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)

Nikolaus Lindner, Katharina Heitzeneder, Nora Hummer, Elisenda Pichler, Doris Haider

Why was it done?

Due to the lack of long-term safety data, the principal goal was to assure a safe and effective use of the available vaccines by coordinating stringent logistical operating procedures as well as by facilitating early detection and evaluation of possible safety signals. A further objective of this initiative was to increase the awareness among healthcare workers regarding the possible health risks associated with a SARS-CoV-2 infection and Covid-19 vaccines as preventable countermeasures.

What was done?

A Covid-19 vaccination pharmacovigilance campaign was implemented in a clinical setting with the focus on patient safety and quality assurance as part of an employee vaccination rollout. The pharmacy department set up a pharmacovigilance service-point to assess vaccine safety as well as potential adverse events and assure patient care by close follow up.

How was it done?

Assessing and reacting to individual safety signals on time represented a critical challenge. Pharmacists designed questionnaires capturing possible adverse events. In order to lower the barriers for participation it was decided to take a paper-based approach instead of electronic distribution. A pharmacovigilance service-point was continuously managed by two pharmacists directly at the vaccination site to achieve a high response rate. Throughout the campaign the completed questionnaires were simultaneously evaluated, as rapid action was key to detect safety signals early and implement measures accordingly.

What has been achieved?

The results showed a high response rate to the questionnaire of 95% and 53% after the first and second dose, respectively. A significant increase of symptoms after the second dose compared to the first dose reflected the findings of the marketing authorisation study. Based on the analysis no further safety precautions were needed. However, appointments before night or weekend shifts had to be discouraged as well as the vaccination of the whole staff from one department on the same day. As a result, disruptions to patient care could be avoided successfully.

What next?

This initiative serves as a valuable model for upcoming vaccination campaigns and especially for pharmacovigilance projects aiming to assess adverse events of recently approved medicines. Moreover, the successfully implemented multi-disciplinary approach represents the basis for further hospital-wide pharmacy projects and may facilitate the implementation of pharmacist-provided vaccination services.

Author(s)

Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer

Why was it done?

The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.

What was done?

In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.

How was it done?

First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.

What has been achieved?

The results show significant impact of this education session on all items especially those regarding the implants and medicines.

What next?

Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.

Author(s)

Charlotte Stafford, Aoife Delaney, Virginia Silvari, Thomas Cronin, Deirdre Lynch

Why was it done?

The Pharmacy Department dispenses clozapine to 142 patients. A new prescription was issued each time a patient was dispensed clozapine (approximately 40 new prescriptions per week). From January 2019 to June 2020 there were 42 clozapine incidents (incidents/month= 2) reported by the Pharmacy Department to the MHU. A four week review also showed that prescription queries (dose changes and transcription errors) consumed 6 hours of pharmacy staff time. The new 6-monthly, electronically stored prescription and the dedicated email address should address these issues.

What was done?

A newly devised proforma clozapine prescription has been developed by the Pharmacy Department and has become valid for 6 months for patients on 4-weekly blood monitoring. A copy of each patient’s prescription is stored electronically in the Mental Health Unit (MHU) share drive. A new dedicated pharmacy clozapine email address has been generated for all clozapine dose changes to be communicated to.

How was it done?

Four new clozapine prescriptions were developed by the Pharmacy Department:
– a maintenance dose prescription
– standard titration days 1 to 8
– standard titration days 8 to 15
– blank titration prescription.
The new prescriptions for patients on 4-weekly blood monitoring, valid for 6 months, are now stored in the MHU share drive to reduce the risk of transcribing errors.

What has been achieved?

Once the new system had been established, a further 4 week review showed that only 10 minutes over 4 weeks was spent by pharmacy staff dealing with a prescription query. All dose changes were now communicated by email. Incident reporting has decreased, with 5 clozapine incidents being reported by the Pharmacy Department between January to June 2021 (incident/month <1).

What next?

A business case highlighting the importance of a dedicated Clozapine Pharmacist has been submitted to further develop the clinic and ensure safety of this vulnerable cohort of patients.

