What’s New in the Patient Safety World

February 2018

 

 

·       10 Years on the Wrong Medication

·       Oxygen Cylinders Back in the News

·       Global Sensory Impairment and Patient Safety

·       FDA Warning on Cough Meds

 

 

 

10 Years on the Wrong Medication

 

 

We’ve often seen patients on unnecessary medications for long periods. The offending agents we’ve seen most often are PPI’s (proton pump inhibitors) or other drugs used to reduce gastric acid. These are often started while patients are in an ICU when there may be an appropriate indication. However, prophylactic gastric acid reduction is really only indicated while those patients are critically ill and those drugs should be discontinued once the patient is transferred out of the ICU. Unfortunately, medication reconciliation at the time of transfer and at the time of subsequent hospital discharge often fails to uncover that such drugs are no longer necessary. And at follow up, if there has been inadequate communication, the primary care physician may be reluctant to discontinue a medication that had been started during a hospitalization. Hence, we’ve seen patients unnecessarily receiving such medications for several years.

 

But we’ve never seen a case as long as 10 years. Recently, a case study was published in which a patient received the wrong medication for 10 years (Comer 2017)! A 69-year old man with schizophrenia was admitted to a hospital because of violent behavior. Because of poor cognitive function and inability by the patient to provide a good medication history, the pharmacy student on rotation performed an in-depth chart review. The review revealed a transcription error in 2003 deleting amantadine 100 mg twice daily and adding amiodarone 100 mg twice daily, later increased to 200 mg twice daily. A consulted cardiologist discontinued the amiodarone, and the primary care provider was notified via letter and discharge papers but on a subsequent admission four months later it was revealed that the nursing facility restarted the amiodarone. Amiodarone was discontinued and the facility was again notified.

 

This case demonstrates several important points. First, it illustrates how the medical record (either electronic or paper) can propagate medication errors over a long run. Second, it illustrates that medication reconciliation is not infallible (since several opportunities to identify this error failed to do so). Third, it emphasizes the need for regular comprehensive reviews of medication regimens (such as the annual “brown bag” review). And fourth, it emphasizes the need for a communication other than a discharge summary or letter in order to ensure that an incorrect or unnecessary medication is not restarted.

 

 

References:

 

 

Comer R, Lizer M. Medication Review and Transitions of Care: A Case Report of a Decade-Old Medication Error. The Consultant Pharmacist 2017; 32(10): 7-12

http://www.ingentaconnect.com/content/ascp/tcp/2017/00000032/A00410s4/art00002;jsessionid=8qu6pf51b71a.x-ic-live-02

 

 

 

 

 

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Oxygen Cylinders Back in the News

 

 

The UK’s National Health Service (NHS 2018) recently issued a warning on incidents related to improper use of oxygen cylinders. Over a three-year period more than 400 incidents involving oxygen cylinders were reported to the National Reporting and Learning System (NRLS). Six patients died, though the NHS could not state with certainty that the deaths were solely the result of the incidents. Incidents involved portable oxygen cylinders of all sizes on trolleys, wheelchairs, resuscitation trolleys and neonatal resuscitaires, and larger cylinders in hospital  areas without piped (wall mounted) oxygen.

                                                                                                             

While in some cases the cylinders were empty and in others the cylinders were faulty, incorrect operation of the cylinders was a frequent problem. In some cases the cylinders were suspected to be empty upon initial investigation, only to be found full on further review.

 

A significant contributing factor appears to be that there is a difference in initiating oxygen flow between oxygen coming from piped sources vs. cylinders. With piped oxygen systems, oxygen begins flowing as soon as the flowmeter dial is turned. However, with oxygen cylinders several steps are required: (1) remove a plastic cap, (2) turn a valve, and (3) adjust a dial. Often staff apparently just set the flowmeter dial to the desired rate and do not realize that oxygen is not flowing without opening the valve.

 

NHS noted the following insights from local investigations:

 

 

We don’t think the NHS recommendations go far enough. They seem to focus primarily on staff education to prevent the problems. As you know from many of our columns, education and training are relatively weak safety interventions (see our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s” and our Power Point presentation “RCA Strong vs. Weak Responses”). The problem at hand merits a stronger safety intervention. Two of their recommendations were somewhat stronger actions. Regularly practicing use of the oxygen cylinders is stronger than just doing training or annual inservicing. And placing the laminated guides in areas where the cylinders are being used is a somewhat stronger action.

