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.

Author(s)

José Luis Revuelta Herrero, Vicente Escudero, Roberto Collado, Belén Marzal, Ana Herranz, María Sanjurjo

Why was it done?

CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. ATMPs are usually associated with strong logistic and traceability requirements, serious adverse events and a high budget impact. Hospital pharmacists can help ensure a safe and efficient use of these drugs.

What was done?

A chimeric antigen receptor (CAR) T cell Therapy Committee was created in 2019 and it included members from the hematology, oncology, pediatric onco-hematology, hospital pharmacy, neurology, critical care medicine and immunology departments. An operating procedure defined the specific functions of the pharmacy department in the management of these drugs in the CAR-T cell program.

How was it done?

As some responsibilities might be shared with other professionals, it was key to define everyone’s contributions. In our case, an operating procedure with the responsibilities of the pharmacy department was developed based on the national and regional action plans for ATMPs in the national health system and the risk management plans for each drug. This operating procedure was reviewed and approved by the Committee.

What has been achieved?

The operating procedure was fully implemented and included the participation of hospital pharmacists in the following steps:
• Procurement: the inclusion of a patient in the program is agreed upon the Committee. The pharmacists provide a purchase order when all the requirements are met.
• Leukapheresis and shipment to the manufacturer: the apheresis is included in the computerized physician order entry (CPOE) and it is verified to confirm wash-out periods. Before the shipment, the pharmacists record the apheresis unique identifier and patient data.
• Product receipt: the pharmacists verify at receipt that the patient identity chain and the integrity of the product have been preserved.
• Bridge and lymphodepleting chemotherapy, CAR-T administration: specific protocols have been included in the CPOE. Prescriptions are verified by the pharmacists with special attention to the drug-free periods. After transporting the drug to the clinical unit and preparation, a pharmacy label for dispensing and administration is generated. This label includes a barcode for patient identity verification at bedside.
• Outcomes monitoring and pharmacovigilance: kits are provided to the clinical units for the management of CAR-T associated toxicities. Pharmacists are responsible for the adverse reactions reporting in coordination with clinicians.

What next?

We developed verification lists for each of the previous steps that have already been published (DOI: 10.3389/fonc.2021.636068). More ATMPs are expected to come and their management will require the participation of hospital pharmacists from different areas of expertise (procurement, clinical pharmacy, compounding etc).

Author(s)

MV VILLACAÑAS PALOMARES, CM VALENCIA SOTO, A GARCIA-AVELLO FERNANDEZ-CUETO, M MARTIN LOPEZ, S BARBADILLO VILLANUEVA, M OCHAGAVIA SUFRATEGUI, V MARTINEZ CALLEJO, M RIOJA CARRERA, P DEL RIO ORTEGA, M VALERO DOMINGUEZ

Why was it done?

This drug is administered continuously during a 28 days infusion. Due to the risk of cytokine release syndrome (CRS) it is initially administered in the inpatient setting and then transitioned to the outpatient, requiring an important interdisciplinary coordination to optimize the process.
Home-based chemotherapy offers several potential benefits: reduced exposure to hospital infections, less disruption of routine and family life, lower health care cost, …

What was done?

Pharmacy and haematology services designed a workflow for the outpatient administration of blinatumomab, a bispecific T-cell engager approved for relapsed ALL.
Here, we describe our experience transitioning from inpatient to outpatient setting.

How was it done?

First step was to review blinatumomab stability, as well as material compatibility and transfer set necessaries for both hospital and domiciliary administration.
Reconstituted blinatumomab may be stored at refrigerated (2-8°C) for up to 24 hours. Prepared infusion bag (with preservative) may be stored at room temperature (up to 27°C) for up to 96 h and for up to 10 days refrigerated (2-8ºC).
Second step was to establish with the haematology service the patient´s scheduled visits to the hospital to ensure maximum stability of the blinatumomab preparation.
We decided to prepare the blinatumomab infusion bag every three- or four-days beginning on Monday, Thursday or Friday avoiding visits on weekends.
In order to take advantage of the rest of the vial, we diluted itn a new bag with stabilizer solution but without in-line filter for the next preparation. We noted the date of elaboration and the amount of medication remaining.
We used this preparation initial in each new visit add the dose necessary and an in-line filter. We primed the filter with the prepared solution for infusion

What has been achieved?

Out of the four patients who have received blinatumomab in our hospital(May 2020 – September 2021), three have benefited from this circuit.18 doses were administered at home, avoiding 68 days of hospital admission.

What next?

Outpatient administration could reduce health expenditure, therefore allowing for additional investments in new therapies.
Since the use of blinatumomab is not very common and there is not much evidence at this respect, our experience can help other Pharmacy Services to implement this circuit.

