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Implementation of a simple continuing training programme for retraining operators in a clean room production

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European Statement

Education and Research

Author(s)

Maria Agerboe Sondrup, Anette Sand Østergaard

Why was it done?

Training of operators has previously been performed, however there was no consistent programme for continuing training in the department to secure optimal training of operators. Equally the effectivity and durability of the training was not evaluated. The aim was to establish a thorough system for continuing training focusing on ongoing confirmation of proper training as well as adaptation and optimization throughout.

What was done?

A programme for continuing training of operators was designed and implemented in a clean room production department by GMP-responsible operators and academics.

How was it done?

A template was designed for the programme. One module takes up to 3 months.
The template is the following:
Observation:
– Trainers observe operators in a clean room
– Current technique is observed and if necessary corrected
Training material:
– Developing educational material based on SOPs
– Short videos, PowerPoint presentations etc.
Individual training:
– Operators answer handed out multiple choice questionnaire (MCQ) by themselves
Group training:
– The correct answers to the MCQ are presented by the trainers at a plenary session
– All answers are discussed
Observation:
– Trainers observe operators in a clean room
– Current technique is observed and if necessary corrected
Evaluation:
– Trainers evaluate the training in terms of improvement from the first to the second observation
– Trainers write a report that is presented to the operators

What has been achieved?

A systematic and relatively simple training programme has been implemented. This streamlines the training of operators, thereby making it easier for the trainers to introduce new subjects and ensures that all new operators are trained the same as the experienced operators. The programme also makes the training system recognizable for the operators, which gives a higher compliance.

What next?

The program has only been implemented on processes related to production in clean room, but the training method can easily be applied to subjects outside of the clean room or in other healthcare settings. To involve the operators in the process, the second observation could be delegated to other operators and not just the trainers.

Establishing Population Health Management Clinic (PHMC) in surgical pre-assessment unit at WMUH

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European Statement

Clinical Pharmacy Services

Author(s)

Thewodros Leka

Why was it done?

Population Health Management is about improving population health by data driven planning and delivery of proactive care to achieve maximum impact.
The aim was to Introduce ‘Making Every Contact Count’ approach in the pre-assessment unit of engaging in conversations with patients about their lifestyle and providing the tools and information they need to make meaningful changes in managing
 Hypertension, Diabetes
 Smoking, Consuming alcohol, high BMI
 Regular physical exercise, Healthy eating schedule
 Adherence to prescribed medicines
In addition, establish link with the community public health team for continuous intervention and support.

What was done?

We proposed to the hospital executive management board to develop and test a novel clinical nurse and pharmacist led ‘Population Health Management clinic’ for the hospital that is grounded in connections to key stakeholders in the community, so that patients are followed up to get lifestyle change interventions to improve their illnesses and medication adherence. The board approved the funding and we established the first of its kind population health management clinic in the hospital.

How was it done?

Obtaining funding for the project was an obstacle.
We surveyed 1,000 patients who attended the pre-assessment unit during the year.
31% were hypertensive, 13% diabetic, 12% were smokers, 29% had anxiety/ depression, 51% drink alcohol more than recommended limit; 50% have BMI >29; 41% were not adherent in taking their regular medicines, 41% do not practice any physical exercise and 50% said they do not follow healthy eating. We presented the audit data to the hospital executive management board proposing to develop a ‘Population Health Management clinic’. The board approved the funding as they found that this is a step forward to improve the health of the population.

What has been achieved?

Since the initiation of the project, the concept of proactive health intervention and life style change approach is well established in the hospital becoming daily practice of the pre-assessment team.

What next?

Establishing Population health management clinic in surgical pre-assessment unit provides a unique ‘teachable moment’, where a patient can be encouraged by a perioperative team to make positive and lasting changes to their lifestyle and medication adherence.

Environmental criteria in medicine procurement

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European Statement

Selection, Procurement and Distribution

Author(s)

Outi Lapatto-Reiniluoto, Suvi Sivula, Elina Ahomäki

Why was it done?

Price has been the most prominent criteria in procurement quality being the second. Environmental aspects haven’t been assessed earlier. Differences between the pharmaceuticals’ environmental burden can be considerable and by choosing wisely we would be more sustainable.

What was done?

