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Preparing for disaster – ensuring and optimizing the supply of medicines to a regional acute Hospital in the event of a major accident

European Statement

Patient Safety and Quality Assurance

Author(s)

Fabrizia Negrini, Giorgia Vella

Why was it done?

The aims of this project were firstly to optimize the content of the stock (choice of medicines and quantity) so that it is suitable for various potential events of different nature that may occur in the region. The second aim was to optimize the management processes in order to reduce costs.

What was done?

To manage extraordinary events (short-lasting phenomenon without contamination) in a region with 1.5 million inhabitants, the hospital pharmacy, in collaboration with a major acute Hospital, manages a designated stock containing medication that may be required during unplanned emergencies.

How was it done?

To achieve these two aims, the first step was to define which major events are possible and most likely to occur in the region. To do this we utilized a risk-based analysis of all disasters and emergencies relevant in the area that was performed by an external company that specializes in developing risk management projects in the context of civil protection1. Based on the identified events, we determined which types of injuries were more likely to occur. The medicine stock was subsequently updated and a process for minimizing the management cost was defined.

What has been achieved?

The hazards that were identified as being of particular importance for the analyzed region are likely to mainly result in blunt, perforating, and burn injuries. In collaboration with the Hospital, a list of 61 different medicines used to treat these types of injuries was established. In order to reduce costs, only drugs which were part of the main stock of the pharmacy were chosen. In this way, it is possible to exchange products with a longer shelf life from the main stock 6 months before expiring and use them without having to discard them.

What next?

In case of extraordinary events in a restricted region, the major acute hospital has an increased need for certain medicines. It is task of the hospital pharmacy to always be ready to supply them with such medicines. This is only possible if the probable emergency scenarios are well understood, and the stock and management processes are well-defined and communicated at all levels.

THE ROLE OF DNA SEQUENCING AND MOLECULAR TUMOR BOARD COUNSELING IN THE SELECTION OF THE MOST APPROPRIATED THERAPY IN ONCOLOGY

European Statement

Clinical Pharmacy Services

Author(s)

Marta Anghilieri, Vito Ladisa, Andrea Vingiani, Giancarlo Pruneri

Why was it done?

The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow parallel sequencing of many samples producing a big amount of data. To give a comprehensive analysis of the data in order to develop new specific and clinically useful therapies, we have introduced the approach to evaluate the data by the MTB, where pharmacists are included as experts of drugs and their preparation and application.

What was done?

The integration of pharmacists into the first Molecular Tumor Board (MTB), a multidisciplinary group, to select the most suitable therapy for oncological patients.

How was it done?

For every patient pharmacists, together with the members of MTB, study the results of NGS to identify known and unknown alterations utilizing a database available to all MTB members. These mutations represent the basic tool to select potential target therapies. The MTB meets weekly to discuss and integrate the alterations observed with the patient clinical history. At the end this approach allows to select the most suitable target therapy.

What has been achieved?

In this study 208 patients affected by No Small Cell Lung Cancer (NSCLC) were evaluated. The tumor has an elevated mortality, even if many target drug available or in development, therefore a correct treatment approach is essential to improve the clinical outcome. The NSG identified 117 altered genes. After an extensive literature search, 15 genes were identified as potential target of drugs available. They marked 116 patients potentially tractable with target therapy: 47 patients were candidate to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, in the candidates to drugs in clinical practice the treatment was started in 65% of cases and in 53% was continued, while in the other group the treatment was started in 23% of cases and in 69% continued.

What next?

• The MTB offers a valid support in the clinical practice
• It individuates a target therapy for a greater number of patients
• The selected therapy has a bigger chance to last longer
• The inclusion of Pharmacist in MTB allow a more aware use and a better selection of drugs

PLAN FOR IMPROVING THERAPEUTIC EQUIVALENCE IN A HOSPITAL GPI

European Statement

Clinical Pharmacy Services

Author(s)

LUCIA JIMENEZ-PICHARDO, INMACULADA LOMARES-MANZANO, LEONOR GOMEZ-SAYAGO

Why was it done?

Hospital with 118 beds in which all medication prescribed by the doctor that was not included in the pharmacotherapeutic guide was purchased through an external pharmacy. The proposed objective was to elaborate an improvement plan in therapeutic equivalence, with the development of a TEG

What was done?

