Author(s)

Helen Cooper, Sheatha Abumehdi

Why was it done?

A lack of licensed formulations for children means that use of unlicensed and off-label medicines is often the only appropriate alternative [1]. Local prescribing data demonstrates wide variability in concentrations of unlicensed specials supplied, at significant cost. This project aims to standardise medicines prescribing for children, improve patient safety by reducing inadvertent dose misadministration due to varying concentrations, reduce spend, and improve the effectiveness of working relationships between hospital and community healthcare teams.

What was done?

Prescribing and procurement data were used to analyse, review and harmonise paediatric prescribing practices in a UK clinical commissioning group, with focus on rationalising use of unlicensed specials.

How was it done?

A target list of ten medicines was identified, based on variability of strengths and formulations available, and cost. A team of two dedicated specialist paediatric hospital pharmacists was funded to set out strategies to standardise prescribing of those target medicines, and to improve understanding of prescribing and supply of unlicensed medicines to children. Various methods were used, including; email communications advertising the roles and support offered; establishing a Paediatric Formulary Group; promoting the local Paediatric Formulary; creating paediatric prescribing pathways; reviewing specials prescribing and supporting switches to alternative formulations; and delivering a paediatric prescribing webinar.

What has been achieved?

Reviews of specials prescribing were initially undertaken in two of the six boroughs in the region. 138 switches to a preferred formulation for safety and/or cost-effectiveness were identified and discussed between July-October 2021. Risks associated with prescribing multiple concentrations of liquid medicines were identified and measures were put in place to prevent patient harm. The webinar was well attended, and although it cannot be quantified, awareness of the Paediatric Formulary has improved. The project is on-going and at this time the impact on spend cannot be shown but will be reported later this year.

What next?

The specific knowledge and skills of specialist paediatric hospital pharmacists are highly valuable in driving specials medicines rationalisation for children in the community. Future plans for expanding the project include extending the service to other boroughs in the region and widening the target list of medicines.

References: 1.Rawlence E et al. Is the provision of paediatric oral liquid unlicensed medicines safe? Arch Dis Child Educ Pract Ed. 2018;103(6):310-3. 2.Neonatal and Paediatric Pharmacists Group. Position Statement 18-01 Using Standardised Strengths of Unlicensed Liquid Medicines in Children. Version 5, April 2020.

Author(s)

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

Why was it done?

Biosimilar medicines have demonstrated their bioequivalence with the original biologic and there is ample scientific evidence to support this.
Our Hospital had a degree of implementation of biosimilars of 8,16% (the lowest in its autonomous community), so it was decided to develop an intervention plan to increase the use of biosimilars and improve this indicator.

What was done?

Develop a plan to increase the use of biosimilar medicines in a tertiary hospital.

How was it done?

It was decided to intervene on these drugs that had commercialized biosimilar drugs: etanercept, adalimumab, trastuzumab, bevacizumab, enoxaparin, epoetin. For the introduction of biosimilars of etanercept and adalimumab, the medical records of all patients with these prescriptions were reviewed and all those that were prescribed by active ingredient and not by brand-name drug, were changed to a biosimilar medication after consensus with the patients. For the new prescriptions of these drugs and of enoxaparin, trastuzumab, and bevacizumab, a document was prepared supported by the medical direction of our Hospital that would start with biosimilar molecules. Regarding epoetin, in our hospital we had epoetin beta that does not have a biosimilar, so it was decided, agreeing with oncology and hematology and based on the evidence, to change the molecule to epoetin alfa with its biosimilar medicine.
The degree of introduction of biosimilars was measured with the formula: nº Definid daily dose of biosimilar drugs dispensed/nº Definid daily dose of biosimilar drugs dispensed+Definid daily dose of the original biologic *100.

What has been achieved?

Before the implementation of the protocol for the introduction of biosimilars, the degree of introduction was 8,16%, 3 months after implementation the result had reached 21,10% and at 6 months it was 30%. This represents an economic impact of 286.295,53 € per year in savings.

What next?

The implementation of protocols agreed with the prescribers for the introduction of biosimilars should be a common practice of the hospital pharmacists to contribute to the sustainability of the health system.

Author(s)

Susana Redondo-Capafons, Laura Soriano, Irene López-Rico, Jorge Del Estal, Rocío Cebrián, Marcela Manriquez, Maria Reventós, Sandra Fernández-Molina, Mònica Gómez-Valent

Why was it done?

Before CTSS was performed, TSS were requested to Pharmacy Department for evaluation and decision. Because of complexity of these treatments, it was decided that it was necessary to evaluate them with other professionals to make a consensual decision.
In May 2019, CTSS was born. It is a multidisciplinary committee with 10 different health professionals: head of pharmacy, head of healthcare management, head of strategy and operations management, a clinical pharmacologist, five pharmacists and a secretary. Requesting doctors and heads of involved services are invited to explain TSS in the meeting.

What was done?

Committee (C) of Treatments in Special Situations (TSS) (CTSS) have been established. Requests are received by a specific email for the committee and a standard template was performed to be completed by requesting doctor (patient clinical information and evidence supporting request) and by Pharmacy Service (regulatory status of the drug, pharmacology and cost of treatment).

How was it done?

Some limitations as lack of human resources with exclusive dedication for making reports and lack of training in evaluation of this kind of treatments are the most important obstacles. Currently, each member is self-taught and under excessive work- pressure.

What has been achieved?

From May 2019 to August 2021, 273 treatments in 59 meetings sessions (average 4.63 evaluations/meeting) were evaluated.
The 91,6% of treatments were approved. In 95,9% of requests, one drug was evaluated.
There were 18 services involved, being oncology and hematology the most active departments.
Evaluated TSS were classified in six categories: 66,7% of requests were drugs without approved indication, 19,8% drugs approved indication pending price by government, 2,5% approved indication but denied funding by government, 1,8% foreign medicines, 4% compassionate use and 5.2% others according to criteria of each autonomous communities in Spain.

What next?

CTSS allows make a consensual decision between different professionals and establishes a flow to manage TSS requests. This multidisciplinary scenario generates knowledge and evidence in the use of these kind drugs reducing uncertainty in TSS use in relation to its efficacy and safety and, in cases of high budgetary impact-drugs, to minimize inequities of access by standardizing decision-making. Applicable to all hospitals.

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.

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

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.

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.

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.

Pdf

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.

Pdf

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.