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.

Alternatives when an authorized medicinal product is not available / F. Selmin, U.M. Musazzi, F. Cilurzo, P. Minghetti. - In: MEDICINE ACCESS @ POINT OF CARE. - ISSN 2399-2026. - 1:1(2017 Jan), pp. 5.e16-5.e21. [10.5301/maapoc.0000005]

Alternatives when an authorized medicinal product is not available

F. Selmin
Primo
;
U.M. Musazzi;F. Cilurzo;P. Minghetti
2017

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.
compassionate use; off-label use; pharmaceutical compounding; unlicensed medicinal product
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
Article (author)
File in questo prodotto:
File Dimensione Formato  
[2017] off-label MAAPOC-D-16-00001.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 601.25 kB
Formato Adobe PDF
601.25 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/473621
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact