Patient Safety Tip of the Week
June 2, 2015 Reminders of Dilaudid Dangers
It’s been almost 5 years since we did our first column on
the dangers of Dilaudid/HYDROmorphone
(see our September 21, 2010 Patient
Safety Tip of the Week “Dilaudid
Dangers”) but it remains one of our most frequently accessed
columns. Unfortunately, many of the systemic problems we’ve noted in
association with Dilaudid treatment persist and
preventable deaths continue to occur. Two new cases serve as a reminder of some
of those key problems.
The first appears in a statement of deficiencies and plan of
correction from the California Department of Public Health (CDPH
2014). A patient was admitted with abdominal pain, nausea, vomiting and
diarrhea and began receiving IV Dilaudid for pain.
Two 1 mg doses were given in the emergency department separated by 3 hours. On
admission to the floor Dilaudid doses were increased
to 2 mg, then 4 mg so that the patient received a total of 20 mg of Dilaudid over a 24-hour period (CDPH calculated that dose
as being equivalent of 133 mg morphine). Unfortunately, the patient was found
unresponsive at 2:56 AM on the day after admission and emergency resuscitation
efforts were unsuccessful.
The rest of that story is typical from our many columns on
failure to appropriately monitor patients who are on opioid therapy (see list
at the end of today’s column). The period between finding the patient
unresponsive and the last prior assessment was 3 hours and 26 minutes. There
was no documentation of the patient’s pain level or sedation level before or
after each Dilaudid dose. And there is no mention of
how respiratory status was to be monitored. We assume pulse oximetry was not
used in this case because the plan of correction adds pulse oximetry to their
revised policy for intravenous dosing of HYDROmorphone.
Of course, you already know that visual assessment of respiration and pulse
oximetry by themselves are not adequate for monitoring for opioid-related
respiratory depression. Rather, monitoring with capnography
and looking for apnea are recommended in addition to pulse oximetry.
Details about comorbidities are not specified in the CDPH
report other than that the Coroner’s Autopsy Report notes under “other
significant conditions” morbid obesity and obstructive sleep apnea. At the very
least those conditions should have placed the patient in a very high risk
category for any opioid therapy. Patients with obstructive sleep apnea usually
have normal appearance of breathing and normal oxygen saturation while they are
awake, providing a false sense of security. It is only when they are not
aroused and fall back to sleep that the obstructive apnea supervenes.
There is also no mention about whether the patient was
opioid-naïve or opioid-tolerant, an important consideration in dosing of any
opioid.
The second case was an 85-year-old patient admitted to a Canadian hospital with a suspected
bowel obstruction and prescribed 1-2 milligrams of Dilaudid
every three hours, to be given by “subcutaneous” injection (Blackwell
2015). The patient suffered
respiratory depression, developed pneumonia and died the next day. This case
appeared in the news media because the physician apparently conveyed to the
family that the medication had nothing to do with the patient’s demise, a
position apparently supported by the coroner’s initial report. However, family
prompted further review of the case and the coroner later issued a new
statement, saying death probably resulted from “narcotic overdose.” The family,
meanwhile, complained to the College of Physicians and Surgeons, which issued
to the physician a “verbal caution” saying he should have been open about the
significance of the “very large” dose of dilaudid
given to an elderly, dehydrated patient unaccustomed to powerful opioids.
Instead, he was “evasive and vague,” the committee concluded.
No further details
about that case are available but it again raises two key issues related to
such cases: (1) physicians (and other healthcare workers) often don’t have an
appreciation of the relative potency of HYDROmorphone
compared to morphine and (2) the issue of opioid-naïve vs. opioid-tolerant
patients is important. And though HYDROmorphone can
apparently be used by the subcutaneous route, we’ve not seen that route used in
hospitalized patients. We suspect that may have been a route unfamiliar to the
pharmacist(s) and nurse(s) at that hospital as well.
The major problem is misperception of the relative potency
of HYDROmorphone. All too many healthcare
professionals mistake HYDROmorphone as being
equivalent to morphine when, in fact, HYDROmorphone
is much more potent on a mg basis. While estimates of equipotency vary considerably in the literature, most now
agree that 1 mg. of Dilaudid is probably the
equivalent of at least 7 mg. of morphine. Chang and colleagues (Chang
2006) had noted several years ago that emergency room physicians and nurses
who were hesitant to administer 7 to 10 mg. of morphine were not reluctant to
administer 1 to 1.5 mg. of Dilaudid. They point out
this is an illusion that less narcotic is being used with that Dilaudid dose.
