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.
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.
Determination of the carbon footprint of morphine tablets and morphine solution for injection – a collaboration between Amgros and the Capital Region Pharmacy
European Statement
Selection, Procurement and Distribution
Author(s)
Bitten Abildtrup, Lone Deleuran, Mira Dysgård, Nina Müller, Sofie Pedersen, Trine Schnor, Ulrik Wøldike
Why was it done?
It is estimated that medicine contribute 20% of the Danish regions total CO2e emissions. Amgros and the Hospital Pharmacies of Denmark are committed to develop carbon reduction initiatives to assist the regions CO2e reduction strategy. It is essential to identify the main contributors of CO2e emissions in the lifecycle of a drug to support CO2e reduction.
What was done?
The Danish procurement organization Amgros I/S is responsible for buying medicine for Danish public hospitals. As part of the ambition for sustainability, The Capital Region Pharmacy (RAP) in collaboration with Amgros has made a bottom-up hotspot life cycle analysis (hLCA) of the carbon-footprint of morphine in tablets and solution for injection. The hLCA identified the main CO2e emission factors from API/excipient production to administration of the drug.
How was it done?
The energy consumption of the production processes was mapped at RAP. Five reference flows were modulated (tablets in three types of primary packaging and solution for injection in two types) and reported. The hLCA data for the API was extracted from literature while data for the excipients and packaging material were calculated using Ecoinvent. Ecoinvent is a life cycle inventory database used to support environmental assessments of products and processes.
What has been achieved?
The preliminary conclusion of the analysis shows the largest CO2e emissions per DDD originates from administering the drug due to the use of single-use materials.
Leaving out administration of the drug, the main CO2e emissions from tablets are API production and packaging materials. Packaging materials are the main CO2e contributor for the solution for injection.
The end report of the LCA was available, end of autumn 2023.
What next?
The hLCA’s are being used internally in Amgros to develop criteria for tenders. The hospital pharmacies can use the hLCA calculations to identify key subprocesses where reduction of the CO2e footprint is greatest.
The results contribute to:
• Danish hospital pharmacies better understand the CO2e emissions when prescribing and administering medicines
• Dialogue with the pharmaceutical industry about their CO2e emissions hotspots
Finally, the results will hopefully encourage other countries to incorporate environmental criteria in future medicinal tendering process for medicines.
Change of local anaesthesia procedure to avoid suture breakage
European Statement
Education and Research
Why was it done?
A wide range of women sustain a perineal tear after delivery with a need of perineal repair. If the suture material fails to last as expected, women might experience wound rupture, impaired healing, and inferior functional outcome.
A clinical observation of increased risk of early breakage of the suture material in women anaesthetized with Xylocaine spray for perineal tear repair, compared with women anaesthetized with Xylocaine gel led to this study. Thus, in an observation period of 9 months 79% of the women who had to go through early secondary wound repair due to suture failure, had received local anesthesia in the form of Xylocaine spray.
The Clinical Pharmacy was contacted by the Obstetric Department with the following inquiry; whether there is a pharmaceutical interaction between local anaesthetics and the suture material.
What was done?
An in-vitro experiment to compare the tensile strength of fast absorbable suture material when impregnated with various agents for local anaesthesia was performed.
How was it done?
An in-vitro experiment was performed in collaboration between midwives, pharmacists and the Danish Technological Institute. We impregnated 120 suture materials divided in four groups (Xylocaine Spray, Xylocaine gel, Isotonic Sodium Chloride and Ethanol 96%) for 72 hours at 37 degrees and then measured the tensile strength of the suture material.
What has been achieved?
In the experiment we saw that Ethanol and Xylocaine spray weakened the tensile strength of fast absorbable sutures. Use of Xylocaine spray containing ethanol for local anesthesia might lead to early breakdown of the suture material and wound rupture.
After the experiment the majority of obstetric departments in Denmark changed their procedure for local analgesia/anaesthesia during perineal repair from Xylocaine Spray to Xylocaine gel.
What next?
Observing and registering the suture breakage percentage in a period of 9 months after application of Xylocaine gel.
Publishing the results at a broader level.
Healthcare impact of a digital health programme for patients with chronic or high-frequency episodic migraine
European Statement
Patient Safety and Quality Assurance
Author(s)
Anna de Dios-López, Neus Pagès-Puigdemont, Montserrat Masip-Torné, Pau Riera-Armengol, Rebeca Pelegrín-Cruz, Cristina Martínez-Molina, Noemí Morollón, Robert Belvís-Nieto, Maria Antònia Mangues-Bafalluy, Mar Gomis-Pastor
Why was it done?
