The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Development of a hospital pharmacist led re-evaluation of medication errors
European Statement
Patient Safety and Quality Assurance
Why was it done?
All errors, whether involving medication or not, are required to be reported and classified in the hospital reporting system. However, the system is poorly adapted for medication management and lacks the relevant terms. This results in the same type of error being classified in various ways, making systematic quality improvement difficult. A pilot study confirmed the system’s shortcomings, after which a new medication management process was developed and evaluated.
What was done?
The existing process for classifying medication errors was supplemented with a new process in which hospital pharmacists reclassified medication errors detected in the reporting system. The reclassification was based on a predefined medication management process.
How was it done?
A medication management process was developed in collaboration with specialist nurses and in accordance with applicable regulations and policies. The process consisted of the following activities: 1) Prescription, 2) Ordering/Delivery, 3) Storage/Narcotics Control, 4) Preparation, 5) Handover/Administration, 6) Medicines information in transitions of care, 7) Follow-up of treatment, and 8) Miscellaneous. The process was validated by having four hospital pharmacists independently classify 176 medication errors. Consistency in the assessment was evaluated, and the process was corrected as needed. All medication errors classified as medication-related in 2022 or containing the word “medication” in free text were thereafter exported from the reporting tool to Microsoft Excel and then into a data processing and performance monitoring tool for further analysis.
What has been achieved?
A total of 756 medication errors were identified in the reporting tool, distributed across 65 different activities. Hospital pharmacists identified an additional 305 errors through free-text searches that had not been reported as medication-related. A total of 1,061 medication errors (756+305) were reclassified and grouped into eight activities. The highest risk of errors was associated with the preparation (19%), followed by storage/narcotics control (18%), and prescription (17%). The new process, involving hospital pharmacists in classification, creates conditions for a more systematic approach to medication errors. The pilot project was presented at the hospital’s themed day for World Patient Safety Day 2022.
What next?
Discussions have been initiated with system developers to improve the reporting tool. Discussions with hospital management will be initiated with the goal of creating a structure in which hospital pharmacists have an active role in the hospital’s work on patient safety related to medication.
An algorithm for the process of selecting pharmaceutical companies in a pharmacy department
European Statement
Clinical Pharmacy Services
Author(s)
Moisés Couñago-Fernández, Marisol Samartín-Ucha, Ana María Regueira-Arcay, Sonia González-Costas, María Alfonsín-Lara, Paula Prado-Montes, Iván Agra-Blanco, Elena Cerdeira-Regueira, Noemí Martínez-López de Castro
Why was it done?
When a new pharmaceutical product should be introduced in a hospital, a multitude of factors must be considered in order to choose a specific brand. A lack of uniformity in the criteria for the selection of new medicines has been detected. To avoid selection errors or arbitrary decisions, a selection structured algorithm was developed using quality tools according to management quality system ISO 9001-2015.
What was done?
To ensure that the process of selecting from several pharmaceutical companies fulfil the requirements of quality and lower cost, a decision-making process for these purchases was designed, through a structured method for the evaluation of new pharmaceutical products based on standardised evaluation criteria.
How was it done?
A multidisciplinary group was created focused on making decisions about criteria. All stakeholders were represented (management pharmacist, quality experts, management assistant and pharmacy director). Also, a survey was given to different specialist pharmacists to complete the criteria. Second, criteria were categorised according to their importance or potential impact in pharmacy practice or patient.
What has been achieved?
The algorithm took into account aspects related to: a)pharmaceutical company and b)aspects related to the pharmaceutical product. Each of these aspects is valued as a percentage.
a)Pharmaceutical company: 40% of the score was based on not having a repeated history of stock-outs, 45% on the evaluation of the provider according to an internal file based on incidences registered, and 15% if the provider was already a known supplier.
b)Pharmaceutical product: 50% was based on the cost of the medicine, 15% unit dose presentation (if applicable), 10% expiry conditions of the medicine, 5% allergens, 5% if it was presented in a pre-filled pen (if applicable), 5% if it could be stored at room temperature, 5% if the drug is supplied in diluted vials (in the case of parenteral medicines) and 5% if it had all the possible indications in the technical data sheet.
This methodology has been used successfully in recent months with the pharmaceutical supplier changes of abiraterone and sugammadex.
What next?
This tool will be used for all changes of medicine brands and new drugs purchased in the hospital, enabling uniformity in the purchasing process for all new drugs.
Use of an integrated research management system on a clinical trials unit of a Portuguese hospital
European Statement
Education and Research
Why was it done?
The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)
What was done?
Evaluation of the use of an Integrated Research Management System based on a retrospective analysis of all clinical trials introduced into the software since 2020.
How was it done?
The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)
What has been achieved?
With the introduction of an integrated management system as a registration platform of investigational product receipt, dispensing and return, were introduced into the software 204 clinical trials.
