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Homemade personalized 3D printed guides for mandibular reconstruction – A pharmacist feedback

European Statement

Production and Compounding

Author(s)

Quentin Misandeau, Romain Bosc, Muriel Paul, Valérie Archer, Lionel Tortolano

Why was it done?

The plastic surgery department bought two 3D printers in order to design and create custom-made medical devices. The main objective was to decrease the delay between mandibular cancer diagnosis and the surgery. The delays of production in the medical device manufacturers may exceed 2 weeks. Those delays are considered as a lost of chance for the patients.

What was done?

We helped our surgeons to secured the production procedure and reduce the risks for patients. We create a management quality system for supply, production, sterilization and using of our homemade personalized 3D printed guides.

How was it done?

First, we created a task force of pharmacist and surgeons.
The main work was a risk analysis with the FMECA method for all the steps in the procedure (software, tools, actors and materials).

What has been achieved?

Some correctives actions were taken. The riskier points were the plastic materials toxicity risk, the sterilization procedure that has been validated and the production traceability. A biocompatibility evaluation was performed. A clinical evaluation has been initiated in the same period.

What next?

Since the new medical device regulatory (2017 /745 CE) was published in 2017, the article five, that regulate the 3D printing in hospital, changes the possibilities. In fact, as personalized 3D printed guides are available on the EU market, homemade personalized 3D printed guides for mandibular reconstruction could be not authorized anymore. The only way would be for the hospital to obtain the regulatory statut of manufacturer and comply with the essential requirements.

Securing the care pathway of patients in the new experimentation of medical cannabis through pharmaceutical interviews

European Statement

Clinical Pharmacy Services

Author(s)

Marie Guedon, Maëliss Laurent, Thibault Vallecillo, Catherine Mennesson, Mélanie Jennesson Lyver, Dominique Hettler, Céline Mongaret

Why was it done?

In March 2021, the “Agence Nationale de Sécurité du Médicament” initiated an experiment to evaluate the relevance and feasibility of the availability of MC as a narcotic drug, in France. In our hospital, we included children to treat drug-resistant epilepsy, and performed a dispensing process to secure the patient care pathway and strengthen collaboration between hospital pharmacists and primary care professional.

What was done?

The aim of this study is to secure the care pathway of patients included in a national experimentation of medical cannabis (MC) by developing pharmaceutical interviews. Thus, to optimize the continuity of patient care, a pharmaceutical report was developed, and addressed to the community pharmacists of the patient.

How was it done?

A working group was created including clinical pharmacists, a neuropediatrician and a coordination nurse. During medical consultations, pharmaceutical interviews were conducted and led to pharmaceutic reports, sent to the community pharmacies of the patients. In order to evaluate this report, a satisfaction survey was carried out.

What has been achieved?

During the first six months of the experimentation, three children were included. The clinical pharmacist team (two senior pharmacists and two pharmacy residents) performed ten dispensing processes. During the eight pharmaceutical interviews, four pharmaceutical interventions were performed. Firstly, the interaction between clobazam and MC (noticed in one patient) required a dosage adjustment. Then, the association between MC and hepatotoxic drugs (found in two patients) requires hepatic monitoring. A pharmacovigilance statement was also drafted to report side effects (digestive disorders). The satisfaction survey of community pharmacists showed that the transmitted information, mostly related to the medication review, was considered as useful for the community pharmacies of the patients. This data helped to guide the pharmaceutical interviews during their dispensing process.

What next?

Pharmaceutical interviews and their reports lead to secure the patient care pathway and improve the communication amongst health care professionals. Those measures provide an optimal case management and avoid therapeutic breakdown. Nevertheless, difficulties have been reported, mostly due to delay in the supply chain of the community pharmacies. Therefore, this system requires some adjustments before it can be applied on a larger scale. One of the suggestions is a provisional calendar of consultations and dispensations.

Elaboration of a Good Practice Guide for the administration of parenteral antibiotics at children’s hospital

European Statement

Patient Safety and Quality Assurance

Author(s)

MOHAMMED ADNANE EL WARTITI, WAFAA ENNEFFAH, BOUCHRA MEDDAH, MUSTAPHA BOUATIA

Why was it done?

The GPG was developed in a concern of practices standardization to guarantee the safety and efficacy of parenteral antibiotics, especially those stored in vials which reuse in possible only if conditions of administration and stability are respected.

What was done?

We developed a Good Practice Guide (GPG) for the usage of major available parenteral antibiotics.

How was it done?

After we listed all parenteral antibiotics available at the hospital pharmacy, we selected the most used ones and we synthesized all manufacturers’ data to establish a GPG for their administration. We also used literature data to complete missing information in “Summaries of Product Characteristics” related to pediatric use of these drugs. Finally we determined the most antibiotics consuming units according to their defined daily doses, where GPG recommendations will be implemented, before their extension to all other units.

What has been achieved?

The GPG concerned the most used antibiotics, which mainly belong to the following classes: Beta-lactam, Glycopeptide and Imidazole antibiotics, Aminoglycosides and Quinolones. It specifies the galenical presentation, used solvents, volume and duration of administration, stability after reconstitution as well as incompatibilities and special measures relating to the use of these drugs. The most antibiotics consuming units are pediatric intensive care units, “IIB” pediatric unit and pediatric surgical emergency department.

What next?

The approach used in this work can be adopted in other similar structures in order to establish GPGs within the framework of a quality control policy aiming to raise the standard of care.

Impact of introducing a Unit Dose blister service in an Austrian hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Theodora Steindl-Schönhuber, Gittler G.

Why was it done?

Medication dispensing is a time-consuming, labour-intensive, error-prone process in the daily routine on the wards. The project was triggered by the tight personnel situation during the Coronavirus pandemic: In November 2020 three wards with COVID-19 patients (91 beds) were integrated into our Unit Dose blister service to assist the nursing staff. A multidisciplinary effort (management, IT-department, doctors, nursing staff, pharmacy holding a GMP-manufacturer´s certificate) and long-established electronic patient records including medication data enabled fast realisation.
After transformation back to a chirurgical, an internal and a geriatric ward the service was continued and extended to the neurological unit (49 beds) due to positive feed-back. We wanted to study the observed positive effects of Unit Dose supply in more detail.

What was done?

In our hospital medication distribution has been switched from manual dispensing by ward staff to automated Unit Dose blister packaging by the pharmacy. Our study investigates the impacts of this change on medication safety, staff satisfaction, time and drug resources.

How was it done?

The percentage of pharmacy-blistered drugs, time gain for nursing staff, employee satisfaction, medication consumption and erroneous blister fillings were investigated.

What has been achieved?

Unit Dose in hospitals is not standard for many countries and is so far unique in Austria. Therefore, we would like to share our experiences and findings with our colleagues: Solid, oral dosage forms could be supplied by 99% via Unit Dose. Time for manual drug dispensing was reduced by 75%. A survey showed high employee satisfaction with the supply process as well as the quality and correctness of the blisters. Consumption of blisterable drugs and stocks on the ward were reduced by 44% and 78%, respectively. Errors in blister fillings in our setting amount to 0,006%. When compared to literature references on error rates for manual medication dispensing (up to low double-digit rates), patients benefit from increased drug therapy safety. On the basis of these results our initiative was granted the Austrian Patient Safety Award 2021 in the field of medication safety.

What next?

We plan to extend Unit Dose to the remaining wards and to investigate patient satisfaction with the blisters, cost-efficiency and distribution of high-cost medications.

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

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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

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European Statement

Patient Safety and Quality Assurance

Author(s)

Hana Sakly

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.