Continuous Ambulatory Delivery Device Use for Patients Managed by an Inpatient Palliative Care Team.

BACKGROUND: The use of Patient Controlled Analgesia (PCA) via a Continuous Ambulatory Delivery Device (CADD) is a common and effective means of pain and symptom management for hospitalized patients with a malignancy. Studies exploring the indications for starting such a device for hospitalized inpatients referred to inpatient palliative care teams are limited. AIM: This retrospective chart review aims to explore indications, timing of initiation, and barriers to the use of a CADD. METHODS: Over a six month period, during daily inpatient palliative care consult team rounds, patients who required a CADD were enrolled in this study. Sixty-one adult patients were identified who required a pump for symptom control. The team's database sheets were used to capture patient demographics. RESULTS: The main reasons for initiating a Continuous Ambulatory Delivery Device in the above setting included: lack of efficacy of oral opioids and to increase patient autonomy of their pain management. Approximately 20% of patients required transfer to another unit that could accommodate the CADD. The median length of stay for these patients was 13 days, with a median length of half a day for a pump to be started. CONCLUSIONS: This initial study provides the Palliative Care Consult Team with information on the indications for the use of a CADD. The lack of universal access to a CADD in various areas of our hospital due to differences in departmental protocols may compromise good symptom management and patient safety. These results strengthen the argument that the existing hospital policy requires revamping to improve CADD access. A CADD has been shown to provide hospitalized patients, with a malignancy, with timely access to effective symptom management, and in turn, reducing their length of stay in hospital. These findings will help inform this organization's CADD policy and support the need to broaden access to this device.

Capturing Essential Information to Achieve Safe Interoperability.

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

Repetitive on-demand drug release from polymeric matrices containing a macroscopic spherical iron core.

A system for multiple on-demand drug release has been prepared that can be activated with an alternating magnetic field as external trigger. The core/shell samples have been developed based on a macroscopic spherical iron core coated with a thermoresponsive polymer, poly(styrene-stat-butyl methacrylate), containing ibuprofen as a model drug. During exposure of the samples to the magnetic field (ON state), the release rate of ibuprofen is significantly increased, up to 35 times the release rate without the magnetic field (OFF state). Using one sample or two samples in line with the magnetic field does not influence the ON/OFF ratio of the system, showing the possibility of using multiple samples to increase and tune the drug dose. Increasing the concentration of ibuprofen in the polymer layer is shown to increase the release rate in both the ON and OFF states. Increasing the size of the iron core and, consequently, decreasing the polymer thickness, was found to only increase the release rate during exposure resulting in higher ON/OFF ratios. The developed on demand drug delivery systems represents a promising development towards on demand drug delivery implants. REFLECTIONS ON CAREER GOALS: During my chemical engineering studies, it was only during my master thesis work that I decided to continue with PhD research as I really enjoyed doing original research. When coming to the end of my PhD research under supervision of Prof. Ulrich S. Schubert, I developed the ambition to pursue an academic career. Fortunately, I got the opportunity to stay with Prof. Schubert as project leader for the Dutch Polymer Institute (DPI). Within this position, I supervised ten researchers and was able to start developing my independent research lines. Despite that I now advise students to not stay in the same laboratory, this first position allowed me to gain some initial independence and to publish a large number of papers that has been a great benefit in my further career. After two and a half years I needed a new challenge that I found by taking up a part-time position at a start-up company in Eindhoven, Dolphys Medical BV, while I also continued as part-time group leader for the DPI. As senior product developer, I was in charge of the research and learned to focus on the application rather than scientific curiosity. This experience made me realize that I prefer the freedom to do academic blue sky research and decided to fully go for an academic position. After personal discussions with some prominent professors in the Netherlands, I applied for a postdoc fellowship in the Netherlands with Prof. Roeland Nolte as well as a Humboldt fellowship in Germany with Prof. Martin Möller, which I both got. As a result, I went one year 'abroad' to Aachen and returned to Nijmegen where I intended to start my independent career. However, another opportunity came along. Via my personal network I was informed that I would make a good chance if I applied for a new professor scheme in Ghent. So I applied and the rest is history. Picture of the Supramolecular Chemistry Group (2017).

