Author(s)

Nina RANJIT, Matthieu GALLET, Anthony TRIPLET, Myriam QUERMONNE , Alexandre COCHET

Why was it done?

The rise of RLT is seeing the emergence of new treatments, using radioisotopes such as 177Lu or 223Ra. The radioactive nature of these treatments raises questions from patients. The aim of pharmaceutical consultations (PCs) is to respond to them by providing appropriate information on treatment modalities, adverse effects (AEs) and radiation protection rules. Thus, we carry out a PC at the initiation of an RIV for all new patients from January 2022 for PLUVICTO.

What was done?

Radioligand therapy (RLT) consists of the administration of a radioactive drug. It makes it possible to treat cancer patients by specifically targeting tumour cells and destroying them using ionising radiation.
These particular treatments raise questions from patients. This is why we have implemented pharmaceutical interviews since 2022 and the beginning of RLT by PLUVICTO® during the first treatment, for all patients concerned. Subsequently, these consultations were extended to other therapies (lutathera, xofigo).

How was it done?

Before initiating RLT to a new patient, radiopharmacists check the eligibility of patients and the conformity of the indication. A few days before the first treatment, the patient’s file is consulted and important information is noted (urinary or fecal incontinence, digestive problems, biological assessment, co-medications). The day of the treatment, a personalized care plan is drawn up by the radiopharmacist and an information sheet bringing together information on the treatment (interval of treatments, dose, etc.), side effects and their management and the rules of radiation protection are provided. to the patient.

What has been achieved?

Collaboration with nuclear doctors has been set up to optimise patient care and information.
When necessary, pharmaceutical interventions are formulated directly to the clinician and plotted in a table.
Facing the success of these PCs we implement them for lutathera and xofigo, the two other RLT available.
In case of side effects, we also declare it to the pharmacovigilance service and give advice to patients and/or clinicians for manage them.
All documents are recorded in the computerised patient file.

What next?

The next step is to evaluate patient’s comprehension before the first interview to adapt its content to the patient.
We also would like to evaluate the patient’s satisfaction and expectations.
Discussions are underway to financially promote these tripartite consultations as exists for oral chemotherapy consultations.

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Author(s)

Almudena Ribed, Alvaro Gimenez-Manzorro, Beatriz Torroba-Sanz, Ana De Lorenzo-Pinto, Maite Portas-Gonzalez, Maria Dolores Ginel-Feito, Pilar Cabrerizo-Torrente, Maria Luisa Martin-Barbero, Ana Herranz-Alonso, Javier Hortal-Iglesias, María Sanjurjo-Saez

Why was it done?

There is a high prevalence of medication errors in the perioperative setting. Health organizations highlight the need for effective practices to ensure safe medication use. A group of pharmacists, surgeons, anaesthesiologists, nurses, and IT technicians coordinated by the management was formed in 2020. Failure mode and effects analysis (FMEA) of the perioperative use of drugs was performed in 2021. The group detected up to 25 failure modes and conducted a bibliographic review to gather and prioritise the implementation of safety practices.

What was done?

We re-engineered the process of medication use in the perioperative setting, from pre-admission to discharge, and implemented safety practices to improve safe medication use in the daily practice.

How was it done?

Obstacles were overcome as a result of the multidisciplinary teamwork, management support and the safety culture existing in our hospital. In addition, we listened to health professionals’ opinions, provided monthly information sessions in the Anaesthesia and Pharmacist Department in 2022 and disseminated information through the hospital website.

What has been achieved?

Eight safety practices were implemented in daily practice:
1.Eight safety practices were implemented in daily practice:
1. Implementation of automated dispensing cabinets.
2. Identification and recommendations for high risk drugs.
3. Standardisation of anaesthesia and difficult airway trolleys.
4. Preparation of general anaesthesia trays with ready to administer drugs.
5. Design, development, and implementation of a one-step computerised provider order entry (CPOE) in the operating room, with bar code administration technology.
6. Implementation of a pharmaceutical care programme for surgical patients based on medication reconciliation in all transitions of care.
7. Implementation of new alerts in the clinical decision support system linked to the CPOE to improve pain, anticoagulation, and antibiotic management in the surgical patient during follow-up.
8. Development of new protocols for perioperative management of chronic medications, anticoagulation, diabetes, and antibiotic prophylaxis in the surgical setting.

What next?

