Clinical radiopharmacy: implementation of pharmaceutical interviews for patients treated by radioligand therapy
European Statement
Clinical Pharmacy Services
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.
Implementation of a protocol to ensure continuity of pharmaceutical care in hospitalised outpatients
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARCELO DOMINGUEZ CANTERO, CARMEN MARIA DOMINGUEZ SANTANA, MARCELINO MORA CORTES, ESMERALDA RIOS SANCHEZ, JUAN MANUEL BORRERO RUBIO
Why was it done?
Patients who withdraw medication from outpatient pharmacies in Spanish hospitals are provided with pharmaceutical care and pharmaceutical care stratification tools in specific outpatient pharmacy consultations. These patients are usually multi-pathological with multiple drug interactions, contraindications, and important adverse effects. Therefore, during the hospital admission of these outpatients, it was appropriate to provide continuous care from the hospital pharmacy. Before the implementation of the protocol, there was no specific and systematic follow-up of hospitalized outpatients.
What was done?
Implementation of a protocol that provides pharmaceutical care to outpatients during hospitalization, ensuring continuity of care through the pharmacy service.
How was it done?
The main problem with the implementation was the real-time detection of hospitalized outpatients. The development of a software tool to facilitate the location of patients provided an impetus for the implementation of the project. The computer tool selected patients who met the inclusion criteria (hospitalized outpatients with medication withdrawal in the outpatient unit in the last two months). Patients treated with erythropoietin and colony stimulants were excluded.
What has been achieved?
Seventy-nine patients were included in the study between April and September 2023; 62.1% were male. Main pathologies included 41.9% oncohaematologic diseases, 18.9% human immunodeficiency virus, and 17.7% immune-mediated inflammatory diseases.
The reason for admission was related to the pathology for which outpatient medication was withdrawn in 27 patients (34.2%), and six patients (7.6 %) were admitted due to an AE of the medication withdrawn in outpatients. Pharmaceutical interventions (PI) were performed in 21.5% of the patients reviewed, and 76.5% were accepted. PI reasons included discontinuation of treatment (64.7 %), modification (17.7 %), initiation (11.8 %) and monitoring (5.9 %).
What next?
With our protocol, we want to show that outpatients within the pool of patients admitted to a hospital are a priority target group. For these patients, the hospital pharmacist can improve treatment during hospitalization with a high degree of pharmaceutical intervention.
A new medication-use process implemented in the perioperative setting
Pdf
European Statement
Patient Safety and Quality Assurance
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.
Novel specialist uveitis pharmacist role in the uveitis multidisciplinary team (MDT) and evaluation of new dedicated patient email helpline
Pdf
European Statement
Clinical Pharmacy Services
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.
The role of hospital pharmacists in gene therapy preparation
Pdf
European Statement
Production and Compounding
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.
Environmental criteria in medicine procurement
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Outi Lapatto-Reiniluoto, Suvi Sivula, Elina Ahomäki
Why was it done?
Price has been the most prominent criteria in procurement quality being the second. Environmental aspects haven’t been assessed earlier. Differences between the pharmaceuticals’ environmental burden can be considerable and by choosing wisely we would be more sustainable.
What was done?
Environmental criteria have not been used in Finland in hospital procurements earlier. We created the criteria which would be acceptable to all parties (hospitals, suppliers), would be reliably assessed, and easily copied to other hospitals.
How was it done?
Our tender had six questions for everyone and two more questions for antibiotics or hormones. The common questions were answered by yes / no / we do not know. Points given were 0, 1, 2. An example of the common question is: Does the company have a plan how to reduce CO2 emissions caused by itself?
Questions for antibiotics and estrogen hormones were: Company has told in which country and in which plant the API is produced and the formulation happens.
What has been achieved?
132 providers answered so far. Quality of answers varied considerably, from 0 to 12 points, mean 7 points. Questions for antibiotics created the most discrepancies: 41 providers; 15 were not able to answer these questions acceptably. The answers showed that the questions were not too difficult, these questions could be answered, and the answers can be analysed.
What next?
The criteria were very simple and assessing the answers was not difficult. Only one question was widely misunderstood. Questions were universal and can be used in other hospitals, too, which is the wish from the industry (same questions everywhere). Wide range of results showed differences between the companies. During this round we did not give any credit for the best products but in the future more responsible products should be rewarded. Antimicrobial resistance e.g., is a global problem but if the company does not know where its products are manufactured how can they look after wastewater treatment of their products.
Supply difficulties in oxygen humidifiers: an opportunity to promote good practice
Pdf
European Statement
Selection, Procurement and Distribution
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.
Environmental and humanisation impact after 3 years of a hospital-community pharmacy collaboration delivery programme
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Andrés Sánchez Ruiz, Rocío Contreras Collado, Lucía Gutiérrez Lucena, Juan Jerez Rojas
Why was it done?
The programme began to be developed in March 2020 as an emergency solution to the COVID-19 pandemic, but over time it was refined due to the benefits seen in different areas, especially for pharmacy patients.
What was done?
A hospital drug dispensing programme was created with the collaboration of a community pharmacy and its pharmaceutical distributor. A daily delivery was conducted from the hospital pharmacy, covering the entire province, with a population area of 622,000 inhabitants and an area of 13,500 km2 that includes widely dispersed population centres with complicated communication.
How was it done?
Interlevel collaboration between hospital pharmacy, official college of pharmacists, pharmaceutical distributor and community pharmacy. After the first year, in which the process was more manual and marked by the pace of the pandemic, the programme began to develop. A web application with two-way communication hospital-community pharmacy was created. Hospital Pharmacy reviews and dispenses these requests, with daily shipments to all community pharmacies in the province through the distributor, which ensures safe transportation of the medication with adequate conditions of humidity and temperature.
What has been achieved?
A total of 57,130 dispensations have been made since 2020 (8,089 in 2020, 14,996 in 2021, 16,629 in 2022 and 17,416 in the first half of 2023). Pharmacy Service has dispensed at least once to 5,091 patients. Thanks to the reduction of individual trips (a total of 3,529,022 kms, 52,669 hours travel time, since 2020), it is estimated that the discharge into the atmosphere of 500 tonnes of CO2 in total has been avoided, which is equivalent to the emission of 500 round-trip Spain to Denmark flights (1,000 medium-sized trees are needed for 50 years to absorb that amount of CO2). Eighty-seven percent of private car use was estimated. We did not take into account movements of patients residing in the urban centre of the hospital. The development of ICTs will allow a more clinical approach and an improvement in patient care. We also expect the improvement of the process with the creation of Patient Reported Outcomes (PROs) protocols, already underway for migraine and psoriasis, and Patient Reported Experience Measures (PREMs) protocols.
What next?
The development of ICTs will allow a more clinical approach and an improvement in patient care. We also expect the improvement of the process with the creation of Patient Reportes Outcomes (PROs) protocols, already underway for migraine and psoriasis, and Patient Reported Experience Measures (PREMs) protocols.
Introducing a clinical pharmacist in a paediatric palliative care unit: how to optimise complex drug regimens
Pdf
European Statement
Clinical Pharmacy Services
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.
Implementation of a screening circuit and prevention of infections in cancer patients treated with immune checkpoint inhibitors
Pdf
European Statement
Clinical Pharmacy Services
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.