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DEVELOPMENT OF GUIDELINES FOR SAFE HANDLING OF ONCOLYTIC VIRUSES (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

Faten Ahmad Díaz, Eugenia Serramontmany Morante, Carla Esteban Sánchez, Pablo Latorre García, Montserrat Carreres-Prieto, Javier Martínez Casanova

Why was it done?

Different critical points were detected: 1) some OV dose prescription depends on tumor size, 2) special storage conditions, 3) special safety measures related to preparation to prevent cross-contamination and technician exposure, 4) special transport conditions in a safety container, and 5) safe administration. The increasing number of clinical trials with OV combined with the identified critical points implies a better coordination between the different departments involved.

What was done?

Development of a standardised working procedure for the safe handling considerations, storage requirements, and modes of administration of oncolytic viruses (OV) in patients with cancer.

How was it done?

Different meetings were arranged with a multidisciplinary team to standardise procedures, in order to avoid errors: 1. The pharmacist validates the prescription volume reflected on the certified sheet according to the tumour size. Then, a pharmacy technician is authorised to remove the vials from the freezer to start the preparation. 2. Special −80ºC freezer is needed to preserve the OV. 3. According to the preventive medicine service, OV must be prepared in biological safety cabinet class II (BSC) with personal protective equipment. At the end of preparation, the BSC must be cleaned with the OV appropriate disinfectant and ventilated for 1 hour before restarting to work again. So, the OV preparation was established at 7 a.m. in order to avoid cross-contamination with the chemotherapy (first preparation in the day). 4. Safety transport must be considered, so OV is packaged in a special hermetic box. 5. The majority of the OV preparations are administered intralesionally at the radiology room so safe administration is needed to avoid the room contamination.

What has been achieved?

By using these procedures, it is possible to work with a single BSC, avoiding delays in the administration of other therapies while reducing the risk of mistakes.

What next?

These types of therapies represent a novel therapeutic modality: their preparation, administration and handling requirements differ from current therapies; pharmacists have an important role in developing new procedures to incorporate them into clinical practice. This protocol may be useful to other centres due to the lack of experience and standardised guidelines to work with this type of therapy.

OPTIMISING WORKFLOW AND MEDICATION IN THE ACUTE WARD − BETTER USE OF PHARMACISTS’ SKILLS (submitted in 2019)

European Statement

Clinical Pharmacy Services

Author(s)

Mia P von Hallas, Trine RH Andersen

Why was it done?

Physicians in acute wards have limited time to see all patients. Time for medication history, reconciliation and review is limited, due to great patient turnover. The physicians did not consider the pharmacist medication review alone as a contribution to the workflow or to relieve the high workload.

What was done?

Through user surveys among the physicians in the Acute Ward, pharmacist tasks were adjusted to benefit the physician’s high work flow. Before the survey, pharmacists performed medication reviews which were communicated to the physician. The adjusted pharmacist tasks on the ward includes medication history, reconciliation and transfer of the medication to the electronic medicine module (Epic), securing up-to-date medicine data during hospitalisation.

How was it done?

A questionnaire was developed regarding four areas (Pharmacist competencies, Pharmacist tasks, Pharmacist medication review, Multidisciplinary teamwork) and distributed among the physicians. Based on the anonymous responses, the pharmacists adjusted their tasks to include medication history, medication reconciliation and transfer of medication to Epic, complying with the suggestions in the questionnaire survey. Obstacles were low percentage of respondents (15/33 (45%) prior to the initiative and 12/39 (31 %) after), and the large replacement of junior physicians in the period between surveys.

What has been achieved?

Pharmacists feel more part of the multidisciplinary team and attitudes towards the pharmacist service among physicians has changed. A new survey after implementation of the new workflow showed that 73% found medication reconciliation was a pharmacist task, compared to 29% before. After implementation, 90% of physicians believed that pharmacists could do medication review (67% before intervention). The acknowledgement that pharmacists were able to transfer medication to Epic was increased from 20% to 90%. The attitude has changed from considering pharmacists as medication advisers to considering pharmacists as part of the multidisciplinary team in the ward.

What next?

The questionnaire survey will be repeated annually to continually improve the workflow and contribution of clinical pharmacist services to the heathcare professional team in the acute ward.

MULTIDISCIPLINARY CAR-T TEAM (submitted in 2019)

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European Statement

Clinical Pharmacy Services

Author(s)

MARGHERITA GALASSI, CHIARA DELLA COSTANZA , CLAUDIA TIRONE, SARA BERTOLI, ERNESTO RUFFINO, ELEONORA FERRARI, ELENA ALIPRANDI , VITO LADISA

Why was it done?