Environmental criteria have not been used in Finland in hospital procurements earlier. We created the criteria which would be acceptable to all parties (hospitals, suppliers), would be reliably assessed, and easily copied to other hospitals.

How was it done?

Our tender had six questions for everyone and two more questions for antibiotics or hormones. The common questions were answered by yes / no / we do not know. Points given were 0, 1, 2. An example of the common question is: Does the company have a plan how to reduce CO2 emissions caused by itself?
Questions for antibiotics and estrogen hormones were: Company has told in which country and in which plant the API is produced and the formulation happens.

What has been achieved?

132 providers answered so far. Quality of answers varied considerably, from 0 to 12 points, mean 7 points. Questions for antibiotics created the most discrepancies: 41 providers; 15 were not able to answer these questions acceptably. The answers showed that the questions were not too difficult, these questions could be answered, and the answers can be analysed.

What next?

The criteria were very simple and assessing the answers was not difficult. Only one question was widely misunderstood. Questions were universal and can be used in other hospitals, too, which is the wish from the industry (same questions everywhere). Wide range of results showed differences between the companies. During this round we did not give any credit for the best products but in the future more responsible products should be rewarded. Antimicrobial resistance e.g., is a global problem but if the company does not know where its products are manufactured how can they look after wastewater treatment of their products.

Advancing regulatory sciences closer to the patient care setting: a course development approach

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European Statement

Education and Research

Author(s)

Anthony Serracino Inglott, Maria Mamo, Amar Abbas, Luana Mifsud Buhagiar

Why was it done?

Regulatory science is not some detached activity performed in secluded offices but is applied by pharmacists as an integral part of their daily work, whether thought of as regulatory intelligence or not. This initiative endeavored to offer educational intervention, for streamlining a patient-centric culture and addressing gaps, while waning concerns regarding potential conflicts arising from regulator-stakeholder interactions.

What was done?

The Malta Medicines Authority (MMA), through the MMA Academy for Patient Centred Excellence and Innovation in Regulatory Sciences, implemented a course intended for collaborative synergy with professionals in patient care settings. Strengthening regulatory intelligence may provide substantial return on investment for the ultimate benefit of patients.

How was it done?

In April 2023, the MMA Academy completed registration as a Further and Higher Educational Institution. An accredited 3-day course, leading to an Award in Basic Regulatory Sciences (Malta/European Qualifications Framework Level 4), was launched across stakeholders. Twenty-four experts were engaged to deliver sessions on legislation, ethics, quality, information sources, digitalization, pharmacovigilance, good practices, risk, and avoiding victims of the system. Registrations were initially slow, owing possibly to the holiday season, increasing to maximal venue capacity following reminder mails and media posts. The course was delivered in September and feedback collected through a Likert scale evaluation exercise.

What has been achieved?

Thirty participants (8 from public, 22 from private entities) completed the course successfully. All respondents to the course evaluation exercise (n=24) expressed satisfaction with course content and willingness to attend further courses. Promisingly, 92% of same respondents found the information presented relevant to their practice, anticipating performance improvement. Feedback included recommendations for future initiatives, particularly on regulatory oversight of aesthetic medicine services and integration of artificial intelligence in hospital pharmacy practices. A continuous educational needs exchange is encouraged for course development tailored to respective patient care settings.

What next?

Interest was expressed by the Health Department (Ministry for Health, Malta) to support eligible candidates for participation, auguring well for enhanced prospective engagement by clinical pharmacists and colleagues in the state hospitals. This may also serve as example to other competent authorities. Going forward, the MMA Academy intends to invest in online provision to reach a wider audience through a virtual environment.

Revolutionising pharmacy recognition: evolution of the Australian and New Zealand College of Advanced Pharmacy

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European Statement

Education and Research

Author(s)

Tom Simpson, Kristin Michaels, Kylee Hayward, Nick Sharp-Paul

Why was it done?

The need to establish a recognition framework that resonated with pharmacists, aligned with their career journeys, and held tangible benefits prompted the inception of ANZCAP. Recognising that existing programmes lacked broad appeal, ANZCAP aimed to redefine recognition in a way that was meaningful, inclusive, and motivated pharmacists towards continuous development.

What was done?

