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IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE

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European Statement

Patient Safety and Quality Assurance

Author(s)

CRISTINA MORA HERRERA, VICTORIA VAZQUEZ VELA

Why was it done?

Occupational exposure to HD can cause health damage to exposed healthcare professionals, so protective measures must be taken

What was done?

The hazardousness of drugs can cause damage due to exposure in healthcare workers from Social Health Centers (CSS). As an objective, the design of a security strategy in the handling of hazardous drugs (HD) was proposed with the elaboration of a safety working procedure (SWP) and preventive measures. In addition, the HDs were identified, with proposals for alternatives and recommendations for handling and administration were released.

How was it done?

Observational cross-sectional study to identify employment MPs in a public CSS. The demographic characteristics of the patients and their Pharmacotherapeutic prescription were recorded. A total of 107 residents were included, with a mean age of 78.9 years and 59.8% (64) men. The average stay in the center was 7.4 years (1-27). Regarding functional capacity, 53.3% were considered assisted, 89% of them with grade III -II assessment, that is, large dependents and severe dependents. Of the valid group (46.7%), 70% belonged to socially excluded. The most prevalent pathologies in the center are vascular, neurodegenerative, osteomuscular and respiratory. The mean number of medications per patient was 4.8. Only 6 patients did not receive Pharmacological treatment.
The design of the security strategy was structured in 3 phases; 1st)Elaboration of an SWP with assignment of functions/responsibilities, preventive measures to be adopted in the handling of HDs, description of the circuit and quality indicators of the strategic procedure; 2nd)Carrying out a descriptive observational cross-sectional study to identify the HDs used. The list of active principles (AP) included “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” was compared with those included in the GFT of the center; 3rd)Releasing of recommendations through information sessions/ workshops for healthcare professionals.

What has been achieved?

An effective and safe employment system/circuit is established in the SWP, with relative preventive measures to control associated risks that may occur in handling and/or administration. 22 HDs were identified. A safer alternative was proposed for 9. Recommendations for the handling of HDs, associated risks and proper use of PPE were disseminated through 2 training sessions.

What next?

The identification of hazardous drugs and communication of improvement actions made it possible to implement a standard work procedure guaranteed safety in handling, and to provide an adequate means to avoid exposure due to healthcare workers.

INCOMPATIBILITIES OF PARENTERAL DRUGS IN INTENSIVE CARE – ANALYSIS AND OPTIMISATION OF ADMINISTRATION SCHEDULES OF CENTRAL VENOUS CATHETERS AND FREQUENTLY USED DRUG COMBINATIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Martina Jeske, Jasmin Stoll, Vanessa Funder, Sabine Bischinger

Why was it done?

Due to the limited number of ports, it is necessary to administer several drug solutions via the same access. Incompatibility reactions can occur and may lead to a reduction or loss of drug efficacy and severe damage to the patient’s health. The objective was to create standardized administration protocols for central venous catheters and verify parenterally administered drugs’ incompatibility reactions. A further purpose was to build multidisciplinary cooperation to improve the drug administration processes.

What was done?

To optimize the drug therapy at four intensive care units (ICUs) of the University Hospital, the pharmacy department, physicians, and care management, jointly implemented a quality assurance project. In multidisciplinary teams, we had to overcome various challenges in different wards to develop standards regarding administering drugs via multi-lumen catheters. We analyzed all frequently used drugs (n=72) for their compatibility and summarized findings in a crosstable.

How was it done?

The current situation was recorded using a questionnaire and collecting individual cases of protocols for central vein catheters. About 2000 drug-drug-combinations were analyzed using three databases, KiK 5.1, Micromedex, Stabilis 4.0, corresponding specialist information, and manufacturer data. Nevertheless, the compatibility check based on the databases is subject to some restrictions. In several cases, the databases give different or contradictory results, and compatibility data are rarely available for some combinations. The project revealed that although infusion therapy is standardized in intensive care units, there are fewer standards regarding administering drugs via multi-lumen catheters. There are significant differences between theory and practice in terms of handling infusion therapy.

What has been achieved?