Migraine is a neurological disorder characterised by frequent headache. Patients with an episodic migraine pattern have <15 monthly migraine days (MMD), whereas patients with a chronic pattern have ≥15 MMD. Migraine has a high prevalence (15-20% of female and 5-8% of male) and a great impact on their quality of life. Many migraine patients can benefit from preventive treatment. The use of a digital health programme in these patients can allow a real-time monitoring of treatment effectiveness (through the register of migraine attacks frequency) and adverse events. Additionally, it can improve the communication between patients and HCP.
What was done?
We tested a patients’ mobile phone (mHealth) application in chronic and high-frequency episodic migraine patients. This application was synchronically linked with a website for healthcare professionals (HCP) and hospital clinical records.
How was it done?
MyPlan is a mHealth application adapted from another one developed in our hospital for heart transplant patients. Firstly, we conducted a focus group with patients to understand their needs and preferences. This platform fulfils the quality and Data Protection Regulation.
What has been achieved?
13 patients and carers participated in two different focus groups. Another focus group was conducted with the Neurology Department of our institution. The results permitted to adapt the mHealth application with the following functionalities and registers:
• Synchronous (videocall) and asynchronous (direct message) communication between patients and HCP
• Medication adherence
• Treatment adverse events
• MMD and monthly headache days (MHD)
• Monitoring through the register of biomeasures (blood pressure, weight), lifestyle habits (diet, exercise) and questionnaires (MIDAS, HIT-6, EQ-5D, MSQ)
• Information
Data registered by the patient was used to guide clinical management and improve patients’ healthcare route.
What next?
The introduction of mHealth in the healthcare route of patients with migraine could benefit both patients and HCP. This strategy could be incorporated in other health facilities that attend migraine patients in an outpatient setting. Nowadays, a clinical trial is being conducted to demonstrate its clinical benefit.
The establishment of The Danish Hospital Pharmacy Research Network.
European Statement
Education and Research
Author(s)
Trine R. H. Andersen, Trine Graabæk, Ulla Hedegaard, Lene J. Kjeldsen, Charlotte Olesen, Hanne T. Plet, Anne B. Walls, The Danish Hospital Pharmacy Research Network (DanHoPR Network) On behalf of
Why was it done?
A decade ago, collaboration between Danish hospital pharmacies regarding knowledge sharing, information, procurement and development of services already existed. However, research activities were scarce, and peer reviewed publications were rare. While the Danish universities didn’t have hospital pharmacy as a research area, the research unit called SAFE had been formed under The Danish regions’ joint procurement and tendering organization, to encourage hospital pharmacies to increase research activities. Meanwhile, a handful of hospital pharmacists scattered throughout Denmark had been initiating PhD-projects, but with no formal cooperation or awareness of each other.
What was done?
A national network for researchers in hospital pharmacy was established 10 years ago to strengthen the research activities within hospital pharmacies in Denmark.
How was it done?
The network was established at a meeting in October 2011 gathering the five PhD-fellows, SAFE and potential researchers. The overall aim was to strengthen hospital pharmacy research in Denmark. The terms of reference included creating a forum where established as well as upcoming researchers can meet twice a year to share knowledge and provide feedback on each other’s research. To further strengthen the network and research, funding was raised for a fieldtrip to UK hospital pharmacy research groups. After this, the network decided to promote a more international profile. A LinkedIn site was established along with the design of a logo, an English translation, name and acronym (DanHoPR Network).
What has been achieved?
The DanHoPR Network now celebrates its 10th anniversary and counts more than 30 members from all Danish hospital pharmacies and from universities.
The amount of published research from Danish hospital pharmacies has increased considerably during the 10 years. In total, network members have first authored more than 35 articles, co-authored more than 70 publications, co-supervised more than 80 master theses and PhD-fellows have multiplied over the decade.
The DanHoPR network gather 2-3 times/year in full-day virtual or IRL meetings to collaborate on research, share ideas and discuss subjects such as methodology, interpretation of results, funding, challenges or celebrations.
What next?
The network seeks to collaborate internationally and hopes to inspire to similar networks across Europe or connect to exiting fellow networks.
