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Safe medicine practices: a multidisciplinary approach

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European Statement

Patient Safety and Quality Assurance

Author(s)

Betânia Abreu Faria, Sara Barroso, Antonieta Silva, Olga Martins

Why was it done?

Portuguese legislation “The Basic Health Law (No. 95/2019) and the National Plan for Patient Safety 2021-2026 (NPPS 2021-2026) and the goals of the World Health Organization (WHO) are fundamental pillars of healthcare safety. The NPPS has promoted patient safety in the Portuguese National Health Service, focusing on specific issues such as safety culture, unambiguous identification of patients, safe surgery, pressure ulcer prevention, prevention of falls, infections associated with healthcare and incident reporting and drug safety. Thus, it is essential to ensure the training of health professionals (HP) in the field of patient safety and the safe and rational use of medicines. The objectives of the training actions focused on the safe use of medication, promoting patient safety and sharing experiences between the various HP, in order to optimise the circuits and procedures already implemented.

What was done?

Multidisciplinary training actions were carried out within the scope of safe medicine practices.

How was it done?

A team of four pharmacists and one nurse carried out training actions in the context of Safe Medicines Practices. The following topics were addressed: medicine circuit; good practices in drug preparation; identification of medicines: Look-Alike Sound-Alike (LASA) and High-Alert Drugs; physicochemical incompatibilities; factors that modify stability after reconstitution/dilution; fractionation and crushing of Solid Oral Pharmaceutical Forms (SOPF); drug information sources; reporting adverse drug reactions and other incidents; good practices in medication administration. 

What has been achieved?

Training actions were carried out with a total of 29 hours of training and 357 participants. Suggestions for improvement were presented: optimisation of drug signage, compliance with established circuits, logistical aspects, on time drug information, improvement of communication channels, increase in the frequency of training actions. The trainees expressed receptiveness and interest in this initiative, which provided content that was little discussed and very relevant to their daily practice. 

What next?

The correct preparation and administration of medicines is essential to safeguard their effectiveness and patient safety, which is the ultimate goal of every health professional’s daily activity. The Pharmacist, as part of the multidisciplinary team, must promote strategies that safeguard Safe Practices throughout the drug circuit. Hence it is important to ensure the continuity of these trainings.

Implementation of a β-lactam Continuous Infusion Protocol in a Coronary Care Unit

European Statement

Clinical Pharmacy Services

Author(s)

Catarina Oliveira, Ana Mirco, Fátima Falcão

Why was it done?

-lactams have proven to be effective and safe antibiotics over their history, and as a consequence, these drugs are typically among the most frequently prescribed in hospital settings. Optimization of treatment with β-lactams can be achieved by their administration by continuous infusion. Furthermore, this approach leads to a reduction of the nursing time devoted to preparation and administration. However, information regarding continuous infusion of β-lactams is not readily available for most antibiotics, leading to doubts about dosing, renal adjustments and administration, particularly uncertainties related to dilution of the antibiotics as most patients benefit from fluid restriction. Also, it was indispensable to understand which antibiotics had stability to be administered through continuous infusion.

What was done?

A protocol for continuous infusion of β-lactams was established in a coronary care unit (CCU), replacing the previous method of intermittent dosing in most patients.

How was it done?

Firstly, we evaluated which antibiotics benefited from this approach and had, simultaneously, stability. The antibiotics selected were Cefotaxime, Ceftazidime, Cefepime, Cefuroxime, Piperacillin/tazobactam, Penicillin G, Ampicillin and Flucloxacillin. In order to stablish a protocol for continuous infusion of these antibiotics, an extensive literature review was performed. Information about loading and maintenance dose, reconstitution, dilution (solvent and maximum concentration), infusion rate, renal adjustments, stability and storage was collected and summarized in a table.

What has been achieved?

A ready-to-use version of the β-lactams continuous infusion protocol was developed. In addition, dosing adjustments in patients on continuous renal replacement therapy, commonly made in patients in the CCU, were included too. This protocol was made available to all health professionals through the hospital’s intranet as well as posted in the CCU in order to be easily accessible by doctors and nurses. Thus, continuous infusion is now the standard for most patients requiring therapy with β-lactams in the CCU.

What next?

The implementation of this protocol has an education purpose, allowing the best use of documented practices in prescribing, medication review and administration continuous infusion of β-lactams. This protocol can similarly be easily implemented in other medical units. In the near future, we plan to monitor the compliance to the protocol and consider further improvements if necessary.

