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A strategy to prevent weekly methotrexate medication mistakes in a regional health service

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European Statement

Patient Safety and Quality Assurance

Author(s)

Vanesa Alonso Castro, Pablo Jimenez Moreno, Marta Alcaraz Borrajo, Angel Luis Mataix Sanjuan, Beatriz Casamayor Lázaro, Maria Dolores García Cerezuela , Cristian Rosas Espinoza, Beatriz Santos Mena, Estrella Maroto García, Beatriz López Centeno, Daniele Alioto, María Jose Calvo Alcántara

Why was it done?

MTX is an immunosuppressor drug utilised in certain types of cancer and inflammatory diseases. Its dosage and frequency of administration varies depending on indication.
Throughout the years, medication errors (ME) have been reported at national and supranational levels where patients have received excessive doses (the most common being daily administration of the drug rather than weekly) with severe consequences for the patients, including death.
In our RHS, 222 ME related to MTX have been reported in the last 5 years,seven of them resulted in harm to the patient.

What was done?

An integral strategy to ensure the correct prescribing of weekly Methotrexate (MTX) was developed in a Regional Health Service (RHS).

How was it done?

1st PHASE (May 2021):
a. Monthly reporting to prescribers of their patients affected by duplicated prescriptions or incorrect dosing instructions for review and amending. These reports are available on the IT platform that collates prescribing indicators.
b. Development and dissemination of training materials to correctly prescribe medications with non-daily dosing instructions in the RHS electronic prescription tool.
2nd PHASE (After two years of follow-up):
a. Request to implement ME prevention plans (MEPP) to the hospitals of the RHS.
b. Creation and dissemination of informative material for patients and/or caregivers, where the weekly dosing instructions is emphasized.

What has been achieved?

Incidence of MTX prescribing mistakes: When this strategy was implemented, prescriptions for 2388 patients had been identified as potential mistakes. 1 year later, the incidence had diminished by 78.1% (2146 cases were resolved, 242 were still active and 310 were new). 2 years later, the incidence remained stable with a reduction of 78.5% thoroughout the whole period and 514 patients affected (150 new MTX prescribing mistakes in the last year).
• MEPP implantation (2nd PHASE): In two months, six hospitals (17.6% of all) implemented a MEPP. The key strategies that should be included in the MEPPs were disseminated to all hospitals by our team.

What next?

Thanks to this strategy, MTX prescribing mistakes have fallen by 78.5% in two years. However, prescribing mistakes continue to be made, which demonstrates the need for continuous training and awareness raising among prescribers to prevent ME related to MTX.

Implementation of a multidisciplinary circuit for the management of haematologic patients under treatment with bispecific antibodies

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European Statement

Patient Safety and Quality Assurance

Author(s)

Carla Noguera-Jurado, Alba Manzaneque, Gloria Molas, Genis Castells, Sandra Jara, Bernat Tenas, Jordi Nicolas

Why was it done?

Bispecific antibodies (BA) have the ability to specifically bind two different antigens, thereby presenting specificity for two different cells. Among the toxicities associated with these drugs are cytokine release syndrome (CRS) and immunoeffector cell-associated neurotoxicity syndrome (ICANS), the management of which requires multidisciplinary action. The purpose of this circuit is to ensure adequate management of these toxicities to guarantee patient safety.

What was done?

Creation of an action plan for haematological patients treated with bispecific antibodies for the detection and proper management of their toxicities.

How was it done?

A multidisciplinary team formed by Pharmacy, Haematology, Nursing, Intensive Care Medicine and Neurology was created and the healthcare professionals involved were specifically instructed. Moreover, an action circuit was implemented for the detection and management of these toxicities, and a specific protocol was created for the preparation and dispensing of tocilizumab. The protocol contemplated: centralisation of the preparation in the pharmacy department (within the pharmacy hours) or preparation in the hospitalisation ward by trained professionals using a kit previously prepared by the pharmacist (containing drug, serum and closed system dispositive for the preparation and administration of tocilizumab outside pharmacy hours).

What has been achieved?

From July 2022 to August 2023, a total of five patients have been treated with BA in our institution (elranatamab (4/5), and teclistamab (1/5)), including clinical trials and compassionate use, for Multiple Myeloma.
Three patients presented grade 1 CRS in the first cycle of treatment, which was resolved with symptomatic therapy, with no need for tocilizumab administration in any case. In addition, one also presented grade 1 ICANS, which only required monitoring without treatment.
The availability of the toxicity management circuit, in addition to staff training, allowed toxicities to be detected and resolved early and, if tocilizumab had been needed, the circuit would have ensured its immediate availability.