The new medication-use process describes a practical and real approach to promote perioperative patient safety in the daily practice. Transfer into other centres is achievable by motivating healthcare professionals, engaging in safety culture and creating multidisciplinary alliances. There is a need to assess the impact and evaluate these safety practices to ensure ongoing improvement.

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Author(s)

Ann-Marie Goacher

Why was it done?

To add expert pharmacy skills to the uveitis MDT. Provide pharmacist led improved education, compliance, monitoring, follow up and access via helpline for uveitis patients on immunosuppression.

What was done?

Expansion of the uveitis (MDT) service to include a specialist pharmacist

How was it done?

COVID allowed us to pilot an innovative service enhancing uveitis patient care. An MDT was established consisting of a specialist consultant, two specialist doctors, optometrist and expert pharmacist in ophthalmology (EPO). The EPO supports weekly MDT sessions through establishing a patient helpline, standardised recorded counselling and on-going follow up of pharmaceutical needs of new and established patients. The main challenge was to obtain funding to maintain this service post COVID. Clinic space remains a challenge due to the limits imposed by the availability of rooms.

What has been achieved?

This innovative pharmacy service provides a blueprint for other specialities to incorporate expert pharmacy skills into the direct care of outpatients. Integration of the EPO into the uveitis MDT benefits clinicians by redirecting prescribing workload, reducing patient enquiries, improvements in clinic flow by moving patient counselling to the EPO and patient safety through instant access to pharmaceutical specialist knowledge. Initial informal MDT feedback has been positive.
Patients profit from access to EPO via the patient helpline. Analysis of 900 emails received over a 2-year period showed the main reasons patients contacted us were for enquires related to blood tests, medication supply, appointments, side effects, worsening symptoms and confirming instructions regarding medication. Feedback from a patient satisfaction survey overall was positive. Patients were asked to rate the service between 1 (poor) and 5 (excellent), with 31 patients responding. The results show access to the team was rated 4.6/5, satisfaction with the speed of the response was 4.29/5 and the quality of response was rated 4.48/5.

What next?

Improved IT databases is something for review, the main barrier being funding. This would make recording and auditing of patient interactions and data more robust. In the future I would like to see national guidance that recommends pharmacists as part of the uveitis MDT as standard.

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Author(s)

Lucija Tominović Gjivić, Gabrijela Kos, Anita Šimić

Why was it done?

In order to ensure correct use of voretigene neparvovec and minimise the risks associated with its administration, the product can be distributed only through treatment centres where qualified staff (vitreoretinal surgeons and pharmacists) have participated in the mandatory risk management plan (RMP) education program required by EMA.
Since voretigene neparvovec has to be transported and stored frozen at ≤-65 ºC, has short shelf life after dilution (4 hours), contains genetically modified organisms and must be handled according to local biosafety guidelines, there was a need for establishing standard operating procedures (SOPs) for each step of the treatment process.

What was done?

The University Eye Clinic, University Hospital Sveti Duh in Zagreb, Croatia, was designated as the world’s 6th gene therapy centre in 2020.
Hospital pharmacists, as part of a multidisciplinary team, play an important role in preparation and administration of the gene therapy product voretigene neparvovec which is indicated for the treatment of patients with vision loss due to inherited retinal dystrophy caused by biallelic RPE65 (retinal pigment epithelium-specific 65 kilodalton protein) mutations.

How was it done?

The multidisciplinary team consists of a paediatric ophthalmologist, an inherited retinal disease specialist, retinal surgeons, pharmacists and nurses.
SOPs were created for: ordering process, storage of the product, coordination between members of the multidisciplinary team, preparation of the product, administration and disposal of waste.
Preparation of voretigene neparvovec is performed under aseptic conditions in a Class II vertical laminar flow biological safety cabinet (BSC) according to Pharmacy Manual which was ensured by the manufacturer.

What has been achieved?

Since 2020. there had been 47 dose applications of voretigene neparvovec (26 patients, Croatian and nonCroatian citizens).
The prevalence of inherited retinal dystrophy associated with biallelic RPE65 mutation is 1:200 000 and it is expected that there are 19 individuals (population of 3,8, million) with biallelic RPE65 mutation in Croatia, and 13 of them were detected since 2020.
There were no registered side effects which could be associated with errors during the preparation or administration of voretigene neparvovec.

What next?

