Risk management and safety in the use of patient-controlled analgesia pumps: a scoping review

Silva, Thamires Ribeiro da; Moraes, Erica Brandão de; Poubel, Juliana Gomes; Figueiredo, Carolina Rosa; Pereira, Anderson de Souza

doi:10.5935/2595-0118.20230041-en

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REVIEW ARTICLE • BrJP 6 (2) • Apr-Jun 2023 • https://doi.org/10.5935/2595-0118.20230041-en copy

Risk management and safety in the use of patient-controlled analgesia pumps: a scoping review

Authorship SCIMAGO INSTITUTIONS RANKINGS

HIGHLIGHTS

Risk management in pain management is of utmost importance.
The use of the patient-controlled analgesia pump requires that proactive risk measures are implemented in order to ensure patient safety.
Risk situations were identified that can assist the professional in the implementation of these preventive measures, such as: programming failures; defective pump; inappropriate patient selection; lack of education and training of professionals, patient and family; errors in prescription, dispensing, preparation and administration of drugs.

ABSTRACT

BACKGROUND AND OBJECTIVES:

Patient-controlled analgesia (PCA) is effective in controlling pain, but has numerous associated risks, such as: hypotension, respiratory depression, seizures and excessive sedation. The promotion of patient safety aims to reduce the risk of unnecessary health injuries and, therefore, it is important to analyze the failures and risk factors present throughout the process proactively. Therefore, the aim of this study was to map the available evidence on the risks of adverse events associated with the PCA technique and patient safety actions.

This is a scoping review conducted according to the JBI methodology, whose research question was based on the PCC strategy. The source of information is open and the search occurred in three stages. The databases used were: Medline/Pubmed; LILACS; CINAHL/ EBSCOhost; CENTRAL; Portal Capes; SCOPUS; Web of Science; Google academic; Brazilian Digital Library of Theses and Dissertations; Portal NICE; and Portal ISMP. The search strategy was divided into 3 stages: the first occurred in Medline and Cinahl to identify articles and index terms on the topic; the second used all keywords in all included databases; the third consisted of tracking searches in the reference lists of the included studies. The search resulted in 1,164 studies, of which 83 were selected based on the inclusion criteria: addressing the risks associated with the PCA pump or safety measures, hospital context, without restriction as to the type of study, language, and year. The studies are distributed in categories: previous diseases, profile of indications, types of opioids, types of pump and infusion, adverse effects, incidents without harm, stages of risk, and safety measures.

CONCLUSION:

This study made it possible to identify the risks of adverse events associated with the use of PCA in different stages and safety actions, demonstrating that when performed with appropriate patients, trained staff, safe devices, and correct prescription it provides a statistically significant improvement in pain relief, safely with advantages that conventional analgesia does not have.

Keywords
Patient safety; Patient controlled analgesia; Risk management

Search	Question	Records retrieved
#1	“Analgesia, Patient-Controlled” [MESH] OR “Analgesia, Patient Controlled” [tw] OR “Patient-Controlled Analgesia” [tw] OR “Patient Controlled Analgesia” [tw]	6,751
#2	“Patient Safety” [MESH] OR “Safety, Patient” [tw] OR “Medical Errors” [MESH] OR “Safety” [MESH] OR “Medical Mistakes” [tw] OR “Mistake, Medical” [tw] OR “Mistakes, Medical” [tw] OR “Errors, Medical” [tw] OR “Error, Medical” [tw] OR “Medical Error” [tw] OR “Medical Mistake” [tw] OR “Never Event” [tw] OR “Event, Never” [tw] OR “Events, Never”	193,624
#3	“Risk Management” [MESH] OR “Management, Risk” [tw] OR “Management, Risks” [tw] OR “Risks Management” [tw]	323,334
#4	Search #1 AND (#2 OR #3)	231

