What’s New in the Patient Safety World

April 2015

 

 

·         Pediatric Dosing Unit Recommendations

·         Duodenoscopes and CRE

·         Anesthesia and QTc Prolongation

·         New ACP Guideline on Pressure Ulcer Prevention and Treatment

 

 

 

Pediatric Dosing Unit Recommendations

 

 

The American Academy of Pediatrics has just issued a new Policy Statement on “Metric Units and the Preferred Dosing of Orally Administered Liquid Medications” (AAP 2015). The statement strengthens some previous recommendations and includes many longer-standing recommendations for dosing safety.

 

First and foremost in the new policy statement is switching to sole use of metric dosing, i.e. strictly using milliliters for dosing of orally administered liquid medications in children and infants. Use of measures such as “teaspoon” and “tablespoon” should no longer be used. Moreover, it emphasizes that the correct abbreviation for milliliters is “mL” (rather than “ml”, “ML”, or “cc”).

 

It also emphasizes several important recommendations that ISMP and other leading medication and patient safety organizations have made regarding good prescribing. Zeroes preceding decimals should be used when doses are less than one mL (eg. 0.5 mL) but trailing zeroes should never be used after decimal points. These help avoid 10-fold (or more) dosing errors. The concentration of the liquid medication should also be included on all prescriptions (eg. in mg/mL). Instructions on the prescription and label should also avoid easily misunderstood directions. For example, “daily” should always be used instead of “qd” (see our prior columns “Is Your ‘Do Not Use’ Abbreviations List Adequate?” and “The Impact of Abbreviations on Patient Safety” regarding use of “once daily” instead of “qd”).

 

It also recommends avoiding dosing to the hundredths of a milliliter. We discussed in our September 9, 2008 Patient Safety Tip of the Week “Less is More and Do You Really Need that Decimal?” the issue of how unnecessary digits following decimal points may lead to 10+ or 100+ dosing errors.

 

Dispensing devices are also critical. The statement recommends that pharmacies, hospitals, and healthcare centers distribute appropriate-volume milliliter-based dosing devices such as syringes. Another important point is that the syringe (or other dosing device) should not be significantly larger than the dose prescribed. It also recommends that manufacturers avoid labeling, instructions or dosing devices that contain units other than metric units.

 

Our November 2014 What’s New in the Patient Safety World column “Out-of-Hospital Pediatric Medication Errors” highlighted a study that was likely a major factor in the AAP coming out with the new policy statement. That study last year showed that parents’ measurement and dosing errors are common (Yin 2014). 39.4% of parents made an error in measurement of the intended dose and 41.1% made an error in the prescribed dose. Furthermore, 16.7% used a nonstandard instrument. Compared with parents who used milliliter-only, parents who used teaspoon or tablespoon units had twice the odds of making an error with the intended and prescribed dose. Associations were greater for parents with low health literacy and non–English speakers. Nonstandard instrument use partially mediated teaspoon and tablespoon–associated measurement errors. The authors concluded that their findings support a milliliter-only standard to reduce medication errors.

 

So an important facet of avoiding pediatric medication errors is providing appropriate education to the parents at the time of prescribing (and dispensing). Health literacy and numeracy are factors important in contributing to medication errors (see our prior columns for June 2012 “Parents’ Math Ability Matters”, November 2014 “Out-of-Hospital Pediatric Medication Errors”, and January 13, 2015 “More on Numeracy”). Therefore, the AAP statement includes attention to use of tools and techniques such as teach-back, show-back, dose demonstration, pictures and drawings when educating the parents about the medication.

 

Recommendations for IT vendors and CPOE systems or other medication ordering systems include not only use of metric units but taking steps to prevent ordering of medications not using metric units.

 

 

 

Some of our other columns on pediatric medication errors:

 

November 2007          1000-fold Overdoses by Transposing mg for micrograms

December 2007           1000-fold Heparin Overdoses Back in the News Again

September 9, 2008      Less is More and Do You Really Need that Decimal?

July 2009                     NPSA Review of Patient Safety for Children and Young People

June 28, 2011              Long-Acting and Extended-Release Opioid Dangers

September 13, 2011    Do You Use Fentanyl Transdermal Patches Safely?

