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What's New in the Patient Safety World?
March 2019
·Another Use for Video Recording
·Newborn Falls
·Does Surgical Gowning Technique Matter?
·Gabapentin and Pregabalin on the Radar Screen
Another Use for Video Recording
In several columns we have discussed the use of video recording as a tool to improve patient safety. Most of our focus has been how reviewing such videotapes can improve teamwork and communication in various healthcare venues, especially the operating room or during handoffs.
Now a new study in the Netherlands (van de Graaf 2019) looked at cases of adults undergoing elective laparoscopic surgery for colorectal cancer and compared technical details of the operations as seen in the video recordings as opposed to those in the normal operative reports. The authors note that certain steps during the surgical procedure are essential but these may not be specifically examined, and might be skipped or inadequately performed. Important steps in laparoscopic colorectal surgery include introduction of trocars under vision, exploration, vascular control, mobilization and resection, creation of anastomosis, and closure. Currently, the only source of information regarding the essential intraoperative surgical steps is represented by the narrative operative report (NR). They therefore postulated that systematic video recording (SVR) might be used to supplement the narrative operative report and better capture these essential steps.
Participating surgeons were asked to systematically capture predefined key steps of the surgical procedure intraoperatively on video in short clips. This method was chosen so that surgeons were committed to consciously start and stop the process of recording these essential steps and the recording of video fragments diminishes the digital storage space necessary, allowing for manageable content (mean duration of case recording was 31 minutes). Intraoperative video clips were recorded according to a surgical checklist under the direction of the primary surgeon and the corresponding steps were marked on the case report form after completion of the procedure. If a step was not relevant in a particular procedure, not applicable or n/a was added next to the step on the the case report form. Cases from their study group were matched with cases from a historical cohort that did not have video recording done.
They found that only 52.5% of the essential technical steps were documented with the traditional narrative operative report compared with 85.1% with the addition of video recording of essential steps.
They also looked at some secondary outcomes. Aside from a significant difference regarding the postoperative length of stay in favor of the study group (8.0 vs 8.6 days), no significant differences were found between the study and historical control groups regarding postoperative and pathologic outcomes.
In an accompanying editorial, Dimick and Scott (Dimick 2019) note that the study only documented the steps that occurred and did not evaluate the quality of those steps (i.e. how well each step was performed). But they did note that prior data from bariatric (Birkmeyer 2013) and pancreatic (Hogg 2016) surgery suggest that surgeon video peer review using a simple Likert scale of technical skill strongly correlates with risk-adjusted outcomes. So such recordings could be used in a peer review process for quality improvement purposes.
We’ve often suggested that organizations videotape their surgical timeouts to assess not only the elements of the timeout but also the “genuineness“ of involvement of the participants. These can be very helpful in facilitating “active” rather than passive participation of all members of the surgical team.
And in several columns we’ve discussed the negative impacts of OR foot traffic and door opening/closing (regarding both distractions and contributing to surgical infections). Video recording is one way to assess how often such door opening/closing occurs and determine the appropriateness of each instance.
Many academic organizations have used video recording of resident-to-resident handoffs as a quality improvement tool. This allows us to critique not just whether the information transmitted was appropriate, but whether the recipeient was allowed to ask questions and get clarification and whether the setting was free from interruptions and distractions.
We’ve often recommended doing video/audio recording in the OR and then play it back for all parties in a constructive fashion so they can see how well (or not so well) they communicated and how distractions or interruptions interfered with their communications. It can help assess how well the team adheres to protocols like the Universal Protocol or surgical timeout procedures or the sponge/instrument “count”. But it could be used to assess interruptions and distractions such as door opening/closing as well. Unfortunately, too many surgeons and hospital attorneys are loathe to use video recording even when it is clearly being done for quality improvement activities and even when the recordings would be destroyed immediately following their use in quality improvement activities. It would probably take very clearcut statutes in every state to protect such recordings from the legal discovery process for us to convince more organizations of the value of video recording.
