Pamene Iyo Ifika ku Mankhwala, Kodi "Mukupeza Zimene Mukulipira"?
Funso lovuta kwambiri lomwe mwakumana nalo ku sitolo kuyambira nthawi yoyamba yomwe munapemphedwa "pepala kapena pulasitiki?" Iwe uli pa pharmacy kudzaza mankhwala anu ndipo wamasitomu akutembenukira kwa iwe kuti akafunse, "Kodi njira yowonjezera ili bwino?" Mumaganizira mozama zomwe mungasankhe: mankhwala osokoneza bongo amawononga ndalama zochepera, koma kodi ndizofanana ndi dzina la chizindikiro ?
Kodi muyenera kupeza ma generic ndi kusunga ndalama zingapo?
Yankho ndilo "mwinamwake." Nthaŵi zambiri, mankhwala ochizira amadziwika kuti ndi otetezeka chifukwa cha njira yoyesera yogwiritsidwa ntchito ndi Food and Drug Administration (FDA).
Zopatsa Mavitamini
Makampani azachipatala amapereka ndalama zochuluka kuti apange mankhwala awo. Pofuna kubwezeretsa ndalamazo, zomwe zingakhale madola mamiliyoni mazana ambiri, boma la US limapereka chilolezo kapena mankhwala okhaokha pa mankhwalawa.
Pulogalamu yamtengo wapatali imatchedwa "ufulu wopezera ena kupanga, kugwiritsa ntchito, kupereka, kugulitsa." Mwa kuyankhula kwina, palibe kampani ina ya mankhwala yomwe ingayambitse mankhwala omwewo mu ma laboratori ndikuigulitsa. Malamulo angapitirire kwa zaka makumi awiri, koma iliyonse ya patent ndi yosiyana. Pulogalamu yapaulendo ikhoza kuperekedwa nthawi iliyonse panthawi yovomerezeka ndi mankhwala. Choncho, mankhwala akhoza kukhala ovomerezeka, koma sanavomerezedwe ndi FDA kuti agwiritsidwe ntchito kwa odwala.
Kugwiritsa ntchito mankhwala osokoneza bongo
Ufulu womwewo umatchedwa kuti wokhawo ungaperekedwe ku kampani ya mankhwala chifukwa cha mankhwala awo atsopano. Kupatula kumatchulidwa kuti "ufulu wopezera malonda operekedwa ndi FDA pa kuvomereza kwa mankhwala." Zapangidwa kuti zithetse pakati pa kulengedwa kwa mankhwala atsopano ndi malonda achibadwa, chokhacho chingakhale chosagwirizana ndi patent.
Kutalika kwadongosolo kumadalira mtundu wa mankhwala omwe apatsidwa, ndipo ukhoza kukhala paliponse kuyambira zaka 3 mpaka 7. Pamene chilolezo ndi zokhazo zatha, makampani ena ogulitsa mankhwala akhoza kubwezeretsa mankhwalawo ndikudzigulitsa iwo okha pansi pa dzina lina. Izi zimatsegula msika wa mpikisano ndipo zimayendetsa mtengo wa magetsi.
Mankhwala Osokoneza Bongo ndi Bioequivalency
Mankhwala osokoneza bongo ayenera kukhala ndi zida zofanana monga dzina, koma zosakaniza zosakanikirana zingakhale zosiyana. Zosakaniza zopanda ntchito zingaphatikizepo mitundu, zosungira, kapena zina zina. Komabe, chifukwa chakuti majeremusi ali ndi zowonjezera zosakaniza zomwe sizimangotengedwa kuti ndizofanana.
Kampani ina yamagetsi yomwe ikufuna kugulitsa mankhwala awo oyenera ayenera kupereka umboni wa bioequivalency kwa FDA. Pofuna kukhala bioquivalent, mankhwala omwe amagwiritsidwa ntchito ndi mankhwala oyenera ayenera kuyamwa mofanana ndi mankhwala omwe ali ndi mankhwalawa. Ma generic sayenera kuchita chimodzimodzi ndi dzina la mankhwala, koma ayenera kugonjetsedwa ndi malangizo ena olembedwa ndi FDA. Malangizo amenewa akhoza kusiyana ndi mankhwala osokoneza bongo.
Kuti mutsimikizire kuti mankhwala omwe mumapereka amapangidwa monga bioequivalent kwa dzina, pezani ndi katswiri wanu wamankhwala.
Wamasamba wanu ali ndi mwayi wodziwa zambiri zokhudza mankhwala ochizira kuchokera ku Buku la Orange la FDA. Buku la Orange lili ndi mndandanda wa mankhwala ndi bioquivalency. Mawonekedwe a pakompyuta amafufuzidwa ndi chogwiritsira ntchito ndi dzina la eni (brand).
Momwe Mungayankhire ndi Nthawi Yomwe Mungasankhe Generic
Ngati adokotala akulembera mankhwala osokoneza bongo omwe akugwiritsa ntchito dzina la mankhwalawa, wa mankhwalawa ayenera kumadzaza ndi mankhwala omwewo. Wamasamalidwe amatha kuyitana dokotala wanu ndikuyankhula za kulowetsa mtundu wa mankhwala. Kapena, mungathe kuyankhula ndi dokotala wanu za mankhwala okhudzana ndi majeremusi ndi mankhwala ovomerezeka pamene mankhwalawa akulembedwa.
Ngati mukudabwa pa kampani ya mankhwala ndi funso lokhudza dzina kapena ma generic, dinani ofesi ya dokotala. Dokotala yemwe wakuuzani mankhwalawa kwa inu adzadziwa ngati mutha kupeza zotsatira zomwe mumazifuna ndizochibadwa.
Zotsatira:
US Food and Drug Administration. "Kodi Mankhwala Osokoneza Bongo Ndi Otani?" FDA.gov 16 Oct 2008.
US Food and Drug Administration. Mafunso Omwe Amafunsidwa Kawirikawiri pa Zobwereza ndi Zokha. " FDA.gov 28 Apr 2006.