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Design and dissemination of infographics to improve safety in drug handling

European Statement

Patient Safety and Quality Assurance

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.

Formation and empowerment for pharmaceutical interview focused on opioids in acute non-cancerous pain

European Statement

Clinical Pharmacy Services

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.

FOLLOW-UP OF OFF-LABEL TOCILIZUMAB PRESCRIPTIONS IN COVID-19 IN A FRENCH UNIVERSITY HOSPITAL

European Statement

Education and Research

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.

Creating a standardized cisplatin hydration protocol

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European Statement

Patient Safety and Quality Assurance

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.

The establishment of The Danish Hospital Pharmacy Research Network.

European Statement

Education and Research

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.

PERFORMING A COMMITTEE OF EVALUATION OF TREATMENTS IN SPECIAL SITUATIONS

European Statement

Clinical Pharmacy Services

Author(s)

Susana Redondo-Capafons, Laura Soriano, Irene López-Rico, Jorge Del Estal, Rocío Cebrián, Marcela Manriquez, Maria Reventós, Sandra Fernández-Molina, Mònica Gómez-Valent

Why was it done?

Before CTSS was performed, TSS were requested to Pharmacy Department for evaluation and decision. Because of complexity of these treatments, it was decided that it was necessary to evaluate them with other professionals to make a consensual decision.
In May 2019, CTSS was born. It is a multidisciplinary committee with 10 different health professionals: head of pharmacy, head of healthcare management, head of strategy and operations management, a clinical pharmacologist, five pharmacists and a secretary. Requesting doctors and heads of involved services are invited to explain TSS in the meeting.

What was done?

Committee (C) of Treatments in Special Situations (TSS) (CTSS) have been established. Requests are received by a specific email for the committee and a standard template was performed to be completed by requesting doctor (patient clinical information and evidence supporting request) and by Pharmacy Service (regulatory status of the drug, pharmacology and cost of treatment).

How was it done?

Some limitations as lack of human resources with exclusive dedication for making reports and lack of training in evaluation of this kind of treatments are the most important obstacles. Currently, each member is self-taught and under excessive work- pressure.

What has been achieved?

From May 2019 to August 2021, 273 treatments in 59 meetings sessions (average 4.63 evaluations/meeting) were evaluated.
The 91,6% of treatments were approved. In 95,9% of requests, one drug was evaluated.
There were 18 services involved, being oncology and hematology the most active departments.
Evaluated TSS were classified in six categories: 66,7% of requests were drugs without approved indication, 19,8% drugs approved indication pending price by government, 2,5% approved indication but denied funding by government, 1,8% foreign medicines, 4% compassionate use and 5.2% others according to criteria of each autonomous communities in Spain.

What next?

CTSS allows make a consensual decision between different professionals and establishes a flow to manage TSS requests. This multidisciplinary scenario generates knowledge and evidence in the use of these kind drugs reducing uncertainty in TSS use in relation to its efficacy and safety and, in cases of high budgetary impact-drugs, to minimize inequities of access by standardizing decision-making. Applicable to all hospitals.

Entrustable Professional Activity in Medical Reconciliation as an assessment tool to measure competency of pharmacy pre-registration students

European Statement

Education and Research

Author(s)

Ula Bozic, Matthias Witti , Jan Zottmann , Martin Rudolf Fischer, Yvonne Marina Pudritz

Why was it done?

Among other functions of EPAs (description of activities as a guide for students, function as a curriculum guideline), they can be used as assessment tools – in our case, to identify gaps in students’ knowledge/skills and, depending on the results, to aid guiding curricula development of our educational program to ensure high quality training service.

What was done?

Entrustable professional activities (EPAs) are observable clinical activities consisting of knowledge, skills and attitudes that can be entrusted to learners over time. In German pharmacy education, EPAs have not yet been developed or used. For this project, we developed a Medical Reconciliation EPA for pharmacy pre-registration students taking part in a rotational programme at LMU University Hospital Munich. Four steps were required for the development: (1) Development of content for EPA description and the associated checklist by a working group of clinical pharmacists through literature review and work analysis. (2) Validation of the developed EPA and checklist by an independent expert group of clinical pharmacists from across Germany. (3) Application of the EPA and checklist in an assessment situation to check for inter-rater reliability. (4) Roll-out of EPA and checklist for assessment of pharmacy pre-reg students at LMU.

How was it done?

Since EPAs are a new concept in (German) pharmacy education, their concept as well as their assessment process with entrustment decisions required explanation in detail to facilitators and students alike in several workshops, which we have successfully organised and executed.

What has been achieved?

Through the implementation of this EPA, we can assess students’ competencies in performing medication reconciliation, identify the weaknesses of our training programme and adapt the content to improve students` skills in their performance.

What next?

Further EPAs with a focus on hospital discharge and medication analysis are being developed. With EPAs, it is possible to translate theoretical competencies into observable activities that can be assessed in a clinical setting. As pharmacists in Germany are increasingly involved in clinical practice, there is a need to assess their skills in performing day-to-day clinical tasks. EPAs are an excellent tool for this purpose.

Evaluation of pharmaceutical interventions documented by a pharmacy technician: where do pharmacy technicians have the biggest impact to avoid drug-related problems?

European Statement

Clinical Pharmacy Services

Author(s)

Ruth Borchers, Linda Krampe, Andreas Fischer, Christian Thomas, Holger Knoth

Why was it done?

The aim of this study was to identify the clinical pharmacy services where the integrating of pharmacy technicians have the biggest impact to avoid drug-related problems.

What was done?

