Patient-Controlled Analgesia-Related Medication Errors in the Postoperative Period

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 malfunction (e.g. due to frayed wires or a crack in the drug cartridge), although only 0.5% of these were associated with harm to patients. In a report based on data from MEDMARX®, a voluntary database that captures reports on medication errors, 7.9% of the PCA-related errors captured over a 5-year period were described as causing harm to patients. Technological advances, such as improved PCA pump designs based on ergonomic and cognitive engineering principles, the use of barcode technology and other ‘smart pump’ safety features, and new postoperative pain management modalities, may play a significant role in reducing the future incidence and severity of PCA medication errors.

[1]  K J Vicente,et al.  Patient-controlled analgesia. , 2001, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[2]  J. Sanchezguijo,et al.  Failure of a patient-controlled analgesia pump in a hyperbaric environment. , 1999, Anesthesiology.

[3]  David W. Bates,et al.  Information technology and patient safety in nursing practice: an international perspective , 2004, International Journal of Medical Informatics.

[4]  D. Bates,et al.  Identifying drug safety issues: from research to practice. , 2000, International journal for quality in health care : journal of the International Society for Quality in Health Care.

[5]  Kim J. Vicente,et al.  Applying Human Factors to the Design of Medical Equipment: Patient-Controlled Analgesia , 1998, Journal of Clinical Monitoring and Computing.

[6]  M. Sager,et al.  Adverse drug events in hospitalized elderly. , 1998, The journals of gerontology. Series A, Biological sciences and medical sciences.

[7]  Jerry Avorn,et al.  Computer-assisted drug data collection , 1992, Journal of Medical Systems.

[8]  K. J. Vicente,et al.  Electrical short circuit as a possible cause of death in patients on PCA machines: report on an opiate overdose and a possible preventive remedy. , 2001, Anesthesiology.

[9]  Jeffrey A. Grass,et al.  Patient-Controlled Analgesia , 2005, Anesthesia and analgesia.

[10]  Matthew C Grissinger Safety and patient-controlled analgesia: part 2: how to prevent errors. , 2008, P & T : a peer-reviewed journal for formulary management.

[11]  David W Bates,et al.  Variability in intravenous medication practices: implications for medication safety. , 2005, Joint Commission journal on quality and patient safety.

[12]  P. Myles,et al.  Analysis of demographic characteristics. , 1994, Anaesthesia and intensive care.

[13]  D. Bates,et al.  How can information technology improve patient safety and reduce medication errors in children's health care? , 2001, Archives of pediatrics & adolescent medicine.

[14]  D W Bates,et al.  Prevention of adverse drug events: a decade of progress in patient safety. , 2000, Journal of clinical anesthesia.

[15]  David W. Bates,et al.  Intelligent Intravenous Infusion Pumps to Improve Medication Administration Safety , 2003, AMIA.

[16]  G. Kuperman,et al.  Computer Physician Order Entry: Benefits, Costs, and Issues , 2003, Annals of Internal Medicine.

[17]  T. Brennan,et al.  Incidence and types of adverse events and negligent care in Utah and Colorado. , 2000, Medical care.

[18]  A. Benzer,et al.  Programming errors from patient-controlled analgesia , 2003, Canadian journal of anaesthesia = Journal canadien d'anesthesie.

[19]  D. Bates,et al.  Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. , 2003, Archives of internal medicine.

[20]  J. E. Ness,et al.  Accuracy of technicians and pharmacists in identifying dispensing errors. , 1994, American journal of hospital pharmacy.

[21]  W. Notcutt Overdose of opioid from patient controlled analgesia pumps. , 1992, British journal of anaesthesia.

[22]  Pascale Carayon,et al.  Using failure mode and effects analysis to plan implementation of smart i.v. pump technology. , 2006, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[23]  T. Woller,et al.  Checking of unit dose cassettes by pharmacy technicians at three Minnesota hospitals. , 1991, American journal of hospital pharmacy.

[24]  P. Kanjanarat,et al.  Nature of preventable adverse drug events in hospitals: a literature review. , 2003, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[25]  Z. T. Grapes,et al.  Factors associated with preventable adverse drug reactions. , 1994, American journal of hospital pharmacy.

[26]  P. White,et al.  Mishaps with patient-controlled analgesia. , 1987, Anesthesiology.

[27]  W. Nelson,et al.  System-Related Events and Analgesic Gaps During Postoperative Pain Management with the Fentanyl Iontophoretic Transdermal System and Morphine Intravenous Patient-Controlled Analgesia , 2007, Anesthesia and analgesia.

[28]  K. Lehmann Patient-Controlled Analgesia: An Efficient Therapeutic Tool in the Postoperative Setting , 1999, European Surgical Research.

[29]  R. D. Paoletti,et al.  Using bar-code technology and medication observation methodology for safer medication administration. , 2007, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[30]  H. Turndorf,et al.  Satisfaction with epidural and intravenous patient-controlled analgesia. , 2001, Pain medicine.

[31]  Kim J. Vicente,et al.  Patient Safety, Potential Adverse Drug Events, and Medical Device Design: A Human Factors Engineering Approach , 2001, J. Biomed. Informatics.

[32]  N. Dickey,et al.  Systems analysis of adverse drug events. , 1996, JAMA.

[33]  D. Bates,et al.  Adverse drug events and medication errors: detection and classification methods , 2004, Quality and Safety in Health Care.

[34]  R. Hicks,et al.  Errors involving PCA pumps , 2004 .