We’ve highlighted a series of articles addressing the
patient safety issues associated with HYDROmorphone
from ISMP Canada in our Patient Safety Tips of the Week for September 21, 2010
“Dilaudid
Dangers”and July 3, 2012 “Recycling
an Old Column: Dilaudid Dangers”. Then in our November 19, 2013 Patient Safety Tip of the Week “Can
We Improve Dilaudid/HYDROmorphone
Safety?” we highlighted a safety bulletin from ISMP Canada (ISMP
Canada 2013) reporting results of a targeted pilot intervention to improve HYDROmorphone safety. They looked at prior recommendations
on HYDROmorphone safety and prioritized them
according to a hierarchy of effectiveness and came up with 5 actions designed
to improve system safety:
- Preparation by pharmacy
of doses less than 1 mg in prefilled syringes
- Availability of
standard-volume chart for usual doses withdrawn from a 2 mg/mL vial or
ampoule
- Creation of an electronic
alert in CPOE screens, pharmacy information systems, and ADC (automated
dispensing cabinet) screens for initial doses greater than 1 mg
IV/IM/SC/PO
- Performance of a weekly
audit to remove high-dose HYDROmorphone (i.e.
parenteral dose greater than 2 mg) from patient care areas
- Distribution of an opioid
information sheet to patients and families
They found that workload issues and alert fatigue were
barriers that limited full implementation at some participating hospitals. They
note that because of concerns about alert fatigue it may be more practical to
limit the dose of HYDROmorphone by using standardized
order sets. We concur with that. Order sets, whether computerized or
paper-based, can help steer away from using HYDROmorphone
as well as helping avoid prescription of inappropriately high doses when it is
prescribed. But in your order sets be very careful about having checkbox items
that would allow a physician to check two boxes for drugs you don’t want to be
used together. For example, in ISMP’s Guideline for Standard Order Sets (see
our March 23, 2010 Patient Safety Tip of the Week “ISMP
Guidelines for Standard Order Sets”) they note that contraindicated
combinations such as IV morphine and epidural HYDROmorphone/bupivacaine
should not appear on the same order set (ISMP 2010).
We strongly recommend that you limit the number of opioids
to be used in your PCA pumps. You can standardize PCA on morphine and restrict
prescription of other opioids to members of your pain management service or
providers who have been specifically credentialed and privileged to order other
opioids. Keep in mind that there may be legitimate indications for using HYDROmorphone in preference to morphine in some cases. For
example, you may have a patient who gets pruritis
with morphine, in which case HYDROmorphone may be an
acceptable alternative.
In our November 19,
2013 Patient Safety Tip of the Week “Can
We Improve Dilaudid/HYDROmorphone
Safety?” we noted that look-alike/sound-alike
(LASA) issues also continue to occur, in which hydromorphone
and morphine are mixed up both in sounding alike and in that vials may be
similar. Use of tall man lettering (HYDROmorphone) is
advised but, frankly, many healthcare workers still mistakenly assume that HYDROmorphone is an equipotent form of morphine.
To reiterate from
our multiple columns on Dilaudid dangers, here are
some strategies you should consider to reduce the risk of Dilaudid
(and other opioid) adverse events:
- Education
of physicians, nurses, pharmacists, etc. on the different potencies of
various opioids (but keep in mind that education and training are
relatively weak patient safety interventions so other preventive
interventions will be needed)
- Equipotency cards/posters/popups for commonly
prescribed opioids
- Consider
dose range alerts during CPOE (eg. note a
typical dose is 0.2-0.5 mg. IV and limit dose to 1.0 mg for an
opioid-naïve patient)
- Other
alerts during CPOE (eg. if a patient is already
on a sedative/hypnotic drug prompt “Are you aware sedative agents make
patient more vulnerable to opioid-induced respiratory depression?”)
- Other
decision support tools for ordering (eg. prompts
asking about whether the patient is opioid-naïve or opioid-tolerant, then
suggest starting dosages)
- Establish
criteria for using intravenous opioids
- Patient
selection/identify hi risk patients (the very young and the very old,
those with obesity, sleep apnea, neuromuscular diseases, COPD, and those
in higher ASA classes, those receiving sedative/hypnotic drugs)
- Screening
for obstructive sleep apnea (OSA) prior to use of IV opioids with a tool
such as STOP or STOP-Bang
- Look
for other risk factors (renal function, coadministration
of sedative/hypnotic drugs, etc.)