September 2011          Dose Rounding in Pediatrics

April 17, 2012             10x Dose Errors in Pediatrics

May 2012                    Another Fentanyl Patch Warning from FDA

June 2012                    Parents’ Math Ability Matters

Septembrer 2012         FDA Warning on Codeine Use in Children Following Tonsillectomy

May 7, 2013                Drug Errors in the Home

May 2014                    Pediatric Codeine Prescriptions in the ER

November 2014          Out-of-Hospital Pediatric Medication Errors

January 13, 2015         More on Numeracy

 

 

 

References:

 

 

AAP (American Academy of Pediatrics). Committee on Drugs. Policy Statement. Metric Units and the Preferred Dosing of Orally Administered Liquid Medications. Pediatrics 2015; 135(4): 784-787; originally published online March 30, 2015

http://pediatrics.aappublications.org/content/early/2015/03/25/peds.2015-0072.full.pdf

 

 

Yin HS, Dreyer BP, Ugboaja DC, et al. Unit of Measurement Used and Parent Medication Dosing Errors. Pediatrics 2014; 134(2): e354-e361; published ahead of print July 14, 2014

http://pediatrics.aappublications.org/content/134/2/e354.abstract?sid=695180bb-684f-492b-9217-53ed71b6eb19

 

 

 

 

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Duodenoscopes and CRE

 

 

There has been considerable media attention recently to the transmission of CRE (carbapenem-resistant Enterobacteriaceae) to patients via contaminated duodenoscopes, resulting in some fatalities (Briggs 2015, Lowes 2015). The problem has now occurred in multiple hospitals in multiple states so one should assume that the risk is likely present anywhere duodenoscopes are used.

 

As a result, new guidelines for appropriate cleaning and reprocessing and validation of sterility have been issued by multiple sources, including the FDA, CDC, ECRI Institute, American Gastroenterological Association, and a device manufacturer.

 

The ECRI Institute recommendations note that they suspect the problem applies to all duodenoscopes, not just those from one manufacturer. Hence it is important to ensure that your processes comply with the manufacturer’s recommendations. But ECRI Institute considers the key step is culturing the duodenoscopes after they have gone through your reprocessing procedures and waiting to release the scopes only after negative cultures are received. They note that those facilities with lesser resources might consider weekly culturing rather than culturing each scope after each reprocessing cycle. We think we will avoid those facilities with “lesser resources”!

 

The new procedures seem to especially focus on the forceps elevator recess. We refer you to the above sites for details. However, we suspect that the guidelines are still evolving and we are likely to hear more down the line.

 

 

References:

 

 

Briggs B, Blankstein A. UCLA Warns Nearly 180 Patients about Dangerous 'Superbug' Exposure. NBC News. February 19, 2015

http://www.nbcnews.com/health/health-news/ucla-warns-nearly-180-patients-about-dangerous-superbug-exposure-n308626

 

 

Lowes R. Infection-Prone Duodenoscopes to Stay on Market, FDA Says. Medscape Medical News March 12, 2015

http://www.medscape.com/viewarticle/841394?src=wnl_edit_tpal&uac=14695HV

 

 

FDA (US Food and  Drug Administration). Center for Devices and Radiological Health. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. FDA March 17, 2015

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf

 

 

CDC (Centers for Disease Control and Prevention). Interim Duodenoscope Surveillance Protocol. Interim Protocol for Healthcare Facilities. Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. CDC March 12, 2015

http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html

 

 

ECRI Institute. High Priority Hazard Report. ECRI Institute Recommends Culturing

Duodenoscopes as a Key Step to Reducing CRE Infections. ECRI Institute 2015; March 3, 2015

https://www.ecri.org/Resources/Superbug/Culturing_Duodenoscopes_Key_Step_to_Reducing_CRE_Infections.pdf

 

 

American Gastroenterological Association (AGA). How to Stop Duodenoscope Infections. March 23, 2015

http://www.gastro.org/news/articles/2015/03/23/how-to-stop-duodenoscope-infections

 

 

Infection Control Today. Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes. Infection Control Today. March 31, 2015

http://www.infectioncontroltoday.com/news/2015/03/olympus-validates-new-reprocessing-instructions-for-model-tjfq180v-duodenoscopes.aspx

