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Early access to the drug: the role of the pharmacist in the management of CNN drugs in oncology

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European Statement

Introductory Statements and Governance

Author(s)

Aldo De Luca, Andrea Ghiori, Cecilia Orsi, Michele Cecchi

Why was it done?

CNN drugs are drugs that have obtained authorisation from EMA and AIFA (Italian drugs authority) but that have not been negotiated for the purposes of the reimbursement of the National Health System. These drugs are often clinical innovations that fill therapeutic gaps. In our Region, access to these therapies is allowed only on a special request made by the clinicians at the Pharmacy that is evaluated positively, presents it to the Regional Authority. The regional assessment is also implied by the presence of specific contractual agreements with the pharmaceutical companies. Requests have been considered for enfortumab vedotin (EV), indicated for urothelial carcinoma, and trastuzumab deruxtecan (T-DXd), indicated for breast cancer. The objective of this article is to highlight the activity of the pharmacist in the management of drugs in the CNN range.

What was done?

A pathway has been developed at regional level to promote early access to new drugs and further therapeutic possibilities.

How was it done?

All requests for CNN drugs received in the semester November 2022 to May 2023 to our Operations Unit and subsequently included in the regional portal were analysed on the basis of approved indications, bibliography, clinical reports, and eligibility card (for T-DXd only) validated by the medical division of the pharmaceutical company.

What has been achieved?

During the period analysed, 25 applications were made (11 for EV, 14 for T-DXd) for a total of 30 treatments (11 for EV, 19 for T-DXd). Of the 25 requests received by the Pharmacy, 24 (96%) were sent to the region for treatment authorisation; one was not submitted because the patient did not comply with the approved indication. We obtained 100% of the required treatment approvals.

What next?

The hospital pharmacist is configured as a collector of clinical requests with an important function as a filter of prescriptive appropriateness in requesting regional authorisation for the treatment of drugs in the CNN range; moreover, the pharmacist is a necessary reference figure between the need for clinical innovation and the need to guarantee sustainability of the system in order to ensure early access to innovative therapeutic opportunities. This model could be exported to other regions at national and European level.

Lean management optimisation of the patient care pathway in an onco-haematology outpatient hospital

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European Statement

Introductory Statements and Governance

Author(s)

Florent MARTY, Sephora BELO-KIBABU, Driss CHAOUI, Jean-Luc PONS, Romy LINOSSIER-ROCHER

Why was it done?

Over the last few years, French healthcare establishments have been moving towards a more ambulatory approach to medical care. The growing number of patients treated in OPH has necessitated a reorganisation of these units. Staff at the onco-haematology OPH and the team at the centralised cytotoxic preparation unit in our hospital have reported organisational problems affecting the care pathway for patients admitted to the unit, leading to excessive delays in treatment and long waiting times for patients. Waiting time is one of the best measures of the quality of care provided.

What was done?

The project is to improve the overall patient flow within the outpatient hospital (OPH) service by reducing so-called non-value-added and compressible waiting times, without affecting the quality of patient care. This should have an impact on the flow of onco-haematology patients and therefore enable the OPH to operate more smoothly. Improvement actions must be simple, quick, easy to implement and inexpensive.

How was it done?

Data collection (waiting times, volume of activity) was carried out using: patient pathway mapping, observation grid, nurse and haematologist questionnaire, Actidiag software. Application of Lean through the development and facilitation of Kaizen workshops. The improvement actions were chosen during a brainstorming session between haematologists, pharmacists and nurses. A new data collection is then carried out and the results compared.

What has been achieved?

The stays of 64 patients were studied before optimization and compared with those of 79 patients after optimization. Improvement actions include : creation of a shared file, installation of a giant screen in the department connected to the new file, anticipation of preparations. Countermeasures reduced overall waiting times by 42%, cutting the patient’s length of stay by 53 minutes. The care time represents 54.6% of the time spent in the OPH, compared with 41.2% previously. This has also enabled the department to take on 18% more patients.

What next?

