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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.

Pharmacological support tool in the paediatric emergency room

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European Statement

Patient Safety and Quality Assurance

Author(s)

IGNASI SACANELLA ANGLÈS, MARTA MARTIN MARQUÉS, HELENA SUÑER BARRIGA, DAVID PASCUAL CARBONELL, PILAR LÓPEZ BROSETA, JÚLIA BODEGA AZUARA, MARÍA VUELTA ARCE, Mª ÁNGELES ROCH VENTURA, ISABEL PLO SECO, ERIKA ESTEVE PITARCH, ANTONIO GARCÍA MOLINA, SÒNIA JORNET MONTAÑA, CARLA DAIANA CIUCIU, SILVIA CONDE GINER, LAURA CANADELL VILARRASA

Why was it done?

Drug dosages and treatment algorithms in paediatric emergencies must be precise and unambiguous to ensure the safety and well-being of patients. Therefore, the introduction of electronic prescription systems in the Paediatric Emergency Room (PER) has become essential to assist clinical staff in prescribing, preparing, and administering the most commonly used drugs.

What was done?

Design and implementation of pharmacological cards as a supporting tool to standardise and streamline the dosages, preparation, and administration of the most frequently used drugs in paediatric emergencies, ensuring a prompt and safe response.

How was it done?

Pharmacological cards were developed for paediatric emergencies, including scenarios such as cardiopulmonary resuscitation (CPR), seizures, sepsis, hypoglycaemia, anaphylaxis, and respiratory emergencies. These cards included the most commonly prescribed drugs, with input and agreement from paediatricians.
The files were organised based on weight categories (3.5-60 kg) and considered the age range of patients (0-15 years). Information collected included the active ingredient, commercial name and presentation, dose per kilogramme, total dosage, dose (expressed as volume for administration), maximum allowable dose, and administration technique. Certain specific conditions were highlighted in colour.
Both medical and nursing staff underwent training in the utilisation of these tools. An evaluation of the protocols was conducted 12 months after their implementation.

What has been achieved?

We developed a total of 21 pharmacological cards, categorised by weight range, encompassing 33 drugs commonly used in paediatric emergencies.
The pharmacological cards were designed in a tabular format, which included the following information: active principle (highlighted in black), commercial name (in red), drug concentration (in blue), standardised dose (in g, mg, mcg, ml, mEq) per kilogramme, total dosage, total volume for administration, maximum allowable dose, route of administration, and administration technique. Additionally, we used background colours to highlight specific situations, such as red for CPR, black for intravenous administration, green for intramuscular routes, and purple for intranasal administration.

During the 12-month evaluation period, we did not encounter any medication-related errors.

What next?

The development of pharmacological cards has helped to standardise practices and simplify the prescription, preparation, and administration of commonly used drugs in paediatric emergency situations. The protocolisation and implementation of this tool have enhanced drug safety in emergency scenarios by reducing human errors and minimising medication-related harm.

Checklist for optimal pharmaceutical validation in very low-birth-weight preterm newborns in the neonatal intensive care unit

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European Statement

Patient Safety and Quality Assurance

Author(s)

IGNASI SACANELLA ANGLÈS, MARTA MARTIN MARQUÉS, JULIA BODEGA AZUARA, PILAR LÓPEZ BROSETA, DAVID PASCUAL CARBONELL, HELENA SUÑER BARRIGA, ALEJANDRO SANJUAN BELDA, CARLA DAIANA CIUCIU, SILVIA CONDE GINER, ERIKA ESTEVE PITARCH, ANTONIO GARCÍA MOLINA, SÒNIA JORNET MONTAÑA, ISABEL PLO SECO, Mª ÁNGELES ROCH VENTURA, MARÍA VUELTA ARCE, LAURA CANADELL VILARRASA

Why was it done?

The NICU is a complex area of paediatric hospitalisation that necessitates specialised healthcare professionals. The role of the NICU pharmacist is vital in ensuring the appropriate and optimised use of medications in various critical situations.

What was done?

