Amachiza amayeza amayeza angekho kwilebheli: Yintoni ekufuneka uyazi

Ulwazi lweziyobisi

Kwiminyaka eyadlulayo, xa ndandinengxaki yokuphazamiseka ngokweemvakalelo, ugqirha wam wandinika iyeza eliqhele ukusetyenziselwa ukunyanga ukuxhuzula. Ndandibhidekile. Kutheni le nto ugqirha wam ebendinika amayeza aboniswe kwimeko eyahlukileyo? Ngaba ibingumgangatho oqhelekileyo wokhathalelo ukuzama iziyobisi kusetyenziso olutsha? Ngaba ukusetyenziswa okunjalo kukhuselekile?

Mhlawumbi kwenzeke kuwe: Inkqubo yakho yezonyango ithumela amayeza kwikhemesti yakho, emva koko ufunda ukuba amayeza aqhele ukusetyenziswa ukunyanga imeko ehluke ngokupheleleyo kuneempawu zakho. Oku kubizwa ngokuba yi-off-label prescribing (ekwabizwa ngokuba kukumisela ukusetyenziswa okungagunyaziswanga). Kodwa yintoni eyenzayo ngokwenene Ndithetha ntoni?

Yintoni amayeza angekho kwilebula?

Xa uLawulo lwezoKutya kunye neDrug (FDA) luvavanya ichiza elitsha, inkampani eyenza amayeza efuna ukwamkelwa kufuneka ingenise ubungqina besayensi-njengeziphumo zovavanyo lweklinikhi- ukuba ichiza liyasebenza ekusetyenzisweni kwalo. Xa iyeza lifumana ukuvunywa yi-FDA (emva kwenkqubo ende yokuvunywa), kunyangwa oko ngokukodwa imeko yezonyango, kunye nesalathiso kuphela. Naluphi na olunye usetyenziso lweziyobisi alukho kwilebula.

Ngaba ukunyuswa kwelebheli engekho mthethweni kusemthethweni?

Xa inkampani eyenza amayeza iqala ukuthengisa iyeza, inokuchaza kuphela imeko eyamkelweyo yonyango ukuba inyangwe. Ukuthengisa ngaphandle kwelebheli , okanye ukuthengisa iziyobisi kusetyenziso olungavunyelwanga, kunokushiya inkampani yoxubo mayeza ivuleleke kwisimangalo. Akukho mthethweni.

Ngaba oogqirha bayavunyelwa ukuba bakhuphe amayeza angekho kwilebula?

Xa ugqirha emisela amayeza okusetyenziswa kwelebheli engekho mthethweni, oko kuthetha ukuba unikezele ichiza ngaphandle kweempawu zalo ezivunyiweyo. Kusemthethweni eUnited States, kwaye kuqhelekile, ukuba oogqirha bamisele ngaphandle kwelebula. Ngapha koko, uninzi lwezigulana aziqondi nokuba amayeza awela ngaphandle kokusetyenziswa kwawo okuvunyiweyo.

Ngamanye amaxesha, izikhombisi ze-FDA zibhekise ngqo kwiidosi okanye kwiimpawu zesigulana (ezinje ngesondo), kunokuba ibe yingxaki yezonyango uqobo. Umzekelo olungileyo weli liqela leminyaka yobudala — uninzi lweemvavanyo zovavanyo lweklinikhi kubantu abadala kunasebantwaneni, ke ukumisela la mayeza kwizigulana ezisencinci ngobuchwephesha kuwela phantsi kwesambulela seelebhile, okanye ukusetyenziswa okungavunyelwanga.

Kutheni le nto oogqirha bemisela amayeza ngaphandle kwelebheli?

Kubalulekile ukwazi ukuba ngenxa yokuba ukusetyenziswa kweziyobisi kungabikho kwilebula, oko akuthethi ukuba kuya kuba lunyango olungasebenziyo. Isizathu sokuba amayeza amiselweyo asetyenziswa ngokubanzi ngaphandle kwelebheli yinto esebenzayo, utsho Amber Cann , Pharm.D, umnini Ubungakanani beVenus . Inkqubo yokufumana ichiza ngenkqubo yolingo lweklinikhi kwaye yamkelwe yi-FDA ingathatha amashumi amabini eminyaka, kwaye ibiza kakhulu, uyachaza. Ngokwesiqhelo akukho ngaphakathi komdla womenzi weziyobisi ukufuna ezinye izikhombisi xa iyeza lisezorhwebo.

