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.
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 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.
LEARNING FROM SARS-CoV-2 EXPERIENCE TO FACE FUTURE EMERGENCIES: ELABORATION OF A HOSPITAL PHARMACY EMERGENCY PREPAREDNESS PLAN
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Edoardo Calzavara, Elena Galfrascoli, Stefania Vimercati, Lorenzo Gambitta
Why was it done?
The discovering of Coronavirus disease in 2019 and the subsequent outbreak in many countries and regions constituted in the first 5 months of 2020 a prominent issue worldwide: hospital pharmacists as well as other health care personnel were hit by pandemic emergency and faced a great challenge. We as hospital pharmacists had to cope with shortage of drugs, disinfectants, test and reagents, Intensive Care Unit medical devices, personal protective equipment. For this reason, we needed to start interventions to meet the needs of the front-line medical and nurse staff.
What was done?
We decided to start a self-auditing process, we aimed to realize an emergency preparedness plan and a procedure, created from our experience, which will be helpful to face future emergencies.
How was it done?
The starting point was our Hospital Pharmacy process map, which identifies all pharmacy activities. For each one, actions taken during the emergency were described. Regulations at local and national level were analysed together with literature and international statements about hospital pharmacist role during health emergency.
What has been achieved?
We developed a process map in which we split up pharmacy activities into five big areas:
1. DIRECTION AND COORDINATION: team communication, role and responsibilities definition (“role mapping”); multidisciplinary external communication with hospital management facilities;
2. LOGISTICS AND ADMINISTRATION (Purchase, management and distribution of medical products): an inventory of drugs, medical devices and diagnostics was created, especially for the ones essential to challenge SARS-CoV-2 health emergency;
3. RESEARCH, GALENIC, “PATIENT CARE”: therapeutic protocols, galenic preparation, studies, home-therapies distribution and communication with patients;
4. PHARMACOVIGILANCE: close monitoring of potential Adverse Drug Reactions (ADRs);
5. REGULATIONS AND LEGISLATION: Updating and intra-hospital divulgation.
From this emergency process we created an emergency preparedness plan and an internal procedure, in which, for every activity area, we assigned specific roles and responsibilities and set operating instructions.
What next?
The emergency preparedness plan developed from our experience during SARS-CoV-2 emergency, will allow hospital pharmacists to anticipate, plan, and prepare strategies in case of future health emergencies, due to biologic infective agents. Our and other Hospital Pharmacies will be able to overcome priority drugs shortages, to set a drug home delivery service, to offer extemporary solutions, communicate and inform patients.
MEDICATION MANAGEMENT OF COMBINATION THERAPY IVACAFTOR , TEZACAFTOR AND ELEXACAFTOR FOR CYSTIC FIBROSIS PATIENTS WITH THE F508del MUTATION BY THE HOSPITAL PHARMACY IN A CENTRAL GENERAL HOSPITAL
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
DESPOINA MAKRIDAKI, KALLIOPI ALLAGIANNI, NIKOLAOS SKORDAS
Why was it done?
In our hospital is located the main CF Unit for Adults in the country. Ensuring that as many as possible young patients benefit from accessing the new and crucial treatment, even during COVID-19 period, reflects our commitment to improve patients’ outcomes and overall survival,
What was done?
A Phase 3, open-label clinical trial (CT) with 3 enrolled patients runs since April 2019 and two early access (EA) programs with 23 enrolled patients run since the end of July 2020 to permit the access of cystic fibrosis (CF) patients with the F508del mutation in the innovative combination therapy of ivacaftor, tezacaftor and elexacaftor (IVA/TEZA/ELEXA) in our hospital.
How was it done?
3 outpatients enrolled in the CT and procedures regarding the protocol have been followed strictly. Medication dispensing is conducted every 12 weeks.
In the EA procedure, 2 parallel programs have been approved by authorities, one for the homozygous including 19 patients and one for the heterozygous including 4 patients. Dispensing is programmed every 4 weeks, although an initial stock for 3 months was shipped to pharmacy.
The role of HPs was decisive for the quick start of the EA programs during COVID-19 period. Roadmap was designed at the beginning by HPs in collaboration with the physicians to accelerate approval and shipment procedures and also regarding licensing for each patient, drug receipt, storage, dispensing, accountability, electronic registry in designated EA platform and additional electronic recording and follow up in the electronic Pharmacy platform for both the IVA/TEZA/ELEXA and supporting therapies (e.g. inhaled antibiotics, a-dornase)
For 17 EA patients with chronic obstructive pulmonary disease in exacerbation, hospitalization before starting the IVA/TEZA/ELEXA therapy was necessary. HPs monitored closely their cartexes to avoid adverse reactions and delays in therapy.
HPs served all outpatients on personal afternoon appointments, to avoid overcrowding in the hospital during the pandemic.
What has been achieved?
Critically ill patients have been able to receive in priority the IVA/TEZA/ELEXA treatment, without cost, and valuable scientific experience has been gained.
What next?
