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.
Patient education after Arthroplasty: what about the implants?
European Statement
Education and Research
Author(s)
Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer
Why was it done?
The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.
What was done?
In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.
How was it done?
First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.
What has been achieved?
The results show significant impact of this education session on all items especially those regarding the implants and medicines.
What next?
Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.
Surveillance system for adverse events after COVID-19 vaccination
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Kornelia Chrapkova, Stanislav Gregor, Michal Hojny
Why was it done?
A passive surveillance system exists in our country, giving limited options for the reporting of adverse drug reactions (ADR) to our National Drug Agency (NDA). The current system does not consider different patient´s criteria such as, age, variety of disabilities and preferences and does not enable healthcare professionals to report ADR in an easily accessible and comprehensive way.
In addition, our aim was to provide support to patients during the pandemic lockdown when accessing their general practitioner was difficult.
What was done?
A surveillance system was created to encourage and facilitate the reporting of potential vaccine adverse events (VAE) after healthcare professionals and patients received a COVID -19 vaccine that was administered in our vaccination centre (VC).
How was it done?
Following patients receiving a COVID-19 vaccination they were sent a text message with an information that in case of VAE they could contact us via text message, email, fill an electronic questionnaire or call us.
We assembled a team of 10 pharmacists providing a non-stop service for reporting VAE. To ensure consistency in advice given to patients a manual was created for a management of the most common and likely VAE.
By liaising with the Information Technology Department, we created an electronic tool integrated into the hospital information system (HIS) for recording VAE. This enabled us to make a comprehensive report and sent it directly to the NDA. Consequently, an alert on each reported VAE after the first dose of vaccine was available for every clinician to maximise patient´s safety.
What has been achieved?
Between 4th January 2021 and 8th June 2021:
6 109 732 vaccines were administered throughout our country.
5402 (0,09%) VAE were reported to NDA.
43 409 vaccines were administered in our VC.
3 456 (7,96%) VAE were reported to our VC out of which 816 were rated as unexpected and 28 as serious.
What next?
Presenting of the results of the project will be used as a part of the education of healthcare professionals in our hospital. By this sharing of knowledge our aim is to enable and maximise patient’s safety and treatment. The integrated electronic tool for recording and reporting ADR will be also applied for all other medications
COVID-19: Guidelines for Infection Prevention and Control in a Hospital Pharmacy According to ISO 9001:2015
European Statement
Patient Safety and Quality Assurance
Author(s)
SUSANA SANCHEZ SUAREZ, JOSE ANTONIO VINAGRE ROMERO, MARIA ISABEL BARCIA MARTIN, CAROLINA AGUILAR GUISADO, MERCEDES GARCIA GIMENO
Why was it done?
To keep occupational health and safety during a crisis in which healthcare settings were overloaded and facing a critical shortage of skilled professionals, due to sick leaves (2,75% of total cases), and for the need to maintain high quality of care processes. These were a big challenge that required to adapt operating procedures. In addition, and due to the effect of COVID-19 on the general population (overall incidence rate of 10.596 per 100,000 people) and in healthcare systems, the Spanish Ministry of Health (SMH) issued a technical document establishing a series of recommendations for COVID-19 infection prevention and control in patients medical assistance. This practice was designed to bring together national guidelines from the SMH that aimed to reduce COVID-19 impact, both in healthcare workers and general population, and meet ISO 9001:2015 requirements in SOP of a HP within a general hospital
What was done?
In order to ensure safe systems of work (SSoW) in the hospital pharmacy (HP) during the COVID-19 pandemic, specific operating procedures (SOP) were adopted in order to prevent the risk of contagion in daily operations for both patients and staff, according to the norm ISO 9001:2015
How was it done?
Four critical areas were identified according to risk management: High-risk areas: Preparation Area (PA) and Outpatient Dispensing Area (ODA); medium-risk area: Pharmacy Administration Area (PAA) and Inpatient Dispensing Area (IDA). Some SOPs were developed within these areas: Autologous serum eye drops preparation in the PA, pharmaceutical care and medication dispensing in the ODA, pharmacy receiving in the PAA and medicines return from COVID-19 areas. Different circuits were implemented for users and professionals, as well as general information and procedures directed at patients and personnel, to prevent infection. The individual protection equipment required in each SOP/area was also established
What has been achieved?
No COVID-19 case has been reported due to patient-professional interactions or working location and tasks. All operating procedures have been revised to fully comply with SMH guidelines and ISO 9001: 2015 requirements mitigating risks and maximizing performance in such critical circumstances
What next?
Adapting SOP to any infectious disease outbreak that may occur in the future and establishing early-detection mechanisms
How to become a resilient chemotherapy preparation unit?
European Statement
Patient Safety and Quality Assurance
Author(s)
Victorine MOUCHEL, Romy LINOSSIER, Chloé FERCOCQ, Jean-Luc PONS, Lucie BAILLET
Why was it done?
