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Creation of a pedagogical tool to optimise the validation of chemotherapies related to rhabdomyosarcoma

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European Statement

Education and Research

Author(s)

Franco Perna, Maria Elisabetta Uda, Maxime Annereau, Hail Aboudagga , André Rieutord, My Lan Vo

Why was it done?

The process of pharmaceutical validation of chemotherapy involves several steps, and the hospital pharmacist must rely on multiple therapy protocols. In addition, pharmacists who have just finished university do not have the appropriate training for pharmaceutical validation. Thus, we decided to develop a tool to support the validation of chemotherapy, in which pharmacists can learn therapy protocols.

What was done?

The hospital pharmacy has developed a pedagogical tool to support pharmaceutical validation in the context of rhabdomyosarcoma (RMS).

How was it done?

We initially carried out a systematic review, following the PRISMA 2020 Statement, to find if there were any educational methods or tools exist to facilitate pharmaceutical validation in paediatric oncology.
Then, we contacted several pharmacists, currently employed in French hospitals and abroad, to understand how they train new pharmacists and resident students about chemotherapies validation. After this first stage, we focused our research on the content of our future educational tool. We created an easy-to-fill questionnaire to obtain information and meet from clinical pharmacists inside our department to understand which information was needed for the tool and what could be the most suitable format for them.

What has been achieved?

Regarding the systematic review, only two studies were identified, in which tools for pharmacists were developed, but none of these concerned the pharmaceutical validation of paediatric chemotherapy. The hospital centres contacted did not develop pedagogical tools, but some of them support the training with standard operating procedures (SOPs).
The questionnaire, in which 15 pharmacists (27% students) were interviewed, revealed that most preferred a tool in pdf (48%) and paper format (22%), containing information on pathophysiology (48%) and epidemiology (22%) of rhabdomyosarcoma, on chemotherapy protocols (32%) and dosage regimens (19%). For this reason, a pedagogical tool has been developed in pdf format and in the form of a paper booklet with the required information.

What next?

This tool could be the first presented regarding the validation of paediatric chemotherapy.
The future prospect would be to develop other tools to support pharmaceutical validation so that we can invest more and more and provide more and more quality training to new hospital pharmacists.

DADA app: automated antibiotic de-escalation. usefulness and results

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European Statement

Clinical Pharmacy Services

Author(s)

Sergio Portillo-Haro, Aída Rueda-Naharro, María Martínez-Pérez, Manuela Martínez-Camacho, David García-Marco

Why was it done?

Currently, multi-resistant microorganisms are a huge global problem of Public Health. In addition, this problem will be bigger in the next decades. The main strategy to face this threat is improve the use of antibiotics. DADA was born with this purpose. The app lets the Pharmacy Department manage a sizable number of inpatients using the time to analyse the results obtained by DADA. In other words, we have improved the efficiency in our use of time.
How was it done?
The app was developed in July 2022, and since then it has been updated multiple times to adapt it to our needs and expectations and the changes in clinical guidelines. Every Monday and Thursday, the app is started up. The results are analysed carefully by a pharmacist and afterwards the conclusions are transmitted to an Infectious Diseases Medician, who decides if modify the treatment.

What was done?

In July 2022, Pharmacy Department designed an app easy to use and comfortable in order to detect active antibiotic treatments that might be de-escalated. This app, DADA (Automated Antibiotic De-escalation) is fed with data of antibiotic treatments and microbiological cultures. DADA reads and understands every gap of information, and finally search results between the active treatments comparing it with theorical de-escalation sequencies, designed by Infectious Diseases Commission in our hospital and based in local epidemiological guidelines. In this way, DADA works with automatic decision algorithms. In addition, DADA also provides alerts of active treatments for resistant microorganisms to that antibiotic.

How was it done?

The app was developed in July 2022, and since then it has been updated multiple times to adapt it to our needs and expectations and the changes in clinical guidelines. Every Monday and Thursday, the app is started up. The results are analyzed carefully by a pharmacist and afterwards the conclusions are transmited to an Infectious Diseases Medician, who decides if modify the treatment.

What has been achieved?

