Jenzer, Helena; Grösser, Stefan; Miljković, Nenad (2023). Availability of Medicines In: Practical Pharmaceutics (pp. 23-55). Cham: Springer International Publishing 10.1007/978-3-031-20298-8_3
Full text not available from this repository. (Request a copy)Fundamental changes and new challenges have been emerging in the last decades as a result of the globalisation of markets and of production, new economic doctrines, tight budgets, development of information technology, as well as the Covid-19 pandemic. This has caused a down-shift in the security of supply. Hospital pharmacists now have to cope with medicines shortages and struggle to ensure availability of the medicinal products for the patients. Medicines are made available as authorised medicines, pharmacy preparations, or investigational medicinal products. For many diseases active substances are available, and yet groups of ‘neglected’ patients or special patient groups will not receive the medicines they need. If a patient needs a medicine, which is not on the national market, it may be imported from abroad or prepared in a pharmacy. Complicated rules for reimbursement (in some countries), which are nationally determined, and long procedures render import a laborious way to make medicines available for the patient. To be reimbursed some countries require that medicines are to be shown whether they are efficacious, appropriate and economic. Medicinal products are produced as unlicensed medicines according to GMP and PIC/S guidelines to cover such shortages. The European Association of Hospital Pharmacists (EAHP) has dedicated a big effort to animate and harmonise pharmacy production. The need for flexibility in preparation and manufacturing processes and the added value of a broad range of pharmacy production have been clearly underlined by the Council of Europe’s resolution CM/ResAP (2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients(1). Council of Europe – Committee of Ministers. Resolution CM/ResAP (2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. (Adopted by the Committee of Ministers on 19 January 2011 at the 1103rd meeting of the Ministers’ Deputies. https://wcd.coe.int/ViewDoc.jsp?id=1734101. Accessed 20 Oct 2021).
Item Type: |
Book Section (Book Chapter) |
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Division/Institute: |
School of Engineering and Computer Science > Institute for Data Applications and Security (IDAS) School of Engineering and Computer Science |
Name: |
Jenzer, Helena; Grösser, Stefan0000-0003-3412-2711 and Miljković, Nenad |
Subjects: |
H Social Sciences > HD Industries. Land use. Labor > HD28 Management. Industrial Management R Medicine > R Medicine (General) |
ISBN: |
978-3-031-20297-1 |
Publisher: |
Springer International Publishing |
Language: |
English |
Submitter: |
Stefan Grösser |
Date Deposited: |
28 Jun 2023 09:33 |
Last Modified: |
28 Jun 2023 09:33 |
Publisher DOI: |
10.1007/978-3-031-20298-8_3 |
Uncontrolled Keywords: |
Globalisation of the pharmacy market Security of supply Medicine shortages Inaccessibility Unavailability Authorised medicines Pharmacy preparations Investigational medicines Medicines for orphan diseases Importation Unlicensed medicines Added value of hospital pharmacy production Pandemic Covid-19 |
URI: |
https://arbor.bfh.ch/id/eprint/19457 |