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INTEGRATED STRATEGY FOR THE MANAGEMENT OF MEDICINE SHORTAGES: INFORMATION, COORDINATION AND PATIENT SAFETY

European Statement

Selection, Procurement and Distribution

Author(s)

N. El Hilali Masó
B. García Javier
R. Merino Mendez
M. Sancho Riba
A. González Bote
J. Fabregas Cortes
R. Diez Hernandez
F. Sala Piñol

Why was it done?

Medicine shortages are increasingly frequent and represent a critical challenge for hospital pharmacy services. These shortages can impact both the procurement and use of medication, potentially compromising patient safety. The introduction of alternative presentations or therapeutic options may lead to errors, particularly dosing errors or issues related to look-alike/sound-alike medicines.
Furthermore, the growing number of outpatient referred from community pharmacies due to shortages increases the pressure on hospital pharmacies and may delay treatment access for patients.

What was done?

Define a system that unifies and updates information on shortages and ensure accurate and timely communication of therapeutic alternatives and associated risks to healthcare professionals and reduce the risk of medication errors associated with alternative drugs. Likewise, a communication channel has been established to strengthen coordination with community pharmacies for the dispensing of medicines to outpatients.

How was it done?

An internal file was created to monitor active shortages and available alternatives for both inpatients and outpatients. When a substitution posed a risk related to prescribing or administration (e.g. dosage errors or look-alike/sound-alike) informative sheets were developed as a preventive measure to reduce medication errors.

What has been achieved?

Unify and update available information. 55 medicine shortages were actively managed through the implemented system. Three information sheets have been prepared to prevent administration errors (nitroglycerin, amiodarone, cotrimoxazole). Pharmacist staff have rapid access to validated information that allows healthcare professionals to take faster and safer clinical decisions. This has also improved collaboration with community pharmacies to enhance the outpatient access to needed medicines, reducing delays and patient burden.

What next?

Integration with the new hospital IT system will enable automated alerts and direct access to therapeutic alternatives through Pharmacy program.
Plans are in place to expand the network of collaborating community pharmacies, allowing patients to collect medicines locally during shortages, reducing unnecessary hospital visits and improving continuity of care. Monitoring and evaluation processes will be established to track the impact of this strategy on patient safety and healthcare efficiency.

TRANSFORMING MEDICATION RECONCILIATION: PHARMACY-ASSISTED PROCESSES IN LARGE ACADEMIC MEDICAL CENTER

European Statement

Patient Safety and Quality Assurance

Author(s)

Victoria Lubarsky, Jacalyn Rogers, Nataly Kuchik

Why was it done?

Accurate home medication history and admission reconciliation are critical during care transitions to prevent harm. In my hospital, the medication history team reviews over 85% of daily admissions, yet providers often face challenges with timely reconciliation. To address this, the pharmacy team proposed a dual-approach initiative: provider education to support reconciliation within 24 hours of admission, and a pharmacy-assisted process enabling pharmacists to reconcile select medications or collaborate with providers to finalize reconciliation.

What was done?

This initiative aimed to meet the hospital’s quality goal of achieving 90% completion of accurate admission medication reconciliations within 24 hours. A retrospective observational study was conducted over nine months in 2024. Data collected was quantitative, focusing on medication reconciliation completion rates, pharmacist interventions, and provider engagement. Descriptive statistics analyzed trends and measured improvements in reconciliation rates.

How was it done?

A dual-strategy approach was implemented: provider education and pharmacy-assisted workflow. A standardized flow sheet and enhanced EMR patient lists improved provider visibility. A new procedure and dashboard enabled pharmacists to identify incomplete medication reconciliations within 24 hours and intervene by reconciling select medication classes (e.g., OTCs, supplements, duplicates, long-acting meds), communicating via secure chat to resolve discrepancies, and documenting post-reconciliation additions in pharmacy notes. Prior to admission, home medication lists were reviewed by pharmacy technicians using the MARQUIS framework to support reconciliation accuracy.

What has been achieved?

A quantitative analysis using descriptive statistics was conducted to evaluate changes in medication reconciliation completion rates before and after implementing the initiative. • Overall reconciliation completion rates increased by 30 percentage points, from 52% to 82% over nine months • The pharmacy team’s consistent contribution accounted for 15% of the total improvement • Provider education accounted for an additional 15%, with 13% from pharmacy’s provider outreach and 2% from education initiatives and process awareness.