What next?

The implementation of a multidisciplinary care circuit led by pharmacy and haematology guarantees the adequate management of toxicities associated with the treatment, ensuring the best quality of care for the patients and their safety.

Design, build and implementation of electronic prescribing and medicines administration in neonatal units across four UK hospital trusts

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European Statement

Introductory Statements and Governance

Author(s)

Holly Jones, Nicola Vosser

Why was it done?

Neonatal units were out of scope during the initial EPMA go-lives due to the complexities in prescribing and the specialist resource required for implementation. This project therefore brought neonatal units in line with all other areas, transitioning from paper drug charts to EPMA. In addition, it supported an ICS wide goal to align practice between trusts, standardising prescribing and facilitating effective use of digital systems in healthcare.

What was done?

A neonatal formulary was developed on an existing Electronic Prescribing and Medicines Administration (EPMA) system shared by four hospital trusts that make up a regional Integrated Care System (ICS). This involved interdisciplinary collaboration and shared decision making to align practice and prescribing guidelines. Complex protocols included continuous variable rate drug infusions, intravenous fluids and parenteral nutrition.

How was it done?

Key guidelines were shared with a collaborative approach to identify and harmonise differences in local practice, including syringe volumes and dose calculation ‘factors’. The EPMA team (comprising specialist pharmacists and medicines management technicians) completed a thorough gap analysis of the existing adult and paediatric drug catalogue and managed all new build work for neonates. Clinical decision making and validation were multidisciplinary tasks with input from specialist clinicians, pharmacists and nurses. Training, go-live planning and implementation were led by the EPMA team.

What has been achieved?

A bespoke neonatal medication build has been successfully implemented, supporting safe and efficient prescribing in neonates across the ICS. The development provides the ability to prescribe medications and document administration clearly and safely, including adjustment of infusion rates. Clinical pharmacists have full visibility of this information and are able to accurately complete pharmacy reviews, interventions and verification. In addition, alignment of practice and standardisation of care has been reached across the ICS, with benefits to both staff and patients.

What next?

The neonatal build is updated and optimised based on feedback from users to maintain the usability and safety of the system. Development of electronic fluid balance charts for neonates, including drug infusion volumes, is also in progress. Details of the neonatal project are being shared with other UK hospital sites using the same EPMA system.

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.

De-prescription initiative for anti-dementia drugs in a sociosanitary centre

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European Statement

Patient Safety and Quality Assurance

Author(s)

Paula Torrano Belmonte, Lydia Fructuoso González, Juan Antonio Gutierrez Sanchez, María Hernández Sánchez , Adrián Martínez Orea, María Guillén Diaz, Cristina Portero Ponce, Alicia Sánchez Blaya , Teresa Alonso Dominguez

Why was it done?

According to Spanish guidelines, medication deprescription would be recommended in the following situations: in the advanced or terminal phase of the disease with a global loss of cognitive and/or functional abilities; in patients who do not experience any benefit; in the presence of intolerable adverse effects or interactions with concurrent treatments. The dose will be progressively reduced every 4 weeks.

What was done?

We designed a project to deprescribe drugs used for dementia in patients at one of the sociosanitary centers (SSC) affiliated with our hospital. The drugs currently used in Spain are: donepezil, rivastigmine, and galantamine for mild to moderate stages, and memantine for moderate to severe stages.

How was it done?

Pharmacists conducted a search using the Savac® pharmaceutical management programme among all residents of the SSC who were prescribed anti-dementia drugs. Once eligible patients were identified, medical team was notified through the electronic prescription programme.

What has been achieved?

According to the previously detailed criteria, there were a total of four eligible patients: one of them was on rivastigmine patch treatment, and the other three were on oral memantine. The results in the first month were not very positive, as an attempt to withdraw memantine from one patient had to be reversed due to aggression issues. Another patient on memantine sadly passed away, and the remaining two, on memantine and rivastigmine, continued with the medication due to potential benefits.

After 10 months of work, the results have been quite promising, and we have successfully completed more withdrawal protocols for other CSS patients. Medication was deprescribed for three patients: one on donepezil and two on memantine. Another patient on rivastigmine is currently in the dose reduction phase.

What next?

Our goal is to achieve the appropriate prescription of anti-dementia drugs, in order to maximise benefits for patients while minimising adverse effects and rationalising public resources.

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

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European Statement

Clinical Pharmacy Services

Author(s)

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

Why was it done?

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

What was done?

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

How was it done?

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

What has been achieved?

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

What next?

