Assessment of the safety of advanced therapy medicinal products (ATMP) process: a tutorial video creation module
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Chloé JADOUL, Audrey DURAND, Rémy TORDJEMAN, Isabelle MADELAINE, Romain de JORNA
Why was it done?
With the development of advanced therapy medicinal products (ATMPs), a specific pharmaceutical process is necessary to secure the handling of genetically modified organisms. Gene therapy includes Chimeric Antigen Receptor T (CAR-T) cell therapy as well as clinical trials with oncolytic viruses and nucleic acids. Limited experience on these new activities and high staff turnover based on resident pharmacist explain the need of additional training material to supplement written procedures. Multimedia support seems to be the most appropriate didactic tool.
What was done?
The objective of this work is to create pedagogical tools as short video clips. The final aim is to standardise hands-on training in order to improve ATMPs circuit safety.
How was it done?
All steps of each activity were listed and filmed in order to create a video database. Clinical trial mock preparations were performed to create the clinical trial tutorials whereas CAR-T cell activities were filmed in real conditions.
Clipchamp (Microsoft) video editing software is used to create tutorial videos. Repetitive parts were edited once and reused for other videos. They are part of the database videos.
As a validation, all staff members’ approbation was required.
What has been achieved?
Activities include, to this day, five gene therapy clinical trials and the CAR-T cell activities: reception, shipment to the pharmaceutical hub, thawing and distribution.
We filmed 55 step clips and edited six repetitive parts. Finally, eight tutorial videos were created: three for clinical trials and four for different CAR-T cell activities.
To make the training more meaningful, we made dynamic videos that last no more than 5 minutes. The average time of a tutorial was 2 minutes 17 seconds.
What next?
The tutorial videos bank is created to be dynamic and can be easily adjusted. Videos of repetitive parts will be reused for new clinical trials implementation. These video tutorials allow new resident, student or technicians to be trained faster and in a more innovative way. They also allow permanent teams to benefit from a quick refresh. In order to assess the efficiency of this new process, next operators will have to read the procedure, watch the videos and will be evaluated in practice.
Software tool development for reconstitution and administration of parenteral antibiotics in hospitals: an international project
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Zora Ćetković, Dragana Rajinac, Ivana Baralić , Jelena Marković, Darija Kuruc Poje, Miroslav Kota, Špela Urh, Irina Tegelj, Vesna Bizjak, Dragana Mitrić, Tijana Kovačević, Andrej Pečet, Irena Radivojša, Sanja Filkova, Vesna Bašić-Milošević
Why was it done?
Medication errors regarding reconstitution and administration of parenteral antibiotics are frequent in hospitals. In our study conducted in 12 Southeastern European hospitals in 2021, we demonstrated the need of parenteral antibiotic reconstitution/dilution database in hospital pharmacy practice. Moreover, according to European Statements of Hospital Pharmacy (statement 5.5.), implementation of electronic decision support system by HPs should help to decrease the risk of medication errors. The purpose of software tools is to gather all relevant information regarding parenteral antibiotic reconstitution/dilution and make them easily accessible.
What was done?
A group of hospital pharmacists (HPs) from 6 Southeastern European countries created new software tools (a mobile-responsive website and mobile applications for Android and iOS) for providing information on reconstitution and administration of parenteral antibiotics in collaboration with software developer. These tools contain parenteral antibiotic reconstitution/dilution database in seven different languages (English, Serbian, Croatian, Slovenian, Bosnian, Macedonian and Montenegrin).
How was it done?
Technical requirements for website and mobile applications were designed by HPs. The development of these software tools was carried out by a software developer and funded by European Association of Hospital Pharmacists (EAHP). The final version of the software went through a rigorous evaluation, conducted by HPs during development and all technical problems were resolved consequently.
What has been achieved?
· Designing and developing these software tools helps HPs to provide evidence-based information about parenteral antibiotic reconstitution/dilution at the point of care, thus improving decision-making process and patient safety. · Reconstitution of parenteral antibiotics in wards is efficient and smooth. · Oral and written instructions for parenteral antibiotic reconstitution/dilution are replaced by electronic decision support tools, designed to prevent medication errors. · HP’s interventions are required to support the use of these software tools.
What next?
Our next challenge is wider use of these software tools in order to ensure the appropriate reconstitution/dilution of parenteral antibiotics in wards by nurses and physicians. These software tools are applicable in hospital setting and can be used by all regional hospitals. Additionally, they can be easily incorporated in hospital information system. We also plan to update periodically antibiotic reconstitution/dilution database, as new information becomes available.
