Izidakamizwa Ezijwayelekile Ziyisimo Esilungile Futhi Kungakusiza Kuze kube ngu-80%
Lesi sihloko mayelana nezidakamizwa ezivamile sincike emininingwaneni evela e-US Yokudla Nezidakamizwa Zokuphatha.
Kungakhathaliseki ukuthi unesidakamizwa sokukhishwa kwezidakamizwa noma cha, uma usebenzisa izidakamizwa ezijwayelekile uma kufanelekile isimo sakho sempilo ungagcina imali - ngokuvamile engaphansi kuka-50% ngaphansi kwegama lomuthi wegama. Kodwa, izidakamizwa ezivamile ziphephile? Ngokusho kwe-US Food and Drug Administration (FDA), imishanguzo yemithi iphephile futhi iyasebenza njengoba igama legama elilinganayo.
Iyini isidakamizwa segama lomkhiqizo?
Igama lomuthi lomuthi lingenziwa kuphela futhi lithengiswe yinkampani ethinta i-patent yomuthi. Izidakamizwa zamagama wegama lomkhiqizo zingatholakala nge-odokotela noma ngaphezulu. Ngokwesibonelo:
- I-Valsartan, imithi esetshenziselwa ukwelapha umfutho wegazi ophezulu, ithengiswa ngodokotela kuphela yi-Novartis Pharmaceuticals ngaphansi kwegama elithi Diovan.
- I-Loratadine, imithi esetshenziselwa ukwelashwa kwemithi, idayiswa phezu kwe-counter by Schering-Plow Health Products Products ngaphansi kwegama brand Claritin.
Yimiphi imithi ejwayelekile?
Uma i-patent yemithi yegama lomkhiqizo iphela, inguqulo yesizukulwane yomuthi ingakhiwa futhi ithengiswe. I-generic version yesidakamizwa kufanele isebenzise isithako (s) esisebenzayo esifanayo njengegama lomuthi wegama lomkhiqizo futhi kumele lihlangabezane nezinga elifanayo nezindinganiso zokuphepha. Ukwengeza, i-FDA idinga ukuthi izidakamizwa ezijwayelekile zifane nomuthi wegama lomkhiqizo ku:
- isilinganiso
- ukuphepha
- amandla
- indlela esebenza ngayo
- indlela ethathwa ngayo
- indlela okufanele isetshenziswe ngayo
- izimo zezempilo ezithinta
Zonke izidakamizwa ezijwayelekile kumele zibuyekezwe futhi zivunywe yi-US Food and Drug Administration (FDA) ngaphambi kokuba zibekwe noma zithengiswe ngaphezulu kwe-counter.
Ingabe imishanguzo yami ejwayelekile iphephile futhi isebenza njengemithi yokwelapha igama?
Ngokusho kwe-FDA, zonke izidakamizwa, ezibandakanya izidakamizwa negama lomuthi kanye nezidakamizwa ezivamile, kufanele zisebenze kahle futhi ziphephile.
Izidakamizwa ezijwayelekile zisebenzisa izithako ezisebenzayo ezifanayo njengama-brand-name counterparts, ngakho-ke, zinengozi kanye nezinzuzo ezifanayo.
Abantu abaningi bakhathazekile ngekhwalithi yemithi ejwayelekile. Ukuze uqinisekise ikhwalithi, ukuphepha nokusebenza, i-FDA ibeka zonke izidakamizwa ezijwayelekile ngokusebenzisa inqubo yokubukeza ngokugcwele kuhlanganise nokubuyekezwa kolwazi lwesayensi mayelana nezithako nezidakamizwa zomuthi ezijwayelekile. Ngaphezu kwalokho, i-FDA idinga ukuthi isitshalo sokukhiqiza izidakamizwa esijwayelekile sihlangabezana namazinga aphezulu afanayo nesitshalo segama lomuthi. Ukuze kuqinisekiswe ukuhambisana nalomthetho, i-FDA iqhuba cishe ukuhlolwa okungaba ngu-3 500 ngonyaka.
Cishe isigamu sazo zonke izidakamizwa ezikhiqizayo zenziwa izinkampani zamagama ezinkampani. Bangase benze amakhophi abo emithi noma ezinye izidakamizwa zegama lenkampani bese bethengisa ngaphandle kwegama lomkhiqizo.
Uma izidakamizwa zami ezijwayelekile zinezithako ezisebenzayo ezifanayo njengenguqulo yegama lomkhiqizo, kungani libukeka lihlukile?
Izidakamizwa ezijwayelekile azivumelekile ukuthi zibukeke njenganoma imiphi eminye imithi edayiswa ngenxa yemithetho yokuthengisa ye-US. Nakuba isidakamizwa esijwayelekile kufanele sibe nesithako esisebenzayo esifanayo njengesidakamizwa segama lomkhiqizo, umbala, ukunambitheka, izithako ezingasebenzi ezingeziwe, nokuma kwemithi kungase kuhluke.
