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IDEA BOX: INVOLVING HOSPITAL PHARMACY ASSISTANTS IN A QUALITY APPROACH

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European Statement

Patient Safety and Quality Assurance

Author(s)

Adeline HERLIN, Hermine ZIGA, Pauline PAYOT

Why was it done?

The aim is to continuously improve quality and efficiency.

What was done?

In the interests of continuous quality improvement, we have set up a suggestion box in the pharmacy’s unit repackaging sector.

How was it done?

We have set up a suggestion box for technician and pharmacists.
Each person can submit ideas or questions, anonymously or not.
After one month, the box was unpacked. The ideas and queries were analysed and discussed.

What has been achieved?

Eight points were raised.
 One point concerns procedures.
The existing procedures on the intranet network are not well known to users. We have provided an easy-to-access binder.
 Three points relate to packaging methods (list of products according to packaging method, removal of expired packaged products, mismatch of the Eticonform® label with the blister pack).
A decision tree was made (Euraf®: large quantities, multi-dose vials, magistral formula, small blister packs). The printing of the ledgers indicates the packaged products and their expiry dates. The removal of expired products is done according to the ledgers. A precaution must be taken when editing labels Eticonform® “laboratory” labels. Indeed, the size of the blister packs differs from one laboratory to another.
 The fifth point concerns the organization.
Technicians wish a storage area dedicated to repackaged specialties to compensate for stock errors.
After discussion, we did not retain this proposal.
 The other point concerns the lack of equipment.
A stool and a ruler were provided.
 The penultimate point concerns the use of returns from services in multi-dose vials.
We propose the packaging of small units with expiry dates < 3 months with the Euraf® bagging machine.
Otherwise (e.g. Carbimazole), we propose the packaging of sufficient quantities for 7 days in the vials with pre-printed labels with an expiry date of one week.
 The last point concerns the labelling of blisters with desiccant capsule (e.g. Nicorandil).
We offer Eticonform® re-labelling with a statement: USE BY xx/xx/202x (30 days after re-labelling).

What next?

The involvement of the technician team in a proactive approach to risk management is essential. We wanted to harness their practical expertise and energize the team.
The box will be integrated into our current practice.

FIVE YEARS OF A BIG CONTRIBUTION FOR THE SMALLEST AMONG US – THE IMPLEMENTATION OF AN INTRAVENOUS-SERVICE ON NEONATAL INTENSIVE CARE UNITS BY THE HOSPITAL PHARMACY

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European Statement

Production and Compounding

Author(s)

Boglárka Lengyel
Nadine Haubenwalllner
Ingrid Sattlecker

Why was it done?

The global shortage of nursing staff increases the risk for medication errors due to higher workload and stress. The intravenous (I.V.)-service, launched in March 2020, alleviates nurses’ workload and minimizes application errors by standardizing concentrations and providing pharmaceutical training. Producing all infusions with producing pumps in the hospital pharmacy’s clean rooms improves microbiological quality and dosing accuracy. Standardized concentrations with defined stability and proper documentation practices ensure consistent quality.

What was done?

We implemented the production of patient-specific I.V.-infusions and total parenteral nutrition (TPN) for neonatal intensive care units (NICU) to meet the specialized needs of neonates and enhance individualized care. Additionally, pharmacy staff assembles patient infusion sets daily, focusing on Y-Site compatibility and catheter types tailored to each patient.

How was it done?

After discussing demand with physicians and nurses, data on NICU medications and dosages were systematically collected. Standard infusion concentrations were harmonized, considering fluid intake and physical-chemical stability. Protocols for automated compounding of continuous infusions and TPN were established, alongside standard operating procedures for additional volumetric preparation. I.V. compatibility of the drugs was researched, and compatibility tables were created.

What has been achieved?

The project successfully implemented individualized compounding of infusions and TPN with established standards in the hospital pharmacy’s clean rooms. Complete traceability and continuous monitoring during production ensure high product quality. The initiative enhanced interprofessional collaboration, strengthening confidence among physicians, nurses, and pharmacists and significantly reduced nurses’ workload for preparing medications, TPN, and assembling patient sets. The service currently supports five wards, producing an average of 98 infusions and TPN daily. The assembly of patient sets is provided for 44 care beds across NICU and Intermediate Care (IMC) wards, averaging 25 sets daily.