Healthcare professionals have noted a smoother flow of activity, making the care pathway more fluid and enabling patients to spend less time in the department, without impacting on patient care. This results in better rotation of OPH beds using a simple and easily reproducible method.

A human albumin (HA) prescription model as strategy to maximise the appropriate use in shortage conditions

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European Statement

Introductory Statements and Governance

Author(s)

Giorgia Babaglioni, Lorenzo Silva, Elena Festa, Daniela Paganotti, Tullio Elia Testa

Why was it done?

In Italy, the rising PDMPs demand had to face the international shortage caused by the SARS-CoV-2 pandemic outbreak. The self-sufficiency level of albumin represents one of the National Blood Centre (NBC) main challenge, in view of the health system sustainability.

What was done?

The hospital pharmacy of a northern Italy centre, in accordance with the Good Use of Blood Committee, introduced a nominal form for human albumin (HA) requests to evaluate and rationalise the HA clinical-therapeutic demand. It represents a pharmacist led intervention approach shared by physicians, in favour of an economically sustainable healthcare contrasting the lack of plasma-derived medicinal products (PDMPs).

How was it done?

Prescription criteria were updated according to the most recent guidelines. The cut-off of blood albumin level above 2.5 g/dl has been introduced as eligibility threshold value and for the daily dose calculation, except for HA calculation based on volumes for plasmapheresis and large volume evacuative paracentesis in hepatic cirrhosis. The pharmacy provides a maximum of five days therapy, then a new revaluation and updating of blood albuminemia was required; 690 total requests were analyzed.

What has been achieved?

In March 2023, HA consumption was 61400 gr, collapsed by 75% in April and then settled at – 58% in May and June. The most important reductions in monthly requirements affected the surgical (- 75%), intensive (- 62%), internist (- 64%) and gastro-hepatological (- 52%) areas. 97,5% of requests were on-label: 20% for plasmapheresis or paracentesis, 21% for liver failure, 16% for cirrhosis of the liver with refractory ascites. 26% of requests (n = 180) reported in-range blood albumin value, while the 14% was unknown or ongoing because administered in emergency phase. 37% of requests has been evaded even if the blood albumin was > 2,5 g/dl due to mandatory clinical need. Thanks to the new prescription model it was possible to save € 91 752 in the second quarter.

What next?

The introduction of the reasoned request allowed to achieve albumin self-sufficiency with voluntary blood donations and reduce the market products purchase. Furthermore, it fostered the clinicians awareness on the HA use appropriateness, considering crystalloids and non-protein colloids as alternative therapeutic strategies as resuscitation fluids.

Design, build and implementation of electronic prescribing and medicines administration in neonatal units across four UK hospital trusts

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European Statement

Introductory Statements and Governance

Author(s)

Holly Jones, Nicola Vosser

Why was it done?

Neonatal units were out of scope during the initial EPMA go-lives due to the complexities in prescribing and the specialist resource required for implementation. This project therefore brought neonatal units in line with all other areas, transitioning from paper drug charts to EPMA. In addition, it supported an ICS wide goal to align practice between trusts, standardising prescribing and facilitating effective use of digital systems in healthcare.

What was done?

A neonatal formulary was developed on an existing Electronic Prescribing and Medicines Administration (EPMA) system shared by four hospital trusts that make up a regional Integrated Care System (ICS). This involved interdisciplinary collaboration and shared decision making to align practice and prescribing guidelines. Complex protocols included continuous variable rate drug infusions, intravenous fluids and parenteral nutrition.

How was it done?

Key guidelines were shared with a collaborative approach to identify and harmonise differences in local practice, including syringe volumes and dose calculation ‘factors’. The EPMA team (comprising specialist pharmacists and medicines management technicians) completed a thorough gap analysis of the existing adult and paediatric drug catalogue and managed all new build work for neonates. Clinical decision making and validation were multidisciplinary tasks with input from specialist clinicians, pharmacists and nurses. Training, go-live planning and implementation were led by the EPMA team.

What has been achieved?

