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Author(s)

STEFANIE HEHENBERGER, IRENE LAGOJA, SANDRA BIELITZ-HOLZER

Why was it done?

Creation of a stoma means change in secretion, intestinal motility and absorption. Depending on localisation, this has also consequences for the absorption of drugs or certain drug forms. Data on absorption of drugs in ostomy patients are rare, but as most drugs are absorbed in the small intestine, ileostomy patients may more likely experience difficulty in absorbing and, therefore, gaining maximum benefit from oral medications.

What was done?

As part of a project, it was evaluated whether and which drug-related problems (DRPs) occur in stoma patients and, if so, measures for optimising drug therapy were proposed.
Relevant drug data (tmax, site of absorption, etc.) were collected and systematised in tabular form and the need for further pharmaceutical interventions was surveyed.

How was it done?

Over a period of 21 weeks, medication of Ileostomy patients (new created and pre-existing) hospitalised in various wards was screened.
A Level 3 medication analysis was performed, and the medication was then analysed with regard to possible stoma-specific DRPs.
All DRPs and pharmaceutical interventions were categorised and documented, and the identified DRPs brought to the attention of the patient’s medical team for review/ discussion in written form and/or personally.

What has been achieved?

Seventy-nine DRPs were identified in 15 medication reviews, of which 49 (62%) were classified as stoma associated DRPs. The pharmaceutical interventions were categorised, most common recommendations were monitoring (18) and change of the medication form (15). Acceptance of the interventions was also recorded (82%). Since a HOS (High output stoma) occurred frequently, an escalation scheme for the therapy of liquid stool and/or stool volume ≥1500ml/day was established. Finally, an interdisciplinary cooperation taking into account the complex patient factors could successfully be established.

What next?

Due to these results it can be assumed that ileostomy patients benefit greatly from pharmaceutical interventions, and that clinical-pharmaceutical care of ileostomy patients contributes to the drug therapy safety of this patient group and is therefore now being continued and incorporated into everyday clinical practice. In addition, further projects such as the creation of a standard operating procedure (SOP) for the interdisciplinary care of ileostomy patients are in progress.

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Author(s)

Franco Perna, Maria Elisabetta Uda, Maxime Annereau, Hail Aboudagga , André Rieutord, My Lan Vo

Why was it done?

The process of pharmaceutical validation of chemotherapy involves several steps, and the hospital pharmacist must rely on multiple therapy protocols. In addition, pharmacists who have just finished university do not have the appropriate training for pharmaceutical validation. Thus, we decided to develop a tool to support the validation of chemotherapy, in which pharmacists can learn therapy protocols.

What was done?

The hospital pharmacy has developed a pedagogical tool to support pharmaceutical validation in the context of rhabdomyosarcoma (RMS).

How was it done?

We initially carried out a systematic review, following the PRISMA 2020 Statement, to find if there were any educational methods or tools exist to facilitate pharmaceutical validation in paediatric oncology.
Then, we contacted several pharmacists, currently employed in French hospitals and abroad, to understand how they train new pharmacists and resident students about chemotherapies validation. After this first stage, we focused our research on the content of our future educational tool. We created an easy-to-fill questionnaire to obtain information and meet from clinical pharmacists inside our department to understand which information was needed for the tool and what could be the most suitable format for them.

What has been achieved?

Regarding the systematic review, only two studies were identified, in which tools for pharmacists were developed, but none of these concerned the pharmaceutical validation of paediatric chemotherapy. The hospital centres contacted did not develop pedagogical tools, but some of them support the training with standard operating procedures (SOPs).
The questionnaire, in which 15 pharmacists (27% students) were interviewed, revealed that most preferred a tool in pdf (48%) and paper format (22%), containing information on pathophysiology (48%) and epidemiology (22%) of rhabdomyosarcoma, on chemotherapy protocols (32%) and dosage regimens (19%). For this reason, a pedagogical tool has been developed in pdf format and in the form of a paper booklet with the required information.

What next?

