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Early access to the drug: the role of the pharmacist in the management of CNN drugs in oncology

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European Statement

Introductory Statements and Governance

Author(s)

Aldo De Luca, Andrea Ghiori, Cecilia Orsi, Michele Cecchi

Why was it done?

CNN drugs are drugs that have obtained authorisation from EMA and AIFA (Italian drugs authority) but that have not been negotiated for the purposes of the reimbursement of the National Health System. These drugs are often clinical innovations that fill therapeutic gaps. In our Region, access to these therapies is allowed only on a special request made by the clinicians at the Pharmacy that is evaluated positively, presents it to the Regional Authority. The regional assessment is also implied by the presence of specific contractual agreements with the pharmaceutical companies. Requests have been considered for enfortumab vedotin (EV), indicated for urothelial carcinoma, and trastuzumab deruxtecan (T-DXd), indicated for breast cancer. The objective of this article is to highlight the activity of the pharmacist in the management of drugs in the CNN range.

What was done?

A pathway has been developed at regional level to promote early access to new drugs and further therapeutic possibilities.

How was it done?

All requests for CNN drugs received in the semester November 2022 to May 2023 to our Operations Unit and subsequently included in the regional portal were analysed on the basis of approved indications, bibliography, clinical reports, and eligibility card (for T-DXd only) validated by the medical division of the pharmaceutical company.

What has been achieved?

During the period analysed, 25 applications were made (11 for EV, 14 for T-DXd) for a total of 30 treatments (11 for EV, 19 for T-DXd). Of the 25 requests received by the Pharmacy, 24 (96%) were sent to the region for treatment authorisation; one was not submitted because the patient did not comply with the approved indication. We obtained 100% of the required treatment approvals.

What next?

The hospital pharmacist is configured as a collector of clinical requests with an important function as a filter of prescriptive appropriateness in requesting regional authorisation for the treatment of drugs in the CNN range; moreover, the pharmacist is a necessary reference figure between the need for clinical innovation and the need to guarantee sustainability of the system in order to ensure early access to innovative therapeutic opportunities. This model could be exported to other regions at national and European level.

Lean management optimisation of the patient care pathway in an onco-haematology outpatient hospital

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European Statement

Introductory Statements and Governance

Author(s)

Florent MARTY, Sephora BELO-KIBABU, Driss CHAOUI, Jean-Luc PONS, Romy LINOSSIER-ROCHER

Why was it done?

Over the last few years, French healthcare establishments have been moving towards a more ambulatory approach to medical care. The growing number of patients treated in OPH has necessitated a reorganisation of these units. Staff at the onco-haematology OPH and the team at the centralised cytotoxic preparation unit in our hospital have reported organisational problems affecting the care pathway for patients admitted to the unit, leading to excessive delays in treatment and long waiting times for patients. Waiting time is one of the best measures of the quality of care provided.

What was done?

The project is to improve the overall patient flow within the outpatient hospital (OPH) service by reducing so-called non-value-added and compressible waiting times, without affecting the quality of patient care. This should have an impact on the flow of onco-haematology patients and therefore enable the OPH to operate more smoothly. Improvement actions must be simple, quick, easy to implement and inexpensive.

How was it done?

Data collection (waiting times, volume of activity) was carried out using: patient pathway mapping, observation grid, nurse and haematologist questionnaire, Actidiag software. Application of Lean through the development and facilitation of Kaizen workshops. The improvement actions were chosen during a brainstorming session between haematologists, pharmacists and nurses. A new data collection is then carried out and the results compared.

What has been achieved?

The stays of 64 patients were studied before optimization and compared with those of 79 patients after optimization. Improvement actions include : creation of a shared file, installation of a giant screen in the department connected to the new file, anticipation of preparations. Countermeasures reduced overall waiting times by 42%, cutting the patient’s length of stay by 53 minutes. The care time represents 54.6% of the time spent in the OPH, compared with 41.2% previously. This has also enabled the department to take on 18% more patients.

What next?

Healthcare professionals have noted a smoother flow of activity, making the care pathway more fluid and enabling patients to spend less time in the department, without impacting on patient care. This results in better rotation of OPH beds using a simple and easily reproducible method.

An algorithm for the process of selecting pharmaceutical companies in a pharmacy department

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European Statement

Clinical Pharmacy Services

Author(s)

Moisés Couñago-Fernández, Marisol Samartín-Ucha, Ana María Regueira-Arcay, Sonia González-Costas, María Alfonsín-Lara, Paula Prado-Montes, Iván Agra-Blanco, Elena Cerdeira-Regueira, Noemí Martínez-López de Castro

Why was it done?