What next?

This initiative demonstrates the effectiveness of provider education and pharmacy-assisted processes in improving timely and accurate medication reconciliation outcomes and patient safety during care transitions. Future directions include expanding pharmacy-assisted hours and replicating the model across additional hospital sites to broaden impact and strategize best practices.

FAILURE MODE AND EFFECTS ANALYSIS OF A TERTIARY LEVEL HOSPITAL ANTIDOTE STORAGE

European Statement

Patient Safety and Quality Assurance

Author(s)

Sánchez Suárez MM¹, Montero Lázaro M², Martín Roldán A², Maganto Garrido S², Sánchez Sánchez MT²
Affiliations
¹Pharmacy Department, Hospital Comarcal de Baza, Granada, Spain
²Pharmacy Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain

Why was it done?

Antidote availability is critical for the management of poisoning and overdose cases. Although hospital protocols for antidote use exist, they are often inconsistent or incomplete, and there is no universal consensus on the essential antidotes that hospitals should stock. This initiative aimed to assess and optimise the antidote inventory in a tertiary hospital to ensure adequate supply and management.

What was done?

A comprehensive review of all antidotes stored in the hospital pharmacy was conducted, focusing on quantity, expiry date, and compliance with national and international recommendations. A failure mode and effects analysis (MFEA) was developed to identify potential risks and propose corrective measures.

How was it done?

A prospective cross-sectional study was performed. The antidote stock was compared with reference lists from other hospitals and published guidelines to evaluate discrepancies in composition and quantities. Data accuracy in the electronic stock records was assessed, and errors in inventory management were categorised. Improvement actions included updating the antidote list, correcting electronic records, defining minimum and maximum stock levels, and implementing a poisoning management protocol. One year after these measures, the stock was re-evaluated.

What has been achieved?

The initial audit identified 48 antidotes (3 compounded formulations); 10% were out of stock, 16% below the required minimum, and 2% expired. Digital record review revealed 64% with data inconsistencies, including missing quantity limits, mismatched real and computerised stock, and incorrect expiry or batch details. After implementing corrective actions, no expired antidotes were found, only two compounded formulations were missing, and all others met minimum stock requirements.

What next?

Continuous monitoring of antidote stocks and regular data validation are necessary to maintain readiness for toxicological emergencies. Extending this model to other hospitals could support the establishment of unified national standards.

IMPLEMENTATION OF STANDARDIZED PRESCRIPTION AND LABELLING IN THE CARDIAC SURGERY OPERATING ROOM

European Statement

Patient Safety and Quality Assurance

Author(s)

Elisabetta Volpi, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Irene Benassi, Specialisation school in Hospital Pharmacy, University of Pisa;
Sara Tonazzini, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Giuseppa Lo Surdo, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Mario Cossu, Information systems and information technologies, Fondazione Toscana Gabriele Monasterio
Maurizio Mangione, Information systems and information technologies, Fondazione Toscana Gabriele Monasterio
Mattia Lorenzini, Nursing, Technical and Rehabilitation Service, Fondazione Toscana Gabriele Monasterio;
Stefania Baratta, Nursing, Technical and Rehabilitation Service, Fondazione Toscana Gabriele Monasterio;
Pierantonio Furfori, Anesthesia and Resuscitation Unit, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Paolo Del Sarto, Anesthesia and Resuscitation Unit, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio;
Stefania Biagini, Hospital Pharmacy, Ospedale del Cuore, Fondazione Toscana Gabriele Monasterio.

Why was it done?

Most preventable adverse events occur during medication use, especially with intravenous (IV) drugs requiring preparation before administration. Furthermore, for infusions, proper labelling is critical to reduce the risk of medication errors.

What was done?

Our hospital has used an electronic therapeutic record (eSTU) for over 10 years. In 2020, a multidisciplinary team of anesthesiologists, pharmacists, nurses and health IT specialists developed a dedicated module to ensure traceability of drug prescribing and administration in the operating room, focusing on cardiac surgery. At the same time, infusion syringe labelling evolved from handwritten to computerized labels, improving safety and traceability. This study aimed to assess impact of a standardized electronic prescribing and labelling system.

How was it done?

All standardized IV prescriptions issued during cardiac surgeries between 2021 and June 2025 were included in the analysis. Prescriptions were categorized by administration mode (bolus or infusion) to assess healthcare professionals’ adherence to the standardized prescribing system. A qualitative evaluation of labels applied to infusions was also performed.