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)

JUDIT PERALES PASCUAL, HERMINIA NAVARRO AZNAREZ, ANA LOPEZ PEREZ, LUCIA CAZORLA PODEROSO, IRENE AGUILO LAFARGA, ANA PEÑAS FERNANDEZ, Mª REYES ABAD SAZATORNIL

Why was it done?

Despite the volume of patients seen at UPEX, the complexity of care and the cost of the treatments, in 2019 the prescription was transcribed by pharmacists with the consequent risk/investment of time that this entails. The aim was to incorporate organizational/technological changes that would improve the safety and quality of pharmaceutical care.

What was done?

An outpatient is a patient who goes to the outpatient unit of their Hospital Pharmacy Service (UPEX) to collect a drug for hospital use/diagnosis or foreign drug (it will be administered without health personnel intervention).
We collaborated in the design and validation of the PresSalud®(Dominion®) program, developing the implementation of assisted electronic prescribing (AEP) as an objective in the SAMPA project (Registration and Promotion Service for Adherence to Medications for Elderly Patients).

How was it done?

Access from the electronic medical record to the prescription, the integration of the latter with the dispensing program and the latter with the pharmacy item program guarantees an increase in the safety of medication use by incorporating clinical decision aids.
Different prescription assistance protocols were developed. Presentations and sessions were given to hospital doctors explaining how to prescribe through PresSalud® adapting them to the different services implemented with AEP.

What has been achieved?

In 2018, the AEP was implemented in the infectious, digestive, dermatology, rheumatology, neurology and hematology service (only in hemophilia consultations). Between May-September 2020, it was expanded. It is currently 92.3% implemented and 100% is expected by the end of 2021 (with the rest hematology consultations).

Currently, the percentage of prescriptions to outpatients using AEP with respect to the total prescriptions in this area is 83%; this increase contributes to avoid errors in transcription and to reduce the time spent in checking the prescription, providing greater safety in the use of the medication and better patient care which translates into higher quality of care.

What next?

The implementation of the AEP guarantees safe and efficient prescription; in short, the organizational/technological changes that this entails contribute to improving the quality of pharmaceutical care received by the patient. The proposed solution can be easily extended to other hospitals implementing AEP.

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)

JUDIT PERALES PASCUAL, ANA PÉREZ LÓPEZ, HERMINIA NAVARRO AZNAREZ, ELENA HERRANZ BAYO, MARIA PEREZ MORENO, CARLOS-IGNACIO DIAZ CALDERON HORCADA, Mª REYES ABAD SAZATORNIL

Why was it done?

In 2019 the UPEX attended a large volume of patients without a scheduled appointment, long waits were generated and the pharmacotherapeutic follow-up was complicated. The purpose was to implement an appointment management module to avoid crowds, excessive waiting times, allowing better organizational management of care and knowledge of patients in each type of consultation.

What was done?

An outpatient is a patient who goes to the outpatient unit of their Hospital Pharmacy Service to collect a drug for hospital use/diagnosis or foreign drug (it will be administered without health personnel intervention).

An appointment management system was implemented in accordance with the objectives of the SAMPA project (Service for Registration and Promotion of Adherence to Medicines for Elderly Patients), included in the European STOPandGo project.

How was it done?

Creating a cross-cutting system for the entire clinical circuit from prescription to dispensing involved a great deal computer involvement. Although it began to be used in November 2018, it was not used by the mostly part of prescribing doctors until the end of 2020.
Now, when the patient leaves medical consultation, he/she will go to the pharmacy and will be seen by a pharmacist. Besides, the program will propose a return appointment when it calculates that the patient has a week’s worth of medication, thus preventing the patient from running out of medication. The pharmacist will decide if the patient needs pharmacotherapeutic follow-up.

What has been achieved?

In 2019, 5 services cited patients while in 2020 it was 14; the percentage of patients attending pharmacy cited increased from 73.2%(2019) to 79.4%(2020).
Currently, the pharmacist knows in advance which scheduled patients he has and can establish a better organizational care management and determine in advance if the patient needs a close pharmacotherapeutic follow-up. Additionally, with this system an average waiting time of 03:55min was achieved (in 2019 appointments with waits >30min were recorded).

