Availability of Medicines

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 as well as the development of information technology. This has brought with it a shift in the security of supply, which now has to cope with drug shortages to prevent a decrease in safety and a worse outcome 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. The complicated rules, which are nationally determined, for reimbursement (in some Countries) and long procedures render importation a laborious way to make medicines available for the patient. To be reimbursed some Countries require that medicines are to be shown to be efficacious, appropriate and economic.

Specials (unlicensed medicines) are being produced according to GMP and PIC/S guidelines to cover these shortages. The European Association of Hospital Pharmacists (EAHP) has dedicated a big effort to animating and harmonising 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.

Based upon the chapter ‘Apotheekbereiding in de geneesmiddelenvoorziening’ by Yvonne Bouwman-Boer and Reinout Schellekens in the 2009 edition of Recepteerkunde.