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”
References:
van de Graaf FW, Lange MM, Spakman JI, et al. Comparison of Systematic Video Documentation With Narrative Operative Report in Colorectal Cancer Surgery. JAMA Surg 2019; Published online January 23, 2019
Dimick JB, Scott JW. A Video Is Worth a Thousand Operative Notes. JAMA Surg 2019; Published online January 23, 2019
Birkmeyer JD, Finks JF, O’Reilly A, et al; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med 2013; 369(15):1434-1442
https://www.nejm.org/doi/10.1056/NEJMsa1300625
Hogg ME, Zenati M, Novak S, et al. Grading of surgeon technical performance predicts postoperative pancreatic fistula for pancreaticoduodenectomy independent of patient-related variables. Ann Surg 2016; 264(3): 482-491
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Newborn Falls
In our July 28, 2015 Patient Safety Tip of the Week “Not All Falls Are the Same” we briefly discussed newborn falls (see below). But a new study has rekindled interest in this topic. Driscoll et al. (Driscoll 2019) reported a cluster of in-hospital neonatal falls associated with a hospital program to improve breastfeeding, which included rooming-in practices. Three fall events occurred within 1 year of commencing improvement efforts as process and outcome metrics associated with breastfeeding improved. All events were associated with mothers falling asleep while feeding their infant, and all occurred between midnight and 6 am. In two of the three cases the mother fell asleep while breastfeeding. In the third, the newborn had just switched from breastfeeding to bottle feeding and the mother fell asleep while burping the baby after feeding. Two of the 3 falls resulted in injuries to the newborns.
Falls occurred from 38.0 to 75.7 hours after birth. No sedating pain medications were administered within 4 hours of any event. In 2 of 3 cases, mothers experienced notable ongoing social stressors. But in all 3 cases maternal fatigue was the most important contributing factor.
Rooming-in was the most significant change involved in health care delivery during the programmatic effort to improve breastfeeding. The authors recommend that monitoring for in-hospital neonatal falls may be needed during projects aimed at improving breastfeeding, particularly if rooming-in practices are involved.
In our July 28, 2015 Patient Safety Tip of the Week “Not All Falls Are the Same” we discussed newborn falls as distinct from most other falls. We had noted that falls on pediatric units are particularly problematic when it comes to categorizing them. Toddlers may have “developmental” falls as they are learning to walk. Older children may have “intentional” falls as they play. One particular type of event that may be labeled a fall is the “baby drop”. This is where a baby is dropped while being carried, held, or transferred from person to person. But distinct from other falls are those on neonatal units, such as an infant rolling off a bed or other piece of furniture. In some fall categorizations all these events would be lumped as “falls”.
In the column we highlighted a Pennsylvania Patient Safety Authority review that found a surprising number of newborn injuries related to falls (PPSA 2014). There were 272 newborn falls reported over roughly a 10-year period and PPSA even suspected this might be an underestimate because parents and family sometimes do not report such falls to staff. They actually categorized 6 types of fall in newborns:
- Family member fell asleep in bed or chair (while holding newborn)
- Newborn slipped out of arms while family member was lying, sitting, or standing
- Newborn rolled out of hospital bed or isolette
- Family member dropped newborn while transferring
- Newborn rolled off family member’s lap
- Unknown
While the numbers at any one hospital are likely to be so low that they would not impact a hospitals overall fall per 1000 patient days rate, they could conceivably impact the falls with injury per 1000 patient days rate because of the high likelihood in injury to the newborn in such falls.
The PPSA review really opened our eyes to a unique population at risk for falls. Combine the unfamiliarity of new parents or relatives with infants and the fatigue or exhaustion from sometimes prolonged labor and it is not surprising that such accidents occur. 58% of the falls occurred between midnight and 7 AM (similar to those in the Driscoll study), with a peak between 5 AM and 6 AM.
