Part II - How to prevent errors - Safety issues with patient-controlled analgesia
From the July 24, 2003 issue
Patient-controlled analgesia (PCA) has considerable
potential to improve pain management.However, errors happen
frequently, sometimes with tragic consequences. In Part I,
published in our July 10, 2003 newsletter, we described how
PCA errors happen. Part II presents a checklist of efforts
related to practice, systems, products, pumps, and regulations
that can reduce the risks associated with this patient-centered
When purchasing a PCA pump
Perform a failure mode and effects analysis
using the actual PCA pump under
evaluation. Examples of questions to explore:
1. Can the pump be programmed easily to deliver the desired
2. Could unsafe administration sets that allow free-flow
be used accidentally?
3. Is the pump operation intuitive for the clinician and
4. What are the default settings for the opiate concentrations
5. Do the drugs, units of delivery, and strengths appear
in a logical sequence?
Limit PCA pumps to a single model to promote
proficiency with programming.
Before distributing the new pumps, verify that all pump
default settings are set up as expected, and place a warning
label on the activation button that states "FOR PATIENT
Before prescribing, dispensing, or initiating PCA
Require PCA prescribers to undergo a privileging
process to verify proficiency with this form of pain management.
Limit the prescribing of fentanyl for epidural PCA to
anesthesia staff, pain management teams, or critical care
Design standard order sets to guide drug
selection, doses, and lockout periods;
patient monitoring; and precautions such as avoiding concomitant
analgesics, and how and when to administer oxygen and
naloxone. Test the order sets using the pump's programming
sequence to reduce the risk of errors.
Provide nurses with relevant information
about opiates used for PCA. Alert them to the dangers
of administering a dose for the patient (PCA by proxy)
and the differences between hydromorphone and morphine.
Teach nurses and pharmacists how to program
PCA pumps, and verify their ability to enter a PCA prescription
accurately. Ensure that training occurs close to the introduction
of new pumps, not months before use, and offer practice
sessions as needed to maintain proficiency.
Run simulations in which staff purposely
write incomplete orders; select an inappropriate drug
or dose; misprogram a pump; ignore double checks; forget
critical monitoring points; and miss obvious signs of
toxicity so that clinicians can identify these at-risk
Ensure that nurses recognize the signs
and symptoms of opiate toxicity and withdrawal, the need
to assess patients with minimal verbal or tactile stimulation,
and the ability to distinguish between oversedation and
other pulmonary, neurologic, or cardiovascular complications.
Provide ongoing education to clinicians
about PCA errors to build awareness, and encourage internal
and external (FDA, ISMP, USP) reporting of PCA errors.
Require annual competency assessments
for all professionals who prescribe, dispense, and administer
Establish patient selection criteria for
PCA. Candidates should have an appropriate level of consciousness
and cognitive ability to self-manage pain. Infants, young
children, and confused patients are unsuitable candidates.
Require the use of PCA standard order
sets (all sections completed) and limit verbal orders
to dose changes.
Always dose PCA opiates in mg or mcg,
not by volume (mL).
Check patient allergies before selecting
the opiate used with PCA.
Use morphine as the opiate of choice.
Use hydromorphone for patients who need very high doses
of opiates. Reserve meperidine for patients who are allergic
to both morphine and hydromorphone.
Consider other medications that the patient
has received (e.g., analgesics taken at home, intraoperative
medications) or currently has prescribed (e.g., antihistamines,
nighttime sedatives) when determining the loading and
Reassess the appropriateness of PCA therapy
at regular intervals.
Establish one standard concentration for
each opiate used for PCA.
Stock only the standard concentrations
of morphine and hydromorphone in patient care units (meperidine
for PCA should be dispensed from the pharmacy).
Separate the storage of hydromorphone
from morphine in the pharmacy and patient care units to
Check patient allergies and ensure that
they are listed in the interactive allergy field on the
patient profile before entering PCA orders into the computer.
Set maximum dose limits for PCA opiates
in the pharmacy computer so an alert appears if safe doses
are exceeded during order entry.
Affix prominent warnings if dispensing
an opiate in a nonstandard concentration.
Use prefilled syringes/bags/cassettes
whenever available commercially. Have pharmacy prepare
all PCA products that are not commercially available.
