From the April 7, 2005
: A hospitalized patient with chronic
pain was able to increase the rate of his hydromorphone infusion
and administer "clinician" bolus doses to himself.
The patient had been receiving hydromorphone via a CADD-Prizm
VIP pump (from Smiths Medical) at home before he was admitted
to the hospital late one evening. The admitting physician
prescribed the same dose of hydromorphone as the patient had
been receiving at home, and allowed the patient to use his
pump from home while in the hospital. The hospital-based pain
service team was following the care of the patient at home
but was not notified of his admission until the following
morning when a resident called to question why the patient's
hydromorphone infusion was running at a different rate than
A member of the pain service told the resident that they
had not changed the dose, and would be unable to see the
patient until later in the day because of a busy clinic
schedule. The resident did not investigate the change in
the infusion rate any further. Eighteen hours elapsed before
the pain service physician was able to visit the patient.
Nursing documentation was vague regarding how much medication
had infused versus how much should have infused. But when
the physician looked at the pump's patient history log,
he quickly discovered that the patient had somehow manipulated
the infusion rate and given himself frequent boluses (which
were not prescribed). The patient's home CADD pump was replaced
with a hospital CADD pump (different model) and secured
with a tackle box and padlock to ensure no further tampering.
Obviously, the patient knew how to manipulate the pump
and had obtained and used the lock level code to alter the
pump settings, and the clinician code to administer bolus
doses. But how did he gain this knowledge? At the request
of FDA and others to provide readily accessible information,
the pump's user manual is available on the manufacturer's
website. This provides patients with knowledge about how
to program the pump. However, the codes are not included
in the web publications; they appear only in the hardcopy
of the user manual that the facility receives. Thus, it's
likely that the patient obtained the lock level and clinician
codes from the pump he used at home by observing practitioners
during pump programming. A much less remote possibility
is that the codes, which are the same for this pump throughout
the US when shipped from the manufacturer, have been communicated
via the Internet or email by others.
Safe Practice Recommendation: While there may be
no foolproof way to prevent patient tampering with pumps
delivering opioids, there are several things that healthcare
providers can do to reduce the risk of tampering or to detect
it quickly if it occurs:
Shielding and scrolling. When programming a pump,
always block the patient's (and visitor's) view and use
the scroll up or down keys if available to prevent patients
from counting how many times the keys are pressed.
Checks and balances. Require home care and hospital
nurses to use carefully designed flow sheets during opioid
infusions to track cumulative doses over time (4 hour increments
for inpatients) while referencing the pump's patient history
log for comparison to the prescribed dose.
Investigate. Consider the possibility of patient
tampering (or an error) if the amount (dose or volume) administered
does not match the prescribed dose, or if the patient's
sedation level, respiratory status, or behavior appears
different than expected.
Staff education. When educating staff and other
caregivers to use pumps, stress ways to minimize the risk
of patients and visitors learning the programming codes.
Check security features. Check all pumps used for
opioid infusions (and new pumps considered for purchase)
to ensure that the locking mechanism for the compartment
that holds the medication is functional and reliable. (Patients
and visitors have used pens, paper clips, or other objects
to push the syringe plunger, syringes with long needles
to aspirate the medication, or moderate pressure to open
the locked compartment.)
Use hospital pumps. To enhance security, use hospital-approved
pumps only to administer opioids to hospitalized patients.
Do not allow patients to use their pumps from home.
Monitor opioid use. Pharmacies that supply opioids
to home care patients, and hospital pharmacists who dispense
opioids, should monitor the amount of opioids dispensed
to ensure that it matches the prescribed doses. Any discrepancies
should be investigated immediately.
Screen patients. Carefully screen patients with
chronic pain to ensure that they are appropriate candidates
for opioid infusions, including patient-controlled analgesia.
Inform patients that opioid use will be monitored.
Change codes. Some pumps offer biomedical staff
the capability of changing the lock level and clinician
codes. Consider changing the codes temporarily for patients
at risk for tampering with the pumps as long as the new
codes can be securely communicated to all practitioners
who need the information.
Utilize a pain service. If you offer a pain service,
notify the team immediately upon admission of a patient
with chronic pain, especially if the patient has been receiving
opioids in the home setting.