SR1: Re-engineering drug preparation

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. 

 

After the presentation the participant should be able: