Rethinking the drug concept – the future medication logistics
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Cathrine Noergaard Peulicke, Michelle Lyndgaard Nielsen
Why was it done?
The process of building a new hospital has led to development and rethinking the drug concept. At the hospital we always have “the patient first” in mind. This is our codex. That is why we are changing the concept for delivery, dispensing and administration of medication. We wanted to ensure that the concept functioned from a patient safety perspective, patient flow perspective, patient involvement perspective, professional development perspective and perspective of a healthy operation. The vision is the right medication, from the right hand at the right time.
What was done?
At the new hospital, the medication logistics will undergo major changes. There will only be medication for acute use at the wards, the rest will be delivered ready-to-use from the main pharmacy or from a decentralised unit, called Pharmaservice. Here IV-solutions with short expiration are being reconstituted and oral solutions are dosed according to the prescription. Tablets and capsules are dispensed in the multi-dose robot at the main pharmacy. The multi-dose medication is equipped with a bar code which is scanned at administration and full electronic documentation is obtained. The majority of the medication will be dispensed daily for 24 hours and delivered in boxes for each patient to the wards.
In order to ease the transformation, we have built a mock up of a Pharmaservice unit where this set-up is enrolled to all inpatient wards in the hospital on the geriatric ward, children’s ward and gynaecology and obstetrics ward.
How was it done?
A steering group was founded and membered by managers from the involved wards including the hospital Pharmacy. Frequent meetings with the involved wards has been necessary to ensure competences and communication. Post-implementation we are closely evaluating the initiative.
What has been achieved?
Patient safety is in focus and with the multi-dose dispensing robot we have achieved full electronic documentation from the prescription, dispensing and administration process, and thereby have reached closed loop medication.
What next?
Having implemented the initiative on three wards, we are now working on enrolling this to the entire new hospital when it is ready in 2024. At the new hospital, we will have five Pharmaservice units servicing all inpatient wards.
Pharmacist-led education of social and healthcare assistants in drug dispensing and administration in hospital wards to alleviate the shortage of nurses
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Trine Birkholm, Trine Rune Høgh Andersen
Why was it done?
The Danish Ministry of Health has declared which healthcare professionals should handle medication such as dispensing and administration to patients in hospitals. Traditionally, primarily nurses and physicians handle administration of medicines in the Danish hospitals. In recent years a massive shortage of nurses in Danish healthcare has called for other professions to participate in administration of medicines. As Denmark has employed less than one clinical pharmacist per 100 beds in hospitals, pharmacists are not able to contribute to the task. However, clinical pharmacists can have an important role in educating other healthcare professionals e.g. HCAs in handling medicines.
What was done?
Because of massive lack of nurses and thereby healthcare professionals to administer medicine in psychiatric wards in Region Zealand, Denmark, the pharmacists developed and implemented a training course for social and healthcare assistants (HCAs) to participate in the task.
How was it done?
As hospital pharmacists should ensure that the information needed for safe medicines use, including both preparation and administration, is accessible at the point of care (EAHP statement 5.9), aiding in the development of a training course for HCAs was ideal for the clinical pharmacists. The training course has a duration of 3 days followed by a mentored trainee period. The course includes psychopharmacology lessons to teach HCAs to observe and react to overdoses, lack of effect or side effects as declared in medicine handling guidelines.
What has been achieved?
Approximately 150 HCAs have attended the course since 2020. Eight out of ten state that the course has enabled them to take on the new work tasks. Nine out of ten believe that they can use the newly acquired knowledge and practical skills for their new work tasks. Today, the administration of medicines in the psychiatry ward is also managed by HCAs, thus relieving the nurses’ time needed for more specialised tasks.
What next?
There is also a shortage of nurses in the somatic hospitals. To ensure patient safety and enough staff to dispense and administer medicines, several hospital wards have requested similar training for HCAs. It is believed that similar training courses with modifications can target somatic wards as well.
Immunoglobulin rationalisation plan in a tertiary hospital during shortage by COVID-19 pandemic
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARIA DE LA TORRE ORTIZ, ESTEFANIA ROSON, LIDIA YBAÑEZ, NATALIA SANCHEZ-OCAÑA, JAVIER CORAZON, PALOMA PASTOR, MARIA FERNANDEZ-VAZQUEZ, JOSE MANUEL MARTINEZ SESMERO
Why was it done?
The demand and use of immunoglobulins (IgGs) is growing, and there are many difficulties in obtaining supplies. This situation has been worsened during and especially after COVID-19 pandemic. A low number of blood donations and apheresis procedures, caused a shortage of IgGs worldwide. The measures implemented (dose and period optimisation) ensured the achievement of an adequate balance between supply and demand, enabling an increase of plasma fractionation industry.
What was done?
A rationalisation plan of human IgGs use was implemented in a tertiary hospital through the multidisciplinary groups, in which Pharmacy Department (PD) participated.
How was it done?
Inside hospital working groups were created between the different IgGs prescribing departments (paediatrics, haematology, immunology and neurology) and PD during a period between 1 May 2021 and 31 October 2021. All patients on regular treatment with IgGs were identified and each one was reviewed: indication, dose, regimen and treatment alternatives. Based on the document “Criteria for the rational use of human immunoglobulins” published by the Madrid Health Service in 2021 and taking into account the clinical circumstances of each patient, decisions were made regarding: continuation or discontinuation of treatment and dose or regimen adjustments.
What has been achieved?
After identifying 184 patients treated with IgGs, a set of pharmaceutical policies has been drawn up in conjunction with stakeholders. Evidence-based intervention focused on assessing the clinical adequacy of actual treatments, optimising indications and dosing, to ensure an equitable supply was done. A total of 34 patients (%) discontinued IgGs, 24 patients reduced doses and 15 increased time between administrations.