Patient-Controlled Fentanyl Iontophoretic Transdermal System Improved Postoperative Mobility Compared to Intravenous Patient-Controlled Analgesia Morphine: A Pooled Analysis of Randomized, Controlled Trials.

BACKGROUND: Postoperative pain management protocols that use patient-controlled analgesia (PCA) can hinder mobility due to attached machinery and tubing. Immobility in the postoperative setting can increase complications, length of stay (LOS), and costs. Early and enhanced mobilization can reduce the cost of care while improving patient outcomes. A needle-free, compact, patient-activated, and portable fentanyl iontophoretic transdermal system (fentanyl ITS, IONSYS; The Medicines Company, Parsippany NJ) has been shown to provide comparable efficacy and tolerability to intravenous (IV) PCA morphine that promotes improved mobility. METHODS: This pooled analysis of 1,882 patients across three randomized, controlled trials compared fentanyl ITS to IV PCA morphine for postoperative pain management. Outcomes of patient mobility were assessed by a validated Patient Ease of Care Questionnaire that was given to patients, patients' nurses, and physical therapists involved in patient care. Safety was assessed via spontaneously reported treatment-emergent adverse events (TEAE). RESULTS: Fentanyl ITS significantly improved overall patient mobility, each mobility subscore (P < 0.0001) across all demographics (male/female; elderly/non-elderly; normal BMI/overweight/obese/morbidly obese) and surgery types, and was consistent across nurses and physical therapists mobility assessments. TEAEs were generally similar between the two groups. However, more patients reported an opioid-related TEAE with morphine IV PCA than with fentanyl IV PCA (P = 0.003). CONCLUSION: Due to improved mobility with fentanyl ITS, complications are expected to be less frequent than with IV PCA and epidural PCA. Incorporation of this strategy into postoperative pain management protocols may reduce LOS and total hospital costs.

Unconventional use of a PCA pump: nurse-activated dosing.

Creative approaches, such as NAD, can be taken to manage pain in patients who would be candidates for PCA therapy if they were physically and cognitively able to manage their own pain. NAD authorizes the patient's primary nurse to administer bolus doses with or without a basal rate via the PCA infusion pump. Doses are administered for breakthrough pain with a basal rate or in scheduled doses to maintain analgesia without a basal rate. It is also used to administer bolus doses before and during painful procedures.

Impact of infusion set characteristics on the accuracy of patient-controlled morphine administration: a controlled in-vitro study.

The aim of our in-vitro study was to assess the impact of infusion set characteristics on the accuracy of morphine doses in patient-controlled analgesia. Two infusion sets differing in conception and dead-space volume were assessed: a standard set and a low dead-space volume Y-set. The patient-controlled analgesia programme parameters were as follows: bolus equal to 1 ml at 100 ml.h(-1) ; lockout intervals equal to 5 and 10 min; and carrier fluid flow rate equal to 10 and 50 ml.h(-1) . Morphine concentration was determined by an ultraviolet spectrophotometric method. The morphine doses were significantly different from one set to the other during bolus and lockout intervals, whatever the patient-controlled analgesia programme. The average doses were approximately 1.3-6.0 times higher with the low dead-space volume Y-set during bolus. Our study underlines the impact of infusion set characteristics on the accuracy of morphine patient-controlled analgesia doses.

[Cost minimization analysis in postoperative pain management : economic efficiency and effectiveness of two infusion pump systems]. / Kostenminimierungsanalyse in der postoperativen Schmerztherapie : Wirtschaftlichkeit und Effektivität von 2 Schmerzpumpensystemen.

BACKGROUND: Besides reliable efficacy and patient satisfaction, economic efficiency is becoming increasingly more important in postoperative pain management. AIM: The present study investigated the effectiveness of two pain pump systems and compared the running costs in treatment. MATERIAL AND METHODS: In this study 40 patients received an interscalene catheter prior to shoulder surgery. Postoperative pain management was provided via an electronic pump with patient-controlled analgesia (PCA) or a mechanical pump without PCA. Patients kept a pain log. After treatment they were interviewed about their satisfaction with the pump. In addition drug consumption, nursing material, staff time for handling and maintenance of the pumps and preparation of medications pro re nata were assessed. RESULTS: Postoperative pain levels and patient satisfaction were comparable in both groups. Economically, the electronic pump was more cost-effective than the electronic model for a duration of treatment of 1 and 2 days. With treatment duration of 2 days the costs of both pumps were equivalent; however, the PCA feature of the electronic pump allowed a reduced intake of systemic analgesics on demand. CONCLUSION: Both pain pump systems provide equally effective pain management, while the electronic model caused less costs. Both pumps offer advantages and disadvantages that should be considered based on local circumstantial demands.

[Direct cost of connecting, maintaining and disconnecting patient-controlled analgesia pump]. / Custo direto da instalação, manutenção e desligamento da bomba de analgesia.

Quantitative research that aimed to identify the mean total cost (MTC) of connecting, maintaining and disconnecting patient-controlled analgesia pump (PCA) in the management of pain. The non-probabilistic sample corresponded to the observation of 81 procedures in 17 units of the Central Institute of the Clinics Hospital, Faculty of Medicine, University of Sao Paulo. We calculated the MTC multiplying by the time spent by nurses at a unit cost of direct labor, adding the cost of materials and medications/solutions. The MTC of connecting was R$ 107.91; maintenance R$ 110.55 and disconnecting R$ 4.94. The results found will subsidize discussions about the need to transfer money from the Unified Health System to hospitals units that perform this technique of analgesic therapy and it will contribute to the cost management aimed at making efficient and effective decision-making in the allocation of available resources.

Non-stimulation needle with external indwelling cannula for brachial plexus block and pain management in 62 patients undergoing upper-limb surgery.

OBJECTIVE: To investigate the feasibility of a non-stimulation needle with an external indwelling cannula for upper-limb surgery and acute postoperative pain management. METHODS: 62 patients undergoing either scheduled or emergency upper-limb surgery received brachial plexus block of modified interscalene or axillary brachial and then postoperative patient-controlled analgesia (PCA) with local analgesics using a specially designed non-stimulation needle with an external indwelling cannula. The outcome measurements included anesthetic effect, acute or chronic complications, postoperative analgesic effect and patient's satisfaction. RESULTS: The success rate of anesthesia was 96.8%. The single attempt placement with the external indwelling cannula was achieved in 85.2% of patients with axillary brachial plexus block and 78.8% with modified interscalene brachial plexus block. The incidence of severe intoxication was 3.7% with axillary brachial plexus block and 3.0% with modified interscalene brachial plexus block. No hematoma at the injection site, Horner's syndrome, hoarseness or dyspnea was observed. Postoperative analgesic effect was achieved in 100% and activities were slightly lowered in 91.7%. The incidence of nausea and vomit was 8.3%; patient's satisfaction was 9.1 on a 10-point scale system. Infection, nerve injury and respiratory depression were absent during the catheter indwelling. The indwelling time of external indwelling cannula was 30.5 h on average. There was no nerve injury related complication after withdrawing the external indwelling catheter. CONCLUSIONS: Brachial plexus block using a non-stimulation needle with an external indwelling cannula has favorable intra-operative anesthetic benefit and provides an excellent postoperative analgesic outcome. The low incidence of complications and favorable patient's satisfaction suggest that non-stimulation needle with an external indwelling cannula is a useful and safe anesthetic tool in brachial nerve block and acute postoperative pain management.

A case study on the safety impact of implementing smart patient-controlled analgesic pumps at a tertiary care academic medical center.

BACKGROUND: As with the use of any therapy involving opioids, patient-controlled analgesia (PCA)-related errors can lead to overdose and even death. "Smart" (computerized) pumps have medication safety enhancements, particularly those related to operator errors during administration, to improve overall safety and efficacy. After the occurrence of PCA-related errors that occurred at a tertiary care academic medical center, an analysis of PCA errors was conducted. The introduction of smart pumps was identified as a possible solution, and the medical center adopted the technology in 2006. A study was conducted to investigate the impact of implementation. METHODS AND RESULTS: The study had three primary objectives: (1) to evaluate history logs stored in the smart PCA pumps to characterize the nature of hard and soft stop alerts and identify potential errors that may have been averted, (2) to examine the impact of smart PCA pumps on voluntarily reported PCA therapy-related errors, and (3) to assess nursing perceptions regarding the improvement in safety due to the introduction of smart PCA pumps. The smart pumps potentially prevented 159 errors for the January-June 2007 period; upper hard limits had the most number of alerts, representing avoidance of errors with the greatest potential to be detrimental to the patient. In addition, pump-programming errors due to wrong concentration were eliminated after implementation. Finally, nursing staff perceived smart pumps to be valuable in improving patient safety. CONCLUSIONS: Smart PCA pumps had an important positive impact on PCA-related patient safety at the medical center. Other facilities should adopt PCA devices with additional safety features such as bar-code verification of the drug and concentration, as well as dosage limits, to prevent pump-programming errors.

[Life-threatening opioid overdose. Decoding the physician pin code of a patient-controlled anesthesia pump by patients]. / Lebensbedrohliche Opioidüberdosierung. Entschlüsselung des Arztboluscodes einer Schmerzpumpe durch Patienten.

Patient-controlled analgesia (PCA) is an established standard therapy for providing postoperative analgesia. To avoid possible abuse by patients each PCA pump is secured by a pin code that should be neither known nor accessible to patients. The two case reports described illustrate how manipulation of a PCA pump led to massive opioid abuse by the patients who decoded the pin code for unlimited additional doses. One patient developed withdrawal symptoms after switching the therapy and, as a consequence even had to be admitted to the intensive care unit (ICU). Easy access to the PCA pump codes on the internet for the patients and the impossibility of changing the pin codes by the medical staff played an important role in these two cases.

A novel approach to pain management in persons with sickle cell disease.

Sickle cell disease (SCD) is an illness that affects red blood cells. Patients with SCD can have chronic pain or acute pain episodes, which must be managed with medical therapy. Although many options are available for pain management, utilization of subcutaneous patient-controlled analgesia for pain management has positive outcomes for patients in both pain management and satisfaction.

[Home care treatment of cancer pain patients with patient-controlled analgesia (PCA)]. / Häusliche Behandlung von Tumorschmerzpatienten mit patientenkontrollierter Analgesie (PCA).

BACKGROUND: Only limited data and experience with patient-controlled analgesia (PCA) in outpatients for palliative home care, related to organization, effectiveness and costs are available. PATIENTS AND METHODS: In our retrospective study we analyzed the effectiveness, care intensity and pain reduction of 108 palliative cancer pain patients with PCA, included in a palliative home care system. RESULTS: After equivalent conversion of the opioid doses from oral/transcutaneus to parenteral administration a dose increase was necessary in 12.9% of the patients. The pain therapy was effective until death for an average of 38.9 days (median 21 days). During 3,889 days of PCA therapy there were 76 unscheduled visits based on technical problems. CONCLUSION: In cases of cancer pain patients with failed oral or transcutaneous opioid medication, sufficient pain reduction can be achieved with parenteral drug administration by PCA. Domestic PCA requires a lot of human and financial resources, with trained nursing services and regular house visits by physicians experienced in palliative medicine but this method is sufficient and safe to use.

Patient-controlled analgesic infusion pumps. Making a painless purchase.

Patient-controlled analgesic infusion pumps give patients the ability to self-administer pain-relieving medication as needed within the limits set by a physician. The most significant risk associated with these pumps is the possibility of oversedation, potentially leading to life-threatening narcotic-induced respiratory depression. We examine nine pumps, basing our ratings on safety and ease of use.

[Comparison of analgesics using two devices for the patient-controlled analgesia].

UNLABELLED: The patient-controlled analgesia with two devices allows to compare analgesic agent and to regulate quantity and quality of multimodal analgesia compounds. The aim of the study is to compare efficiency of analgesic agents in method of patient controlled analgesia with two devices. SUBJECT AND METHODS: 38 patients after major abdominal surgery were included in the prospective blind randomized study the first group of patient conducted with two PCA devices one apparatus was with morphine other one with placebo. Second group of pations were administered morphine and lornoxicam. The doses of analgetic agets were equal in all devices. The level of pain was measured according to visual analog scale (VAS) patients were asked to determine which analgesic providing best result also side effects of analgesia were registered. RESULTS: There were no differences in the intensity of pain between the groups. The latter did not differ in the number of adverse reactions. The largest number of patients of first group made their chose towards morphine 63%; 25% prefer placebo p < -0,05; 12% could not make their choose. CONCLUSION: Most of patients who received morphine and placebo can determine the analgesic agent. Second group of patients choose both analgesic agent equally often. Comparative assessment of analgesics, by employing 2 PCA apparatuses in one patient, allows evaluate the efficiency of analgesics added to the conventional methods.

Patient-Controlled Analgesia (PCA): Intravenous Administration (IV-PCA) versus Oral Administration (Oral-PCA) by Using a Novel Device (PCoA® Acute) for Hospitalized Patients with Acute Postoperative Pain-A Comparative Retrospective Study.

Background: Acute postoperative pain delays recovery and increases morbidity and mortality. Opioid therapy is effective but is accompanied by adverse reactions. Patient-controlled analgesia (PCA) enables self-administration of analgesics. Oral-PCA is a safe and beneficial alternative to intravenous (IV) PCA. We have developed a novel Oral-PCA device, which enables self-administration of solid pills to the patient's mouth. This is a retrospective study comparing the effectiveness and usability of this novel Oral-PCA with those of IV-PCA. Methods: Medical records of patients who received PCA following gynecology and orthopedic surgeries were analyzed. The control cohort (n = 61) received oxycodone by IV-PCA. The test cohort (n = 44) received oxycodone by Oral-PCA via the PCoA Acute device. Outcome measures include the Numeric Rating Scale (NRS) score at rest and movement, side effects, technical difficulties, bolus dose administered, and bolus dose requested. Results: Patient demographics, initial NRS, and PCA duration were comparable between cohorts. NRS reduction in rest and movement was stronger in the Oral-PCA cohort (rest: 1.61 and 2.27, P = 0.077; movement: 2.05 and 2.84, P = 0.039), indicating better pain control and mobility for Oral-PCA. Side effect rates were comparable between cohorts (9% and 11% of patients who experienced side effects, P = 1.000). The rate of technological difficulties was higher in the Oral-PCoA cohort (19.7% and 36.4%, P = 0.056). The mean total bolus dose administered to patients was comparable in both cohorts (18.32 mg and 21.14 mg oxycodone, P = 0.270). However, the mean total boluses requested by patients during lockout intervals were lower in the Oral-PCA cohort (12.8 mg and 6.82 mg oxycodone, P = 0.004), indicating better pain control. Conclusions: Oral-PCA by using PCoA® Acute provides pain control and usability which is noninferior to the IV-PCA, as well as superior to pain reduction in rest and movement. These results, along with the noninvasiveness, medication flexibility, and reduced cost, suggest the potential of Oral-PCA, by using PCoA Acute, to replace IV-PCA for postoperative analgesia.

Impact of a comprehensive safety initiative on patient-controlled analgesia errors.

BACKGROUND: Adverse drug events related to patient-controlled analgesia (PCA) place patients at risk. METHODS: We reviewed all critical incident reports at three tertiary care hospitals dated January 1, 2002, to February 28, 2009. In this longitudinal cohort study, critical incidents attributable to PCA errors were identified, and each incident was investigated. A safety intervention was implemented in February 2006 and involved new PCA pumps, new preprinted physician orders, nursing and patient education, a manual independent double-check, and a formal nursing transfer of accountability. RESULTS: A total of 25,198 patients were treated with PCA during this study, and 62 errors were found (0.25%), with 21 (0.08%) involving pump programming. All errors occurred before the safety interventions were put in place. Compared with the preintervention period, the odds ratio of a PCA error postintervention was 0.28 (95% CI = 0.14, 0.53; P < 0.001) whereas the odds ratio of a pump-programming error postintervention was 0.05 (95% CI = 0.001, 0.30; P < 0.001). Programming the wrong drug concentration was the most common programming error (10 of 21). Improper setup of intravenous tubing was also common (8 of 62), with one incident leading to respiratory arrest. Most PCA errors resulted in no harm, but there was negative impact to patients 34% of the time. CONCLUSION: At less than 1%, the incidence of PCA errors is relatively low. Most errors occur during PCA administration. Safety can be improved by addressing equipment, education, and process issues.

Late intravascular migration of a previously well functioning labour epidural catheter.

Intravascular epidural catheters may result in insufficient labour analgesia or can produce potentially lethal complications following an epidural top-up. We report a case of a previously well functioning epidural catheter positioned epidurally using a combined spinal epidural anaesthesia technique, which subsequently was found to be intravascular. The literature is reviewed.