[35]  L L Leape,et al.  Preventing medical injury. , 1993, QRB. Quality review bulletin.

[36]  David W Bates,et al.  Medication Dispensing Errors and Potential Adverse Drug Events before and after Implementing Bar Code Technology in the Pharmacy , 2006, Annals of Internal Medicine.

[37]  C. Patterson,et al.  Joint Commission on Accreditation of Healthcare Organizations. , 1995 .

[38]  J. Torrie,et al.  Safety assessment of postoperative pain management by an acute pain service , 1993, Pain.

[39]  R. Etches Patient-controlled analgesia. , 1999, The Surgical clinics of North America.

[40]  David W. Bates,et al.  A controlled trial of smart infusion pumps to improve medication safety in critically ill patients* , 2005 .

[41]  D. Bates,et al.  Relationship between medication errors and adverse drug events , 1995, Journal of General Internal Medicine.

[42]  G J Kuperman,et al.  Patient safety and computerized medication ordering at Brigham and Women's Hospital. , 2001, The Joint Commission journal on quality improvement.

[43]  David W Bates,et al.  How many hospital pharmacy medication dispensing errors go undetected? , 2006, Joint Commission journal on quality and patient safety.

[44]  D. Bates,et al.  The Critical Care Safety Study: The incidence and nature of adverse events and serious medical errors in intensive care* , 2005, Critical care medicine.

[45]  A. Domínguez-Gil,et al.  Acontecimientos adversos prevenibles causados por medicamentos en pacientes hospitalizados , 2006 .

[46]  D W Bates,et al.  Medication Errors , 1996, Drug safety.

[47]  L. Kohn,et al.  To Err Is Human : Building a Safer Health System , 2007 .

[48]  R. Morgan,et al.  Introducing patient‐controlled analgesia for postoperative pain control into a district general hospital , 1990, Anaesthesia.

[49]  Jens Rasmussen,et al.  Information Processing and Human-Machine Interaction: An Approach to Cognitive Engineering , 1986 .

[50]  T. Grey,et al.  Patient-Controlled Analgesia , 1988 .

[51]  P. Macintyre,et al.  Safety and efficacy of patient-controlled analgesia. , 2001, British journal of anaesthesia.

[52]  A. Robicsek,et al.  5 Million Lives Campaign , 2008 .

[53]  Brown Sl,et al.  Human error and patient-controlled analgesia pumps. , 1997 .

[54]  E. Chevlen Opioids: A review , 2003, Current pain and headache reports.

[55]  Kim J. Vicente,et al.  Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability , 2003, Canadian journal of anaesthesia = Journal canadien d'anesthesie.

[56]  David W Bates,et al.  Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities. , 2002, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[57]  J. Gagne,et al.  The Rate and Costs Attributable to Intravenous Patient-Controlled Analgesia Errors , 2009 .

[58]  H. Owen,et al.  Patient‐controlled analgesia—the need for caution , 1988, Anaesthesia.

[59]  P. Rolland Occurrence of Dispensing Errors and Efforts to Reduce Medication Errors at the Central Arkansas Veteran’s Healthcare System , 2004, Drug safety.

[60]  B. Bivins,et al.  Patient‐Controlled Analgesia: A New Concept of Postoperative Pain Relief , 1982, Annals of surgery.

[61]  S. Schug,et al.  The safety and utilization of patient-controlled analgesia. , 1997, Journal of pain and symptom management.

[62]  J. Avorn Putting adverse drug events into perspective. , 1997, JAMA.

[63]  D. Bates,et al.  Improving safety with information technology. , 2003, The New England journal of medicine.

[64]  D. Bates,et al.  Medication errors and adverse drug events in pediatric inpatients. , 2001, JAMA.

[65]  C. Inturrisi Clinical Pharmacology of Opioids for Pain , 2002, The Clinical journal of pain.

[66]  J. Avorn Dangerous deception--hiding the evidence of adverse drug effects. , 2006, The New England journal of medicine.

[67]  R. Hicks,et al.  Medication errors involving patient-controlled analgesia. , 2008, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[68]  Brian L. Erstad,et al.  Medication errors and adverse drug events in an intensive care unit: Direct observation approach for detection , 2006, Critical care medicine.

[69]  J. Lau,et al.  Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain. , 2006, The Cochrane database of systematic reviews.

[70]  N. Laird,et al.  Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention , 1995 .

[71]  R. Polomano,et al.  The Impact of Technology on the Analgesic Gap and Quality of Acute Pain Management , 2004, Regional Anesthesia & Pain Medicine.

[72]  D. Bates,et al.  Systems analysis of adverse drug events. ADE Prevention Study Group. , 1995, JAMA.

[73]  John A. Clark,et al.  Adverse events involving intravenous patient-controlled analgesia. , 2007, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[74]  B. Walder,et al.  Efficacy and safety of patient‐controlled opioid analgesia for acute postoperative pain , 2001, Acta anaesthesiologica Scandinavica.

[75]  W. J. Russell,et al.  The ‘'Wrong Drug” Problem in Anaesthesia: An Analysis of 2000 Incident Reports , 1993, Anaesthesia and intensive care.

[76]  R. Hicks,et al.  Medication errors in the PACU. , 2007, Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses.

[77]  D. Bates,et al.  Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units. , 1997, Critical care medicine.

[78]  D. Eade Patient‐Controlled Analgesia—Eliminating Errors , 1997, Nursing management.

[79]  David W. Bates,et al.  Effective drug-allergy checking: methodological and operational issues , 2003, J. Biomed. Informatics.