Author(s)

CRISTINA GONZALEZ PEREZ, LUCIA GALÁN DAVILA, MARTA ORTIZ PICA, ELENA GARCIA SUAREZ, MARIA MOLINERO MUÑOZ, LIDIA YBAÑEZ GARCIA, NATALIA SANCHE-OCAÑA MARTIN, MARIA DE LA TORRE ORTIZ, JAVIER CORAZON VILLANUEVA, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

Our hospital is a reference in our community for this rare disease. Since patisiran was approved, we have treated 19 patients. Due to the high cost of patisiran and the few patients treated, it is necessary to optimize patient treatments in the most efficient way.

What was done?

Transthyretin (TTR) amyloidosis is a rare disease caused by mutations in the TTR gene. These mutations alter the normal function of TTR protein, creating slowly progressive condition characterized by the buildup of abnormal deposits of amyloid in body’s organs and tissues.
Patisiran is a TTR specific small interfering RNA (siRNA) formulation in lipid nanoparticles, which has been shown to substantially reduce the production of abnormal TTR in patients with hereditary amyloidosis TTR.
With this project we look for achieve the greatest possible savings from patisiran drug without affecting the patient’s efficacy.

How was it done?

We created a working group with neurology department, to define patient’s groups according to:
– Prescribed doses (doses per patient weight; 0.3 mg/kg).
– Preparation’s losses because of the filters
– Losses of the extraction process.
– Other individual conditions as posology or personal preferences.
Patients belonging to the same group have to administrate patisiran the same days.
As the patient’s weight can change along the time, we agree with doctors and nurses to weight the patients every six months to perform doses adjustments. Therefore, every six months we should regroup the patients to optimize the most.

What has been achieved?

These clusters have made possible to reduce wasting vials and therefore to permit significant savings. We estimate around 208.115 € savings/year.

What next?

With this practice we look for a more efficient and sustainable rational health system. The savings achieved can be used to treat other patients or promote new investigations. Also, it makes possible a better healthcare team performance, working together for a better attention, health quality, security, and treatments efficiency. Monitoring weights to adjust doses and closer follow-up of patients by the different members of the multidisciplinary team are examples of the achievements.

Author(s)

Fabrizia Negrini, Giorgia Vella

Why was it done?

The aims of this project were firstly to optimize the content of the stock (choice of medicines and quantity) so that it is suitable for various potential events of different nature that may occur in the region. The second aim was to optimize the management processes in order to reduce costs.

What was done?

To manage extraordinary events (short-lasting phenomenon without contamination) in a region with 1.5 million inhabitants, the hospital pharmacy, in collaboration with a major acute Hospital, manages a designated stock containing medication that may be required during unplanned emergencies.

How was it done?

To achieve these two aims, the first step was to define which major events are possible and most likely to occur in the region. To do this we utilized a risk-based analysis of all disasters and emergencies relevant in the area that was performed by an external company that specializes in developing risk management projects in the context of civil protection1. Based on the identified events, we determined which types of injuries were more likely to occur. The medicine stock was subsequently updated and a process for minimizing the management cost was defined.

What has been achieved?

The hazards that were identified as being of particular importance for the analyzed region are likely to mainly result in blunt, perforating, and burn injuries. In collaboration with the Hospital, a list of 61 different medicines used to treat these types of injuries was established. In order to reduce costs, only drugs which were part of the main stock of the pharmacy were chosen. In this way, it is possible to exchange products with a longer shelf life from the main stock 6 months before expiring and use them without having to discard them.

What next?

In case of extraordinary events in a restricted region, the major acute hospital has an increased need for certain medicines. It is task of the hospital pharmacy to always be ready to supply them with such medicines. This is only possible if the probable emergency scenarios are well understood, and the stock and management processes are well-defined and communicated at all levels.

Author(s)

Andrea Ossato, Giuseppe Giovagnoni, Michele Giannini, Anna Francesca Spada, Francesca Realdon, Valeria Mezzadrelli, Lorenza Cipriano, Nicola Realdon, Teresa Zuppini, Roberto Tessari

Why was it done?

Since 1st October 2019, the regional tissue bank that supplies hospital, stopped sending ready-made tissue to the implant, preferring the shipment of tissues frozen at -80°C. For this reason, the hospital pharmacy developed a procedure for the management of orthopedic allografts ensuring a clear and safe supply chain reducing the waste raised from the obligation of immediate use of the thawed tissue.

What was done?

Hospital pharmacists, in agreement with the hospital administrators and the orthopedic surgery department, developed a new service characterized by procurement, processing, preservation, storage, thawing and preparation of human tissues and cells for orthopedic allografts, according to European and national legislation.

