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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.

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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.

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Author(s)

Fiona Watson, Amanda Plummer, Aqleema Akhter

Why was it done?

For discharge medication to be dispensed a medicines list plus discharge letter, often referred to as a To-Take-Out (TTO) is required. The letter section communicates information for safe patient transfer and provides context for the pharmacist clinical verification. With increasing demands on junior doctors, the production of TTOs is often delayed until after all urgent clinical duties are completed, so dispensing commences late in the working day. in addition, junior doctors’ prescribing errors cause delay while queries are resolved. The late completion of TTOs slows patient flow across the whole system. It was accepted that a different strategy, using a PP to prioritise prescribing, needed exploration.

What was done?

A prescribing pharmacist (PP) was embedded within a specialist medical team, to perform prescribing activities in a timely manner, with a focus on discharge prescriptions. The PP was additional to the standard ward pharmacy establishment, allowing prescribing to be the focus of the role.

How was it done?

A PP was embedded within the Respiratory team and another within Gastroenterology with the primary aim of producing TTOs as early as possible. There was a requirement for the PP to learn how to write the discharge letter, via training with junior doctors. The PP prioritised any prescribing to facilitate discharge, but also attended the consultant ward round undertaking medicines optimisation for each patient. Rather than the junior doctor returning later to prescribe, the PP made any necessary medication changes during the ward round, facilitating the timely receipt of appropriate therapy.

What has been achieved?

Both pilots reduced the time from medically fit for discharge to the TTO written by approximately 3 hours. There was a reduction in prescribing error rate of 37% to 1% in Respiratory and 9.5% to 0.7% in the Gastroenterology project.

What next?

The “Embedded Prescribing Pharmacist” role is now permanent within the two pilot specialities, with plans for further extension under consideration. The role demonstrates the “Right first time” concept and a modernised model of hospital pharmacist practice.

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Author(s)

María Calvo Arbeloa, Ana Isabel Idoate Grijalba, Mónica Uxue Beunza Sola, Daniel Fresán Restituto, Regina Juanbeltz Zurbano, Diana Tejada Marín , Andrea Rodriguez Esquiroz, Maite Sarobe Carricas

Why was it done?

Patients with special characteristics show a great variability in pharmacokinetic and pharmacodynamics (PK/PD) parameters, which may influence the efficacy and safety of antibiotic therapy.

What was done?

A Clinical Unit of Pharmacokinetics was implemented in the Service of Pharmacy (PS) for therapeutic drug monitoring (TDM) in patients.

How was it done?

1. Selection of drugs to be monitored: Antimicrobials (Vancomycin, amikacin, linezolid and voriconazole), Immunosuppressants (tacrolimus), Antineoplastics (methotrexate) and digoxin.
2. Installation of the Abbottbase Pharmacokinetic System (Pks®) software.
3. Creation in the Computerised Clinical History (CCH) a sheet for collecting anthropometric and pharmacological data and pharmacokinetic interpretation of the results obtained.
4. Creation in CCH of a consultation option for clinicians to request monitoring from the PS.
5. Formative session for clinicians and nurses.

What has been achieved?

To begin with the unit, we selected three drugs: vancomycin, amikacin and voriconazole. The hospital pharmacist or the clinician chose the susceptible patients.
Between December 2021 and September 2022, 171 determinations were made in 73 patients: 134 (78.36%) for vancomycin, 24 (14.06%) for amikacin and 13 (7.60%) for voriconazole. Forty-six (63.01%) patients were men and the mean age was 56.58 (17-97) years- old. Eighteen (24.66%) patients were obese. The mean creatinine level was 0.82 (0.4-2.69) mg/ml and glomerular filtration according to the Cockcroft and Gault formula was 81.16 (23.68-161.98) ml/min/m².
For vancomycin, 45 (88.24%) patients started the treatment with a standard dose of 1000 mg every 12 hours. In first determinations, 27 (52.94%) were under-therapeutic and 20 (42.55%) were overdosed. After modifying the dosage regimen, 35 (74.47%) were in range, 3 (6.38%) under-therapeutic and 13 (27.66%) supra-therapeutic.
In case of amikacin, 17 (85%) patients started with a standard dose (1000 mg every 24 hours) achieving target levels only in one case. All were under-therapeutic. After modifying the dosage regimen, we achieved the objective in all of them.
For voriconazole 3 patients were monitored. In 10 (43.5%) determinations, a change in dosage regimen was suggested due to subtherapeutic levels. All (100%) of the recommendations given by the PS were accepted.

What next?

The implementation of the unit in our hospital shows the usefulness and the need to extend pharmacokinetic monitoring to other medical services and drugs.

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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.

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Why was it done?

Kidney disease carries a significant worldwide health burden. In more the incidence of stage III chronic kidney disease in more than 9%. Many hospitals in Oman have special units of nephrology but clinical pharmacy services for these patients are almost none. It was important to upskill practicing pharmacists’ knowledge and skills to provide comprehensive pharmaceutical care for patients with renal diseases.

What was done?

An online 8-week course was developed by an experienced and certified renal clinical pharmacist with an aim of enhancing the knowledge and skills of pharmacists practising in primary, secondary and tertiary care hospitals in Oman. The course covered all the topics required to develop the skills of the pharmacists to enable them to deal with renal prescriptions and be able to intervene in any medication related problem in patients with kidney diseases. Before and after knowledge assessment was done for the participants to enable justify the benefits of the Course. Towards the end of the course a satisfaction survey was also completed by the participants to provide ensure achieving desired outcomes.

How was it done?

