Alternatives When an Authorized Medicinal Product is Not Available. Issue 1 (2017)

• Record Type: Journal Article
• Authors: Selmin, Francesca; Musazzi, Umberto M.; Cilurzo, Francesco; Minghetti, Paola
• Is Part Of: Medicine access @ point of care. Volume 1:Issue 1(2017)
• Publication Date: 2017
• Subjects: Compassionate use -- Off-label use -- Pharmaceutical compounding -- Unlicensed medicinal product; Medicine -- Periodicals; Medical care -- Periodicals; 610
• DOI: 10.5301/maapoc.0000005
• Languages: English
• ISSNs: 2399-2026

Abstract

The industrialization of medicinal products has permitted us to reach important results in terms of quality, efficacy, safety, and availability of drugs; however, not all the legitimate expectations of patients are met. When an authorized medicinal product is not available on the market, the physician can prescribe other pharmacological treatments in the following scenario: off-label prescriptions, extemporaneous preparations, compassionate use of medicinal products, and medicinal products authorized in foreign countries. The best solution among these alternatives should be evaluated case-by-case on the basis of good scientific evidence, expert medical judgement, and published literature, also keeping an eye on the availability, the cost, and the regulatory requirements at a national level.