This tool could be the first presented regarding the validation of paediatric chemotherapy.
The future prospect would be to develop other tools to support pharmaceutical validation so that we can invest more and more and provide more and more quality training to new hospital pharmacists.

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Why was it done?

The role of the NMC is to provide guidance about new medicines for use in public hospitals, and recommendations from the NMC can lead to changes in medical treatments. Before changes can be implemented, a variety of preparatory processes are necessary and relevant stakeholders, e.g. drug and therapeutic committees, hospital pharmacies, clinicians, and the national supply organization have to be involved.

Knowledge sharing and coordination among stakeholders are crucial to ensure efficient and nationally aligned implementation.

To undertake these tasks and support the NMC in their work, there was a need for a national group with expertise in implementation of changes of medicines in hospitals.

What was done?

The National Implementation Group was established in September 2019. The main purpose of the Group is to discuss, assess and ensure implementation of recommendations and treatment guidelines from the National Medicines Council (NMC) across regions, hence achieving national consensus on aligned medical treatment.

How was it done?

We formed the National Implementation Group with representatives from all stakeholders for swift and coordinated execution of changes of medicines. Each region designated participants directly involved in the implementation. To ensure effective knowledge sharing and coordination, the Group holds a monthly one-hour virtual meeting one week after NMC recommendations are published.

What has been achieved?

The monthly Group meetings ensure that the national implementation process takes approximately 14 days and the recommendations from the NMC are regularly discussed, assessed, and implemented efficiently and aligned at national level.

In 2022, the Group was evaluated through focus group interviews, highlighting quality and value. Results show that the Group aligns implementation nationally, offers expertise, saves regional resources, and fosters valued knowledge sharing concerning implementation of changes of medicine and adherence to recommendations.

The Group has now been successfully integrated as part of implementation at national level, emphasizing the importance of shared knowledge for efficient implementation of changes of medicines at national scale.

What next?

In future, the Group will increase its focus on identifying differences in treatments based on enhanced utilization of health data.

The Group provides the basis for knowledge sharing and can easily be transferred to other healthcare settings, both nationally and internationally.

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Author(s)

Grainne Johnston, Jennifer Brown

Why was it done?

The High Tech Scheme (HTS) in Ireland facilitates access to high cost drugs with proven cost benefit for patients. Combined national expenditure on adalimumab (Humira®) and etanercept (Enbrel®) exceeded €190 million in 2017. Biosimilar versions of both drugs are available, however largely not utilised. The most cost effective options for each drug were designated as the Best Value Biologic (BVB). Prescribing a BVB option offers the opportunity to save a considerable amount of money for the state.

What was done?

The Mater Misericordiae University (MMUH) Integrated Medicines Optimisation Pharmacist (IMOP) provided education and removed barriers to initiate biosimilar prescribing of adalimumab and Enbrel in the MMUH.

How was it done?

The MMUH IMOP was delegated to assist with implementation of BVBs prescribing.
The MMUH IMOP generated Patient Information Leaflets in relation to BVB switching.
The IMOP reviewed out-patients currently prescribed Humira® or Enbrel®, and provided education and information on switching from the originator to the BVB

What has been achieved?

Prior to the IMOP intervention, no patients in the MMUH had been prescribed a BVB.
Following IMOP intervention, between June 26 and September 27, 2019:
• 291 Humira® or Enbrel® patients were scheduled to attend MMUH rheumatology, gastroenterology and dermatology clinics.
• Of these, 64% (n=185) were switched to a BVB. An additional 19 patients were newly commenced on a BVB.
• The IMOP educated and counselled 91% (n=92), 93% (n=53) and 48% (n=13) of patients switched to a BVB in rheumatology, gastroenterology and dermatology respectively.
The largest contributing factor identified for patients not being prescribed a BVB was, no review by the IMOP prior to medical review; 65% (n=35), 59% (n=10) and 86% (n=12) for rheumatology gastroenterology, and dermatology respectively.

What next?