With the increasing number of gene and cell-based therapies, the need for continuous education of hospital pharmacists and exchange their experiences is greater than ever.

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Author(s)

Margaux DUFOSSE, Claire ANDREJAK, Abir PETIT

Why was it done?

By May 2022, we learned about the sale discontinuation of oxygen humidifiers from one of the two manufacturers in our country, due to the constraints of MDR 2017/745. The second manufacturer restricts its products to hospitals with marketing partnerships. In our hospital, oxygen humidifiers are used regardless of the oxygenation medical device (nasal cannulas, masks, tubes or tracheotomy tube) or oxygen flow rate. We had to define indications and prescriptions to control consumption in our hospital.

What was done?

To promote good use of oxygen humidifiers and control our consumption in a context of shortage we have drawn up a scientific explanatory document, a procedure and a prescription support.

How was it done?

We suppressed services’ allocations for humidifiers, to encourage prescription via the Electronic Patient Record. We set up a working group, including pharmacists, resuscitators, pulmonologists and nurses, to write a good use sheet, underlining high-priority medical indications taking account of scientific literature and respiratory medicine learned societies’ recommendations. To assess its effectiveness, we compared humidifiers’ consumption before and after we set it up and evaluate prescriptions’ number and conformity for the first 4 months, from May to September 2022.

What has been achieved?

The group restricted indications to paediatric patients, patients with tracheotomy and patients with oxygen flow rates above 5L/min and upper respiratory tract lesions such as nose bleeding, nasal discharge congestion, or nasal mucosa’s irritation or lesions. We wrote the good use sheet, mentioning the circuit’s montage and conditions for dispensing humidifiers. Before the new procedure, the mean consumption was 1,415 units per month, versus 39 per month from June. Regarding prescriptions’ conformity, 12 (8.7%) out of 138 were denied: six patients on ambient air, four with nasal cannula, one without any severity criteria, a not nominative prescription.

What next?

This collaborative and multidisciplinary work enabled a change in practices. Supply difficulties, initially seen as challenging, are a great opportunity to promote good use, and secure patient care. Although they have now been resolved, with a new supplier, we maintain our measures to ensure patients’ security and well-being.

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Author(s)

Daniele Mengato, Laura Camuffo, Anna Zanin, Fernando Baratiri, Barbara Roverato, Franca Benini, Francesca Venturini

Why was it done?

PPC patients are children with chronic or terminal illnesses requiring a high intensity of care. Because of their criticality, a strict clinical monitoring is needed, as well as personalised therapeutic strategies.

What was done?

The paediatric palliative care (PPC) unit aims to provide paediatric patients with the best possible care in the management of their disease to ensure the optimal quality of life. The pharmacist has joined the interdisciplinary team with the aim of improving drug management in both acute inpatient and chronic therapies.

How was it done?

From August 2021, the clinical pharmacist joined the PPC staff with the aim of improving medicine management. The pharmacist, primarily, took charge of the medication review process. Individual therapies were periodically reviewed by the multidisciplinary team on the basis of admissions and clinical changes. In addition, a formulary manual for healthcare professionals was drafted, with the description of the crushability of the most commonly used pharmaceutical forms in clinical practice by collecting and keeping up-to-date information from national and international handbooks.

What has been achieved?

Over the past eight months, initial drug reviews have been carried out for all 169 patients followed by the PPC unit, with collegial re-evaluations cyclically carried out for the most critical patients (15). These patients had at least 10 drugs to take each day and therefore assessments were made to simplify treatment regimens by providing 37 suggestions to physicians with the aim of reducing the risk of interactions and facilitating home therapy management. With regard to the handling of pharmaceutical forms, many galenic formulations have been proposed in order to reduce the crushing of solid forms as much as possible. Most of the suggestions were discussed and accepted by the medical team.

What next?

Clinical pharmacist’s intervention is crucial in the management of terminal or chronic therapies for critically ill patients. Next step will be the analysis of caregivers’ care burden, through a specific questionnaire that has already been validated, so as to improve the home management of this particular category of patients.

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Author(s)

Alba Manzaneque, Carla Jurado , Cristina Alonso , Mireia Cairó, Glòria Molas, Fernando Salazar , Lucía Boix, Roser Font, Laura López, Jordi Nicolás, Marc Campayo, Esther Calbo

Why was it done?