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

Implementation of a new work circuit in monography consultation of immune-mediated diseases of the pharmacy service

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European Statement

Patient Safety and Quality Assurance

Author(s)

ALBA MARIA MARTINEZ SOTO, MARIA ONTENIENTE CANDELA, CARLES INIESTA NAVALON, PATRICIA ORTIZ FERNANDEZ, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, ANABEL HERREROS HERNANDEZ, GEMMA MARTINEZ SOTO, CARMEN CABALLERO REQUEJO, MAYTE GIL CANDEL, ELENA URBIETA SANZ

Why was it done?

– Guide the pharmacist in the development of an individualised follow-up strategy for patient evaluating the frequency with which appointments should be established in the consultation of Pharmaceutical Care.
– Use the information from the specific questionnaires to detect possible failures therapeutic.
– Use the results obtained in the PROs to direct the recommendations pharmacotherapeutic to perform, which will be assessed in a multidisciplinary committee of immune-mediated diseases.
– Promote higher quality pharmaceutical care.

What was done?

Implementation of a circuit to improve pharmaceutical care and follow-up pharmacotherapeutic, incorporating the stratification of
patients according to the “Model of Stratification and Pharmaceutical Care for Diseases Immune-mediated Inflammatory Diseases” (MAPEX) and the use of Patient Reported Outcomes (PROs).

How was it done?

1. Selection of patients to include.
2. Design a database in Access for the collection of stratification data and PROs.
3. Selection of specific and generic PROs.
4. Stratification of active patients according to the MAPEX methodology at the beginning of the implantation and in patients who start during the follow-up period will be stratified at the baseline visit.
5. Establish a strategy for carrying out questionnaires (PROs) in consultation.

What has been achieved?

An Access database has been created that incorporates the blocks established by the MAPEX model with each of its variables broken down, allowing us to obtain the patient global score.
3 pathology-specific PROs have been selected (RAPID3 in rheumatoid arthritis, PSAID12 in Psoriatic Arthritis and BASDAI in Ankylosing Spondylitis) and a generic one, EuroQol-5D-5L.
The follow-up strategy based on the stratification was selected as the one proposed by the MAPEX model.
To carry out the PROs, those patients with arthropathies that are were under treatment with biological drugs.
It was decided to pass a specific PRO according to his pathology and the generic having a baseline intake, another at 16 weeks and another a year.

What next?

Design a study to measure the results in terms of quality of care obtained with this new circuit.

Implementation of a screening circuit and prevention of infections in cancer patients treated with immune checkpoint inhibitors

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European Statement

Clinical Pharmacy Services

Author(s)

Alba Manzaneque, Carla Jurado , Cristina Alonso , Mireia Cairó, Glòria Molas, Fernando Salazar , Lucía Boix, Roser Font, Laura López, Jordi Nicolás, Marc Campayo, Esther Calbo

Why was it done?

Although an intrinsic risk of infection has not been associated with ICI, there are different studies and case-series in the literature in which an increased risk of infection is observed, mainly associated with the use of immunosuppressive drugs (like corticoids) for immune-mediated toxicities. The objective of implementing this circuit in our centre is to reduce all preventable infections, by carrying out an initial infection screening that allows detection of those patients susceptible to vaccination measures, prophylaxis, or specific recommendations.

What was done?

Implementation of an infection screening circuit in cancer patients treated with immune checkpoint inhibitor drugs (ICI).

How was it done?

To carry it out, a multidisciplinary work team was created (pharmacy/oncology/infections department) that designed the ICI template and the clinical circuits. At this point, we believed it was necessary to centralise requests, results, and follow-ups in the oncology pharmacy team (OPT) in order to ensure that all patients were included.
Before the patient initiates treatment with ICIs, the OPT makes the request for a pre-established ICI analysis and the oncology nurse (ON) extracts it. Within 7-10 days, the infection department checks the results and makes the necessary recommendations (vaccination/prophylaxis/specific recommendations).
The OPT is then responsible for both vaccination and initiation of prophylaxis.

What has been achieved?

A total of 30 patients (January to September 2022) have been included in the circuit, 25/30 being men and with a mean age of 67.8 (± 8.8) years.
In 25/30 the treatment was with palliative intent, and 21/30 had lung neoplasia.
The ICIs prescribed were: pembrolizumab (15/30) and nivolumab/atezolizumab/durvalumab (5/30 in each case).
Screening results are available for 26/30 patients. Some type of recommendation was made in 25/26 patients, being: 20/26 hepatitis B vaccination, 5/26 start prophylaxis (2/5 hepatitis B and 3/5 tuberculosis), 6/26 hygienic-dietary measures (aimed at toxoplasmosis).
Additionally, all previously unvaccinated patients (23/26) have been vaccinated against pneumococcus.

