Aseptic Unit Research Articles

P09 Lancashire and South Cumbria Critical Care Network Vancomycin Project

Abstract Background This project was a collaborative piece of work across a critical care network that included specialist advice from colleagues including aseptic/technically trained pharmacists and microbiology to optimize care for critical care patients in Lancashire and South Cumbria. We used several members of our workforce including pharmacists, nursing staff, microbiologists, rotational doctors and consultants to work towards a harmonized guideline. Methods During our initial meeting, we identified that different centres were using different glycopeptides and administering them differently: East Lancashire Hospitals (ELHT)—continuous vancomycin infusion; Blackpool Cardiac and Blackpool General—continuous vancomycin infusion, with no formal guideline in place but adopted from ELHT; Lancashire Teaching Hospitals—intermittent vancomycin infusions; and University Hospitals Morecambe Bay—teicoplanin is glycopeptide of choice. Our consultant microbiologist discussed the use of glycopeptides and what infections they are used for in critical care. The pharmacokinetics of vancomycin and the benefit of using a continuous infusion was also discussed. We decided to undertake a clinical audit of our vancomycin guidelines at ELHT to ensure that we had an evidence base to implement our guideline and provide assurance to the working group. We agreed to reconvene the working group after this audit was completed and after the concerns of colleagues had been addressed. Results and conclusions We presented the results of our audit and highlighted the opportunities harmonizing this guideline would provide. We discussed various scenarios such as stepping up from a ward protocol to a continuous infusion and the different methods of calculating creatinine clearance and if this would influence the first 24 h of the infusion. One comment was concerning the administration of vancomycin and the number of times nurses will be changing bags for patients requiring higher doses, i.e. the majority of patients would usually be on 3 g/day or more depending on concentrations. This would mean changing the bag more than twice a day; as much as there is a therapeutic benefit to continuous vancomycin infusions, considering the max. concentration for peripheral and central lines allows for larger volumes, it would be beneficial (except in fluid restricted cases) to have a slightly larger volume to reduce the number of bag changes and plastic consumption. We considered this comment and discussed it with our aseptic services lead pharmacist. We attended a meeting of the ICS Aseptics Working Party across Lancashire and South Cumbria. WE discussed the proposed guideline and requested that aseptic units across Lancashire and South Cumbria developed worksheets to manufacture 5 g in 600 mL or 10 g in 1.2 L for central use to stop breaking the line when changing a bag and reducing plastic consumption. We also met with critical care practice educators across the network to discuss how we can promote this guideline and ensure nursing staff and prescribers are aware of how to prescribe and administer continuous vancomycin infusions. One of our units noted that they have had a few incidents with incorrect concentrations of vancomycin being made up for patients. We developed an e-learning package to educate our workforce.

EE529 Methodology for the Monetization of Vial Remnants in the Aseptic Unit

EE529 Methodology for the Monetization of Vial Remnants in the Aseptic Unit

What is the most cost‐beneficial way to prepare micafungin for paediatric oncology patients?

AbstractBackgroundA recent change in local paediatric antifungal guidelines resulted in an increase in micafungin use. Micafungin is an expensive medicine costing AUD $80 per vial. The pharmacy aseptic production unit (APU) has the ability to compound doses to share vials of micafungin to minimise wastage.AimTo determine whether aseptically compounded and individually prepared doses of micafungin would be more cost‐beneficial than nurses using whole vials prepared on the ward, and to determine which dose and numbers of doses would be most cost‐beneficial to compound.MethodA time and motion study of 20 patients determined how long it took for nurses and the pharmacy APU to prepare doses. An economic analysis of time, cost of labour, and consumables outlined the cost to make one to seven doses with doses ranging from 10 to 200 mg.ResultsOn average, it took the pharmacy APU 42 min and nurses 9 min to prepare a single dose. Aseptically compounding one dose, whole vials (doses of 50 mg increments), and doses near whole vials had no cost‐benefit. Aseptically compounding five doses or more had would result in a cost‐benefit.ConclusionDepending on the dose required, cost savings could be obtained when the pharmacy APU prepared multiple doses, with a maximum saving of $350.10 for a 7‐day course. Determining baseline costs of micafungin preparation is relevant if there are future requests to compound medicines as the data could be extrapolated and applied to the new request.

Validation of a Sporicidal Bio-Decontamination Process for use in Pharmaceutical Isolators in an NHS Aseptic Manufacturing Unit

The recently published revision of EU GMP Annex 1 Manufacture of Sterile Medicinal Products includes a requirement for pharmaceutical isolators to undergo a bio-decontamination process of the interior which should be automated, validated and controlled within defined cycle parameters and include a sporicidal agent. It is widely accepted that the easiest way to achieve this is by converting Hydrogen Peroxide (H2O2) liquid into a state that will diffuse readily through the closed isolator chamber leading to bio-decontamination of all surfaces which it comes into contact with. The technology to do this has been around for years and can be validated to give a high level of assurance of surface bio-decontamination comparable with sterilization when used on surfaces in the isolator critical work zone. This type of activity is routinely used in large-scale sterile manufacturing that takes place in the pharmaceutical industry where the amount of materials and timescales involved make this viable. In the NHS, aseptic preparation and manufacture of sterile products is carried out in isolators both for immediate use and for stock in anticipation of demand. Automated bio-decontamination systems are available but their use is much less than in the pharmaceutical industry and reliance is still placed on manual spraying and wiping of surfaces with disinfectant agents such as alcohol and hydrogen peroxide. This brings a degree of variability and is more difficult to validate. For sterile manufacturing units holding an MHRA Specials Manufacturing licence the expectation is that proper consideration is given to using an automated bio-decontamination process or there is justification for not doing it. For units preparing products for immediate use there is not the same expectation but as standards are improved, it is reasonable to assume it may become the case in the future. To use this type of process requires it to be integrated into the isolator, meaning either buying a new isolator or retrofitting to an existing one. The relatively high cost of this is a barrier to pharmacy department aseptic units using the technology. There is a range of bio-decontamination systems on the market from Devea (www.devea environnement.com)which are claimed to be suitable for use in hospital pharmacy clean room facilities. One model from this range, the Phileas Genius is a simple, stand-alone battery powered unit that generates vapourized hydrogen peroxide of particle size 5-10 µm from 7.4% solution using novel spinning disc technology. This generator can be transferred into and out of any closed isolator work zone through the transfer hatch (as long as the hatch door is wide enough) and can be used to do pre-programmed cycles (called zones) to routinely decontaminate inner surfaces.

Becoming a product approver for an NHS aseptic unit

Becoming a product approver for an NHS aseptic unit

Modernising aseptic compounding through the use of new technology: a validation and proof of concept study

Abstract Introduction There is an urgent need to reform care pathways to keep patients, wherever possible, outside of hospital and in turn freeing up capacity and addressing the elective backlog crisis. To address such issues and futureproof its services, the NHS is modernising its approach to care. Within the aseptic space, current transformation plans1 require the provision of large-scale quantities of injectable medicines and the leveraging of new aseptic technologies to enable the large scale roll out of services such as outpatient antimicrobial therapy (OPAT). Aim CIVAS@IP5 is Wales' first National Pharmacy Technical Services Unit and has recently invested in state-of-the-art technology, which is transforming its aseptic compounding, making it possible to significantly scale up capacity and facilitate the creation of local OPAT services. The technology in question is the Gri-fill®4 2, a semi-automated system for compounding hazardous and non-hazardous sterile preparations. The aim of this study, which is the first in the UK to use the Gri-fill®4, was to report on the suitability of such technology to facilitate the transformation of compounding services. Methods Due to its nature, this pilot study required no ethical approval as no patients were involved nor any patient data collected. Over the course of a number of weeks, validation measurements were carried out on the Gri-fill®4. This included time and motion assessments of the current manual pathway of compounding compared to the semi-automated pathway using the Gri-fill®4. Results Results revealed that the preparation of an infusion bag using the Gri-fill®4 was achieved within an average of 2.64 minutes. This represents a substantial 80% time saving when compared to the average manual preparation time of approximately 13 minutes. Furthermore, batch preparation of 46 infusions was completed with 50% fewer critical manipulations (92 critical manipulations for the Gri-fill®4 versus 184 critical manipulations for the manual pathway), reducing the potential for error whilst also requiring fewer verifications by staff. Once scaled, this increase in productivity will have significant real-world benefits for local services which are reliant on responsive aseptic compounding provisions. On top of productivity improvements, the introduction of semi-automated compounding has afforded sustainability improvements; with less plastic consumables required for the production of each batch. Discussion/Conclusion It is important to note that our data reports on the impact of only one Gri-fill®4 unit. As such there are obvious scalability benefits to our findings but also limitations in regard to the logistics and practicalities of leveraging large scale semi-automated compounding; both of these issues will be explored. In conclusion, the productivity of aseptic units can be drastically improved through the modernisation of compounding technology. This validation study reports on the extent of this improvement and discusses the implications it will have on the future of OPAT and aseptic services.

Impact of implementing the aseptic compounding management system, Medcura, on internal error rates within an oncology pharmacy aseptic unit: a mixed methods evaluation

BackgroundAs cancer survivorship improves, pressure on oncology services to provide safe, timely treatments increases. Traditional manual compounding processes are error prone, putting patients at risk. Additionally, errors have a detrimental...

Recurrent environmental contamination in a centralized radiopharmacy unit by Achromobacter spp: Results of a large microbiological investigation

BackgroundRadiopharmaceuticals preparation unit, such as every aseptic preparation units, are strictly monitored in terms of microbiological contamination. Despite all biocontamination control procedures, our radiopharmacy unit faced repeated environmental contamination by Achromobacter spp which necessitated a large environmental investigation. MethodsMicrobiological controls were carried out using Count Tact agars (Biomérieux) for flat surfaces, dry swabbing for hard to reach areas and containers were filled with a sterile water solution (then filtrated on 0.45 µm membrane and seeded). Microbiological identification was performed by mass spectrometry (MALDI-TOF-MS, Brucker) on each positive sample. ResultsAchromobacter spp was found in 10% of the 413 samples during the 8 months investigation period. The proportion of positive samples was stable among time but their location was unpredictable. The highest inoculum was finally found in the buckets used for biocleaning. DiscussionSamples from cleaning buckets taken by dry swabbing were at first negative, but the use of a non-routinely used sampling method allowed to discover the reservoir of this persistent contamination. ConclusionThis investigation alerted us on the high microbiological risk associated with reusable plastic containers and the importance of a sampling method adapted to critical locations.

Optimisation of an inpatient parenteral nutrition formulary in a secondary care hospital

Compounding units, both in hospital aseptic units and nationally, are under significant pressure.1 This has led to a national drive to standardise prescribing of parenteral nutrition (PN). The aim is to reduce the need for custom, bespoke bags and maximise the use of standard multi-chamber PN. Nutritional requirements recommended by PENG also changed in 20182- both of these factors led to the critical evaluation of the suitability of inpatient parenteral nutrition bag range on the hospital formulary.

In-House Production of Dialysis Solutions to Overcome Challenges During the Coronavirus Disease 2019 Pandemic

In-House Production of Dialysis Solutions to Overcome Challenges During the Coronavirus Disease 2019 Pandemic