 

But the problem is crying out for redesign of the cylinder system. A strong action would be redesigning to push the user do the correct action. Several design issues were found with the cylinders:

 

Apparently, the valve is required to reduce the risk of fires when the oxygen is not in use. But a redesign would tie opening the valve to show flow on the flowmeter, making the process a one-step rather than two-step process. Redesign would also clearly separate any indicator of flow from the indicator of degree of fullness of the cylinder. We know the green for “full” and red for “empty” are useful when staff need to grab a cylinder during an emergency, but some sort of dual display could indicate something like “cylinder 98% full” and “flow rate is 4 liters/min”. The relationship between the cap and the controls should be reassessed. Perhaps there is even a way to use the cap to convey instructions for use.

 

And, of course, monitoring the patient is a critical piece. All such patients should have pulse oximetry and the patient’s oxygen saturation should be monitored after the oxygen flow is assumed to be turned on. We’ll bet that many of the NHS’s events took place during transports and that there was inadequate monitoring of the patients’ pulse oximetry during those transports.

 

In addition to the improper use of the oxygen cylinders, NHS identified incidents suggesting staff found it difficult to estimate how long a cylinder would last, risking smaller cylinders on high flow rates running out in ward-to-ward transfers, and even larger cylinders on slow flow rates while care home residents are on outings or attending outpatient appointments.

 

As far back as our April 8, 2008 Patient Safety Tip of the Week “Oxygen as a Medication” we noted that some studies showed oxygen ran out in as many as 55% of intrahospital transports and thus was born the “Ticket to Ride” concept. The latter, of course, is a checklist to be used during transports to remind all about not just ensuring adequate oxygen supply but also about many other important considerations during transports (see list of our prior columns on “Ticket to Ride” below).

 

In our September 1, 2015 Patient Safety Tip of the Week “Smarter Checklists” we were describing how we would develop a smart checklist for intrahospital transports. In that we included the following statement: “Conceivably, the amount of oxygen remaining in the oxygen cylinder might be populated in the checklist automatically via Bluetooth or other wireless technology.” That is because oxygen runs out in a substantial number of intrahospital transports (not just the transport but also the stay in the area to which the transport occurred, such as radiology). Because manually checking the gauge on the oxygen canister is often a forgotten step before transporting patients, it would be useful to have a technological tool that flags inadequate oxygen supplies.

 

In our November 2016 What's New in the Patient Safety World column “Oxygen Tank Monitoring” we described use of electronic notification technology to deliver real-time alerts about oxygen cylinder status. But we did have a couple caveats about use of such potential electronic notification technologies. One is that most rely on battery power (or at least battery backup) and batteries may run low (see our February 4, 2014 Patient Safety Tip of the Week “But What If the Battery Runs Low?” for examples of problems that might arise when batteries run low). Another potential problem is that methods of electronic communication (Bluetooth, Wi-Fi, etc.) may not work in all locations. And, most importantly, complacency may become an issue in that staff may presume the oxygen cylinder is full because they have not received a notification that it is not.

 

We’ve noted other issues with oxygen cylinders before. In our August 11, 2015 Patient Safety Tip of the Week “New Oxygen Guidelines: Thoracic Society of Australia and NZ” we noted that one of the items we often check on Patient Safety Walk Rounds is the status of oxygen cylinders wherever they may be stored. You’d be surprised how often we find used (empty or partially empty) oxygen cylinders interspersed with full ones. Obviously, that is a serious patient safety vulnerability since one can readily see how in an emergency someone might grab an empty cylinder thinking it is full of oxygen.

 

In our August 11, 2015 Patient Safety Tip of the Week “New Oxygen Guidelines: Thoracic Society of Australia and NZ” we noted that some hospitals have a Medical Gas Committee that oversees all aspects related to oxygen (and other gas) use. Much like your Pharmacy and Therapeutics Committee this should be a multidisciplinary body with expertise from multiple departments (medical staff, nursing, respiratory therapy, central supply, biomedical engineering, etc.).

 

Now is a good time to review your own vulnerabilities to incidents involving oxygen cylinders. Even if you don’t have a Medical Gas Committee you should at least incorporate assessment of oxygen cylinders into your Patient Safety Walk Rounds (not only assessing cylinders in storage areas but also checking safety issues any time you find an oxygen cylinder with a patient during an intrahospital transport). And for those of you looking for a topic for a FMEA (Failure Mode and Effects Analysis), why not this one?

 

 

 

Some of our prior columns on the “Ticket to Ride” concept:

 

 

Some of our prior columns pertaining to oxygen:

 

April 8, 2008 “Oxygen as a Medication”

January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!”

