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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.

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Author(s)

Giuliana Lo Cricchio, Margherita Galassi, Ernesto Ruffino, Claudia Tirone, Vito Ladisa

Why was it done?

In accordance with regional provisions and national guidelines, the initiative has had the dual objective of reducing hospital access, and potential infections, and ensuring therapeutic continuity for cancer patients.

What was done?

Some therapy protocols have been modified for the treatment of blood, gastrointestinal, lung, breast, head and neck tumors, in order to obtain equally effective patterns but with longer intervals between doses.

How was it done?

Patients have been stratified on the basis of the neoplasia location and biology, the general conditions and the treatments characteristics and they have been shifted to modified treatment regimes, even outside the indications temporarily authorized by regional decision: Nivolumab from 240 mg Q2W to 480 mg Q4W for Hodgkin lymphoma, non-small-cell lung-cancer, squamous cell carcinoma of the head and neck; from weekly Paclitaxel to Docetaxel Q3W for breast cancer; Pembrolizumab from 200 mg Q3W to 400 mg Q6W for lung cancer and melanoma; remodulation of protocols including fluoropyridines and platinum coordination compounds for gastroenteric tumors.

What has been achieved?

The schedule modification allowed a reshaping of agendas to reduce the frequency of day-hospital access and the risk of infection with Sars-Cov-2 for patients, carers and health professionals, in addition to reducing the costs of outpatient services. Treatment interruption rate, with possible consequent progression of disease, as reported by early Chinese data in the literature, has been reduced.

What next?

The extraordinary health emergency changed the clinical practice and aroused interest especially in oncology, where the evaluation of the relationship between benefits and risks associated with therapies has required greater attention because they are life-saving therapies that cause immunosuppression in patients for which the adverse course of viral infection is more frequent than that of the non-neoplastic population.
The possibility of using the modified therapy schemes has been limited only to the emergency period and has not yet resulted in an extension of the indications. The achievement of the therapeutic objective, together with the feedback that the new dosages have not led to a significant increase in adverse events compared to normal clinical practice, encourage us to hope that the indications can be extended in Italy, as has already happened in Canada and USA for the Nivolumab.

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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.

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Author(s)

Pauline Barreau, Joséphine Courouble, Pierre Pilven, David Vandecapelle, Thibault Stala, Geoffrey Strobbe, Guillaume Marliot, Frédéric Feutry

Why was it done?

Two prescription assistance software are using in the hospital: DXCare®, for global drug management, and Chimio®, specific to the prescription and preparation of injectable chemotherapies. Clinical pharmacists (DXCare®) and pharmacists in charge of preparation (Chimio®) carry out the pharmaceutical analysis independently and they may not detect potential pharmacokinetics/pharmacodynamics drugs interactions or pathophysiological contraindications, slowing down the pharmaceutical analysis. Pharmaclass® can improve that by crossing all data flows between DXCare® and Chimio® and alerting the pharmacist. The objective were to select and code priority alerts and evaluate the detectability of drugs interactions and pathophysiological contraindications by the software Pharmaclass®.

What was done?

Pharmaclass® is a software based on rules created by the pharmacist, from pharmaceutical algorithms. This rules engine crosses in real time all data flows of several software and sends alerts that must be analyzed by a pharmacist. It was applied in oncology for injectable chemotherapies.

How was it done?

An interface was set up between DXCare®/Chimio® and Pharmaclass® to allow the creation of requests. An analysis of drug consumptions and drugs at risk of interactions helped to select seven molecules (Methotrexate, Bevacizumab, Fluorouracil, Ifosfamide, Irinotecan, Cisplatin, Pemetrexed). A study of the summaries of the product characteristics and the drug interaction thesaurus and a bibliography was conducted and the rules were coded. These were checked by creating test patients with false prescriptions.

What has been achieved?

Eleven rules were created and, after some tests and coding readjustments, all was detected. Nine rules are about drugs interactions: three contraindications (Methotrexate/Trimethoprim, Methotrexate/Acetylsalicylic acid, Bevacizumab/Naloxegol), three associations not recommended (Methotrexate/Amoxicillin, Methotrexate/Ciprofloxacin, Fluorouracil/Antivitamin K), one precaution of use (Ifosfamide/Aprepitant) and two other rules concern enzymatic induction and inhibition of the metabolism of Irinotecan. The last two rules link the glomerular filtration rate with Cisplatin and Pemetrexed.

What next?

