Availability of Medicines

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).