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SR1: Re-engineering drug preparation

Room:

114

Facilitator:

Kart, Trine

Speakers:

Abstract:

 

ACPE UPN: 0475-0000-14-011-L04-P. A knowledge based activity.

Abstract

Traditionally drug manufacturing (to stock as well as ready to administer) is a key task of hospital pharmacy. The production is comprehensive as it includes many different dispensing forms and many different drug substances, and a lot of different methods of preparation are involved. 
 
Drug manufacturing is subject to detailed regulatory control. Staff training, facilities, equipment, materials and procedures continuously have to comply with GMP-standards to make sure that the drugs manufactured and delivered to patients are safe.
 
To have sufficient capacity and to be able to manufacture in accordance with GMP-guidelines is an on-going challenge for hospital pharmacies. The demand for unlicensed medicine tends to increase, as the pharmaceutical industry does not supply drugs to all the special needs of small patients groups. Also the increasing problems with drug shortages, as well as – clinics wishing have more drugs reconstituted and delivered in ready-to-use formulations, put pressure on drug manufacturing in hospital pharmacies. GMP-standards continuously develop, and hence new professional skills have to be developed, new procedures implemented and investments made in staff training, procedures and facilities.
 
Many hospital pharmacies face the dilemma of desiring to be able to produce the required wide range of drugs, whilst simultaneously meeting the economic and professional challenges, and keeping up with regulatory standards. This dilemma has been approached differently throughout Europe. Some countries successfully maintain decentralised drug production within the hospital pharmacies. Other countries have changed the national structure towards a more centralised drug production. Still some others implement automation and some outsource drug production. 
 

Teaching Goals:

  • to present a traditional structure of decentralised drug manufacturing, 
  • to present a structure of centralised drug manufacturing and the development of this system,
  • to discuss the pros and cons of decentralised and centralised drug production.

Learning Objectives:

After the presentation the participant should be able:
  • to describe the advantages and disadvantages of centralised and decentralised drug production,
  • to identify challenges and obstacles when transforming the production structure from decentralised to centralised,
  • to participate in debates and projects looking at re-engineering the compounding process.
 

 

 

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