Author(s)

Mikala Vasehus Holck, Jette Østergaard Rathe

Why was it done?

The role of the National Medicines Council (NMC) is to provide guidance about new medicines for use in the public hospital sector.

Recommendations from the NMC must be implemented at hospitals. Implementation of changes of medicines requires preparation and collaboration and involves numerous stakeholders, e.g. drug and therapeutic committees, hospital pharmacies, clinicians, and the national supply organization (NSO) to public hospitals. Knowledge sharing is crucial to ensure efficient implementation.

We needed a workflow focusing on knowledge sharing at national level, and thus we introduced the structured implementation workflow in September 2019.

What was done?

We have established a structured implementation workflow focusing on knowledge sharing. The workflow ensures rapid and efficient implementation of changes of medicines, and a more aligned treatment at national level.

How was it done?

To ensure knowledge sharing through the workflow, we developed:

– Implementation memo: Summarizes NMC recommendations and treatment guidelines, with information about current and upcoming tendering procedures and prices. The memo is shared with the stakeholders.

– Implementation group: The group is a mix of people with a direct connection to the implementation workflow. The group ensures that implementation of the recommendations from the NMC is regularly discussed and assessed.

– Implementation site: An intranet for the NSO and hospital pharmacies to share information and material related to the implementation of changes of medicines.

– A system to ensure that essential stakeholders receive the same information.

What has been achieved?

The structured implementation workflow has been a success and is now an integrated part of implementation. Evaluation shows that the workflow with knowledge sharing between relevant stakeholders is essential for effective implementation of changes of medicines, and it identifies discrepancies at national level.

What next?

The structured workflow is an integral part of managing the national implementation, and the workflow and outcomes will continue to undergo evaluation.

The workflow provides the basis for knowledge sharing and can easily be transferred to other healthcare settings.

Pdf

Author(s)

ARDIZONE BEATRIZ, MARTA HERNÁNDEZ SEGURADO, MARÍA FORTE PÉREZ-MINAYO, LAURA GARCÍA JIMÉNEZ, ELENA TORTAJADA ESTEBAN, ANA CORDERO GUIJARRO, NATALIA BARRERAS RUIZ, LAURA JIMÉNEZ NAVARRO, JAVIER BÉCARES MARTÍNEZ

Why was it done?

First, we had a high number of patient inquiries by phone and by email. Furthermore, patient queries related with their treatment and their resolution were not recorded in the electronic clinical history. Finally, we needed a communication platform that would guarantee personal data privacy.

What was done?

In collaboration with the IT department, we developed a software tool called “Web Dialogue” within the e-health portal of our institution. This tool allows the patients to communicate with the pharmacist using a chat box where they can write queries about drug interactions, adverse effects and any questions about the hospital dispensing treatments, as well as other medications and herbal products. A pharmacist answers the queries within 24 hours, from Monday to Friday.

How was it done?

We asked the IT department to activate this tool for all active patients to whom we dispensed medication in our service (a total of 8000 patients). The development lasted 2 years (2017-2019), but it was not until March 2020, with the start of the COVID-19 pandemic, that the “Web Dialogue” began to be used by our patients more widely. We also made an informative video that was posted on the e-health portal in order to achieve a wider knowledge of this tool among patients. See link: https://www.youtube.com/watch?v=_Z9pd93sNY8

What has been achieved?

The median number of messages per month in 2020-2021 was 202 (IQR= 100,5; 468). At the beginning of the state of alarm in Spain there was a peak in the use of the “Web Dialogue”, mainly to query about how to access the medication (94% of the queries). Over the following months, the proportion of these consultations decreased and consultations regarding doubts about treatment, adverse effects and drug interactions increased. Furthermore, the Net Promoter Score (NPS), an indicator that allows us to measure the satisfaction of patients, shows that in the last year we have achieved, for the first time, a score over 60, which is considered excellent.

What next?

Some of our ideas for the future are: the possibility of selecting the type of inquiry and the interlocutor by the patient, creating algorithms for the automatic response of certain questions and carrying out Big Data research studies.

Author(s)

PILAR PACHECO, MIGUEL ÁNGEL CARVAJAL, JAVIER IBAÑEZ, LYDIA FRUCTUOSO, PAULA TORRANO, MARIA HERNÁNDEZ, JUAN ANTONIO GUTIERREZ, JOAQUIN PLAZA

Why was it done?

Since the covid 19 pandemic, the hospital environment has become a place of risk, especially for the oncological and immuno-depressed patient, so it is important to reduce the exposure of the patient and the risk of covid19 infection.