CAR-T cell therapies are a new advanced type of personalised immunotherapy against cancer. In the EU the authorised therapies are tisagenlecleucel and axicabtagene ciloleucel, both used in our centre as third line for the registered indication of diffuse large B-cell lymphoma. CAR-T therapies production and administration process consists of multiple stages: patient’s leukapheresis, genetic engineering of lymphocytes, lymphodepleting chemotherapy (LC), CAR-T cell infusion, monitoring of the patient. Considering the complexity of the procedure and the observance of specific schedules, these therapies should be administered in highly specialised centres complying with specific organisational requirements, with disposal of an adequate multidisciplinary team.

What was done?

A multidisciplinary team (CAR-T team) was constituted for the management of CAR-T therapies (Chimeric Antigen Receptor T). The pharmacist was included in the team for the planning and organisational phase of the process.

How was it done?

The pharmacist is responsible for the approval of the physician’s prescription, the LC preparation according to Good Manufacturing Practice (GMP), the LC distribution on scheduled time, the making available of treatments for supporting the patient until CAR-T infusion, and treatments after infusion for management of adverse events. At the arrival of the CAR-T product, the pharmacist is responsible for the check and release of it in good condition. The LC protocols foresee the administration of cyclophosphamide and fludarabine on the 5th, 4th and 3rd day before the CAR-T infusion, and are defined on the basis of the summary-of-product characteristics. The medications are provided locally and refunded by the national health system.

What has been achieved?

In our center 8 patients were treated with compassionate use of axicabtagene ciloleucel. The pharmacist’s presence in the multidisciplinary team was advantageous because, through validation of the therapies and verification of dosages, they guarantee further security to the patients. The high-tech automated centralisation and computerisation of chemotherapies at our centre ensured quality and safety of the preparations.

What next?

The realisation of defined paths and codified proceedings, the respect of fundamental timings for the success of the process and the chemotherapy preparation centralisation could lead to increased investment, decisive for obtaining a high quality product and process level. The experience, now limited to haematology, could be used for future CAR-T applications.

ANTIMICROBIAL STEWARDSHIP: WHAT IF EVERYTHING IS ON YOUR SCREEN? (submitted in 2019)

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European Statement

Introductory Statements and Governance

Author(s)

Marinos Petrongonas, Maria Fragiadaki, Eleni Rinaki, Leonidas Tzimis

Why was it done?

Implementation of antimicrobial stewardship programmes in hospitals is part of the national strategy to promote prudent use of antimicrobials. As HPs chair stewardship teams, they are responsible for assessing prescription and monitoring antimicrobial use. Designing and developing automated informative tools facilitates HPs in their role.

What was done?

Hospital pharmacists (HPs) designed and developed software tools to support the antibiotic stewardship team’s work. Particular developments were: a) Α PC application (GrAD_calc), in Microsoft Excel, to calculate antimicrobial consumption, instead of ABC_calc tool. GrAD_calc takes advantage of the unique codes for each branded product and transforms aggregated data, provided by the Hospital Information System (HIS), into antibiotic consumption in DDDs/100 occupied bed-days. Results are presented in charts and figures, in a format that enables ease of comparative monitoring over time. b) Necessary indexes of the above calculator and documentation needed as justification for restricted antimicrobials dispensing have been integrated into the HIS; in result, data for national surveillance programme for antimicrobial consumption are automatically exported. Useful information for pre- and post-prescription review, like demographics, indication(s), co-morbidities, current and previous treatments, microbiology tests’ results, susceptibility reports, is available and easily accessible to prescribers, HPs, and infection disease specialists.

How was it done?

HPs created GrAD_calc on their own resources, while changes in HIS were made by ICT service provider, following technical specifications described by HPs. A number of technical problems have been resolved with the contribution of HPs.

What has been achieved?

• Monitoring of antimicrobial use by pharmacy is quicker and effortless. • Handwritten documentation included in restricted antimicrobials’ prescriptions has been replaced by an electronic decision support system, as tool to improve antimicrobial prescribing and stewardship. • Useful information from patient’s medical record is directly available to HPs and physicians, and facilitates hospital’s policy for assessing antimicrobial prescriptions. • Data, like indication, medicine, dosage scheme, microbiology results and susceptibility reports, are recorded electronically and update patients’ pharmaceutical records, permitting further use for pharmaco-epidemiology studies. 

