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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.

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.

Assessing the Application of Essential Medication Errors Prevention Strategies in Healthcare Institutes: STOP Medication Error Project

European Statement

Patient Safety and Quality Assurance

Author(s)

Monira Alwhaibi

Why was it done?

This study is the first project of the STOP ME projects which aims to develop a tool that can assess the application of the essential strategies that can stop or minimize MEs in healthcare institutes in Saudi Arabia. Consequently, stakeholders in the healthcare system can identify current gaps that need feature improvement to enhance patient safety

What was done?

Medication Errors (ME) are defined as unintentional drug-induced harm that led to morbidity and mortality. The STOP (ME) project is a comprehensive series of research studies that aim to explore MEs in Saudi Arabia and how to stop such harmful events.

How was it done?

Extensive search of the literature review for the essential strategies to stop or minimize MEs was carried by the research team to develop a draft of the aimed tool. The survey tool was sent in round 1 to the Delphi experts’ panel for review. Based on received recommendations, the tool was updated and sent for round 2 review and consensus. The developed tool was then piloted to test the practicability of the tool before running the survey on large sample size (second project). The study was approved by the King Saud University Medical Centre IRB ethics committee [20/0153/IRB].

What has been achieved?

After using the Delphi technique two major changes happened to the survey. 1) Section A was removed (high alert medications). 2) A new section was added (ISMP publications) with some minor changes. Launching a pilot survey on thirty healthcare practitioners (physicians n=11, pharmacists n=10, nurses n=9) resulted in further minor changes by adding two new columns. The final tool was a survey consists of six sections including Demographics, Prescription, Dispensing, Administration, Monitoring and Quality, and Targeted Medication Safety Best Practices for Hospitals. All combined 86 questions with the determined time to answer the survey is in the range of 25-30 minutes. Overall feedback of the pilot survey was good.

What next?

This initiative “STOP ME” will have a significant impact in the field of medication safety research and will build awareness among institutes in Saudi Arabia that are lacking important strategies that prevent MEs

MEDICATION REVIEW IN FALL-RELATED HOSPITAL ADMISSIONS

European Statement

Patient Safety and Quality Assurance

Why was it done?

Falls in older people are a significant public health problem due to their high prevalence, the injuries they cause and the associated economic burden. They are often caused by multifactorial risks, being the Fall-Risk-Increasing-Drugs (FRIDs) one of the most significant ones. The aim of this initiative is to reduce FRIDs prescriptions among elderly at risk of falling, by assessing their individual Benefit-Risk Balance.

What was done?

A circuit was designed and implemented to review and optimize the medication of patients admitted to hospital after a fall.

How was it done?

On an everyday basis, the Health Management Unit of our tertiary university hospital sends a list of fall-related hospital admissions to the clinical pharmacists (CP), who review those patients’ medication and identify FRIDs (drugs affecting central nervous system, hypoglycemic/antihypertensive agents, among others). Electronic Health Records (EHR) are consulted to evaluate if medication could have had a role in those falls. When a patient’s medication is subject to any optimization, CP contact the referring physician to propose therapeutic modifications. This pharmacist-doctor communication is carried out during the hospitalization period in case of Internal Medicine admissions and by an administrative appointment with the primary care physician (PCP) when patients are admitted in other units, such as Traumatology or Neurosurgery. The PCP evaluates the medication review report attached by CP in patients’ EHR and modifies medication if necessary.

What has been achieved?

Between May and September 2021, 114 patients were admitted to hospital due to a fall. After excluding 10 institutionalized patients (pharmaceutical care provided by their own team), 6 patients having fallen after alcohol consumption or intentional drug overdose, and 7 palliative patients, the medication of 91 patients was reviewed. The mean age was 80 and the 64.8% were female. An average of 3 FRIDs was identified per patient. 52 pharmaceutical interventions were made, mainly dose reductions and FRIDs deprescribing suggestions.

What next?

This initiative is feasible and potentially beneficial for patients’ health care. Medication review leads to the identification of not only FRIDs, but also different drug related problems. We look forward to assessing the impact of our practice in terms of interventions accepted; drug-related negative outcomes avoided and decreased hospital readmissions.