The Australian and New Zealand College of Advanced Pharmacy (ANZCAP) represents a pioneering advancement in pharmacy recognition and career progression. Addressing the limitations of previous models that struggled to gain broad support, ANZCAP emerged as a strategic response to bridge the recognition gap within the pharmacy profession.

How was it done?

The development of ANZCAP commenced with the acquisition of the Advancing Practice (AP) credentialing programme by the Society of Hospital Pharmacists of Australia (SHPA). Previous efforts to engage pharmacists with the programme were reassessed, and a comprehensive review process was initiated to devise an innovative and pragmatic model of recognition. Development comprised multiple phases, including qualitative surveys, workshops, focus groups, and expert consultations. An iterative approach was adopted to refine the model, culminating in a prospective, merit-based system that recognises specialty areas and levels of practice. The focus shifted from individual competencies to broader domains within the National Competency Standards Framework for Pharmacists in Australia 2016, fostering flexibility and practicality.

What has been achieved?

ANZCAP has already recognised pharmacists at all levels – Resident, Registrar, and Consultant – through a Prior Professional Experience process. The college also extends its reach globally, welcoming international pharmacists to join its transformative community.

What next?

ANZCAP’s future involves strengthening the alignment of recognition with promotion and remuneration mechanisms, enhancing engagement among pharmacists. By seamlessly integrating learning experiences with Continuing Professional Development (CPD) activities, ANZCAP aims to foster a culture of lifelong learning and advancement. In the broader landscape, ANZCAP’s journey involves cultivating partnerships with international pharmacy associations, leveraging collective expertise, and fostering an inclusive recognition culture. The programme’s evolution will be guided by feedback, research, and a commitment to advancing pharmacy practice globally.

Stratification of psoriasis patients according to pharmaceutical care needed using the capacity-motivation-opportunity pharmaceutical care model

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European Statement

Clinical Pharmacy Services

Author(s)

NOELIA VICENTE-OLIVEROS, CARMEN PALOMAR FERNANDEZ, TERESA GRAMAGE-CARO, PAULA BURGOS BORDEL, MARÍA DEL CARMEN CALATAYUD SÁNCHEZ, SANDRA CASADO ANGULO, ANA MARTÍN ÁLVARO, MARÍA BEGOÑA RIVERA MARCOS, SONALI KARNANI KHEMLANI, MANUEL VELEZ-DIAZ-PALLARES, ANA ALVAREZ-DIAZ

Why was it done?

Patients with moderate-severe psoriasis require systemic hospital-dispensed treatments. Hospital pharmacists look for actions to anticipate patients’ needs for achieving health outcomes and the system’s sustainability.

What was done?

We stratified psoriasis patients according to the pharmaceutical care needed and established their pharmaceutical care plan. We calculated the time needed in pharmaceutical care after stratification.

How was it done?

An observational, prospective, cross-sectional study was conducted in a university hospital. One hundred psoriasis patients who received medication in the outpatient hospital pharmacy were randomly chosen between March-May 2022.
Capacity-Motivation-Opportunity (CMO) pharmaceutical care model (SEFH, 2018) was used to stratify patients. This model consisted of 23 variables (demographic, clinical, pharmacological, socio-sanitary, cognitive and functional). Each variable scored between 1-4, depending on patient risk. Patients were classified on three levels which determined the subsequent pharmaceutical care to be provided to each patient:
1. global score≥31 points,
2. 18-30 points and
3 ≤17 points.
Information was collected through patients’ interviews and electronic health records review.
A group of nine pharmacists were set up to adapt the CMO pharmaceutical care model to our hospital.
Total time spent in pharmaceutical care was obtained through patient visits before and after stratification. The scheduled average time for each visit was 10 minutes. The number of visits pre-stratification was the sum of all the visits scheduled for the patients, and for post-stratification was the sum of all the visits with the new CMO model (level 1 (biannual), 2 (annual), 3 (as needed).

What has been achieved?

Most patients were stratified on level 3. A pharmaceutical care plan has been designed to meet the needs of each patient.
Stratification has improved the time pharmacists have to accomplish the needs of each patient (16.3 hours/year (98 visits)). Sixty-two percent of patients had as needed visits (level 3), 36% needed annual visits (level 2) and 2% biannual (level 1). However, during pre-stratification, most the patients (70%) had every nine months visits, 18 % every 12 months, 9% every six months and 3% every three months.