Since August 2022 to March 2023, using DADA, the Pharmacy Department has made 25 proposals of antibiotic de-escalation, and 11 proposals were accepted (44.0%) by Medicians. In addition, the Department made two proposals of change for resistance to that antibiotic, both accepted by Medicians. This app has improved efficiency of time in the clinical team.

What next?

The main outcome is to improve the confidence of Medicians in this tool, in order to increase the percentage of acceptance in the proposals. Furthermore, the app can be more complete and interprets data, such as analytics parameters. In the future, other hospitals might use this tool to analyse their patients or in outpatients treatments.

Development of bags ready to use for parenteral nutrition in the preterm patient

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European Statement

Production and Compounding

Author(s)

Eleonora Castellana, Simonetta Felloni, Matilde Scaldaferri, Giuseppina Bonfante, Elena Maggiora, Francesco Cresi, Maria Francesca Campagnoli, Alessandra Coscia, Maria Rachele Chiappetta, Francesco Cattel

Why was it done?

The purpose was to provide the Neonatal-Intensive-Care-Unit (NICU) with ready-to-use bags that could improve patient safety by minimizing procedural incidents and maximize resource efficiency while providing clinically appropriate nutrition for the single PP.

What was done?

Seven standard bags (SSB), ready-to-use, have been formulated and developed for parenteral nutrition (PN) in preterm patients (PP). An assisted prescribing software was developed for selecting the most appropriate standard bags (SB).

How was it done?

The project was carried out in collaboration between pharmacists, nurses and neonatologist of NICU.
The composition of the SB was identified from the retrospective analysis of the types of individualized bags requested from the Pharmacy and from the analysis of the recommended ESPGHAN-Paediatric-Parenteral-Nutrition-2018 contributions.

What has been achieved?

SSB ready-to-use were identified:

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The bags have been produced by an industrial partner according to Good Manufacturing Practice-Annex 1. The shelf life is 90 days.

The SSB were implemented successfully on the PP. Starting from 2021, approximately 250 bags/month have been used, with a reduction in individual preparations by the Pharmacy of approximately 80%.

This approach showed results in terms of clinical results and economic outcomes. The computer program guided the physician to the most appropriate standardized solution.

Early and timely administration of ready-to-use PN showed reduced weight loss and a shorter duration of PN than individualized bags (21 vs 25 days).

What next?

The project described has shown benefits including improved nutrient supply, fewer prescribing and administration errors, lower risk of infection, cost sav-ings, ready availability of the bags 24/7 and safe and effective supply of SB. This project will be strengthened in our hospital.

A human albumin (HA) prescription model as strategy to maximise the appropriate use in shortage conditions

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European Statement

Introductory Statements and Governance

Author(s)

Giorgia Babaglioni, Lorenzo Silva, Elena Festa, Daniela Paganotti, Tullio Elia Testa

Why was it done?

In Italy, the rising PDMPs demand had to face the international shortage caused by the SARS-CoV-2 pandemic outbreak. The self-sufficiency level of albumin represents one of the National Blood Centre (NBC) main challenge, in view of the health system sustainability.

What was done?

The hospital pharmacy of a northern Italy centre, in accordance with the Good Use of Blood Committee, introduced a nominal form for human albumin (HA) requests to evaluate and rationalise the HA clinical-therapeutic demand. It represents a pharmacist led intervention approach shared by physicians, in favour of an economically sustainable healthcare contrasting the lack of plasma-derived medicinal products (PDMPs).

How was it done?

Prescription criteria were updated according to the most recent guidelines. The cut-off of blood albumin level above 2.5 g/dl has been introduced as eligibility threshold value and for the daily dose calculation, except for HA calculation based on volumes for plasmapheresis and large volume evacuative paracentesis in hepatic cirrhosis. The pharmacy provides a maximum of five days therapy, then a new revaluation and updating of blood albuminemia was required; 690 total requests were analyzed.

What has been achieved?

In March 2023, HA consumption was 61400 gr, collapsed by 75% in April and then settled at – 58% in May and June. The most important reductions in monthly requirements affected the surgical (- 75%), intensive (- 62%), internist (- 64%) and gastro-hepatological (- 52%) areas. 97,5% of requests were on-label: 20% for plasmapheresis or paracentesis, 21% for liver failure, 16% for cirrhosis of the liver with refractory ascites. 26% of requests (n = 180) reported in-range blood albumin value, while the 14% was unknown or ongoing because administered in emergency phase. 37% of requests has been evaded even if the blood albumin was > 2,5 g/dl due to mandatory clinical need. Thanks to the new prescription model it was possible to save € 91 752 in the second quarter.