Although an intrinsic risk of infection has not been associated with ICI, there are different studies and case-series in the literature in which an increased risk of infection is observed, mainly associated with the use of immunosuppressive drugs (like corticoids) for immune-mediated toxicities. The objective of implementing this circuit in our centre is to reduce all preventable infections, by carrying out an initial infection screening that allows detection of those patients susceptible to vaccination measures, prophylaxis, or specific recommendations.

What was done?

Implementation of an infection screening circuit in cancer patients treated with immune checkpoint inhibitor drugs (ICI).

How was it done?

To carry it out, a multidisciplinary work team was created (pharmacy/oncology/infections department) that designed the ICI template and the clinical circuits. At this point, we believed it was necessary to centralise requests, results, and follow-ups in the oncology pharmacy team (OPT) in order to ensure that all patients were included.
Before the patient initiates treatment with ICIs, the OPT makes the request for a pre-established ICI analysis and the oncology nurse (ON) extracts it. Within 7-10 days, the infection department checks the results and makes the necessary recommendations (vaccination/prophylaxis/specific recommendations).
The OPT is then responsible for both vaccination and initiation of prophylaxis.

What has been achieved?

A total of 30 patients (January to September 2022) have been included in the circuit, 25/30 being men and with a mean age of 67.8 (± 8.8) years.
In 25/30 the treatment was with palliative intent, and 21/30 had lung neoplasia.
The ICIs prescribed were: pembrolizumab (15/30) and nivolumab/atezolizumab/durvalumab (5/30 in each case).
Screening results are available for 26/30 patients. Some type of recommendation was made in 25/26 patients, being: 20/26 hepatitis B vaccination, 5/26 start prophylaxis (2/5 hepatitis B and 3/5 tuberculosis), 6/26 hygienic-dietary measures (aimed at toxoplasmosis).
Additionally, all previously unvaccinated patients (23/26) have been vaccinated against pneumococcus.

What next?

A comparative analysis of infection with a historical cohort is planned when larger sample size is available, to demonstrate that these types of measures reduce the occurrence of infections. Centralising this type of initiative from the OPT is key to our integration into clinical teams, by avoiding important adverse reactions and taking care of our patients.

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Author(s)

Anna de Dios-López, Neus Pagès-Puigdemont, Montserrat Masip-Torné, Pau Riera-Armengol, Rebeca Pelegrín-Cruz, Cristina Martínez-Molina, Noemí Morollón, Robert Belvís-Nieto, Maria Antònia Mangues-Bafalluy, Mar Gomis-Pastor

Why was it done?

Migraine is a neurological disorder characterised by frequent headache. Patients with an episodic migraine pattern have <15 monthly migraine days (MMD), whereas patients with a chronic pattern have ≥15 MMD. Migraine has a high prevalence (15-20% of female and 5-8% of male) and a great impact on their quality of life. Many migraine patients can benefit from preventive treatment. The use of a digital health programme in these patients can allow a real-time monitoring of treatment effectiveness (through the register of migraine attacks frequency) and adverse events. Additionally, it can improve the communication between patients and HCP.

What was done?

We tested a patients’ mobile phone (mHealth) application in chronic and high-frequency episodic migraine patients. This application was synchronically linked with a website for healthcare professionals (HCP) and hospital clinical records.

How was it done?

MyPlan is a mHealth application adapted from another one developed in our hospital for heart transplant patients. Firstly, we conducted a focus group with patients to understand their needs and preferences. This platform fulfils the quality and Data Protection Regulation.

What has been achieved?

13 patients and carers participated in two different focus groups. Another focus group was conducted with the Neurology Department of our institution. The results permitted to adapt the mHealth application with the following functionalities and registers:
• Synchronous (videocall) and asynchronous (direct message) communication between patients and HCP
• Medication adherence
• Treatment adverse events
• MMD and monthly headache days (MHD)
• Monitoring through the register of biomeasures (blood pressure, weight), lifestyle habits (diet, exercise) and questionnaires (MIDAS, HIT-6, EQ-5D, MSQ)
• Information
Data registered by the patient was used to guide clinical management and improve patients’ healthcare route.

What next?

The introduction of mHealth in the healthcare route of patients with migraine could benefit both patients and HCP. This strategy could be incorporated in other health facilities that attend migraine patients in an outpatient setting. Nowadays, a clinical trial is being conducted to demonstrate its clinical benefit.