What next?

Next challenge is wide use of tools developed, to optimise pharmaceutical services provided and dispense restricted antibiotics only when accordingly justified. GrAD_calc is applicable in hospital setting and HIS’s tool is incorporated and can be used by all regional hospitals.

INCLUSION OF PHARMACY STUDENTS IN AN INTERPROFESSIONAL TRAINING WARD PLACEMENT FOR HEALTHCARE STUDENTS IN SWEDEN (submitted in 2019)

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European Statement

Education and Research

Author(s)

Matts Balgård, Maria Swartling, Srebrenka Dobrić, Lena Klarén, Lina Karlsson

Why was it done?

ITWP for healthcare students is established at various teaching hospitals. However, to our knowledge, no such programme in Scandinavia has included pharmacy students. Clinical pharmacy is a growing profession in Sweden and other healthcare students will in the future work alongside clinical pharmacists. Therefore we set out to add pharmacy students to the ITWP team, believing that it would be a valuable experience for them to collaborate and share knowledge with students from other healthcare professions. Equally important, it is a way to promote the pharmacist’s competence and contribution to the multiprofessional healthcare team, prior to graduation.

What was done?

Final year undergraduate pharmacy students, specialising clinical pharmacy, were given the opportunity to spend two weeks of their six months pharmacy practice to participate in an interprofessional training ward placement (ITWP) together with medical, nursing and physiotherapy students. During this two-week clinical placement, the students were collaboratively responsible for managing the care of geriatric inpatients while under supervision of licensed practitioners.

How was it done?

A working group was formed consisting of teachers from the faculty of pharmacy, a student representative and a working clinical pharmacist. The group developed the initiative, including among other things, prerequisites, an evaluation plan, a workflow tool for clinical rounds, and suggested tasks for pharmacy students during the placement.

What has been achieved?

The programme has been running for three semesters and 6–8 pharmacy students have participated in the ITWP each semester. The initiative has been evaluated using surveys. Participating pharmacy students expressed gaining new knowledge and better insight into nursing care and the roles of the other professions. Nursing students appreciated the support in medication management and medical students found the pharmacy students to be valuable discussion partners that could challenge their drug-related decisions. Tutors expressed that the pharmacy students brought a beneficial dynamic to the ITWP team.

What next?

The opportunity for students from different professions to work together with a common objective in a real-life setting gives them valuable insight into each other’s professional roles early in their careers. This good practice initiative could be used in other interprofessional training ward placements wishing to involve pharmacy students.

DEVELOPMENT OF AN INTERNATIONAL EXCHANGE PROGRAMME IN HOSPITAL PHARMACY PRACTICE (submitted in 2019)

European Statement

Education and Research

Author(s)

Agnes Ann Feemster, Nicoletta Zallocco, Carlo Polidori

Why was it done?

Development of pharmacy education on a global scale is an international initiative. Additionally, employers recognise that global experiences positively impact a variety of applicant qualities, including curiosity, willingness to take risks, a non- judgmental attitude, and a broader worldview. The goal of this collaboration is to expose students to the medication distribution system and role of the pharmacist in an international practice setting with an aim of developing a more well-rounded, culturally aware pharmacist.

What was done?

A partnership between the University of Camerino (UNICAM), Camerino, Italy and the University of Maryland School of Pharmacy (UMSOP), Baltimore, Maryland, USA was formed. Under the agreement, the two universities exchange student pharmacists for five-week internships in hospital pharmacy.

How was it done?

A memorandum of understanding was implemented between the two universities in May 2018 with the first UMSOP student visiting in September 2018. A professor from each university co-coordinates the internship. UMSOP students self-fund travel while UNICAM students self-fund and seek university support; funding is a barrier to pursuing the experience. Housing logistics for the students is also challenging. UMSOP students receive academic credit for the experience, requiring that the Italian site meet the advanced practice experience objectives.

What has been achieved?

The programme intended to exchange one-two students annually. After the inaugural student, eight UMSOP students pursued the UNICAM internship, resulting in six student placements at three Italian hospitals. One UNICAM student pursued a cardiology experience at an academic medical centre in Baltimore. UMSOP students perform a preceptor and site evaluation after the internship. 100% of students completed the evaluation with an overall evaluation score of strongly agree that the preceptor and site provided a positive experience. A structured interview with the UNICAM student indicated a greater understanding of clinical pharmacy practice and the role of a pharmacist on an interdisciplinary team, which may be used to further develop hospital pharmacy services in Italy.