What next?

The service aims to maximize automated production by implementing new compounding pump plans, increasing output to supply more wards. Plans also include expanding the service to the Pediatric Intensive Care Unit (PICU), where both intermittent infusions and patient set assembly will be offered in addition to the existing continuous infusion supply.

PHARMACY TECHNICIANS’ DELEGATED ROLE IN MEDICATION ADJUSTMENT FOR HOSPITALIZED PATIENTS: IMPLEMENTATION OF THERAPEUTIC SUBSTITUTIONS AND DISCONTINUATIONS IN THE ELECTRONIC MEDICATION MODULE

European Statement

Clinical Pharmacy Services

Author(s)

Maibritt Skov Olsen, Bernd Utech

Why was it done?

Pharmacy technicians at the Medical Ward of Bornholm Hospital adjusted medication orders to align with the hospital’s medication assortment. Operating under delegated prescribing authority; they prescribed, paused, and discontinued specific medications within a framework agreement and documented changes in the Electronic Medication Module “Sundhedsplatform” system.

What was done?

Patients often bring medications outside of the hospital’s assortment. Adjustment of these medications is time-consuming and can lead to documentation challenges. Delegating this responsibility to pharmacy technicians aimed to enhance patient safety by ensuring scan-ready medications and freeing up physicians’ time for other tasks.

How was it done?

A medication adjustment list was created by the pharmacy and department physician, outlining which drugs the technicians could adjust or discontinue. Pharmacy technicians were trained, and annual audits were conducted by the department physician. In a period of 13 days, a time study was made to track interventions; consultations with physicians, and time spent adjusting medications in the Sundhedsplatform.Nurses and physicians were asked about their experience of the pharmacy technician’s work.

What has been achieved?

During the test period, 97 patients were dispensed medication, and interventions was made for 39 (40%) of those patients. Technicians performed 60 interventions, of which 11 were physician-consulted. They spent 220 minutes on adjustments and notes, saving physicians 160 minutes. Feedback from nurses and physicians was positive, with improvements in medication scanning and reduced interruptions for physicians.

What next?

The task will be expanded to include all patients in the medical and surgical wards. An extension of the pharmacy technicians’ prescribing authority is also planned.

Enhancing of patient-centric care and employee satisfaction: the “all activities in alignment” programme

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European Statement

Clinical Pharmacy Services

Author(s)

Afke van de Plas, Judith Baars-Timmermans, Hanneke Goossens, Ellen Frankfort

Why was it done?

This initiative aimed to improve:
1. Personalized Healthcare and Patient Satisfaction: In the pursuit of strict regulatory compliance, pharmacy employees sometimes overlooked the pharmacy’s fundamental mission. With limited direct patient interactions, staff were often unaware of patients’ unique needs and preferences.
2. Employee Satisfaction: The program aimed to empower employees by reducing excessive regulations and allowing them to make decisions that aligned with the overarching mission, with the expectation that this would enhance their job satisfaction.
3. Enhancing Awareness of the Pharmacy’s Mission: By connecting all activities to the pharmacy’s core mission, the program attempts to improve personalized healthcare and patient and employee satisfaction.

What was done?

Maastricht University Medical Centre’s hospital pharmacy introduced the “All Activities in Alignment with Underlying Aim” program.

How was it done?

The program’s implementation involved several key steps:
1. Defining the Underlying Aim and Key Principles: The program team identified the overarching aim as “Happy Patients and Employees” and established four key principles: “See the Person Behind the Patient,” “Focus on What Is Possible,” “Take the Lead Yourself,” and “From Rules to Self-Regulation.”
2. Employee Engagement: The new policy was presented and discussed in detail during a meeting with all employees.
3. Communication: Periodic newsletters and monthly team meetings were used to share illustrative examples and foster discussions about initiatives.
4. Evaluation: Customer and employee satisfaction were measured through surveys before and after program implementation.

What has been achieved?

