For the past several
months we had been collecting some recently published studies on medication
safety to include in our What’s New in the Patient Safety World column.
However, there have been so many of them that are clinically relevant that we
thought we needed to include them in one of our Patient Safety Tips of the Week
where we discuss them in more detail. Hence, today’s column.
A study from the UK
(Seden
2012) looked at prescribing errors in admission and discharge
prescriptions. One or more errors was found in 43.8% of prescriptions, over
half of which were considered significant. They found no significant difference
in error rates by level of experience of the prescribing physician. The
strongest predictor of error was the number of items per prescription. The risk
of error increased 14% for each additional item in the prescription. Medication
omission errors accounted for 26.9% of errors, followed by writing errors and
dosing errors at 20.7% and 20.6%, respectively. Medication omissions were very
common in patients acutely admitted. The authors recommend early use of
clinical pharmacists in the medication reconciliation process and better use of
IT systems.
IT systems, however,
are not the full answer. Another recent study (Linsky
2013) looked at medication discrepancies in the electronic medical record
system of ambulatory care patients in the VA system in Boston. They found 60%
of patients had at least one medication discrepancy. Prevalence rates of
commissions were 36%, omissions 27%, alterations 19%, and duplications 11%.
Interestingly, they found an increased number of medications correlated with
more commissions and duplications but fewer omissions. The authors conclude
that relying on EHR’s alone will not ensure an accurate medication list.
Dose omission incidents may potentially lead to patient harm. A study from ISMP Canada’s
reporting database found 159 incidents of patient harm from dose omissions
across different hospital settings over a 2.5-year period (ISMP
Canada 2013). Most involved mild or moderate harm and there were no cases
of severe harm or death. As you might expect, drugs we consider high-alert
medications were most frequently involved. Insulin was involved in 18.9% of
incidents and heparin in 13.2%. Other drugs frequently involved were potassium
chloride, metoprolol, aspirin, HYDROmorphone, metformin, and warfarin. The
authors did qualitative analysis of 79 incidents and found several themes:
·
The most
frequently implicated medications are used in acute clinical situations (eg.
acute coronary syndrome or MI, diabetic ketoacidosis, etc.)
·
Many were
high-alert medications with narrow therapeutic ranges
·
Medications
associated with negative outcomes were often omitted or delayed
They provide
multiple examples of system-based factors contributing to harmful dose omission
incidents, such as delivery of medications to a prior area after a patient had
been transferred, misplacement of the MAR, lack of understanding of nomograms,
etc. But they also identified several themes of at-risk patient care processes:
·
Patient
transfers
·
Complex
medication orders
·
Medication
administration record (MAR) issues
When we do an
introduction to patient safety during incoming residents’ week for all the new
residents in the Buffalo academic consortium of hospitals we especially focus
on medication errors. One of the patient safety practices we strongly encourage
them to use is including the indication for the medication any time they
order a medication. We provide them numerous examples of look-alike sound-alike
(LASA) medication errors that might have been prevented had the prescriber
included the indication for the medication. Unfortunately, many CPOE systems do
not include a field for indication. A recent paper (Wei
2013) showed how a publicly
available, computable resource that links medications with their indications as
represented by concepts and billing codes might be used to benefit clinical EMR
applications. Another recently published study looked at use of indications
tied to the patient’s problem list during CPOE (Galanter
2013). Over a 6-year period over 100,000 alerts fired and resulted in 32
intercepted wrong-patient errors (an interception rate of 0.25 per 1000
alerts). They were able to determine that the prescriber had both patient
charts open in almost 60% of those instances (see our comments below about the
problem of having multiple charts open simultaneously).
Speaking of wrong-patient
medication errors, the Pennsylvania Patient Safety Authority (PPSA) has
just put out an analysis of 813 such occurrences over a 6-month period from
their data base (Yang
2013). Almost 30% were associated with high-alert medications (insulin,
opioids, anticoagulants, etc.). Fortunately, few of these errors resulted in
patient harm. But such errors occurred in multiple healthcare settings and
involved every phase of the medication process, though the majority occurred
during the medication administration phase. Inadequate patient identification
checks were common contributory factors. Sometimes nurses (incorrectly) relied
on the patient or family’s confirmation of the patient’s name to verify identity.
