Isidakamizwa esijwayelekile siyisidakamizwa esingumuthi osebenzisa igama elihlukile. Uzobona amagama amaningi. I-brand ye-Tylenol ine-generic ebizwa nge-acetaminophen. I-Prilosec yigama lomkhiqizo omeprazole ojwayelekile, osiza abantu abanezifo ze-reflux. I-Metformin, esetshenziswa iziguli zesifo sikashukela, yigama elijwayelekile lohlobo lwe-Glucophage.
I-US Food and Drug Administration (i-FDA) ibheka umuthi ojwayelekile ukuthi "ufanise, noma i-bioquivalent, kumuthi wegama lomkhiqizo kwifomu lezilingo, ukuphepha, amandla, indlela yokuphatha , ikhwalithi, ukusebenza, izici, nokusetshenziswa okuhlosiwe."
Kodwa izidakamizwa ezivamile zibiza kancane kunezibizo zabo (ezibizwa nangokuthi "ezintsha"), futhi ngezindleko zokuzamazama komhlaba zokunakekelwa kwezempilo, ukukhetha izidakamizwa ezivamile kungaba yinye indlela yokugcina izindleko eziphansi. Ngenxa yokuthi zindleko kakhulu, kulungile ukubuza umbuzo mayelana nokuthi bangalingani ngempela noma cha.
Uyini Umehluko Phakathi Kwezidakamizwa Ezijwayelekile Nezidakamizwa?
Ngaphandle kwezindleko, kukhona okungenani umehluko wesibili.
Okokuqala, akuzona zonke izidakamizwa ezintsha ezikhiqizayo . Labo abasanda kuthuthukiswa cishe namanje banelungelo lobunikazi; ngakho-ke umkhiqizo awukho. Ukuze uthole izinzuzo zalawo mithi, kuzodingeka usebenzise izinguqulo ezibhalwe igama.
Futhi, "i-bio-equival" kusho kuphela ukuthi izithako ezisebenzayo zidinga ukufana. Imithetho ye-US yezimpawu zokuhweba idinga ukuthi izidakamizwa zibukeke, ngakho-ke inguqulo yobudala ingaba nombala ohlukile, uhlobo oluthile, lunambitheka ohlukile, noma luqukethe izithako ezingasebenzi ezihlukile.
Kube khona izinkinga ezibikwe abantu abaguqulwe kusuka emthini wezokwelapha kuya kohlobo lwabo, futhi ngokufanayo. Ezimweni eziningi, izinkinga zibonakala zivela ngokuhlukahluka kwezithako ezingasebenzi. Amanye kubonakala sengathi avela esilinganisweni sezithako ezisebenzayo ezifakwe kunguqulo ehlukile. Imibiko engalungile ayivamile, kodwa uma uhlangabezana nabo, kufanele uwahlole kabanzi.
Kungani Izidakamizwa Zesizukulwane Zindleko Zingaphansi?
Lapho umkhiqizi wezokwelapha eqala umuthi omusha, uthola i-patent yalowo muthi. I-patent ivikela ukutshalwa kwezimali kumthuthukisi ekuthuthukiseni umuthi, futhi akekho omunye ongayithengisa ngokomthetho umuthi ofanayo ngqo isikhathi esithile. Kuzovikelwa kuze kube yiminyaka engu-17.
Lesi sidakamizwa esivikelwe i-patent yisisidakamizwa esisha. Uma sithenga, sikhokhela izindleko zocwaningo, izindleko ezenziwa ekuqinisekiseni ukuthi ziphephile, izindleko zokuthengisa kanye nokuthutha lesi sidakamizwa, kanye ne-premium uma kuwukuphela kwesidakamizwa esitholakalayo sesibonakaliso esithile, izifo noma isimo . Lezo zindleko zingenza izidakamizwa zibiza kakhulu ukuba sithenge. Umthuthukisi ubheka okuningi kwentengo indlela yokubuyisela izindleko zayo zokuthuthukiswa.