BVB prescribing can save vital health funds for the state while maintaining patient care. The MMUH IMOP is now progressing to adopt BVB prescribing for a number of other biological medicines at significant savings for the MMUH and state.

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Author(s)

SOFIA KONSTANTINIDOU, VANGELIS KARALIS

Why was it done?

Tyrosine kinase inhibitors (TKIs), like erlotinib and gefitinib, are widely used in anticancer therapy. However, after long term administration of TKIs, resistance is observed in the majority of patients. Thus, it is necessary to be able to define individualised dosage regimens for TKIs in cancer patients. Nowadays, modelling and simulation approaches represent the most powerful tool in the hands of clinical pharmacists towards precision medicine.

What was done?

Population pharmacokinetic (PK) – pharmacodynamic (PD) modelling was utilised to simulate erlotinib and gefitinib dosage regimens for non-small cell lung cancer. In silico clinical trials with virtual patients, of several resistance levels, were simulated in order to optimise pharmacotherapy and get better therapeutic outcomes.

How was it done?

The utilised PK/PD model and average parameter values were obtained from the study of Eigenmann and colleagues. This model was fully validated using statistical criteria and goodness of fit plots. In order to simulate many possible conditions that may occur in clinical practice, several different values of erlotinib and gefitinib clearance, absorption rate, pharmacodynamic characteristics (like tumor volume), and resistance were assessed. In addition, several dosage schemes were simulated. The entire modelling work was performed in Monolix® 2019R1.

What has been achieved?

Concentration vs. time and effect vs. time plots for the virtual patients were simulated for a variety of conditions and tumour resistance levels. For both TKIs, decrease of body clearance led to higher plasma concentrations, as well as more intense and longer duration of the effect (i.e. tumour volume shrinkage). Enhanced drug effect on resistant cells resulted in a decrease in tumour volume. In addition, a variety of concentration-time profiles were simulated, making it possible to choose the best regimen for each patient.

What next?

In this study, the use of modelling techniques led to the simulation of many conditions of patients and adjustment of dosage regimens according to their needs. Wider application of in silico methods using virtual patients will allow the design of the most appropriate individualised dosage schemes tailored to the patients’ requirements.

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Author(s)

Beatriz Zurita Alonso, Marta Martí Navarro, Monica Estelrich, Alejandro Ballestero Corominas, Anna Badell Giralt, Diana Patricia Vera Rodríguez, Milagros Ricse Salcedo, Roxana Rubio Vargas

Why was it done?

The use of biosimilar drugs has been a breakthrough to improve the sustainability of the health system. Although since 2015 position papers have been published by some scientific societies, there is no clear consensus about the recommendation for a switch from the original drug to its biosimilar. The rate of biosimilar use in our country is one of the lowest in Europe.

What was done?

The pharmacy service led the creation of a working group formed by rheumatologists, gastroenterologists, dermatologists and pharmacists to promote the use of biosimilar drugs in our hospital.

How was it done?

The working group wrote a consensus document in which it was jointly decided to start all new biological treatments with biosimilars. In addition, it was decided that the prescribers would determine which patients were candidates for switch to a biosimilar based on clinical criteria. If the drug is administered subcutaneously, the pharmacist is responsible to explain the reason for the change and the management of the new device to the patient. In case of disagreement, the original is kept and communicated to the prescribing physician. If the drug is administered intravenously, it is the physician who informs the patient about the change.

What has been achieved?

From May 2019 to September 2019, 17 switches were made: 4 infliximab (66.7%), 9 adalimumab (10.1%) and 4 rituximab (80.0%). This measure led to an economic saving of €111,106.96 per year. Twenty new treatments with biosimilars were started: 1 with etanercept, 2 with infliximab, and 17 with adalimumab. This supposed an economic saving of €141,826.36/year if we compare with the cost of the original drug. The rate of antiTNF biosimilars increased from 33% to 48% in 5 months. None of the patients refused the use of a biosimilar. By now, all treatments maintain their effectiveness without safety issues. This optimisation of treatments will allow the hospital to treat a greater number of patients and invest in innovative treatments.

What next?

