Author(s)

Caroline TRAN VAN HO, Marie-Anne ESTEVE, Pierre BERTAULT-PERES, Marjorie ROUDOT

Why was it done?

SARS-CoV-2 infection leads to pro-inflammatory molecules production (in particular IL-6). If the immune system is overwhelmed and cytokine production spikes, a hyper-inflammatory phenomenon occurs: the cytokinic storm, which can bring lead to the admission in an intensive care unit. Due to the absence of authorized treatment, several clinical trials (CTs) and off-label use of drugs have been set up.

What was done?

The aim of this study is to analyse the off-label use of tocilizumab in a French university hospital in comparison with different CTs.

How was it done?

A retrospective study of tocilizumab prescriptions in Covid-19 was conducted between 01/03/2020 and 30/04/2021 by extracting data from Computerised Physician Order Entry and Pharmacy Management software (Pharma®). History of patients was recovered by electronic medical records (Axigate®).
Results were compared to (1) RECOVERY Collaborative Group. Lancet. 2021, (2) Hermine O. JAMA. 2021, (3) Rosas IO. N Engl J Med. 2021, (4) Salama C. N Engl J Med. 2021.

What has been achieved?

Between 01/03/2020 and 30/04/2021, 68 patients received tocilizumab.
Seventy-seven percent of patients were in the intensive care unit and 42.6% died, whereas 31.0%, 19.7%, 11.1% and 10.4% died according to (1), (3), (2) and (4), respectively. Mechanical or invasive ventilation at the time of tocilizumab prescription was widely used (84%) compared to CTs (54.0%, 27.9%, 24.0%, 12.2% for (1), (3), (2), (4)). According to (1), there is a synergistic action between tocilizumab and dexamethasone. Eighty-four percent of patients received at least one dose of corticosteroids in agreement with (1) and (4).

What next?

The increase in off-label use of tocilizumab is related to the results of CTs. Because of the low number of patients, the differences in COVID-19 stages at tocilizumab initiation, and the absence of a control group, it is difficult to explain our data. Given the weak iatrogenic effects revealed in CTs and in-label use, the benefit/risk seems in favor of tocilizumab use against COVID-19. Further studies are needed to confirm the first hopes. Since Casirivimab / imdevimab, and amlanivimab / etesevimab have been granted early access in France, the therapeutic strategy will be updated.

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Author(s)

Vera Pires, Maria Teixeira, António Gouveia

Why was it done?

Cisplatin is a cytotoxic agent used in CT regimens in ST. (1) Nephrotoxicity is the main toxicity, and hydration is always indicated to prevent kidney damage. [1,2] In 2018, when we computerized the ST’s CT protocols, we verified the existence of variations in CH protocols. According to the bibliography, this lack of standardization could lead to sub-optimal treatment of patients, errors and unnecessary use of resources. [1,3] Thus, it was necessary to develop a standardized hydration protocol designed by pharmacists with the collaboration of oncologists.

What was done?

Standardize the cisplatin-based hydration (CH) protocols used in the solid tumors (ST) chemotherapy (CT) regimens in adults in our institution.

How was it done?

Audit of CH protocols used in ST in adults in our institution and literature review to build a standardized evidence-based protocol.

What has been achieved?

We gathered 31 CT regimens with cisplatin. Verified the existence of variations in the volume of hydration (VH) before and after cisplatin, in the volumes of drug dilution, perfusion time, in the use of oral hydration (OH) and in ionic supplementation. We found that all of them were indicated to perform cisplatin only “if urine output >100ml/min”, use of mannitol before cisplatin and furosemide in SOS. Through the consulted bibliography, 4 regimens were made and implemented in 2019, according to the dosage of cisplatin: HC1< 40mg/m2 (Hday) and HC21000ml, and mannitol is only administered if cisplatin ≥60 mg/m2 (RCM). All protocols have magnesium and potassium supplementation.

What next?

Thus, despite the lack of consensus in the bibliography, a standardized protocol was created based on the evidence and clinical practice of our Institution. It is our intention to assess the impact of this intervention, from the perspective of the patient and the Institution.

Why was it done?

Chemotherapy prescribing errors could arise even when computerized systems are used. Additional evaluation of prescribed chemotherapy is needed, to prevent any harm to the patient and rise the level of patent’s safety.

What was done?

Preparation of written standard operating procedure that could help recognize the errors between the electronic chemotherapy record of prescribing and actual drug delivery.
Chemotherapy prescribing is a complex process encompassing prescription of cytotoxic medicines, infusion fluids and supportive care. Cytotoxic medicines have a narrow therapeutic range and actual dosage is usually adjusted according to the body surface area, weight or creatinine clearance. Minor alterations can have a significant effects on cytotoxicity, therefore the computerized prescribing is preferred. The dose is automatically calculated from the pre-inserted chemotherapy protocols and patient data.

How was it done?

Each computerized chemotherapy prescription should be closely reviewed by standard operating procedure, step by step, to complete the validation of chemotherapy accordingly.
Detected error should be noted by the pharmacist and corrected by the referring oncologist.

