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From the April 7, 2005 issue

Problem: 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 prescribed.

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.