What next?

We will expand the stratification to the rest of the psoriasis patients and other outpatient pathologies.
We will coordinate strategies with Social and Psychological Services, Primary care and Community pharmacy to improve pharmaceutical care.

Setting in situation of pharmaceutical validation of paediatric intensive care prescriptions by fifth year students: state of play and assessment

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European Statement

Education and Research

Author(s)

Omar HANAFIA, Pierre BERTAULT-PERES, Stéphane HONORE

Why was it done?

This internship was proposed to diversify the clinical pharmacy internship opportunities and to allow students to discover and understand paediatrics and intensive care, which are less covered in university courses. It will also be a proof of concept to develop this type of internship in other departments.

What was done?

We have proposed a new clinical pharmacy internship in immersion in paediatric intensive care to 5th year students. It is a hospital internship at the interface between the medical and pharmaceutical teams, the student is responsible for establishing a statement to analyse the drug management, its evaluation and improvement.

How was it done?

The clinical pharmacy student is a full-time employee, fully integrated into the medical team. Their day is divided into two parts: in the morning they attend the relief, the staff and the medical visit. In the afternoon, he/she takes over the patients, compiles the main medical, clinical and biological information in order to pharmaceutically prevalidate the medical prescriptions and propose pharmaceutical interventions (PI) to the pharmacist.

What has been achieved?

Since its opening, the position has been systematically chosen by the students, in 3 years 8 students have chosen it. After a training period of 1 month with the senior pharmacist, all students were able to perform the expected readings, prevalidation and PI. More than 78% of the PIs detected by the students were validated by the senior pharmacist and accepted by the physician.

What next?

This proof of concept shows that students are supportive of this type of initiative and are able to meet the high expectations of this internship.

Towards e-documentation of clinical pharmacist interventions

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European Statement

Clinical Pharmacy Services

Author(s)

Andrea Bor, Nóra Gyimesi, Eszter Erika Nagy

Why was it done?

Intervention-oriented classification systems are helpful tools to document the CPIs in a structured manner. Our aim was to develop a clinical pharmacy platform in the e-documentation system at our institution. This CPI data enables healthcare providers to track medication history, and to systematically analyse the effectiveness and the pharmacoeconomic benefits.

What was done?

A pilot survey was conducted on the traumatology wards to analyse and describe our clinical pharmacist interventions (CPI) based on severity and clinical relevance.

How was it done?

Three clinical pharmacists collected data on the changes of drug therapy at two 31-bed traumatology wards during pre- and postoperative period. We adopted the CPI classification system to our daily practices. This is challenging since the narrow time frame between patient admission and discharge often limits the opportunity to provide clinical pharmacy services. Raw data was previously screened and classified into 5 categories, drug related problems (DRP), clinical pharmacist intervention (CPI), significance (S), outcome (O) and acceptance (A).

What has been achieved?

We have established a data collection process, which allows us to record CPIs in our daily clinical environment in an efficient manner.
The most significant DRPs were incorrect dosage regimen (n=47), untreated indication (n=28), contraindication (n=25), excessive dose (n=19), subtherapeutic dose (n=17), drug interaction (n=15), no indication (n=11), experiencing adverse drug reaction (n=8), failure of drug administration due to shortages (n=5).
CPIs were divided into four groups:
1. Pharmacokinetic cause (dose adjustment, changes of drug dosage regimen, drug discontinuation, drug switch, etc.)
2. Pharmacodynamic cause (adding new drug, drug switch, – discontinuation, etc.),
3. Providing drug information (patient education, new drug, changes of administration route, etc.) and
4. Miscellaneous.
Significance were categorised as major (e.g. oral anticoagulant – LMWH switch, postoperative opioid use), moderate (e.g. loop diuretics – ion supplementation), minor.
Outcomes were therapeutic success, prevention of potential harm (e.g. adverse drug reaction) or cost saving.
73% of the interventions were accepted, the rest were rejected for the first time, but nearly half of them were admitted after minor modifications.

What next?

This CPI platform should be shared in the national digital health system.

