Kodi Mungatani Kuti Mukhale ndi Mavitamini Ovomerezeka?

PCAB imaphatikizapo zifukwa zodziŵira kuti mankhwala osokoneza bongo ndi apamwamba kwambiri

Mu October 2012, madokotala akudandaula kuti mankhwala ozunguzidwa ndi mankhwalawa akugwiritsidwa ntchito ndi New England Compounding Center akugwira ntchito komanso akufa chifukwa cha matendawa. Mankhwala ophatikizidwa owonongeka amatha kutenga miyoyo, madola komanso mbiri ya akatswiri a zamankhwala mwina sangadziwika kwa zaka zambiri.

Chomwe chinawonekera mofulumira kwambiri kuchokera ku US Food and Drug Administration ndi kafukufuku wa boma la pharmacy board, komabe, kuti antchito a NECC sankagwirizana ndi malamulo okhudza mankhwala osokoneza bongo, kapena kutsatira ndondomeko zabwino zowonjezera khalidwe la mankhwala osokoneza bongo.

Olemba ndi odwala ayenera kumakhala osaganizira za pharmacies onse owonjezera. Kuwonetsa zosowazo kumafuna azimayi, asamalima a ophunzira, komanso akatswiri a zamankhwala kuti adzipangitse kuti azitsatira. Njira yabwino yosonyezera dziko lapansi iwe ndi anzanu mukuchita izi ndi kupeza kuvomerezedwa kwa mankhwala.

Chiyambi cha PCAB Chivomerezo

Bungwe la Pharmacy Compounding Accreditation Board lapenda ndikuwonetseratu antchito, malo, ndi njira zogwiritsira ntchito pharmacies oposa 100 ku America kuyambira mu 2006. Iwo amapanga luso komanso ndalama kuchokera ku

• American College of Maphunziro
• National Community Pharmacists Association
• Association of Pharmacists Association
• National Alliance of State Pharmacy Associations
• International Academy of Compounding Pharmacists
• National Home Infusion Association
• Bungwe la National Boards of Pharmacy

• United States Pharmacopeia

PCAB yovomerezeka imasonyeza kuti ogwira ntchito pakuphatikizana amakhala ndi maphunziro abwino komanso opitilira pokonzekera mlingo woyenera; kuti mankhwala amagwiritsira ntchito zogwirira ntchito zogwiritsira ntchito mankhwala ndi zoperewera; komanso kuti njira zonse zowonjezereka zimakonzedwa mokwanira ndikuchitidwa molingana ndi mayendedwe apangidwe.

Chochititsa chidwi, malo ochipatala a Veterans Affairs angagwirizane ndi pharmacies omwe ali ovomerezeka ndi PCAB.

Ma PCAB amalandira mankhwala osakaniza osagwiritsidwa ntchito mankhwala osagwiritsidwa ntchito, koma samafuna ntchito za mankhwala a nyukiliya kapena pharmacy kunja kwa United States.

NECC sinali PCAB yovomerezedwa.

Owerenga amakhulupirira kuti iwo ndi olemba ntchito ndi odwala omwe amam'tumikira adzapindula popeza chivomerezo akhoza kulumphira ku PCAB ndikugwiritsa ntchito pa intaneti.

Ikuyamba ndi Anthu Abwino

Ma pharmacy ovomerezedwa ndi PCAB, malinga ndi bungwe, ayenera kusonyeza kuti "ogwira ntchito onse ogwirizana ... ali oyenerera kuchita ntchito zawo." Izi zikugwiritsidwa ntchito poyang'anira azimayi, azimayi ogwira ntchito zamalonda , asamalonda a ophunzira omwe amapereka ntchito yowonjezereka ndi akatswiri a zamankhwala. Kuwonetsera maluso amayenera kusonyeza kuti ogwira ntchito ali ndi malayisensi, zovomerezeka, zizindikilo, ndi kulembetsa. Pa Jan. 1, 2015, alangizi onse ogwira ntchito pa pharmacies ovomerezeka ayenera kutsimikiziridwa.

Ndiye Mukusowa Makhalidwe, Zida, ndi Malemba

Ogwira ntchito ya pharmacy amafunikanso kulembera kutsata kwa USP 795 osalerile compounding ndi USP 797 steryile compounding miyezo. Izi zikutanthawuza kulemba njira zomwe zimagwiritsidwa ntchito pamapepala kapena pamakompyuta komanso kusunga malemba omwe amalola kuti ziwerengero zikhale zofanana ndi odwala.

Mankhwalawa ayenera kukhala ndi zida za momwe zida zimasinthira, komanso zipangizo zimatsukidwa, ndipo zipangizo zimayesedwa kuti zikhale zabwino komanso zoyera. Ma pharmacy omwe akufuna PCAB kulandirira amafunikanso kutsimikizira kuti amangokhala ndi ma API ndi zipangizo zina zomwe zimagwirizana ndi ma USP ndi National Formulary , kulembetsa ma API onse pa malemba a malonda ndi kusunga zizindikiro zowonongeka ndi zipangizo zamakono zotetezera zomwe amagwiritsa ntchito.

Chinthu chofunika kwambiri kuti tigwirizane ndi USP 797 ndikuvomerezedwa ndi PCAB kuti ma pharmacies akuphatikiza mankhwala osokoneza bongo omwe amachititsa kuti odwala athe kudwala ngati ali oipitsidwa ayenera kukhala ndi zipinda zoyera zogwirizana ndi ISO-8. PCAB ikugogomezera kuti kugwiritsa ntchito zipangizo zowonjezereka monga kuzungulira aseptic isolators sizowonongeka nthawi zonse kuti zitsimikizidwe kuti ndizochepa.

Malipiro apachaka Amafunikira

PCAB kuvomereza kumadalira makamaka zotsatira za malo omwe amafufuza omwe akutsimikizira kuti ali ndi ziyeneretso za anthu, kufufuza zipangizo ndi zipangizo, ndikuonetsetsa kuti zolemba ndi zolemba zili zolondola. Apamtima omwe akuyesa kubvomerezedwa koyamba kapena kubwezeretsa ndalama amalipiritsa ndalama zonse zoyendera.

Ma pharmacies amaperekanso malipiro a nthawi imodzi komanso ndalama zapachaka zochokera kuwonjezera mphamvu.