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Author(s)

Kirsten Lykke Vorbeck, Laila Rabbani, Somia Mohammad, Anne Bøiehøj, Lene Sehested, Majken Cardel, Lone Skovhauge, Lisbet Emmery Jørgensen

Why was it done?

Having different sponsors with individual requirements and interpretations of rules, means a lot of work. The brochure aims to save time on answering questions by describing to every sponsor how Danish Hospital Pharmacies proceed. By demonstrating that we all do many things in the same way and ultimately have the same requirements, we hope to be able to encourage sponsors to adopt a more unified or aligned approach.

What was done?

Through a collaboration of Danish hospital pharmacies, a working group on clinical trials meet regularly to discuss general procedures and challenges to our handling of clinical trials. Via this a common presentation of how we handle clinical trials and what we can offer has been described in a brochure that is given out to sponsors, investigators, clinical trial units (CTUs), clinical wards, monitors etc. The brochure also serves as an inspiration catalogue to hospital pharmacy colleagues.

How was it done?

In the working group we have discussed processes and which administrative and quality requirements we find reasonable and called for (from our point of view and that of our sponsors). We appreciate that we cannot do everything in exactly the same way, but we have tried to include as much as possible in the brochure leaving it up to the individual pharmacy to supplement with local procedures.

What has been achieved?

The brochure is evidence of our cooperation within Denmark. It has been distributed to relevant partners and to “Trial Nation”, a national entry point for companies who wish to conduct clinical trials in Denmark. It is intended as general information and to be handed out to new potential sponsors. It has resulted in an aligned and time-saving procedure.

What next?

Hospital pharmacies are small players in the field of clinical trials but nonetheless important ones. Working together to find general procedures not only helps ourselves to identify good practices but also means we can create a smoother handling of the trials and that we stand stronger when meeting the different requirements from sponsors. This cooperative approach has met with a good response. It promotes further cooperation between all parties, and it is recommended to be implemented in other healthcare settings.

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Author(s)

Chloé JADOUL, Audrey DURAND, Rémy TORDJEMAN, Isabelle MADELAINE, Romain de JORNA

Why was it done?

With the development of advanced therapy medicinal products (ATMPs), a specific pharmaceutical process is necessary to secure the handling of genetically modified organisms. Gene therapy includes Chimeric Antigen Receptor T (CAR-T) cell therapy as well as clinical trials with oncolytic viruses and nucleic acids. Limited experience on these new activities and high staff turnover based on resident pharmacist explain the need of additional training material to supplement written procedures. Multimedia support seems to be the most appropriate didactic tool.

What was done?

The objective of this work is to create pedagogical tools as short video clips. The final aim is to standardise hands-on training in order to improve ATMPs circuit safety.

How was it done?

All steps of each activity were listed and filmed in order to create a video database. Clinical trial mock preparations were performed to create the clinical trial tutorials whereas CAR-T cell activities were filmed in real conditions.
Clipchamp (Microsoft) video editing software is used to create tutorial videos. Repetitive parts were edited once and reused for other videos. They are part of the database videos.
As a validation, all staff members’ approbation was required.

What has been achieved?

Activities include, to this day, five gene therapy clinical trials and the CAR-T cell activities: reception, shipment to the pharmaceutical hub, thawing and distribution.
We filmed 55 step clips and edited six repetitive parts. Finally, eight tutorial videos were created: three for clinical trials and four for different CAR-T cell activities.

To make the training more meaningful, we made dynamic videos that last no more than 5 minutes. The average time of a tutorial was 2 minutes 17 seconds.

What next?

The tutorial videos bank is created to be dynamic and can be easily adjusted. Videos of repetitive parts will be reused for new clinical trials implementation. These video tutorials allow new resident, student or technicians to be trained faster and in a more innovative way. They also allow permanent teams to benefit from a quick refresh. In order to assess the efficiency of this new process, next operators will have to read the procedure, watch the videos and will be evaluated in practice.