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Author(s)

Jorge Fernández-Fradejas, Matías Morín-Rodríguez, Eva Delgado-Silveira, Miguel Ángel Moreno-Pelayo, Ana María Álvarez-Díaz

Why was it done?

There is an increasing number of gene-drug interactions that have the potential to predict patient response. Although the study of some genetic variants can be a useful tool to achieve a safer and more effective pharmacotherapy, the integration of personalised medicine in clinical practice has been challenging over the years, mainly due to prescriber’s scepticism and lack of clinical guidelines and protocols.

What was done?

We have implemented a multidisciplinary Personalised Medicine Unit (PMU) at a third- level hospital to facilitate preemptive pharmacogenetic testing.

How was it done?

The PMU provides its service with the involvement of Pharmacy and Genetics Department according to the following workflow:
1. Physicians order the pharmacogenetic test in the first contact with a patient expected to be treated with a drug with an available pharmacogenetic test.
2. A peripheral blood sample is drawn for DNA extraction and analysed by the Genetics Department.
3. An integrated pharmacogenetics report is generated and uploaded to the patient’s electronic medical record. This report contains the molecular information and its interpretation (responsibility of Genetics Department) and the clinical pharmacotherapeutic recommendation according to the results obtained (responsibility of Pharmacy Department). Dose adjustment recommendations follow the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and Dutch Pharmacogenomics Working Group (DPWG) guidelines.
4. Pharmacy Department follows up pharmacotherapeutic recommendation acceptance and clinical outcomes.

What has been achieved?

Since July 2021 we have implemented pharmacogenetic testing for seven drug-gene interactions:
July 2021. CYP2C9 – Siponimod.
November 2021. DPYD – Fluoropyrimidines (capecitabine, fluorouracil, tegafur).
April 2022. UGT1A1 – Irinotecan, liposomal pegylated irinotecan, sacituzumab govitecan.
Three hundred and seventy patients have benefited from pharmacogenetics testing. These tests have been requested by three different clinical departments and had a mean turnaround time of less than 10 days, preventing any potential treatment delays. An integrated Pharmacy-Genetics report with individualised pharmacotherapeutic recommendations was generated for every patient. These recommendations had an acceptance rate of 100%.

What next?

Since the creation of the PMU, we have been able to implement pharmacogenetic testing in clinical practice with a high level of acceptance. Our next challenges are introducing next- generation sequencing for the study of new gene-drug interactions in the unit portfolio and achieve a deeper integration of pharmacogenetic information in clinical decision support systems.

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Author(s)

Trine R. H. Andersen

Why was it done?

In Region Zealand, 1 of 5 regions in Denmark, clinical pharmacist services have been developed and implemented for the past decade. Especially in the acute wards, clinical pharmacists are an integrated part of the team when receiving, assessing and admitting patients to the hospital. As stated by the EAHP, “Clinical pharmacy services should continuously evolve to optimise patients’ outcomes” (EAHP statement 4.8), and a new approach was taken to further optimise the existing collaboration between the physicians and pharmacists on patients’ medication.

What was done?

The clinical pharmacy department of Region Zealand Hospital Pharmacy engaged a project with a senior year anthropology student. The anthropology student observed clinical pharmacists working with clinical pharmacist services in three acute wards. The observations on the collaboration of patients’ medication processes were disseminated to the pharmacists and physicians at the wards. This will aid in further strengthening of the collaboration and utilisation the healthcare professionals’ individual competencies in the hospital wards.

How was it done?

A senior year anthropology student was engaged to do objective observations of the pharmacists and physicians when collaborating in the acute wards. An anthropologist is trained to suppress subjective opinions and has no previous inception of the healthcare professionals’ work in the acute ward, and hence can do low biased observations. For 4 months the anthropologist made objective observations several times a week at each ward, and towards the end of the studies also supplemented the observations with individual interviews to further understand observed situations.

What has been achieved?

After the field observations and interviews, recurrent observation points were extracted from data and presented to the pharmacist and physicians in plenum. Discussions on the presented observations was found enlightening and strengthened the teamwork by better understanding the differences in the pharmacists’ and physicians’ responsibilities in the medication process respectively. Take home messages were visibility as well as accessibility of the pharmacist, and respect of each other’s contributions to the team.

What next?

The data will further be analysed and processed during the anthropology student’s final year and master’s thesis. The take home messages will be combined in a short introduction leaflet aimed for newly employed clinical pharmacists.