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A coordinated country approach to hospital pharmacies’ handling of clinical trials and the use of a common national brochure

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European Statement

Introductory Statements and Governance

Author(s)

Kirsten Lykke Vorbeck, Laila Rabbani, Somia Mohammad, Anne Bøiehøj, Lene Sehested, Majken Cardel, Lone Skovhauge, Lisbet Emmery Jørgensen

Why was it done?

Having different sponsors with individual requirements and interpretations of rules, means a lot of work. The brochure aims to save time on answering questions by describing to every sponsor how Danish Hospital Pharmacies proceed. By demonstrating that we all do many things in the same way and ultimately have the same requirements, we hope to be able to encourage sponsors to adopt a more unified or aligned approach.

What was done?

Through a collaboration of Danish hospital pharmacies, a working group on clinical trials meet regularly to discuss general procedures and challenges to our handling of clinical trials. Via this a common presentation of how we handle clinical trials and what we can offer has been described in a brochure that is given out to sponsors, investigators, clinical trial units (CTUs), clinical wards, monitors etc. The brochure also serves as an inspiration catalogue to hospital pharmacy colleagues.

How was it done?

In the working group we have discussed processes and which administrative and quality requirements we find reasonable and called for (from our point of view and that of our sponsors). We appreciate that we cannot do everything in exactly the same way, but we have tried to include as much as possible in the brochure leaving it up to the individual pharmacy to supplement with local procedures.

What has been achieved?

The brochure is evidence of our cooperation within Denmark. It has been distributed to relevant partners and to “Trial Nation”, a national entry point for companies who wish to conduct clinical trials in Denmark. It is intended as general information and to be handed out to new potential sponsors. It has resulted in an aligned and time-saving procedure.

What next?

Hospital pharmacies are small players in the field of clinical trials but nonetheless important ones. Working together to find general procedures not only helps ourselves to identify good practices but also means we can create a smoother handling of the trials and that we stand stronger when meeting the different requirements from sponsors. This cooperative approach has met with a good response. It promotes further cooperation between all parties, and it is recommended to be implemented in other healthcare settings.

Smartphone application for managing expiry dates in medicine rooms and reduction of medicine wastage

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European Statement

Clinical Pharmacy Services

Author(s)

Charlotte Arp Sørensen, Karin Aagot Møller Jørgensen, Anne Lund Sørensen, Rune Dalsenni Rask

Why was it done?

Clinical Pharmacy pharmaconomists perform a wide range of tasks at the hospital for example, medicine service with medication ordering, placement and checking of expiry dates. A sustainability project in 2020 highlighted manual and time consuming workflows, for example, manual reading, interpretation and notation of expiry dates in paper forms, when medicine rooms are reviewed for medicine that expires within the next half year. The dream of an easily accessible digital solution arose to make workflows more flexible, modern and sustainable.

What was done?

A smartphone application for managing expiry dates in medicine rooms and reduction of medicine wastage was applied.
With the application, the smartphone camera can be used to scan the data-matrix of medicine packages and get a sorted overview of medicine and its expiry dates. In the application you can register a medicine package as either used, discarded or released. By releasing medicine packages, the medicine is made available to colleagues in other medicine rooms at the hospital.

How was it done?

A smartphone application was developed in close and synergistic collaboration between software engineers, pharmaconomists and pharmacists. The smartphone application was initially tested in small scale, and then adjusted and implemented among pharmaconomists and pharmacists to be used in up to 129 medicine rooms at the hospital from January 2022.

What has been achieved?

The application creates value for the Hospital Pharmacy, the Hospital and the society because:
– It takes significantly less time to check and scan expiry dates
– We avoid misinterpretation of expiry dates; and
– By releasing medicines to be used in other medicine rooms, the application makes it easier for us to work sustainably. In nine months, 1700 packages with a total cost of
€121.000 has been moved between medicine rooms in an attempt to avoid medicine wastage.
At the hospital we have a mutual medicine budget. Therefore, it makes good sense to move medicine between medicine rooms to get the most health for the money.

What next?

Implementation of the smartphone application among pharmaconomists in other hospitals within the same region is considered. Also other hospital pharmacies in the country have shown their interest. In addition, a similar application for utensils is under development.

Creation of an ‘Agrippal’ programme to fight against nosocomial flu

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European Statement

Introductory Statements and Governance

Author(s)

Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy

Why was it done?

The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.

