Izidakamizwa ze-Generic Ziyindlela ekhuselekileyo kwaye iyakusindisa ukuya kuma-80%
Eli nqaku malunga neziyobisi eziqhelekileyo kusekelwe kwingcaciso evela kwi-US Food and Drug Administration.
Ingaba unobungozi beziyobisi okanye awunayo, ukuba usebenzisa iziyobisi eziqhelekileyo xa kufanelekile imeko yakho yempilo ungalondoloza imali - ngokuphindaphindiweyo ngaphezu kwama-50% ngaphantsi kwegama lonyango. Kodwa, ngaba iziyobisi zendalo zikhuselekile? Ngokutsho kwe-US Food and Drug Administration (i-FDA), imishanguzo yendalo ikhuselekile kwaye isebenzayo njengegama elifana negama.
Liliphi igama legama lomhlaza?
Igama lonyango lonyango lingaveliswa kuphela kwaye lithengiswe yinkampani enegunya lobunikazi lonyango. Amachiza egama leBrama angafumaneka nge-odokotela okanye kwi-counter-counter-counter. Umzekelo:
- UValsartan, unyango olusetyenziswa ekuphatheni uxinzelelo lwegazi oluphezulu, luthengiswa ngumyalelo kuphela nguNovotis Pharmaceuticals phantsi kwegama legama elithi Diovan.
- I-Loratadine, amayeza asetyenziswa ukunyanga i-allergies, ithengiswa phezu kwe-counter by Schering-Plow Health Products Products ngaphansi kwegama legama likaClaritin.
Ziyiphi imishanguzo yonyango?
Xa i-patent yegama lonyango ligqityiwe, ukuguqulelwa kwesiqhelo kwisiza kunokuveliswa kwaye kuthengiswe. Uhlobo oluthile lwesiza kufuneka lisebenzise isithako esisetyenziswayo (s) njengegama lonyango kwaye kufuneka lihlangabezane nemigangatho efanayo kunye nemigangatho yokhuseleko. Ukongezelela, i-FDA idinga ukuba iziyobisi eziqhelekileyo zifanane neziyobisi zamagama kwi-:
- umyinge
- khu seleko
- amandla
- ngendlela esebenza ngayo
- ngendlela ethathwa ngayo
- ngendlela okufanele isetyenziswe ngayo
- imeko zezempilo ezithathayo
Zonke iziyobisi eziqhelekileyo mazihlaziywe kwaye zivunywe yi-US Food and Drug Administration (FDA) phambi kokuba zibekwe okanye zidayiswe ngaphaya kwe-counter.
Ngaba imishanguzo yam i-generic ikhuselekile kwaye isebenzayo njengamayeza egama legama?
Ngokutsho kwe-FDA, zonke iziyobisi, kubandakanywa namachiza egama lomenzi kunye neziyobisi eziqhelekileyo, kufuneka zisebenze kakuhle kwaye zikhuseleke.
Izidakamizwa eziqhelekileyo zisebenzisa izithako ezifanayo njengamanye amagama kunye negama-magama, kwaye ke, zinengozi kunye nezibonelelo ezifanayo.
Abantu abaninzi banenkxalabo malunga nomgangatho weziyobisi eziqhelekileyo. Ukuqinisekisa umgangatho, ukhuseleko kunye nokusebenza, i-FDA ibeka zonke iziyobisi eziqhelekileyo ngokusebenzisa inkqubo yokuphonononga ngokubanzi kuquka ukuhlaziywa kolwazi lwesayensi malunga nezithako zeziyobisi kunye nokusebenza. Ukongezelela koko, i-FDA idinga ukuba isityalo sokuvelisa iziyobisi esiqhelekileyo sidibana nemigangatho ephakamileyo efanayo nesityalo segama lomhlaza. Ukuqinisekisa ukuthotyelwa kwalo mgaqo, i-FDA iqhuba malunga nama-3 500 ukuhlolwa kwesayithi ngamnye ngonyaka.
Phantse kwisiqingatha sazo zonke iziyobisi zenziwe ngamaqumrhu amagama egama. Baya kwenza iikopi zabo ngamachiza okanye elinye igama lonyango lonyango baze bathengise ngaphandle kwegama legama.
Ukuba isicatshulwa sam esiqhelekileyo sinesithako esinomsebenzi esifanayo njengenguqulo yegama lomfanekiso, kutheni libonakala lihlukile?