Authors	Type of study	Subject	Results
Vicente et al.⁴⁴44 Vicente KJ, Bekhaled KK, Hillel G, Cassano A, Orser BA. Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability. Can J Anaesth. 2003;50(4):328-32.	Case report	Risk factors for adverse event associated with PCA pump and safety measures.	Programming error with inadequate dose adjustment has resulted in overdose and death. Anaesthesiologists, nurses, engineers and manufacturers can redesign pump interfaces and drug cassettes to minimize programming errors and improve their detection.
Reimer⁵³53 Reimer HD. Intravenous dead space and patient safety in patient-controlled analgesia. Can J Anaesth. 1995;42(7):658.	Letter to the editor	Risk factor for adverse event associated with PCA pump.	Failure to account for pump dead space volume and lockout interval can lead to opioid overdoses.
White¹¹⁵115 White E. A problem with the Graseby 3300 PCA pump. Anaesthesia. 1993;48(11):1013-4.	Editor’s letter	Importance of knowing the pump for PCA safety.	Pump features are important in the safety of PCA, but are not a substitute for professional supervision and monitoring.
Lederer, Benzer and Doyle²⁶26 Lederer W, Benzer A, Doyle DJ. Programming errors from patient-controlled analgesia. Can J Anaesth. 2003;50(8):854-6.	Editor’s letter	Risk factors associated with PCA.	The unpreparedness of the professional involved in PCA programming increases the risks of adverse events, so they should avoid: stress, alcohol or drugs, fatigue and emotional upset.
Prewitt et al.⁹⁷97 Prewitt J, Schneider S, Horvath M, Hammond J, Jackson J, Ginsberg B. PCA safety data review after clinical decision support and smart pump technology implementation. J Patient Saf. 2013;9(2):103-9.	Cohort	Adverse events, risk factors and safety measures associated with PCA.	The following risk factors were identified: advanced age, renal failure, COPD, morbid obesity and sleep apnea. Incidents such as the wrong opioid and concentration selection and concomitant administration of benzodiazepines occurred. Smart pumps and monitoring are recommended.
Paul et al.³⁸38 Paul JE, Bertram B, Antoni K, Kampf M, Kitowski T, Morgan A, Cheng J, Thabane L. Impact of a comprehensive safety initiative on patient-controlled analgesia errors. Anesthesiology. 2010;113(6):1427-32.	Cohort longitudinal	Errors and safety measures associated with PCA.	The incidence of errors in PCA is low (less than 1%), but most occur in administration. Possible safety improvements are: well-designed pumps, printed medical orders, nursing education, independent double-checking, manuals, handover process and computerized order delivery system.
Paul et al.⁹⁴94 Paul JE, Buckley N, McLean RF, Antoni K, Musson D, Kampf M, Buckley D, Marcoux M, Frketich R, Thabane L, Cheng J. Hamilton acute pain service safety study: using root cause analysis to reduce the incidence of adverse events. Anesthesiology. 2014;120(1):97-109.	Prospective cohort	Adverse events and safety measures associated with PCA.	Following the introduction of the Root Cause Analysis process a reduction in the incidence of respiratory depression, severe hypotension and programming errors was noted.
Viscusi¹¹¹111 Viscusi ER. Emerging treatment modalities: balancing efficacy and safety. Am J Health Syst Pharm. 2007;64(4):S6-11.	Controlled clinical trial	Risk factors associated with PCA.	PCA is subject to programming errors, tampering, unauthorized drug administration (proxy PCA) and malfunction.
Tran et al.⁸⁹89 Tran M, Ciarkowski S, Wagner D, Stevenson JG. A case study on the safety impact of implementing smart patient-controlled analgesic pumps at a tertiary care academic medical center. Jt Comm J Qual Patient Saf. 2012;38(3):112-9.	Case study	Risks and safety measures associated with PCA pump.	PCA programming errors were identified. 159 potential errors were avoided within six months after implementing smart pumps with barcode verification of concentration and dosage limits.
Ahmad et al.²³23 Ahmad I, Thompson A, Frawley M, Hu P, Heffernan A, Power C. Five-year experience of critical incidents associated with patient-controlled analgesia in an Irish University Hospital. Ir J Med Sci. 2010;179(3):393-7.	Prospective observational study	Risk factors associated with critical incidents in PCA patient safety.	Three main categories of incidents were identified; programming errors, policy violations and patient selection. The largest contributing factor to PCA ICs was scheduling error. Strategies to minimize this problem include better education and vigilance.
Ohashi et al.³⁴34 Ohashi K, Dykes P, Mcintosh K, Buckley E, Yoon C, Luppi C, Bane A, Bates DW. Evaluation of use of electronic patient controlled analgesia pumps to improve patient safety in an academic medical center. Stud Health Technol Inform. 2014;201:153-9.	Observational prevalence study	Risk factors associated with PCA pump.	Many errors related to correct identification of routes of administration, use of unauthorized drugs, inappropriate scheduling were highlighted. It is suggested to educate nurses, stressing the importance of labeling the routes, standardize the process of handling PCA, how and implement safety package.
Chumbley et al.⁸⁰80 Chumbley GM, Ward L, Hall GM, Salmon P. Pre-operative information and patient-controlled analgesia: much ado about nothing. Anaesthesia. 2004;59(4):354-8.	Randomized controlled trial	Effectiveness of preoperative information related to PCA.	Patients in the leaflet group were better informed about PCA, became familiar with PCA use more quickly, and were less confused than the control group. However, there were no effects on pain relief, concerns about addiction and safety, and knowledge of adverse effects. There was no benefit from the preoperative interview.
and Salmon⁸¹81 Chumbley GM, Hall GM, Salmon P. Patient-controlled analgesia: what information does the patient want? J Adv Nurs. 2002;39(5):459-71.	Randomized uncontrolled trial	Measures that make PCA effective and safe.	Information leaflet on adverse effects and instructions on the technique with clear language facilitated the use of PCA.
