What’s New in the Patient Safety World

January 2016



·         FDA Gets Even Tougher on Codeine in Kids

·         Successful E-Prescribing Alerts in Renal Disease

·         Video Recording

·         HAC’s Have Declined Since 2010




FDA Gets Even Tougher on Codeine in Kids



The use of opioids in children, particularly use of codeine after tonsillectomy, has been associated with dangerous outcomes (see our What’s New in the Patient Safety World columns for September 2012 “FDA Warning on Codeine Use in Children Following Tonsillectomy”, March 2013 “Further Warning on Codeine in Children Following Tonsillectomy” and May 2014 “Pediatric Codeine Prescriptions in the ER”). These 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. Those cases led to the FDA issuing a safety alert (FDA 2012) and additional cases led to a subsequent black box warning for products containing codeine (FDA 2013).


But now the FDA is likely to go further and restrict the use of codeine in children under 18 years of age for both analgesic and antitussive purposes and also to remove over-the-counter (OTC) cough/cold formulations that contain codeine.


The FDA briefing document prepared by FDA staff (FDA 2015) for that meeting is 183 pages long and details the extensive background for the case against use of codeine in children under 18 years old. It lists all the prescription preparations with codeine for analgesia and for suppression of cough, including (much to our surprise!) those over-the-counter (OTC) formulations that contain codeine. Though they could not provide population estimates of severe or fatal reactions to cough preparations containing codeine, they were able to provide case report evidence of respiratory depression following use of codeine for cough suppression. For instance they describe a case of a 6-y.o. girl prescribed guaifenesin with codeine for severe cough and respiratory infection who received a total of 3 doses throughout the day and was noted by her mother to be a “little bit blue” after her last dose. The patient was found dead the next morning by her mother and postmortem codeine and morphine blood concentrations were in the toxic range.


Almost all the pediatric patients who received analgesic codeine-containing products received prescriptions for analgesic codeine-acetaminophen combination products in 2014. For cough/cold 52% and 42% of pediatric patients received codeine-guaifenesin and codeine-promethazine combination products, respectively. Primary care practitioners were the top prescribers for both cough/cold and analgesic codeine-containing products. A majority of the retail sales of OTC codeine-containing cough/cold medications, which declined 85% between 2010 and 2014, were for codeine-guaifenesin combinations.


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. The current boxed warning on codeine applies specifically to its use in children after adenotonsillectomy. The FDA staff now asked the advisory panel to address whether that restriction on codeine use should be extended to all children for both analgesic use and antitussive use and also whether it should be removed from OTC preparations.


That advisory committee to the FDA has now recommended that codeine be contraindicated for pain and cough management in children and adolescents (Firth 2015). They have 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.


The FDA is not required to follow the recommendations of its advisory committees, but it usually does, particularly when the vote of an advisory committee is so overwhelming and its own internal staff has suggested such actions.


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. An FDA action as proposed by the advisory committee would be one more “strong” intervention to reduce the risk of codeine-associated respiratory depression and other adverse events.



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






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




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




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




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






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Successful E-Prescribing Alerts in Renal Disease



Last month we noted how alerts for opioids were largely ignored and failed to reduce adverse events related to opioids, at least in the ED setting (see our December 2015 What's New in the Patient Safety World column “Opioid Alert Fatigue”).


In contrast, e-prescribing alerts may be more successful in reducing adverse events in patients with renal disease. So many drugs are eliminated via the kidneys and their dosages or dosing intervals need to be modified in patients with impaired renal function. But busy clinicians often fail to consider “renal” dosing so incorporating into e-prescribing or CPOE systems background assessment of renal function and its impact on specific drugs and alerting clinicians is a logical step. A prior study showed that a real-time computerized decision support system for prescribing drugs in patients with renal insufficiency appeared to result in improved dose and frequency choices (Chertow 2001). More recently Awdishu and colleagues (Awdishu 2015) developed a clinical decision support (CDS) tool that detected scenarios in which drug discontinuation or dosage adjustment for 20 medications was recommended for adult patients with impaired renal function in the ambulatory and acute settings. Their algorithms were applied both when one of these medications was initially prescribed and later if a change in renal function was noted during monitoring if the patient was already on one of these medications. Prescribing orders were appropriately adjusted 17% of the time in those receiving the alerts vs 5.7% of the time in those where the alert was not visible.