Different hazardous practices got identified and eradicated. The incompatibility table allows a quick assessment. The advantages/disadvantages of varying software systems were broadly discussed. KiK 5.1 was implemented in the ICUs, Micromedex in the pharmacy department. The team agreed that existing uncertainties must be decided jointly. Different practices in different wards may pose a threat to patient safety. The results were presented in a clinic-wide interdisciplinary training.

What next?

The awareness towards the need for cooperation and hospital pharmacists’ competence concerning incompatibility reactions strongly increased, leading to more standardization in the infusion therapy and avoiding incompatible drug combinations. The aim is to initiate a continuous improvement process.

AN ITERATIVE APPROACH TO THE DEVELOPMENT OF PHARMACOLOGICAL MANAGEMENT GUIDELINES FOR THE TREATMENT OF PAEDIATRIC INFLAMMATORY MULTISYSTEM SYNDROME – TEMPORALLY ASSOCIATED WITH SARS-CoV-2

European Statement

Clinical Pharmacy Services

Author(s)

CAROL ANN JONES, NANNA CHRISTIANSEN

Why was it done?

Starting in mid-April 2020 as a result of the Coronavirus pandemic, a cluster of patients displaying multisystem inflammation and shock were admitted to our hospital. Similar cohorts have subsequently been reported internationally. Over a 6 week period, in which our institution cared for over 70 children with the newly described PIMS-TS, we developed new pharmacological treatment guidelines. Due to the novelty of the disease, treatment options were unclear and decisions were made by a multidisciplinary team (MDT) of clinicians and pharmacists.

What was done?

This good practice initiative describes the rapid and iterative development of a treatment pathway for the newly described Paediatric Inflammatory Multisystem Syndrome – Temporally associated with SARS-CoV-2 (PIMS-TS). Due to the similarity to Kawasaki disease and septic shock, the routine treatments for these conditions were considered as well as the experience of our adult colleagues, especially in terms of anticoagulation and hyper-inflammation seen in patients presenting with COVID-19. This ensured holistic management plans could be made to provide the highest quality of care.

How was it done?

A MDT of clinicians (intensivists, infectious diseases, cardiologists, rheumatologist, haematologists, endocrinologists) and pharmacists arranged daily meetings to discuss admitted patients as well as pulling together information to formulate a treatment guideline to enable the safe management of these patients. Version one of the treatment pathway was approved in April 2020, by beginning of June version 6 was published. The final treatment pathway included intravenous (IV) immunoglobulin, IV methylprednisolone, aspirin, venous thromboembolism (VTE) prophylaxis and immunomodulation therapy including tocilizumab, infliximab and anakinra.

What has been achieved?

A total of 74 patients have been successfully treated against the treatment pathway, and discharged from hospital. Managing a new condition with no published evidence on treatment was a huge challenge, especially given the large numbers and high acuity of patients. Collaborative learning and reflection has enabled us to develop a robust treatment pathway for our patients. We have witnessed MDT working at its best, united with the sole aim of combating this rare condition.

What next?

An ongoing coordinated effort is required to undertake paediatric research to understand PIMS-TS and establish the most effective treatment for this novel disease.

Possible interactions from COVID-19 drug employment: the Hospital Pharmacist’s intervention in a regional hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Simone Leoni, Sabrina Guglielmi, Vincenzo Nicola Menditto, Adriana Pompilio, Francesca Vagnoni

Why was it done?

During the pandemic, almost all hospital departments were converted in COVID-19 wards and clinicians of several specializations were asked to work in. In a situation characterized by a great number of patients, mainly old and with several comorbidities, health professionals had to employ quickly drugs never used before and supported by limited scientific evidences. In this context the percentage of possible DDI rises out of proportion exposing patients to potential devastating consequences.

What was done?

During COVID-19 emergency we develop a quick reference tool for clinicians involved in first line assistance to patients. A table summarizing drug-drug interactions (DDI) of the most used therapies was created to allow professionals making the best pharmacological decision.

How was it done?

After a literature review using Micromedex and TERAP (Mario Negri Institute), we have created two table summarizing DDI of lopinavir/ritonavir (LR) and hydroxychloroquine (HC). Those drugs have been grouped according to pharmacological group and clinical relevance. The tables were provided to Infectious Disease, Intensive Care Unit and Emergency Medicine departments.