What has been achieved?

During the period from 1st January to 30st September 2021, approximatly. 13.400 chemotherapy prescription have been received at our pharmacy department. In 848 cases of prescribed chemotherapy, intervention of a pharmacist has been required because of inappropriate prescription. Among that, in 100 cases, computerized prescribing errors were identified. These errors identified were: wrong patient (2), incorrect dose prescribed (38), incorrect chemotherapy protocol chosen (30), incorrect day of chemotherapy administration prescribed (3), erroneous height or weight (1), incorrect glomerular filtration rate calculation for carboplatin (1), dual chemotherapy (9), change of the drug in pre-entered protocol (5), incomplete prescription (missing validation) (11).
Good cooperation with oncologist and oncology nurses, who are aware of clinical pharmacists pivotal role in
error avoidance, is needed.

What next?

Written standard operating procedure should be useful to detect common errors and to guide corrective actions, which can help
experienced clinical pharmacist and should be used as a tool for pharmacist trainees and student to learn
how to work accordingly to the protocols in use.

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Author(s)

Kornelia Chrapkova, Stanislav Gregor, Michal Hojny

Why was it done?

A passive surveillance system exists in our country, giving limited options for the reporting of adverse drug reactions (ADR) to our National Drug Agency (NDA). The current system does not consider different patient´s criteria such as, age, variety of disabilities and preferences and does not enable healthcare professionals to report ADR in an easily accessible and comprehensive way.
In addition, our aim was to provide support to patients during the pandemic lockdown when accessing their general practitioner was difficult.

What was done?

A surveillance system was created to encourage and facilitate the reporting of potential vaccine adverse events (VAE) after healthcare professionals and patients received a COVID -19 vaccine that was administered in our vaccination centre (VC).

How was it done?

Following patients receiving a COVID-19 vaccination they were sent a text message with an information that in case of VAE they could contact us via text message, email, fill an electronic questionnaire or call us.
We assembled a team of 10 pharmacists providing a non-stop service for reporting VAE. To ensure consistency in advice given to patients a manual was created for a management of the most common and likely VAE.
By liaising with the Information Technology Department, we created an electronic tool integrated into the hospital information system (HIS) for recording VAE. This enabled us to make a comprehensive report and sent it directly to the NDA. Consequently, an alert on each reported VAE after the first dose of vaccine was available for every clinician to maximise patient´s safety.

What has been achieved?

Between 4th January 2021 and 8th June 2021:
6 109 732 vaccines were administered throughout our country.
5402 (0,09%) VAE were reported to NDA.
43 409 vaccines were administered in our VC.
3 456 (7,96%) VAE were reported to our VC out of which 816 were rated as unexpected and 28 as serious.

What next?

Presenting of the results of the project will be used as a part of the education of healthcare professionals in our hospital. By this sharing of knowledge our aim is to enable and maximise patient’s safety and treatment. The integrated electronic tool for recording and reporting ADR will be also applied for all other medications

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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.

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Author(s)

Arnaud Potier, Béatrice Demoré, Alexandre Dony, Emmanuelle Divoux, Emmanuelle Boschetti, Laure-Anne Arnoux, Cédric Dupont, Jean-Christophe Calvo, David Piney, Virginie Chopard, Nathalie Cretin, Edith Dufay

Why was it done?

Drug iatrogenia costs global health systems $52 billion annually. The third global patient safety challenge aims at reducing the global burden of iatrogenic medication-related harm by 50% within 5 years [1]. Pharmaceutical analysis is a fundamental activity, a regulatory obligation in many countries but remains a challenge. This practice is highly variable. A graphic definition of the target pharmaceutical analysis has been formalised in December 2017 which sets the basis for its digitalisation, effectively implemented since January 2019. The aim is to build a corpus of the most relevant PA to facilitate clinical pharmacist practice.

What was done?

A computerised clinical pharmacy tool is integrated into the health information system of our group of hospitals (5000 beds) to promote efficiency of pharmaceutical analysis in order to improve patient safety. Pharmaceutical algorithms (PA) are conceptualised to improve drug related problems (DRP) detection and their resolution through pharmaceutical intervention (PI) according to a defined conduct to be held: anamnesis of subjective and objective elements of appreciation, DRP characterisation and PI transmission. Pharmaceutical analysis is performed by the use of PharmaClass® (Keenturtle). This software has been interfaced with 5 health data flow of two health facilities (1000 of the 2000 beds were tested): identity and patient flow, medication data, laboratory results examination, medical history, physiological constants. PA are partially encoded as rules in Pharmaclass® that issues alerts analysed by a pharmacist.

How was it done?

Health data are lacking of semantic interoperability which Pharmaclass® aims at overcoming from Electronical health record (EHR) queries in real time. A corpus of PA has been structured integrating the conduct to be held. PA were created by modeling the pharmaceutical experiment with the thread of criticality. PA were validated by consensus.

What has been achieved?