Injectable anti-cancer drugs are critical drugs and production disruption would result in discontinuity of care. Moreover, 60% of the production is dedicated to external clients as part of outsourcing contracts. To strengthen client’s confidence, we achieved the ISO 9001 certification in 2019. Implementing a BCMS is part of the overall quality and resilience process.
What was done?
In our hospital centre, production of injectable anti-cancer drugs is centralised in a chemotherapy preparation unit. Within the unit, we decided to implement a business continuity management system (BCMS). Therefore, we established and validated a business continuity plan (BCP) to face a production disruption and continue the delivery of products.
How was it done?
We followed the ISO 22301:2019 standard methodology. First, we performed the risk assessment as described by the ISO 22300: 2018 standard. A multidisciplinary working group (pharmacists, pharmacy technician, quality engineer) identified and analysed the risks likely to threaten the unit’s business continuity (BC). Risks were rated in term of criticality (Cr) from 1 to 4 and risks with Cr ≥ 3 were considered as priority risks. Then, a business impact analysis was led by the pharmacists and validated by the department chief. Strategies were set to face priority risks in accordance with the BC objectives. Finally, we documented the BCP and validated it thanks to tests followed by debriefing.
What has been achieved?
The risk assessment highlighted 23 risks and 13 of them (57%) were rated as priority risks. Most of the risks revolve around unavailability of production equipment or premises (fire, flood, natural disaster). The treatment of 7 of these risks was included in the action plan for 2021. Three strategies were documented to treat these risks: extended opening hours of the unit, closed system transfer device used in a contaminated isolator and production relocation in two other centres. Five tests were conducted to check necessary procedures and devices to use these strategies (closed system transfer device, remote access, transportation). Tests will be repeated yearly to maintain the BCP.
What next?
In conclusion, implementing a BCMS represents a continual improvement approach that will improve the unit’s ability to cope with a crisis in an appropriate way.
Value of Integrated Inventory Management and Automation Solution for Medical Devices and Supplies: a case study
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Serdar Kaya, Ulker Sener
Why was it done?
Despite medical devices and supplies are often high-cost products, they are often sub-optimally managed by hospitals. The objectives of the installation were the optimization and the automation of the inventory, and the charge management workflows, to comply with JCI (Joint Commission International) standards and address current challenges as safety, labor, stock-outs, space, costs and charges accountancy, traceability.
What was done?
An integrated Inventory Management and automation solution was implemented at Amerikan Hospital Istanbul (BD Pyxis™ SupplyStation™ system). 83 automated dispensing cabinets, a central management system, and a data analytics solution, are serving the 278-beds hospital.
How was it done?
The workflows for medical devices/supply inventory, and for patients charge management were mapped pre-installation and major challenges identified. Based on these needs, the decision to automate the hospital supply management was made. The cabinets were installed in the whole hospital but in particular in operating rooms, emergency rooms and intensive care units.
What has been achieved?
The impact of automation was measured one-month pre and one-month post installation, and five major areas of improvements have been identified:
1) Significant decrease in workload: -8% for nurses; -30% for charge secretaries
2) Missing charge rate reduced from 2.5% to 0.1%
3) Improved use of space and material organization
4) Inventory optimization: 0% stock-out, -16% expired items; – 45% on-hand inventory
5) Improved materials and patients’ safety, ensuring that supply were managed in the right way by the right staff. Patients are now protected by the risk of being provided with the wrong device.
All the nurses (n>50) were interviewed, reporting great satisfaction and ease of use with the new system. Furthermore, a positive return on investment was achieved in 4 years.
What next?
Due to legal regulations (MDR Regulation/ UDI Tracking requirements) the hospital is planning to leverage the automated system to achieve a full compliance and traceability of critical medical devices throughout their hospital.
The decision of investing in automation demonstrated important benefits in terms of safety and efficiency, with a positive impact on the hospital’s economy as well.
Implementation of a tool for annual quality assessment of drug information provided by hospital pharmacies
European Statement
Clinical Pharmacy Services
Author(s)
Dorothea Strobach, Ute Chiriac, Sigrun Klausner, Claudia Langebrake, Christiane Querbach, Carolin Schuhmacher
Why was it done?
Although guidelines for DI demand regular quality assurance procedures, no method of evaluation is internationally agreed on. The tool should be feasible, reproducible and reflect real-life quality of DI. It should allow to identify areas for quality improvement in general and for every participant.
What was done?
We developed a tool for annual quality assessment of drug information (DI) provided by hospital pharmacies on behalf of the German Association of Hospital Pharmacists ADKA e.V.. The tool has been successfully implemented for four years.
How was it done?
We developed a new tool for quality assessment of DI using a fictitious test enquiry and simulated real-life conditions and proved it representative for real-life quality [1]. The answers for the test enquiry are evaluated by blinded experts for content and formal requirements. For four years, 2017-2020, annual assessment of DI was offered to German language hospital pharmacies with changing topics and enquiry levels. Participants receive their own result in comparison to average of all regarding content-related and formal requirements. A proposal for an answer is published afterwards for educational purposes.
