Development of standard kits with utensils for outpatient parenteral antibiotic therapy
Pdf
European Statement
Production and Compounding
Author(s)
Louise Rasmussen Duckert, Marianne Kjettrup Jensen, Mette Lethan, Trine Schnor
Why was it done?
The hospital pharmacy wishes to support the implementation of OPAT and during the process the need for standardised kits with utensils was identified. The availability of kits with necessary utensils for aseptic handling of parenteral infusion would simplify and standardise the work for hospital and home nurses. Considerations regarding patient safety and sustainability were also in favour of the kits, as choice of utensils could secure compliance to regional guidelines considering use of closed systems and rinse of the line after infusion. Kits containing the exact needed utensils for an administration also reduces the possible waste.
What was done?
The hospital pharmacy has composed standard kits with utensils for outpatient parenteral antibiotic therapy (OPAT).
How was it done?
The kit is composed in collaboration between the pharmacy, hospital nurses and home nurses. The best suited infusion set was chosen – a closed system with two spikes for antibiotic mixing and infusion. Hereby nurses avoid direct contact with antibiotics and avoid antibiotic aerosols in the citizen’s home. The infusion set contains no PVC, phthalates or latex. When fully emptied the infusion set can be discarded as regular waste.
The kit also contains a sterile cover for the workstation, sterile ethanol swabs, gloves, pre-filled saline syringes for rinse of the line after infusion and a written manual. All is packed and labelled by the hospital pharmacy and lot numbers are registered for traceability.
What has been achieved?
The kits have been tested in selected municipalities and the content of the kit has been adjusted. As a result of the feedback a film has been recorded showing the handling of the infusion set. The video is used for training and a QR code on the written manual guides the home nurse to the video if needed. The kit is now used widely in the region and response is positive. With the set-up being identical in all municipalities in the region, handling antibiotics and utensils is simpler for the hospital nurse at discharge.
What next?
As the number of patients in home-based OPAT rises, experiences with the kits will probably result in wishes for adjustments. A new kit with utensils for changing PVK is under development.
Improving people living with HIV therapies compliance: a practical tool customised for patients and designed by hospital pharmacists
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sabrina Trivellato, Daniele Mengato, Maria Mazzitelli, Anna Maria Cattelan, Francesca Venturini
Why was it done?
An optimal compliance is an essential requirement for people living with HIV (PLWHA) to grant drugs effectiveness and safety. Given the complexity of the therapeutic regimen, and the multiple changes to it due to the clinical status, compliance to therapy may be suboptimal. Patients who are not well educated on how to follow their therapy are more keen on quitting the treatment or facing virological failure. According to previous analysis, we reported that 120 patients out of more than 1500 managed by our centre experienced suboptimal adherence to therapy.
What was done?
We created a user-friendly tool to educate HIV-patients on their drugs’ adherence in our University Hospital.
How was it done?
We studied every drug prescribed in our centre and we analysed it from the patient’s point of view. The question we aimed to answer was: “If I were a PLWHA, what would help me assuming the correct drug, at the proper time, avoiding misunderstandings?”. We analysed the shape, colour and dimensions of both the package and the pills/capsules. We focused on the most appropriate way to take every drug and we investigated possible interactions with OTC drugs or dietary supplements.
What has been achieved?
A poster reporting all the drugs available in our formulary was developed: 34 medicines were described in alphabetical order, specifying for each one the image of the package, the usual dosage, the picture of the pill/capsule compared to the dimension of current coins and special warnings about possible drug-drug interactions. We also adopted practical symbols to indicate whether to assume the drug with or without food. The poster became available starting from April 2022 and during the following 5 months a cohort of 960 patients could rely on it.
What next?
In order to help our patients taking their therapies, we expect to get a digital form of this poster to make it available on the phone scanning a QR code. Alongside, we aim to enlarge and improve this digital version by adding a final section with an interactive survey to closely monitor the compliance of the patients and help them to improve it. Through this project we could also obtain an active pharmacovigilance setting.