Therapeutic Exchange Guidelines (TEG) are an intervention on the prescription according to a previously agreed protoco, in which the prescribed drug is subtituted for the one available in the hospital (because it is considered equivalent or because it is a better therapeutic option).
In this way, the most appropriate drug included in the Pharmacotherapeutic Guide (PG) of the hospital would be selected.

How was it done?

A work schedule was established distinguishing five phases: a) Elaboration Phase, which consists of consulting and review of the medical specialties included in the hospital, b) Presentation / approval phase by the Pharmacy Commission, c) Modifications Phase, d) Disclosure Phase, through a clinical session to the hospital’s internists and other hospital medicians and e) Implementation Phase. For its preparation, a manual was consulted for the writing of TEG, guides from other reference hospitals and different bibliography obtained from Pubmed, as well as the technical data sheet of each drug.

What has been achieved?

The TEG is prepared over a period of 3 months and was structured with the following sections:
Therapeutic group according to the ATC classification of drugs (351), Reference drug included in the PG (443 drugs), Medicines not included
(620) y Recommended therapeutic attitude: substitute the one available at the hospital (469) (specifying dose and regimen), continue (82) or suspend treatment (69).
Subsequently, it was presented to the Pharmacy Commission, the appropriate modifications were made and the final version was released through a clinical session before its publication through the hospital’s intranet.

What next?

The therapeutic equivalence improvement plans are considered efficient management strategies, applicable in all hospitals and health centers. It is a multidisciplinary and continuous process that will require periodic reviews.

Structured implementation to secure rapid and efficient changes of medicines: a national workflow

European Statement

Introductory Statements and Governance

Author(s)

Mikala Vasehus Holck, Jette Østergaard Rathe

Why was it done?

The role of the National Medicines Council (NMC) is to provide guidance about new medicines for use in the public hospital sector.

Recommendations from the NMC must be implemented at hospitals. Implementation of changes of medicines requires preparation and collaboration and involves numerous stakeholders, e.g. drug and therapeutic committees, hospital pharmacies, clinicians, and the national supply organization (NSO) to public hospitals. Knowledge sharing is crucial to ensure efficient implementation.

We needed a workflow focusing on knowledge sharing at national level, and thus we introduced the structured implementation workflow in September 2019.

What was done?

We have established a structured implementation workflow focusing on knowledge sharing. The workflow ensures rapid and efficient implementation of changes of medicines, and a more aligned treatment at national level.

How was it done?

To ensure knowledge sharing through the workflow, we developed:

– Implementation memo: Summarizes NMC recommendations and treatment guidelines, with information about current and upcoming tendering procedures and prices. The memo is shared with the stakeholders.

– Implementation group: The group is a mix of people with a direct connection to the implementation workflow. The group ensures that implementation of the recommendations from the NMC is regularly discussed and assessed.

– Implementation site: An intranet for the NSO and hospital pharmacies to share information and material related to the implementation of changes of medicines.

– A system to ensure that essential stakeholders receive the same information.

What has been achieved?

The structured implementation workflow has been a success and is now an integrated part of implementation. Evaluation shows that the workflow with knowledge sharing between relevant stakeholders is essential for effective implementation of changes of medicines, and it identifies discrepancies at national level.

What next?

The structured workflow is an integral part of managing the national implementation, and the workflow and outcomes will continue to undergo evaluation.

The workflow provides the basis for knowledge sharing and can easily be transferred to other healthcare settings.

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.

DEVELOPMENT OF AN IT TOOL TO ESTIMATE THE THERAPEUTIC NEEDS OFHOSPITALISED PATIENTS WITH COVID19 INFECTION BASED ON SIR EPIDEMIOLOGICALMODEL

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European Statement

Selection, Procurement and Distribution

Author(s)

Daniele Leonardi Vinci, Adriano Meccio , Alessio Provenzani, Piera Polidori

Why was it done?

The COVID 19 pandemic unprecedently challenged National Health Services to assure adequate patient care, despite a constantly escalating drugs demand. This complex situation requires appropriate planning to avoid misleading estimations, which would have consequences on patients and overall resources available.

What was done?

We created a tool to perform a timely estimation of the drug needs to treat the COVID-patients based on epidemiological forecasting.

How was it done?