Application of a supplier qualification program for primary packaging materials regulated as medical devices
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Andersen Lilli Moeller, Hansen Tove Solveig, Schnor Trine
Why was it done?
The QMS for the hospital pharmacy did not previously include primary packaging systems regulated by MDR. These packaging systems are a prerequisite for supply to patients of vital medicines like Total Parental Nutrition (TPN) and ready-to-use products such as antibiotics, cytostatics and pain reliefs.
What was done?
Several actions to combine Good Manufacturing Practice (GMP) and Medical Device Regulations (MDR1) were implemented. Among others, comprehensive training programmes were conducted, and quality standards as well as supply chain mappings were included in Quality Management Systems (QMS).
How was it done?
A national strategic initiative was launched with actions decided in open dialogue with the Competent Authority and suppliers.
Priority was given to the most GMP-critical devices as TPN-bags and elastomeric pumps. Specifications were established and supply chains mapped.
To fast roll out competences across hospital pharmacies similar workshops with participation of a consultant with special competences within MDR were given.
What has been achieved?
Due to knowledge of the Supply Chain and extended cooperation with suppliers, a quick and effective reaction in relation to for example recalls is obtained.
Easier to explain suppliers how they can support our need for documentation to fulfill GMP related demands New clinical or political demands to ad-hoc compounding can be met fast and effective.
GMP related issues are part of a current national tender for elastomeric pumps.
What next?
More medical devices like transfer-sets, syringes used as utensils and gloves to be included in the supplier qualification program.
GMP related requirements to be a part of tenders on medical devices used as packaging systems.
Continued cooperation with suppliers to develop solutions in the interface between MDR and GMP.
INTRODUCTION OF REGULATORY AND HEALTH WATCH IN THE CLINICAL TRIALS AREA
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
When the case for a study sponsored by the hospital has been filed a few months ago, the national agency authorizing trials raised the issue of health waltch, particularly the management of drug recalls. With the research department, which alerted us on the lack of resources for health alerts, and at the same time facing an international cease of some drugs, we set up a health alert and a regulatory watch system, to improve the quality of product and the patient’s safety.
What was done?
We set up a daily health and regulatory watch to stay abreast of any news. Regarding health watch, we included : studies for which the hospital is the sponsor ; studies for which the experimental treatments are not provided by the sponsor ; treatments used for adverse events and authorized by the sponsor.
How was it done?
Daily regulatory watch is carried out on the national legislation website with daily updates of national texts. If a new rule applies, it is written in a table to alert everyone.
Daily health watch is also carried out on the site of the national agency of drugs. Four types of information are recorded: drug shortages, alerts, recalls and releases.
What has been achieved?
Tables collecting those information are available on the pharmacy’s network so that anyone can read them, and can be shared with clinical research officers. To that day, some information has been collected due to a european legislation update on the clinical trials and has allowed us to anticipate what will change next year. We have not yet faced a drug recall but what has been done will allow us to react in the best way when this will happen.
What next?
The aim for carrying out regulatory and health watch is to allow us to quickly react and anticipate future problems, while keeping in mind the patient’s safety and the pharmacy practices improvement. This work was therefore completed with success, demonstrating the ability to react and the desire to deploy continuous improvement initiatives to strive for operational excellence and pharmaceutical. We now want to implement this work in the daily activity and extend it to other sectors.
Parameters involved in medication dispensing automation security and performance
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Hind Bouami, Dorine Castillo
Why was it done?
The human-machine system designer has to make decisions to secure and improve the automation process, and handle organization’s complexity. Documenting human agent’s situation awareness is crucial to support human-machine designers’ decision-making. Knowledge about risks, critical parameters and factors that can impact and threaten automation system’s performance and security are valuable for human agents, and should be collected using preventive and retrospective approaches.The evaluation of Macon hospital center’s automation performance enables to identify critical parameters to control in order to secure the human-machine system.
What was done?
An automation evaluation approach has been conducted in Macon hospital center, a hospital equipped with automated drug dispensing solutions for more than 5 years. The analysis of Macon hospital center automation’s feedback provides relevant information to enhance the perception and the comprehension of the system’s complexity fully, environmental factors that interact with the system, and to identify critical parameters in the automation process. Therefore, agents can design a projection of a secure and performant automated organization. This information will enable hospitals to make effective decisions to improve their automation project performance.
How was it done?
We deployed an anthropocentric approach for automated system evaluation in Macon hospital center.
Our approach integrates six steps that are run in automated hospital pharmacies to analyze their feedback [6]:
1) The identification of pharmacy’s automation needs and objectives, and the analysis of operational environment and existing equipment,
2) The analysis of automated equipment functional specifications formalized by the pharmacy,
3) The evaluation of automation deployment results and related gains,
4) The evaluation of specific actions implemented by the pharmacy during automation process,
5) The analysis of the parameters to control for automated equipment integration security and performance,
6) The analysis of factors influencing human-machine interaction.