These results indicate a great opportunity to offer biological treatment to a higher number of patients every year. Therefore, our objective is to achieve the switch of remaining patients as it could generate an additional saving of €630,072.28 per year.

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Author(s)

Maria Rautamo, Niina Laihanen , Laura Lehtola

Why was it done?

Erysipelas was the most commonly treated infectious disease at the home hospital unit in 2015. Previously the standard treatment was broad-spectrum antibiotic cefuroxime three times daily. The infectious disease specialist wanted to improve the antibiotic stewardship by shifting from cefuroxime to a continuous infusion of narrow spectrum benzylpenicillin. The aim of the initiative was also to improve patient care and reduce the number of treatment visits and thus overall treatment costs.

What was done?

The production unit at the hospital pharmacy began preparing elastomeric pumps containing benzylpenicillin for Helsinki city home hospital unit for the treatment of outpatients suffering from erysipelas. A pilot study was conducted in November 2018 before further implementation of the elastomeric pumps.

How was it done?

A benzylpenicillin 10 million IU infusion solution was prepared and transferred to elastomeric pumps (Folfusor LV10, Baxter) in the production unit at the hospital pharmacy. The production method was developed by pharmacists at the hospital pharmacy in cooperation with Baxter and the formulation as well as stability information was received from Baxter. The pilot study was planned and executed in cooperation with Helsinki city home hospital unit. The batch size of prepared elastomeric pumps was 7 pumps a week and the overall pilot period consisted of 5 weeks. A total of 8 patients were treated during this period. The opinions of nurses and patients about the use of elastomeric pumps were investigated through a questionnaire. The impact on treatment costs were also evaluated.

What has been achieved?

Elastomeric pumps containing benzylpenicillin have been implemented as a standard treatment for erysipelas at the home hospital unit. Cost savings from the pilot period of 5 weeks were 125 nurse visits corresponding to approximately 100 hours of work as well as 200 km of driving for nurses to patients’ homes. The patients were very pleased with the elastomeric pumps and the fact that the pump had to be changed only once daily.

What next?

Production and delivery of elastomeric pumps containing benzylpenicillin has expanded to other home hospital units. The implementation of elastomeric pumps containing other active ingredients is under investigation.

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Author(s)

Ana Soares, Armando Alcobia

Why was it done?

Several clinical practice guidelines for LC recommend that multidisciplinary teams should be used to plan patients’ treatment. The evolution of thoracic oncology, namely the increasing knowledge of the diverse histologic and molecular phenotypes in non-small cell LC, has been driven to more complex treatment algorithms in recent years. This complexity increases the need for a multidisciplinary approach in therapeutic decision-making, which must be individualised and based on the best information available. The pharmacist’s inclusion in the multidisciplinary team is essential and was formerly proposed by the Pneumology Director to the Hospital Administration Board.

What was done?

A hospital pharmacist is a permanent member of the lung cancer (LC) multidisciplinary team, which has met weekly since January 2016, to plan the management and treatment of LC patients in our hospital. The pharmacist brings updated information about the efficacy and safety of drug treatments, its cost-effectiveness and its availability. The pharmacist improves communication with the Pharmacy and Therapeutic Committee.

How was it done?

The multidisciplinary team meets weekly to discuss the diagnosis and treatment options of LC patients, and includes a dedicated group of professionals: pulmonary oncologists, a thoracic surgeon, a radiation oncologist, a radiologist, a pathologist, a nuclear medicine specialist, a hospital pharmacist, a palliative care physician and an oncology nurse.

What has been achieved?

About 240 cases, corresponding to 200 patients were discussed per year. An average of 110 solicitations to the Pharmacy and Therapeutic Committee were made. The multidisciplinary team grants a systematic approach to diagnosis and therapeutics, in compliance with evidence-based guidelines, improves communication and coordination between professionals and short waiting times for the patient.

What next?

The next step is to systematise real-world data collecting, from the patients treated, to better understanding the effectiveness of treatment options and the real impact of the multidisciplinary team in patient outcome, ideally, extending it onto a national level.