Since its implementation in 2020, the integrated system has been authorised by the sponsor as a registration platform in 55 clinical trials, corresponding to 79% of clinical trials initiated since that date.
The clinical trials Unit grants remote access to the clinical trials information to CRAs through the filling out of a declaration. Since the adoption of this system, remote access to the platform has been granted to 35 CRAs.
According to the survey distributed between July and August:
-85.7% of CRAs use the system in their monitoring work.
-The use of System has been exclusively approved to replace paper records in 88.9% of active clinical trials (with the exception of receipt confirmation via IWRS – Interactive Web Response System).
-All the CRAs who answered the questionnaire consider remote access to clinical trial data to be an advantage.
– 77.8% believe that by using the platform the time spent on presential visits has been reduced.
What next?
The use of this type of system is essential to ensure the efficiency of the tasks carried out by research teams. The approval of system by the sponsor allowed a significant reduction of paper records and the CRA’s remote access to the platform has allowed the early detection of errors, as well as a substantial reduction on time spent on presential visits. The CRA’s remote access to the movements associated with the experimental product like temperature records, calibration certificates, CVs (Curriculum Vitae) and GCP’s (Good Clinical Practices). Although use of the platform has been increasing, some sponsors still do not authorise the exclusive use of the system. It is therefore essential to share the platform’s added value in order to change the traditional ways of management of clinical trials information.
Pallet box implementation: a combination of improved working conditions, storage and waste optimisation?
European Statement
Selection, Procurement and Distribution
Author(s)
Elisabeth CESAR, Ludivine LECHEVRETEL, Adrien NIERENBERGER, Laurent DIETRICH, Anne FEGER-FALK
Why was it done?
We decided to experiment this new solution on coronarography-packs, which presents the biggest rotation among surgery-packs (5,392 units estimated for 2,023), in order to improve working conditions of logistic workers, decrease musculoskeletal disorders (MSD) and optimise storage.
What was done?
Pallet box have been implemented as a new logistic solution for surgery-packs in our hospital pharmacy on a proposal from one of our biggest suppliers. The aim of this comparative study between 52-pack pallet boxes and the previous storage solution by 4-pack boxes was to assess the potential benefit on handling work, storage, waste and its economic impact.
How was it done?
In order to compare these two solutions, we clocked the time and evaluated the cost of transport from delivery gate to storage room and healthcare-unit order-picking step (from picking up the first pack to cardboard flattening). We also estimated the amount of waste associated.
What has been achieved?
Pallet-boxes enable a 24% room saving (52 pallet-spots yearly (2 pallet-boxes piled on one spot) instead of 68) and a 31% global time saving (22 hours yearly (13h transport + 9h order picking) instead of 32 hours (17h transport + 15h order picking)). Time saving on order picking was 40%: picking step of one pack from a pallet box requires on average 6 seconds whereas 10 seconds were needed from 4-packs-boxes. Yearly 104 pallet-boxes (603 kg of empty cardboards) will be manipulated whereas 1,348 4-pack-boxes (1,213 kg) used to be handled resulting in a 2-fold decrease. Even though pallet-boxes halve cardboard-waste, they represent 1.5 times more wooden-pallets’ waste (104 versus 68). Furthermore the price of coronarography-packs are impacted by a 2% increase representing around 4,100€ yearly which is not balanced by savings on transport or order picking (10h ≈ 150€).
What next?
Logistic workers are unanimously satisfied in implementing pallet-boxes as it facilitates their work on many aspects: pallet transport, order picking, waste disposal. Despite being costlier, a decision has been made to implement pallet-boxes in the long-term in order to improve waste management and working conditions of logistic workers. Our hospital pharmacy is already thinking about extending pallet-boxes to other references in order to assess more precisely their impact on MSD in logistic workers.
A 3-Year transformation of a Belgian clinical trial pharmacy team
European Statement
Education and Research
Author(s)
Marie Coenen, Stefanie Goris, Thomas De Rijdt, Isabel Spriet
Why was it done?
These changes were necessitated by the increasing number of (complex) clinical trials conducted at UHL. This Belgian 1995-bed, tertiary care hospital constitutes an attractive setting for clinical trials and a coveted partner for sponsors, due to its specialisation in a wide range of medical fields to treat complex pathologies. Adopting the changing research field whilst ensuring the highest regulatory compliance was challenging.
What was done?
Since 3 years, the clinical trial team of the University Hospitals Leuven (UHL) pharmacy has gone through several metamorphoses. These were realised by introducing an activity based costing (ABC) model enabling financing of staff expansion, extension of the infrastructure, and extensive digitalisation.
How was it done?
