Pdf

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.

Pdf

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.

Pdf

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:

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.

Pdf

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

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

Author(s)

Catarina Diogo, Rui Caceiro, Maria Helena Duarte, Armando Alcobia

Why was it done?

The core objective of healthcare institutions is to ensure patient safety and maintain the highest quality of care throughout every medical procedure.
This principle must extend to the drug circuit as well. Within our hospital, pharmaceutical services have a dedicated route for producing injectable ophthalmic medications, serving 795 patients and yielding 3720 solutions, in 2022. However, the existing paper-based procedure for medication management is laborious, time consuming and error-prone, demanding full-time constant pharmacist involvement to ensure the secure progression of these medications.

What was done?

A software application was developed on the Power Apps platform to streamline medication management for injectable ophthalmic medications. This application aimed to replace manual paper-based procedures with digital solutions, enhancing efficiency, reducing errors, and providing a comprehensive platform for patient registration, prescription tracking, schedule management, and oversight of injectable solutions’ production.

How was it done?

Over two months, needs of pharmaceutical and ophthalmology services were assessed, soliciting input from pharmacists, ophthalmologists, nurses and administrative personnel. Subsequently, a software application was developed featuring four distinct interfaces, customised for each professional group involved. This application enables patient registration, medical prescription, schedule management and monitoring the injectable solutions’ production – prescription and agenda validation, batch management and generation of identification labels.
This project is presented, therefore, as a customised digital solution, the result of a multidisciplinary collaboration.

What has been achieved?

It is the authors’ belief that this software has allowed for the development of a safer, more efficient, and integrated workflow, as an alternative to paper – which is more prone to errors. In this manner, from a pharmaceutical perspective, it simplifies the workflow, freeing the pharmacist to focus on other important tasks and optimizing personnel management. Furthermore, it is also valuable for ophthalmologists, enabling prescription repetition and access to patient history, as well as for administrative staff, streamlining schedule management. In conclusion, this software is set to transform our injectable ophthalmic medication circuit.

What next?

Further studies confirming its advantages are needed. Its validation would establish its potential and applicability across healthcare settings.

Pdf

Author(s)

Lene Juhl Biltsted, Louise Stilling Rasmussen

Why was it done?

In Denmark, patients with schizophrenia receive free antipsychotic medication for the initial two years post-diagnosis. Post this period, patients transition to the primary sector and assume the medication costs. Historically, the clinic dispensed larger medication quantities, offering short-term relief but not addressing the issue. This approach risks medication waste. The new workflows empower healthcare professionals to help patients establish stable financial arrangements with local pharmacies, curbing fluctuating medication expenses. This enhances patient safety by reducing at-home medication stockpiles. Financial barriers often undermine patient compliance. Healthcare professionals strive to aid patients, curbing relapses and readmissions, through rational, sustainable medication management that minimises resource wastage.

What was done?

Training improved healthcare professional’s understanding of the Danish medication subsidy system and options for deferment in the primary sector.
The healthcare professionals’ new knowledge has provided the foundation for the development of optimised workflows in the treatment process, ensuring a more sustainable medication management during the transition to the primary sector. The project establishes the framework for reducing the risk of medication waste upon the patient’s completion of treatment at the clinic.
It also created a favourable setting for healthcare providers to collaborate with patients, enhancing adherence.

How was it done?

Healthcare professionals received training on deferment arrangements, subsidies, and compliance, with supervision from clinical pharmacists.
Patient cases were analysed to determine factors for future guidelines.
Guidelines were formulated to aid healthcare professionals during the patients’ transition to the primary sector.
A tool (calculator) was created for assessing the patients’ economic choices regarding medication expenses.

What has been achieved?

Healthcare professionals gained confidence in guiding patients on stable medication expenses.
Enhanced rational and sustainable medication use by incorporating the seven rights.
New guidelines now allow an appropriate quality assurance strategy to ensure sustainability and adherence.
Tool to assess medication costs which improves the patients adherence in the sector transition.
Lowered risk of over/under treatment and improper storage.
Diminished treatment failure risk by predicting patient medication expenses during the primary sector transition

What next?

In the next 6 months, the clinic will trial the established guidelines and routines with patients concluding their 2-year treatment.

Pdf

Author(s)

MARÍA ELENA CÁRDABA GARCÍA, SILVIA FERNÁDEZ PEÑA, AMPARO SALVADOR PALACIOS, MERCEDES FERNÁNDEZ PRIETO, CLAUDIA GONZÁLEZ GONZÁLEZ, MARÍA TERESA SÁNCHEZ SÁNCHEZ

Why was it done?

Antineoplastic drugs, chemotherapy specifically, are a clear example of “high risk” medications. The drug administration phase, within the drug utilisation circuit, is where the highest incidence of errors has been detected, ranging between 38%-81%, so the development and implementation of tools aimed at improving security at this stage is very important.

What was done?

The integration of Farmis-Oncofarm ® and Oncosafety-RC® pharmacy software was done, in order to improve the prevention, detection and reduction of medication errors in the administration phase of antineoplastic treatment in the Onco-Haematology Day Hospital (OHDH).

How was it done?

A Drug Library was created in Farmis-Oncofarm® software (v.4.0.11.107). Dosage units, stability, standard concentrations, maximum and minimum doses, time and infusion rate, and preparation and administration recommendations were parameterised and standardised. Parameters for the implantation of Oncosafety-RC® software (accepted percentage of volume deviation in the mixtures, types of intravenous lines, possible adverse reactions, drugs to be used in case of extravasation) were also defined. When the connectivity between Farmis-Oncofarm® and Oncosafety RC® was validated, Oncosafety RC® was implemented in the OHDC.
To evaluate the results of the implementation of this strategy, a retrospective study from May 2022 to May 2023 was carried out. Collected data, obtained from Oncosafety RC® software were: number of mixtures (antineoplastic, supportive drugs and intravenous fluid therapy) and treatments administered, dose deviations, adverse events, incorrect infusion rates, errors avoided due to incorrect medication.

What has been achieved?

12,294 treatments (44,898 mixtures) have been administered in OHDC.
Dose deviations were registered in the 0.01% of the mixtures, due to adverse events that required termination of the infusion. Only three adverse events happened in the study period.
The infusion rate was incorrect in the 0.5% of the mixtures; this information is useful to improve drugs administration and prevent infusion-associated reactions.
This strategy prevented errors due to incorrect medication on 2,499 occasions.

What next?

The integration between Farmis-Oncofarm® and Oncosafety RC® has improved the security in the administration of onco-haematological treatments, allowing the reduction of administration and medication errors. This strategy can be implemented in hospitals that have assisted electronic prescription software and information management software between different clinical management systems and infusion pumps.