Proactive pharmacovigilance program of Covid-19 vaccination in haemodialysis centers

European Statement

Patient Safety and Quality Assurance

Author(s)

Carla Pinto, João Godinho, Luzia Fernandes, Patricia Vieira, Isabel Ferreira, Inês Sousa, Carolina Vieira, Ana Sardinha

Why was it done?

To promote a more effective notification process than the spontaneous reporting of suspected adverse drug reactions and contribute to the knowledge of the safety profile of medicines.
Covid-19 vaccines are medicines under additional monitoring, labelled with a black inverted triangle and expected to play a major role in the control of COVID-19 pandemic due to SARS-Cov2 virus.
This new medicine was administrated in a short time period and simultaneously to a large number of individuals in the beginning of vaccination period in Portugal (January 2021), to patients and healthcare professionals of our haemodialysis centers.

What was done?

Development and implementation of a proactive pharmacovigilance program to identify suspected adverse drug reactions (ADRs) to a covid-19 vaccine administration in haemodialysis centers patients and healthcare professionals.

How was it done?

Maintaining spontaneous report for immediate suspected ADRs, pharmaceutical services developed a form to collect suspected ADRs in the following 7 days after each dose administration. It was applied to each vaccinated exactly 7 days after the administration of each dose. To simplify its filling and application, overcoming workload and lack of resources in this pandemic setting, information was displayed with check mark boxes, including the list of described ADRs sorted by frequency, duration intervals and blank space for unexpected reactions.
Due to the large amount and variability of individuals and centers, the form was distributed in paper and online formats and applied to vaccinated patients by doctors or nurses.
Pharmacists validated the forms to notify the national pharmacovigilance system for serious or unexpected ADRs.

What has been achieved?

From the 9469 covid-19 vaccine administrations we obtained 6962 filled forms (74% of vaccinations) from which 38% (2666 forms) had suspected ADRs. 2nd dose had a lower participation rate of about 10%. These participation rates where due to no filled forms in cases of no symptoms.

What next?

Apply this proactive pharmacovigilance model in the integration in the institution of future medicines under additional monitoring will allow better knowledge of occurrence of adverse reactions, improving safety of medicines.
For the best outcomes program must be adapted to each medicine’s specification, considering even simpler tools to obtain information when there are no symptoms to report.

Implementation of an artificial intelligence tool for the detection of drug safety problems

European Statement

Patient Safety and Quality Assurance

Author(s)

Noe Garin, Laia Lopez-Vinardell, Pau Riera, Adrian Plaza, Ivan Castellvi-Barranco, Jose Mateo-Arranz, M. Antonia Mangues

Why was it done?

APS is a rare disease with a high risk of thromboembolism. Recently, some data suggested an increased risk of thrombotic events with direct-acting anticoagulants (DOAC) compared with vitamin K antagonists in APS. Some agencies advise against the use of DOACs in these patients.

This methodology can be extrapolated to other risk situations, so this was a first step with AI to further detection of safety issues.

What was done?

We implemented an Artificial intelligence (AI) tool based on natural language processing (SAVANA®) to identify patients at risk of thromboembolism, defined as Antiphospholipid Syndrome (APS) diagnosis treated with direct-acting anticoagulants (DOAC). SAVANA® is an AI tool able to extract information contained in free-text from electronic clinical records.

A prior operation work was conducted, involving: direction, pharmacy, documentation, IT, SAVANA®, data protection. The work and previous meetings evaluated: feasibility, previous requirements, privacy issues, IT involvement and contract signings.

How was it done?

The implementation consisted of:
– Transference of medical record information to the SAVANA® cloud.
– Identification of the health problem (APS) and initial search.
– Search algorithm optimization in a multidisciplinary team.
– Evaluation of the search by SAVANA® by peer review in a sample of randomly selected cases (n=200).
– Precision and sensitivity analysis. Algorithm improvement.
– Obtaining the Gold Standard and validation.
– Definitive search for the detection of patients with APS in treatment with DOACs and performance of interventions.

What has been achieved?

The project implementation is at a very advanced stage. The algorithm has currently been evaluated and is being refined after precision and sensitivity analysis. Final validation and definitive identification of patients at risk is expected at the end of 2021. Patients detected during the implementation method have been evaluated with the haematology team.