April 2009 “Nursing Companion to the BTS Oxygen Therapy Guidelines”

October 6, 2009 “Oxygen Safety: More Lessons from the UK”

July 2010 “Cochrane Review: Oxygen in MI”

December 6, 2011 “Why You Need to Beware of Oxygen Therapy”

February 2012 “More Evidence of Harm from Oxygen”

March 2014 “Another Strike Against Hyperoxia”

June 17, 2014 “SO2S Confirms Routine O2 of No Benefit in Stroke”

December 2014 “Oxygen Should Be AVOIDed”

August 11, 2015 “New Oxygen Guidelines: Thoracic Society of Australia and NZ”

November 2016 “Oxygen Tank Monitoring”

November 2016 “More on Safer Use of Oxygen”

October 2017 “End of the Oxygen in MI and Stroke Debate?”

 

 

References:

 

 

NHS Patient Safety Alert. Risk of death and severe harm from failure to obtain and continue flow from oxygen cylinders. Alert reference number: NHS/PSA/W/2018/001; 9 January 2018

https://improvement.nhs.uk/uploads/documents/Patient_Safety_Alert_-_Failure_to_open_oxygen_cylinders.pdf

 

 

 

 

 

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Global Sensory Impairment and Patient Safety

 

 

For years, those of us who are neurologists have recognized the “multiple sensory deficit” syndrome as a major cause of impaired ambulation and falls. Many older patients have impairments of sensory function (such as vision, hearing, vestibular function, and proprioception) that individually are not severe enough to produce disability but collectively have an additive or synergistic effect that does result in disability.

 

Geriatricians have now begun to take a broader look at a related concept, “global sensory impairment” (GSI), and its impact on overall health. Correia and colleagues assessed the 5 classical primary sensations (vision, hearing, touch, taste, and smell) in community-dwelling U.S. adults aged 57 to 85 (Correia 2016). They found that two-thirds of subjects had two or more sensory deficits, 27% had just one, and 6% had none. Seventy-four percent had impairment in taste, 70% in touch, 22% in smell, 20% in corrected vision, and 18% in corrected hearing. Older adults, men, African Americans, and Hispanics had greater multisensory impairment.

 

Many of the same authors then evaluated global sensory impairment (GSI, an integrated measure of sensory dysfunction) as a predictor of physical function, cognition, overall health, and mortality (Pinto 2017). A national probability sample of 3,005 home-dwelling older U.S. adults was assessed at baseline (2005–06) and 5-year follow-up (2010–11) for gait speed, activity, disability, cognition, overall health, and 5-year mortality. A GSI score was calculated based upon assessment of those 5 classical sensory modalities (see the Pinto article for details of the score methodology). At baseline, older adults with worse GSI were slower on the Timed Up and Go test and had more activity of daily living deficits. Five years later, they were still slower, had more disabilities, were less active, had worse cognitive function, were more likely to have poorer overall health and lose weight, and have died.

 

The authors note that GSI predicts many of the components of physical frailty included in three of the major, standard models (e.g., slow gait, weight loss, low activity). We’ve done numerous columns on the health consequences of frailty (see the list below).

 

The authors also note that inclusion of additional clinical measures of sensory function (e.g., near and distance vision, audiometry) may well add to the usefulness of the GSI score. It is likely that the burden of sensory impairments was underestimated, and they felt that better precision in the measures would probably make the results more robust.

 

There are obvious potential clinical implications of these findings. First, the GSI score might serve as a “biomarker” for patients who are vulnerable to health deterioration. But, perhaps more importantly, they point out the need for future studies to determine whether interventions that improve sensory function (eg. eye glasses, hearing aids) can mitigate against that overall deterioration. However, we also need to keep in mind that sometimes there are unintended consequences. For example, several of our prior columns have noted paradoxical increases in falls after certain types of vision correction.

 

 

 

Some of our prior columns on preoperative assessment and frailty:

 

 

Some of our previous columns on falls after correction of vision:

 

June 2010        “Seeing Clearly a Common Sense Intervention”

June 2014        “New Glasses and Fall Risk”

August 2014   “Cataract Surgery and Falls”

 

 

Some of our prior columns related to falls:

 

 

 

References:

 

 

Correia C, Lopez KJ, Wroblewski KE et al. Global sensory impairment in older adults in the United States. J Am Geriatr Soc 2016; 64: 306-313

http://onlinelibrary.wiley.com/doi/10.1111/jgs.13955/full

 

 

Pinto JM, Wroblewski KE, Huisingh-Scheetz M, et al. Global Sensory Impairment Predicts Morbidity and Mortality in Older U.S. Adults. J Am Geriatr Soc 2017; 65: 2587-2595

http://onlinelibrary.wiley.com/doi/10.1111/jgs.15031/full

 

 

 

 

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FDA Warning on Cough Meds

 

 

The FDA (FDA 2018) has announced it is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. The FDA safety announcement includes a list of cough and cold medications containing codeine or hydrocodone.