In the field of clinical pharmacy services there are activities that are suitable for pharmacy technicians under the supervision of a pharmacist. At the university hospital in Dresden one full-time pharmacist and one half-time pharmacy technician (4h/d) are looking after 80 beds in the department of urology. The main tasks of the pharmacy technician are medication reconciliation as well as clinical prioritisation by using guidelines to identify patients who are at high risk of drug-related problems.

How was it done?

Since 2019 the pharmacy technician is recording the interventions in a categorical excel sheet, there are two documentation weeks per quarter. The categories are drug name, short description of the drug related problem, intervention, classification (dose-related problems, consultation of general practitioner, consultation of patient, electronic prescription, other drug-related problems after discussion with the pharmacist, drug substitution).

What has been achieved?

During 22 documentation weeks from 01/2019 till 09/2020 the pharmacy technician documented 468 interventions. The main interventions are drug substitution on admission considering local guidelines (n=181; 39%), consultation of the general practitioner because of identified discrepancies on the medicine lists (n=138; 29%) and consultation of patients because of identified discrepancies (n=78; 17%). Dose-related interventions and other drug-related problems are detected by the pharmacy technician and discussed with doctors under the supervision of the pharmacist (n=49; 10%).

What next?

Especially in the field of medication reconciliation trained pharmacy technicians can be suitable to prevent drug-related problems. The consultation of general practitioners and patients because of identified discrepancies on the medication lists are time-intensive and probably would not happen in the same way without integration of the pharmacy technician. The drug substitution in consideration of local guidelines and the preparation of the electronic prescription lead to fewer queries from nurses or doctors.
Further research should focus on the quality of pharmaceutical interventions conducted by pharmacy technicians under the supervision of pharmacists.

Initial observations on the implementation of a clinical pharmacy service in a rural hospital in Austria

European Statement

Clinical Pharmacy Services

Author(s)

Sonja Guntschnig, Aaron Courtenay, Ahmed Abuelhana, Michael Scott

Why was it done?

The service was established as part of the implementation of a new pharmacy into the hospital. The aim of this good practice initiative was to introduce multidisciplinary work on the wards and provide clinical pharmacy support for the ward personnel. Furthermore, it determined what types of clinical pharmacy interventions are needed at a rural 360-bed hospital in Austria, and assessed the physicians’ acceptance rate of the pharmacists’ suggestions.

What was done?

A new clinical pharmacy service (CPS) was introduced into Tauernklinikum Zell am See.

How was it done?

Data on 550 interventions made by one clinical pharmacist were collected by convenience sampling over a one-year period and rated on a six-point clinical significance scale. A subset of 26 interventions was rated for clinical significance by four independent physicians to determine inter-rater reliability (IRR). A two-way model inter-rater reliability analysis was performed for the four different physician assessments using SPSS to determine intra-class correlation (ICC).

What has been achieved?

Prompt acceptance rate by the physicians involved was 71.3% (392/550). In 26.9% (148/550) of all cases, the physician considered a change. The overall average score for all 550 clinical pharmaceutical interventions taken was 2.2. ICC significance scores were correlated with the pharmacist’s scores, ICC for consistency was 0.732 and 0.732 for absolute agreement, thus both can be considered as “good”. Potential for cost reduction associated with the recommended pharmaceutical changes, namely with medication being stopped or dose reduction was 32.7% (180/550) and 25.1% (138/550), respectively.

What next?

There is great potential and a definite need for the expansion of CPS in Austria. Only 15.8% of Austrian hospitals have a pharmacy department with even less offering CPS. Many countries have demonstrated the benefits of CPS in hospitals over the past 30 and more years. The need for increased pharmacist staffing in Austrian hospitals needs to be demonstrated to Austrian stakeholders.

DELIVERY OF PHARMACY EDUCATION DURING THE COVID19 PANDEMIC, ONE HOSPITAL’S EXPERIENCE

European Statement

Education and Research

Author(s)

Dearbhla Murphy, Patricia Ging, Jennifer Brown

Why was it done?

The Pharmacy Department at our institution are responsible for the delivery of a number of in-house and University level education sessions to pharmacy, nursing and medical students. In 2020, sessions included: a prescribing workshop for final year undergraduate medical students; nursing induction lectures on parenteral drug therapy; leadership workshops, lectures and site visits for pharmacy students; clinical pharmacist education sessions; and weekly journal club for Pharmacy Department staff. During the COVID19 pandemic, Pharmacy delivered education sessions were challenged with addressing the hospital-wide recommendation that face to face meetings be avoided while maintaining essential training for healthcare staff.

What was done?

Pharmacist led education sessions, both at an in-house and University level, were adapted to virtual platforms during the COVID19 pandemic.

How was it done?

• A pharmacy team of key stakeholders were formed for each education session.
• Educational material was reviewed and revised for suitability for a virtual platform.
• Interactive learning components were explored on the various delivery platforms e.g. Brightspace®, Zoom® and Microsoft Teams®.
• For the pharmacy student virtual site visit, Pharmacy staff prepared short videos about their roles.
• Interactive tools from within and outside the delivery platforms were used e.g. breakout rooms, MCQs, ‘chat’ tools, live quizzes and Menti®.
• Feedback on individual education sessions was sought via email or use of online surveys

What has been achieved?

• All education sessions were successfully delivered virtually.
• Positive feedback was received for all sessions.
• Unexpected benefits gained from virtual delivery, include the availability of recordings which can be used to repeat the session for future students.
• Limitations learned include difficulty retrieving student feedback online.

What next?

The Pharmacy Department successfully adapted the delivery of education sessions, at University and hospital levels, during the COVID19 pandemic to ensure continued delivery of high level education, learning and engagement. The initiatives and learnings from this GPI are transferable to other hospital pharmacy departments.