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Author(s)

Carlos José Cortés Sánchez, Josefina Giménez Castellanos, Mónica Abdilla Bonías, Arantxa Valdivia Piqueres, José María Gómez Portolés, Irene Toledo Guasp, Eva García Cortés

Why was it done?

Proper use of antimicrobials is essential to ensure their efficacy and minimize the emergence of resistance. The evaluation of antibiotic prescription in a district hospital can provide information about clinical practice, adherence to local protocols, and the possibility of addressing antimicrobial resistance issues.

What was done?

Review the appropriateness of antibiotic prescription according to local guidelines and protocols.

How was it done?

This is 4-month prospective observational study(May to August 2023) in a district hospital. A daily list of admitted patients on antibiotic treatment was obtained through OrionClinic® electronic prescription. Each patient was reviewed and discussed for appropriateness with antimicrobial stewardship team in a Microsoft-TEAMS© chat. The following data were recorded: registration date, patient identification, hospitalization unit, microbiological culture, treatment modality (prophylaxis, empirical, or targeted) and appropriateness using a Microsoft FORMS©.
Descriptive analysis expressed as number and percentage and relationships derived from registration: percentage of patients by hospitalization unit, treatment modality, and appropriateness. Percentage of patients on empirical treatment with microbiological culture. And appropriateness according to treatment modality.

What has been achieved?

A total of 172 patients were analysed, of which 83(48.25%) were surgical patients (orthopaedic surgery, general surgery, urology, gynaecology, otolaryngology), 64(37.2%) are from internal medicine,MIN, 17(9.9%) from intensive care unit,ICU, and 8(4.7%) from paediatrics,PED. Of the total of patients, 95(55.2%) had requested a microbiological culture. About 52(30.2%) patients were on prophylactic treatment, 103(59.9%) empirically, and 17(9.9%) on targeted treatment. In conclusion, 119(69.2%) antibiotic treatments were appropriate (prophylactic 26/50%, empiric 80/77.67% and targeted treatment 13/76.5%).
Breaking-down data by hospitalization unit and treatment, of the 83 surgical (49 prophylactic, 28 empirical, and 6 targeted) 47(56.6%) were appropriate. Among the 64 MIN patients(1 prophylactic, 56 empirical, and 7 targeted), 54(84.4%) were appropriate. In ICU of 17 patients(2 prophylactic, 12 empirical, and 3 targeted), 11(64.7%) were appropriate. In PED of 8 patients(7 empirical and 1 targeted), 7(87.5%) were appropriate. Of the total of patients on empirical treatment(103), in 28(27.2%) there isn’t microbiological sample.

What next?

This is a preliminary analysis of our hospital’s situation in order to assess where interventions are needed for those patients who are not appropriate. It also helps us identify the hospitalisation units in which it is more necessary to implement strategic non-imposing measures to improve antibiotic prescription.

Author(s)

Greta DUSABE, Jonathan DE GREGORI, Teo TODESCO, Vanessa GOMES, Hélène FEYEUX, Marine AGULLO, Cyril BORONAD

Why was it done?

Chronic Obstructive Pulmonary Disease (COPD) and asthma represent a significant public health issue. Medications are administered using inhaler devices (ID) that require prior demonstration to ensure their proper use. Incorrect usage of inhaler devices might have a major influence on the clinical effectiveness of the delivered drug.

What was done?

The goal of our study was to detect potential errors in the manipulation of inhaler devices (ID) and to provide patients with appropriate information on their correct use in order to improve medication management.

How was it done?

For this study, every hospitalised adult patient with an ongoing treatment with ID underwent a pharmaceutical interview during their hospitalisation.
This interview was done using a questionnaire assessing the patient’s knowledge of their medications and a 12-items evaluation grid covering every step of proper inhalation technique.

What has been achieved?

Between June and August 2023, 27 patients were interviewed: the average age was 73 years. 34 ID manipulations were observed. Dry powder inhalers were the most prescribed DIs (68%), followed by pressurized metered dose inhalers (23%) and soft mist inhaler (9%). For 10 DIs (29%), no explanation was given to the patient. Furthermore, inhaler technique instructions were provided by a pulmonologist (65%), general practitioner (23%), pharmacist (4%), nurse (4%) and therapeutic education program (4%). The interviews revealed that 71% of patients were not familiar with the prescribed molecules or their mechanism of action. Out of the 34 DI manipulations, only 15% were performed perfectly, and 27% were not executed properly. The steps of deep exhalation before inhalation and breath-holding after inhalation were not performed in 70% and 62% of observations, respectively. Finally, 50% of patients did not rinse their mouths after using inhaled corticosteroids.

What next?

This study has highlighted the improper use of DIs, which can lead to a loss of therapeutic effectiveness. Therefore, we have developed 9 information booklets on the correct use of the DIs that describe different handling procedures for proper inhalation. These booklets are provided at the end of the interview. Educating patients on the proper use of these inhalation devices during the initial prescription or dispensing should lead to an overall improvement in patient care.

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Author(s)

RAQUEL AGUILAR SALMERÓN, LÍDIA MARTÍNEZ SÁNCHEZ, ANNA MARIA JAMBRINA ALBIACH, NEUS RAMS PLA, MANEL RABANAL TORNERO, MARIA ÀNGELS GISPERT AMETLLER, MILAGROS GARCÍA PELÁEZ, NÚRIA PI SALA, SANTIAGO NOGUÉ XARAU

Why was it done?

HTDs in infants are defined as those that might cause severe or lethal poisoning in children. Some HTDs are considered “one pill killers”: those in which the ingestion of one unit, a single tablet or tablespoon, in an infant with a body weight of 10 kg, could be fatal. In Spain, there are 29 active ingredients (from seven therapeutic groups) considered “one pill killers”. Counseling and information are crucial activities developed by pharmacists that could help to avoid fatal intoxications.

What was done?

A virtual and interactive course for pharmacists was designed to improve knowledge about highly toxic drugs (HTDs) in infants and potentially fatal intoxications. The education platform integrates microlearning and gamification methodologies, and the course could be followed via web or smartphone.

How was it done?

A group of experts, including toxicologist paediatricians and clinical pharmacists, carried out a literature review and determined the toxic dose for HTDs. They also determined the number of units (considering the most concentrated presentation) needed to achieve the potentially fatal dose in a 10 kg infant. A virtual microlearning platform (Snackson®) was chosen, and specific training content was designed. It will be offered to community pharmacists by our Catalan Ministry of Health.

What has been achieved?

This project has enhanced the collaboration between the group of experts and the Catalan Ministry of Health. An agreement has been signed, and, in this frame, the educational activity has been offered (Autumn 2023) to 250 community pharmacists.
A list of HTDs has been published (DOI: 10.1016/j.anpede.2020.02.007).
A video was recorded, addressed to the general population to inform them about the existence of HTDs. This video is a divulgation tool with recommendations to prevent drug poisoning and is periodically broadcast in the waiting rooms of health centers.
(https://www.youtube.com/watch?v=uSHDRte7Nr8&t=14s).

What next?

The next objective will be to evaluate the impact of the training activity on community pharmacists and the usability of the virtual microlearning platform. Future plans also include the expansion of this education tool to other regions in Spain, and to explore the application of microlearning methodology to other areas of knowledge.

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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)

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.

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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.

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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.

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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.

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.

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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.