To develop a checklist that facilitates pharmacotherapy validation for preterm newborns (PTNB) weighing less than 1000 g and hospitalised in the neonatal intensive care unit (NICU). The primary objective is to ensure a higher quality of hospital care in terms of pharmacotherapy.

How was it done?

We conducted a literature review to identify the pharmacotherapy requirements for preterm newborns (PTNB) weighing less than 1000 g during their first 30 days of life.

In order to design the checklist, we compiled various elements, including drugs, dosages, treatment duration, initiation date, and drug monitoring (when necessary). Additionally, we incorporated recommendations for specific scenarios.

What has been achieved?

The drugs considered for this supportive tool include: pulmonary surfactant, ampicillin, gentamicin, fluconazole, caffeine, ibuprofen, iron (ferrum), dexamethasone, nystatin, vitamin D3, and other vitamins. The checklist was designed to cover the first 30 days of life.

From day 0 to 1: Administer pulmonary surfactant and caffeine citrate. For antibiotic prophylaxis, use ampicillin and gentamicin, and fluconazole for antifungal prevention. In cases of an open ductus arteriosus, intravenous ibuprofen should be added.

Between day 10 to 15: Administer vitamin D3 and a multivitamin complex if the neonate tolerates oral administration. If there is a risk of bronchopulmonary dysplasia, which is characterized by more than 7 days of intubation and difficulty with extubation, consider adding dexamethasone and nystatin.

From day 15 onward: Monitor ferritin and vitamin D3 levels. Begin oral iron supplementation (ferrum) 30 days after birth. Both drugs should be continued for one year.

We have included dose adjustments in case of renal or hepatic dysfunction and pharmacokinetic monitoring for antibiotics. In cases where meningitis is suspected, we have provided recommendations for increasing the dose to ensure adequate penetration into the central nervous system.

What next?

This tool simplifies pharmaceutical validation, particularly for pharmacists who may not specialise in the care of these complex patients. By utilising this tool, we can reduce errors and enhance the quality of care provided to preterm newborns (PTNB) weighing less than 1000 g.

Clinically digital program support for personalised dosing of vancomycin

European Statement

Clinical Pharmacy Services

Author(s)

Wei Wang, Hao Bai

Why was it done?

It depend on the pharmacokinetic (PK)/pharmacodynamic (PD) of vancomycin. Vancomycin can be described as a kinetic model with one compartment connected by a series of first-order kinetic rate processes. The mini programme uses two drug levels during the same dosing interval by the TDM to calculate the area under the curve (AUC) of vancomycin and integrated into patients’ condition and minimal inhibitory concentration of pathogen to provide an optimal dosing regimen of vancomycin.

What was done?

We designed and developed a mini programme support for personalised therapeutic drug monitoring (TDM) of vancomycin. This programme can be easily used in the WeChat by the mobile device.

How was it done?

The traditional vancomycin TDM strategy, which is guided by trough concentrations, has several limitations:
The recommended trough concentration range of 10-15mg/L assumes that the bacteria’s minimum inhibitory concentration (MIC) for vancomycin is ≤1mg/L. However, with the drifting of vancomycin’s MIC values over recent years, this trough concentration has not been able to effectively guide patient prognosis, as has been confirmed by many clinical studies.
There are practical difficulties: for example, the 2009 IDSA guidelines clearly specify that the trough concentration of vancomycin should be sampled half an hour before the fifth dose. However, in reality, due to misunderstandings by nursing staff or excessive workload, sampling times often deviate from this guideline.
After the trough concentration has been determined, there are no explicit measures for dose adjustment. The 2009 IDSA guidelines do not provide recommendations on how to adjust subsequent doses based on trough concentrations.
A decade later, in 2020, the IDSA released new vancomycin TDM guidelines. These guidelines suggest moving away from the trough concentration TDM strategy for vancomycin, and instead recommend using an AUC-guided strategy, determined by two-point blood concentration monitoring of vancomycin.

What has been achieved?