Novel vaccine clinical trials in Africa
European Statement
Education and Research
Author(s)
Trudi Hilton
Why was it done?
The Partnership for Research on Ebola VACcination (PREVAC) established a randomised, double-blind, placebo-controlled, phase 2 study evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Pharmacists from all PREVAC participating country teams were introduced at collaborative calls where the study protocol was presented.
What was done?
UK Hospital Pharmacists with clinical trials experience worked with London School of Hygiene and Tropical Medicines (LSHTM) research teams in Sierra Leone and pharmacists from there, France, Guinea, US and Liberia to establish the Standard Operating Procedures and protocols required to compare two novel vaccines for Ebola Virus Disease (EVD).
How was it done?
The trial pharmacy teams met virtually each month to discuss the development of Standard Operating Procedures to store and prepare the vaccines. We started by ensuring an appropriate space within the research site was identified for the pharmacy. We advised on the equipment required for aseptic preparation, temperature monitoring and controlled storage of Investigational Medicinal Products (IMP). Solar fridges were identified for IMP storage at 2-8 deg C and ambient 15-25 deg C products, with freezers being run on generators. We developed protocols and documents for temperature monitoring and back-up plans for the failure of cooling devices. I set up trial dispensing procedures to enable preparation of the vaccine for ‘blind’ administration. The local pharmacy team advised on the equipment required to work aseptically. Sourcing specialist equipment, much of which is not available locally, takes considerable time so this work was undertaken several months before participant recruitment began, ensuring that it could be calibrated and validated before receipt of IMP.
What has been achieved?
Pharmacists from France and the UK have worked with local colleagues to develop best practice for clinical trials in resource-limited, tropical settings. This learning is invaluable for the future development of vaccines.
https://www.semanticscholar.org/paper/Partnership-for-Research-on-Ebola-VACcination-of-a-Badio-Lhomme/e70c6224c89e28481ea278ca43ee51d163645fea
What next?
Clinical trials must be carried out in the context in which the investigational medicinal product is intended for use, at standards required to achieve EMEA and FDA authorisations. EU hospital clinical trials pharmacists working with university research teams can support their pharmacy colleagues in these settings to ensure optimisation of IMP storage, handling and preparation with accurate record keeping..
FOUR YEARS OF A REGIONAL MEDICINES OPTIMISATION INNOVATION CENTRE – WHAT HAS BEEN ACHIEVED? (submitted in 2019)
European Statement
Introductory Statements and Governance
Author(s)
Michael Scott, Glenda Fleming, Catherine Harrison
Why was it done?
There is a wide recognition that there are significant issues with regard to the issue of medicines, such as the fact that 30−50% of medicines are not taken as required. Thus the DoH decided to set up MOIC as a vehicle to focus activities in order to address this issue and optimise medicines use.
What was done?
A Regional Medicines Optimisation Innovation Centre (MOIC) was set up in 2015 by the Department of Health (DoH) in Northern Ireland as a key enabler for the Government policy document namely the Medicines Optimisation Quality Framework.
How was it done?
The DoH requested the Northern Health and Social Care Trust to locate the centre within the Trust based on the fact that there had been a long standing academic practice centre with the School of Pharmacy at Queens University of Belfast. Barriers that had to be addressed were highlighting the regional nature of the centre, to get engagement with all sectors of the service and building relationships with other key organisations, including the private sector. Initial core funding was provided by the DoH.
What has been achieved?
MOIC has successfully evaluated improved systems with regard to hospital pharmacy such as doctor-light discharge (90 minutes faster), post-discharge telephone follow-up (30 day readmission rate reduced by 9.9%), and medicines optimisation in older people service in care home settings (reduced Emergency Department attendances and medicines costs). In addition MOIC has been successful in 3 EU funding bids relating to medicines optimisation and has published over 30 papers. It has also been accredited as a Statement Implementation Learning Collaborative Centre (SILCC) site and also a Centre of Excellence by the Spanish Hospital Pharmacists Association. MOIC has also successfully worked with the private sector including pharmaceutical, device and technology companies. It has also been accredited as a knowledge provided by Invest NI.
What next?
MOIC has delivered on its key initial objectives, related to medicines optimisation with good collaborative work across health, academia and commercial organisations, in the UK and Europe. It will have a key role in meeting the WHO Global Challenge of reducing medication-related harm by 50% by 2023 for the region and further optimising medicines systems.
This approach with government policy support could be relatively easily established in any other region.