Uma Ifika Emitholampilo, Ingabe "Uthola Okukhokhayo"?
Umbuzo obunzima kunayo yonke ohlangabezane nayo esitolo kusukela okokuqala ucele "iphepha noma ipulasitiki?" Ulapha ekhemisi ukugcwalisa imithi yakho yezokwelapha futhi umakhemikhali uphendukela kuwe ukubuza, "Ingabe inguqulo yesi-generic ilungile?" Wena unesisindo esinqunyiwe okukhethwa kukho: izidakamizwa ezijwayelekile zibiza kancane, kodwa ingabe zifana nhlobo nohlobo lwegama lomkhiqizo ?
Ingabe kufanele uthole i-generic bese ulondoloza amabhakede ambalwa?
Impendulo iyamangalisa "mhlawumbe." Ezimweni eziningi, izidakamizwa ezivamile zibhekwa ziphephile ngenxa yenqubo yokuhlola esetshenziswa yi-Food and Drug Administration (FDA).
Amalungelo Okudakamizwa
Izinkampani zokwelapha zitshala imali eningi kakhulu ekuthuthukiseni izidakamizwa zabo. Ukuze kutholakale lezo zindleko, okungaba ngamakhulu ezinkulungwane zamaRandi, uhulumeni wase-US uphazamisa ilungelo lobunikazi noma ukuphela komuthi.
I-patent ichazwa ngokuthi "ilungelo lokukhipha abanye ekwenzeni, ngokusebenzisa, ukuthengisa, noma ukuthengisa." Ngamanye amazwi, akekho enye inkampani yezidakamizwa ongakha isidakamizwa esifanayo kuma laboratories ayo bese uyayithengisa. Amalungelo obunikazi angahlala isikhathi eside iminyaka engu-20, kodwa i-patent ngayinye ehlukile ihlukile. I-patent ingakhishwa nganoma isiphi isikhathi ngesikhathi senqubo yokugunyazwa kwezidakamizwa. Ngakho-ke, umuthi ungaba nelungelo lobunikazi, kodwa okwamanje awuvunyelwe yi-FDA ukuze usebenzise iziguli.
Ukuzikhethela izidakamizwa
Ilungelo elifanayo elibizwa ngokuthi ubumbano lingabuye linikezwe inkampani yezokwelapha imithi yabo entsha. Ukuzikhethela kuchazwa ngokuthi "amalungelo okuthengisa okukhethekile anikezwe yi-FDA ngokugunyazwa kwesidakamizwa." Idalwe ukushaya ibhalansi emkhatsini wokudalwa kwemithi emisha nokukhangisa okujwayelekile, ukuphela kuphela kungase kungavumelani ne-patent.
Ubude bokuphela buxhomeke kuhlobo lomuthi olunikezwa ngalo, futhi lungaba khona kusukela eminyakeni engu-3 kuya kwengu-7. Uma ilungelo lobunikazi kanye nokuphela liphelelwe isikhathi, ezinye izinkampani ezenza imithi zingaphinda zivuselele izidakamizwa futhi zithengise ngokwazo ngaphansi kwegama elihlukile. Lokhu kuvula imakethe yokuncintisana futhi kuqhuba izindleko zemikhiqizo ejwayelekile.
Izidakamizwa ezijwayelekile kanye ne-Bioequivalency
Izidakamizwa ezijwayelekile kufanele zibe nezithako ezisebenzayo ezifanayo njengegama lomkhiqizo, kodwa izithako ezingasebenzi ezingase zihluke. Izithako ezingasebenziyo zingabandakanya imibala, izivikeli zokuvikela, noma ezinye izitsha. Kodwa-ke, ngenxa yokuthi i-generic inezithako ezifanayo ezingasebenzi ezingacatshangwa ngokuzenzakalelayo ngokulingana okujwayelekile.
Inkampani efaka imithi efuna ukumaketha izidakamizwa zazo kumele inikezele ubufakazi be-bioequivalency ku-FDA. Ukuze ube yi-bioquivalent, izithako ezisebenzayo ezidakamizwa ezijwayelekile kumele zifakwe ngesilinganiso esifanayo kanye nesamba esifanayo njengegama lomuthi wegama. I-generic akudingeki isenze ngokufana ncamashi nomuthi wegama lomkhiqizo, kodwa kufanele iwele ngaphansi kweziqondiso ezithile ezibekwe yi-FDA. Lezi ziqondiso zingase zihluke ezidakamizweni zibe izidakamizwa.
Ukuze uqiniseke ukuthi izidakamizwa ezijwayelekile ozinikezwayo zenziwe njenge-bioequivalent negama lomkhiqizo, hlola nomuthi wemithi yakho.
Isomakhemikhali wakho unokuthola ulwazi mayelana nezidakamizwa ezivamile kusukela ku-FDA sika-Orange Book. I-Orange Book iqukethe uhlu lwezidakamizwa nesimo sabo se-bioequivalency. Inguqulo ye-elekthronikhi iyasetshenziselwa isithako esisebenzayo kanye negama lokuthengisa (igama).
Indlela Nini Yokukhetha Isizukulwane Nini?
Uma udokotela wakho ebhalile imithi yesidakamizwa esebenzisa igama lomuthi walowo muthi, i-pharmist kufanele igcwalise ngalowo muthi othile. I-pharmist ingabiza udokotela wakho futhi akhulume ngokufaka ifomu elijwayelekile lomuthi. Noma, ungakhuluma nodokotela wakho mayelana nezidakamizwa zemithi ejwayelekile kanye nemithi lapho udokotela ebhalwa khona.
Uma umangale ekhoneni lezidakamizwa nombuzo mayelana negama lomkhiqizo noma umuthi ojwayelekile, shayela ihhovisi lakho udokotela. Udokotela obeke umuthi kuwe uzokwazi ukuthi ungathola yini imiphumela oyifunayo nge-generic.
Imithombo:
Ukuphathwa kwe-US nokuDrug. "Ziyini Izidakamizwa Ezijwayelekile?" FDA.gov 16 Okthoba 2008.
Ukuphathwa kwe-US nokuDrug. Imibuzo Ebuzwa Ngokuphindaphindiwe Ngezimvume Zokuzibophezela Nokuzikhethela. " FDA.gov 28 Apr 2006.