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. SelminPrimo
;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.File | Dimensione | Formato | |
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[2017] off-label MAAPOC-D-16-00001.pdf
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