P42 All-in-one parenteral nutrition: a national survey

AimsTo gather details about the current usage of All-in-One (AIO) Parenteral Nutrition (PN) for children in the UK, reasons that organisations have switched to using AIO PN and benefits that occurred. For organisations not using AIO PN, the aim is to find out if they have plans to use it in the future and why/not. The ultimate aim is to determine whether AIO PN should be used locally and/or nationally via standardised paediatric PN to improve patient safety.BackgroundConventional split-phase PN is subject to ‘rate switch’ errors when lipid is infused at the rate intended for aqueous PN and vice versa. A 2017 alert from NHS Improvement (NHSI) highlighted that serious adverse effects have occurred due to overly-rapid infusion of PN in babies and children. Using AIO PN eliminates the risk of rate switch errors although there is scant evidence in literature of enhanced safety. A project group has been developing national standardised paediatric PN, with work ongoing. Local rate switch incidents, the NHSI alert and a desire to provide appropriate national standardised PN are the drivers behind this survey.MethodsA survey monkey® was designed and circulated to members of the Neonatal and Paediatric Pharmacists Group (NPPG) via email. Members were asked to respond on behalf of their organisation if they provided PN to babies or children. The survey included 10 questions/fields, with discrete choices such as yes/no/don’t know or ‘select all that apply’.Results51 responses were received from 48 organisations. Close to 50% were using AIO PN for inpatients. Organisations using AIO PN: 70% used both AIO and split-phase PN. AIO PN was used mainly for larger children: adolescents/children >40 kg (64% of organisations); children 30–39.9 kg (60%); and children 20–29.9 kg (48%). Nurse preference/ease of administration (45%), addressing a local safety concern (25%) and responding to the NHSI safety alert (21%) were the most common reasons for using AIO PN. AIO PN was perceived as having a positive impact including: improved patient safety (42% of organisations); improved local aseptic unit capacity (38%); and improved nurse satisfaction (29%). Methods of providing AIO PN included: locally prepared-licensed multi-chamber bag with additions (54%); externally prepared-as bespoke/scratch (39%); licensed multi-chamber bag without additions (39%); externally prepared-standard bag (12%); externally prepared-licensed multi-chamber bag with additions (12%); locally prepared-as bespoke/scratch either using a compounder or via other method (8% each). Organisations not using AIO PN: 43% of organisations were not planning to use AIO PN or didn’t know and 15% planned to start in the future. 42% selected ‘other’ and gave comments, primarily relating to avoiding AIO PN for neonates, e.g. need to use neonatal network PN (split-phase) or prefer flexibility to stop lipid in case of adverse effects. Eleven organisations answered, ‘Why are you thinking of using AIO PN?’ – examples included releasing aseptic capacity, reducing administration errors/improving safety and the long shelf life of triple-chamber AIO bags.ConclusionAIO PN appears to be an appropriate and safe for local use and should be taken into account in national standard paediatric PN formulation design where practicable.

Implementation of infliximab standardized doses after pharmacokinetic modelization in a cohort of patients with Crohn’s disease

BackgroundAccording to infliximab (IFX) license in Crohn’s disease (CD), infusion doses are based on patient’s body-weight. Dose banding providing standardized doses (SD) has been implemented in parenteral chemotherapy in order to optimize aseptic unit capacity and reduce drug expenditure, duration of hospital stay and costs without decreasing efficacy. Material and methodThe first part was a single-center retrospective analysis of consecutive CD patients receiving IFX maintenance therapy to determine standardized doses covering more than 50% of infusions. The second part was a prospective cohort study assessing the impact of SD compared to body-weight doses (BWD) on admission duration and costs. ResultsSix IFX SD covering more than 90% of infusion doses were implemented for dose banding. According to the Monte-Carlo simulation, there was no significant difference between IFX SD and BWD maintenance regimens. When assessed prospectively in 116 patients (75 patients treated with SD and 41 with BWD) corresponding to 128 infusions, hospitalization duration was shortened by 70 min per patient (p < 0.001). ConclusionAccording to a pharmacokinetic model, IFX SD has a pharmacokinetic profile close to BWD and is associated with reduced length of hospitalization in a cohort of patients with CD. IFX SD implementation could optimize infusion units functioning and, save time and costs without decreasing efficacy.

Council of Europe Resolution CM/Res(2016)2: a major contribution to patient safety from reconstituted injectable medicines?

This article focuses on the reconstitution of parenteral medicines and the work that has been carried out at the European level to improve patient safety. Reconstitution may occur in a...

Implications of parenteral chemotherapy dose standardisation in a tertiary oncology centre.

Dose banding parenteral chemotherapy has the potential to optimise aseptic unit capacity and reduce drug expenditure without compromising the service provided. Dose banding tables from NHS England were implemented into the electronic chemotherapy prescribing system. Compliance to the dose bands was analysed and submitted quarterly. Analysis of drug expenditure, drug use and cost per milligram data was also collected. Expenditure on the 17 drugs identified in the 2016/17 dose standardisation CQUIN reduced by approximately £100,000 per month over the CQUIN despite an increase in the number of prescribed doses of these drugs. At the beginning of the year, the percentage of work compounded in house was 60%, which was reduced to 51% of total workload at the end of the year due to outsourcing commonly prescribed doses from commercial pharmaceutical aseptic manufacturers. Dose banding parenteral chemotherapy is an efficient cost-saving strategy which also can help to increase the capacity of the aseptic unit.

BD PhaSeal™ and particulate contamination

AbstractBackgroundThe closed system transfer device, BD PhaSeal™, is used to compound individual doses of cytotoxic medication in the Aseptic Production Unit (APU) of the Lady Cilento Children's Hospital (LCCH) Brisbane, Queensland, Australia. The APU noted a large number of cytotoxic medications compounded using BD PhaSeal™ required remaking of the product due to visible particulate contamination. The small gray particulate contaminate was assumed to be rubber bung produced by ‘coring’ the rubber stopper of the drug vial when using the BD PhaSeal™ Protector P50 as part of the compounding process.AimThe aim of this study was to determine if substituting the BD PhaSeal™ Protector P50 with the BD PhaSeal™ Protector P55 reduced the level of particulate contamination in cytotoxic compounded products.MethodPhase 1 – baseline collection of contamination over 4 months. Phase 2 – substitute the Protector P50 with the P55 into the compounding process to compound a single medicine product, vincristine in sodium chloride 0.9% 50 mL bags for 2 weeks. Phase 3 – substitute the Protector P50 with the P55 into the compounding process of all cytotoxic medicines for 4 months.ResultsPhase 1 – 134 products were contaminated out of 2501 compounded products (5.3%). Phase 2 – one out of 75 vincristine products had particulate contamination (1.3%) using P55. Phase 3 – 28 contaminated products out of 3877 (0.72%) using P55.ConclusionThis study demonstrated that substituting BD PhaSeal™ Protector P50 with the Protector P55 reduced the incidence of particulate contamination of cytotoxic medicines from 5.3–0.72% of products. This provides significant resource and financial benefits.

Viability of Selected Microorganisms in Non-Cytotoxic Aseptic Preparations

Abstract: Numerous ready-to-use parenteral solutions are aseptically prepared in pharmacy-based aseptic preparation units. Microbiological stability of the preparations is influenced by the cleanroom environment, the complexity of the aseptic process, conditions during administration and the microbiological vulnerability of the products.: The aim of the study was to evaluate the ability of four different pathogens related to hospital infections to grow in ready-to-use, non-cytotoxic parenteral products aseptically prepared in hospital pharmacies.: In four consecutive series the antimicrobial activity of the following products was tested: caspofungin 35 mg or 70 mg in 250 mL 0.9 % NaCl solution (NS), micafungin 0.5 mg/mL in NS, vancomycin 5 mg/mL in G5/G10, heparin-sodium 1 IE/mL in NS, epinephrine 0.02 mg/mL in G5, norepinephrine 0.01 mg/mL in G5, phenylephrine 0.1 mg/mL, KCl solution 0.8 mmol/mL, trace elements 1:1 in G5/G10, midazolam 1 mg/mL injection solution, tranexamic acid 100 mg/mL injection solution, 50 % glucose solution, SMOFlipid 20 % lipid emulsion, 1 % propofol injection.Nine milliliter aliquots of each test solution were inoculated with 1 mL suspension of selected strains, i. e.: Most of the tested preparations induced no growth inhibition of the tested organisms. The selected strains lost viability in preparations containing vancomycin, phenylephrine or midazolam after a period of a few hours or days. Glucose 50 % w/v solution generated antimicrobial activity against: The lack of antimicrobial properties of ready-to-use, non-cytotoxic solutions should be considered while determining the shelf-life of the products. Ready-to-use preparations should be kept refrigerated whenever possible to inhibit the multiplication of any contaminating organism.

PTH-214 An audit reviewing the impact of a nutrition multi-disciplinary team on wastage of adult parenteral nutrition bags

Introduction At our hospital prior to April 2014, patients commenced on parenteral nutrition (PN) were reviewed on a daily basis by the chemical pathology registrar and once weekly on a multi-disciplinary nutrition team (MDT) ward round. PN was prescribed and manufactured in advance where possible to help facilitate the work flow within the pharmacy aseptic unit. In April the nutrition MDT recruited a nutrition clinical nurse specialist (CNS) and introduced twice weekly consultant led MDT ward rounds. In addition, daily reviews of all PN patients are done by the CNS and a pharmacist with the registrar, for daily prescriptions. The aim of this audit was to assess the impact of the enhanced nutrition support MDT on: (1) the percentage of PN bags used for the intended patients, (2) the projected annual financial cost of wasted PN, (3) the percentage of PN bags that have been reallocated where cold chain storage is assured, (4) the cost saving incurred as a result of reallocating wasted PN bags. Method Prospective data was collected on adult PN bags over a three month period between October – December 2014. All PN bags ordered from an external provider and standard PN bags from the aseptic pharmacy department were included. Any PN bags from other hospitals and home PN bags were excluded. Information captured included: total number of adult PN bags, type of PN bag, reasons for wastage or return, why bag could not be reallocated, number of bags reallocated and the cost of the PN bag. The price for each PN bag was calculated based on the cost breakdown from the monthly PbR PN reporting for aseptic services. Results were compared to data collected during a previous audit undertaken between April–July 2014. Results 627 PN bags were ordered during the audit period. Out of which 91% (n = 568/627) were used for intended patient (an increase of 1%); the financial cost of wasted PN was £6,217 per annum (a decrease of 62%); 69% (n = 41/59) were reallocated (increase of 5%); and the cost saving was £8,926 per annum (an increase of 37%). Conclusion The inclusion of a CNS and a pharmacist to the daily ward rounds as well as daily prescribing of adult PN bags significantly improved the utilisation of PN bags appropriately and minimised waste. A system to highlight which PN bags are available for reallocation should be introduced locally to avoid available bags not being utilised. Disclosure of interest None Declared.

AN OBSERVATIONAL STUDY OF THE ROLE OF THE PAEDIATRIC CLINICAL PHARMACIST

Aim Only three UK studies have previously described the role of the paediatric clinical pharmacist in reducing risk to patients1. These involved chart review, medication reconciliation and incident reporting to collect data. Pharmacists are recognised to make regular interventions to reduce or prevent medication errors but these are usually not documented due to time/workload constraints. We wished to describe contributions to patient care/safety made by pharmacists using direct observation to gain a comprehensive overview. Method Fourteen pharmacists were shadowed during 197 ward visits (Jun 2012–Jul 2013) on 15 paediatric wards in two UK NHS Trusts, one secondary and one tertiary care hospital. No widely accepted classification system of pharmacists9 interventions is available, therefore we used the following: Interventions medication error was identified and pharmacist intervened to prevent further doses reaching patient. Definition adapted from the American Society of Hospital Pharmacists,2 Pharmaceutical Care Network Europe Foundation3 and interventions from a previous systematic review.1 Contributions other pharmacist activities to enhance patient care. Definitions were adapted from the hospital medicines codes, NHS careers website4 and from a previous systematic review.1 Results Pharmacists were observed reviewing 6,034 prescriptions for 1,371 patients. They made 3311 contributions (54.8% of prescriptions overall) and 505 interventions (8.4% of prescriptions overall). Similar rates of interventions were identified in the two Trusts (8.7% vs 7.6% of all prescriptions). More pharmacists9 contributions were identified in the secondary care than the tertiary care Trust (62.7% vs. 36.8% of all prescriptions). The acceptance rate of pharmacists9 recommendations by doctors was 99.5%. The most common errors intercepted included: Omission error (28% all errors), e.g. omission of medication on admission (15.2% new patients) and omission of dose. Wrong dose (24% all errors) e.g. overdose (e.g. ten-fold error (1400 mg cefuroxime instead of 140 mg) and misplacing of numbers (gentamicin 210 mg instead of 120 mg)). Illegible prescribing (19% all errors), e.g. unclear drug name or dose. Wrong frequency (5.7% all errors), e.g. prescribing paracetamol five times daily instead of four times daily. The most common contributions included: annotating prescriptions with information (19.2% all prescriptions), e.g. rate of administration for IV drug; drug history and allergy status checking in 97% and 100% of new patients respectively and supplying medications (10% all prescriptions), mostly ready to administer IV doses from aseptic units. Conclusion To our knowledge this is the first study to observe paediatric clinical pharmacists in their daily activities to document their role. They were shown to play an important role in improving healthcare services provided to patients and intercepting medication errors. The acceptance rate of pharmacists9 recommendations by doctors was high.

Evaluation of Chemotherapy Contamination Following the Implementation of Closed System Transfer Devices

This studycompared thecontamination of the chemotherapeutic agent cyclophosphamide between using a conventional admixing procedure and closed system transfer devices (CSTDs). Surface wipes and urine samples were collected for two weeks before and two weeks after the CSTDs were used. The surface wipe samples were collected from critical areas in an aseptic dispensary unit and a chemotherapy patient care unit. The urine samples were collected from healthcare workers. Contamination from cyclophosphamide in the surface wipe samples was detected in fewer areas following the implementation of CSTDs. The mediancyclophospha-mide concentration in aseptic dispensary unit areas following the usage of CSTDs was significantlylower than what was detected when the conventional method (p=0.036, Mann-Whitney’s U-test) was used.Cyclophosphamide contamination was not detected in critical areas of the patient care unit following the use of the CSTDs.This study demonstrates the potential advantages of utilizingCSTDs to reduce contamination from chemotherapeutic agents in a work setting.

Stability of butorphanol-tropisetron mixtures in 0.9% sodium chloride injection for patient-controlled analgesia use.

Tropisetron is an adjuvant for butorphanol used in intravenous patient-controlled analgesia (PCA) and has been reported to provide superior pain control. It is efficacious in reducing the incidence of postoperative nausea and vomiting. However, this admixture is not available commercially and stability data applicable to hospital practice are limited. This study aimed to describe the drug compounding and evaluates the long-term (up to 14 days) stability of butorphanol and tropisetron in 0.9% sodium chloride injection for PCA use.In this study, commercial solutions of butorphanol tartrate and tropisetron hydrochloride were combined and further diluted with 0.9% sodium chloride injection to final concentrations of butorphanol tartrate 0.08 mg/mL and tropisetron hydrochloride 0.05 mg/mL. The polyolefin bags and glass bottles were stored at 4°C and 25°C for up to 14 days. The drug stabilities were determined by visual inspection, pH measurement, and high-pressure liquid chromatography assay of drug concentrations.The data obtained for admixtures prepared and stored at temperatures of 25°C and 4°C show the drugs have maintained at least 98% of the initial concentration. All solutions remained clear and colorless over the 14-day period, and the pH value did not change significantly.The results indicate that admixtures of butorphanol tartrate 0.08 mg/mL and tropisetron hydrochloride 0.05 mg/mL in 0.9% sodium chloride injection solution were stable for 14 days when stored in polyolefin bags or glass bottles at 4°C and 25°C and protected from light. The infusion is feasible for manufacturing in pharmacy aseptic units and can be stored for up to 14 days for routine use in PCA infusions.