What has been achieved?

The tables showed 359 DDI for LR (67% contraindicated/severe, 12% major and 21% moderate) and 176 for HC (96% contraindicated/severe, 1% major and 3% moderate). Almost all contraindicated/severe interactions of HC were the same of LR and regarded: protein kinase inhibitors, beta2 agonists, macrolides and fluoroquinolones antibiotics, some antidepressants, phenothiazines, protease inhibitors and antiarrhythmics. Other LR severe interaction were: factor Xa inhibitors, statins and benzodiazepine derivates. Both LR and HC present moderate interactions with acid pump inhibitors, while LP interacts with Ca and vitamin K antagonists and antiepileptics.
Interactions mentioned have a great impact, since they concern drugs commonly used and hypertension, diabetes, respiratory system disease, cardiovascular disease are the most frequent comorbidities linked to COVID-19. Tables provided had a positive impact in avoiding DDI. Pharmacist was consulted for drug dosing and frequency adjustments. The intervention was fully accepted and extended to the rest of COVID-19 wards.

What next?

The project represents a good example of multidisciplinary collaboration able to improve safety and efficacy in pharmacological treatments. The added value of the Pharmacist and the simplicity of the tool make it useful and easy to extend to other healthcare settings.

ISMP MEDICATION SAFETY SELF ASSESSMENT® FOR HIGH-ALERT MEDICATIONS – ASSESSMENT OF THE SAFETY OF SYSTEMS AND PRACTICES ASSOCIATED WITH SIX CATEGORIES OF HIGH-ALERT MEDICATIONS

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European Statement

Patient Safety and Quality Assurance

Author(s)

A. Sonnleitner-Heglmeier, M. Jeske, C. Petter, S. Grimm, S. Kerndler, U. Horvath

Why was it done?

The aim of this initiative was to assess, from December 14, 2018 to February 7, 2019, the practices associated with six high-risk drug classes – opioids, insulin, anticoagulants, methotrexate for non-oncological indications, muscle relaxants, chemotherapeutics – and high-risk drugs in general at the Unversity Hospital Innsbruck using the ISMP Medication Safety Self Assessment® for high-risk drugs. A further reason was to build up a strong and active cooperation amongst interdisciplinary teams with the focus on clinical pharmacy to raise awareness towards the competencies of clinical pharmacists.

What was done?

We translated, adjusted and introduced the Medication Safety Self Assessment® for High-Alert Medications from the Institute for Safe Medication Practice (ISMP) – U.S.A. to our university hospital. With a clinical pharmaceutical approach in multidisciplinary teams, we revealed challenges on different wards in the hospital and discussed and planed appropriate solutions.

How was it done?

The first step was to find an appropriate assessment accreditation programm which was found by the ISMP Medication Safety Self Assessment® for High-Alert Medications. This tool offers the opportunity to assess the safety of systems and practices associated with up to 11 categories of high-alert medications. As the assessment was written in english it had to be translated by us into german for a better basis for discussions. Further, as the ISMP assessment is implemented in the U.S.A., words and processes had to be adjusted to the work in an austrian university hospital. To optimize the outcome of the ISMP, the drug therapy pharmacy department, health care practitioners, and care management, jointly implemented a quality assurance project.

What has been achieved?

Different hazardous workflows and medication handling processes beginning from pharmacy despensing until receiving patients got identified and discussed. The urgent need of a patient data management system was emphasized to safely ensure a closed loop medication management. This would allow a clear and trackable communication in and between different wards and reduction in errors made by clincal staff.

What next?

The foundation was built for compulsory personal trainings done by clinical pharmacists on different wards. The awareness towards the importance of clinical pharmacy was strongly increased leading to more inclusion e.g. developing guidelines.

RESOURCES OPTIMISATION OF LOPINAVIR/RITONAVIR IN THE SANITARY EMERGENCY DUE TO SARS-CoV-2 IN A THIRD-LEVEL HOSPITAL IN THE ULTRA-PERIPHERY

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European Statement

Selection, Procurement and Distribution

Author(s)

Lierni Goitia Barrenetxea, Natalia Toledo Noda, Moisés Pérez León, Victoria Morales León

Why was it done?

