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Patient Safety Tip
of the Week
April 14, 2020
Patient Safety
Tidbits for the COVID-19 Pandemic
So far, we have refrained from
discussing the COVID-19 pandemic, largely because all of you have been deluged
by articles about it. But there have been a few good recommendations recently
that pertain specifically to patient safety issues that we feel merit your
attention. We probably should not call these “tidbits” because they actually represent extremely serious issues in patient (and
staff) safety.
Antimalarial drugs
The first time we heard President
Trump hyping chloroquine or hydroxychloroquine plus azithromycin for COVID-19,
our patient safety antenna popped up. Those drugs are on our list of drugs that
can prolong the QT interval and predispose to Torsade de Pointes (see our
columns on Torsade listed below). We immediately sent a warning to residents of
our local community, advising those who were considering use of these drugs to
make sure their physician was aware of the danger and planned EKG monitoring if
those drugs were to be used. We have no comment on the efficacy of these
antimalarials in COVID-19 but they are being widely used. Hence, it is
critical that the risk for Torsade be considered.
The Presidents of the American Heart
Association, American College of Cardiology, and Heart Rhythm Society have
issued recommendations on using hydroxychloroquine and azithromycin to treat
COVID-19 in patients (Roden
2020). They recommend the following mechanisms to
minimize arrhythmia:
Electrocardiographic/QT interval monitoring:
- Withhold the drugs in patients with baseline QT prolongation
(eg,QTc ≥500 msec) or with known congenital long QT syndrome.
- Monitor cardiac rhythm and QT interval; withdrawal of the
drugs if QTc exceeds a preset threshold of 500msec.
- In patients critically ill with COVID-19 infection, frequent
caregiver contact may need to be minimized, so optimal
electrocardiographic interval and rhythm monitoring may not be possible
Correction of hypokalemia to levels of
>4mEq/Land hypomagnesemia to levels of >2 mg/dL.
Avoid other QTc prolonging agents whenever
feasible.
Mayo Clinic cardiologist Michael
Ackerman was quite vocal in an interview with NBC News (Przybyla 2020) about laymen
and physicians talking about use of these antimalarial drugs without discussing
the potential serious cardiac rhythm implications. Ackerman and his Mayo Clinic
colleagues have created a nice algorithm, published in Mayo Clinic Proceedings
(Giudicessi 2020),
to help physicians more safely prescribe hydroxychloroquine by identifying
patients at greatest risk for drug-induced sudden cardiac death.
ISMP (Institute for Safe Medication
Practices) also warned about the potential arrhythmogenic effects of these
drugs (ISMP 2020a). They note
that ventricular arrhythmias and torsade de pointes have been reported, and
drug labeling warns against administering these drugs with other drugs that
have the potential to prolong the QT interval. They note that azithromycin
itself may prolong the QT interval, so taking the drug in combination with
hydroxychloroquine or chloroquine may enhance the overall QTc-prolonging
effect. Patients with additional risk factors for QTc prolongation may be at
even higher risk. Thus, patients taking this combination should be monitored
for QTc interval prolongation and ventricular arrhythmias.
Combinations of drugs that can prolong the QT interval might
be expected to be particularly dangerous. Hence, the extreme concern about
adding azithromycin to one of the antimalarial agents. Patients with COVID-19
and other multiple comorbidities are likely to be on other medications that may
prolong the QT interval. Also, since COVID-19 may also present with
gastrointestinal symptoms, some patients may have been taking the commonly used
anti-diarrheal loperamide (Imodium and numerous OTC formulations) that the FDA
warned about in 2016 (FDA 2016).
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 extremely valuable site provides frequent updates when
new information becomes available about drugs that may prolong the QT interval.
The only study we know of where the effects of this
hydroxychloroquine/azithromycin combination on the QT interval has not been
peer reviewed but showed the QTc was prolonged maximally from baseline between
days 3 and 4 (Chorin
2020). In 30% of patients the QTc increased by greater than 40msec
and in 11% of patients the QTc increased to >500 msec
(considered the dangerous level in most).