Akridge⁴⁵45 Akridge J. New pumps outsmart user error. 2011 [acesso em 2022 25 out]. Disponível em: https://cdn.hpnonline.com/inside/2011-04/1104-OR-Pumps.html. https://cdn.hpnonline.com/inside/2011-04...	Clinical practice guide	PCA pump safety measures.	Smart pumps with built-in drug library and dose limits at various concentrations prevent medication errors.
Pasero³⁹39 Pasero CL. PCA: for patients only. Am J Nurs. 1996;96(9):22-3.	Clinical practice guide	Risk factor for adverse event associated with PCA pump and safety measures.	Triggering PCA by family members is dangerous and therefore patient and family should be educated.
Cohen¹⁹19 Cohen H. Avoid PCA errors with education. Don’t let family members administer medication. Hospital Home Health. 2004;21(5):56-7.	Clinical practice guide	Medication errors associated with PCA pumps.	The most frequently cited practice-related problems: incorrect PCA pump programming, a variety of programming steps, proper patient selection, family interference in analgesic administration.
Institute For Safe Medication Practices¹⁷17 Institute For Safe Medication Practices. Safety Issues with Patient-Controlled Analgesia Part I - How erros occur. KBN Connection. 2005;3(1):21-3.	Clinical practice guide	Adverse events during PCA use.	PCA has great potential to improve pain management. However, it is necessary to know the factors that often contribute to the occurrence of adverse events during its use.
Institute For Safe Medication Practices²⁷27 Institute For Safe Medication Practices. Safety Issues with Patient-Controlled Analgesia Part II - Pratical Error-Reduction Strategies. KBN Connection. 2005;3(1):21-3.	Clinical practice guide	Strategies employed to reduce risks associated with PCA.	Practical strategies that reduce the risk of adverse events are described.
Cohen²⁹29 Cohen MR. Safety issues with patient-controlled analgesia wake-up call: unlabeled containers lead to patient’s death. Hospital Pharmacy. 2005;40(2):117-26.	Clinical practice guide	Risk factors and safety measures associated with PCA.	Problems associated with PCA: proxy activation, improper patient selection, failure to monitor, failure to educate the patient, mixing medications, programming errors, device design failure, improper training, and prescribing errors. Some security measures cited were labeling and regular security rounds.
Pasero C and McCaffery M⁹³93 Pasero C, McCaffery M. Authorized and unauthorized use of PCA pumps: clarifying the use of patient-controlled analgesia, in light of recent alerts. Am J Nurs. 2005;105(7):30-1, 33.	Clinical practice guide	Authorization for use of PCA pumps.	Conditions for use of other sedatives should be identified, provide adequate monitoring and rapid intervention in case of complications.
Weir¹¹⁴114 Weir VL. Preventing adverse drug events. Nurs Manag. 2005;36(9):24-30.	Clinical practice guide	Evaluation of the PCA infusion system.	Need for changes to improve patient safety. Improvement for infusion monitoring. Integration of wireless connectivity decreases adverse events by 12%. For home use of PCA there is a need for improvement.
D’arcy²⁴24 D’arcy Y. Eyeing capnography to improve PCA safety. Nursing. 2007;37(9):18-9.	Clinical practice guide	Use of oximetry or capnography in monitoring opioid respiratory depression via PCA pump.	Capnography is the most reliable indicator for monitoring respiratory depression due to opioid use during PCA. Professionals should associate the other safety measures during the use of PCA by the patient.
Cohen⁵⁴54 Cohen MR. Misprogramming patient-controlled analgesia concentration leads to dosing errors. Hospital Pharmacy. 2008;43(12):960-4.	Clinical practice guide	Safety measures associated with PCA.	Recommendations to reduce programming errors: assess vulnerability to serious errors, limit concentrations, distinguish custom concentrations, clarify labels, employ independent double-checking, use barcode technology, use smart pumps and standardization of commands by pump suppliers.
D’arcy²⁵25 D’arcy Y. Keep your patient safe during PCA. Nursing. 2008;38(1):51-5.	Clinical practice guide	Risk factors and safety measures associated with PCA.	Problems associated with PCA are inadequate patient selection, use of continuous infusion in opioid-naïve patients, proxy PCA and scheduling errors. Safety measures involve: use of smart pumps, training, independent verification, monitoring with capnography and pulse oximetry.
American Nurse Association⁴⁸48 American Nurse Association. Avoid the dangers of opioid therapy. 2009 [acesso em 2022 25 out]. Disponível em: https://www.myamericannurse.com/avoid-the-dangers-of-opioid-therapy/. https://www.myamericannurse.com/avoid-th...	Clinical practice guide	Safety measures associated with PCA.	It is important to obtain patient’s health history, analyze risks, individualize dosage, monitor carefully, offer psychotherapeutic options in interdisciplinary team, maintain list of dangerous drugs and provide methods to decrease confusion between drugs.
Reg and David¹⁰⁴104 Reg S, David L. Respiratory care departments take a lead role in postoperative monitoring. J Respir Care Pract. 2013;25(7):8-12.	Clinical practice guide	Safety measures associated with the use of PCA in the postoperative period.	Spot checks of oxygenation with pulse oximetry and respiratory rate are not reliable to detect drug-induced respiratory depression. Continuous electronic monitoring of ventilation and oxygenation are preferable for any postoperative patient on opioids. Capnography should be used if that patient is on supplemental oxygen.
Stewart⁵¹51 Stewart D. Pearls and pitfalls of patient-controlled analgesia. US Pharm. 2017;42(3):24-7.	Clinical practice guide	Safety measures associated with PCA.	The study cites that there should be a rational framework for patient selection, analgesic agents, initial doses and subsequent dose adjustments.
Weininger et al.¹¹³113 Weininger S, Jaffe MB, Rausch T, Goldman JM. Capturing essential information to achieve safe interoperability. Anesth Analg. 2017;124(1):83-94.	Clinical practice guide	Safety measures associated with PCA.	The application of platform-based solutions to PCA pump enables a safety lockdown that responds to respiratory depression.
Notcutt and Morgan³¹31 Notcutt WG, Morgan RJ. Introducing patient-controlled analgesia for postoperative pain control into a district general hospital. Anaesthesia. 1990;45(5):401-6.	Longitudinal retrospective	PCA in postoperative pain management.	The identification of specific hazards and management issues has led to improvements in the safety of the patient-controlled analgesia system.
