Safe medicine practices: a multidisciplinary approach
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Betânia Abreu Faria, Sara Barroso, Antonieta Silva, Olga Martins
Why was it done?
Portuguese legislation “The Basic Health Law (No. 95/2019) and the National Plan for Patient Safety 2021-2026 (NPPS 2021-2026) and the goals of the World Health Organization (WHO) are fundamental pillars of healthcare safety. The NPPS has promoted patient safety in the Portuguese National Health Service, focusing on specific issues such as safety culture, unambiguous identification of patients, safe surgery, pressure ulcer prevention, prevention of falls, infections associated with healthcare and incident reporting and drug safety. Thus, it is essential to ensure the training of health professionals (HP) in the field of patient safety and the safe and rational use of medicines. The objectives of the training actions focused on the safe use of medication, promoting patient safety and sharing experiences between the various HP, in order to optimise the circuits and procedures already implemented.
What was done?
Multidisciplinary training actions were carried out within the scope of safe medicine practices.
How was it done?
A team of four pharmacists and one nurse carried out training actions in the context of Safe Medicines Practices. The following topics were addressed: medicine circuit; good practices in drug preparation; identification of medicines: Look-Alike Sound-Alike (LASA) and High-Alert Drugs; physicochemical incompatibilities; factors that modify stability after reconstitution/dilution; fractionation and crushing of Solid Oral Pharmaceutical Forms (SOPF); drug information sources; reporting adverse drug reactions and other incidents; good practices in medication administration.
What has been achieved?
Training actions were carried out with a total of 29 hours of training and 357 participants. Suggestions for improvement were presented: optimisation of drug signage, compliance with established circuits, logistical aspects, on time drug information, improvement of communication channels, increase in the frequency of training actions. The trainees expressed receptiveness and interest in this initiative, which provided content that was little discussed and very relevant to their daily practice.
What next?
The correct preparation and administration of medicines is essential to safeguard their effectiveness and patient safety, which is the ultimate goal of every health professional’s daily activity. The Pharmacist, as part of the multidisciplinary team, must promote strategies that safeguard Safe Practices throughout the drug circuit. Hence it is important to ensure the continuity of these trainings.
Improving people living with HIV therapies compliance: a practical tool customised for patients and designed by hospital pharmacists
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sabrina Trivellato, Daniele Mengato, Maria Mazzitelli, Anna Maria Cattelan, Francesca Venturini
Why was it done?
An optimal compliance is an essential requirement for people living with HIV (PLWHA) to grant drugs effectiveness and safety. Given the complexity of the therapeutic regimen, and the multiple changes to it due to the clinical status, compliance to therapy may be suboptimal. Patients who are not well educated on how to follow their therapy are more keen on quitting the treatment or facing virological failure. According to previous analysis, we reported that 120 patients out of more than 1500 managed by our centre experienced suboptimal adherence to therapy.
What was done?
We created a user-friendly tool to educate HIV-patients on their drugs’ adherence in our University Hospital.
How was it done?
We studied every drug prescribed in our centre and we analysed it from the patient’s point of view. The question we aimed to answer was: “If I were a PLWHA, what would help me assuming the correct drug, at the proper time, avoiding misunderstandings?”. We analysed the shape, colour and dimensions of both the package and the pills/capsules. We focused on the most appropriate way to take every drug and we investigated possible interactions with OTC drugs or dietary supplements.
What has been achieved?
A poster reporting all the drugs available in our formulary was developed: 34 medicines were described in alphabetical order, specifying for each one the image of the package, the usual dosage, the picture of the pill/capsule compared to the dimension of current coins and special warnings about possible drug-drug interactions. We also adopted practical symbols to indicate whether to assume the drug with or without food. The poster became available starting from April 2022 and during the following 5 months a cohort of 960 patients could rely on it.
What next?
In order to help our patients taking their therapies, we expect to get a digital form of this poster to make it available on the phone scanning a QR code. Alongside, we aim to enlarge and improve this digital version by adding a final section with an interactive survey to closely monitor the compliance of the patients and help them to improve it. Through this project we could also obtain an active pharmacovigilance setting.
Reconciliation of shared medicine record at discharge: hospital pharmacy ensures correct information on patients’ transition
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Linda Jeffery, Maria Grønkjær Abrahamsen, Anja Alrø Bøtkjær, Lotte Aggergaard, Ann Brit Andersen
Why was it done?
Our country has a national SMR for every citizen. The SMR shows the current medication that the citizen has been prescribed, from all sectors. All sectors can see the SMR, which is considered/ought to be the ‘truth’ about the patient’s medication. On discharge from the hospital the SMR is updated by the doctor. Afterwards, pharmacy technicians dispense medicines for discharge. The technicians, at this stage, often find discrepancies in the SMR compared to the medication prescribed and given during admission. The SMR is electronically updated but not adequately reconciled. False information in the SMR may ultimately lead to adverse drug safety events in the primary sector.
What was done?
The regional hospital pharmacy patient safety network studied how many patients do not have a reconciled electronic Shared Medication Record (SMR) at discharge, despite the doctor having electronically updated it.
How was it done?
The technician recorded the discrepancies found before contacting the doctor to get the SMR corrected.
Each discrepancy was reported into the national patient safety database.
The technicians do not dispense medicines to all discharged patients, so our results were extrapolated to all discharged patients in the time period (there was no reason to expect bias).
The study was carried out in the whole region (5 hospitals) during the same week in September 2022.
What has been achieved?
Preliminary data shows that 994 patients were discharged from the wards studied.
Technicians dispensed medicines to 278 patients. They found one or more discrepancies in 65 SMRs (23,4%).
Extrapolation of these results revealed that, in the period, there were potentially 232 patients with drug-related problems from these wards (and approx. 17,000/year in the region).
What next?
Our results showed that the SMR is not adequately reconciled in 23% of discharges, despite the doctor feeling that the task is completed. This gives drug related problems in the primary sector, often resulting in calls to the ward etc. that are time consuming and difficult to solve after discharge. Updating the SMR at discharge is essential for patient safety under transition of care. Our results will be brought to the hospital administrations, patient safety organisations and the regional medicines board for further discussion about the problem and possible solutions.
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,