Also the prospective alerts (those applied at the time the medication was initially prescribed) were much more likely to be heeded (leading to appropriate adjustment of dose) than those delivered after a patient was already on one of these medications (55.6% vs 10.3%). We’ve noted in multiple previous columns that when an alert is activated for a drug they have already prescribed, physicians seldom stop that drug but they are more likely to heed such alerts at the time of original prescribing.


Actually, the Awdishu study is a good news/bad news one. The bad news is that the overall prescribing at appropriate doses for patients with impaired renal function was quite low. The good news is that such prescribing was at least moderately improved with the clinical decision support tools and alerts.


Another recent study piloted a clinical decision support system (CDSS) for renal risk drugs in a primary care setting (Hellden 2015). The tool used the Cockcroft-Gault formula (ClCG) to estimate renal function (the article discussion discusses use of the ClCG vs. the eGFR). If the EMR identified a patient via the ClCG, a window on the computer screen would pop up with identification color-coded by level of renal function and a list of that patient’s medications that could be impacted by that level of renal dysfunction. Clicking on each listed medication would provide evidence-based short texts and recommendations about possible dose or dosing interval adjustments. The system was piloted with a small group of primary care practitioners and was well-received. Physicians liked its simplicity, speed and possibilities of choice.


Renal dosing of medications is only one aspect of managing patients with chronic kidney disease (CKD). Clinical decision support systems also have the capability to help better manage multiple other aspects of care of the CKD patient. Several years ago recommendations were made for CDSS to support such management in CKD patients (Patwardhan 2009). Such systems could help identify patients as having CKD, stage the CKD, diagnose the primary cause, establish a co-management (PCP and nephrologist) plan, manage comorbid conditions, monitor progression of CKD, help plan for permanent vascular access, and help implementation of a patient education plan including identification of reasons for noncompliance.


We expect use of such clinical decision support systems will become more widespread in the future to help manage patients with CKD.







Chertow GM, Lee J, Kuperman GJ, et al. Guided Medication Dosing for Inpatients With Renal Insufficiency. JAMA 2001; 286(22): 2839-2844




Awdishu L, Coates CR, Lyddane A, et al. The impact of real-time alerting on appropriate prescribing in kidney disease: a cluster randomized controlled trial. JAMIA 2015; First published online: 28 November 2015




Hellden A, Al-Aieshy F, Bastholm-Rahmner P, et al. Development of a computerised decisions support system for renal risk drugs targeting primary healthcare

BMJ Open 2015; 5: e006775 doi:10.1136/bmjopen-2014-006775




Patwardhan MB, Kawamoto K, Lobach D, et al. Recommendations for a Clinical Decision Support for the Management of Individuals with Chronic Kidney Disease. Clin J Am Soc Nephrol. 2009 Feb; 4(2): 273–283







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Video Recording



One underutilized patient safety tool that we have recommended for the past decade – video recording – is finally starting to get attention in the literature. Two recent articles have noted some of the potential benefits of video recording in healthcare settings.


First was an editorial in the British Medical Journal (Makary 2015). Makary and colleagues use the analogy of video recording in the OR to that of the “black boxes” in airplanes. They can be used retrospectively to review what actually happened in cases with unwanted outcomes rather than relying simply on the recollection of all involved. But they also note the potential of the “Hawthorne effect” to lead to improvements. They also note that “if concerns about consent, privacy, and data security are dealt with carefully, video data can tell a story that simply cannot be matched by written documentation.”


Makary has written previously about the benefits of video recording (Makary 2013). He noted that North Shore University Hospital was able to improve hand washing compliance from 6.5% to 81.6% after installing cameras to monitor hand washing (see our March 2012 What's New in the Patient Safety World column “Smile...You’re on Candid Camera!”). He also noted that many procedures are already being recorded, noting that colonoscopy performance measures improved considerably once physicians became aware that someone might review the videos of their procedures. He also describes how reviewing videos of procedures can be used in a “coaching” manner to improve performance, similar to a coach reviewing play with players after an athletic contest. Importantly, as we have often discussed, video recording is also a good way to identify and deal with disruptive behavior and other behaviors that interfere with good teamwork. And he also notes that patients generally like the idea of having their procedures recorded, even receiving a copy of some of these videos.