80 PA were encoded into Pharmaclass®: 40 are targeting serious adverse drug events. 1516 alerts were analysed and 539 PI transmitted during the 9-month test period.

What next?

This practice is applicable to any pharmaceutical analysis that uses data from an EHR. Clinical pharmacy societies should host and take care of updating corpus of PA. Its educational interest should be exploited. A European interest group for artificial intelligence in clinical pharmacy is being created.

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Author(s)

Marie-Claire Jago-Byrne, Sinead McCool, Caroline Reidy, Stephen Byrne

Why was it done?

Published research had demonstrated that 50% of discharge prescriptions were non-reconciled(1). A recent study demonstrated that 43% of patients experienced post-discharge medication errors(2). The prevalence of polypharmacy (>5 medications) has increased over the 15 years to 2012, from 17.8% to 60.4% in people 65 years and older in Ireland(3).

What was done?

The aim of this project was to improve medication safety at the point of hospital discharge by using targeted medication reconciliation and producing a computer-generated prescription. This new model for discharge prescribing was introduced for patients who met both of the following criteria in two acute hospitals:
• Prescribed 9 or more medications, at the time of admission.
• Aged 70 years and over

How was it done?

The new model for discharge prescribing used collaborative medication reconciliation and the e-Discharge software to improve the quality of discharge prescriptions. The model was introduced in both hospitals and received support from community and hospital colleagues. Clinical pharmacists became the project champions and worked closely with medics during the change process. Key safety aspects were:
• Clinical double check for this high-risk process- the pharmacist and the doctor sign the prescription.
• Increased legibility
• Explanation for all prescription changes to community colleagues.
Phase 2: The software was further tested on 200 patients in a bench top exercise

What has been achieved?

Phase 1: The overall compliance with the national discharge prescription standards increased from 50.4% to 96.9% with the new model for discharge prescribing. The biggest change in compliance was observed in the three communication categories, which explain to community healthcare providers the rationale behind the medication changes made during the hospital stay. A user acceptability survey of HCP involved in the project demonstrated that all those involved had benefited from improved workflows in hospital and community settings, and more appropriate and efficient use of resources. All users requested expansion of this service.
Phase 2: This review allowed for the improvement of the e-Discharge Software using anonymised patient cases to test issues identified in Phase 1.

What next?

In Phase 3 the model will be introduced to a third hospital to evaluate transferability of the concept alongside current practice outlined above

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Author(s)

T. De Rijdt

Why was it done?

Medication errors find their origin mostly in prescribing, transcribing and administration of medication. Only 4 % of the errors occurs in the pharmacy process. As we covered the major reasons by deployment of a electronic prescribing system with decision support and bedside scanning before administration the next step in augmenting patient safety is preventing dispension errors in the pharmacy.

What was done?

All medication orders from the electronic prescribing system are revised by a hospital pharmacist for appropriateness and send to a set of handheld barcode scanners for guiding the pharmacy technicians through the picking process. They identify themselves, the ship label, the picking location and the medication by scanning. The scanner checks if the right drugs are dispensed for the right patient.

How was it done?

Due to bedside scanning all orders are electronically available and all medication have barcodes on the single dose. All locations are barcoded for reasons of replenishment of stock. By simply sending the orders to handheld terminals it’s a small effort to verify the picking.

What has been achieved?

All electronic medication orders are checked by barcode scanning or a second hospital pharmacist resulting in a diminishment of picking errors to (nearly) zero. We can show an online status of the medication order to nurses and physicians and we shifted pharmacist time from checking drugs to checking appropriateness of therapy.

What next?

In a next step we will also check retour medication by barcode scanning preventing possible misplacement.

Why was it done?

So far, only pharmacists could access the pharmaceutical care record. The creation of the electronic medical record in the Health System has allowed patient data to be centralised and can be accessed easily and quickly. It is an opportunity to integrate our care service as pharmacists within the multidisciplinary care as well as to facilitate data consultation to other professionals that care for the same patient.

What was done?

Integrate the outpatient pharmaceutical care record to the electronic patient record via an application form included in the process of each pathology.

How was it done?

First question was where the application form should be included when the patient came in for a consultation. In order to unify all the actions relating to the process, it was decided to include the form in the main process instead of creating a specific process for the pharmacy department. For example, a form for an HIV patient should be included in his Infectious Disease Consult process.

Another issue was to define what items should be taken into account for the follow up.

Finally, the following items were included: reason for the visit, pathology, clinical data, outpatient treatment, regular treatment, drug-related problems, adverse drug allergies/past issues, adherence, checks to mark whether the patient has received the oral and written information, the leaflet from the host to the Outpatient Pharmacy Service and a free text to write down given recommendations.

What has been achieved?

Improvement of patient care, increased safety in the use of drugs and in the avoidance of medical errors has all been achieved, as well as the promotion of teamwork amongst professionals who attend to the patient. From the information technology perspective, data export can be provided for future researches.

What next?

All professionals should integrate their activities to take advantage of collaboration and increasing synergies.