Uma leso sikhathi esiphephile se-patent sidlulile, noma yimuphi omunye inkampani ingakwazi ukukhiqiza nokuthengisa umuthi enezithako ezifanayo njengegama elilodwa. Kodwa-ke, i-FDA igcizelela ukuthi isidakamizwa esijwayelekile kufanele sinikezwe igama elisha. Njengoba inkampani eyenza i-generic ayizange ibangele izindleko zocwaningo lokuqala, ukuhlolwa noma ukumaketha, izindleko ziphansi.
Uma unesiphakamiso somshuwalense ohlanganisa izidakamizwa zemithi, ungase umangale ukwazi ukuthi ezinye izidakamizwa ezibizwa ngokuthi yizidakamizwa empeleni ziyokubiza kancane ngaphansi kwephaketheni lakho kunezizukulwane zobuchwepheshe.
Izinkampani zomshuwalense wezempilo zixoxisana ngentengo nabakhiqizi bezidakamizwa nabathengisi bezidakamizwa, ngezikhathi ezithile kubangele ukuthi kube nemali enhle kakhulu kumakhasimende abo aqinisekisiwe ngemithi egunyaziwe.
Inkampani yakho yomshuwalense igcina uhlu lwezidakamizwa ezithandwayo, okuthiwa i- formulary , ezisiza ukuqonda amanani. Uma ukukhetha kungacacile, hlola inkampani yakho yomshuwalense ukuze unqume ukuthi ngabe igama noma umkhiqizo ojwayelekile uzokuncipha.
Ingabe Kukhona Ukuhlaselwa Kwezidakamizwa Zesizukulwane?
Ukwazi ukuthi singalondoloza imali esingakanani uma sikhokha izidakamizwa zethu, futhi singakanani imali esingayilondoloza kuyo yonke uhlelo lwezempilo uma samukela ama-generics ngokusebenzisa izinhlelo zethu zomshuwalense wezempilo , kufanele sizibuze ukuthi kungani singavumi ngaso sonke isikhathi ukuthatha ama generic.
Impendulo iningi mayelana nokuthi abakhiqizi bezidakamizwa abavamile basebenzelana kanjani, ukungabi nongamela kwe-FDA, futhi okungenani ngombuzo wangempela wokuthi ngabe ama generic "azosebenza."
Iningi lezidakamizwa ezivamile zenziwa kwamanye amazwe; hhayi e-US. I-FDA inenkathazo eyanele yokulawula izidakamizwa ezenziwe ezweni lakubo; angeke futhi angenzi umsebenzi omuhle wokulawula abakhiqizi ngaphandle kwezwe. Esinye isibonelo sale nkinga yi-Ranbaxy debacle ngo-2013 lapho ekugcineni i-FDA ihlawulisa imali eyizigidi eziyizigidi ezingu-500 zamaRandi ngoba u-Ranbaxy wayephinga izidakamizwa ngamabomu. Akukho mbuzo ukuthi abanye abakhiqizi bathengisa ngokusemthethweni izinguqulo ezingalungile zezidakamizwa ezivunyelwe ukuzenza, futhi.
Indlela engcono kakhulu yokuqiniseka ukuthi uthola kahle imithi oyidingayo, ebizwa ngegama noma ejwayelekile, ukuthi uxoxe nodokotela wakho. Uma udokotela wakho ebeka isidakamizwa kuwe, buza ukuthi kukhona okulinganayo okujwayelekile . Uma ukhona, buza ukuthi yiluphi uhlobo lomuthi olwenza umqondo omkhulu kuwe.
Uma unesifiso sokutholakala kwezinhlobo ezijwayelekile zezidakamizwa okwamanje ozithathayo, i-FDA igcina irejista ebizwa ngokuthi i-Orange Book.
Uma ufuna ukwazi kabanzi mayelana nokuthi inkampani yakho yomshuwalense ithengisa kanjani izidakamizwa zayo, kokubili okukhiqizwayo kanye nokwaziswa, ungafunda kabanzi mayelana namathenda kanye namanani e-formulary .