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PRODUCT DOSSIER AND RISK EVALUATION FOR EXTEMPORANEOUS PREPARATIONS KEEPS FOCUS ON PATIENTS (submitted in 2019)

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European Statement

Production and Compounding

Author(s)

Mette Lethan, Marianne Lund Sørensen, Jakob Kronkvist Hoe, Heidi Waenerlund Poulsen, Louise Rasmussen Duckert

Why was it done?

On July 1st, 2016, an EU resolution caused a new national requirement to establish a PD for new as well as known EP’s produced by the hospital pharmacy. PD’s had to be established for 450 known products in our facilities.

What was done?

A Product Dossier (PD) for extemporaneous preparations (EP) was established in our hospital pharmacy. They contain a risk evaluation and information about the specific value of the preparations, a demonstration that the active pharmaceutical ingredient(s) (API), excipients and containers meet relevant requirements, an evaluation of the stability of the product, and a description of the preparation process and analysis.

How was it done?

To approach the task, an interdisciplinary project group was formed. It consisted of members from Quality Assurance/Control, Stability, Drug Information Center and Production. A formulation for a collaborative approach was established to ensure a high and uniform quality of the PDs. The information obtained included e.g. information and evaluation of API and excipients, ongoing stability studies, indication of the drug and alternative preparations. A few examples were concluded in the group to ensure a quality baseline of the PDs.

What has been achieved?

PDs for 150 products have been successfully implemented. In some cases the formulation regarding excipients was changed to better suit the patient group. In other cases, it was evaluated whether a drug registered in another country could better ensure patient safety. Based on stability data, storing of some products were changed. Collaboration across departments has enabled us to ensure compilations of PDs for our pharmaceutical stock preparations. Completing the PDs on existing products has ensured a pool of knowledge about our products collected in one document and accessible to all departments in the hospital pharmacy.

What next?

Through the interdisciplinary approach PDs ensure focus on the quality, safety and benefits for the patients. All existing EPs will be maintained and evaluated anytime there may be a change in production. For all new products a PD will be prepared according to the guidelines set up. Having the information in one document (PD) ensures that all departments can quickly obtain information needed to consistently maintain and evaluate product quality and thereby the specific value of our production.

IMPLEMENTING A NATIONAL PORTFOLIO OF EXTEMPORANEOUS PHARMACEUTICAL PREPARATIONS USED IN DANISH HOSPITALS

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European Statement

Introductory Statements and Governance

Author(s)

Janne Jensen, Solvej Wandy Pedersen, Susanne Nørregaard, Karin Herkell, Anne Thestrup Nielsen, Anita Gorm Pedersen

Why was it done?

A group of hospital pharmacists representing all hospital pharmacies in Denmark have in a previous study identified and slimmed a national portfolio of extemporaneous pharmaceutical preparations used by Danish hospitals from a total of 2,754 preparations down to approximately 750 preparations being considered of clinical importance. Without a common overview of the national portfolio there will be initiated production of duplicates and almost identical products resulting in a large and inconsistent portfolio.
The purpose of this GPI was to make the national portfolio of extemporaneous pharmaceutical preparations accessible to all hospital pharmacists in Denmark and to implement a common procedure to evaluate preparations before adding them to the national portfolio to avoid duplets and obsolete products.

What was done?

A common national procedure for adding new preparations to the national portfolio was developed and implemented to avoid duplets and to ensure a uniform quality and appropriate risk assessment of the preparations.

How was it done?

A national database was developed and tested. Each hospital pharmacy entered their own extemporaneous pharmaceutical preparations in the database. Also, the extemporaneous pharmaceutical preparations manufactured by community pharmacies and used in the hospitals were entered in the database.
One hospital pharmacist in each of the five regions in Denmark was appointed as gatekeeper for the national portfolio. A template for an application form for new preparations was developed. When a physician requests a new preparation the application form will be completed by the clinical pharmacist. It is forwarded to the gatekeeper who will evaluate the preparation before approving it as a candidate for the national portfolio.

What has been achieved?

430 extemporaneous pharmaceutical preparations from the hospital pharmacies are entered and quality approved in the database. 255 extemporaneous pharmaceutical preparations manufactured by community pharmacies were entered in the database.
A national group of five gatekeepers was formed, and the workflow for both the group and the individual gatekeeper was described and implemented at all Danish hospital pharmacies.

What next?

The GPI provides an easy-accessible overview of the national portfolio of extemporaneous pharmaceutical preparations, releasing production time and resources at the manufacturing pharmacies.

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