UBND TiNH CAO BANG CONG HOA XA HO' CHU NGHIA VIVT NAM S6 Y TE Dlic 14p - Tir do - Hanh phtic

s6: 3 5g /SYT-NVD

V/v cap nhat thong tin lien quan den khang sinh nhom Plymyxin (thuoc chfra colistin va natri colismethat), thuoc chfra valproat va thuOc chfra

testosteron

Cao B'ang, ngay Mang 3 nam 2015

Kinh giri: - Cac doanh nghiep kinh doanh thu6c trong tinh; - Cac co so. kham chfra benh twig tinh.

Theo cong van s6 2484/QLD-TT, ngay 11/2/2015 dm Cue Quan 1ST Duoc ve viec cung cAp th6ng tin lien quan den khang sinh nh6m Plymyxin (thu6c chira colistin va natri colismethat), thuoc chira valproat va thu8c chira testosteron. De dam bao muc tieu sir dung thuoc an toan, hop 1ST va hieu qua, SO Y to thong bao tai cac co so kham chira benh, cac don vi kinh doanh duoc ten dia ban tinh cac thong tin lien quan den dO an toan, hieu qua va ket Juan cua HOi dOng Tu vAn cAp SO dang 14 luu hanh thu6c - BO Y t6 d6i vai cac thu6c neu tren.

Thong tin chi tiet ve dO an toan, hieu qua ding ket Juan cua HOi dOng Tu vAn cAp SO dang ky luu hanh thu6c d6i vai cac thuoc khang sinh nhom Plymyxin (thuoc chira colistin va natri colismethat), thuoc chira valproat va thuoc chira testosteron ducic ghi trong Phu luc "Cap nhat thong tin lien quan den tinh an toan cira thuoc" dinh kern trong ding van nay, dung thai dugc dang tai tren trang th6ng tin dien tur So. Y to Cao Bang. De nghi cac don vi cap nhat cac thong tin &roc 1ST lien quan den chi dinh, lieu dung va cach dung, canh bao va than trong khi sir dung, tac dung khong mong muon cua cac loai thuoc neu tren de sir dung thuoc an toan hop 1S, va hieu qua.

Doi voi cac co so. kham, chfra benh phai tang cuong theo r8i, phat hien va xir tri cac trui'mg hop xay ra phan img co hai cua thuoc neu ten (neu c6). Girl bao cao phan img co hai cua thuoc ve: Trung tam quoc gia ye Thong tin thuoc va Theo dOi phan img co hai cua thu6c (13-15 Le Thanh Tong, Quan Hoan Kiem, Ha NOi) va 01 ban giri ve Phong Nghiep vu Duge So Y

Y t6 thong bao de cac don vi biet va thvc hien./. Nei nhein: - Mu( tren; - Ph6 GD So Y to (D/c Cao); f 0 - Phong Nghie'p vu Y; i z - Website Sa Y te; - Ltru: VT, NVD. \*

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Ham Trung Cao

M DOC DO

PHU INC p nh4t thong tin lien quan c en tinh an toan thuOc

(Dinh kern theo Cong van ngay .,i,(thangt,Lnam 2015)

1. Khang sinh nhom polymyxin (thaw china colistin va natri colismethat):

Ngay 24/10/2014, Ca quan Quan 1)'T Dugc Chau Au (EMA) thong bao da a

soat lai d6 an toan va hieu qua cua cac cha pham khang sinh china colistin hoac natri colistimethat va lchuyan cao can thay doi nhan thu6c va 0 huong dan sir dun (HDSD) cua cac thuoc nay de dam bao an toan cho benh nhan trong dieu tri ca tnreng hop nhigm khuan nghiem trong da de khang vdi cac khang sinh thong thu6ng

lily ban thu6c sir dung tren ngtrai (CHMP) da xem xet thong tin ve dugc d6r hoc, hieu qua va an toan cua cac khang sinh nhom polymyxin. Cac thu6c dugc ra soat dot nay bao g6m cac thu6c chira natri colismethat dUng duang tiem hoac dung khi dung du6i clang dich long vao ph6i. Natri colismethat dugc chuyen h6a thanh boat chat colistin trong ca the nguad.