What next?

This methodology can be implemented in any centre with computerized medical records. The use of AI is the only tool available for the identification of certain groups of patients when health problems are not coded. In other cases, its use regarding the extraction of lists allows a great capacity for analysis, absence of biases derived from human error, guarantee of reproducibility and complementary data obtention, mainly in samples of high size.

IMPLEMENTATION OF AN APPOINTMENT MANAGEMENT MODULE APPLIED TO THE OUTSIDE PATIENT AREA

European Statement

Patient Safety and Quality Assurance

Author(s)

JUDIT PERALES PASCUAL, ANA PÉREZ LÓPEZ, HERMINIA NAVARRO AZNAREZ, ELENA HERRANZ BAYO, MARIA PEREZ MORENO, CARLOS-IGNACIO DIAZ CALDERON HORCADA, Mª REYES ABAD SAZATORNIL

Why was it done?

In 2019 the UPEX attended a large volume of patients without a scheduled appointment, long waits were generated and the pharmacotherapeutic follow-up was complicated. The purpose was to implement an appointment management module to avoid crowds, excessive waiting times, allowing better organizational management of care and knowledge of patients in each type of consultation.

What was done?

An outpatient is a patient who goes to the outpatient unit of their Hospital Pharmacy Service to collect a drug for hospital use/diagnosis or foreign drug (it will be administered without health personnel intervention).

An appointment management system was implemented in accordance with the objectives of the SAMPA project (Service for Registration and Promotion of Adherence to Medicines for Elderly Patients), included in the European STOPandGo project.

How was it done?

Creating a cross-cutting system for the entire clinical circuit from prescription to dispensing involved a great deal computer involvement. Although it began to be used in November 2018, it was not used by the mostly part of prescribing doctors until the end of 2020.
Now, when the patient leaves medical consultation, he/she will go to the pharmacy and will be seen by a pharmacist. Besides, the program will propose a return appointment when it calculates that the patient has a week’s worth of medication, thus preventing the patient from running out of medication. The pharmacist will decide if the patient needs pharmacotherapeutic follow-up.

What has been achieved?

In 2019, 5 services cited patients while in 2020 it was 14; the percentage of patients attending pharmacy cited increased from 73.2%(2019) to 79.4%(2020).
Currently, the pharmacist knows in advance which scheduled patients he has and can establish a better organizational care management and determine in advance if the patient needs a close pharmacotherapeutic follow-up. Additionally, with this system an average waiting time of 03:55min was achieved (in 2019 appointments with waits >30min were recorded).

What next?

The implementation of the appointment management system has made possible to achieve better organizational management of care,avoid crowds,excessive waiting times, and provide better patient care and pharmacotherapeutic follow-up. The proposed solution can be extended to other hospitals.

INCOMPATIBILITIES OF PARENTERAL DRUGS IN INTENSIVE CARE – ANALYSIS AND OPTIMISATION OF ADMINISTRATION SCHEDULES OF CENTRAL VENOUS CATHETERS AND FREQUENTLY USED DRUG COMBINATIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Martina Jeske, Jasmin Stoll, Vanessa Funder, Sabine Bischinger

Why was it done?

Due to the limited number of ports, it is necessary to administer several drug solutions via the same access. Incompatibility reactions can occur and may lead to a reduction or loss of drug efficacy and severe damage to the patient’s health. The objective was to create standardized administration protocols for central venous catheters and verify parenterally administered drugs’ incompatibility reactions. A further purpose was to build multidisciplinary cooperation to improve the drug administration processes.

What was done?

To optimize the drug therapy at four intensive care units (ICUs) of the University Hospital, the pharmacy department, physicians, and care management, jointly implemented a quality assurance project. In multidisciplinary teams, we had to overcome various challenges in different wards to develop standards regarding administering drugs via multi-lumen catheters. We analyzed all frequently used drugs (n=72) for their compatibility and summarized findings in a crosstable.

How was it done?