A bespoke neonatal medication build has been successfully implemented, supporting safe and efficient prescribing in neonates across the ICS. The development provides the ability to prescribe medications and document administration clearly and safely, including adjustment of infusion rates. Clinical pharmacists have full visibility of this information and are able to accurately complete pharmacy reviews, interventions and verification. In addition, alignment of practice and standardisation of care has been reached across the ICS, with benefits to both staff and patients.

What next?

The neonatal build is updated and optimised based on feedback from users to maintain the usability and safety of the system. Development of electronic fluid balance charts for neonates, including drug infusion volumes, is also in progress. Details of the neonatal project are being shared with other UK hospital sites using the same EPMA system.

A National implementation group – aligned and efficient changes of medicine and treatments nationally across hospitals

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European Statement

Introductory Statements and Governance

Why was it done?

The role of the NMC is to provide guidance about new medicines for use in public hospitals, and recommendations from the NMC can lead to changes in medical treatments. Before changes can be implemented, a variety of preparatory processes are necessary and relevant stakeholders, e.g. drug and therapeutic committees, hospital pharmacies, clinicians, and the national supply organization have to be involved.

Knowledge sharing and coordination among stakeholders are crucial to ensure efficient and nationally aligned implementation.

To undertake these tasks and support the NMC in their work, there was a need for a national group with expertise in implementation of changes of medicines in hospitals.

What was done?

The National Implementation Group was established in September 2019. The main purpose of the Group is to discuss, assess and ensure implementation of recommendations and treatment guidelines from the National Medicines Council (NMC) across regions, hence achieving national consensus on aligned medical treatment.

How was it done?

We formed the National Implementation Group with representatives from all stakeholders for swift and coordinated execution of changes of medicines. Each region designated participants directly involved in the implementation. To ensure effective knowledge sharing and coordination, the Group holds a monthly one-hour virtual meeting one week after NMC recommendations are published.

What has been achieved?

The monthly Group meetings ensure that the national implementation process takes approximately 14 days and the recommendations from the NMC are regularly discussed, assessed, and implemented efficiently and aligned at national level.

In 2022, the Group was evaluated through focus group interviews, highlighting quality and value. Results show that the Group aligns implementation nationally, offers expertise, saves regional resources, and fosters valued knowledge sharing concerning implementation of changes of medicine and adherence to recommendations.

The Group has now been successfully integrated as part of implementation at national level, emphasizing the importance of shared knowledge for efficient implementation of changes of medicines at national scale.

What next?

In future, the Group will increase its focus on identifying differences in treatments based on enhanced utilization of health data.

The Group provides the basis for knowledge sharing and can easily be transferred to other healthcare settings, both nationally and internationally.

A coordinated country approach to hospital pharmacies’ handling of clinical trials and the use of a common national brochure

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European Statement

Introductory Statements and Governance

Author(s)

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

Why was it done?

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

What was done?

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

How was it done?

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

What has been achieved?

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

What next?

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

Creation of an ‘Agrippal’ programme to fight against nosocomial flu

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European Statement

Introductory Statements and Governance

Author(s)

Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy

Why was it done?

The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.

What was done?

Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.

How was it done?

Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.

What has been achieved?

The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.

What next?

This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.

ASfarMA Project. HUMANIZATION OF PHARMACEUTICAL CARE FOR PATIENTS WITH SEVERE ASTHMA

European Statement

Introductory Statements and Governance

Author(s)

Hilario Martinez-Barros, Maria Muñoz-Garcia, David Gonzalez-de-Olano, Silvia Sanchez-Cuellar, Enrique Blitz-Castro, Gonzalo De-los-Santos-Granados, Dario Antolin-Amerigo, Ana de-Andres-Martin, Patricia Fernandez-Martin, Elena Gemeno-lopez, Ana Maria Alvarez-Diaz

Why was it done?

• To understand directly and holistically the patients’ vision of their illness, treatment, healthcare experience and how they impact their daily lives.
• To define the ideal SAU by identifying innovations and changes that satisfy patients’ needs.