Author(s)

Gregorio Romero Candel, Maria Jesus Sanchez Cuenca , Nieves Cano Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera

Why was it done?

The healthcare provided in the SSC is not fully integrated into the structures of the National Health System. These patients present a higher risk of adverse events related to pharmacotherapy, due to patient factors, with the treatment, the health system and the institutionalisation. The integral approach of the pharmaceutical benefit was necessary for improving the efficiency, safety, health and economic results due to the process using drugs and other health products in the SSC.

What was done?

A pharmacotherapeutic benefit model has been started through the hospital pharmacy to the Socio-Sanitary Centres (SSC) of our health area. A pharmacotherapeutic management system based on the evaluation and selection of drugs and diet therapy items has been established.

How was it done?

An adherence protocol was made to the hospital pharmacy service, with the benefits that were to be provided to them. A guide was prepared with drugs and nutritional supplements that were available to them according to the Pharmacotherapeutic Guide of the Hospital Pharmacy Service, thus guaranteeing the most efficient products. A request model of both drugs and dietotherapics was developed for the SSC, assigning each centre one day per month to request the order and another day of dispensation. Finally, a calendar of distribution routes for each SSC was prepared.

What has been achieved?

For 12 months, eight SSC have been assigned to this programme, with 538 patients. Twelve shipments have been made to each centre, which have been provided with a total of 682,484 units of 223 active ingredients. The dispensation in diet therapy contained 28,045 units of 13 specialties. It has been possible to improve the pharmacotherapeutic coverage of these patients and reduce the expenditure on drugs in the area through centralised supply.

What next?

Development of follow-up programmes for patients with high health or economic impact drugs. Also, the adherence of new SSC, as well as increasing the dispensing portfolio, and achieving the integration of information systems, to have a total traceability from the patient to the different assistance levels.

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Author(s)

Aude Desnoyer, Anne-Laure Blanc, Christian Skalafouris, Rolf Hauri, Alain Lorenz, Pascal Bonnabry, Bertrand Guignard

Why was it done?

PIM (i.e. over-/under-/mis-prescriptions, and drug interactions) occurs frequently and is a well-known risk factor for adverse drug events and morbi-mortality (1). Its incidence is high and underestimated in internal medicine (2). While many paper checklists, providing explicit statements, related to PIM in geriatrics exist (3), none had been developed for adults in internal medicine. Moreover, as all these tools are only available as paper versions, they are not easily accessible in daily practice (4). Therefore, we decided to develop an electronic checklist, dedicated to adults in internal medicine.

What was done?

We developed an electronic screening checklist to detect potentially inappropriate medication (PIM) in internal medicine.

How was it done?

We conducted a 4-step study including literature review, 17 semi-structured interviews, a 2-round Delphi survey, and a forward/back-translation process (French English) to develop PIM-Check (5). Sixty-five medical specialists and pharmacists, from 22 hospitals in Belgium, Canada, France, and Switzerland were enrolled. Experts agreed on 160 statements, in 17 medical domains, and 56 pathologies. These statements were then integrated in a specifically developed web-based electronic tool. Each statement is associated with at least one pathology and one medication (1600 ATC encoded).

What has been achieved?

The application is available in French and in English on a website (www.pimcheck.org). A “Screening” function allows users to select for a specific patient, his/her co-morbidities and medications to switch on statements that are the most relevant. A “Favourites” function, gives quick access to selected statements, and a “Learning” function gives access to the list of all statements, those unread and those already read. Details regarding the conception of the tool, direct access to the references (n=333) and useful links (n=29), publications related to the tool and a contact section, are also available. Between February and September 2016, PIM-Check has been visited more than 75.000 times, in over 66 countries.

What next?

Several studies assessing the impact of PIM-Check are ongoing. The algorithm and content of the tool are constantly updated. Thanks to the English version, PIM-Check can be used in different European countries and healthcare settings (6), and will be helpful to support clinical pharmacists’ education in appropriate prescription analysis.