In a series of letters commenting on his 2013 editorial, issues of legal protection and patient privacy were raised (Kels 2013, van der Veldt 2013). Makary’s reply (Makary 2013b) was that improving patient satisfaction by providing video recording may well reduce the threat of malpractice suits and that the patient privacy issues can be dealt with by informed consent and securing the video as securely as the medical record is secured.


The other recent publication was a controlled trial of video monitoring in the OR with real-time feedback (Overdyk 2015). It demonstrated that compliance with the surgical safety checklist improved significantly in those OR’s receiving real-time feedback. In addition, OR efficiency improved in that mean turnover times for scheduled cases was reduced by 14% in the OR’s receiving real-time feedback. The video streams were audited by a 10-person audit team to identify and time OR milestones to the nearest 20 seconds. Real-time feedback metrics were posted to OR display boards or sent as email or text alerts to the OR team. An example of an alert might be “time out failed”, which allowed surgeons, anesthesia providers and nurse managers to intervene.


The Overdyk study goes way beyond what we had envisioned in the utility of video monitoring. While virtually all of our recommendations involved retrospective review of activities recorded, the Overdyk study demonstrates the potential power of using this modality in real-time. That is really exciting! The Overdyk study does include any data on the costs of the system, which appear to be moderate. However, the improved OR efficiencies and the potential savings from prevention of errors may well cover the cost of such extensive systems.


Overdyk and colleagues also discuss how they were able to overcome the two most common barriers to use of video recording: (1) concerns about legal “discoverability” and (2) patient privacy issues. Their study was also designed to measure team performance rather than individual performance and was done in a non-punitive fashion. The researchers felt this was a significant factor in acceptance of use of the technology by the staff.


The Overdyk study utilized only video feeds and did not include audio recording. For most of the uses for which we have recommended recording the audio portion is at least as important (and often more important) than the video portion.


We’ve, of course, advocated for various uses of video recording over the past decade. Constructive review of recorded OR sessions is a great way to enhance teamwork and communication in the OR. Also, in our September 23, 2008 Patient Safety Tip of the Week “Checklists and Wrong Site Surgery” we advocated use of video recording as a way to improve compliance with Universal Protocol, the WHO Surgical Safety Checklist, and other OR activities.


In our March 17, 2015 Patient Safety Tip of the Week “Distractions in the OR” we noted that video recordings could be used to identify distractions in the OR. And in our November 24, 2015 Patient Safety Tip of the Week “Door Opening and Foot Traffic in the OR” we noted that review of video recordings might also be a useful way to determine the reasons for door opening in the OR in attempt to identify and reduce unnecessary door openings and unnecessary foot traffic.


And video recording is not just for the OR. In our November 2011 What's New in the Patient Safety World column “Restricted Housestaff Work Hours and Patient Handoffs” we noted that recording of handoffs is a potential way to improve the quality of handoffs. We noted in that column that doing video/audio recording is preferable to just audio recording since so much of such interactions involve non-verbal behavior. We’ve already noted how video recording can be used to improve hand hygiene compliance. It could also be used to constructively help housestaff perform bedside procedures.


We concur with Makary et al. that the time has come to make better use of video recording technology. And that study by Overdyk et al. takes this technology tool to a whole new level.



Some of our previous columns discussing video recording:


September 23, 2008 “Checklists and Wrong Site Surgery

December 6, 2010 “More Tips to Prevent Wrong-Site Surgery

November 2011 “Restricted Housestaff Work Hours and Patient Handoffs

March 2012 “Smile...You’re on Candid Camera!