In 2016, an ABC-analysis was conducted by the Belgian Association of Hospital Pharmacists to determine the cost of various pharmacy activities within a clinical trial. In 2019, the outcome of the analysis was revised to concur the fast-growing clinical research field.
To affirm the need to apply these updated prices, a retrospective evaluation was performed in 2020 documenting the number of clinical trial protocols, pharmacy staffing and applied prices over the past 4 years.
What has been achieved?
Rapid growth of pharmacy research activities was shown by an increase in the total number of active clinical trial protocols from 964 in 2017 to 1256 in 2020. Until then, quantitative expansion was not followed by qualitative growth since staffing remained steady at 13 full-time equivalents (FTE) and the applied costs were outdated and not cost-effective. To enable this transition, an up-to-date pharmacy budget table was developed based on the latest ABC-analysis and, along with an estimate of future income, approved by the hospital board in 2020. This allowed the pharmacy research staff to be reinforced to 19 FTE and the infrastructure to be extended to integrate extra storage capacity and research dedicated clean rooms. Starting from 2021, the budget table was implemented into practice using computerised support enabling automated billing.
What next?
Future directions include further digitalisation by automating accountability and compounding and focusing on qualitative growth by advancing the role of clinical trial pharmacists into a specialised member of the hospital research development team and of the clinical pharmacy team.
Optimising the process for incoming requests for new extemporaneous products
European Statement
Production and Compounding
Author(s)
Mette Lethan, Tove Hansen, Louise Rasmussen Duckert, Trine Schnor
Why was it done?
In the clinic, a need for a NEP, as either a change in an existing product or a new formulation, may arise. Requests are risk assessed by the Hospital Pharmacy Drug Information Centre (DIC) before production is initiated. However, there was no clear process for handling requests, resulting in prolonged process times. NEP may require searching for new raw materials, new packaging or developing of a new formulation, which are time consuming tasks. Therefore, the wish to optimise the process arose.
What was done?
A procedure for handling requests for new extemporaneous products (NEP) in a Good Manufacturing Practice (GMP) regulated production was developed to improve success rate and aligning the process.
How was it done?
A small unit was formed with the purpose of handling requests for NEP. The unit consists of academics employed in the production department with expert knowledge about both sterile and non-sterile production.
A standard operating procedure was formed, in collaboration with DIC, which included a form, to be filled out with information needed for handling the request. This includes drug formulation, strength and dosage, along with any specific requirements.
The unit evaluates the request – is it possible for us to manufacture, sterile or non-sterile, are raw materials available in appropriate quality, analysis requirements, and stability of the product. The evaluation is made in communication with departments like Purchasing, Quality Control/Assurance, Stability as well as the relevant production department.
If a positive outcome, the request is given to the production department, to finalise production. If the outcome is negative a rejection is sent to the requester with a reason.
What has been achieved?
Based on data from the last three years, we now know how many requests we receive, which type of products are requested, processing times, and which products were made and why/why not.
There is a clear path of communication into the pharmacy and between relevant departments, ensuring that essential pharmaceuticals will be developed in a timely manner or a justified rejection is sent enabling the clinic to look for alternatives.
What next?
Some products are difficult to handle, such as cytostatics, antibodies and hormones. Next step is to investigate these product types.
Assessment of the safety of advanced therapy medicinal products (ATMP) process: a tutorial video creation module
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.
Development of a pharmacy-led technical assessment pathway for personal protective equipment
European Statement
Selection, Procurement and Distribution
Author(s)
Rachel Huey, Catherine Goudy, Michael Scott
Why was it done?
The assessment process was developed in partnership with the Business Services Organisation Procurement and Logistics Service (BSOPaLS) and regional Infection Prevention and Control (IPC) colleagues in response to the outbreak of COVID-19 and escalating demand for PPE. In March 2020, early World Health Organization (WHO) guidance formed the basis of COVID-19 PPE ensemble recommendations. Prior to the COVID-19 pandemic, BSOPaLS procured such items from reputable market leaders. However, during this time of unprecedented demand on supply chains, there were many new manufacturers and suppliers with no previous experience of appropriate supply to healthcare. There were also many counterfeit goods being placed on the healthcare market.
What was done?
During the COVID-19 pandemic, the Medicines Optimisation Innovation Centre (MOIC) utilised pharmacist skills to undertake technical assessment of all Personal Protective Equipment (PPE) items procured for use across Health and Social Care Northern Ireland (HSCNI).
How was it done?
MOIC reviewed and validated all technical documentation associated with each PPE product to ensure that items procured were genuine, fit for purpose and met the relevant standards and regulations. Benchtop assessments were carried out by IPC colleagues and BSOPaLS carried out all procurement due diligence checks on potential suppliers. Early data from 1 April 2020 to 15 May 2020 showed that only 98 (16.5%) PPE offers reviewed met the required standard for approval, while 264 (44.6%) were rejected and a further 230 (38.9%) remained open. Some reasons for rejection included documentation deficiencies and misleading labelling.