What has been achieved?

The standardized prescription system was used in 5.272 procedures (4.542 adults; 730 pediatric), averaging 1.009 adult and 162 pediatric surgeries per year. A total of 93.291 prescriptions were recorded (81.861 in adults, 18 per procedure; 11.430 in pediatric cases, 16 per procedure), with a progressive increase from 18.211 prescriptions in 2021 to 20.955 in 2024 (+15.1%). These results confirm the system’s usability and effectiveness of staff training. Qualitative analysis of labelling practices initially showed syringe labels were handwritten and included limited information (e.g., drug name, concentration). With the computerized system, printed labels now contain detailed data: drug name, identifying code, dose, diluent, concentration, preparation date and time.
Our data demonstrate, for the first time, that the adoption of a standardized prescription system in cardiac surgery is an effective strategy, offering a fast, safe and user-friendly approach. Furthermore, computer-generated labelling ensures complete traceability and reduces the risk of medication errors.

What next?

Growing adoption of standardized prescription in both adult and pediatric cardiac surgery confirms its feasibility in high-complexity settings. Extending this system to other surgical areas (e.g., Gynecology, Hemodynamics, Electrophysiology) may further enhance medication safety across the hospital.

SYSTEMATIC PHARMACEUTICAL REVIEWS IN THE DISPENSING OF RESERVE ANTIMICROBIAL DRUGS

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European Statement

Clinical Pharmacy Services

Author(s)

Tea Stiplošek, Alenka Kovačič

Why was it done?

The growing misuse of antimicrobials, resulting in resistant microorganisms and more adverse reactions, has been identified as a significant concern. To tackle this issue, a system was put in place to systematically monitor the hospital’s dispensing and use of reserve antimicrobials.

What was done?

We established a system where each reserve antimicrobial prescription in the hospital is reviewed by a pharmacist, who decides whether to dispense the drug or suggest therapy adjustments. The dispensation of antimicrobial drug to the patient is then recorded in the patient’s medical documentation.

How was it done?

A special prescription form has been prepared, used exclusively for ordering reserve antimicrobials from the pharmacy in our hospital, separate from other medications. The form is reviewed by a pharmacist, who calculates the patient’s creatinine clearance, examines inflammatory markers, checks the alignment of treatment with the antibiogram, and reviews potential interactions with other therapies before deciding whether to dispense the drug. If necessary, the pharmacist suggests modifications to the antimicrobial treatment. Each time the antimicrobial is dispensed, it is recorded in the patient’s medical documentation for easier treatment tracking.

What has been achieved?

This approach has established systematic control over the prescription of reserve antimicrobial drugs, with a clinical pharmacist introducing an additional prescription checkpoint. Analysis of data from our work between 2020 and 2023 shows that during this period, we dispensed 16,464 courses of reserve antimicrobials, with pharmacists recommending therapy adjustments in 2,211 cases (13.6%). On average, we recommended dose reductions in 43.5% of cases due to impaired kidney function and dose increases in 23.5% due to improved kidney function or the need for appropriate dosing for specific indications. Pharmacokinetic monitoring (TDM) interventions, including those for vancomycin, amikacin, and gentamicin, accounted for 29.75% of the interventions, while 3.35% of our recommendations involved therapy changes due to inappropriate treatment based on antibiograms or the patient’s impaired kidney function.

What next?

We are digitizing the ordering system, allowing departments to request antimicrobial drugs directly through the hospital information system. We are also developing an application to calculate kidney function and verify the correct antibiotic dosage for each patient, all in one place.

Development of a new method for risk assessment related to management of clinical trials in hospital pharmacy: classification of protocols by risk index (ρ) and development of strategies for errors’ minimization

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European Statement

Patient Safety and Quality Assurance

Author(s)

Giulia CANCELLIERI, Piera POLIDORI

Why was it done?

Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.

What was done?

With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.

How was it done?

In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.

What has been achieved?

We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.

What next?

We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.

Reconciliation of weekly methotrexate for non-oncologic use: results from a prospective cohort

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European Statement

Clinical Pharmacy Services

Author(s)

Adrian Viudez-Martinez, Ana Ramirez-Lopez, Javier Lopez-Nieto, Geronima Riera, Eduardo Climent-Grana

Why was it done?