Following these creations, Pharmaclass® has allowed to detect drug interactions and pathophysiological contraindications that were not previously detectable. Thereafter, objective will be to establish an organization for the management of alerts and evaluate the number and the relevance of these alerts. New rules will be created for all injectable chemotherapies used in the hospital. Other center of Unicancer will be able to use these rules.

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Author(s)

Rawa Ismail, Jesper van Breeschoten, Michel Wouters, Anthonius de Boer, Alfonsus van den Eertwegh, Maaike van Dartel, Caspar van Loosen, Doranne Hilarius

Why was it done?

Most drugs obtain approval based on limited numbers of highly selected patients and mostly surrogate outcomes. Little is known on hospital variation on the use of new treatments in daily clinical practice. Benchmark information can be used to limit between hospital variation and provides real world evidence on the value of these treatments.

What was done?

In the Dutch Institute for Clinical Auditing (DICA) medicines project, administrative data on the use of expensive drugs from hospital pharmacies were linked to clinical data from national quality registries and hospital declaration data. Data were visualised in six dynamic dashboards (lung cancer, breast cancer, rheumatic disorders, colorectal cancers, gynaecological cancers and metastatic melanoma), leading to insight into expensive drugs use and clinical outcomes in real-world practice.

How was it done?

The three data sources were linked using patient-specific data and provide real-world insights in anti-cancer drug use and outcomes. After linkage, data were validated by individual sessions with hospital pharmacists and medical specialists.

What has been achieved?

Hospital pharmacists and medical specialists gained insight into expensive drugs use and treatment patterns in patient groups, compared to other hospitals. The dashboards also contain information on outcomes such as toxicity, emergency admissions, time-to-next treatment and users receive signals when their use of expensive medicines deviates from the benchmark. An example of the information provided by the dashboards was the number of stage IV non-small cell lung cancer patients treated with only one or two gifts of pembrolizumab. All hospitals received a report on this subpopulation to improve their treatment approach. Other findings were differences in the adjuvant treatment of stage III colon carcinoma patients and the treatment duration of trastuzumab/pertuzumab as adjuvant treatment in breast cancer patients.

What next?

The DICA medicines project is an example of good practice as it reuses available data sources without any additional registration burden. In the future, the dashboards will be extended with survival data and PROMs data. The focus of the program in the next year will be to include all hospitals in the Netherlands and to extend the dashboards with more features.

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Author(s)

María Mar Alañón Pardo, Alejandro Marcos de La Torre, Beatriz Proy Vega, Adrián Pérez Facila, María Luisa Moreno Perulero, Clara Notario Dongil

Why was it done?

Numerous publications have demonstrated a correlation between serum concentrations (Cs) of anti-TNF drugs and the therapeutic response and a wide interindividual variability in pharmacokinetics among patients with IBD. TDM permits dosage individualization and optimization of anti-TNF therapy.

What was done?

Pharmacokinetic monitoring (TDM) of anti-TNF therapies (infliximab/adalimumab) in inflammatory bowel disease (IBD) was implemented in our hospital by a multidisciplinary team of pharmacists, gastroenterologists and clinical analysts.

How was it done?

A computer platform was developed within the hospital electronic records system to manage consultations of gastroenterologists with the Clinical Pharmacokinetics Unit (CPU) of the Pharmacy Department. Variables in this electronic interconsultation system were: “anti-TNF drug”, “concomitant immunomodulator (IMM)”, “diagnosis”, “reason for consultation”, “date of last dose”, “date of extraction”, “weight/height”, and “observations”. Laboratory tests ordered from the Department of Clinical Analysis on the electronic request form included blood count, Cs of infliximab/adalimumab, albumin, C-reactive protein and faecal calprotectin. Quantum Blue® lateral flow immunoassay was used to quantify Cs of the anti-TNF drugs; when undetectable, the presence of anti-drug antibodies (ADAs) was investigated.
The CPU developed pharmacotherapeutic recommendations based on therapeutic algorithms, pharmacokinetic/pharmacodynamic principles and population models implemented using MW-Pharm++® software, which incorporates the principle of Bayesian estimation. For a correct interpretation of the Cs observed, adherence to anti-TNF ± IMM regimens was evaluated using electronic dispensing records and the self-administered Morisky-Green questionnaire.

What has been achieved?

