Stručni rad

https://doi.org/10.46419/vs.51.4.9

Off-label use of veterinary medicinal products

Svjetlana Terzić orcid.org/0000-0002-6023-5798 ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Miroslav Andrišić ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Irena Žarković orcid.org/0000-0002-3263-2024 ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Anja Vujnović orcid.org/0000-0002-8311-9407 ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Eleonora Perak Junaković ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Katja Vretenar Špigelski orcid.org/0000-0002-1720-0848 ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Sonja Sinković ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Mirta Pehnec ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Dominika Fajdić orcid.org/0000-0002-3338-523X ; Hrvatski veterinarski institut, Zagreb, Hrvatska
Ksenija Šandor orcid.org/0000-0002-8730-5282 ; Hrvatski veterinarski institut, Zagreb, Hrvatska

Sažetak

Despite the number of approved veterinary medicinal products (VMPs) in Croatia, there is an occasional need for certain other VMPs, including those for dogs, cats and horses. Availability of VMPs improved significantly with Croatia’s accession to the European Union in 2013, though there are still situations when unauthorized medicines are used. Apart from their lack on the market, there are other reasons for their use, such as the price of substitute medicines, expectations of greater efficacy or quality of human medicines, etc. European and national legislation provides several possibilities for using unapproved VMP to reduce animal suffering or for treatment purposes. One is the possibility to use a VMP that is not approved in Croatia, but is approved in one of the EU Member States or outside the EU (third countries) under certain conditions. The second possibility is use of a VMP approved in Croatia, but for a different
target species, and the third possibility is the use of these drugs in humans. In all these cases, the use of a VMP in non-target species or category, or in a dosage or route of administration different from that approved, or for an indication not specified on the label is considered off-label use or extra-label use. If required, the veterinarian may administer the unapproved VMP at his own risk, on the basis of a benefit-risk assessment and in accordance with national regulations, taking into account the withdrawal period in the case of food-producing animals. Records on such use must be kept, including identification data about the animal and owner, all data on
the administered drugs, including dose, all performed procedures (diagnosis, duration of treatment) and the withdrawal period, if applicable. Since medicines used outside the approved instructions can also have side effects, it is necessary to ensure they are recorded and reported to the competent authorities.

Ključne riječi

use of unauthorized veterinary medicinal products; “off-label use”

Hrčak ID:

238286

URI

https://hrcak.srce.hr/238286

Datum izdavanja:

12.6.2020.

Podaci na drugim jezicima: hrvatski

Posjeta: 1.318 *