Schug and Torrie¹⁰⁰100 Schug SA, Torrie JJ. Safety assessment of postoperative pain management by an acute pain service. Pain. 1993;55(3):387-91.	Longitudinal retrospective	PCA in postoperative pain management..	PCA compared with other systemic opioid administration techniques did not result in a higher number of complications.
Sidebotham, Dijkhuizen and Schug¹⁰²102 Sidebotham D, Dijkhuizen MR, Schug SA. The safety and utilization of patient-controlled analgesia. J Pain Symptom Manage. 1997;14(4):202-9.	Longitudinal retrospective	Risk factors for adverse event associated with PCA pump and safety measures.	The risk of serious complications associated with PCA is low, with the exception of hypoxemia and bradypnea. High-risk patients should be identified and prescribed with caution.
Teng et al.¹⁰⁹109 Teng Y, Hu JS, Tsai SK, Liew C, Lui P. Efficacy and adverse effects of patient-controlled peridural or intravenous analgesia after major surgery. Chang Gung Med J. 2004;27(12):877-86.	Longitudinal retrospective	Efficacy and adverse effects among PCA models.	Patients receiving epidural fentanyl-bupivacaine experienced better overall pain relief, whereas morphine via PCA, epidural or intravenous caused more adverse effects. The use of continuous epidural PCA with fentanyl-bupivacaine is considered safer in patients undergoing elective major surgery.
Hankin et al.⁸⁶86 Hankin CS, Schein J, Clark JA, Panchal S. Adverse events involving intravenous patient-controlled analgesia. Am J Health Syst Pharm. 2007;64(14):1492-9.	Longitudinal retrospective	Adverse events involving intravenous administration of PCA.	Malfunctioning pumps were one of the main causes of adverse events reported. Operator errors were the most likely to be associated with more serious adverse outcomes. Incidences of major problems and vulnerabilities of PCA pumps should be identified and addressed.
Lee, Kim and Kim⁹¹91 Lee Y, Kim K, Kim M. CE: original research: errors in postoperative administration of intravenous patient-controlled analgesia: a retrospective study. Am J Nurs. 2019;119(4):22-7.	Longitudinal retrospective	Risk factors associated with postoperative PCA.	The main errors were: incorrect programming, device malfunction, prescription and patient error. Of the 222 operator errors, the most frequent type was failure to initiate drug administration, followed by programming errors by non-anaesthetic providers not authorized to program the device and wrong infusion rates set by authorized anaesthetists.
Hicks et al.⁸⁸88 Hicks RW, Sikirica V, Nelson W, Schein JR, Cousins DD. Erros de medicação envolvendo analgesia controlada pelo paciente. Am J Health Syst Pharm. 2008;65(5):429-40.	Longitudinal retrospective	Risk factors and safety measures associated with PCA.	Causes of errors involve: human factors, equipment, communication, systems error, storage, labeling, packaging, documentation, contraindications, name confusion and incorrect order entry. Safety measures are: easy-to-set-up equipment, independent double-checking, standardized forms and staff training.
Moss ⁹²92 Moss J. Reducing errors during patient-controlled analgesia therapy through failure mode and effects analysis. Jt Comm J Qual Patient Saf. 2010;36(8):359-64.	Longitudinal retrospective	Implementation of Failure Modes and Effects Analysis (FMEA) as a strategy for identifying and correcting PCA failure modes.	In 2004, when most corrective actions were taken, there were 22 reported PCA errors. In October 2007, a new online occurrence reporting program was implemented, making reporting much easier. From October 2007 to September 2008, there were only 8 reported PCA errors, representing a 69% reduction from baseline. No serious adverse events were associated with any of these PCA errors.
Weber, Ghafoor and Phelps⁵⁶56 Weber LM, Ghafoor VL, Phelps P. Implementation of standard order sets for patient-controlled analgesia. Am J Health Syst Pharm. 2008;65(12):1184-91.	Longitudinal retrospective	PCA safety measures.	A standard order set was implemented, which decreased the number of cases of respiratory depression.
Peters, Mcguire and Ridling⁹⁵95 Peters L, Mcguire T, Ridling D. Proactive patient safety and opioids: failure mode effect analysis (FMEA) applied to patient controlled analgesia (PCA). J Pain. 2014;15(4):S94.	Longitudinal retrospective	Safety measure linked to PCA.	Failure Model and Effect Analysis (FMEA) applied by an interdisciplinary team was implemented to systematically identify risks associated with specific causes. In PCA FMEA identifies the failure; assigns severity, occurrence and classification; calculates the risk priority number (RPN); evaluates the results of interventions.
Pon and Huang⁹⁶96 Pon D, Huang J. Identification of inappropriate patient-controlled analgesia (PCA) prescribing patterns to improve patient safety. J Pain. 2015;16(Suppl): S88.	Longitudinal retrospective	Risk factors and safety measures associated with PCA.	PCA may be related to adverse events due to very high bolus doses, particularly in opioid-naive patients. Invested in prescriber education and modification of the order form.
Ladak et al.⁹⁰90 Ladak SS, Chan VW, Easty T, Chagpar A. Right medication, right dose, right patient, right time, and right route: how do we select the right patient-controlled analgesia (PCA) device? Pain Manag Nurs. 2007;8(4):140-5.	Observational descriptive	Safety measures related to PCA.	A key strategy to improve patient safety is the development of an interdisciplinary team and smart pumps.
Tsui et al.¹⁴14 Tsui SL, Irwin MG, Wong CM, Fung SK, Hui TW, Ng KF, Chan WS, O’Reagan AM. An audit of the safety of an acute pain service. Anaesthesia. 1997;52(11):1042-7.	Protocol	Adverse events and risk factors associated with PCA.	Episodes of bradypnea, hypercapnia and oxygen desaturation were identified, associated with female gender and systemic analgesia. Monitoring is recommended.
Chisakuta⁷⁷77 Chisakuta AM. Nurse-call button on a patient-controlled analgesia pump. Anaesthesia. 1993;48(1):90.	Case report	Risk factor for PCA-associated adverse event.	Confusing the PCA button with the nurse call button can lead to a dangerous overdose.
