were asked to limit their practice or retire.


After completion of screening and/or full neuropsychological testing, the MSRC determined that 18 clinicians (12.7%) demonstrated cognitive deficits that were likely to impair their ability to practice medicine independently. Of interest, none of these 18 clinicians had previously been brought to the attention of medical staff leadership because of performance problems. These 18 clinicians elected to discontinue their practice or moved into a closely proctored environment. All of these practitioners agreed to make changes in their practice voluntarily.


Two editorials accompanying the Cooney paper (Saver 2020, Armstrong 2020) describe programs utilized at some other organizations and discuss the many challenges in addressing the problem.


Of particular concern, but not surprising to us, was the fact that none of the 18 clinicians in the Yale New Haven experience who had cognitive deficits likely to impair their ability to practice independently had previously been brought to the attention of medical staff leadership because of performance problems. In our two previous columns dealing with the aging physician we described some of the barriers to raising concerns. The physician is often a very well liked and respected physician who has practiced at the hospital and community for many years. But he/she may not be aware of any decline and everyone is afraid to confront him/her about it. Most of his/her patients still love him/her and the board members are his/her friends or have long interacted with him/her in community activities. You may hear whispers amongst staff about their concerns regarding this physician. They all know that sooner or later he/she is going to do something that might result in patient harm. But they are not willing to come forward with specific examples. Medical directors and medical executive committees are often handcuffed when no one is willing to formally come forward with negative information on such physicians. Having a formal process, such as the Yale New Haven one, is one way to bring problems forward without appearing discriminatory toward any one clinician.


We think the process developed at Yale New Haven is both practical and considerate of the individual’s status. It adds an element of objectivity to processes that have often been purely subjective in the past. It can serve as a model to replicate in your organizations.



Our prior columns dealing with the issue of the aging physician:







Cooney L, Balcezak T. Cognitive Testing of Older Clinicians Prior to Recredentialing. JAMA 2020; 323(2): 179-180



Armstrong KA, Reynolds EE. Opportunities and Challenges in Valuing and Evaluating Aging Physicians. JAMA 2020; 323(2): 125-126



Saver JL. Best Practices in Assessing Aging Physicians for Professional Competency. JAMA 2020; 323(2): 127-129





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Print “February 2020 What's New in the Patient Safety World (full column)”

Print “February 2020 NICU: Decolonize the Parents”

Print “February 2020 The FDA and Long-Acting Opioids”

Print “February 2020 DVT and Behavioral Health”

Print “February 2020 The Older Physician: A Practical Approach?”



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