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.

Author(s)

Sonja Guntschnig, Aaron Courtenay, Ahmed Abuelhana, Michael Scott

Why was it done?

The service was established as part of the implementation of a new pharmacy into the hospital. The aim of this good practice initiative was to introduce multidisciplinary work on the wards and provide clinical pharmacy support for the ward personnel. Furthermore, it determined what types of clinical pharmacy interventions are needed at a rural 360-bed hospital in Austria, and assessed the physicians’ acceptance rate of the pharmacists’ suggestions.

What was done?

A new clinical pharmacy service (CPS) was introduced into Tauernklinikum Zell am See.

How was it done?

Data on 550 interventions made by one clinical pharmacist were collected by convenience sampling over a one-year period and rated on a six-point clinical significance scale. A subset of 26 interventions was rated for clinical significance by four independent physicians to determine inter-rater reliability (IRR). A two-way model inter-rater reliability analysis was performed for the four different physician assessments using SPSS to determine intra-class correlation (ICC).

What has been achieved?

Prompt acceptance rate by the physicians involved was 71.3% (392/550). In 26.9% (148/550) of all cases, the physician considered a change. The overall average score for all 550 clinical pharmaceutical interventions taken was 2.2. ICC significance scores were correlated with the pharmacist’s scores, ICC for consistency was 0.732 and 0.732 for absolute agreement, thus both can be considered as “good”. Potential for cost reduction associated with the recommended pharmaceutical changes, namely with medication being stopped or dose reduction was 32.7% (180/550) and 25.1% (138/550), respectively.

What next?

There is great potential and a definite need for the expansion of CPS in Austria. Only 15.8% of Austrian hospitals have a pharmacy department with even less offering CPS. Many countries have demonstrated the benefits of CPS in hospitals over the past 30 and more years. The need for increased pharmacist staffing in Austrian hospitals needs to be demonstrated to Austrian stakeholders.

Author(s)

Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer

Why was it done?

The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.

What was done?

In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.

How was it done?

First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.

What has been achieved?

The results show significant impact of this education session on all items especially those regarding the implants and medicines.

What next?

Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.

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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