What was done?

The pharmacy service (PS) has designed this new delivery circuit for supportive treatment (master suspension formula for mucositis and colony-stimulating factors) with the aim of reducing the risk of Covid-19 infection associated with the hospital environment.

How was it done?

The circuit and the main stages are:
1. The MDH orderly comes to the PS to deposit the medical prescriptions of the patients who are receiving treatment at that time.
2. The PT prepares the treatment of each patient, always checking that prescriptions and the date of the current day. If it is a continuation of treatment, the PT will verify that the same dose is maintained and will proceed to dispense the medication with the dispensing program. If it is a new treatment or a change in dose, the PT will notify the pharmacist so that he must validate the prescription first and then the PT can dispense it.
3. The prepared medication, together with its information sheet, is placed in bags that are identified with the patient’s name pending let the orderly come to remove them.

What has been achieved?

The circuit was implemented in January 2021, after analyzing the risks that excessive wandering around the hospital poses for immunosuppressed patients, including stays in the PS waiting room.

Since the implantation of the circuit, have been dispensed: 43 suspension formula for mucositis, 25 filgrastim, 12 darbepoetin and 11 pegfilgrastim. So far, the circuit has operated in a coordinated way, contributing to the improvement patient care, avoiding wandering through crowded areas, without giving up individualized care.

What next?

The fact of preventing patients from going to the pharmacy waiting room to withdraw their support treatment, which in most cases they carry continuously and know very well, supposes a decrease in hospital ambulation and thus reduces the risk of infection by covid 19.

Author(s)

Natalia Toledo Noda, Víctor Quesada Marqués, María Leonor Oliva Hernández, Nayra Sangil Monroy, Marta María Piñero González, María Victoria Morales León

Why was it done?

The implementation would allow access to this novel therapy to patients who have already exhausted all lines of treatment. The Ministry of Health decides to establish an administration point in the hospital, since due to its geographical location (European ultra-periphery) it would avoid the transfer of patients to other reference centers.

What was done?

Development and implementation of a CAR-T cell therapy administration program in adults.

How was it done?

In November 2018, the Ministry of Health authorized the center to use CAR-T treatment in adult patients with relapsed or refractory diffuse large B-cell lymphoma or with B-cell acute lymphoblastic leukemia. The hospital was prepared to meet specific quality criteria (JACIE Accreditation). Interhospital protocols were developed for the referral, transport, and study of candidate patients from other centers.

What has been achieved?

1. A multidisciplinary team was created made up of professionals from Hematology, Intensive Care Medicine, Neurology and Pharmacy Services, with the aim of assessing candidate patients. A qualified team oversees the clinical management, follow-up, analysis of adverse effects and results obtained.
2. The professionals involved were trained to ensure safe administration and to identify and treat possible complications.
3. Due to the special storage conditions of the drug, a circuit was established. It is storage in the Hematology Service under the supervision of the hospital pharmacist specialized in onco-hematology.
4. One of the most frequent complications of the therapy is cytokine release syndrome. Depending on the gravity, drugs such as tocilizumab should be given as soon as possible. To ensure its availability, the Pharmacy Service permanently reserves two doses. At the time of performing a CAR-T, the automated dispensing system of the hematology ward is provided with the first dose, along with a preparation sheet and its corresponding label in order not to delay its administration. The second dose remains in the Pharmacy Service.

To date, 8 infusions have been made. 100% of the patients had diffuse large B-cell non-Hodgkin lymphoma.

What next?

Facilitate access to this therapy to more patients. Generate data that support its efficacy and safety in real life.
Obtain the accreditation of the center to use the new therapies authorized by the European Medicines Agency.

Author(s)

Andreia Fernandes, Mafalda Brito, Tatiana Mendes, Armando Alcobia

Why was it done?

Many patients had their health care needs compromised due to accessibility issues. They could not come to the PS because of the mandatory confinement, prophylactic isolation and medical indication.

What was done?

In the context of the Covid 19 pandemic, between April and June 2020, pharmaceutical Services (PS) instituted several alternatives delivery processes that guaranteed patients’ access to the medication, usually provided on the PS.

How was it done?

Pre-existing accessibility projects to deliver medication in community and hospital pharmacies have been adopted. In order to respond to all requests, new ways and protocols of medication distribution/delivery, like city hall transport, courier services and humanitarian aid (for example, motards), were created. For all deliveries outside PS, pharmaceutical telephone follow-up (teleconsultation) was realized.

What has been achieved?