Vancomycin follows first-order pharmacokinetics. To monitor the AUC of vancomycin, it is necessary to measure the serum vancomycin concentration at two steady-state points, then use Monte Carlo simulations and Bayesian software to calculate the AUC and adjust the dosage. This process requires a large number of calculations. Therefore, there is an urgent need for an auxiliary decision making system in clinical practice that can facilitate personalised dosing of vancomycin.

What next?

This mini programme has run above 1 year, providing personalised medicine service of vancomycin to hundreds of patients in China, guiding the precise and rational use of antimicrobial drugs , enhancing the effectiveness of vancomycin and reducing drug toxicity in clinical practice.

DEVELOPMENT AND IMPLEMENTATION OF A MOBILE APPLICATION FOR MONITORING AND COMMUNICATION WITH PATIENTS WITH IMMUNE-MEDIATED INFLAMMATORY DISEASES TREATED WITH BIOLOGICAL THERAPIES

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European Statement

Clinical Pharmacy Services

Author(s)

ROSA MARIA ROMERO JIMENEZ, VICENTE ESCUDERO VILAPLANA, ESTHER CHAMORRO DE VEGA, MARIA FERRIS VILLANUEVA, ELENA LOBATO MATILLA, DANIEL GOMEZ COSTAS, JUAN VICENTE VALOR, ANA HERRANZ ALONSO, MARIA SANJURJO SAEZ

Why was it done?

BT for patients with IMID have increased the effectiveness, but also with adverse events (AE) or problems in their administration. In addition, patients have greater formation and communication needs. We wanted to develop an app to improve communication and monitoring of these patients.

What was done?

In 2020, we developed a mobile application (app) to improve communication and monitoring of Immune-mediated inflammatory diseases (IMID) patients treated with biological therapies (BT). We implemented the app in December 2020.

How was it done?

A multidisciplinary group composed of pharmacists, dermatologists, rheumatologists, gastroenterologists, and nurses designed an app for IMID patients in a tertiary hospital. The app consists of the following modules: Medication, Questionnaires, Adverse Events (AE), Useful Information, Messages, and Patient Profile. We offered the app to IMID patients who initiated a new BT. We performed an observational, longitudinal study to assess the app’s impact on medication adherence, safety, and communication. The inclusion period was from December 2020 to August 2022. The inclusion criteria were age ≥ 18 years, diagnosis of an IMID, and ownership of a Smartphone. Patients with language barriers were excluded.

What has been achieved?

380 patients were included (mean age: 43.6 years [SD=13.9] and 58.3% were female). Concerning the type of IMID, 61.1% of patients had a rheumatologist disease, 26.3% a dermatologist disease, and 12.6% a gastrointestinal disease. The mean follow-up time for app use was 20.5 (14.5) months. In the Medication module, 100% of patients registered their biological therapy and 51.1% also used this module to record each dose of medication administered. 85.3% of patients had adherence >90%. A total of 433 AE were registered. 31.3% of patients registered at least 1 AE. The most frequent AEs were fatigue (32.1%), injection site reaction (15.2%), headache (11.8%), and diarrhoea (8.3%). 53% of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (29.8%), logistical and citation issues (20.8%), and drug interactions (17.9%).

What next?

The next steps will be that the app can be used in other hospitals in our country and also adapt the app to be used in other pathologies.

THE ROLE OF DNA SEQUENCING AND MOLECULAR TUMOR BOARD COUNSELLING IN THE SELECTION OF THE MOST APPROPRIATED THERAPY IN ONCOLOGY

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European Statement

Clinical Pharmacy Services

Author(s)

Marta Anghilieri, Francesco Guidoni, Vito Ladisa

Why was it done?

The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow the parallel sequencing of many samples producing in short times a big amount of data. To enable comprehensive analysis of the data and develop new specific and clinically useful therapies, we have introduced the approach of evaluating the data by the MTB, which includes pharmacists as experts in drugs and their use.

What was done?

