Skip to content

Establishing a medicine donation circuit for non-governmental organisations at a pharmaceutical service in the Basque country (Spain)

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Ariadna Martin Torrente , Itziar Palacios Zabalza, María Olatz Ibarra Barrueta, Maialen Palacios Filardo, Garazi Miron Elorriaga

Why was it done?

To optimise the functioning and the management of the procedures and an accessible and effective communication system in the PS. Moreover, the quality of the shipment is guaranteed all the time. The development of a circuit has allowed being faster and more efficient during its preparation than before.

What was done?

Establishing the circuit of execution, preparation, distribution, and delivery of medicine to Non-Governmental Organisations (NGO) from the Pharmaceutical Service (PS) of a tertiary hospital in the Basque Country (Spain). The circuit has been designed taking into account the criteria in a context of humanitarian donations, published and updated by the Spanish Agency of Drugs and Sanitary Products (AEMPS) on 16 March 2022

How was it done?

Since it has been included in the daily activity of the service it has cause and increase its amount of work, hence, daily routine tasks have been slowed down, given the increase of petitions the hospital has had during last year. However, its creation has allowed being faster and more efficient during its preparation.
The circuit begins with the request of NGO, which has to be authorised by the hospital’s directory. Then, in the procedure participate pharmacists; pharmacy technicians and office clerks who prepare the donation rely on the personalised list that the donation has created. Once, the necessary documents are filled out and they are sent to the AEMPS.

What has been achieved?

From November 2021 to September 2022, 7 donations have been carried out; these contained 100 active ingredients, concretely 15.198 units. We could find most of them in the WHO model lists of essential medicines. The NGO’s destinations have been Guatemala, Romania, Ukraine and Senegal. The medications sent most according to the ATC classification were 21% anti-infective medicines, 17% cardiovascular, 13% nervous system, 12% systemic hormonal preparations and 3% alimentary tract and metabolism.

What next?

The project is easily enforceable in any Spanish PS that is willing to process a donation at any given occasion. Some of our ideas for the future are the creation of a standard list including common medications, avoiding personalised lists, in addition to connect it to our internal programme to be faster when preparing the donation.

Homemade personalized 3D printed guides for mandibular reconstruction – A pharmacist feedback

European Statement

Production and Compounding

Author(s)

Quentin Misandeau, Romain Bosc, Muriel Paul, Valérie Archer, Lionel Tortolano

Why was it done?

The plastic surgery department bought two 3D printers in order to design and create custom-made medical devices. The main objective was to decrease the delay between mandibular cancer diagnosis and the surgery. The delays of production in the medical device manufacturers may exceed 2 weeks. Those delays are considered as a lost of chance for the patients.

What was done?

We helped our surgeons to secured the production procedure and reduce the risks for patients. We create a management quality system for supply, production, sterilization and using of our homemade personalized 3D printed guides.

How was it done?

First, we created a task force of pharmacist and surgeons.
The main work was a risk analysis with the FMECA method for all the steps in the procedure (software, tools, actors and materials).

What has been achieved?

Some correctives actions were taken. The riskier points were the plastic materials toxicity risk, the sterilization procedure that has been validated and the production traceability. A biocompatibility evaluation was performed. A clinical evaluation has been initiated in the same period.

What next?

Since the new medical device regulatory (2017 /745 CE) was published in 2017, the article five, that regulate the 3D printing in hospital, changes the possibilities. In fact, as personalized 3D printed guides are available on the EU market, homemade personalized 3D printed guides for mandibular reconstruction could be not authorized anymore. The only way would be for the hospital to obtain the regulatory statut of manufacturer and comply with the essential requirements.

DEVELOPMENT OF NEW PRODUCTION WHEN NEITHER PACKAGING NOR SOME OF THE RAW MATERIALS CONFORM TO EUROPEAN STANDARDS

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Katrine Bødker Rubach-Larsen, Anne Rungø, Anette Eskildsen, Lone Skovhauge

Why was it done?

A research team at the MR Centre (MRC2) wished to set up the production of Pharmacy Kits, but had no prior experience of, or licence to, manufacture drugs. Thus, the hospital pharmacy was asked to participate in the development of such production.

What was done?

A new MR-scanning technology, hyperpolarisation, for the quantification of metabolic processes with an extremely high sensitivity enables physicians early detection of treatment effects in, for example, cancer and diabetes. A so-called Pharmacy Kit is used in the hyperpolarisation process and consists of a specially designed packaging with tubes, vessels and filters containing the contrast agent and buffer solutions. The objective for the hospital pharmacy1 was to manufacture Pharmacy Kits complying with Good Manufacturing Practice (GMP), though neither packaging nor two of the raw materials conformed to European standards.

How was it done?

The MRC research team presented the hospital pharmacy with the desired combination of compounds and the packaging required for Pharmacy Kit production. The task for the hospital pharmacy was then to set up a manufacturing process that met these requirements and complied with the guidelines for GMP. A production complying with GMP was developed in close collaboration with the MRC and an ongoing contact with the Danish Medicines Agency. During the process the hospital pharmacy carried out its own microbiology test in order to determine if, and for how long, the non-CE-marked packaging could store the contrast agent and buffer solutions. Risk assessment of the raw materials not found in the European Pharmacopeia were conducted. The method investigated by the MRC already takes place at a few other places in and outside of Europe. Experiences from these production sites were implemented and expanded with process optimisation, and specially designed equipment for the production.

What has been achieved?

Due to a strong inter-professional collaboration between the MRC and the hospital pharmacy and due to qualified risk assessments, it was possible to set up a production of Pharmacy Kits according to GMP.

What next?

When researchers contact hospital pharmacies with new ideas, we have to be willing to work with GMP in a different way by applying knowhow and risk assessments in order to ensure developments within the healthcare system.
1. Hospital Pharmacy Central Region, Production, Aarhus, Denmark.
2. MR Centre, Aarhus University Hospital, 8200 Aarhus N, Denmark

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.