7448 medication dispensations were registered, of which 80.7% were realized in person in the hospital PS (n = 6679). In the homolog period, 10621 dispensations were registered, of which 95.9% were in person (n = 10183).
438 deliveries were sent to community pharmacies, a total of 219 patients (54.3% female, maximum age 100, minimum 9 years). 41% increase compared to 2019. 198 shipments were realized to different hospitals and others healthcare units, corresponding to 120 patients (56 female, maximum age 85, minimum 8 years). 25% increase over the previous year.
New alternatives: City Hall 66 deliveries for 62 patients (58.0% female, minimum age 18, maximum 97 years), other deliveries 35 users (50.7% male, maximum age 94 and minimum age 10 years).

What next?

The Covid-19 pandemic triggered a need for adaptive evolution of pre-existing accessibility projects, but also the creation of new protocols and alternative means to respond to all patients who may have their healthcare compromised due to accessibility issues. The positive points were the implementation speed, maintenance of adherence to therapy (teleconsultation), traceability, reduced costs, synergy between patients/associations/pharmacists/healthcare professionals and a high degree of satisfaction. In spite of some limitations (dependent on volunteering; need for human resources; structured communication) we aspire to improve the new approaches of medication delivery on a nation level.

Pdf

Author(s)

Hana Sakly

Why was it done?

The pharmacy must assess its own activity in order to better manage, to structure, respond to needs. This assessment is necessary in order to measure the productivity.

What was done?

The purpose of our work is to identify the key performance indicators for management and piloting a hospital pharmacy. The aim is to develop dashboards, a real management tool, for the management and monitoring of pharmaceutical activities in order to optimize performance and ensure continuous improvement.

How was it done?

The methodological basis of our study is based on a process-based management of hospital pharmaceutical activities. Our target is to achieve the same approach to these processes, within the various functional and concerned units, in order to harmonize and simplify the quantitative and qualitative monitoring of pharmaceutical activities.

What has been achieved?

Macroscopic cartography of pharmacy processes was established and the most critical processes were selected on the basis of a matrix. In total, eight key processes have been identified. The identity cards for these processes have been drawn up. Quality indicators have been identified. These indicators are intended to assess and monitor the processes. A first design of dashboards with the elements collected was proposed. This dashboard could evolve during the implementation of this project within the Pharmacy department.

What next?

These dashboards have to be finalized, validated and officially put into practice within the Pharmacy department. This methodology must be applied to the discipline of Clinical Pharmacy. Quantitative and qualitative assessment of the activities carried out within the pharmacy should be a subject for priority debate at the national level to finally find agreement on a relevant measurement tool.

Pdf

Author(s)

Martina Jeske, Jasmin Stoll, Vanessa Funder, Sabine Bischinger

Why was it done?

Due to the limited number of ports, it is necessary to administer several drug solutions via the same access. Incompatibility reactions can occur and may lead to a reduction or loss of drug efficacy and severe damage to the patient’s health. The objective was to create standardized administration protocols for central venous catheters and verify parenterally administered drugs’ incompatibility reactions. A further purpose was to build multidisciplinary cooperation to improve the drug administration processes.

What was done?

To optimize the drug therapy at four intensive care units (ICUs) of the University Hospital, the pharmacy department, physicians, and care management, jointly implemented a quality assurance project. In multidisciplinary teams, we had to overcome various challenges in different wards to develop standards regarding administering drugs via multi-lumen catheters. We analyzed all frequently used drugs (n=72) for their compatibility and summarized findings in a crosstable.

How was it done?

The current situation was recorded using a questionnaire and collecting individual cases of protocols for central vein catheters. About 2000 drug-drug-combinations were analyzed using three databases, KiK 5.1, Micromedex, Stabilis 4.0, corresponding specialist information, and manufacturer data. Nevertheless, the compatibility check based on the databases is subject to some restrictions. In several cases, the databases give different or contradictory results, and compatibility data are rarely available for some combinations. The project revealed that although infusion therapy is standardized in intensive care units, there are fewer standards regarding administering drugs via multi-lumen catheters. There are significant differences between theory and practice in terms of handling infusion therapy.

What has been achieved?

Different hazardous practices got identified and eradicated. The incompatibility table allows a quick assessment. The advantages/disadvantages of varying software systems were broadly discussed. KiK 5.1 was implemented in the ICUs, Micromedex in the pharmacy department. The team agreed that existing uncertainties must be decided jointly. Different practices in different wards may pose a threat to patient safety. The results were presented in a clinic-wide interdisciplinary training.

What next?

The awareness towards the need for cooperation and hospital pharmacists’ competence concerning incompatibility reactions strongly increased, leading to more standardization in the infusion therapy and avoiding incompatible drug combinations. The aim is to initiate a continuous improvement process.