What has been achieved?
The analysis of Macon hospital center pharmacy’s automation specifications revealed that 66.22% of automation requirements are technical, 29.73% concern human-machine interaction, and 4.05% relate to human aspects.
80.95% of automation specification related to the chosen Sinteco’s automated solution are met. The performance of the chosen automated solution is involved in 28.38% of automation specifications performance in Macon hospital center. The remaining systemic parameters involved in automation specifications performance need to be controlled.
Critical systemic parameters involved in automated solutions specifications and performance that have been identified through Macon hospital’s automation feedback are: the specificities of the chosen automated solution, hospital’s strategic decisions and budgetary constraints, the complexity of the hospital’s organization, the complexity of hospital’s information system, the constraints related to the packaging of drugs by pharmaceutical firms, users training, the complexity of the automated system, and users’ requirements and constraints.
The five parameters influencing human-machine interaction that should be managed to secure automated systems are: understanding the system’s complexity, defining relevant levels of automation, determining human and automated agents’ authority, determining human and automated agents’ autonomy, and understanding the human complexity.
What next?
Handling life-critical systems complexity such as medication delivery activity requires to be equipped with appropriate technology, and to control automation risks. The integration of human-machine principles is crucial to secure automation in hospitals, and to maintain a good balance between automation and human skills.
A toolbox for patients safety challenge
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
CHIARA CARCIERI, SILVIA SCALPELLO, MARISA FIORDELISI, MARIA CARMEN AZZOLINA, ANNALISA GASCO
Why was it done?
Errors in drug therapy affect the entire drug management process. The literature show that 56% of patients are at risk of having medications discrepancies and errors at transitions of care. Ineffective communication between healthcare professionals and patients/care-giver or interprofessional, can generate patient intake errors, sub-adherence and therapeutic failures. This harms are avoidable and the aim of this work was to minimise errors and optimise medicines use by different strategy, as recomands by the World Health Organization (WHO) in The Global Patient Safety Action Plan 2021–2030.
What was done?
At the Mauriziano Hospital a multilevel system has been developed to prevent, early identify, resolve and monitor the problems that, in different steps of patients path, can generate risks related to therapy at transitions of care.
How was it done?
Different tools has been developed and implemented in the patients clinical path in order to assurance risk management for patients in transition of care:
1. Hospital pharmacist consulting has been activated to support physician in for in patients medical reconciliation;
2. Therapeutic reconnaissance and reconciliation electronic card (SRR-T) has been developed and integrated in the dicharge letter;
3. Classification of the hospital pharmacists interventions in the transition of care to avoid medical errors was created as risk management tool.
4. Telepharmacy service to monitor patients follow-up at distance was activated.
5. Educational paths have been implemented to improve patient medication literacy throught professional counselling by pharmacists in discharges.
What has been achieved?
Medication safety tools implemented have improved communication between healthcare professionals (intra and inter-hospital) and between healthcare professionals and patients. The patient-centred approach allows to focus on key points in the medication process to correct intake therapy and minimized correlated risks. Physician was supported by pharmacists and facilitated in the correct management of prescriptins. In 4 months the pharmacists carried out 470 corrective interventions of which 31 with possible clinical impact for the patient. Appropriate process put in place allow to minimize expenditure of supplementary health resources by National Healthcare Service.
What next?
In the future it will be useful to develop specific pathways for polytherapy patients and invest in automation of processes such as drug logistics.
Improving medication barcode identification on the smallest unit of use: Start-up first ePIL (electronic leaflet) project for medicines used in hospitals in Spain
European Statement
Patient Safety and Quality Assurance
Author(s)
E Sulleiro, C Garrido, A Santamartina, O Delgado, B Aguado, I Alvarez Novoa, M Amérigo , L Calatayud, M Cardenal, J Carretero , J Corredoira, MA De la Peña, MJ De la Torre, S Domingo-Carranza, M Ercep, E Emili, M Eugui, E Falco, M Garcia , S Hernandez, M Hidalgo, J Hierro, M Jamali, C Joglar, S Juan, N Longás, A Lopez de la Rica, JJ Martínez , M MIllán , P Paris, C Ramirez, M Serrano
Why was it done?
Medication errors are one of the most common causes of preventable adverse events in the healthcare system. A complete identification of a medicine, up to the moment of administration, is therefore a key element of a safe medicines dispensing procedure in hospitals.