What has been achieved?
The annual DI quality assessment tool was successfully implemented as shown by increasing numbers of participating hospital pharmacies (45/71/79/118). Areas for improvement have been identified in general and can be identified by each participant as well. As an example, presentation of references has improved over the years [2]. Since 2018, a certificate of participation is offered as document for quality assurance audits thereby underlining the importance of this hospital pharmacy service.
What next?
Annual quality assessment for DI by hospital pharmacies will be further offered. Results over years will be evaluated for overall effect of the annual test tool on quality improvement regarding content-related and formal requirements. This method for annual quality assessment of DI provided by hospital pharmacies could be implemented by other countries.
References
1. Strobach D et al. EJHP 2020 online ahead of print. doi: 10.1136/ejhpharm-2020-002409
2. Strobach D et al. Krankenhauspharmazie 2020;41:187-91
IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
CRISTINA MORA HERRERA, VICTORIA VAZQUEZ VELA
Why was it done?
Occupational exposure to HD can cause health damage to exposed healthcare professionals, so protective measures must be taken
What was done?
The hazardousness of drugs can cause damage due to exposure in healthcare workers from Social Health Centers (CSS). As an objective, the design of a security strategy in the handling of hazardous drugs (HD) was proposed with the elaboration of a safety working procedure (SWP) and preventive measures. In addition, the HDs were identified, with proposals for alternatives and recommendations for handling and administration were released.
How was it done?
Observational cross-sectional study to identify employment MPs in a public CSS. The demographic characteristics of the patients and their Pharmacotherapeutic prescription were recorded. A total of 107 residents were included, with a mean age of 78.9 years and 59.8% (64) men. The average stay in the center was 7.4 years (1-27). Regarding functional capacity, 53.3% were considered assisted, 89% of them with grade III -II assessment, that is, large dependents and severe dependents. Of the valid group (46.7%), 70% belonged to socially excluded. The most prevalent pathologies in the center are vascular, neurodegenerative, osteomuscular and respiratory. The mean number of medications per patient was 4.8. Only 6 patients did not receive Pharmacological treatment.
The design of the security strategy was structured in 3 phases; 1st)Elaboration of an SWP with assignment of functions/responsibilities, preventive measures to be adopted in the handling of HDs, description of the circuit and quality indicators of the strategic procedure; 2nd)Carrying out a descriptive observational cross-sectional study to identify the HDs used. The list of active principles (AP) included “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” was compared with those included in the GFT of the center; 3rd)Releasing of recommendations through information sessions/ workshops for healthcare professionals.
What has been achieved?
An effective and safe employment system/circuit is established in the SWP, with relative preventive measures to control associated risks that may occur in handling and/or administration. 22 HDs were identified. A safer alternative was proposed for 9. Recommendations for the handling of HDs, associated risks and proper use of PPE were disseminated through 2 training sessions.
What next?
The identification of hazardous drugs and communication of improvement actions made it possible to implement a standard work procedure guaranteed safety in handling, and to provide an adequate means to avoid exposure due to healthcare workers.
Implementation of a dashboard within a quality management system in the pharmacy department
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
The pharmacy must assess its own activity in order to better manage, to structure, respond to needs. This assessment is necessary in order to measure the productivity.
What was done?
The purpose of our work is to identify the key performance indicators for management and piloting a hospital pharmacy. The aim is to develop dashboards, a real management tool, for the management and monitoring of pharmaceutical activities in order to optimize performance and ensure continuous improvement.
How was it done?
The methodological basis of our study is based on a process-based management of hospital pharmaceutical activities. Our target is to achieve the same approach to these processes, within the various functional and concerned units, in order to harmonize and simplify the quantitative and qualitative monitoring of pharmaceutical activities.
What has been achieved?
Macroscopic cartography of pharmacy processes was established and the most critical processes were selected on the basis of a matrix. In total, eight key processes have been identified. The identity cards for these processes have been drawn up. Quality indicators have been identified. These indicators are intended to assess and monitor the processes. A first design of dashboards with the elements collected was proposed. This dashboard could evolve during the implementation of this project within the Pharmacy department.
What next?
These dashboards have to be finalized, validated and officially put into practice within the Pharmacy department. This methodology must be applied to the discipline of Clinical Pharmacy. Quantitative and qualitative assessment of the activities carried out within the pharmacy should be a subject for priority debate at the national level to finally find agreement on a relevant measurement tool.
INCOMPATIBILITIES OF PARENTERAL DRUGS IN INTENSIVE CARE – ANALYSIS AND OPTIMISATION OF ADMINISTRATION SCHEDULES OF CENTRAL VENOUS CATHETERS AND FREQUENTLY USED DRUG COMBINATIONS
Pdf
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.