The current situation was recorded using a questionnaire and collecting individual cases of protocols for central vein catheters. About 2000 drug-drug-combinations were analyzed using three databases, KiK 5.1, Micromedex, Stabilis 4.0, corresponding specialist information, and manufacturer data. Nevertheless, the compatibility check based on the databases is subject to some restrictions. In several cases, the databases give different or contradictory results, and compatibility data are rarely available for some combinations. The project revealed that although infusion therapy is standardized in intensive care units, there are fewer standards regarding administering drugs via multi-lumen catheters. There are significant differences between theory and practice in terms of handling infusion therapy.

What has been achieved?

Different hazardous practices got identified and eradicated. The incompatibility table allows a quick assessment. The advantages/disadvantages of varying software systems were broadly discussed. KiK 5.1 was implemented in the ICUs, Micromedex in the pharmacy department. The team agreed that existing uncertainties must be decided jointly. Different practices in different wards may pose a threat to patient safety. The results were presented in a clinic-wide interdisciplinary training.

What next?

The awareness towards the need for cooperation and hospital pharmacists’ competence concerning incompatibility reactions strongly increased, leading to more standardization in the infusion therapy and avoiding incompatible drug combinations. The aim is to initiate a continuous improvement process.

BUILDING THE FOUNDATIONS OF A MEDICATION SAFETY PROGRAMME IN AN ACUTE HOSPITAL (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Bernie Love, Tracy McFadden, Patrick Martin, Val Connolly, Deirdre Brennan, Michelle Griffin, Danielle Bracken, Siobhan Maguire, James Carr

Why was it done?

Avoidable harm caused by medication is one of the most commonly reported adverse events in healthcare settings.

What was done?

Connolly Hospital Blanchardstown launched a formal Medication Safety Programme in November 2017 by appointing a Medication Safety Facilitator and establishing a multidisciplinary Medication Safety Committee to promote and support the safe use of medications. The Medication Safety Committee undertook a number of activities to establish the programme in the hospital.

How was it done?

-An evidence-based literature review to define and guide the scope, breadth and direction of the programme. -A baseline in-depth analysis of locally reported medication incidents (2016/2017) on the National Incident Management System (NIMS) was conducted to identify initial targets for improvement. Analysis was undertaken using NCC-MERP, a recognised and validated tool used specifically for medication incidents. -An annual work-plan, incorporating necessary elements of a medication safety programme, was devised by the committee defining goals for the year.

What has been achieved?

Safety Culture:  Prominent commitment from hospital management to medication safety.  Investigations into medication errors aligned to a just and fair systems approach.  Promotion and encouragement of medication safety reporting and learning with a Medication Safety Awareness Day.  Implementation of the ‘Know, Check, Ask’ campaign to enhance medication safety by empowering patients. Governance:  Organogram updated to reflect reporting relationship of new committee.  Medication Safety made standing item at Quality & Safety Executive meetings.  Annual report submitted to Hospital Executive Committee Measurement & Monitoring of medication incidents:  Quarterly report produced and disseminated to front-line staff tracking and trending medication incidents including narratives.  Performance indicators established for: -No. of incidents reported (2018 reporting increased by 32% over 2017); -Reporter of incidents; -Category of harm; -Stage of medication use process where incidents have occurred. Education & Training:  Regular face-to-face education sessions arranged with front-line staff.  Quarterly medication safety bulletin devised and disseminated, informed by audit findings and incident reports.  The successful Medication Safety Minute initiative from St James’s Hospital was adopted and implemented, with content informed by local incidents. Development, Updating and Dissemination of PPPGs.  New IV drug administration guides (n=53) developed and updated.  Introduction of one-page ‘Medicines Information Sheet’ as quick reference guides for key topics.  DOAC prescription and administration guide developed and circulated. Audit:  Audit programme established informed by incident analysis, complaints and best-practice including introduction of an ‘audit window’ to gather hospital-wide data. Quality Improvement:  Informed by incident analysis, best-practice and audit findings, a number of moderate-high leverage quality improvement projects were initiated including removal of concentrated potassium from general clinical areas, introduction of an insulin & glucose monitoring record and introduction of an automated dispensing cabinet for out-of-hours access to medication.

What next?

The structural aspects established for the Medication Safety Programme have been successful in establishing a programme in the hospital and are reproducible by other centres.
Work continues in Connolly Hospital to identify themes of incidents, audit of practice and implementation of quality improvement initiatives.

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