Furthermore, the additive effect of
drugs on the QT interval may not just apply when the drugs are given
concomitantly. ISMP (ISMP 2020b) described a
patient who suffered cardiac arrest while on hydroxychloroquine after
azithromycin had been discontinued. The hydroxychloroquine was started one day
after azithromycin had been discontinued. On day 5 the patient developed
ventricular fibrillation and cardiac arrest and subsequent EKG showed a QTc of
605 msec (a QTc above 470 msec
is considered abnormally long in women). The article goes on to describe the
long half lives of each of these drugs
(hydroxychloroquine 40 days, chloroquine 5 days, azithromycin 72 hours).
If use of any of these drugs is considered, the patient
should have both a baseline EKG to measure the QTc interval and regular EKG’s
to monitor for prolongation. For those patients who are hospitalized, many
physiological monitoring systems have the capability of monitoring the QT
interval and can provide alerts. In those patients not on continuous monitoring
(or where the monitors cannot determine QT intervals) daily 12-lead EKG’s
should be done.
Congenital and drug-induced QT
prolongation are not the only factors putting these patients at risk for
malignant arrhythmia. Hospitalized patients have a whole host of other factors
that may prolong the QT interval and precipitate malignant arrhythmias in
vulnerable patients. These include underlying heart disease, electrolyte
abnormalities (eg. hypokalemia, hypomagnesemia, hypocalcemia),
COPD, renal or hepatic impairment, and bradycardia) all of which may be
precipitating factors. Many seriously ill patient
hospitalized with COVID-19 may also share some of these conditions.
For those of you who are interested, there is a YouTube
video about multiple other aspects of chloroquine and hydroxychloroquine from
the University of Washington Medicine (Escobar
2020).
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”
April 2015 “Anesthesia and QTc Prolongation”
October 10, 2017 “More
on Torsade de Pointes”
June 25, 2019 “Found Dead in a Bed – Part 2”
Fire risk in an oxygen-rich environment
The UK National Health Services
issued an alert warning of the risk of fire in the COVID-19 hospital
environment (NHS 2020). The density
of ventilators on COVID-19 units may lead to an oxygen-rich environment that
can predispose to fires. In such and oxygen-rich environment, any spark or heat
source (for example, from a defibrillator) could trigger a fire. One might
anticipate that splitting ventilators (i.e. using one ventilator for two
patients) might make oxygen leaks easier and increase the oxygen in the air.
Even in non-ICU settings, the increased use of oxygen could be problematic. The
NHS alert stresses facilities need to ensure there is good natural and
mechanical ventilation in all areas where oxygen is being used.
Thrombotic tendencies
COVID-19 has increasingly been associated with thrombotic events
(large vessel clots, DVT/PE, arterial events, small vessel disease, and
microvascular thrombosis (Phend 2020).
The International Society on Thrombosis and Haemostasis
(ISTH) has published guidelines regarding anticoagulants in COVID-19 patients (Moll
2020). An article on coagulopathy in COVID-19 (Shaw
2020) discusses multiple opinions on the issues of prophylactic
anticoagulants versus full anticoagulation.
A recent correspondence in the New England Journal of
Medicine (Zhang
2020) described an older man in China with a history of hypertension,
diabetes, and stroke who developed COVID-19 and required mechanical
ventilation. He had evidence of ischemia in 3 limbs and CT scan of the brain
showed bilateral cerebral infarcts in multiple vascular territories. Lab
findings included leukocytosis, thrombocytopenia, an elevated prothrombin time
and partial thromboplastin time, elevated levels of fibrinogen and d-dimer, and
antiphospholipid antibodies. Two other patients in the ICU had similar
findings. They note that the presence of these antibodies may rarely lead to
thrombotic events that are difficult to differentiate from other causes of
multifocal thrombosis in critically patients, such as disseminated
intravascular coagulation, heparin-induced thrombocytopenia, and thrombotic
microangiopathy.
A cohort study from Wuhan, China found that D-dimer levels
over 1 mcg/L at admission predicted an 18-fold increase in the odds of death
before discharge, though the exact mechanism for this is unclear (Zhou
2020).
Independent double checks
We’ve discussed the pros and cons of
double checks in numerous columns, Truly independent double checks do have a role in certain scenarios.