When a new pharmaceutical product should be introduced in a hospital, a multitude of factors must be considered in order to choose a specific brand. A lack of uniformity in the criteria for the selection of new medicines has been detected. To avoid selection errors or arbitrary decisions, a selection structured algorithm was developed using quality tools according to management quality system ISO 9001-2015.

What was done?

To ensure that the process of selecting from several pharmaceutical companies fulfil the requirements of quality and lower cost, a decision-making process for these purchases was designed, through a structured method for the evaluation of new pharmaceutical products based on standardised evaluation criteria.

How was it done?

A multidisciplinary group was created focused on making decisions about criteria. All stakeholders were represented (management pharmacist, quality experts, management assistant and pharmacy director). Also, a survey was given to different specialist pharmacists to complete the criteria. Second, criteria were categorised according to their importance or potential impact in pharmacy practice or patient.

What has been achieved?

The algorithm took into account aspects related to: a)pharmaceutical company and b)aspects related to the pharmaceutical product. Each of these aspects is valued as a percentage.

a)Pharmaceutical company: 40% of the score was based on not having a repeated history of stock-outs, 45% on the evaluation of the provider according to an internal file based on incidences registered, and 15% if the provider was already a known supplier.

b)Pharmaceutical product: 50% was based on the cost of the medicine, 15% unit dose presentation (if applicable), 10% expiry conditions of the medicine, 5% allergens, 5% if it was presented in a pre-filled pen (if applicable), 5% if it could be stored at room temperature, 5% if the drug is supplied in diluted vials (in the case of parenteral medicines) and 5% if it had all the possible indications in the technical data sheet.

This methodology has been used successfully in recent months with the pharmaceutical supplier changes of abiraterone and sugammadex.

What next?

This tool will be used for all changes of medicine brands and new drugs purchased in the hospital, enabling uniformity in the purchasing process for all new drugs.

Development of a compact, disposable filter to reduce the discharge of pharmaceutical waste into the sewer

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European Statement

Production and Compounding

Author(s)

Annemarie Aart van der – Beek van der, Mattijs Maris, Erwin Koetse, Alex Hol, Meilof Feiken

Why was it done?

Hospital Pharmacies and especially the laboratories produce wastewater containing medicine residue. When this wastewater is discharged into sewage it contributes to the load of pharmaceutical residue and ultimately to pollution of surface-, ground and drinking water. To reduce this load, waste can be collected and transported to a processing facility for incineration and deactivation or alternatively treated locally. Our goal was to develop a practically applicable method that could effectively reduce the pharmaceutical sewage load locally, at the source.

What was done?

We developed a practical, compact, disposable filtration system that can be used on-site to reduce the amount of pharmaceutical residue in wastewater of our pharmaceutical laboratory. We tested and optimized the composition of the filter to effectively collect organic substances from locally produced wastewater (influent). We monitored filter performance and durability by analysis of filtrates (effluent).

How was it done?

Laboratory wastewater was collected during one month to yield 10 L influent. Portions of influent were filtered through 9 different types of filter packing and the effluents collected for analysis.
The influent reference and effluent samples were analysed using an iontrap LC/MS screening method using diazepam-D5 as an internal standard. The signal abundance 12 most relevant substances was chosen to evaluate the level of reduction by filtration. Based on these analyses, the optimal filter packing was determined.

What has been achieved?

In the effluent of the best performing filter packing, the abundance of 9 substances was reduced by 91,5-99,9%. The abundance for the other 3 substances was below detection limit.
Substances removed more >99%: atorvastatine, carbamazepine, clarithromycine, diclofenac, granisetron, midazolam, naproxen, propranolol and rocuronium. Substances removed between 91-99%: cefazolin, ephedrine and ropivacaine.

What next?

The optimal filter composition will be tested in practice in a test setup. In addition, cost effectiveness and sustainability compared to alternative waste collection methods will be evaluated.

Optimising medication procurement through integrated database

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European Statement

Selection, Procurement and Distribution

Author(s)

Irene Ruiz-Jarabo Gómez, Marcos Gómez Bermejo, Rocío Vázquez Sánchez, Antonio Illescas Bermudez, Elena Martín Suarez, Teresa Molina García

Why was it done?