 

 

 

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Anesthesia and QTc Prolongation

 

 

In several of our prior columns (see list at the end of today’s column) we’ve discussed the risks of developing ventricular tachycardia and, specifically, Torsade de Pointes in hospitalized patients with prolonged QT intervals. There are a number of reasons why this syndrome is more likely to both occur and result in death in hospitalized patients. Hospitalized patients have a whole host of other factors that may help precipitate malignant arrhythmias in vulnerable patients. They tend to have underlying heart disease, electrolyte abnormalities (eg. hypokalemia, hypomagnesemia, hypocalcemia), renal or hepatic impairment, and bradycardia, all of which may be precipitating factors. More importantly they may have the sorts of conditions for which we prescribe the drugs that are primarily responsible for prolonging the QT interval (eg. haloperidol, antibiotics, antiarrhythmic agents, etc.). And many of those drugs are given intravenously and in high doses in the hospital as compared to the outpatient arena. Rapid intravenous infusion of such drugs may be more likely to precipitate Torsade de Pointes than slow infusion. For a full list of drugs that commonly cause prolongation of the QT interval and may lead to Torsade de Pointes, go to the CredibleMeds™ website. That site also has a list of drugs that prolong the QT interval and might possibly cause Torsade de Pointes and another list of drugs that have conditional risk (eg. only when combined with other drugs).

 

But one factor we have never mentioned is surgery and anesthesia. Many of those hospitalized patients noted above were in the hospital for surgery or had some sort of surgery performed during their hospital stay. Now a new study demonstrates that QTc interval prolongation is actually not uncommon after surgery and anesthesia (Duma). Researchers from that same group (Nagele 2012) had previously shown that postoperative QT-interval prolongation is common and that several perioperatively administered drugs are associated with a substantial QT-interval prolongation. In the new study Duma et al. prospectively looked at 300 patients undergoing a variety of surgical procedures. QTc duration was continuously recorded by 12-lead Holter ECG from 30 minutes preoperatively to up to 60 minutes postoperatively. They found that QTc prolongation is not an isolated postoperative phenomenon and is common during surgery under general and spinal anesthesia but not under local anesthesia. Long QTc episodes (QTc > 500 ms for at least 15 minutes) were over 5 times more frequent with general anesthesia than with spinal anesthesia.

 

In their previous study (Nagele 2012) the researchers had found 80% (345 of 429) of the patients experienced a significant QTc interval prolongation at the end of surgery. In 8% the increase in QTc interval was >60 msec. One patient developed torsades de pointes. Several drugs had a large effect on the change in QTc: isoflurane, methadone, ketorolac, cefoxitin, zosyn, unasyn, epinephrine, ephedrine, and calcium. Postoperative body temperature had a weak negative correlation with the change in QTc and they found no correlation with serum magnesium, potassium, and calcium concentrations.

 

The above studies did not assess the impact of QT-interval prolongation on patient outcomes. At least one previous study, done in heart failure patients undergoing cardiac surgery, found that pre-operative QTc interval prolongation have increased mortality rates (Vrtovec 2006). But we don’t know of any studies looking at the impact of post-operative QTc interval prolongation on patient outcomes.

 

Clearly, a study looking at the impact of post-operative QTc interval prolongation on patient outcomes is in order. However, in the meantime, hospitals should consider use of a clinical decision support tool like that developed at the Mayo Clinic (Haugaa 2013) as described in our April 9, 2013 Patient Safety Tip of the Week “Mayo Clinic System Alerts for QT Interval Prolongation” or that developed by Tisdale et al. (Tisdale 2014) as described in our June 10, 2014 Patient Safety Tip of the Week “Another Clinical Decision Support Tool to Avoid Torsade de Pointes”. While we would not recommend a full post-operative EKG in all patients, most do have some sort of cardiac monitoring post-op that could serve as a source for a QTc interval measurement that could be fed into a clinical decision support system.

 

The Duma and Nagel studies, at a minimum, add yet another potential precipitating factor into the equation and may help identify patients at risk for Torsade de Pointes or other serious arrhythmias.