Ngamaxesha athile, umenzi weziyobisi uya kutyala imali kwisibonakaliso esongezelelweyo, ukuze bakwazi ukuthengisa ngokuthe ngqo ichiza ukulungiselela loo njongo, utshilo uGqirha Cann. Umzekelo, iPaxil ye-antidepressant Paxil (paroxetine), yayikhona kangangexesha elithile ngaphambi kokuba umenzi, uGlaxoSmithKline, afune izikhombisi ezongezelelweyo zelebheli kwiphakheji yokufaka uxinzelelo ngokubanzi kunye nokuphazamiseka okungafunekiyo.

Olu hlaziyo lunqabile-kwaye xa zisenzeka, zithatha ixesha. Kungathatha iminyaka ngaphambi kokuba iilebheli zibambe idatha yeklinikhi ebonisa ukuba ichiza linokusebenza ngengxaki ethile, utsho Amarish Dave , MD, ugqirha wemithambo-luvo kunye nomlawuli wezonyango onxulumene naye Inceba eIllinois. Kule minyaka ingenelelayo, ukusebenzisa iziyobisi ngaphandle kwelebheli kunokubonelela abaguli ngononophelo oluphuculweyo.

Imibuzo yokubuza ugqirha wakho malunga nokusetyenziswa kwelebheli emiselweyo

Ukuba unomdla malunga nokusetyenziswa kwelebheli-okanye woyike malunga nayo- kulungile kumalungelo akho njengesigulana ukubuza imibuzo. Unokufuna ukwazi:

• Ngaba amayeza angekho kwilebhile yale meko?
• Yintoni amayeza avunyiweyo ukuba anyange?
• Kutheni le nto ugqirha wakho ekumisela?
• Ngaba amayeza aya kuyinyanga njani imeko okanye iimpawu?
• Zithini iziphumo ebezingalindelekanga?
• Zithini izibonelelo zonyango ngaphandle kwelebheli?
• Ngaba i-inshurensi yakho yezempilo iya kuligubungela eliyeza ngenxa yale meko?

Uninzi lwamagqirha kunye noosokhemesti bonwabile ukuxoxa ngezalathi ezitsha kunye nokhuseleko lweziyobisi ukuba isigulana sinenkxalabo.

Ngaba iziyobisi ezingekho kwilebheli zigutyungelwe yi-inshurensi kunye neMedicare?

Unokudinga ukwenza uphando ukuze ufumane ukuba i-inshurensi yakho, i-Medicare, okanye iMedicaid iya kugubungela i-off-label label. Umyinge uxhomekeke kwiziyobisi-kwaye ugqirha umisela ukuba uphathe yiphi imeko. Ukuhlawulwa kwamayeza amiselweyo ngaphandle kwelebheli ngamanye amaxesha kunokuba nzima, njengoko iinkampani zeinshurensi zinokulumka ukuhlawulela izizathu zobuqhetseba. Ukuba oku kuyenzeka kuwe, thetha nomboneleli wakho wezempilo okanye usokhemesti malunga namanye amayeza. Unokusebenzisa isixhobo sokujonga amaxabiso sodwa ukubona ukuba ulondolozo lwethu lubetha ixabiso lemali.

Izibonelelo zokusetyenziswa kwelebheli engekhoyo

Ukumisela iziyobisi ezingekho kwilebheli kunika iingcali zonyango iindlela zonyango ngakumbi ukuba iyeza elinye alisebenzi kuwe. Iluncedo ngakumbi kwiimeko ezinqabileyo ezinokhetho lonyango olunomda. Umzekelo, ichemotherapy ihlala ivunywa kuphela kuhlobo olunye lonyango lomhlaza. Oogqirha banokuyisebenzisa ngaphandle kwelebheli ukujolisa kwiindidi ezahlukeneyo.