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Author(s)

Lone Møller Deleuran, Bitten Abildtrup, Sofie Pedersen, Ulrik Wøldike, Nina Winther Müller

Why was it done?

Amgros is committed to make its mark on the sustainability agenda regarding medicine – both nationally and internationally. Thereby improving access to medicines for patients in a more sustainable way – this project serves as a first step in this direction.

What was done?

In 2021, the Danish procurement organisation Amgros I/S issued the first national pilot tender for hospital medicines in which environment was an important award criterion along with price. Amgros procures 99% of the pharmaceuticals used at public hospitals. The pilot project was conducted to gain knowledge and experience about planning and executing future tenders with environmental criteria. The pilot tender was limited to the hormonal therapeutic area.

How was it done?

The chosen environmental criteria were environmental management, packaging (plastics and paper/cardboard), transportation and social responsibility.
It was a long process, including external help from consultants (The Technical University of Denmark), legal consultation, market dialogue with feedback, developing and adjusting the criteria to comply with national procurement legislation. Hence assuring the evaluation of the offers could be conducted in a meaningful, simple, and structured manner during the subsequent evaluation phase.
As a part of the final tender, a questionnaire was attached consisting of multiple choice questions concerning the environmental criteria. In the evaluation, the price weighed 80%, whereas the environmental criteria weighed 20%.

What has been achieved?

Amgros received 85 offers from 19 suppliers of which 76 offers contained the questionnaire about environment. Sixteen (84%) of the bidding suppliers completed the questionnaire. Three suppliers won the tender solely due to their environmental capability.
The tender with environmental criteria did not seem to discourage suppliers from bidding nor resulted in increasing price levels.
The pilot tender has created a great deal of awareness among the suppliers about the importance of environment and sustainability in production, distribution, and sales of medicine.

What next?

The experience obtained from this pilot tender is paving the way for the future broader implementation of more sustainable medicines in all tenders. Furthermore, the results will be shared nationally and internationally. Hopefully, the results will encourage other countries to incorporate environmental criteria in future medicinal tendering processes.

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Why was it done?

Kidney disease carries a significant worldwide health burden. In more the incidence of stage III chronic kidney disease in more than 9%. Many hospitals in Oman have special units of nephrology but clinical pharmacy services for these patients are almost none. It was important to upskill practicing pharmacists’ knowledge and skills to provide comprehensive pharmaceutical care for patients with renal diseases.

What was done?

An online 8-week course was developed by an experienced and certified renal clinical pharmacist with an aim of enhancing the knowledge and skills of pharmacists practising in primary, secondary and tertiary care hospitals in Oman. The course covered all the topics required to develop the skills of the pharmacists to enable them to deal with renal prescriptions and be able to intervene in any medication related problem in patients with kidney diseases. Before and after knowledge assessment was done for the participants to enable justify the benefits of the Course. Towards the end of the course a satisfaction survey was also completed by the participants to provide ensure achieving desired outcomes.

How was it done?

The course was hybrid and the beginning with some sessions carried out face-to-face and some online.
The course included topics such as acute kidney injury, chronic kidney disease, drug induced kidney diseases, medication management in renal replacement therapy and kidney disease complications. The course was interactive with case study discussions, question and answer sessions and some assignments done by the participants at home. The course was designed based on Kirkpatrick foundational principles with consideration of the four levels of learning.

What has been achieved?

Twenty pharmacists participated in the first cohort and 23 in the second cohort. The attendance was more than 90% throughout the course. The pharmacists were keen to learn and ask questions. There was a clear difference in knowledge before and after the course with only 19% of participants passing the pre-course assessment compared to more than 80% of participants passing the post-course assessment.

What next?

The course was highly appreciated by the participants and would run the course and regular intervals with considerations to applications from the Gulf region since they share similar practice and disease burden.

Author(s)

Mathieu Fournel, Herve Trout , Jean Eudes Fontan , Marie Cabagnols

Why was it done?