And parents, family and friends are not the only ones who might drop an infant. In one incident, a tired nurse dropped an infant (Grossman 2015). The family was told that the nurse was feeding the newborn infant and burping him, and she was drowsy and fell asleep and dropped him. Apparently there was a resultant skull fracture and intracranial bleeding.
The PPSA review provides strategies for reducing the risk of newborn falls. These include staff education, parent and family education, discussion with parents at each shift, rooming-in without bed-sharing, review of maternal medications, hourly rounding with nurses intervening when finding a sleepy mother with a newborn in her arms, protocols for transport of newborns, and environmental assessments. Parents in one facility were also encouraged to call staff before and after newborn feeding so bedrails could be raised or lowered as appropriate.
PPSA also noted a number of maternal characteristics from the literature that were associated with newborn falls, including:
- High level of fatigue
- Breastfeeding or breast/bottle feeding
- Cesarean birth
- Second or third postoperative night
- Pain medication in the last two to four hours
- Age 18 to 28 years
- Prior near miss (e.g., nurses found mother either falling asleep or asleep while holding newborn)
- History of narcotic substance use and/or methadone treatment program
The American Academy of Pediatrics notes that rooming-in (i.e., sharing the same room) without bed-sharing (i.e., sharing the same bed) is most likely to prevent suffocation, strangulation, and entrapments that might occur when the newborn is sleeping in an adult bed (AAP 2016). PPSA also notes other safe infant sleeping recommendations include placing the bassinet close to the parent’s bed for feeding, comforting, and monitoring of their newborn. Newborns may be brought into the bed for feeding or comforting but should be returned to their own bassinet when the parent is ready to return to sleep.
The PPSA website also has a variety of tools and educational materials pertinent to preventing newborn falls, including an excellent form for post-fall huddles after newborn falls.
If your neonatal unit encourages rooming-in, what are you doing to help avoid incidents like those discussed by Driscoll and colleagues?
Some of our prior columns related to falls:
- April 16, 2007 “Falls With Injury”
- July 17, 2007 “Falls in Patients on Coumadin or Heparin or Other Anticoagulants”
- January 1, 2008 “Fall Prevention”
- October 7, 2008 “Lessons from Falls....from Rehab Medicine”
- November 18, 2008 “Ticket to Ride: Checklist, Form, or Decision Scorecard?”
- August 4, 2009 “Faulty Fall Risk Assessments?”
- September 22, 2009 “Psychotropic Drugs and Falls in the SNF”
- December 22, 2009 “Falls on Toileting Activities”
- January 2010 “Falls in the Radiology Suite”
- June 2010 “Seeing Clearly a Common Sense Intervention”
- May 29, 2012 “Falls, Fractures, and Fatalities”
- June 5, 2012 “Minor Head Trauma in the Anticoagulated Patient”.
- January 15, 2013 “Falls on Inpatient Psychiatry”
- March 2013 “Sedative/Hypnotics and Falls”
- December 3, 2013 “Reducing Harm from Falls on Inpatient Psychiatry”
- June 2014 “New Glasses and Fall Risk”
- July 8, 2014 “Update: Minor Head Trauma in the Anticoagulated Patient”
- August 2014 “Cataract Surgery and Falls”
- November 4, 2014 “Progress on Fall Prevention”
- March 2015 “Another Paradox: Falls Due to Walking Aids”
- June 9, 2015 “Add This to Your Fall Risk Assessment”
- July 28, 2015 “Not All Falls Are the Same”
- October 2015 “Patient Perception of Fall Risk”
- October 27, 2015 “Sentinel Event Alert on Falls and View from Across the Pond”
- February 16, 2016 “Fall Prevention Failing?”