What was done?

Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.

How was it done?

Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.

What has been achieved?

The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.

What next?

This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.

Development of a pharmacy-led technical assessment pathway for personal protective equipment

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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.

Parameters involved in medication dispensing automation security and performance

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European Statement

Patient Safety and Quality Assurance

Author(s)

Hind Bouami, Dorine Castillo

Why was it done?

The human-machine system designer has to make decisions to secure and improve the automation process, and handle organization’s complexity. Documenting human agent’s situation awareness is crucial to support human-machine designers’ decision-making. Knowledge about risks, critical parameters and factors that can impact and threaten automation system’s performance and security are valuable for human agents, and should be collected using preventive and retrospective approaches.The evaluation of Macon hospital center’s automation performance enables to identify critical parameters to control in order to secure the human-machine system.

What was done?

An automation evaluation approach has been conducted in Macon hospital center, a hospital equipped with automated drug dispensing solutions for more than 5 years. The analysis of Macon hospital center automation’s feedback provides relevant information to enhance the perception and the comprehension of the system’s complexity fully, environmental factors that interact with the system, and to identify critical parameters in the automation process. Therefore, agents can design a projection of a secure and performant automated organization. This information will enable hospitals to make effective decisions to improve their automation project performance.

How was it done?

We deployed an anthropocentric approach for automated system evaluation in Macon hospital center.
Our approach integrates six steps that are run in automated hospital pharmacies to analyze their feedback [6]:
1) The identification of pharmacy’s automation needs and objectives, and the analysis of operational environment and existing equipment,
2) The analysis of automated equipment functional specifications formalized by the pharmacy,
3) The evaluation of automation deployment results and related gains,
4) The evaluation of specific actions implemented by the pharmacy during automation process,
5) The analysis of the parameters to control for automated equipment integration security and performance,
6) The analysis of factors influencing human-machine interaction.

What has been achieved?

The analysis of Macon hospital center pharmacy’s automation specifications revealed that 66.22% of automation requirements are technical, 29.73% concern human-machine interaction, and 4.05% relate to human aspects.
80.95% of automation specification related to the chosen Sinteco’s automated solution are met. The performance of the chosen automated solution is involved in 28.38% of automation specifications performance in Macon hospital center. The remaining systemic parameters involved in automation specifications performance need to be controlled.
Critical systemic parameters involved in automated solutions specifications and performance that have been identified through Macon hospital’s automation feedback are: the specificities of the chosen automated solution, hospital’s strategic decisions and budgetary constraints, the complexity of the hospital’s organization, the complexity of hospital’s information system, the constraints related to the packaging of drugs by pharmaceutical firms, users training, the complexity of the automated system, and users’ requirements and constraints.
The five parameters influencing human-machine interaction that should be managed to secure automated systems are: understanding the system’s complexity, defining relevant levels of automation, determining human and automated agents’ authority, determining human and automated agents’ autonomy, and understanding the human complexity.

What next?

Handling life-critical systems complexity such as medication delivery activity requires to be equipped with appropriate technology, and to control automation risks. The integration of human-machine principles is crucial to secure automation in hospitals, and to maintain a good balance between automation and human skills.

IMPLEMENTATION OF A PHARMACEUTICAL PROTOCOL FOR THE RECEPTION, STORAGE AND DISPENSING OF SARS-COV-2 VACCINES

European Statement

Selection, Procurement and Distribution

Author(s)

Pablo Ciudad Gutiérrez, Marta Mejías Trueba, Héctor Luis Acosta García, Maria Victoria Gil Navarro, Sandra Flores Moreno

Why was it done?

To establish a protocol for the reception, storage and dispensing of SARS-COV-2 vaccines.

What was done?

A standardised work protocol was prepared detailing the role of hospital pharmacists in the reception, storage and dispensing of vaccines, which was approved by the Head of the Pharmacy Service. A certificate of receipt was also prepared with a view to keeping a record of the number of vials received, expiry date, batch, thawing date and temperature, as well as details of each person involved in the circuit.

How was it done?

Phase 1: Preparation, approval and diffusion of the protocol in the Pharmacy Service, anticipating the imminent arrival of SARS-COV-2 vaccines.

