Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority PCA by Proxy—An Overdose of Care P atient-controlled analgesia (PCA) has consider- able potential to improve pain management for patients, allowing them to self-administer more fre- However, another report stated that during the chang- ing of a patient’s linens, the patient experienced se- vere sternal pain. When the patient was asked what quent but smaller doses of analgesia. When used as was wrong, he verbally expressed that he was in intended, PCA actually reduces the risk of over- pain. When asked if he was using his PCA button, the sedation, which is an unintended consequence of the patient responded "What button?" Further investiga- more traditional method of nurse-administered anal- tion by the organization revealed that the patient had gesia in larger, less frequent doses. In fact, with PCA, been given pain medication throughout the night, but patients often develop a synergism with the device the nurse had been pushing the button. The patient and can quickly learn how to manage their pain while had not received any education on pain control before avoiding undue mental clouding. the initiation of PCA therapy. Several safety features exist with PCA to make sure Similar cases have been reported to other patient patients do not receive too much analgesia. These safety reporting systems. For example, the USP- include a lockout interval that specifies the minimum ISMP Medication Errors Reporting Program (MERP), amount of time between each dose, and a maximum received a report involving nurse-controlled analgesia allowable amount that may be administered during a in which a 72-year-old woman, following cancer sur- set time interval. gery, was prescribed PCA with a 2 mg morphine load- ing dose and 1 mg every 10 minutes as needed (6 mg Another “built-in” safety feature that is often over- maximum per hour). Initially, the patient was restless looked is that the device is intended for patient use. A and agitated in the post-anesthesia care unit, but she sedated patient will not press the button to deliver remained obtunded after surgery. Despite the pa- more opiate, thus avoiding toxicity. However, family tient’s inability to verbalize pain, nurses pushed the members and health professionals have administered PCA button and delivered frequent doses of morphine doses for the patient, by proxy, hoping to keep them over the next 48 hours. Subsequently, the patient suf- comfortable. This well-intentioned effort has resulted fered a cardio-respiratory arrest and seizure, leading in cases of over-sedation, respiratory depression, and to hypoxic encephalopathy. She died several months even death.1 later without ever regaining consciousness.2 PA-PSRS has received a number of reports where In this case, the patient was most likely not a good family members activated the PCA bolus. In one such candidate for PCA, and adequate assessment tools report, a patient received morphine PCA at 1 mg/hr were not used to guide nurse-controlled analgesia. with a 1.5 mg patient-administered bolus every eight This patient was at risk for morphine toxicity because minutes as needed. When the attending physician she was obtunded, obese, and had compromised from the Pain Service entered the patient’s room, he lung capacity. Though vital signs were recorded peri- witnessed the patient’s boyfriend pushing the PCA odically (oxygen saturation monitoring was not used), button for the patient. The patient was placed on a nurses did not recognize the signs of morphine toxic- monitor, and it was noted that her oxygen saturation ity and continued to administer the analgesic despite had dropped to 40%. Her PCA was stopped, and she serious hypotension and very shallow respirations.2 was placed on 100% oxygen until her oxygen satura- tion improved. This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. 2—June 2005. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI & ISMP under contract to the Authority as PA-PSRS has also received reports of nurse- part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). controlled analgesia. Nurse-controlled analgesia may be used in critical care settings if patient selection Copyright 2005 by the Patient Safety Authority. This publication may be re- protocols have been established and assessment printed and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their tools are in place to guide the level of pain and seda- entirety and without alteration provided the source is clearly attributed. tion. To see other articles or issues of the Advisory, visit our web site at www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) PCA by Proxy—An Overdose of Care (Continued) Based on 15 reports of PCA error by proxy submitted sessment of vital signs, alertness, pulse oxi- to the U.S. Pharmacopeia (USP) medication error metry or capnography, and patient self-reported databases—12 cases were attributed to family mem- pain using a consistent pain scale. If support bers, two to a nurse, and one to a pharmacist.3 Based staff takes vital signs, a timely clinician’s review on this information, the Joint Commission on Accredi- is important. If continuous pulse oximetry or tation of Healthcare Organizations has recently is- capnography is not available for all patients, sued a Sentinel Event Alert, which is being distributed using it for those with heightened risk of toxicity to more than 8,500 accredited hospitals, critical ac- and when nurse-controlled analgesia is em- cess hospitals and home-care organizations across ployed may be wise. the country, on errors related to patient-controlled analgesia by proxy.3 • Requiring two clinicians to independently double check patient identification and PCA To help reduce the risk of overdoses with PCA, con- device dose settings prior to use (and each sider the following steps: pump refill) to detect possible errors. • Establishing selection criteria for PCA and • Educating patients and families about the nurse-controlled analgesia. While PCA is used proper use of PCA before initiation. Starting this for a wide range of patients to safely manage education during the preoperative testing visit pain (not agitation or restlessness), some pa- may improve patient understanding and recall. tients are unsuitable candidates due to level of Warning family members and visitors about the consciousness, psychological reasons, or lim- danger of PCA by proxy may also help to pre- ited intellectual capacity. Consider: vent this type of error.5 − The types of patients who may be suitable for nurse-controlled analgesia. • Educating staff about proper use of PCA. − Risk factors (age, weight, preexisting condi- One strategy is to encourage clinicians to critically tions, concomitant medications, etc.) that might think about the cumulative dose that the patient necessitate increased monitoring. could receive if the maximum dose limits were − Periodic reassessment of the appropriateness given. Ensuring that staff receives adequate train- of therapy at regular intervals.4 ing on all pumps that are used to deliver analgesics is also important. • Developing protocols and standardized or- der sets to guide the selection of drugs, dos- Notes ing, lockout periods, and infusion devices. Con- 1. ISMP. Medication Safety Alert! 10 Jul 2003; (8), 14. sider: 2. ISMP. Medication Safety Alert! 29 May 2002; (7), 11. − Avoiding use of meperidine (due to the risk 3. Joint Commission on Accreditation of Health Care Organiza- tions. Sentinel event alert: patient controlled analgesia by proxy of neurotoxicity), and if hydromorphone is [online]. 20 Dec 2004; (33). [Cited 2005 Feb 21.] Available from used, ensuring proper dosing based on Internet: http://www.jcaho.org/about+us/news+letters/ narcotic equivalents. sentinel+event+alert/sea_33.htm. − Prohibiting use of other analgesics while 4. ISMP. Nurse Advise-ERRTM. Feb 2005; (3), 2. PCA is being administered. 5. ISMP. Medication Safety Alert! 24 Jul 2003; (8), 15. • Increasing patient monitoring. Opiates, even at therapeutic doses, can suppress respiration, heart rate, and blood pressure, so the need for monitoring and observation cannot be overem- phasized. This can be more important during the first 24 hours and at night since the effects of opiate analgesics on intellectual functioning are not entirely predictable, and nocturnal hy- poxia can be a serious side effect. Monitoring parameters might include regular clinician as- Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 2 (June 2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP's efforts are built on a non-punitive approach and systems-based solutions. ©2005 Pennsylvania Patient Safety Authority Page 3