EA programs have received 3 months extension until reimbursement negotiations are completed by authorities. In the meantime, we design a cost affordable procedure to ensure continuity of access for our patients.
Integration of clinical trials management into a safe and fully-automated onco-haematology workflow
Pdf
European Statement
Production and Compounding
Author(s)
FRANCESCA VAGNONI, ANDREA MARINOZZI, SABRINA GUGLIELMI, CHIARA CAPONE, FRANCESCA MURA, ADRIANA POMPILIO, SIMONE LEONI
Why was it done?
The management of CT requires thorough documentary evidence and well-organized reporting system in compliance with the Good Clinical Practice. Since 2009, the entire onco-haematology workflow is fully-controlled by information technology devices and robotic systems to prevent medication errors and guarantee data integrity. The implementation of APOTECAtrial was aimed to extend the same level of control to CTs.
What was done?
In 2018, a clinical trial (CT) managing system (APOTECAtrial) was integrated into the existing fully-automated workflow of the chemotherapy production unit. APOTECAtrial was developed to enable real-time visualization of CT-related data and trace the processing of investigational (IMP) and non-investigational (NIMP) medical products, such as delivery, assignment, preparation, return, and disposal.
How was it done?
A team of hospital pharmacists, physicians, clinical data managers, and IT specialists analysed the CT workflow and defined the system specifications. Data related to IMP/NIMPs (both for parenteral and oral administration), patients enrolled, and investigator/sponsor affiliations were entered into APOTECAtrial and sorted by CT. The onco-haematology unit’s electronic prescribing system was bidirectionally interfaced with APOTECAtrial. Aseptic preparation of patient-specific injectable therapies was implemented in the supporting device for manual preparation that checks dosage accuracy and identity by photographic and barcode recognition.
What has been achieved?
Since 2018, the overall number of CTs managed was 95. In total, 81 IMPs/NIMPs and 135 patients were entered into the system, while 2740 injectable therapies were prepared, 690 oral medications and 60 pre-filled syringes delivered. The following major objectives were achieved: automated inventory accounting and stock management, reduced manual time-consuming activities (i.e. documentation, transcription), standardized reports in digital not-editable format, and full traceability. In addition, audit trail tool tracks all user edits and changes performed at any stages of the CT management by electronically recording user’s name, date, and time. APOTECAtrial was evaluated by clinical research associates (CRA), clinical research organizations (CRO) and CT sponsors and approved for use in the daily clinical practice.
What next?
The project represents a good example of multidisciplinary collaboration focused on improving the quality of the processes in healthcare settings. The implementation of information technology and automation ensures improved data integrity, safety, and working efficiency, which are key determinants for managing CTs in hospital pharmacies.
OPIOIDS STOCK OPTIMISATION UTILISING AUTOMATIC DISPENSING SYSTEMS DURING AND AFTER COVID-19 PANDEMIC
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
MARINA RODRÍGUEZ MARÍN, HILARIO MARTÍNEZ BARROS, MARÍA DEL ROSARIO PINTOR RECUENCO, BEATRIZ MONTERO LLORENTE, ANA MARÍA ÁLVAREZ DÍAZ
Why was it done?
It was done in order to optimize opioids stock to meet the needs of COVID-19 patients and protocolize the correct quarantine without modifying the computerized registration in the 39 ADS.
What was done?
A procedure was implemented to optimize the stock and manage the quarantine of opioids in Automatic Dispensing Systems (ADS) during and after their use in hospital units hosting COVID patients.
How was it done?
As hospitalization units were being adapted to host COVID-19 patients, opioids stock had to be modified to meet their new demands. Reversely, when hospitalization units were recovered to host their usual type of patient, the opioids had to be replaced and quarantined for ten days, according to our Preventive Medicine Unit. All these movements were recorded.
We followed this process:
1. Physical and computerized unloading of opioids without dispensing in recent months and emptying of the returned drawer (storage space for opioids withdrawn from the ADS which were not used).
2. Relocation to hospitalization units hosting COVID-19 patients,
3. Replacement of all (minidrawers) where opioids were kept with clean ones
4. Quarantine in the Pharmacy Service, for the drugs unloaded which were unable to be immediately relocated.
5. Cleaning and sanitizing of the removed minidrawers from COVID-19 hospitalization units’ ADS to be used in the next conversion.
What has been achieved?
29 ADS of the 39 available in the hospital were optimized.
Given the decreased in COVID-19 admissions during May, the hospital made a schedule to return to normality which allowed to leave 5 ADS in quarantine without the need to unload or replace any drug,. The other 24 ADS had to be cleaned and disinfected,. It led to the physical unloading of 182 specialties (a total of 1,519 units), the physical and computerized unloading of 124 specialties (850 units) and the emptying of the returned drawers (18 specialties and 20 units). 504 minidrawers were replaced by other cleaned and disinfected ones and 298 specialties (2,080 units) were replaced.
What next?
Enhancing our protocol to allow us to spend more time with the patients in Covid’s further waives.