August 27, 2013 “Lessons on Wrong-Site Surgery

March 17, 2015 “Distractions in the OR

November 24, 2015 “Door Opening and Foot Traffic in the OR







Overdyk FJ, Dowling O, Newman S, et al. Remote video auditing with real-time feedback in an academic surgical suite improves safety and efficiency metrics: a cluster randomised study. BMJ Qual Saf 2015; Published Online First 11 December 2015




Makary MA, Xu T, Pawlik TM. Can video recording revolutionise medical quality? BMJ 2015; 351 (Published 21 October 2015)




Makary MA. The power of video recording: taking quality to the next level. JAMA 2013; 309(15): 1591-1592




Kels CG. Video Recording of Medical Procedures. JAMA. 2013; 310(9): 979-980




van der Veldt AAM, Kleijn SA, Nanayakkara PW. Video Recording of Medical Procedures. JAMA. 2013; 310(9): 979-980




Makary M. In reply: video recording of medical procedures. JAMA 2013; 310(9): 979-980






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HAC’s Have Declined Since 2010



In our February 2015 What's New in the Patient Safety World column “17% Fewer HAC’s: Progress or Propaganda?” we discussed the preliminary data from AHRQ which showed that there was a 17% reduction in hospital-acquired conditions (HAC’s) in the previous 3 years, saving 50,000 lives and $12 billion (AHRQ 2014). The improvement was largely attributed to government-sponsored programs. Our “hype radar” immediately went into high gear. However, after assessing the data and some corroborative data from other sources, we conceded this was one instance where our “hype radar” was wrong and that this truly was progress.


AHRQ has now released its interim data for 2010 to 2014 (AHRQ 2015). The measured interim rate for 2014 held steady from 2013 at 121 HACs per 1,000 discharges, down from 145 in 2010. That is a 17% decline in the HAC rate over the four year period. They estimate that nearly 87,000 fewer patients died in the hospital as a result of the reduction in HACs and that approximately $19.8 billion in health care costs were saved from 2010 to 2014. The news was heralded by a press release from HHS (HHS 2015) attributing the improvement to the Accountable Care Act, CMS financial incentive and penalty programs, widespread adoption of electronic medical records, the Partnership for Patients program, and HENS (Hospital Engagement Networks), among others.


Some have noted a “positive spin” in the most recent report since, in reality, HAC’s remained at the same level in 2014 that they were at in 2013. That is after the rather steep decline the previous three years. The good news is that the HAC rate for 2014 did not increase, as it might if the previous “progress” were really just a statistical fluke. But does the plateau mean we’ve hit a barrier? The AHRQ report admits that the HAC rate is still too high and we need to continue to do more to avoid these conditions.


Over the 4-year period the biggest reductions in HAC’s percentage-wise were seen for CLABSI’s (-72%), CAUTI’s (-38%), and post-op venous thromboembolism (-43%). But the greatest financial savings came from reductions in pressure ulcers and adverse drug events ($6.5B of the total $7.8B savings came from just these 2 categories). And of the estimated 36,295 avoided deaths, 22,444 came from reduction in pressure ulcers.


We’re not surprised at the success in reducing CLABSI’s and CAUTI’s given the substantial evidence-based preventive interventions that have now been widely adopted for several years. But we are, frankly, surprised at the magnitude of the reduction (-23%) in pressure ulcers.


So, of course, we would look to see if there is other evidence corroborating this significant improvement in prevention of pressure ulcers. And, in fact, we find it in data accumulated in the PA-PSRS (Pennsylvania Patient Safety Reporting System) database and reported by the PPSA (Pennsylvania Patient Safety Authority). That report (Feil 2015) confirms a substantial reduction in hospital-acquired pressure ulcers from 2011 to 2013. Feil and Bisbee describe the Pennsylvania Hospital Engagement Network (PA-HEN) Pressure Ulcer Prevention (PUP) project that achieved a 62.7% reduction in the incidence rate of stage III and IV hospital-acquired pressure ulcers in Medicare patients. That PPSA report has links to the PUP project site and to the evidence-based pressure ulcer prevention guidelines from multiple quality and patient safety organizations. You’ll find that article to be very useful.







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




AHRQ (Agency for Healthcare Research and Quality). Saving Lives and Saving Money: Hospital-Acquired Conditions Update. Interim Data from National Efforts To Make Care Safer, 2010-2014. AHRQ 2015




HHS (Health and Human Services). National patient safety efforts save 87,000 lives and nearly $20 billion in costs. Press release December 1, 2015




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






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Print “January 2016 FDA Gets Even Tougher on Codeine in Kids

Print “January 2016 Successful E-Prescribing Alerts in Renal Disease

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