Ingabe zonke izidakamizwa zegama lomkhiqizo zinomuthi ojwayelekile?
Imithi yegama lomkhiqizo ngokuvamile inikezwa ukuvikelwa kwe-patent cishe iminyaka engu-17. Lokhu kuhlinzeka ukuvikelwa kwenkampani yezokwelapha ekhokhela ukucwaninga, ukuthuthukiswa, kanye nezindleko zokuthengisa zalesi sidakamizwa esisha. I-patent ayivumeli noma yimuphi omunye inkampani ukuthi yenze futhi idayise lesi sidakamizwa. Kodwa-ke, uma i-patent iphela, ezinye izinkampani ezenza imithi, uma sezivunyelwe yi-FDA, zingaqala ukukhiqiza nokuthengisa uhlobo olujwayelekile lomuthi.
Ngenxa yenqubo yegunya lobunikazi, imishanguzo ebekwe emakethe iminyaka engaphansi kwengu-17 ayinayo i-generic equivalent.
Kodwa-ke, udokotela wakho angase anikeze imithi efanayo ukuphatha isimo sakho esinalo elilinganayo lomkhiqizo. Isibonelo, uma uthatha i-Lipitor (Atorvastatin), esisekhona ekuvikelweni kwe-patent, nge-cholesterol ephakeme, udokotela wakho angakushintsha ku-simvastatin, inguqulo yesizukulwane ye-Zocor.
Kungani izidakamizwa ezivamile zingabizi ngaphezu kwezidakamizwa zamagama?
Ngokusho kwe-Pharmaceutical Research and Manufacturers of America, kuthatha iminyaka engaphezu kwengu-7 ukuletha isidakamizwa esisha ukuthengisa futhi kubiza okungaphezu kwamaRandi ayizigidi ezingu-800. Njengoba izinkampani ezidakamizwa ezidakamizwa akudingeki ukuba zihlakulele imithi kusukela ekuqaleni, kubiza kakhulu ukuletha umuthi emakethe.
Lapho imithi yokwelashwa isuselwe, izinkampani eziningana zingase zikhiqize futhi zithengise lesi sidakamizwa. Lo mncintiswano usiza amanani aphansi. Ngaphezu kwalokho, izidakamizwa eziningi ezijwayelekile zisekelwe kahle, imithi esetshenziswa kaningi engadingeki ukuthi ithwale izindleko zokukhangisa. Izidakamizwa ezijwayelekile ngokuvamile zibiza u-30% kuya ku-50% ngaphansi kwezidakamizwa zamagama.
Kungani abanye abahlinzeki bezempilo behluleka ukuncoma noma banikeze imithi ejwayelekile?
Naphezu kokuthi i-ingredient esebenzayo emithini yemithi efana neyomlingani wegama lomkhiqizo, umehluko omncane ungathinta indlela imithi yokwelapha esebenza ngayo emzimbeni wakho. Lokhu kungahle kube ngenxa yokuthi imithi yokwelapha ikhiqizwa noma uhlobo kanye nenani lezinto ezingasebenzi ezikhona kule mithi. Kwabanye abantu, lokhu kungezwani okuncane kungenza imbangela ingasebenzi kahle noma iholele emiphumeleni emibi.
Isibonelo sokuphikisana mayelana nemithi yokwelapha ngegama elibizwa nge-generic versusus yi-levothyroxine yezidakamizwa, esetshenziselwa ukuphatha abantu abanezimo eziphansi ze -roid (hypothyroidism). Njengoba abantu abaningi abane-thyroid ephansi bezwela izinguquko ezincane emkhakheni wemithi yabo, ukushintsha phakathi kwegama lomkhiqizo kanye ne-generic ye-levothyroxine kungabangela izimpawu zemithi encane kakhulu yegciwane noma imiphumela emibi evela emithini eningi kakhulu.
Ngaphambi kokushintshela kwisidakamizwa esijwayelekile, khuluma nodokotela wakho futhi uqinisekise ukuthi kokubili ukhululekile ngoshintsho.
Izinsiza ezivela ku-FDA
- I-Orange Book ye-Generic Equivalents - Umthombo we-intanethi wokuthola ulwazi mayelana nazo zonke izidakamizwa ezikhona ezivunywa yi-FDA
- Uhlu Lokuvunyelwa Kwezidakamizwa Zenyanga Zonke - Uhlu lwezidakamizwa ezijwayelekile ezisanda kuvunywa, izakhi zokuqala zesikhathi esidlule, kanye nokugunyazwa kokuthinta