Digitization was considered essential in reducing costs related to inventory management and improving responsiveness in critical situations, such as supply shortages. Traditional manual inventory checks and order verifications were time-consuming and error-prone, prompting the need for a digital transformation.

What was done?

In our quest for enhanced medication procurement efficiency within our Hospital Pharmacy Service, we have developed an integrated database.

How was it done?

We have developed a database by consolidating data from two primary sources: our automated medication storage system, Smart Ulises®, and the Economic Management software, Farmatools®. This database encompassed information related to medications falling below predefined minimum stock levels, historical acquisition records, pending medication orders, and warehouse capacities for each medication. Additionally, it seamlessly integrated data obtained from the Spanish Agency of Medicines and Medical Devices (AEMPS) regarding medication shortages.
This database enabled several essential functionalities:
It generates reports suggesting orders for medications below the minimum stock levels, recommending quantities based on historical acquisitions and available storage space.
By considering the suppliers for medications at minimum stock levels, it also identifies medications in alert status (1/3 above the minimum stock) for these suppliers.
Cross-referencing with AEMPS’ medication supply problem database swiftly detects critical medications during shortages
It permits agile identification of pending medication orders.
It identifies locations with incomplete medication inventories and propose medication grouping within our automated medication storage system.

What has been achieved?

The outcomes of our project were transformative:
  We streamlined medication procurement significantly and maximized each medication supply request while promoting sustainability by reducing laboratory-specific medication orders.
  We optimized storage space within our automated medication storage system, aligning medication orders precisely with storage capacities for each medication, leading to more efficient space utilization and reduced storage costs.
  Early detection of medication shortages enabled proactive preparation of alternative solutions to effectively mitigate shortages.
  Simplification of tracking pending medication orders enhanced operational efficiency in claim processing or supplier changes.

What next?

Our next phase focuses on continuous system improvement. This involves incorporating additional data sources to refine medication supply predictions and exploring the potential for complete automation of the medication ordering process. We will also enhance performance measurement to evaluate the effectiveness of our improvements.

Use of an integrated research management system on a clinical trials unit of a Portuguese hospital

European Statement

Education and Research

Why was it done?

The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)

What was done?

Evaluation of the use of an Integrated Research Management System based on a retrospective analysis of all clinical trials introduced into the software since 2020.

How was it done?

The evaluation of the use of the software was based on a retrospective analysis of all clinical trials introduced since 2020 and the interpretation of the results of a survey (carried out from July to August 2023) aimed at Clinical Research Associates (CRAs)

What has been achieved?

With the introduction of an integrated management system as a registration platform of investigational product receipt, dispensing and return, were introduced into the software 204 clinical trials.
Since its implementation in 2020, the integrated system has been authorised by the sponsor as a registration platform in 55 clinical trials, corresponding to 79% of clinical trials initiated since that date.
The clinical trials Unit grants remote access to the clinical trials information to CRAs through the filling out of a declaration. Since the adoption of this system, remote access to the platform has been granted to 35 CRAs.
According to the survey distributed between July and August:
-85.7% of CRAs use the system in their monitoring work.
-The use of System has been exclusively approved to replace paper records in 88.9% of active clinical trials (with the exception of receipt confirmation via IWRS – Interactive Web Response System).
-All the CRAs who answered the questionnaire consider remote access to clinical trial data to be an advantage.
– 77.8% believe that by using the platform the time spent on presential visits has been reduced.

What next?

The use of this type of system is essential to ensure the efficiency of the tasks carried out by research teams. The approval of system by the sponsor allowed a significant reduction of paper records and the CRA’s remote access to the platform has allowed the early detection of errors, as well as a substantial reduction on time spent on presential visits. The CRA’s remote access to the movements associated with the experimental product like temperature records, calibration certificates, CVs (Curriculum Vitae) and GCP’s (Good Clinical Practices). Although use of the platform has been increasing, some sponsors still do not authorise the exclusive use of the system. It is therefore essential to share the platform’s added value in order to change the traditional ways of management of clinical trials information.

Routine generation of real-world evidence: an integrated system for the systematic recording of clinical data on innovative outpatient hospital medicines

European Statement

Patient Safety and Quality Assurance

Author(s)

Manuel Mazarío-García, Amparo Molina Lázaro, Gemma Garrido Alejos, Ferran Sala-Piñol, Núria Juvanet Ribot, Lluís de Haro i Martin

Why was it done?