- March 14, 2017 “More on Falls on Inpatient Psychiatry”
- July 2017 “Mobility vs. Falls”
- February 2018 “Global Sensory Impairment and Patient Safety”
- February 20, 2018 “Delirium and Falls”
References:
Driscoll CAH, Pereira N, Lichenstein R. In-hospital Neonatal Falls: An Unintended Consequence of Efforts to Improve Breastfeeding. Pediatrics 2019; 143(1): e20182488
Pennsylvania Patient Safety Authority (PPSA). Balancing Family and Newborn Bonding with Patient Safety. Pa Patient Saf Advis 2014; 11(3): 102-108
http://patientsafety.pa.gov/ADVISORIES/Pages/201409_102.aspx
Grossman J. Drowsy Nurse Drops Newborn Baby in Pennsylvania. Huff Post Blog
Posted: 07/06/2015
http://www.huffingtonpost.com/van-winkles/drowsy-nurse-drops-newbor_b_7737062.html
Newborn Fall UOR Debrief Form. PPSA 2014
http://patientsafety.pa.gov/pst/Pages/Newborn%20Injuries/form.aspx
AAP (American Academy of Pediatrics). Task Force on Sudden Infant Death Syndrome.
Policy Statement. SIDS and Other Sleep-Related Infant Deaths: Updated 2016. Recommendations for a Safe Infant Sleeping Environment Pediatrics 2016; 138(5) February 2016
http://pediatrics.aappublications.org/content/138/5/e20162938
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Does Surgical Gowning Technique Matter?
Sterile technique is obviously a key factor in avoiding surgical infections. We go to great lengths to scrub our hands, gown up, glove up and use other equipment (eg. masks, hats, etc.) to minimize the risks of introducing microbial contamination to surgical fields.
But are some of the processes we use for sterility flawed? A recent study (Panas 2019) looked at the process of surgical gowning using the “2-person” technique. In the 2-person technique a surgical assistant or other persn assists a surgeon in the gowning process. The researchers applied an ultraviolet (UV) resin powder to the lower portion of technicians’ gowns to simulate contamination. They then observed the gowns of the surgeons under UV light to assess whether “contamination” had taken place.
Overall, there was a 66.67% rate of contamination of the surgeon’s gown sleeves while being gowned by a surgical technician. But, most interestingly, the degree of contamination varied with the height of the surgeon. Median contamination for the short surgeon was 1.3 cm2, 1.4 cm2 for the medium height surgeon, the overall median contamination was 1.4 cm2, and 2.9 cm2 for the tall surgeon.
Note that the technician’s height did not matter, nor did the experience level of the surgeon.
The authors suggest that the two-person method must be highly monitored or that the single-person gowning technique should be used to reduce contamination rate during the gowning process.
The study only involved 3 surgeons (1 short, 1 tall, and 1 medium height) and 3 technicians and only 27 gowning events were observed, so the generalizability of the findings may be limited. We are also unaware of any statistics comparing surgical infection rates by method of gowning (or by physician height!). But the Panas study is most interesting. A retrospective analysis would likely be difficult because the method of gowning is not likely to have been recorded anywhere. But, particularly if 2-person gowning is the standard practice at a facility, it would be of interest to compare surgical infection rates by surgeon height.
This interesting finding needs further study. But sometimes it’s the small things that matter!
References:
Panas K, Wojcik J, Falcon S, et al. Surgical Gowning Technique. Are We Contaminated Before We Cut? Journal of Orthopaedic Trauma 2019; Publish Ahead of Print January 01, 2019
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Gabapentin and Pregabalin on the Radar Screen
In our November 2017 What's New in the Patient Safety World column “Bad Combination: Gabapentin and Opioids” we highlighted a study (Gomes 2017) which found that among patients receiving prescription opioids, concomitant treatment with gabapentin was associated with a substantial increase in the risk of opioid-related death. We noted that study only looked at use of gabapentin. It did not evaluate those using pregabalin, the precursor of gabapentin that is more widely prescribed for certain types of chronic pain in the US. We suggested this may represent an opportunity of clinical decision support tools (in either CPOE or e-prescribing systems) to alert prescribers when an opioid is being started in a patient who is already receiving gabapentin or vice versa.
