Skip to content

Assesing cold chain compliance for biotherapy drugs in a university hospital’s medical departments

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI

Why was it done?

It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.

What was done?

Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.

How was it done?

Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.

What has been achieved?

A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.

What next?

The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.

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

Pdf

PDF Icon

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.

Design, implementation and impact on patient safety of a mobile application for patients on antiretroviral therapy

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Esther Chamorro de Vega, Carmen Rodriguez Gonzalez, Belen Mayo Canaleja, María Pilar Montero Anton, Sergio Herrera Bermejo, Rosa Romero Jimenez, Vicente Escudero Vilaplana, Roberto Collado Borrell, Ana Herranz Alonso, María Sanjurjo Sáez

Why was it done?

The profile of patients receiving antiretroviral therapy (ART) has changed. Patients are more active, autonomous and have greater information and communication needs.
Mobile health, especially apps, can help to healthcare professionals to optimize pharmacotherapeutic follow-up and provide patients greater autonomy facilitating communication with healthcare professionals and contributing to the humanization of their care.
Through this application we seek to achieve the following objectives:
– Allow patients to participate in their illness and/or treatment, promoting their compliance and safety and communication with the healthcare professional.
– Strengthen pharmacotherapeutic monitoring of patients receiving ART, avoiding visits to the emergency room and hospital consultations.
– Generate pioneering evidence on the impact of mobile applications on the pharmacotherapeutic monitoring of patients on ART.

What was done?

FarMCuida® is a mobile application designed for a closer and better pharmacotherapeutic monitorization of patients on antiretroviral therapy (ART). Through this app the patient can actively participate in his or her disease and treatment.

How was it done?

A multidisciplinary group was created to design and develop an app called FarMCuida® for patients on ART in a tertiary hospital. Once the app was designed and developed, we offered the app to patients starting or undergoing ART. Identification and inclusion of candidate patients was performed in the Pharmaceutical Care Consultation of the Pharmacy Service. The pharmacists responsible for the Infectious Diseases area performed real-time pharmacotherapeutic follow-up of the patients.
Records of adverse effect (AE) and Safety-related messages received (Adverse effects, interactions, drug administration) can be analyzed. All data can be exported from FarmCuida®. Informed consent is requested from all the patients included.

What has been achieved?

FarMCuida® was designed as a digital health mobile application that allows our patients to participate in their disease and/or treatment, promoting treatment safety, as well as making available a source of information and bidirectional communication, in real-time, between patients and healthcare professionals.
During a period of 13 months, a total of 152 patients were included in FarMCuida®. Seventy-two percent of the patients were diagnosed with HIV infection while 27.6% of them were included in the HIV pre-exposure prophylaxis programme.
In AE module, 58 adverse events (AEs) were registered. Twenty-two percent of the patients registered at least one AE.
Thirty-two percent of patients used the Messages module to communicate with healthcare professionals.
One hundred and twenty-six telematic consultations were carried out. Two hundred and five messages were exchanged between the patient and the pharmacist.
Forty-three percent of the consultations corresponded to doubts about interactions: 66.7% interactions with other drugs, 28.5% with herbal products and 4.8% with vitamin supplements. Three type D interactions and one type X interaction were identified.
In addition, 11% of the consultations corresponded to doubts about the administration of ART while 5.2% were related to adverse effects experienced by the patient.
At least three visits to the emergency department were avoided, resulting in health care and economic savings for the health system.

What next?

Based on the limited studies on the impact of mobile applications on the pharmacotherapeutic follow-up of patients, the results obtained will allow us to generate evidence in this regard. It is worth highlighting the flexibility of FarMCuida® design, being easily adaptable to different pathologies and hospital centres.

On-line education for pharmacists about one pill killers

Pdf

PDF Icon

European Statement

Education and Research

Author(s)

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

Why was it done?

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

What was done?

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

How was it done?

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

What has been achieved?

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

What next?

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

Centralised DataMatrix reading for drug authenticity verification

European Statement

Selection, Procurement and Distribution

Author(s)

Leonor Romero, Paloma Lozano, Veronica Canales, Vanesa Dechado, Marta Puebla, Ricardo Villarubia, Isamar Gomez, Estefanía Ramírez, Juan Rodríguez, Belén Soto

Why was it done?

According to Directive 2011/62/EU, one of the measures is the inclusion in the secondary packaging of the drug of a Unique Identifier that allows the recognition of a unitary case at any point in the supply chain until it is dispensed to the patient. Another is the development of a European repository that allows the traceability of medicinal products for human use within the European market. In Spain, in accordance with Article 84.1 of Royal Decree 717/2019 of 5 December 2009, the SNSFarma Node was established as an instrument for technological integration and information exchange with the national repository known as the SEVeM.

What was done?

The logistics company of our hospital aggregates several codes corresponding to the Datamatrix of the individual containers in an electronic file, in order to send the reading automatically to Spanish Medicines Verification System (SEVeM).

How was it done?

The shipment of the drugs and the electronic file will be linked by the Seria Shipping Container Code (SSCC), which will univocally guarantee traceability between the two. The Pharmacy Service staff receive the delivery notes by reading the barcode without the need to scan the Datamatrix of each container.
Since the implementation of this project between July 2023 to September 2023, a total of 61 delivery notes have been registered under the code aggregation system with 27 suppliers involved. The number of packages read was 2151.

What has been achieved?

This project ensures the automatic sending of readings to SEVeM and to facilitate the reception of delivery notes at the Pharmacy Services by barcode reading.
This has allowed pharmacy staff to save time in receiving delivery notes, to improve traceability of batches and expiry dates of medicines, to improve stock control thanks to the confirmation of quantities received and to verify the medicines in accordance with European regulations to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.

What next?

A limitation is the existence of suppliers that are not involved in this project since their delivery is not done through the logistics company. In these cases, the datamatrix reading must be performed on each container individually.

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

Pdf

PDF Icon

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

Pdf

PDF Icon

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

Pdf

PDF Icon

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

Pdf

PDF Icon

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

Pdf

PDF Icon

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.

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.