In 2011, the Catalan Health Service (CatSalut) introduced the Registry of Patients and Treatments of Outpatient Hospital Medicines (RPT-OHM) within their Standard Health Record Platform (SHRP) for the comprehensive evaluation, effectiveness and safety of OHM. CatSalut requires fulfilling RPT-OHM before medicines billing. However, SHRP lacked integration with ICS’ clinical and billing information systems.

What was done?

The Catalan Health Institute (ICS) is the largest healthcare provider in Catalonia and is made up of eight hospitals. The ICS developed and implemented a structured data collection tool named the Hospital-Information-System-integrated Registry of Patients and Treatments (RPT-HIS). This tool systematically collects a range of critical information, spanning from prescription inception to treatment cessation, such as:
• Administrative patient, prescriber, and treatment particulars.
• Active ingredients or combinations, initiation and termination dates, therapeutic indications, and ICD-10 diagnoses.
• Baseline clinical variables recorded upon treatment commencement.
• Dynamic clinical data captured or typed from medical records throughout follow-up according to predefined intervals.
• Cessation variables detailing reasons for treatment discontinuation.

How was it done?

At ICS’ headquarters, a dedicated team of internal business analysts and functional support officers, along with contracted developers, collaborated to design, implement, and maintain RPT-HIS. Monthly coordination meetings ensure efficient integration of new OHM and monitor the registry’s progress. Simultaneously, a network of local reference pharmacists emerged in all eight ICS hospitals, fostering continuous knowledge exchange and driving innovative enhancements.

What has been achieved?

In the first half of 2023, 52,907 initiation, follow-up, or discontinuation forms were completed. Among these, 93.7% met all preset treatment-specific validation rules, underscoring the initiative’s effectiveness. Subsequently, utilization and budgetary impact reports across ICS hospitals have been elaborated, covering general and special patient populations, indicating a positive impact on operational efficiency and patient care.

What next?

In the near future, the real-world data amassed and stored in RPT-HIS could help to underpin refined drug therapy, optimize health outcomes, and strategically position medicines for specific conditions, also aiding in selection and purchase. This initiative serves as a model of good practice, demonstrating the potential of integrated data collection systems, aligned with the routine process of OHM utilization, to improve patient care. The successful implementation of RPT-HIS suggests its viability for adoption in other healthcare settings.

Setting up automated dispensing cabinets in a cardiac surgery intensive care unit: what impact for the nursing team and the pharmacy?

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European Statement

Selection, Procurement and Distribution

Author(s)

MARIANNE DE LACROIX DE LA VALETTE

Why was it done?

Managing medications in hospitals is both a health and an economic issue.
Hospital pharmacists are working to improve supply, traceability, safety and stock management in order to meet these challenges.
Healthcare staff must be able to administer the medications prescribed to patients in complete safety, with the products available at the time of order. The management of medications within the department represents a significant amount of time that needs to be reduced.

What was done?

The objective of this study was to analyse the impact of deploying automated dispensing cabinets (ADC) in a cardiac surgery intensive care unit within a university hospital in France.

How was it done?

In 2022, an on-site study was conducted in the cardiac intensive care unit (18 beds) at Rennes University Hospital. The aim was to quantify the time allocated to manage medications before and after the installation of the automated dispensing cabinet.
Several types of measurable metrics were identified and compared. These include picking time for nurses of medications for administration to the patient; time allocated for ordering and storing medications; time to respond to emergency orders; management of narcotics; and time in the management of expired medications.

What has been achieved?

A comparison of the pre and post installation of the automated dispensing cabinet showed nursing time savings in the picking of controlled drugs of 53%. Overall restocking time was decreased by 9%. The number of urgent order requests to pharmacy was decreased by 51%.
The time allocated towards removing expired medications was reduced by 3.8 days / year (nurse FTE). Lastly, the implementation of automated dispensing cabinets reduced the value of the department’s stock by 26%.

What next?

The time spent by nurses in managing medications was significantly reduced after the installation of automated dispensing cabinets. However, some of this time is transferred to the central pharmacy towards restocking the medications into the automated dispensing cabinets.
The automated dispensing cabinets makes it possible to monitor the stock of medicines in a department on a daily basis. This enables for data driven decision making on selection of decentralized stock and respective quantities to maintain.
The deployment of automated dispensing cabinets improves overall efficiencies and allows more time for nurses to provide direct patient care.