What next?

The introduction of the reasoned request allowed to achieve albumin self-sufficiency with voluntary blood donations and reduce the market products purchase. Furthermore, it fostered the clinicians awareness on the HA use appropriateness, considering crystalloids and non-protein colloids as alternative therapeutic strategies as resuscitation fluids.

A strategy to prevent weekly methotrexate medication mistakes in a regional health service

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European Statement

Patient Safety and Quality Assurance

Author(s)

Vanesa Alonso Castro, Pablo Jimenez Moreno, Marta Alcaraz Borrajo, Angel Luis Mataix Sanjuan, Beatriz Casamayor Lázaro, Maria Dolores García Cerezuela , Cristian Rosas Espinoza, Beatriz Santos Mena, Estrella Maroto García, Beatriz López Centeno, Daniele Alioto, María Jose Calvo Alcántara

Why was it done?

MTX is an immunosuppressor drug utilised in certain types of cancer and inflammatory diseases. Its dosage and frequency of administration varies depending on indication.
Throughout the years, medication errors (ME) have been reported at national and supranational levels where patients have received excessive doses (the most common being daily administration of the drug rather than weekly) with severe consequences for the patients, including death.
In our RHS, 222 ME related to MTX have been reported in the last 5 years,seven of them resulted in harm to the patient.

What was done?

An integral strategy to ensure the correct prescribing of weekly Methotrexate (MTX) was developed in a Regional Health Service (RHS).

How was it done?

1st PHASE (May 2021):
a. Monthly reporting to prescribers of their patients affected by duplicated prescriptions or incorrect dosing instructions for review and amending. These reports are available on the IT platform that collates prescribing indicators.
b. Development and dissemination of training materials to correctly prescribe medications with non-daily dosing instructions in the RHS electronic prescription tool.
2nd PHASE (After two years of follow-up):
a. Request to implement ME prevention plans (MEPP) to the hospitals of the RHS.
b. Creation and dissemination of informative material for patients and/or caregivers, where the weekly dosing instructions is emphasized.

What has been achieved?

Incidence of MTX prescribing mistakes: When this strategy was implemented, prescriptions for 2388 patients had been identified as potential mistakes. 1 year later, the incidence had diminished by 78.1% (2146 cases were resolved, 242 were still active and 310 were new). 2 years later, the incidence remained stable with a reduction of 78.5% thoroughout the whole period and 514 patients affected (150 new MTX prescribing mistakes in the last year).
• MEPP implantation (2nd PHASE): In two months, six hospitals (17.6% of all) implemented a MEPP. The key strategies that should be included in the MEPPs were disseminated to all hospitals by our team.

What next?

Thanks to this strategy, MTX prescribing mistakes have fallen by 78.5% in two years. However, prescribing mistakes continue to be made, which demonstrates the need for continuous training and awareness raising among prescribers to prevent ME related to MTX.

Computerised registration of drug prescriptions in the operating room during cardiac surgery: simplicity and traceability

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European Statement

Patient Safety and Quality Assurance

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Mattia Lorenzini, Anna Carmignani, Debora Luccetti, Stefania Baratta, Mario Cossu, Maurizio Mangione, Pierantonio Furfori, Monica Baroni, Paolo Del Sarto, Stefania Biagini

Why was it done?

This implementation was designed to provide a safe tool for the particular context of the operating room, in which prescription and administration are actions usually urgent and concomitant. The program suggests a rapid list of prescriptions standardized for adult patients (i.e. dose, diluent, bolus/drip) and allows to register any other drug or modify default information, respecting the rules for a clear prescription before registration.
Our aim was to demonstrate the possibility to validate this program and prove its functionality.

What was done?

In 2019 a multidisciplinary group (doctors, nurses, pharmacists, computer scientists) created an electronic program dedicated to the Cardiac Operating Room of the Heart Hospital, Fondazione Monasterio (Italy), which allow the prompt registration of drug prescriptions and administrations. Furthermore this program guarantees traceability of the drugs administered by the nurses, in order to improve medication safety practice.