In other cases room numbers (which you’ll recall from the Joint Commission
NPSG’s should not be used as a patient identifier) were involved or the
medications of two patients in a room were confused. Failure to correctly use
the MAR was another contributory factor identified. Transcription errors were
also noted, such as transcribing an order into the wrong chart or affixing the
wrong patient label to an order. Verbal orders were also identified as
contributing factors. Prescribing errors were also common, with the prescriber
entering the order on the wrong chart or giving verbal orders on the wrong
patient. Errors during the dispensing phase included both filling and delivery
errors. Errors in the monitoring phase most often related to laboratory values.
The most common
contributing factor they identified was the same medication being ordered (but
different doses for each of the two patients). This was considered a factor in
6.4% of the events. Verbal orders and similar patient names were considered
factors in about 3% each. And 1.4% were related to confusion with a discharged
patient (eg. a medication intended for a patient who had previously been in
that bed).
The PPSA article
offers several risk reduction strategies. Following the Joint Commission NPSG
for accurate patient identification (at least 2 identifiers, which are not
to include the patient’s room number or location) is an obvious one. So is
limited use of verbal orders. Proper storage of medications needs to be
addressed (eg. correct labeling of bins, ensuring that medications are removed
from beens and ADC’s when patients are discharged, etc.). Empowering the
patient and family, encouraging them to question and speak up, are important as
well since many such potential errors were intercepted by patients or families.
Technology may be
important. Proper use of barcoding systems is important. Similarly, using all
the capabilities of automated dispensing cabinets (ADC’s) is important. Transitioning
from paper to CPOE is recommended, though they appropriately point out that
such errors may occur during CPOE as well (see also our Patient Safety
Tips of the Week May 20, 2008 “CPOE
Unintended Consequences: Are Wrong Patient Errors More Common?”, June 26,
2012 “Using
Patient Photos to Reduce CPOE Errors”, and July 17, 2012 “More
on Wrong-Patient CPOE”).
Despite the numerous
examples of errors introduced by CPOE, the overall effect of CPOE on medication
errors has been beneficial. A recent systematic review and meta-analysis (Radley
2013) estimates that processing a
prescription drug order through a CPOE system decreases the likelihood of error
on that order by 48% and that, given this effect size and the degree of CPOE
adoption and use in hospitals in 2008, an overall 12.5% reduction in medication
errors in the US annually. The authors do, however, acknowledge that it remains
unknown whether this error reduction results in a reduction in harm to patients
or not.
Another recent study
demonstrates the value of the Leapfrog CPOE evaluation tool in monitoring and
reducing the occurrence of preventable adverse drug events (Leung
2013). A 43% relative reduction in the rate of preventable ADE was
predicted for every 5% increase in Leapfrog scores. We previously described use
of the Leapfrog tool in our July 27, 2010 Patient Safety Tip of the Week “EMR’s
Still Have a Long Way to Go” and our June 2012 What’s New in the Patient
Safety World column “Leapfrog
CPOE Simulation: Improvement But Still Shortfalls”.
Many of the drugs
noted in several of the studies noted above and another recent review of
factors associated with preventable adverse events (Beckett 2012) were
high-alert medications. These are drugs associated with a high likelihood
of patient harm if given incorrectly or omitted incorrectly. So timely is a new
ISMP Medication Safety Alert that points out that many hospitals have high-alert
medication lists that are ineffective because they don’t have associated
risk-reduction strategies in place (ISMP
2013). It has a great list of key strategies for organizations to implement
at multiple levels to reduce the risks of harm from drugs on those high-alert
medication lists.
One of those
recommendations is doing a FMEA (failure mode and effects analysis). A
good example of how to do a FMEA related to medications was also recently
published (Lago
2012). They did a FMEA on medication prescribing and administration on
pediatric wards and found 37 higher-priority potential failure modes and 71
associated causes and effects. So they were able to identify multiple targets
for improvement from a safety perspective.
It is important to
recognize that medication errors may vary across different settings. For
example, in the pediatric study noted above errors in calculating drug doses
and concentrations had the highest risk priority numbers (RPN’s). Similarly, in
adults there are differences in medication errors between ICU and non-ICU
settings (Latif
2013). The authors, reviewing data from the MEDMARX database found ICU
medication errors to be more likely associated with patient harm compared to
those in non-ICU settings. While errors occurred most often in the
administration phase in both settings, administration errors were more frequent
in ICU settings. Leading sources of errors identified in the ICU were deficits
in both knowledge and performance, procedure or protocol not being followed,
communication, and dispensing device errors. Sources in non-ICU settings were
similar except that inaccurate or omitted transcription was more frequent than
dispensing device errors. The authors ascribe the greater risk of harm in ICU
patients to a variety of factors, including patients being older and sicker
with more comorbidities, more medications, more potent drugs, more infusions,
more necessary dose calculations, and others.