Digitization is a trend affecting all levels of our society and medicines are no exception. Increased use of Datamatrix code in the outer packaging of medicines has facilitated many healthcare professionals to become familiar with this technology. It is now possible to easily retrieve online information about a medicine, which raises the possibility of obtaining updated information of medicines without necessarily using a paper leaflet. Moreover, paper leaflets in the hospital setting are very often disposed of without reaching their end user, the patient.
Additionally, hospitals have other needs closely related to digitalization, considering errors in the reconciliation of prescription versus dispensing and administration, that can be reduced due to automated capture of the code linked to a particular medicine in the smallest unit of use, and also when dealing with compounding traceability preparations for patients.
What was done?
Spanish Agency of Medicines and Medical Devices (AEMPS), Spanish Society of Hospital Pharmacy in coordination with Hospital Committee of the General Council of Official Pharmacist Associations , and a series of pharmaceutical companies, mostly integrated in National Trade Association of the Spanish based pharmaceutical industry (Farmaindustria), have launched a project consisting of removing paper leaflet from the packaging components of a series of medicines exclusively administered in hospitals. These medicines will have a Datamatrix code in the primary packaging. When scanned, Datamatrix will allow to capture official PIL text from the information hosted in the Medicine Online Information Center of AEMPS (CIMA), which can be used for patient safety purposes at hospital pharmacy.
How was it done?
The Project began in November 2020 creating an ad-hoc working group on “Technical Regulation of Pharmaceutical Medicines” from Farmaindustria with AEMPS and representatives of Hospital Pharmacists. After 10 TCs and after having the participation of different partners, the main lines were agreed
Stakeholders agreed a proposal for pilot description and AEMPS informed the European Commissionin due course.
What has been achieved?
1. From January, 1 2022, a list of medicines meeting the established requirements will be able to be marketed without paper leaflet
2. Non-serialized Datamatrix will be included in the primary packaging, shall be compliant with GS1 standardization and may be pre-printed. It will contain specific NTIN/GTIN that will enable access through a correspondence table to Marketing Authorization Number (pharmaceutical form and dose) of the medicine hosted in AEMPS Nomenclator for Prescription (a medicine database intended to provide core prescription information to the care information services). In case technically feasible, companies may include also batch variable information such as Batch Number and Expiry date in the Datamatrix on a voluntary basis.
What next?
Assessing the impact of this practice in terms of efficiency, flexibility and safety is a key priority and this pilot project will gather enough data and information to help EC and Member States to revise relevant provisions in the legislation by 2022.
EU citizens will be able to benefit from the development of new technologies, as an underlying driver for delivering timely and easily accessible an up-to-date medicinal product information,
Design and dissemination of infographics to improve safety in drug handling
European Statement
Patient Safety and Quality Assurance
Author(s)
Paula Hernando Martínez, María Antonia Meroño Saura, Caridad Marti Gil, Lidia Martínez Valdevieso, Jaime Fernández-Bravo Rodrigo, Dolores Barreda Hernández
Why was it done?
There is a wide bibliography on how human errors related to drugs put the patient’s health at risk. Drug preparation and administration errors, dose calculation errors, lack of knowledge about drugs or interactions, to name but a few. There must be protocols to ensure that drugs are safe for patients, including procedures which professionals should fulfill in order to reduce those errors in processes and guarantee, in such cases, that they will not have adverse effects on patients.
What was done?
Development of infographics for assembling drugs which are susceptible to a higher rate of errors in their preparation and administration to hospitalized patients.
How was it done?
During September 2021, a working group was formed in the pharmacy department (PD). Through the nominal group technique, the design and content of drug infographics was proposed as a solution to the raised problem. Subsequently, a bibliographic research of susceptible drugs to human errors during administration or preparation and those which requiring special handling was reviewed through the list of high-alert medication from National Institute for the Safe Use of Medications website and NIOSH list of hazardous drugs. To this end, the PD databases were analysed, obtaining the drugs that required the greatest number of pharmacotherapeutic consultations made by nursing staff on drug administration and recommendations made during pharmaceutical validation.
What has been achieved?
An infographic model has been designed which includes the description of the drug (name of drug, excipients, dose, pharmaceutical form, dosage regimen, route of administration, concentration), the preparation and administration protocol (reconstitution, dilution, infusion rate, premedication), observations (maximum doses, conditioning, incompatibilities, alerts) and storage conditions (conservation and stability). Infographics on dantrolene, intravenous phenytoin solution, intravenous nimodipine solution and potassium chloride solutions are currently being distributed. These documents are available at the nursing controls and on the hospital’s internal website.
What next?