Heath⁸⁷87 Heath ML. Safety of patient controlled analgesia. Anaesthesia. 1995;50(6):573.	Case report	Risk factor for adverse event associated with PCA pump.	Programming of the pump by anesthesiologists and resetting the parameters to zero at the end of each procedure increases the safety of PCA.
Berry⁷⁹79 Berry K. Root cause analysis in response to a “Near Miss”. J Healthc Qual. 2000;22(2):16-8.	Case report	Measures to make PCA effective and safe.	A root cause analysis system increases the effectiveness and safety of PCA.
Farbstein and Clough⁸³83 Farbstein K, Clough J. Improving medication safety across a multihospital system. Jt Comm J Qual Improv. 2001;27(3):123-37.	Case report	Adverse events and risk factors associated with PCA.	PCA-related incidents were: pump failure, ordering error, administration and dispensing. The team implemented the following actions: checklist; pump standardization; revised order forms; references for medication calculations; staff education and manual.
Elannaz et al.¹⁶16 Elannaz A, Chaumeron A, Viel E, Ripart J. Morphine overdose due to cumulative errors leading to ACP pump dysfunction. Ann Fr Anesth Reanim. 2004;23(11):1073-5.	Case report	Adverse event related to PCA pump defect.	The incident was the result of multiple misuse: a disconnection of the tubing between the morphine bag and the patient, thus bypassing the anti-siphon valve, and an PCA cassette incorrectly stuck in an open position not detected by the pump. This indicates that vigilance must remain strict despite the widespread routine use of PCA.
Musshoff, Padosch and Madea²⁰20 Musshoff F, Padosch S, Madea B. Death during patient-controlled analgesia: piritramide overdose and tissue distribution of the drug. Forensic Sci Int. 2005;154(2-3):247-51.	Case report	Adverse event associated with the use of PCA.	Mortality from user programming errors in PCA was estimated as a low probability event. Experts recommend mechanisms to improve the safety of medical devices.
Dunwoody, Skledar and Freeman⁵⁵55 Dunwoody C, Skledar S, Freeman S. Changes in patient-controlled analgesia following a meperidine overdose. Jt Comm J Qual Patient Saf. 2006;32(9):528-30.	Case report	Safety issues with Meperidine use in PCA.	This provided a review of adverse events that were the basis for preventing unintended harm from PCA use. Drop in meperidine use to less than 10% of total opioid use. Adverse events decreased from 12 to less than 2 events per year.
Cohen and Smetzer¹⁸18 Dev R, Fabbro ED, Bruuera E. Patient-controlled analgesia in patients with advanced cancer. Should patients be in control? J Pain Symptom Manage. 2011;42(2):296-300.	Case report	Adverse event associated with PCA.	The use of PCA in cancer patients may be beneficial for initial opioid titration but has the potential to induce or exacerbate delirium.
Russell, Middleton and Hale⁹⁸98 Russell J, Middleton C, Hale J. PCA test protocol delivers potentially fatal morphine overdose . Anaesthesia. 2012;67(7):802.	Case report	Incident associated with PCA pump.	The pump was reset to default programming. With a different morphine dosage setting than administered caused an overdose, with no harm to the patient. This was recorded as device malfunction.
Hicks⁷⁸78 Hicks RW. Death by PCA. AORN. 2013;99(66):782-832.	Case report	Risks, adverse events and safety measures associated with PCA.	The pump was improperly programmed, leading to morphine overdose and death. There were failures to double-check the device and to identify the adverse effects of opioids. Smart pumps, trained staff, electronic ordering, barcoded medications, capnography monitoring and continuous pulse oximetry are recommended.
Grissinger⁴¹41 Grissinger M. Fatal PCA adverse events continue to happen: better patient monitoring is essential to prevent harm. P T. 2016;41(12):736-7.	Case report	Risk factors, adverse events and safety measures associated with PCA.	One PCA-related death revealed numerous flaws. High-dose morphine was prescribed in an obese, opioid-naive patient, without continuous or frequent monitoring, with uninformed family who administered and also pressed the PCA button. Appropriate prescribing, patient and family education, and adequate monitoring are recommended.
Institute For Safe Medication Practices⁴³43 Institute For Safe Medication Practices. Worth Repeating… Recent PCA By Proxy Event Suggests Reassessment of Practices that May Have Fallen by the Wayside. 2016 [acesso em 2022 25 out]. Disponível em: https://www.ismp.org/resources/worth-repeating-recent-pca-proxy-event-suggests-reassessment-practices-may-have-fallen. https://www.ismp.org/resources/worth-rep...	Case report	Risk factors, adverse events and safety measures related to proxy PCA.	A confused postoperative patient with delirium received high doses of analgesia by the activation of the pump by the companion, generating respiratory depression. There were failures in patient selection, family and staff education, signaling the prohibition of button use by others, and monitoring. Attention should be paid to patient, family and staff education, appropriate patient selection, visual reminders to avoid dose activation by anyone other than the patient and adequate monitoring.
Ferguson, Williams and Beard⁸⁴84 Ferguson R, Williams ML, Beard B. Combining quality improvement and staff development efforts to decrease patient-controlled analgesia pump errors. J Nurses Staff Dev. 2010;26(5):E1-4.	Experience report	Educational strategies employed to reduce errors associated with PCA.	The results of this investigation showed that there was a clinically significant difference in PCA pump errors, and this is also true statistically. Therefore, the educational intervention was effective in decreasing errors with the PCA pump.
Thomas and Rose¹¹⁰110 Thomas VJ, Rose FD. Patient-controlled analgesia: a new method for old. J Adv Nurs. 1993;18(11):1719-26.	Review	Measures to make PCA effective and safe.	The appropriate choice of opioid, settings for the demand dose and lockout interval influence the safety of PCA.
