PCA allows the patient to self-administer his or her own pain medication on an as-needed basis by simply touching a button on a small, wristwatch-like device. This replaces the traditional method of a nurse administering medication by an injection, but takes a monitoring element out of the process that could contribute to medication errors.
One solution to the problem will be to introduce bar codes or wireless radiofrequency identification (RFID) technology on all PCA medications at the point-of-care, the USP suggests.
Some newer PCA systems, including Abbott Laboratories' LifeCare PCA3 product that was launched just over a year ago, incorporate safety features such as built-in bar code readers and systems for automatically identifying the drug and dose in prefilled vials.
CAPS said it was necessary to alert practitioners and patients about the high rate of medication errors associated with patient-controlled analgesia (PCA), after a study revealed that the average overall harm rate for error reports submitted to MEDMARX - the US national database for medication errors - over the past several years has been approximately 2 per cent.
The most common types of error involving PCA pumps were delivery of an improper dose/quantity, accounting for 38.9 per cent of the total. This was followed by administration of an unauthorized or incorrect in 18.4 per cent of cases, dose omissions in 17.6 per cent.
The USP notes that in non-critically ill patients, PCA pumps have been shown to improve pain management with less sedation, less opioid consumption, and potentially fewer adverse effects (e.g., respiratory complications). The pumps offer several safety features to prevent the administration of excessive amounts of analgesic medication, such as a 'lockout interval' that specifies the minimum amount of time between each dose and an established maximum allowable amount of drug during a predefined time period.
"Despite these advantages, medication errors involving PCA pumps continue to occur," it said.
One worrying sign is that the newest technology in PCA pumps provides many pre-programmed features that, while helpful to those operating them, can introduce error into the process, commented Diane Cousins, vice president of CAPS.
She also noted that many facilities still have pumps based on older technologies, thus creating mixed and potentially confusing scenarios for those using the pumps.
Moreover, the fact that these pumps are supposed to rely on the patient for self-administration of a dose poses new threats when well-intentioned family members administer doses on behalf of a patient or if the patient is not a good candidate to make decisions about the need for a dose, she added.
The USP also says that a Failure Modes & Effects Analysis (FMEA) should be conducted for existing pumps, as well as for new pumps that are brought into a healthcare facility, while double checks systems should be in place for initial set-up and maintenance, as well as dose changes/change orders.
Additional recommendations and data from the study are available here.