To increase the availability of drug’s infographics and to update those that have already been developed when necessary. In addition, from the PD, the preparation of administration kits for the solicited drugs is proposed so as to ensure that all the necessary materials for the preparation and administration are included along with the corresponding drug and infographic.
A prospective observational study of medication prescribing errors in an Emergency Department.
European Statement
Patient Safety and Quality Assurance
Author(s)
Carmen Ortí Juan, Cristina Toro Blanch, Maria Àngels Gispert Ametller, Ana Perez Plasencia, Cristina Lecha Ochoa, Anna Dordà Benito, Rosa Sacrest Güell
Why was it done?
Prescribing errors (PE) are an important cause of medication-related adverse events in the Emergency Departments (ED) but limited data are available in ED with electronic prescribing and administration (ePA) systems. Knowing the frequency and types of PE can help healthcare professionals to prevent and reduce the risk of them occurring.
What was done?
To determine the rate of PE in the ED, to classify incident types and to identify critical points where measures should be implemented to improve patient safety.
How was it done?
Prospective, observational and cross-sectional study in an ED with ePA system during 6 working days (May-June 2021). The inclusion criteria were patients stayed more than 8 hours in the ED and all patients awaiting hospitalization. Prescriptions were analyzed by a multidisciplinary team made up of two pharmacists, an emergency physician and the person in charge of the hospital’s medication errors committee. PE were reported to the hospital’s patient safety-related incident notification system.
What has been achieved?
Of the 65 prescriptions revised during the study period, PE were reported in 84 cases and 15 situations with the capacity to cause errors were detected. The average age of patients was 67 ± (SD=17,9) years and each prescription had an average of 8.4 medications. The rate of PE was 1.52 errors per patient, being higher in less severe patients than monitored patients (1.09 vs 2.0 PE per patient, respectively). The most common types of EP were omission of the usual medication (60.7%), wrong dose (15.5%), wrong frequency (7.1%) and drug is not indicated (7.1%). No adverse reactions related to EP were detected. According to the Spanish consensus about Medication Reconciliation in Emergency Units, 47.1% of omissions of usual medication were drugs that should be reconciled during the first 4 hours in the ED. The results of the study and the importance of medication reconciliation are highlighted in a session in the ED.
What next?
The PE rate in the ED was 1.52 per patient and the main type was omission of the usual medication. A cross sectional study will be made in the future and compared to the current one to establish the impact of the implemented measures on the PE rate.
EVALUATION OF RENAL DRUG DOSING ADJUSTMENT IN CHRONIC KIDNEY DISEASE PATIENTS
European Statement
Patient Safety and Quality Assurance
Author(s)
Pilar Fernández-Villacañas Fernández, Manuel Ríos Saorín, Patricia Ortiz Fernández, Alba María Martínez Soto, Consolación Pastor Mondéjar, Carmen Caballero Requejo, Lorena Rentero Redondo, Alberto Quesada Asencio, Elena Urbieta Sanz
Why was it done?
Due to kidney pathologies affect the normal pharmacokinetics of many drugs, it is necessary to adjust the dose of the drug for each patient. It is also necessary to ensure effectiveness and safety for the hospitalized patients with renal failure, associated with higher morbidity and mortality. The main objective is to minimise validation and prescription errors.
What was done?
A review of drug dosing according to the patient´s creatinine clearance was performed. This dose adjustment was included as alerts in the electronic prescription system.
How was it done?
For each drug, the data of the dosage adjustment in patients with renal impairment were compiled by consulting the technical data sheets and the national guidelines. In the case of antimicrobials, the information was obtained from the Antimicrobial Therapy Guide 31th Edition March 2021. The data were organized in an Excel table to later integrate them into the hospital’s electronic prescription system.
What has been achieved?
The dose adjustment was made for 848 presentations of different drugs: antibacterials (186), antipsychotics and antidepressants (109), antiepileptics (63), opiates (57), antivirals (49), NSAIDs (26), diuretics (24), anticoagulants (22), antimycotics (21), antidiabetics (15), antiparasitics (11), antiemetics (11), antitumors (4), among others. A large number of drugs are highly dependent on kidney function, especially antibacterials, antipsychotics and antidepressants, making that an incorrect dosage of renal drugs can worsen kidney function and produce toxic effects due to their accumulation.
What next?
This dosage adjustment for patients with renal failure should be periodically reviewed by the hospital’s pharmacy service in order to keep the alerts of the electronic prescription system up-to-date. Additionally, this system can be implemented for other pathologies such as liver failure, or to avoid overdose by establishing the maximum dose limit allowed. In conclusion, the importance of an adequate electronic prescription program that facilitates daily clinical practice is established, preventing possible medication errors.