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IMPLEMENTATION OF AN ADVANCE PREPARATION OF MEDICINES MODEL IN A CYTOTOXIC PREPARATION UNIT

European Statement

Production and Compounding

Author(s)

Grangeia R, Pereirinha P, Rodrigues R, Salvador R, Marques M, Queirós M, Moreia A, Cunha E, Lebre AC.

Why was it done?

The increase in cancer incidence, combined with new and more innovative oncology treatments, leads to the necessity to increase the compounding capacity of oncology medicines. This consequently has a negative impact on the workload of oncology pharmacists. About 80% of these medicines are to be administered during the morning or early afternoon, affecting the response time due to the large workload and lack of production capacity in short periods.
The ready-to-use model allows to:
1. Reduce the morning workload and distribute tasks equitably throughout the day, since fixed doses are prepared in the afternoon or at the weekend;
2. Medication is readily available for administration;
3. Reduce medication-related errors.

What was done?

A ready-to-use model was implemented for those medicines whose dose is fixed, as part of a strategy to optimize the unit’s human resources.

How was it done?

This model is based on three foundations:
• Standard aseptic handling plus the use of closed system transfer devices (CSTD);
• Microbiological control upon batch release;
• Robust bibliography that supports the physical-chemical stability used as a reference for expiration dates.

It was implemented in two phases:
1- Preparation of a test batch of fixed-doses, with elaboration of the specific protocols, compounding procedures and labels;
2- Full implementation of the model, with implementation of a digital circuit.

The first medicines included were: daratumumab, nivolumab, pembrolizumab and pertuzumab.

What has been achieved?

The ready-to-use model was evaluated at three levels:
1. Financial impact: positive balance. Medicine vials are saved since compounding is done at the same time. The ratio between the investment required to acquire CSTD and the saved is 1:4,5;
2. Preparation time: Similar to normal compounding;
3. Annual effectiveness rate – 54%: This is the percentage of fixed doses that were prepared in advance.

What next?

The model proved to be effective in improving human resources management. With the effectiveness rate obtained, 4% of the total medicines that are administered are previously prepared. This value could reach 8% when the model is fully implemented.
It can be replicated in a dose-banding system12. Selecting, for example, rituximab, 5-FU and azacitidine, 25% of the daily preparations depends only on the time profitability of the cytotoxic preparation unit.

PUBLICATION OF THE FIRST TEXTS IN THE EUROPEAN PAEDIATRIC FORMULARY (submitted in 2019)

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European Statement

Production and Compounding

Author(s)

Jane Francomb, Dirk Leutner

Why was it done?

Formularies for extemporaneous formulations of paediatric medicines of appropriate quality are currently available in some regions or countries, but no pan-European equivalent exists. Some formulations in use are not appropriate due to a lack of knowledge of best practices. The idea behind the new formulary is to collect, review and then select the most appropriate formulations currently used in Europe which meet today’s requirements.

What was done?

The European Paediatric Formulary was launched at the end of 2019. It is a freely available online publication for pharmacists and clinicians that is intended to provide guidance on the use and preparation of standardised paediatric medicines of an appropriate quality when a suitable licensed medicinal product is not available. The first two monographs and two explanatory texts of the European Paediatric Formulary have now been published by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

How was it done?

Criteria for selection and evaluation of formulations were developed by 2015. Since then the current work is carried out by the European Paediatric Formulary Working Party under the supervision of the European Pharmacopoeia Commission and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The EDQM provides the scientific secretariat. Monographs for development were prioritised based on patient need. Many formulations currently described in national formularies and other well-established formulations have been gathered from stakeholders throughout Europe. The information available for the most appropriate formulation was transferred into a common format with full quantitative composition details, extemporaneous preparation instructions, validated test methods for quality control and storage conditions.

What has been achieved?

Monographs for hydrochlorothiazide 0.5mg/mL oral solution and sotalol hydrochloride 20mg/mL oral solution were published at the end of 2019. These were accompanied by an introduction and general principles which describe the purpose and content of the European Paediatric Formulary.

What next?

Monographs for Azathioprine oral suspension, Chloral hydrate oral solution, Furosemide oral solution, Isoniazid oral solution, Omeprazole oral suspension and Ranitidine oral solution and a monograph on an oral vehicle are currently under development. Further prioritised items will subsequently be added. Draft monographs for public consultation and final texts will be made available on https://paedform.edqm.eu.

DIAZOXIDE 10MG/ML ORAL SUSPENSION AS A COST-EFFECTIVE ALTERNATIVE TO THE COMMERCIAL PREPARATION (submitted in 2019)

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European Statement

Production and Compounding

Author(s)

Beatriz Sánchez Sanz, Iván González Barrios, Siria Pablos Bravo, Sara Ortiz Pérez, Cristian Rosas Espinoza, María Arrieta Loitegui, Francisco Martínez de La Torre, Dolores Canales Sigero, José Miguel Ferrari Piquero

Why was it done?

The objective is the elaboration of a formulation as a cost-effective alternative to the diazoxide oral suspension not commercialised in Spain, to treat patients with hyperinsulinaemic hypoglycaemia.

What was done?

Diazoxide is the first line therapy in infants with hypoglycaemia due to hyperinsulinism. A formulation to facilitate the dosage in newborns has been developed due to the increasing demand at our Hospital.

How was it done?

To evaluate the solubility, a research on Pubmed was executed including terms such as “diazoxide AND solubility” and “tiazides AND solubility”. To determine the stability, the agreement approved by the “Pharmacotechnics Group of the Spanish Society of Hospital Pharmacy” concerning the viability of the non-sterile oral formulations was reviewed. In terms of effectiveness, a retrospective observational study was conducted. Demographic and clinical (duration of the therapy and blood sugar levels 24 hours after first administration, sorted as “sensitive” if those levels were over 60mg/dL) variables were collected.

What has been achieved?

Carboxymethyl cellulose gel 1.5% (CMC) was evaluated as suspending agent, with adequate results. The steps to compounding the formulation of diazoxide 10mg/mL oral suspension were: 1. Four capsules of 25mg were opened and spread over a mortar. 2. 10ml of CMC was measured on a test tube. 3. CMC was added slowly over the powder while stirring the mixture to obtain a homogenized milky creamy. 4. Suspension was stored in an amber bottle. Following our stabilities studies and the lack of preservatives, an expiration date of seven days at ambient temperature was assigned. In our hospital, seven neonates (four males) aged 5.8±2.3 days have been treated with this oral suspension, for an average period of 28 days. Six of them were classified as “sensitive” with levels of 105±30mg/dL while one showed no improvement. Analysing the global expense, one pack of 100 capsules costs €21. Thus, 1 unit of our suspension 10mL cost €0.84 versus 1 bottle of 30mL (€473); the savings are remarkable.

What next?

The preparation constitutes a suitable alternative by using a simple and cheap technique since its introduction. In the future, full studies of stability must be designed to prolong its period of validity and monitor its security.

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