Lopinavir/ritonavir is a HIV-1 and HIV-2 proteases inhibitor indicated for HIV. It was used in patients with a positive SARS-CoV-2 test after being recommended by the Chinese health authorities. The hospital protocol guideline was: 400/100mg every 12 hours orally. It was presented in both tablets and oral solution, which was reserved for patients intubated in the ICU and those who were not able to take tablets.

What was done?

Optimizing the use of lopinavir/ritonavir solution during the state of sanitary emergency.

How was it done?

Descriptive study of resources optimization for lopinavir/ritonavir and actions carried out to ensure the availability of the antiviral in intubated SARS-CoV-2 positive patients. Preparation and stability data were obtained from official sources (Spanish Agency for Medicines and Health Products) and from the Spanish Society of Hospital Pharmacy.

What has been achieved?

The Pharmacy Service designed a protocol to repackage lopinavir/ritonavir 80/20mg/mL solution in syringes containing the exact amount for a single dose (400/100mg in 5ml), for single use. The solution is formulated on an alcoholic basis and there is an interaction with the polyurethane nasogastric tube because the polyurethane absorbs alcohol causing the catheter to swell and deteriorate, which is why, other services were notified to use polyvinyl chloride catheters or silicone. Likewise, the syringes used to repackage the solution were exclusive for oral administration used in pediatrics, with the aim of reducing medication administration errors, since it is not possible to connect parenteral injection needles with them. These measures were intended to make the dispensing system as efficient as possible, as once the drug entered a unit with patients with a positive test, it was contaminated, therefore it could not be reused. Additionally, the fact that the hospital is located on an island made it even more difficult to acquire the medicine, given the supply problems nationwide, the great restriction of air and maritime traffic and loan limitations from other hospitals.

What next?

The measures adopted managed to ensure the availability of lopinavir/ritonavir solution in all admitted patients, optimizing the scarce availability of a solution medication whose presentation is formulated in multidose containers. By adding the use of syringes for exclusive oral use, administration errors were prevented.

Standard Operating Procedures for urgent chemotherapy mixture preparation by non-experienced staff

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European Statement

Production and Compounding

Author(s)

Ana Marín-Romero , Inés Monge-Escartín , Esther Carcelero-San Martín , Gisela Riu-Viladoms , Rubén González-García, Jaume Planas-López , Dolores Merino-Calderón , Rodolfo Juncos-Pereira , Carolina Lesta-Domene , Carmen López-Cabezas, Dolors Soy

Why was it done?

Cytostatics are hazardous drugs that must be prepared under safe and sterile conditions. In some life-threatening situations, there is an urgent need to initiate chemotherapy immediately. However, not all hospitals have experienced personnel in safe-handling cytotoxic drugs for 24 hours and 7 days per week.
The objective is to create a consensual protocol to be used when immediate start of chemotherapy is required, and preparation must be done out of working hours of specialized pharmacy staff. A secondary objective is to confirm that non-experienced staff can prepare cytostatics safely and to guarantee their quality by following this protocol.

What was done?

The oncohematology pharmacy team created a visual guide aimed to pharmacy personnel who do not routinely work with intravenous mixture preparations. This guide includes instructions about parenteral cytotoxic drug preparation for chemotherapy regimens that should be immediately initiated.

How was it done?

Urgent regimens were agreed with clinicians. They are: (i) fixed-dose intrapericardial cisplatin, (ii) intravenous carboplatin and etoposide, (iii) intravenous cisplatin and etoposide, (iv) intravenous cyclophoshamide and (v) fixed-dose intravenous daunorubicin. For schemes with different possible doses, fixed banding doses were agreed with clinicians.
A visual guide with images of all the material and preparation steps (including labelling, packaging and protection measures), for each scheme, was developed and attached to a prescription form to be completed by the physician and associated with a material kit that contained personal protective equipment, expendable material, cytostatic vials and serum bags.
The guide was distributed to pharmacy personnel external to preparation area, accompanied by a training session. Selected trained workers were supervised while preparing the mentioned cytostatic drugs in a simulated-base patient scenario.

