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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.

Design and implementation of a course on “Improving the understanding of biosimilar formulation science through Real-World Training”

European Statement

Education and Research

Author(s)

Paola Minghetti, Giuseppe Danilo Norata, Francesca Selmin, Paolo Rocco, Vito Ladisa, Margherita Galassi

Why was it done?

The availability of mAbs to treat different pathologies is steadily growing, causing a steep increase in the level of training needed in different areas of pharmacists’ intervention, including compounding, handling and storage. As this process will be sustained by the increasing availability of biosimilars, pharmacists, the key health professionals responsible for their compounding and handling, will face new challenges.
The aim of this project is to overcome the common problems encountered by hospital pharmacists in obtaining education on biosimilars, included limited financial support, heavy workload or inadequate educational resources.

What was done?

A self-paced educational course has been designed and implemented with the aim of providing a fundamental grounding in the physical chemistry, pharmacology and technology of monoclonal antibodies (mAbs)-based medicines in oncology, both originators and biosimilars and the methodology associated with their compounding and handling.
The primary target audience for this project consists of hospital pharmacists in the EU, though students in the specialization in Hospital Pharmacy and community pharmacists may benefit from the course.

How was it done?

The course has been designed and developed to address, previously assessed, unmet educational needs. The resulting format comprises both theoretical and remote real-world training on the pharmacology, technology and stability of mAbs, the technology and rationale of biosimilars and the regulatory aspects of biotechnological medicinal products.

What has been achieved?

A series of webinars in on demand movie format has been produced. The webinars contain a comprehensive theoretical section – covering biosimilar mAbs pharmacology and formulative and regulatory aspects – and a practice section in which the preparation steps of oncology mAbs are filmed and discussed in a hospital setting. All training activities have been recorded in remote both in Italian and in English. Every module is designed to be used as a single unit and has a duration of approximately 30 minutes. The total duration of the course is 8 hours.

What next?

The course will be CME accredited in Italy through Fondazione Francesco Cannavò, nonprofit CME provider of the Federation of Italian Pharmacists Associations. It will be made available to pharmacists through national and international CME platforms, providing fundamental grounding in the methodology associated with oncology monoclonal antibody biosimilar formulation.

Implementation of a workshop about the role of the hospital pharmacist role during the clinical clerkship in medical training

European Statement

Education and Research

Author(s)

Vincent ARCANI, Stéphane HONORÉ, Guillaume HACHE

Why was it done?

Interprofessional collaboration as an effective means for improving healthcare outcomes. In order to achieve an effective level of collaborative healthcare practice, health care educators must focus attention on interprofessional education in undergraduate programs. Knowledge of professional role of others is a key competency for interprofessional practices and there is a lack of knowledge on hospital pharmacists’ roles among other health care professionals.

What was done?

We developed a workshop focused on the role of hospital pharmacists, to be integrated into the curricula of other health professionals.

How was it done?

The workshop was developed by a resident in hospital pharmacy and a senior hospital pharmacist, and we first targeted medical curriculum. The session integrated: students’ perception of hospital pharmacists’ role, didactic learning on the role of hospital pharmacists according to the European statements in hospital pharmacy, immersion in practice and evaluation. The assessment of the learning effect was performed by a pre-/post-workshop questionnaire, assessing satisfaction, metacognition and acquired knowledge. In addition, students provided open feedback on the workshop.

What has been achieved?

We implemented the workshop during the first year of clinical clerkship in medical education. Preliminary results highlighted (i) a high satisfaction, illustrating the relevance of the initiative; (ii) an increase in perceived knowledge and (iii) an increase in knowledge about hospital pharmacists’ roles, especially about pharmaceutical technologies and medical devices. Verbatim analysis of the feedback suggested that the workshop modified medical students’ perceptions on the role of hospital pharmacists, and that they may be more inclined to seek collaboration with hospital pharmacists.

What next?

To integrate the workshop into the curricula of the other professions in order to raise awareness on hospital pharmacy and promote interprofessional teamwork.

What role can French hospital Geriatric units play in vaccination coverage of the elderly?

European Statement

Clinical Pharmacy Services

Why was it done?

Vaccination coverage of the French elderly is low. Geriatricians asked for pharmacist’s help in increasing their patients’ vaccination rates.

What was done?

Pharmacist staff investigated the vaccination status of patients admitted to our Short-stay and Long-stay Geriatric Units (SSGU and LSGU). Results of these investigations enabled systematic catch-up vaccinations for patients before discharge.

How was it done?

