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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
Print “March
2019 Another Use for Video Recording”
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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2019 Newborn Falls”
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
Print “March
2019 Does Surgical Gowning Technique Matter?”
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
Print “March
2019 Gabapentin and Pregabalin on the Radar Screen”
Print “March
2019 What's New in the Patient Safety World (full column)”
Print “March
2019 Another Use for Video Recording”
Print “March
2019 Newborn Falls”
Print “March
2019 Does Surgical Gowning Technique Matter?”
Print “March
2019 Gabapentin and Pregabalin on the Radar Screen”
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