What has been achieved?

All the cytostatic drugs were prepared correctly reaching a maximum preparation time of 45 minutes since physician’s prescription. The personnel involved maintained all the specified protection measures and reported feeling confident while cytostatic manipulation.
The guide proved to be useful to cover a possible urgent chemotherapy treatment outside the stipulated work schedule.

What next?

Re-training in safe-handling of cytotoxic drugs should be ongoing with regular updates to ensure a proper follow-up of this guide. This work methodology could be extrapolated to other pharmacy areas with similar needs.

RESHAPING OF CLINICAL PRACTICE AND REORGANISATION OF CHEMOTHERAPEUTIC PROTOCOLS DURING COVID-19 PANDEMIC: THE INITIATIVE OF THE NATIONAL INSTITUTE OF TUMORS

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European Statement

Clinical Pharmacy Services

Author(s)

Giuliana Lo Cricchio, Margherita Galassi, Ernesto Ruffino, Claudia Tirone, Vito Ladisa

Why was it done?

In accordance with regional provisions and national guidelines, the initiative has had the dual objective of reducing hospital access, and potential infections, and ensuring therapeutic continuity for cancer patients.

What was done?

Some therapy protocols have been modified for the treatment of blood, gastrointestinal, lung, breast, head and neck tumors, in order to obtain equally effective patterns but with longer intervals between doses.

How was it done?

Patients have been stratified on the basis of the neoplasia location and biology, the general conditions and the treatments characteristics and they have been shifted to modified treatment regimes, even outside the indications temporarily authorized by regional decision: Nivolumab from 240 mg Q2W to 480 mg Q4W for Hodgkin lymphoma, non-small-cell lung-cancer, squamous cell carcinoma of the head and neck; from weekly Paclitaxel to Docetaxel Q3W for breast cancer; Pembrolizumab from 200 mg Q3W to 400 mg Q6W for lung cancer and melanoma; remodulation of protocols including fluoropyridines and platinum coordination compounds for gastroenteric tumors.

What has been achieved?

The schedule modification allowed a reshaping of agendas to reduce the frequency of day-hospital access and the risk of infection with Sars-Cov-2 for patients, carers and health professionals, in addition to reducing the costs of outpatient services. Treatment interruption rate, with possible consequent progression of disease, as reported by early Chinese data in the literature, has been reduced.

What next?

The extraordinary health emergency changed the clinical practice and aroused interest especially in oncology, where the evaluation of the relationship between benefits and risks associated with therapies has required greater attention because they are life-saving therapies that cause immunosuppression in patients for which the adverse course of viral infection is more frequent than that of the non-neoplastic population.
The possibility of using the modified therapy schemes has been limited only to the emergency period and has not yet resulted in an extension of the indications. The achievement of the therapeutic objective, together with the feedback that the new dosages have not led to a significant increase in adverse events compared to normal clinical practice, encourage us to hope that the indications can be extended in Italy, as has already happened in Canada and USA for the Nivolumab.

DETECTION OF PHARMACOKINETIC/PHARMACODYNAMIC DRUG INTERACTIONS OR PATHOPHYSIOLOGICAL CONTRAINDICATIONS WITH INJECTABLE CHEMOTHERAPIES: IMPLEMENTATION OF THE SOFTWARE PHARMACLASS® IN ONCOLOGY

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European Statement

Clinical Pharmacy Services

Author(s)

Pauline Barreau, Joséphine Courouble, Pierre Pilven, David Vandecapelle, Thibault Stala, Geoffrey Strobbe, Guillaume Marliot, Frédéric Feutry

Why was it done?

Two prescription assistance software are using in the hospital: DXCare®, for global drug management, and Chimio®, specific to the prescription and preparation of injectable chemotherapies. Clinical pharmacists (DXCare®) and pharmacists in charge of preparation (Chimio®) carry out the pharmaceutical analysis independently and they may not detect potential pharmacokinetics/pharmacodynamics drugs interactions or pathophysiological contraindications, slowing down the pharmaceutical analysis. Pharmaclass® can improve that by crossing all data flows between DXCare® and Chimio® and alerting the pharmacist. The objective were to select and code priority alerts and evaluate the detectability of drugs interactions and pathophysiological contraindications by the software Pharmaclass®.