Pharmacy and medical students were trained to determine SSGU and LSGU patients’ vaccination status and report findings to unit geriatricians. Training and procedures for Admission and Discharge Medication Reconciliation (AMR and DMR) were updated to include the recording of patients’ immunisation status. Furthermore, at discharge patients were supplied with an updated vaccination booklet and apprised of the importance of full vaccination coverage. During 2021, 3 groups were compared to evaluate our practices: before AMR new procedure, after AMR new procedure and after multidisciplinary decisions for AMR and DMR.

What has been achieved?

In SSGU and LSGU, all patient admission leads to an AMR. 45 patients were included in the first group, 39 in the second group and 46 in the final group. Since the 1st of March, AMR help geriatricians regarding vaccination status. Between March and April, 46% (17) of AMR found the entirety of the patient immunisation status compared to 2% (1) in the first group (p<0,01), and 35% (14) of AMR found at least one immunisation status among French recommendation compared to 24% (11) in the first group (p=0,12). In June, multidisciplinary medical team improved AMR et DMR practices to increase patient’s vaccination rates. In July, 51% (23) of all unit patients discharged had an up-to-date vaccination status compared to 2% (1) in the first group (p<0,01). 22 patients required pneumococcal vaccination: 8 received a dose during their stay and 2 had a dose prescribed at discharge. 27 patients required a Tetanus immunisation: 8 were vaccinated during their stay and 1 had a dose prescribed at discharge. Moreover, 46% (21) of patients received a short education from a pharmacist student and an up-date vaccination booklet. To conclude, 42,8% (15 of 35) of SSGU patients with incomplete vaccination coverage benefitted from catch-up vaccinations in July.

What next?

Vaccination coverage of eldery in not only a local public health preoccupation and systematic catch-up vaccination is easy to implement.

Distribution optimization of oral oncology therapy in the treatment of advanced renal cell carcinoma: between environmental impact and indirect costs

European Statement

Introductory Statements and Governance

Author(s)

Nicola Nigri, Maria Antonietta Calzola, Silvia Di Marco, Elisa Di Maio, Benedetta Fagotti, Martina Savoia, Luciana Negroni, Fausto Bartolini

Why was it done?

The 1st line treatment in RCC provides Pembrolizumab 200mg IV/21 days plus Axitinib (56cps/pack) P.O./BIS meaning two journeys. The PT and or CG have to come back to the hospital at different moments from the infusion date for 9 times/year, affecting negatively: the compliance, the IC, the patient’s follow-up and, the environmental impact.

What was done?

In Italy, the 1st line treatment of advanced renal cell carcinoma (RCC) involves 4791 new diagnoses/year. The most innovative therapies imply the association of intravenous therapy (IV) and oral chemotherapy.
In this case, the Hospital Pharmacist (HP) can assist the compliance and help to minimize the impact linked to indirect costs (IC), often unconsidered, through the reduction of the patient (PT) and or caregiver (CG) trips, improving also their quality of life. The HP can participate in decreasing the CO2 emissions that, in 70% of the cases, are generated by road transportations.

How was it done?

On the IV therapy day, is given to the patient, the oral treatment too (42cps), provided with the necessary documents.
To measure the IC has been considered the organizational costs to the PT and or CG. The time commitment was estimated, in the worst case, in a 2h return journey (150km) between the PT/CG location and the dispensation point. It has been considered 30min as the estimated time to park, arrival, waiting time in pharmacy, drug pick-up and back.
The average hourly earnings considered has been 13,6 €/h. The average diesel-engined utility car emits 95g/km of CO2 emissions.

What has been achieved?

Each avoided trip is 2h x 13,6€ = 34€ for missing productivity or 68€ if both are involved. The total IC avoided/year/PT is the number of avoided journeys/year x 34 = 306€ (612€ if both are involved).
The CO2 emissions are equal to 95g x 150km =14,25kg/distribution/PT, 128,25 kg/year/PT, equal almost to 2,3% of CO2 emission perceived in Italy, that, in the worst case, times the incident PTs/year that will become 614.000tonnes/year.

What next?

The HP shows, even more, its influence on more layers: clinic, economic, and environmental to benefit the patient, our NHS, and our planet, hoping in this approach in more combined therapies.

Patient education after Arthroplasty: what about the implants?

European Statement

Education and Research

Author(s)

Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer

Why was it done?

The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.

What was done?

In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.

How was it done?

First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.

What has been achieved?

The results show significant impact of this education session on all items especially those regarding the implants and medicines.

What next?

Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.