Removing false beta-lactam allergy warnings: role of the clinical pharmacist in collaboration with the allergology service
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Carlos Santos Rodríguez, Silvia Irene Corrales Vargas, Maria de los Ángeles Peña Peloche, Alfredo Julian Jover Sáenz, Miguel Ángel Ramos Gil, Arturo Morales Portillo, Marta Mir Cros, Francisco Ignacio Torres Bondia, Lluis Marqués Amat, Joan Antoni Schoenenberger Arnaiz
Why was it done?
Beta-lactam antibiotics are the most commonly used group of antimicrobial drugs but are also the ones with the most significant induction of allergic reactions. However, it is known that many of these patients do not present reactions upon rechallenge or have false allergy warnings in the medical records.
What was done?
To assess the impact of a pharmacist-driven programme for active beta-lactam allergy warning removal in adults in collaboration with the Allergology service.
How was it done?
We identified adults with active beta-lactam allergy warnings among outpatients aged 35 to 45 years over 26 months.
Both in the hospital and primary care setting the pharmacist assessed the current information of the cases in the electronic medical records (EMR) and through personal interviews or by telephone. The following data were retrieved: year of allergy registration, type of reaction described, tolerance of beta-lactam antibiotics, and the existence of Allergology reports.
The pharmacist, previously trained by the Allergology service, could proceed to remove or confirm the allergy label, if applicable, or refer the patient to the Allergology service for allergy tests.
What has been achieved?
We reviewed a total of 1178 cases with active beta-lactam allergy warnings. The most frequently implicated beta-lactam drug was amoxicillin, with 170/1178 (14.4%) cases.
111/1178 (9.4%) of cases had an allergic reaction in childhood, and in 714/1178 cases (60.6%) EMR did not describe the symptomatology or treatment that justifies the allergy.
The allergy warning was directly removed in 93/1178 (7.9%) of patients, as they had previous reports of Allergology, had tolerated antibiotics after the allergic reaction, or did not present symptoms compatible with an allergic reaction.
The review confirmed allergic warnings in 43/1178 (3.65%) cases, according to the symptomatology and the information recorded in the Allergology reports.
One thousand and forty-two cases were referred for beta-lactam allergy test performance in the allergology service, of which 47% yielded a negative result.
What next?
The pharmacist is qualified to remove the warning in cases with a doubtful allergy to beta-lactam antibiotics after a thorough medical record review and informed consent. Moreover, the pharmacist can provide valuable information that allows the classification of warnings according to the detected risk and facilitates subsequent decision-making by the allergist.
Reconciliation of shared medicine record at discharge: hospital pharmacy ensures correct information on patients’ transition
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Linda Jeffery, Maria Grønkjær Abrahamsen, Anja Alrø Bøtkjær, Lotte Aggergaard, Ann Brit Andersen
Why was it done?
Our country has a national SMR for every citizen. The SMR shows the current medication that the citizen has been prescribed, from all sectors. All sectors can see the SMR, which is considered/ought to be the ‘truth’ about the patient’s medication. On discharge from the hospital the SMR is updated by the doctor. Afterwards, pharmacy technicians dispense medicines for discharge. The technicians, at this stage, often find discrepancies in the SMR compared to the medication prescribed and given during admission. The SMR is electronically updated but not adequately reconciled. False information in the SMR may ultimately lead to adverse drug safety events in the primary sector.
What was done?
The regional hospital pharmacy patient safety network studied how many patients do not have a reconciled electronic Shared Medication Record (SMR) at discharge, despite the doctor having electronically updated it.
How was it done?
The technician recorded the discrepancies found before contacting the doctor to get the SMR corrected.
Each discrepancy was reported into the national patient safety database.
The technicians do not dispense medicines to all discharged patients, so our results were extrapolated to all discharged patients in the time period (there was no reason to expect bias).
The study was carried out in the whole region (5 hospitals) during the same week in September 2022.
What has been achieved?
Preliminary data shows that 994 patients were discharged from the wards studied.
Technicians dispensed medicines to 278 patients. They found one or more discrepancies in 65 SMRs (23,4%).
