Mawaniro Ekuwana Pharmacy Kuwedzera Kubvumirana

PCAB mapurogiramu ekutsanangurira kukwidzika kwepamusoro-mhando yemishonga inokonzera mishonga

Zvinodhaka zvinokonzera kushandiswa kwemashoko ehurumende muna October 2012 apo vakuru vehutano veUnited States vakaparidza kuti varwere vakayirwa nemishonga yakagadzirwa neNew England Compounding Center vaibvumirana uye vachifa nefungal meningitis. Nzira dzakasvibiswa dzakasvibiswa nemishonga inotora muhupenyu, madhora uye unhu hwemhizha hwevashandi vezvemishonga inogona kunge isingazikamwi kwemakore.

Chii chakakurumidza kuonekwa kubva pakutanga kweU.S. Food and Drug Administration uye kuongorora mapurisa ehurumende, zvisinei, ndechokuti vashandi veNECC vakanga vasingateereri mitemo inoronga pharmacy kuwedzera, kana kutevedzera nzira dzakanakisisa dzekugadzirisa zvinodhaka zvemhando yehutano uye hutsika.

Vanyori nevarwere vaigona kunzwisisika kusava nehanya nezvema pharmacy ose ekuwedzera. Kunyatsogadzirisa izvo zvinotarisirwa zvinoda varapi, vadzidzisi vezvokurapa, nevadzidzisi vezvemishonga kuti vazviise kune zvakanakisisa zvekuwedzera. Nzira yakanakisisa yokuratidza nyika iwe nevamwe vako vari kuita izvi ndeyokuwana mushonga wekugadzirisa zvinodhaka.

Kutanga kwaPABAB Kubvumirwa

Iro Pharmacy Compounding Accreditation Board rakarongedza uye rakaratidza vashandi, zvivako, uye maitiro pane makumi maviri emaAmerica emakemikari emakemikari mumasangano 38 kubva muna 2006. Inotora unyanzvi uye mari kubva kune

PCAB kubvumidzwa kunoratidza kuti vashandi vanobatanidzwa mukugadzirisa vane maitiro akanaka uye anoenderera mberi mukugadzirira maitiro akaenzaniswa; kuti pharmacy inoshandisa zvakanyanya kushandiswa kwemishonga inoshandiswa nemishonga uye zvisingashandisi zvinhu; uye kuti zvose zvinogadzirisa maitiro zvakanyatsorongedzerwa uye zvinogadziriswa maererano nezvakaumbwa mazano.

Zvinonzwisisika, Veterans Affairs zvipatara zvinogona kubvumirana chete nemapromita anonzi PCAB-anogamuchirwa.

PCAB zvibvumirano zvisingabatsiri uye zvisiri izvo zvinodhaka zvinokonzerwa nemishonga asi hazvibvumirwi nemitemo ye nyukliya kana ma pharmacy kunze kweUnited States.

NECC yakanga isiri PCAB-yakagamuchirwa.

Vaverengi vakavimbisa kuti ivo nevanyori nevarwere vavanoshumira vanozobatsirwa nekuwana kubvumirwa vanogona kusvika kune PCAB manual uye yekushanda kwekushandisa.

Inotanga neVakarurama

A pharmacacy yePACAB-yakagamuchirwa, maererano nebhodhi, inofanira kuratidza kuti "vose vanobatana pamwe nekugadzirisa ... vane kodzero yekuita basa ravakapiwa." Izvi zvinoshanda pakutarisira vafarimisi, vashandi vezvemasimist , vadzidzisi vezvokurapa vanodzidzisa kugoverana mabasa uye vadzidzisi vezvemishonga. Kuratidza unyanzvi kunoda kuratidzira kuti vashandi vane zvikwereti zvose zvakakodzera, zvigwaro, zvigwaro, nekunyora. Pakazosvika Jan. 1, 2015, vese vanogadzirisa zvinyanzvi pamapromasi vanobvumirwa vanofanira kubvumidzwa.

Ipapo Unoda Maitiro, Zvishandiso, uye Zvinyorwa

Vashandi vezvemishonga vanofanirwawo kunyora kubvumirana ne USP 795 kusagadziriswa kwekodzero uye USP 797 isina kumira mitemo. Izvi zvinoreva kunyora kushandiswa kwemaitiro akaitwa pamapepa kana mumakombiyuta uye kuchengeta marekodhi anobvumira kubatanidza dhesi nemumwe munhu anorwara.

Mishonga yepamusoro inofanirawo kuva nematanda ekuti sei uye nguva ipi iyo inotenderedzwa, zvigadzirwa zvinoshandiswa uye zvakanyatsogadziriswa, uye zvinhu zvakaongororwa zvehutano nekuchena. Ma Pharmacies achitsvaga kubvumirwa nePACAB anodawo kuratidza kuti anongowanikwa neAAPIs nezvimwe zvinhu zvinosangana ne USP uye National Formulary maitiro, inyore ma API ose pamakero emakambani uye kuchengeta zvivako zvekuongorora uye zvinhu zvekuchengetedza dhidhiketi dzemashizha yezvinhu zvose zvavanoshandisa.

Chimwe chinodikanwa chekuzadza kwakakwana kwe USP 797 uye PCAB kuvimbiswa ndeyokuti ma pharmacy anowedzera zvinodhaka izvo zvinokonzera ngozi kune hutano hwevarwere kana vakasvibiswa vanofanira kuva nehana dzakachena dzinosangana neIO-8 mitemo. PCAB inotsanangura kuti kushandisa zvinyorwa-zvakajairika zvakadai sekugadzirisa aseptic isolators hazvisi nguva dzose zvakakwana kuita kuti sterility igone.

Mari Yegore negore inodikanwa

PCAB kubvumirwa kunowanzoenderana nemigumisiro ye-site-chekuongorora apo vatsigiri vanosimbisa unyanzvi hwevashandi, chekuongorora zvishandiso uye zvivako, nekuvimbisa kusarurama kwezvinyorwa uye zvinyorwa. Ma Pharmacies anokumbira kubvumidzwa kwekutanga kana kuberekwazve kubhadhara mari yakazara yekuongorora imwe neimwe.

Pharmacies uyewo anobhadhara mari yekushanda kwemaawa imwe chete uye mari yegore negore zvichienderana nekuwedzera kwevhesi.