What has been achieved?
This process resulted in procurement of only safe and effective products, putting safety of HSCNI staff and patients at the forefront. In addition, BSOPaLS worked closely with local manufacturers with no previous PPE experience, to establish more resilient supply chains for the future. Products manufactured locally were also assessed via this process, to ensure suitability for use within healthcare.
What next?
This efficient assessment process has now been implemented into the PPE procurement pathway for all future HSCNI purchases, enabling the application of due diligence in a transparent, robust and evidence-based manner. Provided there is opportunity to develop an appropriate knowledge base of the relevant regulations and standards, this process is transferable across many healthcare organisations.
Integration of a hospital pharmacy preparer within a new interventional technical platform
European Statement
Selection, Procurement and Distribution
Author(s)
Morgane HOUIX, Valérie VIAUD, Cécilia HURLUPE, Yannick POIRIER
Why was it done?
The pooling of stock for the 5 rooms required a referent for stock management. In order to free up caregivers from the administrative and logistical tasks related to pharmaceutical products, pharmacy has been directly integrated into the project of ITP.
What was done?
In May 2021, interventional cardiology, rhythmology and coronary angiography have been gathered in an interventional technical platform (ITP) of 5 operating rooms. A full-time hospital pharmacy preparer (HPP) position has been set up within the ITP.
How was it done?
For the success of the project, the 2 chosen PPH had to easily becoming part of ITP’s teams and must learn specifics of medical devices of each speciality. For this purpose an immersion in each sector was carried out during the installation of the ITP and continues today by participating in interventions. They shared in the process of installing the PTI’s arsenal of pharmaceuticals with careteams by grouping the initials allocations of products of each speciality. The products common to each endowment were gathered and harmonized after discussion with caregivers. Each sector has kept a stock of specific devices, called “out-of-stock”.
What has been achieved?
The installation took about 632 hours of HPP time. The allocations for each sector were respectively 68, 69 and 83 references, not including out-of-stock. The HPP’s work allowed reducing the common endowment from 220 to 134 products references. A satisfaction survey of PTI teams (doctors, nurses,…) after 4 months of practice showed a level of 78% of satisfaction. 1.3% of the responses concerned activities related the management of devices affected by production delay or stoppage and information on product changes to be unsatisfactory or moderately satisfactory. Every ITP teams now considers their presence essential, believes that it has improved relations with the pharmacy and management of stocks. A saving in nursing time was also noted.
What next?
The creation of this HPP position seems to satisfy all the ITP teams. A quantitative analysis of the benefits measuring the impact on care time, the amount of over-storage and the compliance indicators of the implantable medical device circuit will be carried out during 1 year, in order to assess the impact of the creation of HPP positions within the PTI.
Project for the optimization of processes for the reception, conditioning and storage of medicines
European Statement
Production and Compounding
Author(s)
PATRICIA ORTIZ FERNANDEZ, Alba Maria Martinez Soto, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, IGNACIO SALAR VALVERDE
Why was it done?
The objective is to improve patient safety, detecting mistake in real time. Review good work practices and achieve greater effectiveness. Improve the communication of the work team.
What was done?
Improve the quality of the reception, conditioning and storage processes that are carried out in the pharmacy service using tools that in the field of quality have shown great effectiveness. Simplify processes and update work instructions and standardize these. Establish quality indicators.
How was it done?
ing the `Lean healthcare´methodology based on eliminating inefficiencies in work processes and identifying opportunities for improvement which are specific, measurable, achievable, relevant and time bounded. Another of the methodologies used is the `5S´ (five basic elements: selection, systematization, cleaning, normalization and self-discipline) and `PDCA´(plan, do, check, act).
1. Establish a multidisciplinary group.
2. Training on the methodology developed in 5 sessions.
3. Elaboration of a project charter with the objetives, the scope and the planning.
4. Analyze the chosen processes with the following dynamics: a) Team visit to the work area, b) Interview an expert from each process, c) Registration of inefficiencies and process data in a value steam mapping, d) Compilation of possible improvement actions, e) Meeting for consensus and realization of an action plan to prioritize and assign those responsible for carrying out the improvement actions.
What has been achieved?
Number of meetings with the multidisciplinary team: 10
Reception process: improvements implemented(II): 11, pending improvements (PI): 2, indicators evaluated (IE): 4
Conditioning process: II: 4, PI: 0, IE: 2
Storage process: II: 13, PI: 2, IE: 2
What next?
Must be maintained and evaluated over time and anytime there that may be a change. These improvements allowed a better anticipation. The process improvement approach aimed to identify solutions was very fruitful and led to outcome practical. This method could be applied to improve other types of processes in our pharmacy service.