Patient-Controlled Analgesia-Related Medication Errors in the Postoperative Period
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REVIEW ARTICLE
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Patient-Controlled Analgesia-Related Medication Errors in the Postoperative Period Causes and Prevention Jeff R. Schein,1 Rodney W. Hicks,2 Winnie W. Nelson,3 Vanja Sikirica4 and D. John Doyle5 1 2 3 4 5
Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA US Pharmacopeia, Rockville, Maryland, USA Johnson & Johnson Pharmaceutical Services, Raritan, New Jersey, USA Ethicon, Inc., Somerville, New Jersey, USA Cleveland Clinic, Cleveland, Ohio, USA
Contents Abstract. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Analgesia as a Contributor to Patient Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Classification of Patient-Controlled Analgesia (PCA) Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1 Potential Causes of Human-Related PCA Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Potential Causes of Equipment-Related PCA Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Device and Medication Error Reporting Databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1 Manufacturer and User Facility Device Experience (MAUDE) Database . . . . . . . . . . . . . . . . . . . . 3.2 MEDMARX Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Reducing PCA Medication Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Abstract
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Patient-controlled analgesia (PCA) is a common and effective means of managing postoperative pain. Unfortunately, the complex processes and equipment associated with the setup, programming and administration of intravenous or epidural PCA have allowed it to become a significant source of preventable medication errors. These errors can be classified into two major categories: human (operator) errors and equipment errors (malfunctions). Such errors are potentially harmful to patients, time-consuming for hospital staff and costly for healthcare providers. The objective of this article is to describe PCA medication errors and examine systems and modalities that may help reduce the incidence of system-related errors. Data from the US FDA’s Manufacturer and User Facility Device Experience (MAUDE) database indicate that 6.5% of intravenous PCA-related events were due to operator error. Most (81%) of these errors were due to pump misprogramming, of which almost half were associated with patient harm; 76.4% of adverse events were attributed to device mal
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