What next?

This international exchange demonstrated a high degree of satisfaction among participants. While currently limited to students, this initiative should be considered for practising pharmacists. Sharing of best practices and the interchange of ideas may generate practice enhancements, lead to innovations, and stimulate personal growth.

INTEGRATION OF THE CLINICAL PHARMACIST IN A MULTIDISCIPLINARY TEAM IN A BURNS UNIT

European Statement

Clinical Pharmacy Services

Author(s)

Ángel Guillermo Arévalo Bernabé, Pilar Lalueza Broto, Jordi Serracanta Doménech, Jacinto Caparrós Baena, José Manuel Collado Delfa, Jordi Aguilera Sáez, Romy Rossich Verdés, Pablo Sánchez Sancho, Juan Carlos Juárez Giménez, Maria Queralt Gorgas Torné

Why was it done?

The burns unit of a third-level hospital includes a patient’s great heterogeneity depending on his population group and his clinical condition (extension, degree and depth of his burns, etiological agent of the burns and associated comorbidities), which makes the managing of these patients complex and they need multidisciplinary solutions. In addition, extensive burns provoke physiopatological alterations that involve changes in the pharmacokinetical and the pharmacodynamical modelling of some drugs. The knowledge that the pharmacist has about the changes that take place in vascular dynamics, the clearance and the distribution volume of the drugs, and the degree of union from these to plasmatic proteins, makes his active participation in the care of the burns patient, and in the optimisation of his pharmacotherapeutic plan, very interesting.

What was done?

The integration of the pharmacist into a multidisciplinary group of assistance to the burns patient constituted as the Managing Committee of Cases and was integrated by plastic surgery, intensive medicine, intensive paediatric medicine, preventive medicine, infectious diseases, psychiatry, psychology, social work and infirmary, as well as pharmacy.

How was it done?

A protocol was devised that standardises and systematises the review of the pharmacotherapeutic plan of all patients in the burns unit, including burn critical and paediatric. Also, there is included a model of record and codificate of pharmaceutical interventions. The multidisciplinary group meets weekly and every patient is analysed from all clinical points of view, the pharmacist intervening in relation to the pharmacotherapeutic and nutritional plan.

What has been achieved?

The active integration of the pharmacist has been achieved in the clinical group of assistance to the burns patient. In addition, there has been created a collaborative attitude that has benefited joint projects of investigation. The degree of acceptance of the offers of modification that the pharmacist realises is 90%.

What next?

The following step must be, depending on the obtained results, to establish improvement assistance measures, including the accomplishment of protocols and the development of investigation projects that help to generate knowledge about the use of some drugs in burns patients, such as immunoglobulin or proteolitic enzymes for the extraction of bed sores.

THE PHARMACIST IN THE LUNG CANCER MULTIDISCIPLINARY TEAM

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Clinical Pharmacy Services

Author(s)

Ana Soares, Armando Alcobia

Why was it done?

Several clinical practice guidelines for LC recommend that multidisciplinary teams should be used to plan patients’ treatment. The evolution of thoracic oncology, namely the increasing knowledge of the diverse histologic and molecular phenotypes in non-small cell LC, has been driven to more complex treatment algorithms in recent years. This complexity increases the need for a multidisciplinary approach in therapeutic decision-making, which must be individualised and based on the best information available. The pharmacist’s inclusion in the multidisciplinary team is essential and was formerly proposed by the Pneumology Director to the Hospital Administration Board.

What was done?

A hospital pharmacist is a permanent member of the lung cancer (LC) multidisciplinary team, which has met weekly since January 2016, to plan the management and treatment of LC patients in our hospital. The pharmacist brings updated information about the efficacy and safety of drug treatments, its cost-effectiveness and its availability. The pharmacist improves communication with the Pharmacy and Therapeutic Committee.

How was it done?

The multidisciplinary team meets weekly to discuss the diagnosis and treatment options of LC patients, and includes a dedicated group of professionals: pulmonary oncologists, a thoracic surgeon, a radiation oncologist, a radiologist, a pathologist, a nuclear medicine specialist, a hospital pharmacist, a palliative care physician and an oncology nurse.

What has been achieved?

About 240 cases, corresponding to 200 patients were discussed per year. An average of 110 solicitations to the Pharmacy and Therapeutic Committee were made. The multidisciplinary team grants a systematic approach to diagnosis and therapeutics, in compliance with evidence-based guidelines, improves communication and coordination between professionals and short waiting times for the patient.