Institute for Safe Medication Practices⁴⁶46 Kluger MT, Owen H. Patient-controlled analgesia: can it be made safer? Anaesth Intensive Care. 1991;19(3):412-20.	Literature review	Safety actions in patient-controlled analgesia in teaching hospitals.	Effectiveness and safety of PCA can be achieved with patient selection, comprehensive education and equipment familiarization.
Langdale⁴4 Langdale A. Analgésie contrôlée par le patient. Bénéfices, risques, modalités de surveillance. Ann Fr Anesth Réanim. 1998;17(6):58-98.	Literature review	Measures to make PCA effective and safe.	Patient and nurse education and protocols specifying prescribing, monitoring and treatment of adverse effects are key to PCA safety.
Etches³⁶36 Etches RC. Patient-Controlled analgesia. Surg Clin North Am. 1999;79(2):297-312.	Literature review	PCA in postoperative pain management.	PCA in appropriately selected patients has superior analgesia to traditional models.
Stone and Wheatley¹⁰⁵105 Stone M, Wheatley B. Patient-controlled analgesia. Br J Anaesth. 2002;2(3): 79-82.	Literature review	Risk factors for adverse event associated with PCA pump and safety measures.	Risk factors for respiratory depression are: background infusion, morphine bolus >1mg, elderly, respiratory disease, proxy control, concomitant sedatives, operator error and equipment failure. Safety measures are: staff education, pump standardization, provision of clear instructions, human resources, monitoring and management plan.
Hicks et al.³²32 Hicks RW, Becker SC, Krenzischeck D, Beya SC. Medication errors in the PACU: a secondary analysis of MEDMARX findings. J Perianesth Nurs. 2004;19(1):18-28.	Literature review	Medication errors in PACUs.	Errors resulted in a higher than expected harm threshold (6.8%), with the majority of errors occurring during the administration phase (59%). Almost a quarter of the errors involved an inappropriate dose of a medication. Three-quarters of errors were influenced by distractions. More than 130 different products were present in the sample of cases analyzed. Problem areas identified involved epidural analgesia, patient-controlled analgesia and duplicate doses.
Cohen and Smetzer²⁸28 Cohen MR, Smetzer J. Patient-controlled analgesia safety issues. J Pain Palliat Care Pharmacother. 2005;19(1):45-50.	Literature review	Risk factors related to patient safety in PCA.	PCA by proxy, appropriate selection of patients for PCA, patient monitoring, patient education, medication mix-ups and prescription-related errors.
Tan and Schug¹⁰⁷107 Tan TY, Schug SA. Safety aspects of postoperative pain management. Rev Analg. 2006;9(1):45-53.	Literature review	Use of PCA in patients being treated for acute pain.	PCA alone had a significantly lower rate of respiratory depression than PCA with background infusion or continuous morphine infusion. No serious complications resulting in morbidity or mortality occurred.
D’arcy⁵⁰50 D’Arcy Y. Patient safety issues with patient-controlled analgesia. Topics in Advanced Pract Nurs J. 2007;7(1).	Literature review	Safe use of PCA for pain relief.	The majority of patients who use PCA postoperatively do not experience problems. However, proper patient selection, constant monitoring during use, correct pump operation and programming, correctly applied policies and procedures, and adequate patient education on PCA use should be performed.
Eugene and Viscusi¹¹11 Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210.	Literature review	Risks and benefits of PCA modalities.	PCINA has the potential to significantly improve postoperative pain due to the inherent simplicity and non-invasiveness of its administration. Fentanyl ITS has been shown to be safe and effective for postoperative pain management in several large randomized controlled trials, with efficacy equal to that of a standard IV morphine PCA regimen.
Alberta³⁵35 Alberta RN. Beware of basal opioid infusions with PCA therapy. Alta RN. 2009;65(9):12-3.	Literature review	Risk factors and safety measures associated with PCA.	The study addresses genetic and metabolic differences that cause variations in opioid response, increasing risk. It is important to be aware of drugs with similar names and programming errors such as selecting the wrong block or concentration. Safety measures: proper patient selection, use two independent nursing checks, identify lines, use prefilled bags or syringes and standardized orders.
Schein et al.⁹⁹99 Schein JR, Hicks RW, Nelson WW, Sikirica V, Doyle DJ. Patient-controlled analgesia-related medication errors in the postoperative period: causes and prevention. Drug Saf. 2009;32(7):549-59.	Literature review	PCA pump-related errors and safety measures.	Most errors are related to poor pump programming and device malfunction. Smart pumps with barcode technology and other advances can make PCA safer.
Chumbley e Mountford⁴⁷47 Chumbley G, Mountford L. Patient-controlled analgesia infusion pumps for adults. Nurs Stand. 2010; 25(8):35-40.	Literature review	Risk factors and nursing care associated with PCA.	Programming errors are common, so nurses should be familiar with the parameters and settings.
Lattavo³⁰30 Lattavo K. Safe use of patient-controlled analgesia on a medical-surgical unit. Acad Med-Surg Nurses. 2010;19(2):11-4.	Literature review	Risk factors associated with PCA and nursing care to improve safety.	Some risks should be considered in patient selection such as: obstructive sleep apnea, use of central depressants and morbid obesity. Pump malfunction may be due to faulty motor, display board or software. Programming errors are due to improper medication, dosage and blockage. Patient errors were due to tampering or activation of the button by family members. The nurse should perform systematic evaluation of sedation.
Taylor¹⁰⁸108 Taylor SA. Safety and satisfaction provided by patient-controlled analgesia. Dimens Crit Care Nurs. 2010;29(4):163-6.	Literature review	Risk factors associated with PCA.	Factors such as scheduling errors, improper dosing, inadequate patient selection and failure to monitor can be fatal.
Sardin et al.⁴⁰40 Sardin B, Lecour N, Terrier G, Grouille D. À propos des paramètres de sécurité des pompes d’analgésie contrôlée par le patient (PCA). Ann Fr Anesth Reanim. 2012;31(10):813-7.	Literature review	Risk factors associated with PCA pump.	The maximum bolus number (Bmax) is an important parameter missing in some pumps. It prevents overdosing. Maximum cumulative dose (Dcmax) is more present, however it is more associated with problems as when reached it needs human intervention to reprogram.