Since then, Gomes and colleagues (Gomes 2018) also looked at the combination of pregabalin and opioids. They conducted a population-based, nested case–control study of over 6500 Ontario residents eligible for public drug coverage who received prescription opioids between 1 August 1997 and 31 December 2016. They found that concomitant exposure to pregabalin and opioids was associated with significantly increased odds of opioid-related death compared with exposure to opioids alone (adjusted OR 1.68). High dose of pregabalin (>300 mg/d) was associated with substantially increased odds of opioid-related death relative to no pregabalin exposure (adjusted OR 2.51) and low or moderate dose (≤300 mg/d) was associated with relatively lower, but still significantly increased, odds of opioid-related death (adjusted OR 1.52).
In the accompanying editorial (Throckmorton 2018), FDA officials Douglas Throckmorton and Janet Woodcock note the number of patients receiving gabapentinoids with opioid analgesics or benzodiazepines has increased and more than half of patients concurrently dispensed both a gabapentinoid and an opioid analgesic. They suggest that clinicians who may seek to minimize opioid dosing by co-prescribing alternative medications might thus be inadvertently introducing new risks.
But it’s not just in the Canada and the US that risks associated with pregabalin have garnered attention. A study from Sweden (Abrahamsson 2017) looked at coprescribing in patients taking opioids. They found that pregabalin prescriptions (hazard ratio 2.82) so called “Z-drug” (HR 1.60) were associated with overdose death. And, in the sensitivity analysis, all categories of sedatives, including benzodiazepines, were significantly associated with overdose death in opioid users.
A recent study from Australia (Crossin 2019) found that rates of pregabalin misuse‐related “ambulance attendances” in Victoria increased markedly over the past 6 years (increasing from 0.28 cases per 100 000 population in the first half of 2012 to 3.32 cases per 100 000 in the second half of 2017). The attendance rate correlated strongly with prescription rates in Australia.
Furthermore, 49% were for people with a history that may have contraindicated prescribing pregabalin. Pregabalin was frequently misused with other sedatives (68%), particularly benzodiazepines (37%). 39% were associated with suicide attempts. People who misused pregabalin with other sedatives more frequently presented with moderate to severe impairments of consciousness, but the frequency of suicide attempts was similar whether other sedatives were concurrently used or not.
The authors urge that caution is required when prescribing pregabalin for people taking other sedatives and suggest that limiting the dispensing of this drug may reduce the risks associated with its misuse.
And recent articles from the Australian lay press (Mannix 2018a, Mannix 2018b) raise the question about possible addiction, note it’s being misused by drug users and traded on the black market. Apparently, euphoria as a side effect has led to recreational use of pregabalin. They also note possible links to suicidal ideation.
A 2014 review of pregabalin safety found safety issues were uncommon (Toth 2014). The most commonly noted adverse effects were sedation, dizziness, peripheral edema and dry mouth. It did acknowledge the risk of a withdrawal syndrome abrupt discontinuation. It also mentioned potential for abuse of pregabalin has been described.
But a more recent systematic review of gabapentinoid (pregabalin and gabapentin) abuse (Evoy 2017) found that increasing numbers of patients are self-administering higher than recommended doses to achieve euphoric highs. In the general population, a 1.6% prevalence of gabapentinoid abuse was observed, whereas prevalence ranged from 3% to 68% among opioid abusers. Risk factors for gabapentinoid abuse include a history of substance abuse, particularly opioids, and psychiatric co-morbidities. While effects of excessively high doses are generally non-lethal, gabapentinoids are increasingly being identified in post-mortem toxicology analyses.
Practitioners also need to be aware of possible withdrawal effects when gabapentin or pregabalin are discontinued or reduced. Both gabapentin and pregabalin appear on ISMP’s list of drugs for which there is a credible signal related to withdrawal effects (ISMP 2017). ISMP also noted the only discussion in the prescribing information for pregabalin and gabapentin was a brief mention that anti-epileptic drugs should not be discontinued abruptly due to an increased risk of seizures.