CHMP kat Juan rang tiem hoac truyen (nhe giot) natri colistimethat chi nen uu tien de dieu tri cac tnrerng hop nhiem khuan nghiem trong do cac chUng vi khuan nhay cam khi viec lua chon cac khang sinh khac bi han cha. Khang sinh nay ne, n

dugc dung phi hop voi cac khang sinh khdc nau c6 the. CHMP ding khuyan ca 0

lieu dung cda natri colistimethat nen dugc ke don theo don vi qu'L t6 (IU). Do lie dung cua natri colismethat c6 the dugc viat du6i nhieu dang khac nhau nen can c 0 mot bang quy d6i trong nhan thu6c va to( HDSD. Nhang benh nhan nang nen dugc

dang lieu tai de nhanh chong dat dugc n6ng d6 khang sinh co hieu qua trong co th e.

Mac du nhang thong tin hien co rat han cha, 11y ban nay van dua ra khuyan coo v e lieu dung cho benh nhan co suy than va tre em, d6ng that cung cap nhang huong can ve lieu dung cho benh nhan nguai 16.n tiem thu6c vao tuy song hoac nao that.

Tai Viet Nam, hien co 07 s6 dang 14. (SDK) thu6c trong ntrac c6 china na colismethat dang b6t pha tiem va chua c6 SDK thu6c nuacc ngoai nao chira colisti n

hoac natri colismethat. cl -dng Tic yin ccip SDK ltru hanh thuac - Bo Y ti hien clang tiip tic xem A

va se dua ra kit luan c of vai cac thueic nay sau khi cap nhat them quyit clinh ctia c quan quan ly cac ntrac khac co lien quan.

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2. Thu6c chfra valproat 2.1. Ca quan quan 1)", Dugc Chau Au Ngay 21/11/2014, Nh6m dieu ph6i thuoc sir dung cho con nguai theo nhting

quy trig- h khong tap trung va thira rthan1L nhau giaa cac thanh vien trong lien mink Chau Au (Coordination Group for Mutual Recognition and Decentralised Procedures — Human — CMDh) da chap thuan viec that chat viec han sir dung thuc chda

valproat tren phu nil do nguy ca gay quai thai va cac r6i loan phat trien theo lira tuai d6i vai tre tirng bi phai nhigm thuc chira valproat tix trong thai kY, tiep theo kien nghi cua Uy ban Danh gia nguy Ca Canh giac Dugc Chau Au (PRAC) true thuc Ca quan Quin ly Dugc Chau Au (EMA) vao ngay 10/10/2014 tnrac do.

Cac bac sy dugc khuyen cao khong nen ke dan thuc chira valproat cho benh Ong kinh hoac r6i loan tam than Wing cuc dOi vai tre vi thanh nien nit va phu nir dang mang thai hoac du dinh mang thai trir truang hop cac phac do dieu tri lchac khong co hieu qua hoac benh nhan khong dung nap dugc. Trong truang hgp bat bu6c sir dung thuc chira valproat, phai sir dung bien phap tranh thai c6 hieu qua va viec dieu tri phai dugc bat dau va dugc giam sat bai bac sy CO kinh nghiem trong dieu tri benh. Benh nhan nu dugc ke dan thuc nay khong nen dimg thuc ma khong c6 kien bac sy dieu tri vi c6 the gay hau qua nghiem trong cho chinh benh nhan hoac cho thai nhi. u nhieu nuac, thu6c chira valproat dugc cho phep sir dung de pheng benh dau nira dau. Trong trung hap nay, phu nit tuyet d6i khong dugc sir dung thuc nay vai muc dich a phong dau nira dau khi dang mang thai. Viec phong tranh thai phai dugc tien hanh tnrac khi bat dau dieu tri bang thuc chira valproat va phu MI nen sir