How was it done?

The management of orthopedic allografts took place as follows: was established a dedicated path for communications with orthopedic surgery and bank tissue; tissue thawing and washing was centralized in the clean-room of the hospital pharmacy and were guarantee adequate training of all personnel involved as well as complete standard operating procedure documentation for all stages of the process and appropriate control measures.

What has been achieved?

Evaluation of the process showed that it was favourable in terms of practicality, safety, traceability and cost saving. Especially, the centralization of tissue preparation within clean‐rooms with aseptic technique, allows microbiologically safer setups reducing clinical risk. A further guarantee of safety is given by the sterility process’s validation through Media Fill test. This organisation allowed us to reduce the waste through a more effectively management of the tissues shelf life and any missed surgery with a cost saving and an ethical behaviour.

What next?

Optimise patient outcomes through working collaboratively within multidisciplinary teams and using the limited health systems resources responsibly, are two main goals expressed by the last European Statements of Hospital Pharmacy (ESHP). This study demonstrated how the centralization of tissues management in the hospital pharmacy make the process more efficient and safer and thus comply with the ESHP’s goals; leading to a clinical advantage for patients and better economic impact for the hospital.

Author(s)

Francesco Falbo, Oscar Martinazzoli, Agnese Bruni, Rosanna Lettieri, Simona Polito, Luisa Zampogna, Valentina Marini, Michela Mazzucchelli, Marcello Sottocorno

Why was it done?

The involvement of the pharmacist featured:
– Drug supply and storage
– Medical devices (MD) and personal protective equipment supply
– The creation of a catalog of required drugs
– Medication supply chain management and dispensing
– Management of medical gases
– Evaluation of the effectiveness and safety of drug therapy.

What was done?

As the COVID-19 epidemic spread, temporary critical care hospitals have been opened in order to attend the incoming burden of infected patients. In April 2020, one of the largest ever temporary healthcare structure was created in only 10 days. The ark hospital was opened for nearly 10 months and hospital pharmacists supported the effort for the pharmacy management.

How was it done?

The development of a catalog of required drugs has been accomplished using the consumption analysis on drugs and MD in March 2020 of the permanent hospital Covid unit. Thus, we created a dynamic catalog – constantly updated – consisting of 530 drugs and 345 medical devices. The medical staff members of the temporary hospital filled a special form for extra-catalog material. Running a cost-effectiveness analysis, the pharmacist managed to evaluate the purchase, rather than recommend a valid alternative from the material on the catalog.
The pharmacy warehouse was planned by dividing the MDs categories. Likewise, the drugs were stored according to their pharmaceutical form and their alphabetical order.

What has been achieved?

The materials requirements planning was achieved in 15 days, including medical supply ordering and the pharmacy warehouse organization. Pharmacists ensured the optimization of resources, the availability, safety and optimal use of medicines and MDs, as well as the monitoring of the adverse drug reactions (ADR). Hence, all patients received the appropriate pharmacotherapy. The pharmacist played a key role in the good functioning of the ark hospital in collaboration with all the medical team.

What next?

In conclusion, a new protocol and standard of care for managing health emergency will be the following and challenging step.

Why was it done?

To avoid stock breaks by ensuring at all times the existence of the medicines included in a 2nd level hospital.

What was done?

Optimization of medication management in a Hospital Pharmacy Service (HPS) through the development and use of a purchasing planner.

How was it done?

One obstacle we encountered was knowing the inventory in real time. This required a computer program for stock management, human resources or intelligent warehouses to enable real-time inventory control.
After the training, learning and updating of working procedures, an analysis of the consumption of the drugs included in the pharmacotherapy guide was carried out in order to calculate the minimum stocks, safety stocks, maximum stocks and order points.
Data were loaded into the management software and parameters were defined so that when a drug reached the point of order a purchase proposal would be made until the maximum stock was reached.

What has been achieved?

In February 2020, the purchasing planning system was implemented. The planner’s lists were parameterized to organize the drugs by therapeutic groups or areas of interest within the HPS. In addition, communication among all professionals was enhanced for rapid response to a lack of medication and a periodic inventory counting plan was designed to ensure adequate stock.
After changes, more than 80% of HPS medications are ordered through purchasing planning, reducing stock breaks due to never reaching the safety stock of selected drugs.

What next?

This system is applicable to all HPS that has the same management software. It is necessary to have an optimization system in the drug management to ensure their real stock in the hospital environment and their availability for patients.

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.

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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.