Implementation of a screening circuit and prevention of infections in cancer patients treated with immune checkpoint inhibitors

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European Statement

Clinical Pharmacy Services

Author(s)

Alba Manzaneque, Carla Jurado , Cristina Alonso , Mireia Cairó, Glòria Molas, Fernando Salazar , Lucía Boix, Roser Font, Laura López, Jordi Nicolás, Marc Campayo, Esther Calbo

Why was it done?

Although an intrinsic risk of infection has not been associated with ICI, there are different studies and case-series in the literature in which an increased risk of infection is observed, mainly associated with the use of immunosuppressive drugs (like corticoids) for immune-mediated toxicities. The objective of implementing this circuit in our centre is to reduce all preventable infections, by carrying out an initial infection screening that allows detection of those patients susceptible to vaccination measures, prophylaxis, or specific recommendations.

What was done?

Implementation of an infection screening circuit in cancer patients treated with immune checkpoint inhibitor drugs (ICI).

How was it done?

To carry it out, a multidisciplinary work team was created (pharmacy/oncology/infections department) that designed the ICI template and the clinical circuits. At this point, we believed it was necessary to centralise requests, results, and follow-ups in the oncology pharmacy team (OPT) in order to ensure that all patients were included.
Before the patient initiates treatment with ICIs, the OPT makes the request for a pre-established ICI analysis and the oncology nurse (ON) extracts it. Within 7-10 days, the infection department checks the results and makes the necessary recommendations (vaccination/prophylaxis/specific recommendations).
The OPT is then responsible for both vaccination and initiation of prophylaxis.

What has been achieved?

A total of 30 patients (January to September 2022) have been included in the circuit, 25/30 being men and with a mean age of 67.8 (± 8.8) years.
In 25/30 the treatment was with palliative intent, and 21/30 had lung neoplasia.
The ICIs prescribed were: pembrolizumab (15/30) and nivolumab/atezolizumab/durvalumab (5/30 in each case).
Screening results are available for 26/30 patients. Some type of recommendation was made in 25/26 patients, being: 20/26 hepatitis B vaccination, 5/26 start prophylaxis (2/5 hepatitis B and 3/5 tuberculosis), 6/26 hygienic-dietary measures (aimed at toxoplasmosis).
Additionally, all previously unvaccinated patients (23/26) have been vaccinated against pneumococcus.

What next?

A comparative analysis of infection with a historical cohort is planned when larger sample size is available, to demonstrate that these types of measures reduce the occurrence of infections. Centralising this type of initiative from the OPT is key to our integration into clinical teams, by avoiding important adverse reactions and taking care of our patients.

App PharmaClick

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European Statement

Clinical Pharmacy Services

Author(s)

Catarina da Luz Oliveira, Maria Augusto, Carla Ferrer

Why was it done?

Ideally, clinical pharmacy should be performed continually and not only at the Pharmaceutical Consultation. The usage of technologies as new communications channels between patients and pharmacists would contribute to this notion of continuous clinical pharmacy, so we started to develop the app PharmaClick. With this app, the pharmacist will be able to remotely monitor the patient therapy, to mitigate medication errors, to control adverse drug reactions, to detect possible drug interactions, and to promote therapy adherence.

What was done?

We are developing a web application called PharmaClick. This app will allow the patient, after the respective Pharmaceutical Consultation at the hospital outpatient clinic, to communicate on time with his pharmacist and to give access to several features related with his medication.

How was it done?

The app PharmaClick is being developed using open source technology, Ruby on Rails, and is currently in a small-scale implementation to prove the viability of the project.

What has been achieved?

The PharmaClick app is now a pilot project and is being used as support on the Pharmaceutical Consultation. The patient is invited to download the app PharmaClick and he is introduced to its features, such as:
• How to identify his medication and dosage;
• How to set alarms for taking the medication and making the respective register, allowing the pharmacist to check the therapy adherence rate;
• How to request the scheduling of a new pharmaceutical appointment;
• How to communicate with the pharmacist using the chat to clarify some doubts that he may have after the appointment;
• How to register possible adverse drug reactions;
• How to submit the quality of life form, which will allow to indirectly measure the therapy efficiency.

What next?

The project is sustainable since it is easily applied on other health institutions. The app allows to anticipate possible medication problems. The goal is to provide health solutions that are remote and effective, to improve the patient participation in the healing process and in his wellbeing in the long run. The treatment success is easily improved at the distance of a PharmaClick.