Also, somewhat
surprising in an era of disclosure and apology, when medication errors did
occur patients and families were apparently seldom informed about them. This
was also seen more often in ICU patients.
Another striking
finding in the Latif study was that the staff member responsible for the error
was informed of the error a third of the time or less. While feedback should be
done in a constructive rather than punitive manner in most circumstances, such feedback
is critical if we really expect to reduce errors. A recent study providing
feedback regarding prescribing errors to prescribers in a NICU demonstrated a significant
improvement in narcotic prescribing errors but not in antibiotic prescribing
errors (Sullivan
2013). The authors in the NICU study speculate that narcotic prescribing
errors were more likely due to “slips” and “lapses” and were more amenable to
feedback than antibiotic prescribing errors, which were much more complex. The
best part of the Sullivan study, however, is a great description of the
barriers encountered and development of the best way to deliver the feedback.
They found that delivering the feedback via carefully structured emails that
were short, personal, informative and constructive worked best. They were more
likely to be read when the message was in the body of the email rather than in
an attachment. And the inclusion of a disclaimer reinforcing the non-punitive
nature of the feedback was felt to be very important.
Another study (Eijsbroek
2013) from the Netherlands looked at medication related problems occurring
in patients that had been in an ICU during a hospitalization. While the overall
occurrence of such problems was relatively infrequent, they did identify cases
where chronic medications had not been continued and others where medications
intended for short-term use had been inadvertently continued. Our August 30,
2011 Patient Safety Tip of the Week “Unintentional
Discontinuation of Medications After Hospitalization” discussed a Canadian
study (Bell 2011)
showing quite similar issues. The Netherlands study attributed the relatively
infrequent occurrence of problems to good medication reconciliation in hospital
and to use of a followup clinic that specifically addressed medication issues.
Lastly, the issue of
dissemination of medication safety alerts arose again. In our February 26, 2013
Patient Safety Tip of the Week “Insulin
Pen Re-Use Incidents: How Do You Monitor Alerts?” we focused on the problem
of providers not seeing important safety alerts. However, our focus was
primarily at the institutional level. Of course, failure to see (or heed) such
alerts is just as important at the individual provider level. An abstract just
presented at the American Academy of Neurology annual meeting showed just how
widespread and significant that problem may be (Bell
2013). The authors surveyed U.S. neurologists on their knowledge of four
recently announced safety risks regarding antiepileptic drugs and determined
whether they altered patient care as a result. They found approximately 20% of
neurologists were not aware of four major drug safety risks. Many others were
aware of such alerts but had not altered their practices as a result of those
alerts. Though neurologists learned about drug safety risks from many sources only
notifications from specialty organizations were associated with an accurate
knowledge of safety risks.
Alerts come from multiple authoritative sources (FDA, ISMP,
CDC) and are often also noted in resources like Medscape, specialty journals,
trade publications, manufacturers and others. But that may actually also be
part of the problem. The alerts come from so many sources, are often
duplicative, and may be included with many other alerts that are not relevant
to all providers. Often when we get an email from the FDA it has alerts on
medications, foods, and devices all interspersed. There are often so many that
we miss the important ones as we rapidly scroll through the document(s). Having
the alerts come through in a filtered manner would obviously be helpful. Neurologists receive drug safety information
non-systematically from multiple sources. Most would prefer implementing
"a formal warning process via specialty organizations" and emails
with updated product insert warnings directed to specialists.