Extrapolation of these results revealed that, in the period, there were potentially 232 patients with drug-related problems from these wards (and approx. 17,000/year in the region).
What next?
Our results showed that the SMR is not adequately reconciled in 23% of discharges, despite the doctor feeling that the task is completed. This gives drug related problems in the primary sector, often resulting in calls to the ward etc. that are time consuming and difficult to solve after discharge. Updating the SMR at discharge is essential for patient safety under transition of care. Our results will be brought to the hospital administrations, patient safety organisations and the regional medicines board for further discussion about the problem and possible solutions.
Prescription review of digoxin-treated inpatients: Pharmacist involvement in its pharmacokinetic monitoring and dosage adjustment
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
DEL RIO GUTIERREZ JOSE MANUEL, MARTA MIARONS FONT, SONIA GARCIA GARCIA, TONI SORIANO COLOMÉ, ALBA PAU PARRA, ARIADNA GRACIA MOYA, NIEVES HERRANZ MUÑOZ, BRUNO MONTORO RONSANO, PAU RELLO SABATE, GERARD ORISTRELL SANTAMARIA, MARIA QUERALT GORGAS TORNER
Why was it done?
Digoxin is a drug frequently implicated in medication errors due to its difficult clinical management. It has also been observed that digoxin pharmacokinetics could change in acute medical conditions, compromising its effectiveness and safety. As hospital pharmacists, we have the opportunity to review which dose is the most appropriate for every patient.
What was done?
Twice-weekly active and extensive pharmaceutical review of digoxin-treated inpatients was established to identify whether the prescription was adequate and to adjust dosage according to plasma concentrations (PCs) and clinical situation.
How was it done?
1. A multidisciplinary team comprising pharmacists and cardiologists was created to identify possible solutions to improve digoxin prescribing.
2. It was agreed that a twice-weekly extensive review of digoxin-treated inpatients would be conducted by a pharmacist. Candidates for digoxin monitoring were:
a. Patients on chronic digoxin therapy and with at least one of the following risk factors: presence of renal failure (RF), recent surgery, elderly patients (≥65 years), critically ill patients, or patients with suspected toxicity.
3. Once the patients were identified by the pharmacist, they would be discussed with the cardiology team.
4. Digoxin prescriber would be contacted to recommend performing a determination of digoxin PC. PC reference range was set at 0.8–1.2 µg/L for atrial fibrillation (AF) and 0.5–0.8 µg/L for heart failure (HF).
5. PCs would be interpreted using a pharmacokinetic monitoring software (PKS Abbot).
6. Monitoring results and recommended dosage adjustments would be communicated.
What has been achieved?
From August 2021 to May 2022, 190 patients were identified. Sixty-five (33.7%) were considered for monitoring, of whom 21 (32.3%) were women. The average age was 77.9 (SD 11.7). Sixty-five (100%) with AF and 8 (12.3%) also with HF. The most prevalent risk factors warranting monitoring were patients aged 65 years or older (N=57, 61.9%) and RF (N=31, 33.7%). Thirty-three (51%) of monitored patients required a dosage adjustment, of whom 23 (69.8%) required a dose decrease, 5 (15.1%) an increase and 5 (15.1%) to stop the treatment. Median digoxin concentrations were 1.23 µg/L (interquartile range: 0.75-2.03).
What next?
The process described applies to any centre able to monitor digoxin CPs both in inpatient and outpatient settings.
Creation of an ‘Agrippal’ programme to fight against nosocomial flu
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy
Why was it done?
The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.
What was done?
Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.
How was it done?
Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.
What has been achieved?
The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.
What next?
This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.
Software tool development for reconstitution and administration of parenteral antibiotics in hospitals: an international project
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Zora Ćetković, Dragana Rajinac, Ivana Baralić , Jelena Marković, Darija Kuruc Poje, Miroslav Kota, Špela Urh, Irina Tegelj, Vesna Bizjak, Dragana Mitrić, Tijana Kovačević, Andrej Pečet, Irena Radivojša, Sanja Filkova, Vesna Bašić-Milošević
Why was it done?