INCOMPATIBILITIES OF PARENTERAL DRUGS IN INTENSIVE CARE – ANALYSIS AND OPTIMISATION OF ADMINISTRATION SCHEDULES OF CENTRAL VENOUS CATHETERS AND FREQUENTLY USED DRUG COMBINATIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Martina Jeske, Jasmin Stoll, Vanessa Funder, Sabine Bischinger

Why was it done?

Due to the limited number of ports, it is necessary to administer several drug solutions via the same access. Incompatibility reactions can occur and may lead to a reduction or loss of drug efficacy and severe damage to the patient’s health. The objective was to create standardized administration protocols for central venous catheters and verify parenterally administered drugs’ incompatibility reactions. A further purpose was to build multidisciplinary cooperation to improve the drug administration processes.

What was done?

To optimize the drug therapy at four intensive care units (ICUs) of the University Hospital, the pharmacy department, physicians, and care management, jointly implemented a quality assurance project. In multidisciplinary teams, we had to overcome various challenges in different wards to develop standards regarding administering drugs via multi-lumen catheters. We analyzed all frequently used drugs (n=72) for their compatibility and summarized findings in a crosstable.

How was it done?

The current situation was recorded using a questionnaire and collecting individual cases of protocols for central vein catheters. About 2000 drug-drug-combinations were analyzed using three databases, KiK 5.1, Micromedex, Stabilis 4.0, corresponding specialist information, and manufacturer data. Nevertheless, the compatibility check based on the databases is subject to some restrictions. In several cases, the databases give different or contradictory results, and compatibility data are rarely available for some combinations. The project revealed that although infusion therapy is standardized in intensive care units, there are fewer standards regarding administering drugs via multi-lumen catheters. There are significant differences between theory and practice in terms of handling infusion therapy.

What has been achieved?

Different hazardous practices got identified and eradicated. The incompatibility table allows a quick assessment. The advantages/disadvantages of varying software systems were broadly discussed. KiK 5.1 was implemented in the ICUs, Micromedex in the pharmacy department. The team agreed that existing uncertainties must be decided jointly. Different practices in different wards may pose a threat to patient safety. The results were presented in a clinic-wide interdisciplinary training.

What next?

The awareness towards the need for cooperation and hospital pharmacists’ competence concerning incompatibility reactions strongly increased, leading to more standardization in the infusion therapy and avoiding incompatible drug combinations. The aim is to initiate a continuous improvement process.

A multi-disciplinary teams’ collaborative approach to transition benralizumab dependent severe eosinophilic asthmatic patients to self-administration in response to the COVID-19 pandemic

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European Statement

Clinical Pharmacy Services

Author(s)

Grainne D’Ancona, Niall Stewart-Kelcher, Schaya Bains, Andrew Hearn, Joanne Kavangh, Cris Roxas, Linda Green, Linda Thomson, Marianna Fernandes, Brian Kent, Alexandra NanzerKelly, David Jackson, Jaideep Dhariwal

Why was it done?

The COVID-19 pandemic necessitated the rapid transition of benralizumab dependent SEA patients onto home administration to facilitate on-going therapy in a cohort of patients who were “shielding” under UK government guidance.

What was done?

246 severe eosinophilic asthmatic (SEA) patients treated with benralizumab; a biologic agent targeting the human interleukin-5 receptor (IL-5Rα), at a specialist NHS asthma clinic, were transferred to self-administration at home in response to the COVID-19 pandemic. Alongside this, patients continued to need to be newly initiated on benralizumab therapy in spite of the pandemic and innovative pathways were created to ensure rapid initiation of therapy and home administration.

How was it done?

A varied multi-disciplinary team including pharmacists, pharmacy technicians, specialist nurses, doctors, physios and phycologist conducted a variety of in-person and virtual (telephone and video) consultations to consent and train patients on self-administration in their own homes in a rapid transfer to home administration.

What has been achieved?

We have investigated this patient cohort for any unwarranted effects by comparing the last Asthma Control Questionnaire-6 (ACQ6) measured in clinic with that collected by telephone consultation 8-12 weeks after transition to home administration. 246 benralizumab patients were included in the analysis, of whom 49 (20%) were new. There was no significant difference in pre-biologic ACQ6, pre-homecare (baseline) ACQ6 or post-homecare ACQ6 between the new and established patient groups. Both cohorts exhibited a similar magnitude of improvement in their ACQ6 following the transition to home administration (-0.73 in the established group vs -0.73 in the new group, both P<0.0001). We have demonstrated that early transition to home administration in patients treated with benralizumab is not associated with worse clinical outcomes as assessed by ACQ6.