What was done?

Pharmaclass® is a software based on rules created by the pharmacist, from pharmaceutical algorithms. This rules engine crosses in real time all data flows of several software and sends alerts that must be analyzed by a pharmacist. It was applied in oncology for injectable chemotherapies.

How was it done?

An interface was set up between DXCare®/Chimio® and Pharmaclass® to allow the creation of requests. An analysis of drug consumptions and drugs at risk of interactions helped to select seven molecules (Methotrexate, Bevacizumab, Fluorouracil, Ifosfamide, Irinotecan, Cisplatin, Pemetrexed). A study of the summaries of the product characteristics and the drug interaction thesaurus and a bibliography was conducted and the rules were coded. These were checked by creating test patients with false prescriptions.

What has been achieved?

Eleven rules were created and, after some tests and coding readjustments, all was detected. Nine rules are about drugs interactions: three contraindications (Methotrexate/Trimethoprim, Methotrexate/Acetylsalicylic acid, Bevacizumab/Naloxegol), three associations not recommended (Methotrexate/Amoxicillin, Methotrexate/Ciprofloxacin, Fluorouracil/Antivitamin K), one precaution of use (Ifosfamide/Aprepitant) and two other rules concern enzymatic induction and inhibition of the metabolism of Irinotecan. The last two rules link the glomerular filtration rate with Cisplatin and Pemetrexed.

What next?

Following these creations, Pharmaclass® has allowed to detect drug interactions and pathophysiological contraindications that were not previously detectable. Thereafter, objective will be to establish an organization for the management of alerts and evaluate the number and the relevance of these alerts. New rules will be created for all injectable chemotherapies used in the hospital. Other center of Unicancer will be able to use these rules.

HOW TO SECURE THE COLD CHAIN MANAGEMENT OF TEMPERATURE-SENSITIVE PRODUCTS IN THE HOSPITAL AND WHAT IS THE ECONOMIC IMPACT?

European Statement

Patient Safety and Quality Assurance

Author(s)

Cyril Magnan, Elise Betmont, Guillaume Saint Lorant, Hubert Benoist

Why was it done?

Evaluate the economic impact of improvement actions taken since 2017 on TSPs management.

What was done?

Cold chain is a major issue in the pharmaceutical industry as a growing number of its products are temperature-sensitive and also in hospitals. In 2017, 27 cold chain breaks were declared by care units (CU) within a French teaching hospital, resulting in a risk for patient care and a potential loss of 40,363 euros, of which 18,505 euros (45%) could be avoided. Following this first study, a set of measures have been implemented in our establishment in order to secure the cold chain.

How was it done?

Potential losses and avoided losses of TSPs have been analyzed continuously since 2017 according to the same methods in a teaching hospital with 1,600 beds. In case of a thermal excursion (ET), the pharmacy is, according to the institutional procedure, immediately warned by an electronic alarm day and night or by a call from the care service, making it possible to define the action required from the service concerning the methods of keeping TSPs.

What has been achieved?

Since 2017, a mobile isothermal enclosure has been implemented for the transport of TSPs during the day in the CU. Connected temperature-monitoring sensors have been installed on so-called “at-risk” refrigerators. The alarm reports to the pharmacy was instituted in order to intervene as quickly as possible. Part of the refrigerators has been renewed and awareness has been raised among all CUs for the good traceability of temperature readings, allowing a drop from 24% in 2018 to 65% of compliant traceability in 2019. Following these improvement actions, 53 ETs with a potential loss of 53,769 euros were declared in 2019, of which 39,753 euros of losses could be avoided. Currently, 74% of ET losses can be avoided compared to 43% in 2017.

What next?

This economic assessment of the potential losses and the avoided losses of PTs shows the positive impact of the various improvement measures taken since 2017 as well as education of the UDS to secure TSPs. A regional awareness was implemented thanks to a collaboration with the regional health agency in order to promote TSPs management in the hospitals.

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