Hospital Pharmacists (HPs) are integrated into the Molecular Tumour Board (MTB), a multidisciplinary group, to select the most appropriated therapy for oncology patients, ensure and facilitate patient access, and demonstrate therapeutic appropriateness found by MTB analisys.

How was it done?

MTB members, including HPs, perform DNA sequencing on each patient using NGS to identify known/unknown alterations. These data are entered into a database available to all MTB members and are the basic tool for selecting potential target therapy. The MTB meets once a week to discuss and integrate the observed DNA alterations with the patient’s clinical history. In this way, the most appropriate target therapy for the patient can ultimately be selected. The HPs then provide the patient with access to medications.

What has been achieved?

In this study, 208 patients affected by Non-Small Cell Lung Cancer were evaluated. DNA sequencing of patients identify 117 altered genes. After an extensive literature search, 15 genes were highlighted as potential targets for available drugs. They marked 116 patients potentially tractable with target therapy, of which 47 patients were candidates to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, among candidates for drugs in clinical practice, treatment was started in 65% and continued in 53%; among those treated with drugs not in clinical practice, treatment was started in 23% and continued in 69%.

What next?

The inclusion of HPs in MTB allows for more deliberate use and better selection of drugs. HPs provide valid support to select drugs and facilitate access to them: HPs individualise the applicable therapy for a larger number of patients through MTB, they analyse the therapeutic outcome (MTB-selected therapy has a bigger chance to last longer) and the cost impact on the NHS.

Implementation of medication sessions in a post-stroke therapeutic education programme

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European Statement

Clinical Pharmacy Services

Author(s)

Florian Poncelet, Cedric Mwamba, Valentine Foulon , Anne-sophie Da Silva Rego, Catherine Floret

Why was it done?

Medication adherence of post-stroke treatments is important in preventing stroke recurrence. Problems of adherence with these medications are frequently encountered. Patient education is therefore essential in the management of this pathology.

What was done?

The creation of tools for the medication session of the post-stroke therapeutic education programme and the measure of the activity impact on patients’ knowledge of their treatments.

How was it done?

The session is led by a pharmacist in the form of a Game of the Goose, with the cards divided into 3 different colours, each corresponding to one of the 3 categories seen during the activity: General Questions, Statins and Anticoagulants/Anti-aggregants. This form allows participants to learn in a fun way and to promote interactions.
To evaluate the impact of these sessions, the same quiz is filled out by the patients at the beginning and end of the session, in order to measure the improvement of their knowledge. This quiz is in the form of an evaluation grid, composed of 20 questions with binary answers (True/False) covering the concepts discussed during the activity. The answers allow the attribution of a grade out of 20.

What has been achieved?

33 game cards were created (12 cards for general questions, 8 for statins and 13 for anticoagulants/anti-aggregants, of which three concern anti-vitamin K).
The patients take turns drawing a card and think collectively. The correct answer is later explained by the pharmacist. At the end of the activity, forms summarising the points discussed are given to the patients.
Concerning the quiz, the evaluation of the impact of these sessions was carried out on a first group of seven patients. The average score was 14 (12-17) at the beginning of the activity and 17 at the end (15-20), thus an average improvement in knowledge of 21% (0-58%).

What next?

An analysis of the questions with the lowest rate of positive responses will help us to improve the messages during the activity. A treatment plan given to patients at the end of the session to help them take their medication is also being discussed.

Determination of dihydropyrimidine dehydrogenase genotypes to guide physicians in the dosing of fluoropyrimidines

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European Statement

Clinical Pharmacy Services

Author(s)

Aina Oliver Noguera, Luis Pérez de Amezaga Tomáss, Margarita Nigorra Caro, Fernando Do Pazo Oubiña, Esther Falcó Ferrer, Teresa Fernández Rodriguez, Maria Fiorella Sarubbo, Antònia Obrador de Hevia, Montserrat Vilanova Boltó

Why was it done?