Iziyobisi eziqhelekileyo azivumelekanga ukuba zibukeke njengawo naziphi na ezinye iziyobisi ezithengiswa ngenxa yemithetho yokuthengisa ye-US. Nangona isilwanyana esiqhelekileyo kufuneka sibe nesithako esisisigxina esifana nesiqhamo segama-brand, umbala, ukunambitheka, izithako ezongezelelweyo ezingasebenzi, kunye nokuma kweyeza kunokuhluka.
Ngaba zonke izibizo zegama-zinezidakamizwa eziqhelekileyo?
Igama lemithi yeBrama ngokuqhelekileyo linikezelwa ukukhuselwa kwephepha lobungakanani malunga neminyaka eyi-17. Oku kukhusela inkampani yezobisi ehlawulela uphando, uphuhliso, kunye neendleko zokuthengisa zonyango elitsha. I-patent ayivumeli nayiphi na enye inkampani ukuba yenze kwaye ithengise isiza. Nangona kunjalo, xa i-patent iphela, ezinye iinkampani zonyango, emva kokuvunywa yi-FDA, zingaqala ukwenza nokuthengisa i-generic version yeliza.
Ngenxa yenkqubo yomenzi wechiza, amayeza asemarikeni engaphantsi kweminyaka eyi-17 ayinalo i-generic equivalent.
Nangona kunjalo, ugqirha wakho unokumisela imithi efana nayo ukunyanga imeko yakho enokulingana okukhoyo. Umzekelo, ukuba uthabatha i-Lipitor (Atorvastatin), eqhubekayo ekukhuseleni i-patent, kwi-cholesterol ephezulu, ugqirha wakho unokukutshintsha kwi-simvastatin, i-generic version yeZocor.
Kutheni ukuba izidakamizwa eziqhelekileyo zingabizi ngaphantsi kweelwimi zamagama?
Ngokutsho koPhando lweMishanguli kunye nabakhiqizi baseMelika, kuthatha iminyaka engaphezu kweyisixhenxe ukuzisa izilwanyana ezintsha ukuthengisa kunye neendleko ezingaphezu kwezigidi eziyi-800 zamaRandi. Ekubeni iinkampani zamachiza eziqhelekileyo akudingeki ukuba ziphuhlise amayeza ngokukhawuleza, ixabiso eliphantsi kakhulu ukuzisa le nkunkuma kwimarike.
Emva kokuba imithi yonyango ivunyiwe, iinkampani ezininzi zingavelisa kwaye zithengise izidakamizwa. Olu khuphiswano lunceda amaxabiso aphantsi. Ukongezelela, ezininzi iziyobisi zenziwe ngokusisigxina, eziqhelekileyo zisetyenziswe imichiza engadingeki ukuba ithwale iindleko zokuthengisa. Izidakamizwa eziqhelekileyo zihlala zibiza i-30% ukuya kwi-50% ngaphantsi kwegama lamachiza.
Kutheni abanye ababoneleli bezempilo benqwenela ukucebisa okanye banikeze imithi yonyango?
Nangona into yokuba isithako esisebenzayo kwimithi yonyango ifana neyomlingani wegama-magama, ukungafani kancinci kunokuchaphazela indlela iyeza zonyango ezisebenza ngayo emzimbeni wakho. Oku kungakho ngenxa yokuveliswa kwamachiza okuvelisa okanye uhlobo kunye nezixhobo ezingasebenziyo ezikhoyo kumachiza. Kwabanye abantu, le mihluko embalwa ingenza ukuba iziyobisi zingasebenzi kakuhle okanye zikhokelela kwimiphumo emibi.
Umzekelo wempikiswano malunga neyeza elibizwa ngokuba yi-generic versus brand nameyeza ye-levothyroxine, esetyenziselwa ukuphatha abantu abane-condition ephantsi ye -roid (hypothyroidism). Ekubeni abantu abaninzi abanesifo se-thyroid baxhomekeke kwiinguqu ezincinci kwiqondo lamachiza abo, ukutshintsha phakathi kwegama-brand name and generic versions ye-levothyroxine kunokudala iimpawu zonyango elincinci okanye imiphumo emibi kakhulu kumachiza amaninzi.
Ngaphambi kokutshintshela kwisiyobisi esiqhelekileyo, thetha nodokotela wakho kwaye uqinisekise ukuba ukhululekile kunye noshintsho.
Izixhobo ezivela kwi-FDA
- I-Orange Book ye-Generic Equivalents - Umthombo we-intanethi wolwazi malunga nazo zonke iziyobisi ezikhoyo ezivunywe yi-FDA
- Uluhlu lweMvume yoLwabiwo lweMigodi yoNyaka - Iluhlu lwezilwanyana zamachiza ezivunyiweyo, i-generic time-generic