 

 

 

Some of our prior columns on QT interval prolongation and Torsade de Pointes:

 

  June 29, 2010 “Torsade de Pointes: Are Your Patients At Risk?

  February 5, 2013 “Antidepressants and QT Interval Prolongation

  April 9, 2013 “Mayo Clinic System Alerts for QT Interval Prolongation

  June 10, 2014 “Another Clinical Decision Support Tool to Avoid Torsade de Pointes

 

 

 

References:

 

 

CredibleMeds™ website.

http://www.azcert.org

 

 

Duma A, Pal S, Helsten DL, Stein PK, Nagele P. A High-Fidelity Analysis of Perioperative QTc-Prolongation in General, Spinal, and Local Anesthesia. Abstract 1020. American Society of Anesthesiologists Annual Meeting 2014

http://www.asaabstracts.com/strands/asaabstracts/abstract.htm;jsessionid=43E6159845642E217868B46328CD377D?year=2014&index=4&absnum=3422

 

 

Nagele P, Pal S, Brown F, et al. Postoperative QT interval prolongation in patients undergoing noncardiac surgery under general anesthesia. Anesthesiology 2012; 117(2): 321-328

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3406265/

 

 

Vrtovec B, Yazdanbakhsh AP, Pintar T, et al. QTc Interval Prolongation Predicts Postoperative Mortality in Heart Failure Patients Undergoing Surgical Revascularization. Tex Heart Inst J 2006; 33: 3-8

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1413604/

 

 

Haugaa KH, Bos JM, Tarrell RF, et al. Institution-Wide QT Alert System Identifies Patients With a High Risk of Mortality. Mayo Clin Proc 2013; 88(4): 315-325

http://www.mayoclinicproceedings.org/article/S0025-6196%2813%2900071-2/abstract

 

 

Tisdale JE, Jaynes HA, Kingery J, et al. Effectiveness of a Clinical Decision Support System for Reducing the Risk of QT Interval Prolongation in Hospitalized Patients. Circulation: Cardiovascular Quality and Outcomes 2014; published online before print May 6, 2014

http://circoutcomes.ahajournals.org/content/early/2014/05/06/CIRCOUTCOMES.113.000651.abstract

 

 

 

 

 

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New ACP Guideline on Decubitus Prevention and Treatment

 

 

In our February 2015 What’s New in the Patient Safety World column “17% Fewer HAC’s: Progress or Propaganda?” we concluded that the reduction in hospital-acquired conditions (HACs) documented in an AHRQ study (AHRQ 2014) was likely legitimate. In that AHRQ study preliminary estimates for 2013 show a further 9 percent decline in the rate of hospital-acquired conditions (HACs) from 2012 to 2013, and a 17 percent decline from 2010 to 2013. About 40 percent of this reduction is from ADEs (adverse drug events), about 20 percent is from pressure ulcers, and about 14 percent from catheter-associated urinary tract infections (CAUTI’s).

 

So some progress has taken place in reducing hospital-acquired pressure ulcers. Pressure ulcers were targets that were included in some of the improvement projects in the Partnership for Patients initiatives that worked with the HEN’s (Hospital Engagement Networks) funded through the Affordable Care Act (ACA).

 

Meanwhile, the Pennsylvania Patient Safety Authority notes that hospital-acquired pressure ulcers remain a top concern for hospitals. The PPSA recently reported on hospital-acquired pressure ulcers (HAPU’s) reported through Pennsylvania’s PA-PSRS database over the period 2007 to 2013 (Feil 2015). The total number of reports increased from 2007 through 2009, due in part to addition of some new reporting hospitals and changes in reporting of pressure ulcers not only for the PA-PSRS but also for new CMS requirements. Then total pressure ulcer event reports decreased 10.0% from 2009 to 2013. Between 2012 and 2013 alone, there was a 5.9% decrease.

 

The PPSA notes that hospitals which have implemented evidence-based best practices in pressure ulcer risk assessment and prevention, such as those participating in the Pennsylvania Hospital Engagement Network Pressure Ulcer Prevention project, have reported successful reductions in the incidence of HAPUs stage II or greater. The PPSA study includes links to evidence-based pressure ulcer prevention guidelines.