- Monitor,
monitor, monitor…
- Continuous
pulse oximetry and capnography or apnea
monitoring
- Close
monitoring (in an ICU setting if necessary for high-risk patients)
- Pain
assessment, RASS (Richmond Agitation-Sedation Scale) or other scale for
level of arousal
- Enforce
RASS (by requiring input of RASS score at BMV or when taking out of ADC)
- Tie
recommended course of action to the RASS score
- Always
have narcotic reversal agents readily available where IV opioids are being
used and have protocols that deal with issues like renarcotization
- Standardized
order sets
- Different
order sets for opioid-naïve and opioid-tolerant patients
- Avoid
order sets that allow a provider to check boxes for contraindicated
combinations such as IV morphine and epidural HYDROmorphone/bupivacaine
on the same order set
- Avoid
basal rates for PCA in opioid-naïve patients
- Warnings
when taking it out of ADC (eg. “This is
DILAUDID. Is this what you wanted?”) or require a witness for overrides
when using ADC
- Independent
double checks
- Use
tall man lettering “HYDROmorphone”
- Consider
limiting the number of different opioids you use for acute pain management
(eg. use morphine as your “preferred”
opioid and reserve Dilaudid for rare patient who gets pruiritis
from morphine)
- Have
pharmacists prepare and dispense the doses in prefilled unit dose syringes
- Stock
HYDROmorphone only in lower doses on patient
care floors and ADC’s
- Stock
HYDROmorphone and morphine in different
concentrations and keep them separate in stock
- Add
labels to avoid confusion (consider using brand name “HYDROmorphone
(DILAUDID)”)
- Involve
patients and families in educational efforts about IV opioid therapy
- Perform
regular audits with feedback for doses of HYDROmorphone
exceeding 1 mg
- Make
sure HYDROmorphone is on your “High-Alert” drug
list
- Consider
doing a FMEA (Failure Mode and Effects Analysis) to determine your
potential vulnerabilities to Dilaudid incidents
“Dilaudid Dangers” is not just a
catchy title. It’s a real risk lurking in most hospitals and other healthcare
settings today despite warnings from multiple patient safety organizations.
Our prior columns on
patient safety issues related to Dilaudid/HYDROmorphone:
- September 21, 2010 “Dilaudid
Dangers”
- November 2011 “FDA
Changes on Dilaudid/HYDROmorphone”
- July 3, 2012 “Recycling
an Old Column: Dilaudid Dangers”
- November 19, 2013 “Can
We Improve Dilaudid/HYDROmorphone
Safety?”
Other Patient Safety
Tips of the Week pertaining to opioid-induced respiratory depression and PCA
safety:
- January
4, 2011 “Safer
Use of PCA”
- July
13, 2010 “Postoperative
Opioid-Induced Respiratory Depression”
- May
12, 2009 “Errors
With PCA Pumps”
- September
21, 2010 “Dilaudid
Dangers”
- November
2010 “More
on Preoperative Screening for Obstructive Sleep Apnea”
- February 22, 2011 “Rethinking
Alarms”
- May 17, 2011 “Opioid-Induced
Respiratory Depression – Again!”
- September 6, 2011 “More
Tips on PCA Safety”
- December 6, 2011 “Why
You Need to Beware of Oxygen Therapy”
- February
21, 2012 “Improving
PCA Safety with Capnography”
- September 2012 “Joint
Commission Sentinel Event Alert on Opioids”
- September 2012 “FDA
Warning on Codeine Use in Children Following Tonsillectomy”
- July 3, 2012 “Recycling
an Old Column: Dilaudid Dangers”
- February 12, 2013 “CDPH:
Lessons Learned from PCA Incident”
- February 19, 2013 “Practical
Postoperative Pain Management”
- May 6, 2014 “Monitoring
for Opioid-induced Sedation and Respiratory Depression”
- March 3, 2015 “Factors
Related to Postoperative Respiratory Depression”
- Tools:
PCA
Pump Audit Tool and the PCA
Pump Criteria
References:
CDPH (California Department of Public Health). Complaint
Intake Number CA00394996. 2014
http://www.cdph.ca.gov/programs/Documents/Mercy%20AP%20040010992%20POC%20redacted.pdf
Blackwell T. Ontario doctor rebuked for denying role of
‘gross medication error’ in patient’s death. National Post 2015; May 24,
2015
Chang AK, Bijur PE, Meyer RH, et
al. Safety and Efficacy of Hydromorphone as an
Analgesic Alternative to Morphine in Acute Pain: A Randomized Clinical Trial.
Ann Emerg Med 2006; 48: 164-172
http://www.annemergmed.com/article/S0196-0644%2806%2900398-2/abstract
ISMP Canada. Safeguards for HYDROmorphone–Results
of a Targeted
Demonstration Project. ISMP Canada Safety Bulletin 2013; 13
(10): 1-5 November 4, 2013
http://www.ismp-canada.org/download/safetyBulletins/2013/ISMPCSB2013-10_HYDROmorphone.pdf
ISMP (Institute for Safe Medication Practices). ISMP’s
Guideline for Standard Order Sets. 2010
http://www.ismp.org/tools/guidelines/standardordersets.pdf
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