Phase 2: Implementation of the protocol, which consists of the following protocol:

1. The vaccine distributor will contact the Pharmacy Service within 30 minutes before the delivery.

2. Upon arrival of the delivery person, the pharmacist will receive the vaccines and both parties will sign a certificate of receipt including: their full name and ID card number, the date and time of receipt, the batch number and expiry date of vials, the date of thawing, as well as the vial temperature upon delivery. This certificate will be kept by the administration staff along with the delivery note.

3. The pharmacist responsible for the reception will store the vials received in the fridge and monitor their temperature.

4. The vaccines will be handed over to the Preventive Medicine Service, the service responsible for administering them, after filling out a certificate of receipt including: date, full name and ID card number of the persons delivering and receiving the vials, number of vials delivered and expiry date. This certificate, duly completed and signed, will be filed by the Pharmacy Service administration staff.

What has been achieved?

An efficient and scheduled protocol was implemented, registering all the certificates of reception, delivery notes, as well as the temperature of the fridges containing the vials.This allowed to identify and correct errors, achieving proper use and traceability of all the vials received, resulting in increased safety for patients.

What next?

This protocol is applicable to Hospital Pharmacy Services responsible for the reception, storage and dispensing of SARS-COV-2 vaccines.

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.

Added value of centralised compounding of vaccines against SARS-CoV-2 in Hospital Pharmaceutical Services – a quantitative analysis

European Statement

Production and Compounding

Author(s)

Rui Relvas, Rui Pedro Marques, Ana Castro, Sérgio Nobre, João Paulo Lopes da Cruz

Why was it done?

Medicines compounding by the HPS-staff is a primordial activity, and its centralisation allows several benefits in levels such as patient safety, quality, efficiency, and pharmacoeconomics. Despite this recognised importance, it is not always possible to quantify its added value. The fact that vaccines against SARS-CoV-2 are supplied in multi-dose vials and the need to prepare and assure enough doses to vaccinate a broad population presented itself as an excellent opportunity to analyse such indicators.

What was done?

A quantitative analysis of the importance and added value of centralised preparation and compounding of vaccines against SARS-CoV-2 at the Hospital Pharmaceutical Services’ (HPS) Compounding Unit from a Central Hospital in Portugal.

How was it done?

Between 27th December 2020 and 2nd August 2021, 13.030 doses were prepared (96.9% Pfizer/BioNTech; 3.1% AstraZeneca). At the first 3 vaccination sessions, multi-dose vials were diluted at the HPS, and each syringe measured by the nursing-staff previously to the administration.
After these initial sessions, each dose started to be individualised by the HPS-staff on pre-filled, ready-to-use syringes. Each vaccine dose was individualised on a horizontal laminar flow cabinet according to a previously approved operational procedure.
Reception, preparation, and dispensation records were retrospectively analysed. Key performance indicators were quantified.

What has been achieved?

During the first 3 sessions of vaccination, when nursing-staff measured each vaccine volume, a total of 1640 doses were administered. However, it would be possible to measure a total of 1932 doses (84,9%). The daily maximum of people vaccinated was 770.
In the following sessions was possible to prepare 11.390 doses, with a theoretical maximum of 10.892 (104,6%) and a daily maximum of 1.113.
This yield, over 100%, allowed an excess of 498 doses, which translated into the vaccination of 249 extra individuals fully vaccinated with the 2 doses. Factors like needle and syringe selection and preparation beyond an aseptic and validated environment contributed for the yield increase.

What next?

Series-production of compounded medicines in a sterile, validated, and controlled environment allows important benefits and this analysis shows the potentiation of every key performance indicator considered. These data should be considered for the future planning of population-wide activities involving the massive preparation of sterile medicines.

Critical points in the management of intratumoral treatments in oncology clinical trials

European Statement

Clinical Pharmacy Services

Author(s)

Lorena Garcia Basas, Pablo Latorre Garcia, Eugenia Serramontmany Morante, Patricia Garcia Ortega, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, Maria Queralt Gorgas Torner

Why was it done?

Increasing number of CT with IT, in different pathologies, with different tumor locations, contributes an increase in the complexity of drug compounding and procedures. Their preparation, administration and handling requirements differ from current therapies.

What was done?

Identification of critical points concerning intratumoral treatments (IT) preparation in patients with cancer included in clinical trials (CT).

How was it done?