But requiring a double check may increase the exposure of a healthcare
professional to COVID-19. ISMP (ISMP 2020c) recently
addressed the need to balance the benefits of double checks versus the risks of
exposure and the need to conserve personal protective equipment (PPE) when
doing double checks in the COVID-19 environment. They found that most
organizations are establishing ways to conduct critical parts of independent
double checks without entering a patient’s room. For example, a hard stop in EHR’s
requiring
dual documentation
of verification before proceeding now reflects only those components of the
check that can be accomplished outside the patient’s room.
They also describe how some hospitals became innovative.
Where infusion pumps remain in the patient’s room, the nurse who enters the
room takes a picture of the pump screen using a mobile phone device left in the
room, and sends the picture to a nurse outside the room via a secure messaging
system. This allows most components of the independent double check to occur.
(We’ll have to add that to our list of pros and cons of smartphones in
healthcare!).
Medication reconciliation and discharge communication
ISMP Canada (ISMP
Canada 2020) received a report about a student health care provider who
obtained a best possible medication history (BPMH) from a patient in a
face-to-face interview. It was later discovered that the patient was under
investigation for suspected COVID-19 virus. A review of the circumstances of
this incident brought to light an opportunity for improvement. The facility
consequently planned to implement a process to conduct medication history
interviews by phone.
That means you need to evaluate (both on the hospital side
and the patient side) the availability for telephone, video-calling, and email
communication, including security and practicality of internet access, email
accounts, in-room telephone, mobile phone, internet-based video-calling
platform, intercom, or 2-way communicating baby monitors. Staff in your
registration department will need to document the patient’s mobile phone number
and email address to facilitate virtual conversations and reduce the need for
in-room meetings.
They go on to describe the process of medication
reconciliation, including not only digital identification of medications but
also visual identification (via video or sending photographs of the pills or
containers via email).
They go on to describe how the same systems can be used to
educate patients at or just after hospital discharge (including ways to involve
the patient’s PCP and community pharmacy).
Wow! They did this because of the COVID-19 pandemic, but think how this could be used at any time.
Particularly now that CMS is relaxing its guidelines on telemedicine, what
better way to conduct the annual “wellness visit” than by using telemedicine. The
patient doesn’t have to bring in their “brown bag” of medications but can
simply show everything in their medicine cabinet to you via these communication
links. It saves all time and still allows for face-to-face interaction.
Prehabilitation for
COVID-19
Last week’s Patient Safety Tip of the
Week “From
Preoperative Assessment to Preoperative Optimization”
discussed how prehabilitation may help reduce
complications prior to surgery. An opinion piece (Silver 2020) in the most recent issue of the British
Medical Journal suggests we should use prehabilitation
to prepare patients for COVID-19 infections. Julie Silver, Chair of Harvard’s
Department of Physical Medicine, notes that strategies we’ve employed to slow
the spread of COVID-19
(eg. social distancing, sheltering in
place) could have the unintentional effect of decreasing physical activity and
contributing to cardiopulmonary deconditioning. That would be particularly
devastating in the elderly, who are already at risk of increased morbidity and
mortality if they get COVID-19. She goes on to posit that there currently exists
a window of opportunity whereby physicians can recommend a best practice
approach and advise patients and the public about how to maintain and optimize
their baseline fitness and nutritional health, using techniques used prior to
surgery, such as a combination of exercise, nutrition, smoking cessation, and
stress reduction. She emphasizes that small changes in cardiopulmonary fitness
may have a large impact on patients who are frail, including elderly patients
with multiple comorbidities. All these interventions can be delivered while
patients are practicing social distancing or are sheltering in place and can be
easily delivered via telemedicine. These are great recommendations. Don’t just
think about managing patients once they contract or have been exposed to
coronavirus. Identify your highest risk patients (the elderly, those with
multiple comorbidities, and the frail) and interact with them via telemedicine
to get them involved in prehabilitation to improve
the chances of survival if and when they do develop
COVID-19.
References:
Roden DM, Harrington RA, Poppas A, Russo AM. Considerations for Drug
Interactions on QTc in Exploratory COVID-19 (Coronavirus Disease 2019)
Treatment. Circulation 2020; Published ahead of print April 8, 2020
https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.120.047521
Przybyla H. Mayo
Clinic cardiologist: 'Inexcusable' to ignore hydroxychloroquine side effects.
