EUnited States, igama lomenzi wegama lomhlaza lucetyiswa phantsi kokukhuselwa kwephepha lomenzi. Ikhamphani yeziyobisi ingachitha iminyaka - amashumi eminyaka, kwano-uphando kunye nokuvavanya ngaphambi kokuzisa isilwanyana esitsha ukuthengisa. Ukushiya ingxabano malunga negama legama elibizwa ngegama elibizwa ngokuba yi-drug name 'iindleko eziphezulu ngaphandle kwexabiso, umlinganiselo wokuqala wokuvelisa amayeza aquka zonke iindleko zophuhliso ezenziweyo kulo mziza.
Amalungelo abenzi abenzi begama lonyango ngokugqithiseleyo bagcina iminyaka eyi-10 ukuya kwe-20.
Njengoko umhla wokuphela kwephepha lobunikazi usondela, nawuphi na umenzi weziyobisi (kubandakanye nalowo ovelise igama lohlobo lwegama-mveliso) angafaka isicelo semvume yokuvelisa inguqu ye-generic yeyeza. Iinkampani ezenza iinguqu eziguqukayo zemithi ayinayo:
- Yenza uphando olufunekayo ukudala isilwanyana kwindawo yokuqala;
- Beka iyeza ngokusebenzisa izilingo zeekliniki; okanye
- Ukuseka iiprogram zokurhweba iziyobisi.
Ukuphelisa le miba emithathu kwindleko yokuveliswa kweziyobisi eziqhelekileyo kuthetha ukuba i-generic ingathengiswa ngexabiso eliphantsi kakhulu kunegama lohlobo lwegama.
Iimfuneko kwiiGenerics
Ngokutsho kwe-US Food and Drug Administration (FDA), "Ukuze ufumane imvume ye-FDA, iziyobisi kufuneka zi:
- ziqulethe izithako ezifanayo njengoko i-innovator drug (izithako ezingasebenziyo zingahluka)
- mazifane ngendlela efanayo, ifom yefayili kunye nendlela yokulawula
- zineendlela ezifanayo zokusebenzisa
- ube ngumlinganiso
- ukuhlangabezana neemfuno ezifanayo zentengo ye-identity, amandla, ubumsulwa kunye nomgangatho
- kufuneka zenziwe phantsi kwemigangatho echanekileyo yemigaqo ye-FDA yokusebenza ngokufanelekileyo efunekayo kwimveliso entsha "
Ukuze isilwanyana sibe yi-bioequivalent kunye negama layo lomenzi wegama lomhlaba, kufuneka lihambise inani elifanayo lesithako esisebenzayo kwisamba esifanayo njengento yokuqala.
Oku akuthethi ukuba zonke iimpawu zonyango lonyango zifana nelizwi lonyango lokuqala. I-generic akufuneki ibonakale njengeyantlandlolo ngenxa yokukhuselwa komqondiso. Kwakhona, izithako ezingasebenzi, izithambiso, izitya, kunye needayi zizahlukahlukileyo kwigama lomhlaza.
Iingxaki Ngezidakamizwa Zesizukulwana
Uninzi lwezidakamizwa zeso sihlandlo zikhuselekile kwaye zisebenza njengama-brand name-partners, kodwa iingxaki zivela. Isizathu esona siqhelo sobunzima ngeziyobisi eziqhelekileyo kukuba izithako ezingasebenziyo okanye izinto ezikhethiweyo zihlukile. Ukuhluthwa kweNewfoundland neLabrador, inhlangano yolwazi kunye nokukhuthaza, inqaku:
- Isithako esisebenzayo esinceda ukulawula ukutshatyalaliswa kwakho kufanayo kwiibini zombini kunye negama elithi 'generic' kodwa izinto ezisetyenzisiweyo njengezitsha, idayi, okanye izibophelelo, ngamanye amaxesha ziyahluka. Oku kunokwenza ngokuthe ngantlukwano kwindlela ekukhawulezileyo ukuxhamla ngayo esiswini sakho okanye uqhutywe ngumzimba wakho. Oku kunokuchaphazela ukuba uncedo luni na.
Abanye abantu baxhamla kwabanye abantu. Ukongeza, umzimba womntu usenokuba ujwayelene nomxube wonke wezithako ezisebenzayo kunye ezingasebenziyo kwisicatshulwa esinye somenzi, kwaye utshintshe umxube - nokuba ngaba akukho nto ingayifumani isithako esitsha - kunokubangela utshintsho kwimpendulo kumachiza.
Imizekelo yeengxaki nge-generics:
- I-pharmacy yaseKimberly yatshintshi esuka kumvelisi omnye komnye kwenye yeyeza zakhe. Kwiiveki ezimbini wafumana i-gesi ebuhlungu kunye nesifo sohudo xa umzimba wakhe ulungelelaniswa ne-generic entsha.
- I-pharmacy ye-Marcia yaguqula umyalelo wakhe ukusuka ku-Prozac ukuya kwi-generic version, i-fluoxetine. Waqhekeza ngokukhawuleza-ngokubonakalayo ukuphendulwa komzimba komnye wezinto eziphambili kwi-generic.
Ukuqapha
Akufanele ucinge ukuba uya kuba neengxaki xa ushintshe ukusuka kwigama lesigqirha ukuya kwisizukulwana okanye kwi-version eyodwa yesiqhelo kwisiza kwenye. Nangona kunjalo, kukho amanyathelo amaninzi ongayithatha ukunciphisa umngcipheko weengxaki ngemithi yonyango, kubandakanywa ukuphawula umenzi kwiluhlu lwamachiza akho kwaye uhlolisise uluhlu ngalunye xa ufumana ukuzaliswa ukuze ubone ukuba umenzi washintsha.
> Iingcaciso:
> Izidakamizwa Zesizukulwana: Imibuzo neempendulo. Iziko loVavanyo lweeDrug kunye noPhando (CDER), i-FDA. 2004.
> I-Generic Drug. Wikipedia
> I-FDA-Approved Bargain Drugs: Iimveliso Zesizukulwana kufuneka zihlangabezane neMigangatho ePhakamileyo. US Food and Drug Administration. 2003.
> Imibuzo Ngezizukulwana. Medco. 2003.
> Uhlobo lweMveli okanye iGrith Name Medication. Isifo seNewfoundland neLabrador. 2001.
> Brownlee, CL Ukongeza ukuba "i-spoonful sugar" kunye nokunye. UkuThengiswa KweMithi Yamhlanje. 2002.
> Izidakamizwa eziqhelekileyo: Ukwenza utshintsho. Aetna Pharmacy. 2006.
> I-Hendershot, R. "Igama leMpawu zeBhanki, izidakamizwa eziqhelekileyo, kunye nezidakamizwa ezingekho mthethweni." Izihloko ze-Linknet 2006.