What next?

The next step is to systematise real-world data collecting, from the patients treated, to better understanding the effectiveness of treatment options and the real impact of the multidisciplinary team in patient outcome, ideally, extending it onto a national level.

ANTIMICROBIAL STEWARDSHIP ALERTS SYSTEM

European Statement

Patient Safety and Quality Assurance

Author(s)

Emma Ramos Santana, Enrique Tevar Alfonso, Maria Jose Castillos Mendez, Maria Luz Padilla Salazar, Lucy Abella Vazquez, Jesus Ode Febles, Marcelino Hayek Peraza, Javier Merino Alonso

Why was it done?

The implementation of an antimicrobial stewardship program (AMS) is very important, but it has to be accompanied by personal resources. It is therefore necessary to effectively use the time spent in the AMS.

What was done?

We have worked with the Information Technology Service to develop an “Intelligent Antimicrobial Screening Program” (IASP).

How was it done?

Using the information available in Electronic Health Record (EHR) and in pharmacy and microbiology applications we have developed a computer tool that analyze hundreds of situations through pre-established conditions

What has been achieved?

Currently the system analyzes more than 40 conditions related to the correct use of antimicrobials based on antibiotic characteristics, patient situation and microbiological data.
Some of the most relevant conditions are:
●Antibiotic prescribed more than 6 days.
●Patient with parenteral antibiotic for more than 3 days and with other oral medicines.
●Antibiotic that must be adjusted in patients with renal impairment prescribed in patients with glomerular filtration rate (GFR)65 years old, GFR5 days prescribed or other nephrotoxic prescribed.
●Patients with linezolid and thrombocytopenia or anemia or without an hemogram in the last week.
●Patients with daptomicyn and high creatininkinase (CK) or without a recent determination.

What next?

This software allows to collect information contained in different systems and displays it in an organized view to the user. This makes it an easily system that can be exported to other hospitals.
Our next objective is to consult the microbiological information. Therefore the system will be able to recommend about the optimal antimicrobial treatment, detecting situations in which the treatment can be de-escalated or alerting in case of resistance.

A PHARMACIST IN THE MULTIDISCIPLINARY ONCOLOGY TEAM

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European Statement

Clinical Pharmacy Services

Author(s)

Ulrike Guger-Halper

Why was it done?

The pharmacy of the hospital supplies four hospitals with cytotoxic infusions. In the past it was found that the integration of a pharmacist in the oncology team brings benefits.

What was done?

Integration of a pharmacist in the oncology team

The aim was to evaluate the participation of a pharmacist in the multidisciplinary oncology team. The team consists of the clinical pharmacist, medical oncologists, residents, oncology nurses, dieticians, medical documentation assistent and a clinical psychologist.

How was it done?

Data were collected from May 2014 to September 2015.
All chemotherapy protocols were electronically prescribed in CATO® (computer aided therapy for oncology) and included cytotoxic drugs and concomitant medications.
In addition to production in the cytostatic unit the pharmacist participated in the daily morning meetings, the two-week tumor boards and bimonthly team meetings.
Pharmacist interventions (PI) took place during the meetings and were also communicated by phone and mails.

What has been achieved?

3335 cycles of chemotherapies were prescribed and 914 interventions were recorded.
CATO®-related PI (33,3%) were categorized in: literature research (4,7%), chemotherapy protocols (3,2%), dose selection (16,7%), treatment duration (1,4%), application/infusion time (0,9%) and others (6,4%).
Not CATO®-Related PI (66,7%) were categorized in: logistics (24,2%), patient-related (26%), drug-related (16,5%)
Under pharmaceutical participation: 15 guidelines, 1 abstract for a poster presentation, 27 work tools, 2 workshops, 2 publications, 1 lecture, 15 staff trainings, wipe samples in preparation

What next?

In this observational study we demonstrated the significant role of the clinical pharmacist as a part of the multidisciplinary oncology team. The supply by a pharmacist means to optimize treatment protocols and procedures and improving patient safety.
Medication errors occur despite electronic prescription of standardized protocols. Clinical pharmacists with special experience in oncology play an important role to identify errors in oncology.
A plausibility check by a pharmacist is still needed.

References: Sessions J. K. et al., Role of Oncology Clinical Pharmacists in Light of the Oncology Workforce Study, J Oncol Pract. 2010 Sep; 6(5): 270–272.