Require a pharmacist to review all PCA
orders before initiation (exception: when a pharmacist
is not on site) and suggest renal dose adjustments or
an alternative opiate when appropriate. If meperidine
PCA is used, have pharmacy set dose limits and reassess
the patient every 24 hours.
Use "tall man" lettering on
pharmacy-applied labels for HYDROmorphone to help avoid
confusion with morphine.
Alert clinicians to potential drug shortages
with PCA opiates and, if encountered,
recommend an alternative drug with clear dosing instructions.
Check patient allergies, which should
be visible on the medication administration record (MAR),
before initiating PCA.
Connect PCA to a port close to the patient
(to avoid dead space) and prominently label the infusion
line at this connection to avoid mix-ups with other lines.
Provide laminated instructions for programming
PCA pumps for reference by nurses who may infrequently
Require two clinicians to independently
double-check the patient's identification, drug and concentration,
PCA pump settings, and the line attachment before use
(and before pump refill or programming change). Bedside
bar-coding can be used to verify the patient and drug/concentration;
however, pump settings may still require an independent
Avoid nurse-controlled PCA unless special
monitoring in place (see page 3).
Verify PCA settings each shift, immediately
after receiving report.
Avoid administering concomitant opiates
(an alert should appear on the MAR).
Have oxygen and naloxone readily available.
Educate patients about the proper use
of PCA before initiation. Start during the preoperative
testing visit so patients are not too groggy to understand.
Warn family members and visitors about the danger of PCA
When monitoring the effects of PCA
Establish a standard measurement scale
to assess the patient's level of pain.
Develop monitoring requirements for patients
who are receiving PCA and be alert for signs of oversedation.
At a minimum, evaluate the patient's level of pain, alertness,
and vital signs, including rate and quality of respirations,
every 4 hours.
Evaluate all patients with minimal verbal
and tactile stimulation to obtain an accurate assessment
of their level of sedation.
Monitor patients more frequently during
the first 24 hours and at night, when hypoventilation
and nocturnal hypoxia may occur.
Establish risk factors that could increase
respiratory depression (e.g., obesity or low body weight,
concomitant medications that potentiate opiates, preexisting
conditions such as asthma and sleep apnea) and determine
the level of enhanced monitoring that would be required
if these patients use PCA (e.g., capnography, apnea alarms
Identify the infrequent situations where
critical care patients may be suitable for nurse-controlled
analgesia, and the level of enhanced monitoring that would
be required for these patients.
Do not rely on pulse oximetry readings
alone to detect opiate toxicity. Since capnography is
currently not available for all PCA patients, reserve
its use for those with a heightened risk of toxicity,
and with nurse-controlled analgesia.
Keep flowsheets at the bedside to document
PCA doses and patient monitoring.
Monitor the use of naloxone to identify
adverse events related to PCA.
Recommendations for pharmaceutical companies
Improve the visibility of label information
about preservatives in opiates.
Distinguish the packaging of opiates and
the varying strengths used for PCA. Use "tall man"
letters for HYDROmorphone to help avoid confusion with
Seek FDA approval of hydromorphone for
PCA so the product can be packaged in prefilled syringes
or bags for PCA use.
Provide wholesalers and healthcare providers
with early warnings about potential drug shortages to
allow providers time to prepare for short-term alternatives.
Recommendations for PCA pump manufacturers
Ensure free-flow protection for all administration
sets and extension tubing.
Provide visual and auditory feedback to
patients about doses that are administered when the activation
button is pressed.
Require pumps to be programmed in mg/mL
or mcg/mL, not just mL.
Establish default settings of zero for
all opiate concentrations.
Change the appearance of the activation
button to avoid looking like a call bell.
Develop technology to alert users and
stop PCA if a syringe or bag is empty.
Explore design standards to prevent connecting
an IV PCA to an epidural line.
Develop technology for PCA to alert clinicians
to unsafe dose settings, programming errors, and respiratory
Contact healthcare providers immediately
when pump problems are recognized.
Recommendations for regulatory bodies
Require PCA pump manufacturers to provide
a patient guide for use.
Enhance FDA communication to providers
about PCA problems, and issue hazard alerts or recalls
on unsafe devices currently on the market.
Require pump manufacturers to perform
premarket testing of the device using clinicians and potential