Hicks, Hernandez and Wanzer³³33 Hicks RW, Hernandez J, Wanzer LJ. Perioperative pharmacology: patient-controlled analgesia. AORN J. 2012;95(2):255-65.	Literature review	Risk factors, opioid pharmacology and nursing safety measures associated with PCA in the perioperative period.	Human errors occurred at every stage of opioid use, from prescribing (through transcription), dispensing, administration and monitoring. Opioids should be assessed for adverse effects and contraindications to avoid respiratory depression. Perioperative nurses can establish standardized processes.
D’Arcy⁸²82 D’Arcy Y. PCA by proxy: taking the patient out of patient-controlled analgesia: this controversial practice can be done safely in carefully controlled circumstances. Dimens Crit Care Nurs. 2013;32(4):200-3.	Literature review	Risk factors and safety measures associated with PCA.	Proxy PCA is not recommended due to the high risk of complications. Proper patient selection, monitoring with continuous pulse oximetry and capnography, pain assessment, patient and family education and clear prescription should be performed.
Lisi¹³13 Lisi DM. Patient-controlled analgesia and the older patient. US Pharm. 2013;38(3):2-6.	Literature review	Adverse events, risk factors and safety measures associated with PCA.	Adverse events described are: respiratory depression, sedation, confusion, nausea, vomiting, pruritus and urinary retention. Risk factors for respiratory depression are: background infusion; PCA by proxy; advanced age; head injury; hypovolemia; use of hypnotics or sedatives; renal, hepatic, pulmonary or cardiac failure; sleep apnea and obesity. Stakeholders should be educated and safety measures implemented in pump purchase, prescription, dispensing and monitoring.
Surprise and Simpson¹⁰⁶106 Surprise JK, Simpson MH. PCA: is that patientor provider-controlled analgesia? J Radiol Nurs. 2014;33(1):18-22.	Literature review	Safety measures associated with PCA.	Appropriately selected and educated patients can receive PCA. The provider should look at the individual needs of the patient in order to choose the appropriate settings for PCA thus allowing him/her control over the prescription.
Golembiewski, Dasta and Palmer⁸⁵85 Golembiewski J, Dasta J, Palmer PP. Evolution of patient-controlled analgesia: from intravenous to sublingual treatment. Hosp Farm. 2016;51(3):214-29.	Literature review	Risk factors associated with intravenous PCA.	Several disadvantages related to intravenous PCA have been described: programmer error, patient exposure to analgesic gaps, intravenous line permeability, dose stacking and catheter-related infection.
Shola and Neela Narayanan¹⁰¹101 Shola UR, Neela Narayanan V. A review on patient-controlled analgesia infusion system. Asian J Pharm Clin Res. 2017;10(13):117-21.	Literature review	Adverse events, risk factors and safety measures associated with PCA.	The most prevalent problems related to PCA are device safety events, operator error, opioid adverse reactions and patient-related. It focuses on improving the PCA pump with interoperable interface to improve safety.
Abrolat et al.²²22 Abrolat M, Eberhart LHJ, Kalmus G, Koch T, Nardi-Hiebl S. Patientenkontrollierte analgesie: methoden, handhabung und ausbaufähigkeit. Anästhesiol Intensivmed Notfallmed Schmerzther. 2018;53(4):270-80.	Literature review	Safety measures associated with PCA.	The implementation of an acute pain service is desirable, but even without the institution, proper patient selection, patient and staff education should be considered. Regular visits and documentation of therapy, extended monitoring in patients with risk factors such as sleep apnea should also be performed.
Dening¹⁵	Case series	PCA in postoperative pain management.	The introduction of PCA in a planned and careful way, with training of staff and patients, makes the method effective and safe.
Etches⁵²52 Etches RC. Respiratory depression associated with patient-controlled analgesia: a review of eight cases. Can J Anaesth. 1994;41(2):125-32.	Case series	Risk factors and incidence of respiratory depression during PCA.	Factors associated with higher risk of respiratory depression are: concomitant use of background infusion and sedatives, advanced age and sleep apnea. The risk in PCA is the same as in traditional intramuscular and spinal administration.
Syed et al.²¹21 Syed S, Paul JE, Hueftlein M, Kampf M, McLean RF. Morphine overdose from error propagation on an acute pain service. Reg Anesth Pain. 2006;53(6):586-90.	Case series	Adverse event propagation during PCA use.	Need for training and updates for professionals. Adverse events need to be reported and investigated to ensure learning and safe use of PCA in the perioperative period.
Sousa et al.¹⁰³103 Sousa AM, de Santana Neto J, Guimaraes GM, Cascudo GM, Neto JO, Ashmawi HA. Safety profile of intravenous patient-controlled analgesia for breakthrough pain in cancer patients: a case series study. Supp Care Cancer. 2014;22(3):795-801.	Case series	Risks and adverse effects associated with PCA in cancer patients.	The most common adverse effects in cancer patients were sedation, constipation and nausea. Morphine had a higher risk than fentanyl for sedation.
Williams J¹¹⁶116 Williams J. Saving lives, saving families: continuous monitoring for patients on opioids. Biomed Instrum Technol. 2015;49(1):40-4.	Case series	Risk factors, adverse events and safety measures associated with PCA.	Failure to monitor culminated in 2 deaths related to respiratory depression during or after PCA use. One patient had no risk factor, the other had obstructive sleep apnea. The study addresses the need for continuous monitoring during PCA pump use, regardless of risk factors.
Wong, Mabuyi and Gonzalez¹¹⁷117 Wong M, Mabuyi A, Gonzalez B. First National Survey of Patient-Controlled Analgesia Practices. In: Society of Anesthesia and Sleep Medicine (SASM) 3rd Annual Conference, 2013.	Transversal	Safety measures associated with PCA.	It was noted that there may be more safety in hospitals that use only smart pumps, present educational materials, monitoring with pulse oximetry or capnography.