Medication errors regarding reconstitution and administration of parenteral antibiotics are frequent in hospitals. In our study conducted in 12 Southeastern European hospitals in 2021, we demonstrated the need of parenteral antibiotic reconstitution/dilution database in hospital pharmacy practice. Moreover, according to European Statements of Hospital Pharmacy (statement 5.5.), implementation of electronic decision support system by HPs should help to decrease the risk of medication errors. The purpose of software tools is to gather all relevant information regarding parenteral antibiotic reconstitution/dilution and make them easily accessible.
What was done?
A group of hospital pharmacists (HPs) from 6 Southeastern European countries created new software tools (a mobile-responsive website and mobile applications for Android and iOS) for providing information on reconstitution and administration of parenteral antibiotics in collaboration with software developer. These tools contain parenteral antibiotic reconstitution/dilution database in seven different languages (English, Serbian, Croatian, Slovenian, Bosnian, Macedonian and Montenegrin).
How was it done?
Technical requirements for website and mobile applications were designed by HPs. The development of these software tools was carried out by a software developer and funded by European Association of Hospital Pharmacists (EAHP). The final version of the software went through a rigorous evaluation, conducted by HPs during development and all technical problems were resolved consequently.
What has been achieved?
· Designing and developing these software tools helps HPs to provide evidence-based information about parenteral antibiotic reconstitution/dilution at the point of care, thus improving decision-making process and patient safety. · Reconstitution of parenteral antibiotics in wards is efficient and smooth. · Oral and written instructions for parenteral antibiotic reconstitution/dilution are replaced by electronic decision support tools, designed to prevent medication errors. · HP’s interventions are required to support the use of these software tools.
What next?
Our next challenge is wider use of these software tools in order to ensure the appropriate reconstitution/dilution of parenteral antibiotics in wards by nurses and physicians. These software tools are applicable in hospital setting and can be used by all regional hospitals. Additionally, they can be easily incorporated in hospital information system. We also plan to update periodically antibiotic reconstitution/dilution database, as new information becomes available.
INTRODUCTION OF REGULATORY AND HEALTH WATCH IN THE CLINICAL TRIALS AREA
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
When the case for a study sponsored by the hospital has been filed a few months ago, the national agency authorizing trials raised the issue of health waltch, particularly the management of drug recalls. With the research department, which alerted us on the lack of resources for health alerts, and at the same time facing an international cease of some drugs, we set up a health alert and a regulatory watch system, to improve the quality of product and the patient’s safety.
What was done?
We set up a daily health and regulatory watch to stay abreast of any news. Regarding health watch, we included : studies for which the hospital is the sponsor ; studies for which the experimental treatments are not provided by the sponsor ; treatments used for adverse events and authorized by the sponsor.
How was it done?
Daily regulatory watch is carried out on the national legislation website with daily updates of national texts. If a new rule applies, it is written in a table to alert everyone.
Daily health watch is also carried out on the site of the national agency of drugs. Four types of information are recorded: drug shortages, alerts, recalls and releases.
What has been achieved?
Tables collecting those information are available on the pharmacy’s network so that anyone can read them, and can be shared with clinical research officers. To that day, some information has been collected due to a european legislation update on the clinical trials and has allowed us to anticipate what will change next year. We have not yet faced a drug recall but what has been done will allow us to react in the best way when this will happen.
What next?
The aim for carrying out regulatory and health watch is to allow us to quickly react and anticipate future problems, while keeping in mind the patient’s safety and the pharmacy practices improvement. This work was therefore completed with success, demonstrating the ability to react and the desire to deploy continuous improvement initiatives to strive for operational excellence and pharmaceutical. We now want to implement this work in the daily activity and extend it to other sectors.
Parameters involved in medication dispensing automation security and performance
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Hind Bouami, Dorine Castillo
Why was it done?
The human-machine system designer has to make decisions to secure and improve the automation process, and handle organization’s complexity. Documenting human agent’s situation awareness is crucial to support human-machine designers’ decision-making. Knowledge about risks, critical parameters and factors that can impact and threaten automation system’s performance and security are valuable for human agents, and should be collected using preventive and retrospective approaches.The evaluation of Macon hospital center’s automation performance enables to identify critical parameters to control in order to secure the human-machine system.