What next?

Evaluation of patient experience on the switch to self-administration is currently being carried out via patient surveys with this data due to be completed in early 2021. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.

A multi-disciplinary teams’ collaborative approach to transition mepolizumab dependent severe eosinophilic asthmatic patients to self-administration in response to the COVID-19 pandemic

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European Statement

Clinical Pharmacy Services

Author(s)

Grainne D’Ancona, Niall Stewart-Kelcher, Schaya Bains, Andrew Hearn, Joanne Kavanagh, Cris Roxas, Linda Green, Louise Thomason, Marianna Fernandes, Brian Kent, Alexandra NanzerKelly, David Jackson, Jaideep Dhariwal

Why was it done?

The COVID-19 pandemic necessitated the rapid transition of the remaining 41 mepolizumab dependent SEA patients onto home administration to facilitate on-going therapy in a cohort of patients who were “shielding” under UK government guidance.

What was done?

87 severe eosinophilic asthmatic (SEA) patients treated with mepolizumab; a biologic agent targeting interleukin-5 (IL-5), at a specialist NHS asthma clinic, were transferred to self-administration at home compared to usual practice of administration in a hospital setting. 40 patient were transferred in late 2019 as a planned ‘pilot’ transition and 47 patients were transferred unplanned due to the COVID-19 pandemic. We investigated whether there was a change in asthma control following the transition to home administration and whether a differential response to treatment exists following transition to homecare before and after the onset of the COVID-19 pandemic.

How was it done?

A varied multi-disciplinary team including pharmacists, pharmacy technicians, specialist nurses, doctors, physios and phycologist conducted a variety of in-person and virtual (telephone and video) consultations to consent and train patients on self-administration in their own homes in a rapid transfer to home administration

What has been achieved?

Patients receiving mepolizumab at home were stratified according to those who had a planned transition prior to 1st Feb 2020 versus those who had an unplanned transition after this date necessitated by the COVID-19 pandemic. The last Asthma Control Questionnaire-6 (ACQ6) measured in clinic (“baseline”) was compared with that collected by telephone consultation 6-8 weeks after transition. Immediately prior to transition to homecare (baseline), the planned group had a lower mean ACQ6 than those in the unplanned group (1.19 vs 1.90, P=0.004). The ACQ6 on home administration decreased significantly in both groups (-0.47 in the planned group vs -0.56 in the unplanned group, both P<0.001). The ACQ6 for the planned cohort during homecare was significantly lower than that for the unplanned group (0.72 vs 1.34, P=0.012).

What next?

Evaluation of patient experience on the switch to home administration is currently being carried out via patient surveys with this to be completed in early 2021. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.

A NOVEL CLOSED SYSTEM DRUG-TRANSFER DEVICE FOR ORAL DOSAGE FORM HELPING PATIENTS WHO CANNOT SWALLOW SOLIDS (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

SALIM HADAD

Why was it done?

It remains that new solutions to increasing the safety of handling Solid Dosage Form hazardous drugs have to be developed. Conceptually, through operating in a closed system, CSTDs should significantly reduce the risks to pharmacists and nurses There are two main drawbacks of the known solutions:
1. The crushing and dilution of the solid dosage form medicine is done with an open vessel to the environment, such as a porcelain crater, which may cause the work environment to be contaminated with carcinogenic or teratogenic substances, that could expose and endanger the medical staff to hazardous substances in the course of their duties as providers of medical care.
2. The tools available today are reusable, requiring a thorough cleaning process between different materials (drugs), which can lead to cross-contamination between different doses of drugs, which are crushed one after the other with the same instrument.

What was done?

CSTD – for oral dosage form new device of its kind, combines the act of crushing the various drugs, dissolve in liquid and give to a patient who cannot swallow for various reasons, that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.

How was it done?

We designed the device with 3D software (solid wark). It consists of a number of functional parts. The main ones are: a 20 ml barrel, a top part of which is a piston with a bottom basket loaded with the solid medicine; this part is sealed as a barrel from above. With the help of mechanical rotation, the drug breaks down into small particles that fall into the inner space of the barrel. Adding the liquid through a fluid port disposed on the bottom barrel which it is completely sealed. The removal of the liquid drug through a unique adapter which at its end is adapted to the gastric tube or oral administration to the patient,

What has been achieved?