 

The FDA recommends health care professionals reassure parents that cough due to a cold

or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, it notes that alternative medicines are available, including over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.

 

Our previous 7 columns on the dangers of codeine in children discussed the multiple prior safety alerts from the FDA (FDA 2012, FDA 2013, FDA 2015, FDA 2017). These columns described cases of death and serious adverse effects in children treated with codeine following adenotonsillectomy for obstructive sleep apnea. The problem originally noted for codeine was that there are genetic variations that cause some people to be “ultra-rapid metabolizers” of codeine, which leads to higher concentrations of morphine in the blood earlier.

 

In our January 2016 What's New in the Patient Safety World column “FDA Gets Even Tougher on Codeine in Kids” we noted that an advisory committee to the FDA recommended that codeine be contraindicated for pain and cough management in children and adolescents (Firth 2015). They also recommended restricting codeine's over-the-counter availability for this group. Of 29 voting members, 20 voted to contraindicate use of the drug for pain and cough in children younger than 18 years old. Most of the others voted to restrict its use only in younger children. However, the FDA did not take formal action on those recommendations until now.

 

While the initial warnings focused on avoiding codeine in children who were undergoing adenotonsillectomy for obstructive sleep apnea (OSA), the dangers apply more globally to children. Perhaps influencing the FDA was the American Academy of Pediatrics in a statement “Codeine: Time to Say ‘No’ ” (Tobias 2016) that we discussed in our October 2016 What's New in the Patient Safety World column “Another Codeine Warning for Children”. That paper reiterated the evidence of adverse effects of codeine in children and their mechanisms. It noted that codeine is still available in over-the-counter cough formulas in 28 states and the District of Columbia without a prescription. The Tobias paper also discussed the pros and cons of alternatives to codeine in the pediatric population, noting that almost all of them also have some potential downsides.

 

Our May 2014 What's New in the Patient Safety World column “Pediatric Codeine Prescriptions in the ER” noted the continued frequent prescription of codeine-containing products in children despite the previous warnings about adverse reactions. In our November 2015 What's New in the Patient Safety World column “FDA Safety Communication on Tramadol in Children” we noted that education does not seem to have reduced prescription of codeine-containing products. We therefore advocated incorporating “hard stops” (alerts requiring acknowledgement of the warnings about codeine or other opioid in children) into CPOE and e-prescribing systems.

 

And our May 2017 What's New in the Patient Safety World column “FDA Finally Restricts Codeine in Kids; Tramadol, Too” discussed the FDA (FDA 2017) issuing its strongest warning, a Contraindication, alerting that codeine and tramadol should not be used to treat pain in children younger than 12 years, and codeine should not be used to relieve cough in these children. And it added a new Contraindication to the tramadol label to restrict its use in children younger than 18 years to treat pain after a tonsillectomy and/or adenoidectomy.

 

The newest FDA alert (FDA 2018) pertains to cough and cold medicines containing codeine or hydrocodone and limits the use of these products to adults 18 years and older, effectively recommending against use of these in children of any age.

 

We hope you will all update the clinical decision support systems on your CPOE or e-prescribing systems to include “hard” stops when an attempt is made to order one of the products listed in the current FDA alert. Those of you who prescribe for children should also become familiar with the list of alternatives for cough and colds in children listed in the most recent FDA alert.

 

 

 

Some of our previous columns on opioid safety issues in children:

 

 

References:

 

 

FDA (US Food & Drug Administration). FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. FDA Safety Announcement; January 11, 2018

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM591992.pdf

 

 

FDA (US Food & Drug Administration). FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. FDA Safety Announcement 2017; April 20, 2017

https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

FDA. FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. 8/15/12

http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm

 

 

FDA. FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy. Update February 20, 2013

http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm

 

 

FDA (Food and Drug Administration) Briefing Document: The safety of codeine in children 18 years of age and younger. Joint Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting . December 10, 2015

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM475975.pdf

 

 

Firth S. FDA Panel Urges Stronger Regulation of Codeine. An FDA advisory committee voted 28-0 to remove the drug from its OTC monograph for cough and cold. MedPage Today 2015; December 11, 2015

http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/55159

 

 

Tobias JD, Green TP, Cotι CJ, Section on Anesthesiology and Pain Medicine, Committee on Drugs. Codeine: Time to Say “No”. Pediatrics 2016; Originally published online September 19, 2016

http://pediatrics.aappublications.org/content/early/2016/09/15/peds.2016-2396

 

 

 

 

 

 

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