Since its implementation (January 2019 – August 2020), the CPU has responded to 269 consultations on 121 patients treated with infliximab (46.3%) or adalimumab (53.7%): 70.2% were prescribed with IMM (89.4% with thiopurines); 93.4% adhered to the anti-TNF regimen and 82.4% to the IMM. Baseline anti-TNF Cs were subtherapeutic in 37.2% of patients, therapeutic in 35.5% and supratherapeutic in 27.3%. ADAs were positive in 28.6% of patients with undetectable anti-TNF Cs (n=28). A large proportion (84.8%) of consultations were related to proactive monitoring (to optimise treatment) and the remainder were reactive (after treatment failure). A very high percentage (89.9%) of the gastroenterology specialists accepted recommendations.

What next?

Extend TDM to other biological therapies and immune-mediated diseases.

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Author(s)

Sinem Şeker Şimşek

Why was it done?

In terms of medication and patient safety, to establish a safe non-cytotoxic medication preparation process, to ensure continuity of well-educated and motivated pharmacy staff are the key elements of pharmacy-based medication preparation units. This work aimed to share our experiences about how to be challenged with the risk in the drug preparation process during the pandemic as a university hospital pharmacy centered non-cytotoxic medication preparation unit.

What was done?

We have taken general precautions recommend by the World Health Organization. However, the protocol we have used to prepare Lopinavir/Ritonavir, Preparation of Hydroxychloroquine sulfate, Favipiravir and Hydroxychloroquine sulfate with Simple Syrup, Preparation of intravenous drugs (Tocilizumab)

How was it done?

The preparation of solid oral dosages, which should be administered to intubated Covid-19 patients through a nasogastric tube, was prepared by the ready to administration team of our pharmacy.
There is no evidence-based data on the bioavailability of these enteric-coated tablets after being crushed and administered to these vulnerable patients. The biggest challenge was lack of the reliable medication information sources. Before starting the Covid-19 medications preparation process, possible risks that could arise if crushed administration of these drugs were evaluated with a multidisciplinary team.

What has been achieved?

We suspended the Lopinavir/Ritonavir with dextrose during the preparation phase. We preferred the lavage syringe for intravenous administration risk elimination through ensuring patient and drug safety by preventing the risk of intravenous administration of the diluted suspended drug we have prepared. However, when we used a 3-way infusion manifold the strain during pushing and easy disconnection of the joints thus the risk of dose loss were the disadvantages.

What next?

The two pillars of dealing with the COVID-19 epidemic, which has affected the whole globally, are the proper preparation of the necessary medicines for treatment and the treatment itself. Drugs were prepared in line with the search for “a practical solution immediately” and the directives of the Ministry of Health and successfully administered to the patients. Our study is noteworthy as it shows that drugs can be prepared not only by the default ways but also by the different methods

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Author(s)

Elodie Delavoipière, Laura Fazilleau, Carine Lehoussel, Isabelle Goyer, François-Xavier Roth, Julien Mourdie, Agnès Bobay-Madic, Simon Rodier, Bernard Guillois, Albane Cherel

Why was it done?

360° virtual room of errors is an innovative educational tool which can be included in strategies of ME risk management. NICUs are high-risk areas and consequently, a priority target. Therefore, we developed and evaluated a virtual reality-training program based on medication error management in the NICU of a university hospital centre.

What was done?

A virtual reality-training course was developed and evaluated, regarding prevention and management of medication errors (ME) in NICUs.

How was it done?

A multidisciplinary working group was set up (2 pharmacists, 2 neonatologists, 1 pharmacy resident and 3 NICU nurses) to define: the target audience, the training model, the assessment methods (pre-training and post-training evaluations), training days and educational materials.

What has been achieved?

The program was intended for professionals involved in the medication circuit in the NICU: physicians, residents, and nurses. Weekly sessions have been scheduled in order to train 99 professionals. Every session was run by 3 professionals (physician, nurse and pharmacist) and lasted two hours and a half. The session was divided into 5 stages: 1/pre-training evaluation, 2/briefing, 3/360° digital simulation allowing ME detection, 4/debriefing, 5/ post-training evaluation. Although, it was a digital-training, a pedagogical formula with “classroom” training sessions has been chosen in order to promote interactivity between learners and trainers particularly during the debriefing. This virtual reality-training course was assessed by Kirkpatrick’s four levels of training evaluation model: satisfaction questionnaires, knowledge evaluation and skills self-assessment, audits of practices, monitoring of indicators (adverse event reports). Assessments were done before each session, immediately after and within 3 months of the session, to both evaluate and enhance educational impact.

What next?