The outcomes of the program were highly encouraging:
• The adoption of “Happy Patients and Employees” as the guiding aim resulted in numerous instances of personalized healthcare and enhanced collegiality.
• The four key principles empowered employees to align their actions with the program’s aim. The empowerment to decide in the patient’s interest increased from 58% to 73%.
• Surveys indicated improved customer and employee satisfaction.
• Enhanced awareness of the pharmacy’s mission (from 47% to 66%) led to stronger connections between activities and the overarching aim (from 73% to 85%).

What next?

The “All Activities in Alignment” program serves as a successful model for other hospital pharmacies seeking to elevate personalized healthcare, patient and employee satisfaction. Its simplicity and effectiveness make it a valuable initiative worth considering for broader implementation.

Checklist for optimal pharmaceutical validation in very low-birth-weight preterm newborns in the neonatal intensive care unit

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European Statement

Patient Safety and Quality Assurance

Author(s)

IGNASI SACANELLA ANGLÈS, MARTA MARTIN MARQUÉS, JULIA BODEGA AZUARA, PILAR LÓPEZ BROSETA, DAVID PASCUAL CARBONELL, HELENA SUÑER BARRIGA, ALEJANDRO SANJUAN BELDA, CARLA DAIANA CIUCIU, SILVIA CONDE GINER, ERIKA ESTEVE PITARCH, ANTONIO GARCÍA MOLINA, SÒNIA JORNET MONTAÑA, ISABEL PLO SECO, Mª ÁNGELES ROCH VENTURA, MARÍA VUELTA ARCE, LAURA CANADELL VILARRASA

Why was it done?

The NICU is a complex area of paediatric hospitalisation that necessitates specialised healthcare professionals. The role of the NICU pharmacist is vital in ensuring the appropriate and optimised use of medications in various critical situations.

What was done?

To develop a checklist that facilitates pharmacotherapy validation for preterm newborns (PTNB) weighing less than 1000 g and hospitalised in the neonatal intensive care unit (NICU). The primary objective is to ensure a higher quality of hospital care in terms of pharmacotherapy.

How was it done?

We conducted a literature review to identify the pharmacotherapy requirements for preterm newborns (PTNB) weighing less than 1000 g during their first 30 days of life.

In order to design the checklist, we compiled various elements, including drugs, dosages, treatment duration, initiation date, and drug monitoring (when necessary). Additionally, we incorporated recommendations for specific scenarios.

What has been achieved?

The drugs considered for this supportive tool include: pulmonary surfactant, ampicillin, gentamicin, fluconazole, caffeine, ibuprofen, iron (ferrum), dexamethasone, nystatin, vitamin D3, and other vitamins. The checklist was designed to cover the first 30 days of life.

From day 0 to 1: Administer pulmonary surfactant and caffeine citrate. For antibiotic prophylaxis, use ampicillin and gentamicin, and fluconazole for antifungal prevention. In cases of an open ductus arteriosus, intravenous ibuprofen should be added.

Between day 10 to 15: Administer vitamin D3 and a multivitamin complex if the neonate tolerates oral administration. If there is a risk of bronchopulmonary dysplasia, which is characterized by more than 7 days of intubation and difficulty with extubation, consider adding dexamethasone and nystatin.

From day 15 onward: Monitor ferritin and vitamin D3 levels. Begin oral iron supplementation (ferrum) 30 days after birth. Both drugs should be continued for one year.

We have included dose adjustments in case of renal or hepatic dysfunction and pharmacokinetic monitoring for antibiotics. In cases where meningitis is suspected, we have provided recommendations for increasing the dose to ensure adequate penetration into the central nervous system.

What next?

This tool simplifies pharmaceutical validation, particularly for pharmacists who may not specialise in the care of these complex patients. By utilising this tool, we can reduce errors and enhance the quality of care provided to preterm newborns (PTNB) weighing less than 1000 g.

Optimised and sustainable distribution and handling of medicines to psychiatric outpatients

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European Statement

Patient Safety and Quality Assurance

Author(s)

Louise Stilling Rasmussen, Lene Juhl Biltsted, Majken Nørskov Petersen

Why was it done?