Medication errors harm at least 1.5 million people every year. According to the Institute for Safe Medication Practice (ISMP), ongoing errors with oral methotrexate (MTX) for non-oncologic use suggest that more needs to be done to reduce the risk of patient harm, especially considering its potentially severe side effects.

What was done?

Identification and prevention of MTX-related medication errors for non-oncologic use by medication reconciliation at hospital admission. Analysis of errors’ type prevalence were also performed.

How was it done?

Design: prospective cohort performed in a tertiary hospital from September 2021 to April 2023.
Inclusion criteria: Inpatients with weekly methotrexate for non-oncologic use.
Intervention applied: medication reconciliation comparing inpatient’s e-prescription, clinical record, outpatient medication history and pharmacist-driven interview.
Data analysed: demographic data (age, sex, admission cause) treatment-related data (indication, methotrexate and folic acid posology, administration route, day of the week).

What has been achieved?

Out of 79 admission episodes (53.1 % men, median age: 72 years (range: 18-96 years), 63 (80% )were urgent.
Most patients had been prescribed methotrexate for rheumatoid arthritis (n=56), but also for polyarthritis (n=9), psoriatic arthritis (n=8), pulmonary sarcoidosis (n=2), pemphigus (n=1), spondylarthritis (n=1) and Still syndrome (n=1).
Methotrexate doses’ frequency were: 15 mg (28.9%), 10 mg (27.6%), 20 mg (11.9%), 7.5 mg (9.2%), 25 mg (7.9%), 12.5 mg (6.6%), 17.5 mg (5.3%) and 5 mg (2.6%).
Medication errors were identified and prevented in 38 out of the 77 episodes recorded (49.4%). There were classified as follows: dose (38.5%), day (17.9%), dose and day (17.9%), dose and administration route (10.3%), omission (10.3%), administration route (2.6%) and lack of indication (2.6%).
Folic acid doses’ frequency was: 10 mg the day after MTX (47%), 5 mg the day after MTX (28%), 5 mg daily except the same day as MTX (17%), 15 mg the day after MTX (8%).

Medication errors were identified and prevented in 51 out of the 77 episodes recorded (66.2%). There were classified as follows: omission (38.8%), day (33.3%), day and dose (16.7%), dose (9.3%) and drug (1.9%).

What next?

Performing medication reconciliation in every admission, measuring its potential benefits using validated tools for clinical pharmacists’ intervention assessment, such as the CLEO tool, which can, ultimately, serve as preamble to objectively measure the pharmacists’ impact in healthcare efficiency and patients’ safety.

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.

Nationwide German standardised concentration list for continuous infusions in intensive care patients

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European Statement

Patient Safety and Quality Assurance

Why was it done?

In intensive care patients, numerous drugs are continuously administered. Standardised concentrations and dose adjustment by infusion rate are recommended to minimise medication errors, e.g., by the EAHP Special Interest Group for investigating Medication Errors in Intensive Care Units. This principle is also followed more and more in German hospitals. However, there is a lack of a national standardised concentration list.

What was done?

The joint working group aimed to develop and implement a nationwide standardised concentration list for continuously administered infusions in intensive care patients in German hospitals.

How was it done?

A joint working group of the German Society of Hospital Pharmacists (ADKA e.V.) and the German Interdisciplinary Association of Intensive and Emergency Care (DIVI e. V.) compiled a nationwide continuous infusion standard for intensive care patients. Based on a national survey conducted in 2021, a list of plausible, commonly used drugs and concentrations was compiled. Drugs and concentrations to be listed were further evaluated in a multi-stage process based on predefined criteria (e.g. volume sparing concentration, one concentration per drug [where applicable], preferring ready-to-use medication, operational considerations).

What has been achieved?

A joint working group of the German Society of Hospital Pharmacists (ADKA e.V.) and the German Interdisciplinary Association of Intensive and Emergency Care (DIVI e. V.) compiled a nationwide continuous infusion standard for intensive care patients. The national continuous infusion standard encompasses 41 drugs and 49 standard concentrations, recommended vehicle solutions and data on the physicochemical stability of the infusions during administration. Thirty-seven active substances are listed with one concentration, heparin with two concentrations, epinephrine and sufentanil with three concentrations, and norepinephrine with four.

What next?

Healthcare professionals in German intensive care units are encouraged to adopt this standardised concentration list to improve medication safety. Flowcharts provided by the working group will facilitate the implementation of the defined standard concentrations.

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