Too good to go – sharing medication near expiry with a digital solution

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European Statement

Clinical Pharmacy Services

Author(s)

Charlotte Sørensen, Karin Aagot Møller Jørgensen, Anne Grethe Nørgaard Kyndi, Charlotte Lund Madsen, Line Scriver Poulsen, Charlotte Hjorth, Gitte Slyngborg Morbjerg, Janni Østergaard Jensen, Mette Juul-Gregersen, Rune Dalsenni Rask

Why was it done?

A sustainability project in 2020 highlighted manual and time-consuming workflows when checking expiry dates in hospital medicine rooms. For example, manual reading, interpretation and notation of expiry dates in paper forms every half year. Therefore, a smartphone application was developed and implemented in a large university hospital in 2022. The application was a huge success and colleagues from other Clinical Pharmacy departments in other hospitals within the same region wanted to be part of the success of the initiative.

What was done?

A smartphone application for managing expiry dates in medicine rooms was applied in one hospital in 2022 and in four other hospitals in 2023. The data-matrix of medicine packages is scanned with a smartphone camera and the application gives a sorted overview of medication near expiry. 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.

How was it done?

The smartphone application was implemented in Clinical Pharmacy departments in four other hospitals, one by one from February 2023. After implementation the application is used in 373 medicine rooms.

What has been achieved?

Clinical Pharmacy staff are happy with the application. It takes significantly less time to check and scan expiry dates with the digital solution.
From February to September 2023 (five hospitals)
• 47491 packages were scanned
• 5251 packages were released (11%)
• 2664 packages were moved between medicine rooms to avoid medicine wastage (51%; 147000 €). Most activity (78%) was seen at the hospital that had been using the application since 2022. Most packages were moved between medicine rooms at the same hospital; however, in 215 cases (8%), medicines were exchanged between hospitals as well (20.000 €)
• 10918 packages were discarded due to expiry (743168 €; 0.5% of bought medicine).

What next?

The full potential of the digital solution remains to be achieved.
Pharmaconomists have to release medicine in the application a few months earlier than they do now. To go shopping in the application before ordering from the pharmacy, will probably also result in discarding less medicine. Sharing medication across hospitals to a greater extent will also be relevant to consider.

Implementation of a multidisciplinary circuit for the management of haematologic patients under treatment with bispecific antibodies

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European Statement

Patient Safety and Quality Assurance

Author(s)

Carla Noguera-Jurado, Alba Manzaneque, Gloria Molas, Genis Castells, Sandra Jara, Bernat Tenas, Jordi Nicolas

Why was it done?

Bispecific antibodies (BA) have the ability to specifically bind two different antigens, thereby presenting specificity for two different cells. Among the toxicities associated with these drugs are cytokine release syndrome (CRS) and immunoeffector cell-associated neurotoxicity syndrome (ICANS), the management of which requires multidisciplinary action. The purpose of this circuit is to ensure adequate management of these toxicities to guarantee patient safety.

What was done?

Creation of an action plan for haematological patients treated with bispecific antibodies for the detection and proper management of their toxicities.

How was it done?

A multidisciplinary team formed by Pharmacy, Haematology, Nursing, Intensive Care Medicine and Neurology was created and the healthcare professionals involved were specifically instructed. Moreover, an action circuit was implemented for the detection and management of these toxicities, and a specific protocol was created for the preparation and dispensing of tocilizumab. The protocol contemplated: centralisation of the preparation in the pharmacy department (within the pharmacy hours) or preparation in the hospitalisation ward by trained professionals using a kit previously prepared by the pharmacist (containing drug, serum and closed system dispositive for the preparation and administration of tocilizumab outside pharmacy hours).

What has been achieved?

From July 2022 to August 2023, a total of five patients have been treated with BA in our institution (elranatamab (4/5), and teclistamab (1/5)), including clinical trials and compassionate use, for Multiple Myeloma.
Three patients presented grade 1 CRS in the first cycle of treatment, which was resolved with symptomatic therapy, with no need for tocilizumab administration in any case. In addition, one also presented grade 1 ICANS, which only required monitoring without treatment.
The availability of the toxicity management circuit, in addition to staff training, allowed toxicities to be detected and resolved early and, if tocilizumab had been needed, the circuit would have ensured its immediate availability.

What next?

The implementation of a multidisciplinary care circuit led by pharmacy and haematology guarantees the adequate management of toxicities associated with the treatment, ensuring the best quality of care for the patients and their safety.

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