What was done?
An automation evaluation approach has been conducted in Macon hospital center, a hospital equipped with automated drug dispensing solutions for more than 5 years. The analysis of Macon hospital center automation’s feedback provides relevant information to enhance the perception and the comprehension of the system’s complexity fully, environmental factors that interact with the system, and to identify critical parameters in the automation process. Therefore, agents can design a projection of a secure and performant automated organization. This information will enable hospitals to make effective decisions to improve their automation project performance.
How was it done?
We deployed an anthropocentric approach for automated system evaluation in Macon hospital center.
Our approach integrates six steps that are run in automated hospital pharmacies to analyze their feedback [6]:
1) The identification of pharmacy’s automation needs and objectives, and the analysis of operational environment and existing equipment,
2) The analysis of automated equipment functional specifications formalized by the pharmacy,
3) The evaluation of automation deployment results and related gains,
4) The evaluation of specific actions implemented by the pharmacy during automation process,
5) The analysis of the parameters to control for automated equipment integration security and performance,
6) The analysis of factors influencing human-machine interaction.
What has been achieved?
The analysis of Macon hospital center pharmacy’s automation specifications revealed that 66.22% of automation requirements are technical, 29.73% concern human-machine interaction, and 4.05% relate to human aspects.
80.95% of automation specification related to the chosen Sinteco’s automated solution are met. The performance of the chosen automated solution is involved in 28.38% of automation specifications performance in Macon hospital center. The remaining systemic parameters involved in automation specifications performance need to be controlled.
Critical systemic parameters involved in automated solutions specifications and performance that have been identified through Macon hospital’s automation feedback are: the specificities of the chosen automated solution, hospital’s strategic decisions and budgetary constraints, the complexity of the hospital’s organization, the complexity of hospital’s information system, the constraints related to the packaging of drugs by pharmaceutical firms, users training, the complexity of the automated system, and users’ requirements and constraints.
The five parameters influencing human-machine interaction that should be managed to secure automated systems are: understanding the system’s complexity, defining relevant levels of automation, determining human and automated agents’ authority, determining human and automated agents’ autonomy, and understanding the human complexity.
What next?
Handling life-critical systems complexity such as medication delivery activity requires to be equipped with appropriate technology, and to control automation risks. The integration of human-machine principles is crucial to secure automation in hospitals, and to maintain a good balance between automation and human skills.
Digitization: a key to improve health condition of patients with cancer disease
European Statement
Clinical Pharmacy Services
Why was it done?
the app was developed in order to improve therapeutic adherence, pharmacological counseling, management of adverse events and increase pharmacovigilance’s reports with higher data quality. The World Health Organization recognizes that 20% of health is due to medical care, 20-30% to lifestyle, while the remainder depends on the environmental, social, genetic and psychological conditions of the individual. The goal of this app is to improve patient’s therapeutic path at different levels and breaking down geographical barriers.
What was done?
the Sars-cov-2 pandemic entailed a lot of new challenges for the Hospital pharmacist . As the scenario was completely new, it was developed an app to better manage patients with cancer disease treated with oral chemotherapy.
How was it done?
Patient has been divided into two groups, of which only one group use the app to manage the therapy. The primary endpoint was the improvement of therapeutic adherence, while the secondary endpoints are: improve in the quality of patient life (HRQoL), increase pharmacovigilance’s reports and avoid therapeutic errors.
What has been achieved?
The continuous dialogue between patients and hospital pharmacist througt system’s online messaging app improved the management of patients needed and reduce drug interactions. Digital management led to a 56% increase of pharmacovigilance reports. It was also detected a reduction in overall costs and patient uneasiness.
What next?
the health system has to be reorganized around patient’s needed, by promoting the use of more and more homogeneous, safe, transparent and accessible technologies.
Regulatory authorities should accelerate the adoption of digital solution. In this new framework hospital pharmacist will play a key role in the development of value based medicine and in the process of treatment humanization as a patient’s landmark person too.