This concept promotes the link between clinicians from the NICU and the multi-disciplinary approach concerning the risk management of ME. By directly involving all the healthcare professionals, this innovative training provides a patient-safety culture development and the implementation of safety measures. The implementation of this training concept in a multi-centric assessment of professional practices should enable to confirm pedagogical interest of such innovative sessions and his deployment in other health facilities.

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Author(s)

Xando Díaz-Villamarín, Ana Pozo-Agundo, Paloma García-Navas, Celia Castaño-Amores, Alba Antunez-Rodriguez, Cristina Lucía Dávila-Fajardo

Why was it done?

Pharmacogenetics (PGx) has the potential to predict patient´s drug response. Many genetic polymorphisms have been associated with variable drug response. This has been demonstrated with the highest level of evidence in fact many of them have been included in clinical dosing guidelines such as those from the Dutch Pharmacogenomics Working Group (DPWG) and Clinical Pharmacogenetics Implementation Consortium (CPIC). Actually, many drug labels include the recommendation about genotyping specific single nucleotide polymorphisms (SNP) prior to drug prescription.

What was done?

We have implemented pharmacogenetic tests in our hospital for a total of nine drugs.

How was it done?

Our hospital provides a PGx test service according to the following workflow. Physicians order the PGx test to the Pharmacy Unit, we take a saliva sample with sterile-cotton tipped swabs and send them to the Genomic Unit at Genyo. There, we extract the DNA and genotype the variants of interest. Genetic results are reported back to the Pharmacy Unit within 48-72 hours. After genotype-phenotype-recommendation translation according to the CPIC and DPWG dosing guidelines, we upload the dosing recommendation as a PGx report to the electronic patient´s medical history.

What has been achieved?

Since 2012, 2414 patients have benefited from our PGx test service for at least one drug-gene interaction. These tests have been requested by seven hospital departments with regard to a total of nine different drugs. We have reported 932 PGx dosing recommendations: Clopidogrel with 2013 genotyped patients and 845 dosing recommendations; Azathioprine with 208 and 21; Capecitabine: 48 and 1; 5-FU: 5 patients without recommendations; Tamoxifen: 117 and 48; Trastuzumab: 34 and 15; Irinotecan: 4 and 2; Simvastatin/Atorvastatin: 2 genotyped patients and no recommendations.

What next?

Since the first PGx test in 2012, we have been able to implement PGx tests in daily clinical routine in our hospital affecting 9 drugs. 2414 patients have benefited from this service and we are working on the implementation of new polymorphisms affecting drug response to expand our services.

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Author(s)

Lotte Deschepper, Kenny Noerens, Nilgün Kizilmese

Why was it done?

The COVID-19 pandemic caused limited availability of critical drugs and rapidly evolving treatment guidelines. Patient safety must be guaranteed at all times. However, the pandemic took the follow-up of drug shortages to an unprecedented level, increasing the risk of errors. Fulfilling this task was therefore difficult and new strategies needed to be implemented.

What was done?

In our hospital one pharmacist was dedicated fulltime to the COVID-19 drug management. Another pharmacist was committed to ensure the safe and efficacious use of drugs by conducting medication reviews and giving relevant drug and laboratory recommendations.

How was it done?

Microsoft Power BI ©, a tool to analyze data, was used to monitor the specific drug needs on the COVID-wards. Higher drug consumption was more rapidly detected and more specific actions could be executed. The available stocks in the hospital were also registered in a database and this information was updated and reported daily to the medical staff. In this way treatment guidelines could be proactively adjusted if necessary. Medication alerts were sent regularly by mail to ensure that all health care providers were informed about (temporary) changes in order to reduce the risk of medication errors.
Additionally, pharmacists collected evidence‐based drug information concerning indications, dosing, possible side effects, drug‐drug interactions and other precautions based on (inter)national guidelines. This information was used to develop a back-office validation tool that supported pharmacists to conduct medication reviews in a uniform manner. Daily updated reports from Microsoft Power BI © were used to analyze relevant interactions and contra-indications. Pharmaceutical recommendations were promptly documented and reported in the medical record of the patient and the physician was contacted immediately if urgent.

What has been achieved?

Due to the multi-disciplinary approach and guided medication use, therapy continuation could be guaranteed for all patients. Our validation tool resulted in the early detection and interception of medication errors ensuring patient safety.

What next?

A retrospective risk assessment will be done to evaluate our approach and a disaster plan concerning medication will be established based on our experience. The development of a computer-based analytical tool will be encouraged to maximize patient safety while minimizing risk of medication errors.