References:
Seden K, Kirkham JJ, Kennedy T, et al. Cross-sectional study of prescribing errors in patients admitted to nine hospitals across North West England. BMJ Open 2013; 3: 1-14 e002036 doi:10.1136/bmjopen-2012-002036
http://bmjopen.bmj.com/content/3/1/e002036.full?sid=df02209d-197f-4ff8-b399-8ef7907cc89a
Linsky A, Simon SR. Medication discrepancies in integrated electronic health records. BMJ Qual Saf 2013; 22(2): 103-109 Published Online First: 25 October 2012 doi:10.1136/bmjqs-2012-001301
http://qualitysafety.bmj.com/content/22/2/103.abstract?sid=23e8b9c9-c622-4d5f-93a6-3311b4358ad4
ISMP Canada. Aggregate
Analysis of Dose Omission Incidents Reported as Causing Harm. ISMP Canada
Safety Bulletin 2013; 13(2): 1-6 March 27, 2013
http://www.ismp-canada.org/download/safetyBulletins/2013/ISMPCSB2013-02_Dose_Omission_Incidents.pdf
Wei W-Q, Cronin RM, Xu H, et al. Development and evaluation of an ensemble resource linking medications to their indications. J Am Med Inform Assoc 2013; Published Online First: 10 April 2013 doi:10.1136/amiajnl-2012-001431
http://jamia.bmj.com/content/early/2013/04/09/amiajnl-2012-001431.abstract
Galanter W, Falck S, Burns M, et al. Indication-based prescribing prevents wrong-patient medication errors in computerized provider order entry (CPOE). J Am Med Inform Assoc 2013; 20(3): 477-481 Published Online First: 9 February 2013 doi:10.1136/amiajnl-2012-001555
http://jamia.bmj.com/content/20/3/477.abstract?sid=c883c51d-5fed-425a-92e7-a658dc287049
Yang A, Grissinger
M. Wrong-Patient Medication Errors: An Analysis of Event Reports in
Pennsylvania and Strategies for Prevention. Pa Patient Saf Advis 2013
[prepublication]
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/Documents/2013_wrongpatient_prepub.pdf
Radley DC, Wasserman MR, Olsho LEW, et al. Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems. J Am Med Inform Assoc 2013; Published Online First 20 February 2013 doi:10.1136/amiajnl-2012-001241
http://jamia.bmj.com/content/early/2013/01/27/amiajnl-2012-001241.full
Leung AA, Keohane C, Lipsitz S, et al. Relationship between medication event rates and the Leapfrog computerized physician order entry evaluation tool. J Am Med Inform Assoc 2013; Published Online First 18 April 2013 doi:10.1136/amiajnl-2012-001549
http://jamia.bmj.com/content/early/2013/04/17/amiajnl-2012-001549.abstract
Beckett RD, Sheehan, AH, Reddan JG. Factors Associated with Reported Preventable Adverse Drug Events: A Retrospective, Case-Control Study. Ann Pharmacother 2012; 46: 634-641; published ahead of print April 17, 2012, doi:10.1345/aph.1Q785
http://www.theannals.com/content/46/5/634.abstract
ISMP (Institute for Safe Medication Practices). Your high-alert medication list—Relatively
useless without associated risk-reduction strategies. ISMP Medication Safety
Alert! Acute Care Edition 2013; April 4, 2013
http://www.ismp.org/Newsletters/acutecare/showarticle.asp?id=45
Lago P, Bizzarri G, Scalzotto F, et al. Use of FMEA analysis
to reduce risk of errors in prescribing and administering drugs in paediatric
wards: a quality improvement report. BMJ
Open 2012; 2:6 Published 18
December 2012 e001249 doi:10.1136/bmjopen-2012-001249
http://bmjopen.bmj.com/content/2/6/e001249.full?sid=45248008-0aa3-4b44-9ec8-743d90a51167
Latif A, Rawaat N, Pustavoitau A, et al. National Study on the Distribution, Causes, and Consequences of Voluntarily Reported Medication Errors Between the ICU and Non-ICU Settings. Crit Care Med. 2013; 41(2): 389-398
Sullivan KM, Suh S, Monk H, Chuo J. Personalised performance feedback reduces narcotic prescription errors in a NICU. BMJ Qual Saf 2013; 22(3): 256-262 Published Online First: 4 October 2012 doi:10.1136/bmjqs-2012-001089
http://qualitysafety.bmj.com/content/22/3/256.full?sid=7b432e85-0e51-4b58-b8b1-797095d9c282
Eijsbroek H, Howell DCJ, Smith F, Shulman R. Medication issues experienced by patients and carers after discharge from the intensive care unit. Journal of Critical Care 2013; 28(1): 46-50
http://www.jccjournal.org/article/S0883-9441%2812%2900177-3/abstract
Bell CM, Brener SS, Gunraj N, et al. Association of ICU or Hospital Admission With Unintentional Discontinuation of Medications for Chronic Diseases. JAMA 2011; 306(8): 840-847
http://jama.ama-assn.org/content/306/8/840.short
Bell S, Matsumoto M, Shaw S, et al. (Abstract) Evaluating U.S. Neurologists' Knowledge of New Anti-Epileptic Drug Safety Risks (S48.005). Neurology February 12, 2013; 80(Meeting Abstracts 1): S48.005
http://www.neurology.org/cgi/content/meeting_abstract/80/1_MeetingAbstracts/S48.005
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