dung ,bien phap tranh thai hieu qua trong su6t third gian dieu PRAC cling da khuyen cao cac bac sy khi ke dan thu6c chira valproat phai cung cap day dd thong tin cho benh nhan nu de dam bao rang benh nhan hieu ro ve nguy ca nay va ling h6 quyet dinh cda bac sy. Ben canh do, bac sT dieu tri phai tin hanh ra soat lai dua tren thuc hanh lam sang thuang quy d6i \Tad viec dieu tri cho tre vi thanh nien nir va phu

bao g6m ca thai gian day thi va chuan bi mang thai. PRAC cling nhan manh rang phu nu dang trong thoi gian dieu tri khong nen toy dimg thu6c chira valproat ma khong tham Ichao y kien bac sy. Cac thong tin san pham a chau Au danh cho nhan vien y to va benh nhan ding se dugc cap nhat thong tin va khuyen cao mai nhat nay.

2.2. Ca quan Quan 1y Dugc Uc (TGA) Gan day, Ca quan Quan ly Dugc Uc (TGA) cling cra cap nhat thong tin lien

quan giaa viec dimg thuc chira valproat trong thai ky mang thai va suy giam nhan thirc a tre.em ten to Thong tin san pham cua cac the pham chira valproat hien hanh

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Uc. Trong muc Dung thu6c trong thai ky da dugc b6 sung canh bao -,/&‘ m6i lien quan gifra r6i loan ph6 to ky va nguy co r6i loan phat tri6'n theo dO tu6i a tre em vai phai nhigm thu6c chira valproat trong thai kST.

2.3. Ca quan Quan Dugc va Thuc pham Hoa KST (FDA) Ngay 05/06/2013, Ca quan Quan ly Dugc Pham va Thvc pham Hoa KS/ (FDA)

clang da dua ra khuyen cao nhan vien y to va Ong (long ve viec chong chi dinh cac thu6c ch6ng dOng kinh chira valproat (bao g6m natri valproat, acid valproic va natri divalproex) dung du phang dau nira dau & phu nu có thai vdi lS'T do nguy co giam chi so IQ tren tr .& bi phai nlam thu6c chira valproat trong thai kV. FDA da chuyen tt:r mirc D (igi ich cua thuoc o mirc chap nhan dugc ben canh nguy co thuoc gay ra ten phu nir mang thai) sang mire X (nguy co cua thu6c vugt tri 16 rang so vai lgi ich thu6c mang lai ten phu nu mang thai) d6i Canh bao cho phu nu mang thai ten nhan cua cac thu6c chira valproat d6i \Teri chi dinh du phong dau nira dau. Tuy mirc dO Canh bao cho phu nu mang thai doi \TM chi dinh di'eu tri dOng kinh va roi loan luting cuc van giir nguyen mirc D nhung FDA clang khuyan cao chi nen ke don thu6c chira valproat trong tuang hgp cac thu6c khac khong dat dugc hieu qua di'eu tri mong muon.

Tai Viet Nam, hien co. 13 SDK thu6c nuac ngoai va 05 SDK thu6c trong nu&c Cua thuoc có chira valproat.

Cuc Quan ly Du-oc - BO Y to se co tong van gt:ri cac clan vi clang ky, san xucit thuoc yeu ccju va htdrng dan viec cap nkit cac thong tin canh bao nay vao ter hwang dZin sir dung cita cac thuoc có lien quan.