Treatment with fluoropyrimidine produces severe toxicity in about 30% of the patients. This toxicity has been related to a reduction in the activity of DPD, the rate-limiting enzyme for fluoropyrimidine catabolism. This is due to certain genetic variants of DPYD, the gene encoding DPD. For this reason, regulatory agencies such as the European Medicines Agency (EMA) recommend determining DPD deficiency in all patients who are candidates for treatment with fluoropyrimidines.

What was done?

Design of a protocol for the Implementation of dihydropyrimidine dehydrogenase (DPD) genotype tests in our hospital so that the results can be clinically interpreted by the pharmacists, and then used to guide physicians in the dosing of fluoropyrimidines (5-fluorouracil/capecitabine). The project was done with the collaboration of the Genetic and Genomic Laboratory (GGL) located in the reference hospital of our territory.

How was it done?

The elaboration of the protocol took place as follows, coordinated by the oncology pharmacist:
– Informatics. They created a formulary at the electronic prescription programme (HP-HCIS®) for the inclusion of the patients in the testing protocol.
– Oncologists and nursing service. They were trained in the implementation of this new determination, as well as in the procedure for obtaining and sending samples to the GGL.
– GGL. They conducted the DPYD genotype tests and report the results to the oncology pharmacist.
– Oncology pharmacist. They did the clinical interpretation of the result based on the following European Society for Medical Oncology (ESMO) recommendations for heterozygous DPYD variant allele carriers:
-DPYD*2A (rs3918290): dose reduction of 50%
-c.1679T>G (rs55886062): 50%
-c.2846A>T (rs67376798): 25%
-c.1236G>A/HapB3 (rs56038477): 25%

What has been achieved?

Since the implementation of the protocol, 73 determinations of DPYD polymorphisms have been performed (November 202 to August 2022). Three patients (4.1%) were found to be heterozygous DPYD gene variant carriers (two DPYD*2A and one c.2846A>T).
The average time for obtaining the results was 17.5 days. For this reason, in most cases the treatment was started before the result was obtained.

What next?

We are working on the implementation of a new fluorescence technique that will allow us to shorten the time of obtaining the genotype result.

Improving people living with HIV therapies compliance: a practical tool customised for patients and designed by hospital pharmacists

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European Statement

Patient Safety and Quality Assurance

Author(s)

Sabrina Trivellato, Daniele Mengato, Maria Mazzitelli, Anna Maria Cattelan, Francesca Venturini

Why was it done?

An optimal compliance is an essential requirement for people living with HIV (PLWHA) to grant drugs effectiveness and safety. Given the complexity of the therapeutic regimen, and the multiple changes to it due to the clinical status, compliance to therapy may be suboptimal. Patients who are not well educated on how to follow their therapy are more keen on quitting the treatment or facing virological failure. According to previous analysis, we reported that 120 patients out of more than 1500 managed by our centre experienced suboptimal adherence to therapy.

What was done?

We created a user-friendly tool to educate HIV-patients on their drugs’ adherence in our University Hospital.

How was it done?

We studied every drug prescribed in our centre and we analysed it from the patient’s point of view. The question we aimed to answer was: “If I were a PLWHA, what would help me assuming the correct drug, at the proper time, avoiding misunderstandings?”. We analysed the shape, colour and dimensions of both the package and the pills/capsules. We focused on the most appropriate way to take every drug and we investigated possible interactions with OTC drugs or dietary supplements.

What has been achieved?

A poster reporting all the drugs available in our formulary was developed: 34 medicines were described in alphabetical order, specifying for each one the image of the package, the usual dosage, the picture of the pill/capsule compared to the dimension of current coins and special warnings about possible drug-drug interactions. We also adopted practical symbols to indicate whether to assume the drug with or without food. The poster became available starting from April 2022 and during the following 5 months a cohort of 960 patients could rely on it.

What next?

In order to help our patients taking their therapies, we expect to get a digital form of this poster to make it available on the phone scanning a QR code. Alongside, we aim to enlarge and improve this digital version by adding a final section with an interactive survey to closely monitor the compliance of the patients and help them to improve it. Through this project we could also obtain an active pharmacovigilance setting.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.