NBC News 2020; April 7, 2020
Giudicessi
JR , Noseworthy PA, Friedman PA, Ackerman MJ. Urgent
guidance for navigating and circumventing the QTc prolonging and torsadogenic potential of possible pharmacotherapies for
COVID-19. Mayo Clin Proc 2020; 95(x): xx-x [published online ahead of print
March 25, 2020]
https://mayoclinicproceedings.org/pb/assets/raw/Health%20Advance/journals/jmcp/jmcp_covid19.pdf
ISMP (Institute for
Safe Medication Practices). Limit use and protect supplies of unproven but
widely prescribed COVID-19 treatment. ISMP Medication Safety Alert! Acute Care
Edition 2020; Special Edition 25(6): 1, 3-5 March 26, 2020
https://www.ismp.org/acute-care/medication-safety-alert-march-26-2020
FDA (US Food and
Drug Administration). FDA Drug Safety Communication: FDA warns about serious
heart problems with high doses of the antidiarrheal medicine loperamide
(Imodium), including from abuse and misuse. FDA Safety Announcement June 7,
2016
http://www.fda.gov/Drugs/DrugSafety/ucm504617.htm
CredibleMeds® website
Chorin
E, Dai M, Shulman E, et al. The QT Interval in Patients with SARS-CoV-2
Infection Treated with Hydroxychloroquine/Azithromycin. medRxiv 2020;
2020.04.02.20047050; Preprinted without peer review April 3, 2020
https://www.medrxiv.org/content/10.1101/2020.04.02.20047050v1
ISMP (Institute for
Safe Medication Practices). Patient taking hydroxychloroquine right after
discontinuing azithromycin develops QTc prolongation and cardiac arrest. ISMP
Medication Safety Alert! Acute Care Edition 2020; Special Edition 25(7): 1, 3-4
April 9, 2020
https://www.ismp.org/acute-care/special-edition-medication-safety-alert-april-9-2020
Escobar ZK.
Chloroquine & Hydroxychloroquine. University of Washington Medicine.
YouTube March 19, 2020
https://www.youtube.com/watch?v=an4WZv_spT4&list=PL9P1nWBXsofsRyl96njQIQUFTEoeg7aXU&index=4&t=0s
NHS (National Health
Services UK). Novel coronavirus (COVID-19) standard operating procedure. Design
note: COVID-19 ward for intubated patients. NHS 2020; March 22, 2020
Phend
C. Anticoagulation Guidance Emerging for Severe COVID-19
— Pragmatic choices
dominate as guidelines are shaping up. MedPage Today
2020; April 8, 2020
https://www.medpagetoday.com/infectiousdisease/covid19/85865
Moll S. COVID-19 and
Coagulopathy – Two Management Guidance Documents For
Health Care Professionals. Clot Connect 2020; Posted on March 26, 2020
Zhang Y, Xiao M,
Zhang S, et al. Coagulopathy and Antiphospholipid Antibodies in Patients with
Covid-19. NEJM 2020; April 8, 2020
https://www.nejm.org/doi/full/10.1056/NEJMc2007575
Shaw G. Abnormal
Clotting and COVID-19. Infectious Disease Special Edition 2020; April 9, 2020
Zhou F, Yu T, Du R,
et al. Clinical course and risk factors for mortality of adult inpatients with
COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet 2020;
395(10229): 1054-1062
https://www.sciencedirect.com/science/article/pii/S0140673620305663
ISMP (Institute for
Safe Medication Practices). Suspending independent double checks. ISMP
Medication Safety Alert! Acute Care Edition 2020; Special Edition 25(7): 1-2
April 9, 2020
https://www.ismp.org/acute-care/special-edition-medication-safety-alert-april-9-2020
ISMP Canada. Virtual
Medication History Interviews and Discharge Education. ISMP Canada Safety
Bulletin 2020; 20(2): April 7, 2020
Silver JK. Prehabilitation could save lives in a pandemic BMJ 2020; 369 :m1386
https://www.bmj.com/content/369/bmj.m1386
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