3. Thu6e ehfra testosteron - Ngay 10/10/2014, Uy ban danh gia nguy ca Canh gide Dugc Chau Au

(PRAC) trvc thuOc EMA thong bao da hoan thanh qua trinh danh gia dg an toan cua cac the pham chira testotsteron teen toan lanh thO Lien minh Chau Au, dac biet tap trung ra soat cac tac dung phu nghiem trong tren tim mach, mach mau bao gOm Ca nhOi mau ca tim. Ban bao cao cua PRAC chua ghi nhan b.Lag chimg chimg minh viec sir dung testosteron ten benh nhan nam - nhang nguai khong san xuat dit testosteron (lam tang nguy co cac bin c6 tim mach. PRAC clang clanh gia loi ich cf4a viec sir dung testosteron van vuot trOi how nguy co', tuy nhien PRAC dOng theri khuyan cao rang cac the pham chira testosteron chi nen dugc sir dung trong trung hgp su thiau but testosteron dugc xac dinh bang ca trieu chi:mg lam sang va xet nghiem can lam sang.

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- Bang chimg ve nguy co bien co tim mach nghi8m trong cua loci thu6c nay van có nhieu mau thuk Trong mot se) nghien ciru NT'' 0 an toan cua testosteron dugc cong be) gan day, có ba nghien ciru cho rang nguy co 'Dien co tim mach & nhom nam gioi sir dung testosteron tang cao hors nhom nam gioi khong sir dung loci thu6c nay. Tuy nhien cac nghien ciru khdc 'thong Ichang dinh nguy co nay va ba nghien ciru tren van con ton tai mot se) lean die. Mat khdc, PRAC cang cho rang ban than su thieu but testosteron ding có the lam tang nguy ca b8nh tim. Vi Vey, PRAC khuyen cao rang chi nen sir dung cac che pham nay khi lugng testosteron trong co the thuc su thieu but va su thieu but nay phai dugc khana- clinh qua cac tri8u chi:mg lam sang va cac ket qua xet nghi8m. To thong tin san pham dia toan b6 che pham china testosteron er EU can phai cep nhet khuyen cao nay ding nhu cac carih bdo then trong sir dung thu6c nay ten d6i trang nam gioi clang mac cac b8nh nghiem tong tren tim, gan, than. Ngoai ra, 0 thong tin san pham ciing se clugc yeu cau nhan marsh din li8u ve hi8u qua va 0 an toan cda thu6c tren b8nh nhan ten 65 tu6i con han che ding nhu ten thi..rc to luong hormon nay sut giam theo do tu6i va hi8n chua co cac gid tri tharn chieu n6ng cto testosteron tirong irng theo cho tu6i.

- D6 an toan dia cac che pham china testosteron can phai dugc tiep tuc giam sat. Dac biet mot se) nghien ciru van clang dugc lien hanh va cac ket qua dm nhang nghien ciru nay se tiep tuc dug.c! can nhAc trong cac danh gia. lgi ichinczuy co dill:611c,

quy cuoi voi testosteron trong thoi gian

- Khuyen nghi nay cua PRAC da dugc trinh tai Nhom dieu ph6i thu6c sir dung tren nguoi dugc ph8 duy8t theo nhang quy trinh khong tap trong va thda nhan tihau (Coordination Group for Mutual Recognition and Decentralised Procedures -Human - CMDh) che chef dua ra quy& clinh cu6i ding.

- FDA Bang tien hanh danh gid nguy co gay Ot quy, nh6i mdu co tim va tin vong ding nhu danh gia cac bien co tim mach lien quan den kna nang xuat hi8n cuc mdu clang O. dOng mach tren b8nh nhan sir dung testosteron. Kat qua cu6i ding se clugc cong be) trong thei gian tai.

Tai Vi8t Nam hi8n co 04 SDK thu6c nu& ngoai va 01 SDK thueic trong nuac cna thu6c co chira testosteron.

H6i clang Tu• win cap SDK litu hanh thuac - B6 Y to hien clang tie'', tuc xem xit va se dua ra k'jt luau clai vol cac thuac nay sau khi cap nhat them quyet dinh cita co quan quail l.)" cac khac c6 lien quail.

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