SAD and magistral pharmaceuticals


Amgros owns marketing licences for about 65 SAD pharmaceuticals manufactured by hospital pharmacies themselves. These are registered pharmaceuticals approved by the Danish Medicines Agency. The knowledge Amgros and hospital pharmacies have on manufacturing pharmaceuticals is also applied for what are known as magistral pharmaceuticals. These are pharmaceuticals manufactured by hospital pharmacies for individual patients or small groups of patients with special needs that cannot be met by industrial products. Manufacture of both SAD pharmaceuticals and magistral pharmaceuticals entails strict documentation requirements for the quality of raw materials, manufacturing processes and the finished pharmaceuticals. Amgros works closely with hospital pharmacies to obtain and maintain this documentation.

SAD pharmaceuticals generally cover patients with special needs, and in many cases they cannot be purchased from the industry. Therefore, they are an important component in the supply of pharmaceuticals for hospitals. There are many changes in the lifecycle of a pharmaceutical.

In collaboration with the hospital pharmacies, Amgros makes sure that drugs comply with all the relevant rules and standards. This helps secure high quality and safety for patients. Amgros is responsible for submitting amended documentation to the Danish Medicines Agency for marketing licences for around 65 SAD pharmaceuticals.

PRODUCTION

SAD pharmaceuticals are manufactured at four of the eight hospital pharmacies. Amgros supports production by coordinating complaints management. We deal with administrative tasks regarding labelling, packaging and shelf life.

RAW MATERIALS

On behalf of the hospital pharmacies, Amgros procures many of the raw materials used by hospital pharmacies in their production. This saves resources at the individual hospital pharmacy. We analyse the market and ensure the correct quality of the raw materials delivered for hospital pharmacy production. We do this by coordinating audits of suppliers. We also check that suppliers live up to current regulations and standards, and that they have documentation in place.

PHARMACOVIGILANCE

Amgros monitors SAD pharmaceuticals to enhance safety for various patient groups and in situations where the drugs are used in combination with other drugs. In addition to studies of the literature on the area, this work includes information from patients, physicians, the pharmaceuticals industry and authorities in Denmark and abroad.

If the hospital pharmacies change the way they manufacture a pharmaceutical, or if monitoring of pharmaceuticals gives rise to changes in how clinics use or manage the pharmaceutical, we will send a variation application to the Danish Medicines Agency. Amgros will also update the product summary for the pharmaceutical, and communicate the changes to the clinical pharmacists.

!
Report side effects
Anyone can report side effects from using a SAD drug directly to Amgros via email to safety@amgros.dkor by contacting Quality and Registration of Pharmaceuticals on telephone +45 88713000.

Read more

SAD and magistral pharmaceuticals

Horizon Scanning

Amgros works systematically to establish an overview of the future opportunities for pharmaceuticals treatments

READ MORE
SAD and magistral pharmaceuticals

Price negotiations and effective competition

Amgros manages procurement of almost all the medicine used in Danish public hospitals. It is our task to organise tendering procedures for pharmaceuticals so that we cover hospital needs

READ MORE
SAD and magistral pharmaceuticals

Procurement and supply

Amgros informs the hospital pharmacies when we have set up an agreement to purchase a pharmaceutical. After this, hospital pharmacies send their purchase orders to the supplier

READ MORE