As a result, it has been possible to continue the treatment in those patients for whom its use was a vital urgency during shortage period.
What next?
Long-term follow-up is necessary to better analyse the impact of the established measures. Registries play an important role in collection of systematic data to analyse, synthetise, and obtain valuable information for decision support. five patients had to restart IgGs treatment and seven patients had to come back to the initial regimen. Even so, politic rationalisation in special situations is a key factor of pharmaceutical activity to ensure treatments for patients who need it the most.
DEVELOPMENT OF A PROTOCOL TO STANDARDISE CELL-BASED MEDICINAL PRODUCTS HANDLING IN AN ONCO-HAEMATOLOGY CLINICAL TRIALS UNIT
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
JOSE MANUEL DEL RIO GUTIERREZ, EUGENIA SERRAMONTMANY MORANTE, SARA GIMENEZ GINER, PILAR ROVIRA TORRES, PATRICIA GARCIA ORTEGA, CARLOTA VARON GALCERA, ISABEL CIDONCHA MUÑOZ, MARIA QUERALT GORGAS TORNER
Why was it done?
One of the most important challenges we currently face is the increase of clinical trials (CTs) including CBMPs. These drugs require special storage, preparation, delivery and administration; so developing standard operating procedures (SOPs) and ensuring proper coordination between all professionals involved, including pharmacists, is essential.
What was done?
Management of cell-based medicinal products (CBMPs) was protocolised in an onco-haematology clinical trials unit.
How was it done?
Pharmacists, doctors and nurses participate in a multidisciplinary team to standardise CBMPs handling. The following protocol was agreed:
1.The entire multidisciplinary team is notified when a CBMP prescription is planned to ensure proper coordination.
2.The CBMP is manufactured by the CT sponsor. Then, it is transferred to the blood bank for cryopreservation. CBMPs usually require a temperature between -80ºC and -200ºC and expire in some weeks.
3.Before CBMP administration, patients undergo lymphodepletion. The lymphodepletion regimen is performed according to the CT protocol or arranged between medical and pharmacy teams. Chemotherapy, serum therapy and antiemetic regimen are discussed and specified.
4.Once the treatment is prescribed, it is verified by a pharmacist who ensures its suitability.
5.On the infusion day, the blood bank delivers the CBMP. Then, a pharmacist checks if it arrives in proper condition and it is defrosted. The pharmacy department reconditions the CBMP in another infusion bag or syringe if required. This is the most critical point because CBMP expires after some minutes of defrosting, requiring extensive coordination.
6.CBMP is administered according to the CT protocol.
What has been achieved?
72 patients were recruited in 15 CT. 8 of them use as CBMP Chimeric Antigen Receptor T-Cells (CAR-T-CELLS), 4 Specific Peptide-Enhanced Affinity Receptor T-Cells (SPEAR-T-CELLS), 2 Tumour-Infiltrating Lymphocytes (TILs) and one cytokine-stimulated Natural-Killer-Cells (CS-NK-CELLS). Seven assays are intended for haematological neoplasms and eight for solid malignant neoplasms. One assay requires CBMP syringe reconditioning in the pharmacy department.
The described process optimises CBMPs handling, avoids delays in administration and reduces the risk of misuse.
What next?
CBMPs represent a novel therapy, and pharmacists have an essential role in developing new procedures to incorporate them into clinical practice. This protocol may be helpful for other centres to implement guidelines to work with CBMPs.
Safe medicine practices: a multidisciplinary approach
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Betânia Abreu Faria, Sara Barroso, Antonieta Silva, Olga Martins
Why was it done?
Portuguese legislation “The Basic Health Law (No. 95/2019) and the National Plan for Patient Safety 2021-2026 (NPPS 2021-2026) and the goals of the World Health Organization (WHO) are fundamental pillars of healthcare safety. The NPPS has promoted patient safety in the Portuguese National Health Service, focusing on specific issues such as safety culture, unambiguous identification of patients, safe surgery, pressure ulcer prevention, prevention of falls, infections associated with healthcare and incident reporting and drug safety. Thus, it is essential to ensure the training of health professionals (HP) in the field of patient safety and the safe and rational use of medicines. The objectives of the training actions focused on the safe use of medication, promoting patient safety and sharing experiences between the various HP, in order to optimise the circuits and procedures already implemented.
What was done?
Multidisciplinary training actions were carried out within the scope of safe medicine practices.
How was it done?
A team of four pharmacists and one nurse carried out training actions in the context of Safe Medicines Practices. The following topics were addressed: medicine circuit; good practices in drug preparation; identification of medicines: Look-Alike Sound-Alike (LASA) and High-Alert Drugs; physicochemical incompatibilities; factors that modify stability after reconstitution/dilution; fractionation and crushing of Solid Oral Pharmaceutical Forms (SOPF); drug information sources; reporting adverse drug reactions and other incidents; good practices in medication administration.
What has been achieved?
Training actions were carried out with a total of 29 hours of training and 357 participants. Suggestions for improvement were presented: optimisation of drug signage, compliance with established circuits, logistical aspects, on time drug information, improvement of communication channels, increase in the frequency of training actions. The trainees expressed receptiveness and interest in this initiative, which provided content that was little discussed and very relevant to their daily practice.
What next?
The correct preparation and administration of medicines is essential to safeguard their effectiveness and patient safety, which is the ultimate goal of every health professional’s daily activity. The Pharmacist, as part of the multidisciplinary team, must promote strategies that safeguard Safe Practices throughout the drug circuit. Hence it is important to ensure the continuity of these trainings.
A coordinated country approach to hospital pharmacies’ handling of clinical trials and the use of a common national brochure
Pdf
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
Pdf
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
Pdf
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
Pdf
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
Pdf
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.