1. The complete process of crushing and liquefying of the solid drugs is carried out under sealed conditions to the immediate environment and without fear of exposure to residues of toxic substances to the medical caregiver. 2. A one-time use system saves complex cleaning process. 3. There is no risk of cross-contamination between different drugs. 4. Saving personal protective equipment such as gloves, masks, lab coats clean rooms, etc. which is necessary for protection and for the safety of the caregiver team.

What next?

Applied research will be carried out by pharmacists and nurses to test the efficiency of the new device (as a basic prototype). These experiments will take various non-cytotoxic pills, will be dummy operations, in which the crushing and liquefying will be performed, and the solution or suspension will be transferred through the gastric tube, according to an approved research protocol.

THE OPIOID WORKING GROUP: AN INTERDISCIPLINARY WORKING GROUP TO IMPROVE THE CORRECT PRESCRIPTION AND APPLICATION OF OPIOIDS IN THE HOSPITAL SETTING (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Imke Willrodt, Delia Bornand, Jimena Ramos, Stojan Petkovic, Giulia Mohr, Anne Leuppi-Taegtmeyer

Why was it done?

Due to critical incidents involving opioids reported internally at the University Hospital Basel in 2018, there was an urgent need to evaluate underlying reasons for these events. The Opioid AG was established with the aim to mitigate risks for the correct prescription and application of opioids, and therefore to improve patient safety.

What was done?

The Opioid Working Group at the University Hospital Basel is an interdisciplinary working group including representatives from different professions (physicians, nurses, pharmacists) and departments (medical, surgery, gynaecology, emergency, pain therapy, palliative care, pharmacology and toxicology, patient safety and information technology).

How was it done?

The thorough analysis of root causes for the critical incidents revealed prescribing and application errors, such as non-observance of kidney failure, pharmacodynamic interactions of opioids with other prescribed drugs, inadvertent overdosing – in particular with liquid drug formulations, or patient mix-ups.

What has been achieved?

Consequently, the following steps are being taken to address these risks: 1. Optimisation of the prescribing software including opioid prescription templates, links to existing opioid unit conversion tables for liquid forms of diamorphine, morphine, hydrocodone and oxycodone (milligrams to millilitres) as well as clearer display of “as required” opioid prescriptions on the patients’ electronic drug charts. 2. Preparation of Standard Medication Preparation Schemes for nursing staff of the emergency department. 3. Development of an additional label (concentration, patient initials, date of reconstitution, date of expiry of reconstituted solution) for parenteral diamorphine. 4. Improvement in detailed written instructions for the correct preparation, labelling, application and disposal of intravenous and oral drugs (to include opioids). 5. Evaluation of a hospital opioid safety self-assessment tracking tool.

What next?

A comprehensive evaluation will take place, 6 months after the implementation of all measures. We will use the number of naloxone prescriptions on the wards as a key performance indicator to measure the success of this project. The reported critical incidents involving opioids will also be assessed before and after the implementation of all measures.

This evaluation will help to identify open questions, potential gaps and further needs for improvement to be addressed by the interdisciplinary team.

A ROBUST LEAN METHOD FOR IMPROVING THE MEDICATION MANAGEMENT PROCESS

European Statement

Patient Safety and Quality Assurance

Why was it done?

Hospitals are facing strong economic constraints and increasing requirements in terms of quality and safety of care. To address these difficulties, a solution could be to reorganise processes and relocate resources through the use of industrial engineering Business Process Improvement approaches such as Lean.

What was done?

An original Lean method for business process improvement was designed and tested in an acute general medicine department in order to improve the mediation management process.

How was it done?

A Lean method for the hospital setting was elaborated based on a triangulation between literature data, semi-structured interviews and a case study. This method, relies on 5 operational activities (Understand the process, Measure, Analyse, Improve, Implement) and 6 support activities (Establish top management support, understand the environment, Organize a project team, Manage change, Monitor and continuously improve). A multidisciplinary project team (nurses, head nurses, pharmacists, physicians, pharmacy technicians, nurse’s aide) was then formed to experiment this method in the acute general medicine ward.

What has been achieved?

This project allowed improving the efficiency and quality of the medication management process. Medication errors at admission and risk for medication errors during administration were reduced (46% vs 12%), non -value added activities during administration were eliminated (25 minutes/nurse/day saved), ward stock management was streamlined (double bin system) and medication delivery was secured. More than 80% of the stakeholders surveyed (45) considered that the changes made to the process improved their working conditions (no impact for the others) and all the participants to the project team were satisfied or very satisfied with the project. The team now meets once a month to continuously improve the process.

What next?

The top management of the hospital has decided to promote this method and is currently creating and training a specific improvement team to support other improvement projects in the hospital.