The course was hybrid and the beginning with some sessions carried out face-to-face and some online.
The course included topics such as acute kidney injury, chronic kidney disease, drug induced kidney diseases, medication management in renal replacement therapy and kidney disease complications. The course was interactive with case study discussions, question and answer sessions and some assignments done by the participants at home. The course was designed based on Kirkpatrick foundational principles with consideration of the four levels of learning.

What has been achieved?

Twenty pharmacists participated in the first cohort and 23 in the second cohort. The attendance was more than 90% throughout the course. The pharmacists were keen to learn and ask questions. There was a clear difference in knowledge before and after the course with only 19% of participants passing the pre-course assessment compared to more than 80% of participants passing the post-course assessment.

What next?

The course was highly appreciated by the participants and would run the course and regular intervals with considerations to applications from the Gulf region since they share similar practice and disease burden.

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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.

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Author(s)

Nóra Gyimesi, Andrea Bor, Eszter Erika Nagy, András Süle

Why was it done?

Evidence suggests that the rate of bacterial co-infection among COVID-19-infected patients is low. However, routine use of antibiotics was common in the early stages of the treatment.

What was done?

Clinical pharmacist participated in the therapeutic decision making of COVID-19 patients treated in our institution in order to ensure the optimal choice of medicines with special regard to the use of antibiotics.

How was it done?

A daily therapeutic discussion was started in the quarantine department from 2021, with the participation of clinical pharmacists, during which all therapy initiation were consulted. The pharmacist was involved in the walk-arounds and reviewed the medication therapies of each patient daily. The clinical pharmacist advised on the starting, or, if it was considered unnecessary, the stopping of the antibiotic therapies, as well as the monitoring required. The choice and dosage of antibiotics were also consulted.

What has been achieved?

Of the 314 patients treated in the Quarantine Department of our institution between September 2020 and May 2021 104 (33%) received antibiotic therapy during treatment, with 73% of cases initiated within 72 hours of admission. In 68 cases, bacterial superinfection was the indication for antibiotic therapy, of which only 9 cases had radiologist-confirmed bacterial co-infection. The rate of antibiotic usage has decreased after the intervention was started. During the second wave of the coronavirus epidemic (until February 2021), 41% of patients received antibiotics, while during the third wave (from March 2021), 28% of patients.

What next?

The pharmacist involvment, along with increasing experience and evidence for the clinical management of COVID-19, have moderated antibiotic use, however antibiotic overuse is still significant. Our Department of Pharmacy developed a local COVID-19 treatment guideline with emphasis on antibiotic use requirements. The education and promotion of this guideline will be undertaken by clinical pharmacists. Multidisciplinary therapeutic decision-making and strengthening of antibiotic stewardship programs are necessary for proper antibiotic use practices in the treatment of coronavirus patients.

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Author(s)

Diane Le

Why was it done?

When the case for a study sponsored by the hospital has been filed a few months ago, the national agency authorizing trials raised the issue of health waltch, particularly the management of drug recalls. With the research department, which alerted us on the lack of resources for health alerts, and at the same time facing an international cease of some drugs, we set up a health alert and a regulatory watch system, to improve the quality of product and the patient’s safety.

What was done?

We set up a daily health and regulatory watch to stay abreast of any news. Regarding health watch, we included : studies for which the hospital is the sponsor ; studies for which the experimental treatments are not provided by the sponsor ; treatments used for adverse events and authorized by the sponsor.

How was it done?

Daily regulatory watch is carried out on the national legislation website with daily updates of national texts. If a new rule applies, it is written in a table to alert everyone.
Daily health watch is also carried out on the site of the national agency of drugs. Four types of information are recorded: drug shortages, alerts, recalls and releases.

What has been achieved?

Tables collecting those information are available on the pharmacy’s network so that anyone can read them, and can be shared with clinical research officers. To that day, some information has been collected due to a european legislation update on the clinical trials and has allowed us to anticipate what will change next year. We have not yet faced a drug recall but what has been done will allow us to react in the best way when this will happen.

What next?

The aim for carrying out regulatory and health watch is to allow us to quickly react and anticipate future problems, while keeping in mind the patient’s safety and the pharmacy practices improvement. This work was therefore completed with success, demonstrating the ability to react and the desire to deploy continuous improvement initiatives to strive for operational excellence and pharmaceutical. We now want to implement this work in the daily activity and extend it to other sectors.

Why was it done?

the app was developed in order to improve therapeutic adherence, pharmacological counseling, management of adverse events and increase pharmacovigilance’s reports with higher data quality. The World Health Organization recognizes that 20% of health is due to medical care, 20-30% to lifestyle, while the remainder depends on the environmental, social, genetic and psychological conditions of the individual. The goal of this app is to improve patient’s therapeutic path at different levels and breaking down geographical barriers.

What was done?

the Sars-cov-2 pandemic entailed a lot of new challenges for the Hospital pharmacist . As the scenario was completely new, it was developed an app to better manage patients with cancer disease treated with oral chemotherapy.

How was it done?

Patient has been divided into two groups, of which only one group use the app to manage the therapy. The primary endpoint was the improvement of therapeutic adherence, while the secondary endpoints are: improve in the quality of patient life (HRQoL), increase pharmacovigilance’s reports and avoid therapeutic errors.

What has been achieved?

The continuous dialogue between patients and hospital pharmacist througt system’s online messaging app improved the management of patients needed and reduce drug interactions. Digital management led to a 56% increase of pharmacovigilance reports. It was also detected a reduction in overall costs and patient uneasiness.

What next?

the health system has to be reorganized around patient’s needed, by promoting the use of more and more homogeneous, safe, transparent and accessible technologies.
Regulatory authorities should accelerate the adoption of digital solution. In this new framework hospital pharmacist will play a key role in the development of value based medicine and in the process of treatment humanization as a patient’s landmark person too.