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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.

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.

Implementation of a protocol to ensure continuity of pharmaceutical care in hospitalised outpatients

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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

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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.

Safety Team, a team to promote a safety culture in the Pharmacy Service

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European Statement

Patient Safety and Quality Assurance

Author(s)

Laura Doménech Moral, Raquel López Martínez, Maria Eugenia Palacio Lacambra, Emili Vallvé Alcon, Ángel Arévalo Bernabé, María Guerra González, Maria Queralt Gorgas Torner

Why was it done?

At PS Vall d’Hebron, one of our strategic objectives is to enhance the patient safety culture internally and externally within PS.

What was done?

Establishment of a core safety team within the Pharmacy Service (PS) with representatives from various areas and positions, along with established activities and indicators: the Safety Team.

How was it done?

By organising internal meetings of the Safety team to manage, lead, and plan activities related to medication safety. These activities include:
Advising on and/or managing medication safety incidents reported to the Patient Safety Incident Notification System of Catalonia (SNiSP) Vall d’Hebron.
Conducting biweekly “5 minutes of safety” meetings between pharmacy technicians and a member of the Safety team in the General, Maternal-Infant, Trauma, Outpatient, and Oncology-Haematology areas. In each meeting, the minutes from the previous one are reviewed to report on agreements and progress related to the topics discussed. Incidents reported to SNiSP related to medication dispensing and logistics are discussed, and there is an open discussion for technicians to share safety issues, questions, and medication-related incidents. These situations (reported incidents and those detected by technicians) are collectively analysed to propose prevention measures. Minutes of each meeting are documented and made available in a shared resource.
Weekly “safety pearls” presentations where sentinel medication incidents are presented, along with root cause analysis, by a representative of the Safety team. Situations that have led to medication incidents/errors in prescription and treatment validation are also discussed, along with proposed prevention measures by other PS members.
Conducting sessions related to safety during PS Sessions to present the actions taken by the safety core team and its collaboration with the Hospital’s Error Prevention Subcommittee.

What has been achieved?

More than 100 medication incidents reported to SNiSP have been managed.
Over 50 meetings with PS technicians, resulting in more than 45 improvement actions derived from notifications and detected issues, such as creating infographics for proper medication identification (everolimus, vitamin D), improving the urgent medication dispensing process without a prescription, or enhancing the management of “off-label” medications.
Around 20 safety pearls involving all pharmacists, leading to the creation of protocols, default guidelines, and updates to prescription and administration advice in the prescription programme.
Two annual patient safety-related sessions.

What next?

Continuing to enhance the safety culture through sessions and meetings involving various stakeholders, implementing an online medication error prevention course, and expanding the team.

Evaluation of microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices

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European Statement

Production and Compounding

Author(s)

Timea Botházi, Lone Madsen

Why was it done?

The purpose was to find data for an increased microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf-life from 24 hours to 7 days. Existing data were studied to find evidence to support the prolonged shelf-life.

What was done?

The purpose was to find data for an increased microbiological shelf life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf life from 24 hours to 7 days. Existing data was studied to find evidence to support the prolonged shelf life.

How was it done?

A team from the production and quality assurance departments worked together on writing a report that could provide the rationale for the change of shelf-life.
We collected data from
– supplier qualification of the medical devices
– aseptic process simulations (APS)
– process validations
Data were evaluated and risk assessment was performed.
Six medical devices were included.
All suppliers were qualified as low risk.
APS for the specific production process showed no growth.
Process validation data for two types of medical devices showed no concern regarding sterility of preparations.

What has been achieved?

The increase of shelf life was accepted. First product was Blincyto® in infusion bag with Take Set Swan-Lock ® with shelf life increased to 4 days. Patients now visit the oncology clinic only twice a week instead of daily thus saving time and transportation.

What next?

The result means that new product implementation is quick because the only things to evaluate are the stability of the substance and the compatibility of this with materials in contact with it.

Supply difficulties in oxygen humidifiers: an opportunity to promote good practice

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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.

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.

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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.