What was done?

ASfarMA is a hospital pharmacist-led project within a multidisciplinary Severe Asthma Unit (SAU) that aims to apply different innovative measures encompassing humanization to improve treatment related results and patient experiences.

How was it done?

Human-Centered Design (HCD) is an approach to problem-solving that aims to make systems usable and useful by focusing on the users and their needs.

A core group was constituted with at least one member from each of the specialities that are part of our SAU. Members of an HCD-team devised and contributed to organize the following activities:

  • A first core group session was held in which, using different dynamics, 4 patient archetypes were identified, and the patients´ journey through the Unit was described.
  • HCD-team members interviewed both SAU professionals and 8 patients who matched the previously defined archetypes. The latter was also given a patient diary designed to obtain descriptive and emotional information within the SAU.
  • Utilizing the previously obtained data, a co-creation workshop was held by the HCD-team involving both the core group and the participating patients.

What has been achieved?

A series of proposed measures that respond to patients and professionals’ reported needs were made. They were classified as either “transformative solutions” or “quick wins”:

– 7 transformative solutions, which provide holistic responses that require greater development, effort and resources, were identified. E.g. Two-way communication APP, onboarding kit, design of common spaces for SAU members, patient coordinator.

– 14 quick wins, which provide significant benefits but can be implemented with lesser effort and resources, were identified. E.g. Non-urgent consultation mailbox, pediatric-adult patient transition consultation, asthma-specific emergency department circuits, coordinated consultation agendas between severe asthma unit members, expert patient workshops.

What next?

This project, which has a qualitative nature and is based on the experiences of both patients and professionals, has allowed us to understand their needs and identify innovative solutions that will be applied progressively to our SAU and other hospitals.

HIGH DOSES OF TREPROSTINIL ENTAIL LOWER HOSPITALIZATION COSTS IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION IN NINE EUROPEAN COUNTRIES

European Statement

Introductory Statements and Governance

Author(s)

Irene Lizano, Ferran Montpart, Elisenda Pomares, Guillem Saborit-Canals, Míriam Fernández

Why was it done?

Treprostinil is a prostacyclin analogue indicated for the treatment of PAH. A recent retrospective study analyzed drug safety events observed in the clinical trials of oral and subcutaneous (SC) treprostinil. This analysis showed that higher treprostinil doses were associated with lower PAH-related hospitalization rates, compared to lower doses.

What was done?

To estimate annual pulmonary arterial hypertension (PAH)-related hospitalization costs in patients treated with different treprostinil doses in nine European countries (Belgium, France, Germany, Italy, Poland, Portugal, Spain, The Netherlands and the United Kingdom).

How was it done?

A cost estimation model was developed to calculate hospitalization costs in patients with PAH who were treated with treprostinil at different doses. Annual hospitalization rates were gathered from a retrospective analysis of an oral and SC treprostinil global safety database. Patients were categorized into three groups based on total daily dose: low, medium and high. Low dose was defined as <4.0 and <1.9 mg/day (9.0 and >7.6 mg/day (>30 ng/kg/min). PAH-related hospitalization costs were included and, when not available, heart failure-related costs were considered as it is the main cause of hospitalization in PAH patients. Mean annual hospitalization costs per dose were calculated using annual PAH-related hospitalization rates (0.9 for low dose, 0.4 for medium dose, and 0.3 for high dose) and unit costs per hospitalization in each country. All costs were obtained from national databases or published literature and were expressed in 2021 euros.

What has been achieved?

Mean annual PAH-related hospitalization costs ranged from €1,649 to €8,382 for low dose, from €733 to €3,726 for medium dose, and from €550 to €2,794 for high dose. Thus, hospitalization costs for high-dose patients were 3 times lower than for low-dose patients (mean difference €2,610) and 1.3 times lower than those for medium-dose patients (€435).

What next?

High doses of treprostinil result in lower hospitalization costs than low and medium doses in patients with PAH. Therefore, an appropriate drug titration might lead to potential cost savings in various European settings.

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.

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