To implement EAHP statements on Patient Safety and Quality Assurance the hospital pharmacist carried out the intervention in one of the largest psychiatric clinics in the region. The following challenges were observed: Lack of transparency for healthcare professionals. Inflexible and time consuming workflow which did not accommodate the needs in the medical treatment at the clinic. The workflow caused waste of medicine. Changes in the medical treatment, which caused medicine being surplus and ended up expiring. The distribution was expensive and not sustainable.

What was done?

By changing the handling and distribution of medication for psychiatric patients who are entitled to free medicine from the hospital, we now have an agile, streamlined, patient-safe and transparent workflow that ensures patient safety by accommodation of the seven rights, increases the flexibility and availability of medicine to the patient’s current treatment and gives a more sustainable handling of medicine. Furthermore, resulted in direct and indirect financial savings (estimated direct savings 8%, DKK 250,000).

How was it done?

A medication room was reorganised by the pharmacist according to ATC codes, shelf fronts, active ingredients and expiry date.
Establishment of a computer and scanner, linked to the national Shared Medication Record containing all patients’ prescriptions.
Medicine is ordered online from the hospital pharmacy.

What has been achieved?

New modern quality assured medication room with electronic registration of medicines dispensed to the patients. This provides transparency of the medical treatment across the healthcare sector. The medicines are stored correctly, and the integrity is maintained until immediate use and permit correct administration. Elimination of medication waste and reduced time consumption for healthcare personnel gave an estimated direct savings of approx. DKK 250,000 plus an uncalculated saving of staff time. Finally, a more sustainable management of medicines and reduced the risk of errors regarding medical distribution was achieved.

What next?

The results of this project have scaling potential. A presentation for decision-makers about implementing the solution elsewhere is ongoing. The handling and distribution has been changed from patient-labelled medication to secure digital registration of the medication dispensing from the medicine room, which now allows complete traceability of all medicines dispensed by the pharmacy.

IMPLEMENTATION OF A BIGDATA ANALYSIS PROGRAM FOR STOCK MANAGEMENT IN A PHARMACY SERVICE

European Statement

Clinical Pharmacy Services

Author(s)

LUCÍA SOPENA, VICENTE GIMENO, OLGA PEREIRA, Mª ANGELES ALLENDE, RAQUEL FRESQUET, RAQUEL GRACIA, BEATRIZ BONAGA, MERCEDES ARENERE, TRÁNSITO SALVADOR, ALBERTO FRUTOS

Why was it done?

The growing technological development of pharmacy services involves the coexistence of traditional warehouses with automated medicine dispensing systems controlled by different computer programs. The information was splitted into different systems and databases giving rise to possible errors due to the greater complexity.
This is a threat but also an opportunity for the hospital pharmacist to lead the development, review, and improvement of medicine use processes and the use of health technologies.
KNIME data analysis covered the need of our Pharmacy Service to blend data from any source in a single file simplifying the process.

What was done?

The Pharmacy Service of a tertiary-level hospital has implemented Konstanz Information Miner (KNIME) data analysis and treatment program to optimize the stock management of several medicines.

How was it done?

An initial algorithm was designed by the union of 7 files and can be executed at any time to obtain the updated data.

What has been achieved?

This file provides up-to-date information about the stocks, stock-outs, consumptions, orders and purchasing data of all medicines (average price, laboratory, date and number of orders, units to be received).
In addition, KNIME calculated the coverage time from consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows linking and merging data of the list for shortages of medicines, supply disruptions and restocking time provided by the Spanish Agency of Medicines and Medical Devices (AEMPS).
KNIME program has been especially important in our Pharmacy Service during the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Big data analysis has allowed the hospital pharmacist to anticipate missing specialties and to make a rapid response in ensuring the availability of Essential Medicines List (EML) composed by 75 proposed by AEMPS and 138 by our hospital (e.g. antiinfectives, analgesics, muscle relaxants, anesthetics).

What next?

KNIME is a tool that could be successfully implemented and appropriately generalized as recommended to all Pharmacy Services that use different data sources, and want to have a generalized view of the information.
KNIME represents an advance in the stock and stockpiling management of medicines specialties to work more efficiently, which improve patient care and safety.

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

Integration of clinical trials management into a safe and fully-automated onco-haematology workflow

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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.

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