At night, our Pharmacy residents are alone to lead the patient interview, which can be stressful and complex. They currently receive a theoretical course as training, which is insufficient and lead us to reinforce their training by organizing this simulation program.

What was done?

In our hospital, treatments for accidental exposition to blood or other body fluids (AEB) are prescribed by the emergency unit doctors and are delivered by our pharmacy residents who also give associated advices. In order to improve the quality of this procedure and train our pharmacy residents, we created and tested simulation case-scenarios of pharmaceutical interview of AEB’s victims with role-playing game.

How was it done?

We based our training program on the French Health Authority guidelines. Scenarios are based on our real-life experiences and potential clinically relevant situations.

What has been achieved?

First, we evaluated pharmacy residents’ theoretical knowledge and their self-confidence about AEB interview with anonymous questionnaires.
We created five different scenarios and tested them during six role-playing game sessions in two weeks with six pharmacy residents.
Every session lasted approximatively one hour, each resident played one scenario as a resident and one as a patient. Sessions started with briefing and ended with a detailed debriefing. All our scenarios are efficient, and debriefings were interactive and interesting. Evaluation of the sessions by pharmacy residents showed great satisfaction. They evaluated our scenarios as relevant and rated simulation training higher than lecture-based courses. Moreover, informal feedbacks are very positive.

What next?

Our next step is to film a simulated pharmaceutical interview of AEB’s patient for new pharmacy resident as an example before their first interview. Simulation will be part of the training of every new pharmacy resident in our hospital. Furthermore, we would like to extend simulation training to other types of patient’s pharmaceutical interviews.

Author(s)

Paula Hernando Martínez, María Antonia Meroño Saura, Caridad Marti Gil, Lidia Martínez Valdevieso, Jaime Fernández-Bravo Rodrigo, Dolores Barreda Hernández

Why was it done?

There is a wide bibliography on how human errors related to drugs put the patient’s health at risk. Drug preparation and administration errors, dose calculation errors, lack of knowledge about drugs or interactions, to name but a few. There must be protocols to ensure that drugs are safe for patients, including procedures which professionals should fulfill in order to reduce those errors in processes and guarantee, in such cases, that they will not have adverse effects on patients.

What was done?

Development of infographics for assembling drugs which are susceptible to a higher rate of errors in their preparation and administration to hospitalized patients.

How was it done?

During September 2021, a working group was formed in the pharmacy department (PD). Through the nominal group technique, the design and content of drug infographics was proposed as a solution to the raised problem. Subsequently, a bibliographic research of susceptible drugs to human errors during administration or preparation and those which requiring special handling was reviewed through the list of high-alert medication from National Institute for the Safe Use of Medications website and NIOSH list of hazardous drugs. To this end, the PD databases were analysed, obtaining the drugs that required the greatest number of pharmacotherapeutic consultations made by nursing staff on drug administration and recommendations made during pharmaceutical validation.

What has been achieved?

An infographic model has been designed which includes the description of the drug (name of drug, excipients, dose, pharmaceutical form, dosage regimen, route of administration, concentration), the preparation and administration protocol (reconstitution, dilution, infusion rate, premedication), observations (maximum doses, conditioning, incompatibilities, alerts) and storage conditions (conservation and stability). Infographics on dantrolene, intravenous phenytoin solution, intravenous nimodipine solution and potassium chloride solutions are currently being distributed. These documents are available at the nursing controls and on the hospital’s internal website.

What next?

To increase the availability of drug’s infographics and to update those that have already been developed when necessary. In addition, from the PD, the preparation of administration kits for the solicited drugs is proposed so as to ensure that all the necessary materials for the preparation and administration are included along with the corresponding drug and infographic.

Author(s)

Esteban CHAUMET, Johanna RAYMOND, Eric BARAT, Catherine CHENAILLER, Rémi VARIN

Why was it done?

