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Availability of Medicines

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Practical Pharmaceutics

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Abstract

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).

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Authors and Affiliations

  1. Bern University of Applied Sciences BFH, Bern, Switzerland

    Helena Jenzer

  2. Hospital of Psychiatry, University of Zurich, Zurich, Switzerland

    Helena Jenzer

  3. School of Engineering, Bern University of Applied Sciences, Biel-Bienne, Switzerland

    Stefan Groesser

  4. Institute of Orthopaedics Banjica, Belgrade, Serbia

    Nenad Miljković

  5. European Association of Hospital Pharmacists (EAHP), Brussels, Belgium

    Nenad Miljković

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  1. Helena Jenzer
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  1. Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands

    Paul Le Brun

  2. Pharmacy Department, MINT URM Inserm 1066 CNRS 6021, University of Angers, CHU Angers, Angers, France

    Sylvie Crauste-Manciet

  3. Apotheke der Universitätsmedizin, Mainz, Rheinland-Pfalz, Germany

    Irene Krämer

  4. JCS Pharma Consulting Ltd., Newport, Gwent, UK

    Julian Smith

  5. Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands

    Herman Woerdenbag

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Jenzer, H., Groesser, S., Miljković, N. (2023). Availability of Medicines. In: Le Brun, P., Crauste-Manciet, S., Krämer, I., Smith, J., Woerdenbag, H. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-031-20298-8_3

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