How was it done?

This program was created into the electronic prescribing system available in Fondazione Monasterio. The standardized prescriptions already in use in the operating room were reviewed by a pharmacist, consulting the information in the Summary of Product Characteristics (SmPC), in the literature or by contacting the company that holds the MA. For each discrepancies identified a solution was proposed and shared with the working group, in order to validate a definitive list.
The prescriptions extracted by the IT Systems unit 6 months before and after the implementation of the new program were therefore analyzed.

What has been achieved?

A list of 182 standardized prescriptions was validated and reported in the program.
Among the 10,320 prescriptions made before the new program none had traceability of the drugs administered, while the 8,730 of the following period were complete and 99.6% of them fell within the standardized prescriptions, demonstrating the functionality and correct selection by the working group.
The development of a program for the computerized registration of prescriptions made during the surgery, which respond to the requirements of drug safety and traceability, represents an example of good practice.

What next?

We have implemented this tool in the paediatric population, with particular precautions due to the weight variability (i.e. dose/kg). The next step could be integration with further assessments (e.g., kidney function evaluation) and the transfer to other settings

Medication reconciliation practice at transitions of care: a new challenge or opportunity for the clinical pharmacist?

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European Statement

Clinical Pharmacy Services

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Sara Tonazzini, Stefania Alduini, Maurizio Mangione, Umberto Paradossi, Monica Baroni, Sergio Berti, Stefania Biagini

Why was it done?

Several data suggest that pharmacists and physician collaboration, direct pharmacist interaction with patients or caregivers through medication reconciliation and discharge counselling decreases the number of adverse drug events (ADEs) and plays an overall positive role in transitional care. Our aim is to demonstrate the constant necessity of pharmacist led medication reconciliation in order to maintain a high standard of care and safe medication use.

What was done?

Medication reconciliation at hospital discharge is essential for the prevention of medication discrepancies and patient harm. Hospital pharmacists are recognised as one of main healthcare providers that can support the physicians in this activity.
Since 2016, the medication reconciliation process has been performed by physicians and clinical pharmacists before home discharge from the Heart Hospital, Fondazione Toscana G.Monsaterio in Italy.

How was it done?

We analysed the medication reconciliation activity performed in our hospital over time and we observed that the number of unintentional discrepancies was always around 20%.
A shared pre-discharge prescription review programme has been activated with all doctors, so when the final lists of drug prescriptions are ready, the pharmacist examines them and suggests improvements or corrections to the doctor before the discharge letter is delivered to patients. Among the unintentional discrepancy observed, the most frequent were omissions of chronic therapy, lack of information about suspension for low molecular weight heparin or antibiotics.

What has been achieved?

A strong collaboration between physicians and clinical pharmacists has been achieved as we shared the results of this improvement. The same activity has been required and extended to the paediatric ward where the demand of simple, clear and complete information is even more crucial given the particular inter-individual variability and fragility of this population.

What next?

We would like to improve the prescription review programme also at admission in order to minimise drug omissions and at transition between different wards or different hospitals with the aim of improving communication between health care settings.

Novel specialist uveitis pharmacist role in the uveitis multidisciplinary team (MDT) and evaluation of new dedicated patient email helpline

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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.

De-prescription initiative for anti-dementia drugs in a sociosanitary centre

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European Statement

Patient Safety and Quality Assurance

Author(s)

Paula Torrano Belmonte, Lydia Fructuoso González, Juan Antonio Gutierrez Sanchez, María Hernández Sánchez , Adrián Martínez Orea, María Guillén Diaz, Cristina Portero Ponce, Alicia Sánchez Blaya , Teresa Alonso Dominguez

Why was it done?

According to Spanish guidelines, medication deprescription would be recommended in the following situations: in the advanced or terminal phase of the disease with a global loss of cognitive and/or functional abilities; in patients who do not experience any benefit; in the presence of intolerable adverse effects or interactions with concurrent treatments. The dose will be progressively reduced every 4 weeks.

What was done?

We designed a project to deprescribe drugs used for dementia in patients at one of the sociosanitary centers (SSC) affiliated with our hospital. The drugs currently used in Spain are: donepezil, rivastigmine, and galantamine for mild to moderate stages, and memantine for moderate to severe stages.

How was it done?

Pharmacists conducted a search using the Savac® pharmaceutical management programme among all residents of the SSC who were prescribed anti-dementia drugs. Once eligible patients were identified, medical team was notified through the electronic prescription programme.

What has been achieved?

According to the previously detailed criteria, there were a total of four eligible patients: one of them was on rivastigmine patch treatment, and the other three were on oral memantine. The results in the first month were not very positive, as an attempt to withdraw memantine from one patient had to be reversed due to aggression issues. Another patient on memantine sadly passed away, and the remaining two, on memantine and rivastigmine, continued with the medication due to potential benefits.

After 10 months of work, the results have been quite promising, and we have successfully completed more withdrawal protocols for other CSS patients. Medication was deprescribed for three patients: one on donepezil and two on memantine. Another patient on rivastigmine is currently in the dose reduction phase.

What next?

Our goal is to achieve the appropriate prescription of anti-dementia drugs, in order to maximise benefits for patients while minimising adverse effects and rationalising public resources.

Electronic prescription protocols for personalised sterile preparations for the paediatric surgery department

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European Statement

Production and Compounding

Author(s)

Isabel María Carrión Madroñal, Concepción Álvarez del Vayo Benito , Begoña Balboa Huguet , Santiago Lora Escobar , Paloma Barriga Rodríguez

Why was it done?

-Improve security, planning, and access to information for correct prescription, administration, and management.
-Guarantee the traceability of all processes.
-Improve the satisfaction of the services involved, preventing forgetfulness and therefore management of emergency calls, unjustified need for the prescribed preparations, and incorrect packaging.
-Improve communication and the work circuit from PD.

What was done?

To prepare a protocol with the processes of prescription, validation, preparation and dispensing of personalised sterile formulations in the Paediatric Surgery Department (PSD: Otorhinolaryngology, Ophthalmology and Neurosurgery) from the Pharmacy Department (PD).

How was it done?

1. Creation of a multidisciplinary team in which a circuit for the prescription, validation, preparation and dispensing of sterile preparations was agreed.
2. Analysis with the departments involved of the personalised sterile-medications prepared by PD for use in paediatric-surgical-rooms, and the most frequent doses used.
3. Bibliographic review: PubMed®, Cochrane®, Uptodate®, Stabilis® and other sources such as the Good Clinical Practices (GCP) and the book ‘Preparation of Drugs and Magistral Formulation for Ophthalmology (JM Alonso).
4. Creation of electronic prescription protocols in ATHOS-Prisma®, containing:
• help notes and preconditions for the prescription.
• information for the administration and management of waste.
• detailed brew sheet and custom label for the PD.
5. Review of the protocols created and the circuit proposed for the prescription, preparation and dispensing.
6. Start-up of the circuit: review and validation of prescriptions, preparation of sterile formulations centralised in PD through laminar flow hoods and dispensing directly to the surgical-room on the scheduled date.

What has been achieved?

Piloting began with sterile otorhinology formulations in 2021, expanding to ophthalmology and neurosurgery in 2022-2023.
– Creation of three groups of protocols that will contain those related to each specialty to facilitate location and prescription by surgeons:
*Paediatric ophthalmology:
• Mitomycin 0.2mg/ml intraoperative-solution-trabeculectomy
• Fluorouracil 5mg/0.1ml intraoperative-solution-trabeculectomy
• Intracameral-cefuroxime 2mg/0.2ml (antibiotic-prophylaxis)
*Paediatric otorhinology:
• Cidofovir 5mg/ml intralesional (laryngeal-papillomatosis)
• Bevacizumab 2.5mg/ml intralesional (laryngeal-papillomatosis)
• Mitomycin 0.5mg/ml (choanal-atresia)
*Paediatric neurosurgery:
• Interferon-alpha 3MIU/0.6ml intralesional (craniopharyngioma)
– Sixty-two preparations have been prepared and dispensed for a total of 30 children; average age of 4 years (1-10). No adverse events were reported in any patient after the administration of these sterile preparations.
– A study limitation was sample size. Circuit under development.

What next?

The protocol is applicable to any hospital with electronic-prescription and surgical-area.