Ongoing CT with IT in our unit were reviewed to identify critical points regarding prescription and preparation process. 14 trials with IT, 8 (57%) of which have ongoing patients were identified. Two of these trials are “first in human”. The critical points were:

  • Nature of the IT: virus (4, 29%), nanoparticles (3, 21%), ribonucleic acid (2, 14%), cyclic dinucleotides (2, 14%), monosaccharides (1, 7%), phospholipids (1, 7%) and proteins (1,7%).Particularly, virus have special safety measures and transport conditions
  • Dosing units: mcg (4, 29%), plaque-forming unit/mL (PFU/mL)(3, 21%), mL (3, 21%), mg (2 14%), ng (1, 7%), 50% Tissue Culture Infectious Dose (TCID50)(1, 7%).
  •  Prior dilution before filling the syringe: 8 (57%) of our preparations require at least one prior dilution.
  •  Drug volume to prepare according to the tumor size: 8 (57%) IT preparations depend on the tumor size.
  •  Depending on the depth of the target tumor lesion (visceral or superficial), different size of needle is required. This is important because different priming volumes of the needles are necessary.

 

What has been achieved?

The whole information necessary for a complete prescription, validation and correct preparation goes further than information usually needed for current therapies such as chemotherapy. The results of the study of the critical points allow us to elaborate the standardized operational procedures (SOP) for each CT and IT.  These SOPs include the necessary information for a correct preparation for each IT, reducing risk of mistakes and achieving uniformity in the process.

What next?

These types of therapies represent a challenge, and pharmacists have an important role in developing new procedures. Communication between radiology, oncology and pharmacy departments in a multidisciplinary teamwork is essential. This information may be useful to other centers due to the lack of experience and SOPs to work with this type of therapy.

TELEPHARMACY ANALYTICS AND DATA VISUALIZATION THROUGH BUSINESS INTELLIGENCE

European Statement

Clinical Pharmacy Services

Author(s)

Cristina González Pérez, Laura Llorente Sanz, Ángel Liras Medina, Ana Andrea García Sacristán, María Molinero Muñoz, Lidia Ybañez García, José Alberto Peña Pedrosa, Henar González Luengo, María Luaces Méndez, José Manuel Martínez Sesmero

Why was it done?

Telepharmacy implementation in the context of SARS-CoV-2 pandemic conducted us through the management of a high volume of complex, real-time both clinical and economic data. A multidisciplinary working group (biomedical engineers from the Innovation Unit, clinicians, managers and hospital pharmacists) developed a software tool in April-May 2021.

What was done?

The design of an agile, customizable and dynamic dashboard for the visualization and analysis of Telepharmacy key performance indicators (KPI) through Business Intelligence (BI).

How was it done?

Phases:
1. Situation analysis. KPI definition. Ethics committee approval submission.
2. Extraction and processing of raw databases (Telepharmacy database, outpatient dispensing program, hospital admission database, drug catalog) through data mining.
3. Co-creation of the comprehensive dashboard in PowerBI®, by integrating database sources. Different panels have been designed where filters such as age, time frame, medical service, pathology, etc. can be applied.
• Description of general variables: patients, demography, shipments, time frame, medical department.
• Geolocation of the destinations of the patients’ home delivery.
• Pharmacological profile: top 10 drugs, distribution by active ingredient and drug classification group.
• Relative analysis of the beneficiary patients of Telepharmacy vs global outpatients
4. Pilot project by different types of users (administrative staff, clinicians and managers)
5. Structure design for automatic updating of the panels from the successive updates of the source databases
The quality of the raw databases can be a limitation. It has been necessary to define how to handle missing and duplicate data. Pre-processing, normalization and transformation data processes have been applied too.
Working within the hospital network ensures that there are no security gaps in terms of patient data protection.
For the external use of the dashboard, the granularity of the data is modulated to ensure enough clustering to avoid the identification of individual patients.

What has been achieved?

Processing the huge dataset (more than 2.4 million records) was possible by BI tools that synthesizes data, provides dynamic and engaging visualization (charts and graphs), allows the interactive reports customization for more effective communication of results and apply analysis based on Artificial Intelligence.

What next?

Applying new technologies will help us improve strategic decisions: interactions, behaviors and trends perceiving, weak points identifying, uncertainty reducing and over time monitoring.

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Problems caused by shortages are serious, threaten patient care and require urgent action.

Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

Our aim is to investigate the causes of medicine and medical device shortages in the hospital setting,  while also gathering effective solutions and best practices implemented at local, regional, and national levels.

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Join us in Prague for the 2nd edition of BOOST!

Secure your spot in the Movement for Shortage-Free World

BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.