What next?

A comparative analysis of infection with a historical cohort is planned when larger sample size is available, to demonstrate that these types of measures reduce the occurrence of infections. Centralising this type of initiative from the OPT is key to our integration into clinical teams, by avoiding important adverse reactions and taking care of our patients.

Pharmacological reconciliation as an improvement chance: a hospital ward experience

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European Statement

Patient Safety and Quality Assurance

Author(s)

Annamaria Tesse, Cataldo Procacci, Domenica Ancona, Salvatore Lenti

Why was it done?

Often the elderly patient suffers from several pathologies at once and commonly he is in polytherapy. According to the Italian Ministerial Recommendation No. 17, errors in drug therapy can cause serious harm to the patient. By increasing the patient’s awareness and reducing the number of potentially inappropriate prescriptions, it will be possible to improve the effectiveness of therapies and to reduce side effects.

What was done?

In an Internal Medicine department, the concurrence between doctors and pharmacists has led to a project that aims to reduce duplications of therapy and to improve the health status of the patients. This through pharmacological recognition and subsequent therapeutic reconciliation carried out on patients in discharge.

How was it done?

In Internal Medicine ward, from June to August 2022, we gather the terapies for 48 hospitalised patients aged over 65 years and suffering from two or more chronic diseases. Reconciliation boards were then developed using Intercheck Web a “Mario Negri” Institute of Pharmacological Research’s software. Sequentially the physician, according to the chemist, proceeded to remodulate the therapies especially in those cases where there were serious interactions.

What has been achieved?

140 drug interactions were detected, on average 2.91 interactions per patient. Especially, 16 class D (very serious), 22 class C (major), 83 class B (moderate), 19 class A (minor) reactions were archived. The modified or partially modified therapies at discharge were 71%. This restriction bought to a curtailment of drugs taken and a removal of unnecessary drugs.

What next?

The team are doing a patient follow-up to six months and a year so earlier results will be soon available. Reducing drug intake is possible, and it involves a downsizing in side effects and in an increase in patient compliance. Information to the patient is essential and, by using this procedure on a large scale, it will be possible to optimise the management of the chronic patient at home and inpatient care.

Establishing a medicine donation circuit for non-governmental organisations at a pharmaceutical service in the Basque country (Spain)

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European Statement

Selection, Procurement and Distribution

Author(s)

Ariadna Martin Torrente , Itziar Palacios Zabalza, María Olatz Ibarra Barrueta, Maialen Palacios Filardo, Garazi Miron Elorriaga

Why was it done?

To optimise the functioning and the management of the procedures and an accessible and effective communication system in the PS. Moreover, the quality of the shipment is guaranteed all the time. The development of a circuit has allowed being faster and more efficient during its preparation than before.

What was done?

Establishing the circuit of execution, preparation, distribution, and delivery of medicine to Non-Governmental Organisations (NGO) from the Pharmaceutical Service (PS) of a tertiary hospital in the Basque Country (Spain). The circuit has been designed taking into account the criteria in a context of humanitarian donations, published and updated by the Spanish Agency of Drugs and Sanitary Products (AEMPS) on 16 March 2022

How was it done?

Since it has been included in the daily activity of the service it has cause and increase its amount of work, hence, daily routine tasks have been slowed down, given the increase of petitions the hospital has had during last year. However, its creation has allowed being faster and more efficient during its preparation.
The circuit begins with the request of NGO, which has to be authorised by the hospital’s directory. Then, in the procedure participate pharmacists; pharmacy technicians and office clerks who prepare the donation rely on the personalised list that the donation has created. Once, the necessary documents are filled out and they are sent to the AEMPS.

What has been achieved?

From November 2021 to September 2022, 7 donations have been carried out; these contained 100 active ingredients, concretely 15.198 units. We could find most of them in the WHO model lists of essential medicines. The NGO’s destinations have been Guatemala, Romania, Ukraine and Senegal. The medications sent most according to the ATC classification were 21% anti-infective medicines, 17% cardiovascular, 13% nervous system, 12% systemic hormonal preparations and 3% alimentary tract and metabolism.

What next?

The project is easily enforceable in any Spanish PS that is willing to process a donation at any given occasion. Some of our ideas for the future are the creation of a standard list including common medications, avoiding personalised lists, in addition to connect it to our internal programme to be faster when preparing the donation.

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