The 2014 safety review of pregabalin (Toth 2014) noted that, when pregabalin discontinuation is planned, a gradual tapering should occur. An abrupt discontinuation of pregabalin has uncommonly been linked to development of a syndrome similar to alcohol or benzodiazepine withdrawal. Such withdrawal symptoms can persist for 1–2 days should gabapentinoids be abruptly discontinued.
Pregabalin has been very helpful in our management of many patients with chronic pain. Most of us have regarded it as a drug with a relatively good safety profile and an alternative to analgesics that have riskier safety profiles. But, as use of pregabalin has skyrocketed, these reports of potential adverse effects and unexpected consequences are appearing.
Pregabalin has been one of the top 10 prescribed drugs in recent years, buoyed by extensive direct-to-consumer advertising (also a top 10 advertised drug). Spending on advertising for pregabalin was $20 million per month until the spending was reduced to $3.8 million in anticipation of expiration of its patent at the end of 2018 (Bulik 2018).
Prescribers need to be aware that concomitant use of pregabalin and opioids or sedating agents may be dangerous. We need to use our CPOE and e-prescribing systems to alert prescribers when such combinations are in play.
References:
Gomes T, Juurlink DN, Antoniou T, et al. Gabapentin, opioids, and the risk of opioid-related death: A population-based nested case–control study. PLOS Medicine 2017; Published: October 3, 2017
http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002396
Gomes T, Greaves S, van den Brink W, et al. Pregabalin and the Risk for Opioid-Related Death: A Nested Case–Control Study. Ann Intern Med 2018; 21 August 2018
Throckmorton DC, Woodcock J. Combined Gabapentinoid and Opioid Use: The Consequences of Shifting Prescribing Trends. Ann Intern Med 2018; 21 August 2018
Abrahamsson T, Berge J, Öjehagen A, Håkansson A. Benzodiazepine, z-drug and pregabalin prescriptions and mortality among patients in opioid maintenance treatment—A nation-wide register-based open cohort study. Drug and Alcohol Dependence 2017; 174(1): 58-64
https://www.sciencedirect.com/science/article/pii/S0376871617300856
Crossin R, Scott D, Arunogiri S, et al. Pregabalin misuse‐related ambulance attendances in Victoria, 2012–2017: characteristics of patients and attendances. Med J Aust 2019; 210 (2): 75-79
Mannix L, Dow A. Popular pain drug linked to rise in overdoses, suicides. The Sydney Morning Herald (Australia) 2018; 26 November 2018
Mannix L. This popular drug is linked to addiction and suicide. Why do doctors keep prescribing it? The Age (Australia) 2018; 18 December 2018
Toth C. Pregabalin: latest safety evidence and clinical implications for the management of neuropathic pain. Ther Adv Drug Saf 2014; 5(1): 38-56.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110876/
Evoy KE, Morrison MD, Saklad SR. Abuse and misuse of pregabalin and gabapentin. Drugs 2017; 77: 403-426
https://link.springer.com/article/10.1007%2Fs40265-017-0700-x
ISMP (Institute for Safe Medication Practices). QuarterWatch™ (2016 Annual Report) Part I: Consumers at Risk from Drug Withdrawal Symptoms. ISMP Medication Safety Alert! Acute Care Edition 2017; July 13, 2017
Bulik BS. Goodbye to Lyrica ads? Big TV spender drops off top 10 list in October, FiercePharma 2018; November 5, 2018
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Print “March 2019 What's New in the Patient Safety World (full column)”
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Print “March 2019 Newborn Falls”
Print “March 2019 Does Surgical Gowning Technique Matter?”
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PO Box 1230
Grantham, NH 03753
ph: 716-550-1106
btruax