 

But just how strong is the evidence for pressure ulcer prevention and treatment? The American College of Physicians (ACP) recently released 2 guidelines, one on the comparative effectiveness of risk assessment scales and preventive interventions for pressure ulcers (Qaseem 2015a) and a second on the comparative effectiveness of treatments of pressure ulcers (Qaseem 2015b). Both grade the quality of evidence and strength of recommendations by using ACP's clinical practice guidelines grading system.

 

On the prevention side the following were recommended by ACP:

 

Recommendation 1: ACP recommends that clinicians should perform a risk assessment to identify patients who are at risk of developing pressure ulcers. (Grade: weak recommendation, low-quality evidence)

 

Recommendation 2: ACP recommends that clinicians should choose advanced static mattresses or advanced static overlays in patients who are at an increased risk of developing pressure ulcers. (Grade: strong recommendation, moderate-quality evidence)

 

Recommendation 3: ACP recommends against using alternating-air mattresses or alternating-air overlays in patients who are at an increased risk of developing pressure ulcers. (Grade: weak recommendation, moderate-quality evidence)

 

One the treatment side the following were recommended by ACP:

 

Recommendation 1: ACP recommends that clinicians use protein or amino acid supplementation in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)

 

Recommendation 2: ACP recommends that clinicians use hydrocolloid or foam dressings in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)

 

Recommendation 3: ACP recommends that clinicians use electrical stimulation as adjunctive therapy in patients with pressure ulcers to accelerate wound healing. (Grade: weak recommendation, moderate-quality evidence)

 

Probably the most important take-home message from the two ACP articles and the accompanying editorial (Black 2015) is that the evidence base for pressure ulcer prevention is, in fact, quite weak. In that editorial, Black notes that the 2014 International Clinical Practice Guideline on Prevention and Treatment Pressure Ulcers includes only 77 statements with evidence to support them, whereas the remaining 498 statements are based on expert opinion. She cites the need for more objective scientific research into the issues. Nevertheless, the bedside clinician and other caregivers are left with tools and treatments that may not have the highest levels of evidence and must try to implement them in the best manner while we await those more scientific outcomes studies.

 

Something must be working to see the sort of improvements seen in the AHRQ study and the PPSA study. To see the multiple tools and interventions and their corresponding levels of evidence, we refer you to the two ACP guidelines (Qaseem 2015a, Qaseem 2015b), the 2014 International Clinical Practice Guideline on Prevention and Treatment Pressure Ulcers and the PPSA article (Feil 2015).

 

 

 

References:

 

 

AHRQ. Interim Update on 2013 Annual Hospital-Acquired Condition Rate and Estimates of Cost Savings and Deaths Averted From 2010 to 2013. AHRQ Partnership for Patients 2014

http://www.ahrq.gov/professionals/quality-patient-safety/pfp/interimhacrate2013.pdf

 

 

CMS. Partnership for Patients.

http://partnershipforpatients.cms.gov/

 

 

Feil M, Bisbee J. Hospital-Acquired Pressure Ulcers Remain a Top Concern for Hospitals. Pa Patient Saf Advis 2015; 12(1): 28-36

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2015/mar;12%281%29/Pages/28.aspx

 

 

Qaseem A, Mir TP, Starkey M, Denberg TD for the Clinical Guidelines Committee of the American College of Physicians. Risk Assessment and Prevention of Pressure Ulcers: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med 2015; 162(5): 359-369

http://annals.org/article.aspx?articleid=2173505

 

 

Qaseem A, Humphrey LL, Forciea MA, Starkey M, Denberg TD for the Clinical Guidelines Committee of the American College of Physicians. Treatment of Pressure Ulcers: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med 2015; 162(5): 370-379

http://annals.org/article.aspx?articleid=2173506

 

 

Black J. Pressure Ulcer Prevention and Management: A Dire Need for Good Science (Editorial). Ann Intern Med 2015; 162(5): 387-388

http://annals.org/article.aspx?articleid=2173511

 

 

National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC: National Pressure Ulcer Advisory Panel; 2014

http://www.npuap.org/resources/educational-and-clinical-resources/prevention-and-treatment-of-pressure-ulcers-clinical-practice-guideline/

 

 

 

 

 

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