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DADA app: automated antibiotic de-escalation. usefulness and results

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European Statement

Clinical Pharmacy Services

Author(s)

Sergio Portillo-Haro, Aída Rueda-Naharro, María Martínez-Pérez, Manuela Martínez-Camacho, David García-Marco

Why was it done?

Currently, multi-resistant microorganisms are a huge global problem of Public Health. In addition, this problem will be bigger in the next decades. The main strategy to face this threat is improve the use of antibiotics. DADA was born with this purpose. The app lets the Pharmacy Department manage a sizable number of inpatients using the time to analyse the results obtained by DADA. In other words, we have improved the efficiency in our use of time.
How was it done?
The app was developed in July 2022, and since then it has been updated multiple times to adapt it to our needs and expectations and the changes in clinical guidelines. Every Monday and Thursday, the app is started up. The results are analysed carefully by a pharmacist and afterwards the conclusions are transmitted to an Infectious Diseases Medician, who decides if modify the treatment.

What was done?

In July 2022, Pharmacy Department designed an app easy to use and comfortable in order to detect active antibiotic treatments that might be de-escalated. This app, DADA (Automated Antibiotic De-escalation) is fed with data of antibiotic treatments and microbiological cultures. DADA reads and understands every gap of information, and finally search results between the active treatments comparing it with theorical de-escalation sequencies, designed by Infectious Diseases Commission in our hospital and based in local epidemiological guidelines. In this way, DADA works with automatic decision algorithms. In addition, DADA also provides alerts of active treatments for resistant microorganisms to that antibiotic.

How was it done?

The app was developed in July 2022, and since then it has been updated multiple times to adapt it to our needs and expectations and the changes in clinical guidelines. Every Monday and Thursday, the app is started up. The results are analyzed carefully by a pharmacist and afterwards the conclusions are transmited to an Infectious Diseases Medician, who decides if modify the treatment.

What has been achieved?

Since August 2022 to March 2023, using DADA, the Pharmacy Department has made 25 proposals of antibiotic de-escalation, and 11 proposals were accepted (44.0%) by Medicians. In addition, the Department made two proposals of change for resistance to that antibiotic, both accepted by Medicians. This app has improved efficiency of time in the clinical team.

What next?

The main outcome is to improve the confidence of Medicians in this tool, in order to increase the percentage of acceptance in the proposals. Furthermore, the app can be more complete and interprets data, such as analytics parameters. In the future, other hospitals might use this tool to analyse their patients or in outpatients treatments.

A National implementation group – aligned and efficient changes of medicine and treatments nationally across hospitals

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European Statement

Introductory Statements and Governance

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.

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.

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.

BIG ECONOMIC GAIN IN IMPLEMENTING NATIONAL TREATMENT GUIDELINES FOR WET AGE-RELATED MACULAR DEGENERATION, DIABETIC MACULAR OEDEMA AND RETINAL VEIN OCCLUSION

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European Statement

Selection, Procurement and Distribution

Why was it done?

The consumption of medicine for the treatment of wAMD, DME and RVO is increasing. The medicines used are in the top five of the most expensive drugs in Denmark. With the prospect of more patients, greater costs and the introduction of new drugs in the field, there was a need to develop a national treatment guideline.

What was done?

An expert committee prepared a national treatment guideline including a clinical medicine comparison report for the treatment of wet age-related macular degeneration (wAMD), diabetic macular oedema (DME) and retinal vein occlusion (RVO). The aim was to create uniform treatment across the country and to trigger competition between medicines in the hope of achieving lower prices.

How was it done?

An expert committee consisting of physicians, clinical pharmacist, clinical pharmacologist and medicine procurement pharmacist was appointed. The committee prepared a national treatment guideline including a clinical medicine comparison report based on existing clinical evidence and Danish practice. The committee reached the conclusion that the anti-vascular endothelial growth factor (VEGF) drugs ranibizumab and aflibercept are ranked equally in terms of effect and side effects. The choice of anti-VEGF should be determined solely by price and dosage. A tender was prepared in alignment with the guidelines. This result led to the development of a medicine recommendation, which was passed onto hospital pharmacies, clinical pharmacists and physicians to ensure implementation in the clinic. Feedback from the clinics concerning estimated consumption was forwarded to the drug suppliers and was continuously monitored by the procurement pharmacist to ensure compliance at the clinics.

What has been achieved?

The clinicians switched patients to the new first-line choice. The market share of first-line treatment was 89% compared to 25% before the guideline. Two tenders were published based on the guideline. The first resulted in a price reduction of 28%, the second a reduction of 54%. Total actual savings in the first tender (based on a 31-month contract period) was €38m. In the second tender (based on the first 12 months of the contract period) was €35m.

What next?

New medicines are expected to be approved in the near future. We will continue to use and develop national treatment guidelines in combination with tender procedures and proper implementation of guidelines to obtain better and cheaper treatment options for patients.

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