What next?

The implementation of the appointment management system has made possible to achieve better organizational management of care,avoid crowds,excessive waiting times, and provide better patient care and pharmacotherapeutic follow-up. The proposed solution can be extended to other hospitals.

Author(s)

SILVIA BOULLOSA LALE, Fernando Bustelo Paz, Claudia Barca Diez, María Francisca Fernández Ribeiro, Lara González Freire, Susana Castro Luaces, Irea Celtia Proupín Cantelar, Carlos Crespo Diz

Why was it done?

The aim of this study is to evaluate the use, duration and safety of palbociclib treatment in real clinical practice in our healthcare area.

What was done?

Palbociclib is a cyclin-dependent kinase 4/6 inhibitor indicated for the treatment of metastatic breast cancer(MBC).

How was it done?

Retrospective observational study. All patients treated with palbociclib between June 2016-March 2021 were included.
Data collection was carried out using the electronic medical record and the pharmacotherapeutic management software application.
The variables collected were: gender, age, metastases, initial date, first/second line of treatment, concomitant treatment, delay of treatment, reason for dose reduction and for discontinuation of treatment.
Neutropenia was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE)4.0.

What has been achieved?

Data from 47 patients was collected, 100% were women. Median age: 60(33-85) years. 100% of patients were diagnosed with MBC:51.1%(24) visceral metastases.
Palbociclib was administered in 36.2%(17) of patients concomitantly with an aromatase inhibitor as first line of hormonal treatment for metastatic disease. 63.8%(30) of patients had already received prior hormonal therapy.
A first dose reduction was required in 42,5%(20) of patients, followed by a second reduction to 75 mg in 37.5%(6) of them. These reductions were due to grade 4 neutropenia in 19.2%(5) of patients and recurrent grade 3 in 80.8% (21). All neutropenias resolved after the respective reductions.
Treatment was definitively discontinued in 76.6%(36) of patients: 77.8% (28) due to progression; 13.9% (5) due to neutropenia; 5.5% (2) due to neutropenia and anaemia; and in 2.8%(1) of the patients the previous line of treatment was restarted for non-compliance.
Median overall progression free survival (PFS) was 11.23 months(CI95%:5.76-30.66).
Median PFS in the first-line treatment group was 30.66 months (CI95%:8.33-34.20). In second line it was 9.1 months(CI95%: 5.76-20.83). No statistically significant differences were shown (p=0.2).

What next?

The profile of palbociclib use in our area is predominant in second line treatment for MBC. The PFS achieved did not show any significant differences between second or first line.
The observed treatment duration was longer in patients who discontinued the treatment due to progression versus toxicity.
It is a safe drug: neutropenia, the most frequent cause of treatment reduction/discontinuation, is in all cases transient.

Author(s)

Ghalib Abbasi

Why was it done?

As we venture into the 2020s, health-system pharmacies need to consider these novel approaches to deliver pharmaceutical care to their patients given the changing population needs, lifestyles, and available home technologies accessible to most patients. The ultimate goals are to enhance patient safety, increase hospital pharmacy operational efficiency, and maximize revenue.

What was done?

Novel technologies were implemented at Houston Methodist to enhance patient safety and experience. These include voice-activated devices in patient rooms, smart glasses for pharmacists, smart phones for hospital pharmacy service provision, artificial intelligence, and tele-health

How was it done?

Careful infrastructure considerations/build took place along with pharmacist-driven algorithm write-up. During this GPI, we’d like to discuss specific steps to make this happen along with sensible benefits we realized from implementing each technology.

What has been achieved?

Our hospital pharmacists got significantly more involved in direct patient care where notable efficiencies were realized on the operational side. In addition, medication education was significantly enhanced with improved patient access to their in-house hospital pharmacist.

What next?

Next steps include deploying these these technologies to further service lines and patient care areas, as well as investing into further meaningful technologies. We’ll review what’s in the pipeline as well.