A clinical study, including a PI focused on the management of acute non-cancerous pain with opioids, was implemented in post-emergency units of our teaching hospital. Formation and empowerment procedures for PIs are little or not described in the literature. Given the multiplicity of actors, which could perform those PIs, it appeared necessary to standardize our practices and key messages delivered to the patient.

What was done?

Create an adapted formation allowing standardization of practices between various actors performing a pharmaceutical interview (PI) focused on the management of acute non-cancerous pain with opioids.

How was it done?

Creation of different tools : a resource pack with opioids literature to train learners; a theoretical and practical formation schedule and an empowerment procedure, supervised by a qualified tutor; an interview frame with topics to be addressed during the PI; two audio simulations of patient interviews; complex questions that the patient might ask during the PI.

What has been achieved?

The resource pack contains 11 documents that provide the learner with relevant concepts and the key messages to deliver to patients. The formation schedule consists of several stages. Firstly, theoretical formation : learning with the resource pack; written restitution of knowledge on the interview frame and identification of the points to be improved with the tutor; completion of the e-learning on performing a PI (currently being created by the French Society of Clinical Pharmacy); listening to the two audio simulations and oral restitution of information to the tutor; restitution by the learner, during a reversed class, of knowledge on opioids and key messages for the patient; answering complex questions. The practical formation consists of observing the tutor during a PI, then performing PIs with a qualified tutor.

What next?

The formation and empowerment will be implemented in November 2021. As part of a quality approach, learner’s satisfaction and general appreciation will be collected in order to optimise the formation. The creation of this procedure will guarantee a uniform, complete and modern formation based on a quality system thus minimising the biases induced by the multiplicity of actors performing the PIs. In the future, this formation schedule and empowerment could be adapted to other PI topics.

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.

Author(s)

Trine R. H. Andersen, Trine Graabæk, Ulla Hedegaard, Lene J. Kjeldsen, Charlotte Olesen, Hanne T. Plet, Anne B. Walls, The Danish Hospital Pharmacy Research Network (DanHoPR Network) On behalf of

Why was it done?

A decade ago, collaboration between Danish hospital pharmacies regarding knowledge sharing, information, procurement and development of services already existed. However, research activities were scarce, and peer reviewed publications were rare. While the Danish universities didn’t have hospital pharmacy as a research area, the research unit called SAFE had been formed under The Danish regions’ joint procurement and tendering organization, to encourage hospital pharmacies to increase research activities. Meanwhile, a handful of hospital pharmacists scattered throughout Denmark had been initiating PhD-projects, but with no formal cooperation or awareness of each other.

What was done?

A national network for researchers in hospital pharmacy was established 10 years ago to strengthen the research activities within hospital pharmacies in Denmark.

How was it done?

The network was established at a meeting in October 2011 gathering the five PhD-fellows, SAFE and potential researchers. The overall aim was to strengthen hospital pharmacy research in Denmark. The terms of reference included creating a forum where established as well as upcoming researchers can meet twice a year to share knowledge and provide feedback on each other’s research. To further strengthen the network and research, funding was raised for a fieldtrip to UK hospital pharmacy research groups. After this, the network decided to promote a more international profile. A LinkedIn site was established along with the design of a logo, an English translation, name and acronym (DanHoPR Network).

What has been achieved?

The DanHoPR Network now celebrates its 10th anniversary and counts more than 30 members from all Danish hospital pharmacies and from universities.
The amount of published research from Danish hospital pharmacies has increased considerably during the 10 years. In total, network members have first authored more than 35 articles, co-authored more than 70 publications, co-supervised more than 80 master theses and PhD-fellows have multiplied over the decade.
The DanHoPR network gather 2-3 times/year in full-day virtual or IRL meetings to collaborate on research, share ideas and discuss subjects such as methodology, interpretation of results, funding, challenges or celebrations.

What next?

The network seeks to collaborate internationally and hopes to inspire to similar networks across Europe or connect to exiting fellow networks.