The tool’s epidemiological forecasting was based on a compartmental model in which the population is divided into three compartments (Susceptible-Infectious-Removed, SIR), and transmission parameters are specified to define the rate at which persons move between stages. The appropriate data entry was guaranteed by the creation of a form in which users can enter information regarding: The population considered, the R0 calculation, the number of already known infected cases, the application of Non-Pharmaceutical Interventions and the number of hospital beds. The drugs need for the forecasted patients was calculated according to a list of critical care drugs compiled consulting previous published scientific works, national and international guidelines. The list includes 51 drugs belonging to different therapeutic group, such as: antiarrhythmics, antibiotics, antipyretics, antivirals, heparins, IV-fluids, local anesthetics, neuromuscular blockade agents, sedative agents and vasopressors. For each drug it was estimated the percentage average ICU uptake for therapeutic group and active principle.

What has been achieved?

A tool consisting of an excel template, that, based on the information inserted, automatically calculate the number of patients classified by the intensity of care (hospitalized not-ICU, Hospitalized ICU, ventilated, intubated or with shock) and creates a table that includes, for each drug to be used, the following information: therapeutic group, active principle, dosage considered, pharmaceutical form, total dosage for patients considered and total quantity of unit doses for patients considered. The tool is also made adaptable to different clinical situations, through the possibility of editing the assumptions adopted regarding the epidemiological and therapeutical parameters or the inclusion of new items in the drugs list.

What next?

Our tool represents an opportunity for the immediate and efficient estimation of the drugs necessary to assist the COVID19 patients during emergency scenarios. It will be periodically updated as new evidences will be available.

PHARMACOGENETICS IS GROWING FAST

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European Statement

Clinical Pharmacy Services

Author(s)

Xando Díaz-Villamarín, Ana Pozo-Agundo, Paloma García-Navas, Celia Castaño-Amores, Alba Antunez-Rodriguez, Cristina Lucía Dávila-Fajardo

Why was it done?

Pharmacogenetics (PGx) has the potential to predict patient´s drug response. Many genetic polymorphisms have been associated with variable drug response. This has been demonstrated with the highest level of evidence in fact many of them have been included in clinical dosing guidelines such as those from the Dutch Pharmacogenomics Working Group (DPWG) and Clinical Pharmacogenetics Implementation Consortium (CPIC). Actually, many drug labels include the recommendation about genotyping specific single nucleotide polymorphisms (SNP) prior to drug prescription.

What was done?

We have implemented pharmacogenetic tests in our hospital for a total of nine drugs.

How was it done?

Our hospital provides a PGx test service according to the following workflow. Physicians order the PGx test to the Pharmacy Unit, we take a saliva sample with sterile-cotton tipped swabs and send them to the Genomic Unit at Genyo. There, we extract the DNA and genotype the variants of interest. Genetic results are reported back to the Pharmacy Unit within 48-72 hours. After genotype-phenotype-recommendation translation according to the CPIC and DPWG dosing guidelines, we upload the dosing recommendation as a PGx report to the electronic patient´s medical history.

What has been achieved?

Since 2012, 2414 patients have benefited from our PGx test service for at least one drug-gene interaction. These tests have been requested by seven hospital departments with regard to a total of nine different drugs. We have reported 932 PGx dosing recommendations: Clopidogrel with 2013 genotyped patients and 845 dosing recommendations; Azathioprine with 208 and 21; Capecitabine: 48 and 1; 5-FU: 5 patients without recommendations; Tamoxifen: 117 and 48; Trastuzumab: 34 and 15; Irinotecan: 4 and 2; Simvastatin/Atorvastatin: 2 genotyped patients and no recommendations.

What next?

Since the first PGx test in 2012, we have been able to implement PGx tests in daily clinical routine in our hospital affecting 9 drugs. 2414 patients have benefited from this service and we are working on the implementation of new polymorphisms affecting drug response to expand our services.

Impact of an Integrated Medicines Optimisation Pharmacist (IMOP) on Biosimilar Uptake in the Mater Misericordiae University Hospital

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European Statement

Clinical Pharmacy Services

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.

BIOSIMILARS: LET’S START RUNNING (submitted in 2019)

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European Statement

Clinical Pharmacy Services

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.

IMPROVING ANTIBIOTIC STEWARDSHIP AT A HOME HOSPITAL UNIT BY IMPLEMENTING THE PRODUCTION OF ELASTOMERIC PUMPS CONTAINING BENZYLPENICILLIN (submitted in 2019)

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European Statement

Production and Compounding

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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Problems caused by shortages are serious, threaten patient care and require urgent action.

Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

Our aim is to investigate the causes of medicine and medical device shortages in the hospital setting,  while also gathering effective solutions and best practices implemented at local, regional, and national levels.

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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.