Ngamanye amaxesha ukusetyenziswa kwelebheli kunokugcina imali. Rhoqo amayeza enziwe afana nalawo aveliswe ngumenzi asetyenziswa ngaphandle kwelebheli anokusebenza ngendlela efanayo neyeza 'elamkelweyo' angabiza kakhulu, utshilo uGqirha Dave. Ezinye izibonelelo zibandakanya iziphumo ebezingalindelekanga ezilungileyo.

Umngcipheko wokusetyenziswa kwelebheli engekhoyo

Njengawo nawaphi na amayeza, kusenokubakho iingozi. Kuba ukusetyenziswa kweziyobisi ezingekho kwilebheli akubanga phantsi kwenkqubo engqongqo yovavanyo lwezonyango kunye nokuvavanywa, njengoko kwenzelwe ukusetyenziswa okuvunyiweyo, kunokubakho iziphumo ebezingalindelekanga. Kodwa uGqirha Dave uthi, Uninzi lokusetyenziswa kwelebheli engekho kumachiza asele eneprofayile yecala lesiphumo esaziwayo.

Iziyobisi ezithandwayo ezingekho kwilebula

Zininzi iimeko zokumiselwa eziwela kudidi lweelebhile ezingekhoyo. Ugqirha unokuyalela i-tricyclic antidepressants ukunyanga i-ADHD, okanye ukumisela i-anticonvulsant, njengeTopiramate, yoxinzelelo.

Ngamanye amaxesha, ukusetyenziswa kwelebheli engaqhelekanga kuxhaphakile kuba yinto zaseprayimari sebenzisa. Ayisiyonto ingaqhelekanga ekusetyenzisweni kwelebheli ekugqibeleni ukuba yamkelwe yi-FDA. I-Minoxidil liyeza lakudala elalisetyenziselwa uxinzelelo lwegazi oluphezulu, utshilo uGqirha Cann. Kwafunyaniswa ukuba [ngoko] ngelishwa isiphumo sokukhuthaza ukukhula kweenwele. Elo chiza ngoku kakhulu kunqabile ukuba isetyenziswe njengonyango lwexinzelelo, kodwa ihlala isetyenziswa njengemveliso yokukhula kweenwele. Ngoku siyazi njengo… Rogaine.

Amanye amayeza abathi abagqirha basebenzise ngaphandle kwelebheli kubandakanya:

Igama leziyobisi	Usetyenziso oluvunyiweyo	Ileyibheli engeyiyo emiselweyo
Iprazosin HCL	Unyango lwexinzelelo	Amaphupha amabi / i-PTSD
clomiphene-citrate	Unyango lokungachumi kwabasetyhini	Unyango lokungachumi emadodeni
Namenda	Unyango lwezifo ze-Alzheimer	Unyango lwe-ADHD kunye ne-OCD yabantwana
ICatapres	Unyango loxinzelelo lwegazi oluphezulu	I-ADHD, iiFlash Hot, iTourette's Syndrome
KwiSeroquel	Unyango lwe-Antipsychotic kunyango lwe-schizophrenia, iBipolar Disorder kunye ne-Major Depression Disorder	Ukuphuthelwa, ukuphazamiseka koxinzelelo, i-OCD, isifo sengqondo esivela kwisifo sikaParkinson
itopiramate	I-Anticonvulsant yonyango lokuthintela, ukuthintela migraine	Ukuphazamiseka kwengqondo, i-PTSD, ukunciphisa umzimba
I-sildenafil citrate	Ukungasebenzi kakuhle kwe-erectile (emadodeni	Ukuphazamiseka kwesini kwabasetyhini
gabhapentin	Unyango lokuxhuzula	Ukuphazamiseka kwiBipolar, iiFlash Hot, iNeuropathy
ipropranolol	Unyango lwexinzelelo	Ukuxhalaba kokusebenza
Tegretol	I-Anticonvulsant yonyango lokubanjwa	Ukuphazamiseka kwiBipolar, i-ADHD