Variables	n (%)
Previous illnesses	7 (100%)
Obesity	3 (44%)
Sickle cell anemia	2 (28%)
Sleep apnea	1 (14%)
Chronic renal failure	1 (14%)
Profile of referrals	27 (100%)
Post-operative	22 (81%)
Oncological pain	4 (15%)
Acute pain	1 (4%)
Types of opioids	43 (100%)
Morphine	27 (63%)
Hydromorphone	7 (16%)
Meperidine	3 (7%)
Fentanyl	3 (7%)
Oxycodone	2 (5%)
Piritramide	1 (2%)
Types of pumps	16 (100%)
Abbott	7 (44%)
Graseby	6 (38%)
Baxter	1 (6%)
Master	1 (6%)
Carefusion	1 (6%)
Deltec	1 (6%)
Types of infusion	43 (100%)
No basal infusion	30 (70%)
With basal infusion	13 (30%
Adverse effects	66 (100%)
Respiratory depression	26 (39%)
Death	10 (14%)
Nausea, constipation, vomiting or itching	5 (7%)
Over-sedation	4 (6%)
Seizures	4 (6%)
Inadequate analgesia	4 (6%)
Respiratory arrest	3 (5%)
Cardiorespiratory arrest	3 (5%)
Coma	2 (3%)
Delirium	2 (3%)
Cardiac arrest	1 (1%)
Renal insufficiency	1 (1%)
Gastrointestinal bleeding	1 (1%)
Hypoxic encephalopathy	1 (1%)
Anaphylaxis	1 (1%)
Hypotension	1 (1%)
Incidents without injuries	5 (100%)
Overdosage	5 (100%)
Risk stages	71 (100%)
Programming	19 (27%)
PCA device	15 (21%)
Administration	9 (13%)
Prescription	9 (13%)
Patient selection	8 (11%)
Education	5 (7%)
Drug dispensing	3 (4%)
Preparation	3 (4%)
Safety measures	83 (100%)
Education	16 (19%)
Safe pump	13 (16%)
Proper patient selection	9 (11%)
Safe preparation and dispensing	8 (10%)
Appropriate PCA requests	7 (8%)

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Risk management and safety in the use of patient-controlled analgesia pumps: a scoping review

HIGHLIGHTS

ABSTRACT

BACKGROUND AND OBJECTIVES:

CONTENTS:

CONCLUSION: