SỞ Y TẾ TỈNH HÀ TĨNH 910.signed

SỞ Y TẾ TỈNH HÀ TĨNH 910.signed tài liệu, giáo án, bài giảng , luận văn, luận án, đồ án, bài tập lớn về tất cả các lĩnh...

LONG HOA XA HOI CHU NGHIA VItT NAM

Dick lap — Tkr do — Hanh One

UBND TINH HA TiNH

SOYTE S6: 9,10 /SYT-NVD V/v cap nh4t htrang dAn sir dung thu6c ch.Ong viem khong steroid (NSAIDs) va

khong /Thai aspirin

Ha Tinh, ngayArthang 5 nam 2017

Kinh giri:

- Cac dun vi kham chira bOh;

- Trung tarn,Y to du phong cac thi xa, thanh ph6 ;

- Phong Y to cac huyesn, thi xa, thanh pho;

- Cac Cong ty dugc trong tinh

Can cu Cong van, s6 5749/QLD-DK ngay 27 thang 4 nam 2017 ,ciia Cyc Quan dugc - BO Y to v&' vi& cap nhAt hu6ng dan sir dung thuoc chong viem khong steroid (NSAIDs) va khong phai aspirin;

,De' dam bao sir citing thu6c an toan, hgp So' Y to sao giri Phu ltic I "Nguy

co bien co teen tim mach lien quan den v* sir dung cac thuoc chong viem khong steroid, khong phai aspirin"; Phu lye II "Cac not dung thay doi, be, sung tren nhan, huang dan sir citing cua cac thuoc chong viem khong steroid, khong phai aspirin va diclofenac dung du6ng toan than"; Phu hic III "Cac not dung thay , b6 sung tren huong dan sir citing cua cac thuoc china diclofenac dung du6ng toan than" va you cau:

- Cac dun vi kham chcia Nnh thong bao r6ng rai cho can b6 vien chtrc cac khoa phong, b6 phAn biet thong tin lien quan den tinh an toan cua thuoc chong viem khong steroid (NSAIDs) va kh6ng phai aspirin;

- Trung tam Y to du phong cac huye'n, thi xa, thanh ph6 thong bao cho cac tram y to xa, ,phtiong, thi tran teen dia ban Net thong tin lien quan den tinh an toan cua thuoc chong viem khong steroid (NSAIDs) va khong phai aspirin;

- Phong Y to cac huy0, thi xa, thanh ph6 thong bao cho cac nha thu6c to nhan va cac co so hanh nghe y to nhan tren dia ban Net thong tin lien quan den tinh

an toan cua thuoc chong viem khong steroid (NSAIDs) va kh6ng phai aspirin;

- Cac Cong ty dugc thong bao cho cac chi nhanh, quAy thu6c, dg.i 13", trong he thong phan phoi cua minh biet thOng tin lien quan den tinh an toan cua thuoc chong viem khong steroid (NSAIDs) va khong phai aspirin;

- Cac dun vi kinh doanh, sir citing thu6c tang cuang thgc hie‘n vie;c theo dai tac dung khong mong muon cua thuoc trong qua trinh sir citing va luu hanh Girl bao cao ADR (neu co) cua thuoc ve: Trung tam quoc gia ve Th6ng tin thuoc va

Người ký: Sở Y

tế

Email:

soyte@hatinh.g

ov.vn

Cơ quan: Tỉnh

Hà Tĩnh

Thời gian ký:

15.05.2017

09:13:33 +07:00

Theo dal cac phan irng c6 hai cila thu6c (13-15 Le Thanh Tong, Quan Hoan Ki6m,

Ha Nc)i) va Ph6ng Nghiep vu dugc - Si Y fL

Noi nht:in:

- Nhir tren;

- Website Sa Y t6;

- Liru: VT,P.NVD

Giri van ban giay va die;ntir 'lime_

BO Y TE CONG HOA XA HOI CHO NGHIA VICT NAM

CUC QUAN LY DUOC Doc lap - Tut do — Hanh phfic

PHU LUC I NGUY CO BIEN CO TREN TIM MACH LIEN QUAN DEN VIEC SU" DUNG CAC THUOC CHONG VIEM KHONG STEROID, KHONG PHAI ASPIRIN

(Dinh kem theo cong van so5-170 /QLD-DK ngely2Mgclittia Cyc Quan ly

Dine)

1 Tong quan ve do an toan tren tim mach ciia cac thuOc chtmg viem khong steroid va quyet dinh cua cac quan Quan 1y Dtryc phAm tren the gieri

Co' quan Quan ly Thu& va Thyv pham Hoa K,y (USJ:DA):

Tir dau nhimg nam 2000, du lieu thu dugc tir cac thir nghiem lam sang ngAu nhien co c"6 mau doi chirng bon da cho thay nguy ca huyet khi tim mach khi sir dpng cac thuoc chOng viem khong steroid (NSAIDs) ire the ch9n 19c tren COX-2 Thang 9/2004, nha san xuat Merck to nguyen rat rofecoxib khoi thi trikmg sau khi xac dinh dirge nguy Ca bien c6 tim mach tang len khi sir dung thu6c nay trong thir nghiem lam sang ve hqi chimg da polyp tuyen CO tinh chat gia dinh Day dugc coi

la diem khOri dau cho su ra dai dm hang boat bao cao tong quan, phan tich g6p the

thir nghiem lam sang va nghien curu dich to dugc hQc ye tat ca the NSAIDs irc the ch9n 19c tren COX-2 va khong ch9n 19c

Ngay 9/7/2015, US.FDA tiep tic thong bao ve viec tang cuang canh bao nguy ca nhoi mau ca tim va d6t quy, khi sir dpng cac NSAIDs US.FDA yeu cau nhan thu6c va to HDSD cua tat ca cac thu6c NSAIDs can ke don va khong can ke dam (OTC) du can cap nhat de phan anh mot s6 thong tin nhu: nguy ca nh6i mau

ca tim va d6t quy, c6 the xuat hien sam trong vai tuan du tien sir dung NSAIDs, nguy co nay tang ben khi sir dung NSAIDs lieu cao va keo dai CO quan niem cho thay tat ca cac NSAIDs deu CO nguy co tucmg tix nhau Tuy nhien, theo US.FDA, chua CO dAy du bang chimg de co the xac dinh chac chan NSAID cu the nao c6 nguy Ca cao han hay thap han NSAID khac NSAIDs co the lam tang nguy co nhoi mau co tim hoac d6t,quy benh nhan mac kern hoac khong mac kern benh tim, CO hoac khong co cac yeu to nguy co xuat hien benh tim, ty le uac down khae nhau

giira cac nghien ciru, php thu6c vao loaf thu6c va lieu thuoc da sir dung

Thang 11/2016, ket qua ctia thin nghiem lam sang PRECISION mai dugc ding b6 Day la mot thir nghiem lam sang niau nhien, mu doi, co doi chimg, cac nham sir ding thuoc song song nham danh gia d6 an toan tren tim mach dm celecoxib, ibuprofen hoac naproxen trong dieu tri thodi hoa khop hoac viem khap Bang thap 6 benh nhan san co ho4 co nguy co cao xuat hien benh tim mach khi sir dung cac thuoc nay Ket qua cho thAy celecoxib su dung o mire lieu trung binh c6 d6 an toan tren tim mach khong thua kern ibuprofen holac naproxen Tuy nhien, da

so benh nhan trong thir nghiem PRECISON dugc sir dung celecoxib 0 lieu 200 mg

Vi vay, ket qua Gila nghien ciru chi phan anh dO an, toan caa viec sir dung mirc lieu trung bin.h celecoxib ma khong nghien ciru den anh huang cua viec sir dung thuoc a mire lieu cao

Co' quan Quan ly Duvc pham Chau Au (EMA):

Nam 2005, Ca quan Quan 13% Dugc pham Chau Au (EMA) ding da c6 met

so dOng thai lien quan den viec sir dung cac NSAIDs chgn 19c va khong ch9n 19c Ket Juan cua EMA co diem khac biet so v6i US.FDA, cho rang cac thu6c uc the ch9n 19c COX-2 c6 nguy Ca huyet khei tim mach cao han so v6i cac NSAIDs khOng chon 19c Do c6 mOi lien quan gifra nguy ca tim mach va viec sir dung cac

NSAIDs irc the ch9n 19c COX-2, cac thuec nay dugc khuyen cao sir dung 6 lieu

hang ngay thap nhat CO hieu qua trong th6i gian ngan nhat co the Tuy nhien, EMA cling khong loaf trir viec sir dung cac NSAIDs khong ch9n 19c co lien quan den st; tang nhe nguy ca huyet khoi tim mach, cl4c biet 6 benh nhan dimg lieu cao, Iceo dai

Nam 2012, theo a nghi dm Ca quan Quan ly Duce pham Anh (MHRA) ding v6i nhang phat hien ve dO an toan cua cac NSAths m6i dugc dog be, Uy ban danh gia nguy co Canh giac dugc (PRAC) dia EMA da bat dau den hanh ra sok lai du lieu ve de an toan cua cac NSAIDs Tren ca s6 de, PRAC khuyen cao cac bien phap giam thieu nguy ca huyet khei tim mach khi sir dung cac thuec tare the ch9n 19c COX-2 ding an ap dung cho diclofenac Hoi (Ring Chau Au da ra quyet Binh cuOi cling, ap dung khuyen cap ten yeti cac thuec chira diclofenac ten toan Chau Au vao ngay 25/09/2013 Nguy ca nay cling dugc canh bao voi ca them thuec va khuyen cao tat ca cac NSAIDs nen dimg lieu hang ngay thap /that CO hieu qua trong thei gian ngan nhat c6 the

Co' quan Quan If Duvc ph A dm Australia (TGA)

Nam 2012, Co quan QuanlY Dugc pham Australia (TGA) da den hanh phan tich du lieu y6 nguy co tim mach trong y van lien quan den viec sir dung 8 thuec NSAIDs dugc km hanh tai Australia Ca quan nay ding long quan diem v&i US.FDA va EMA cho rang viec sir dung cac thu6C irc the COX-2 va hau het cac NSAIDs ce dien deu lam tang nguy ca benh,tim mach a mu trung With tuang tkr nhau Nhan thuoc va HDSD cac thuoc ke dan c6 china NSAIDs clang km hanh 6 Australia cleu da the hien dugc phu hgp va day du cac bang chimg hien CO

ve do an toan teen tim mach dm cac NSAIDs

Co quan Quan ly Duvc pham Singapore (HSA):

Tai Singapore, Ca quan Quan ly Dugc pham (HSA) da giam sat chat the dO

an toan tren tim mach khi sir dung cac NSAIDs tir nam 2005 Ngay tin then diem do, sau khi ti6n hanh danh gia can bang nguy ca - lgi ich, HSA da ket lu'O.n c6 su tang rifle nguy ca tim mach lien quan den viec sir dung NSAIDs Twang tix nhu cac Ca quan Quan ly Dugc pham khac, HSA nhan thay trong nhimg nam gan day, cac bang chi:mg ye vec sit dung lieu cao, keo dai diclofenac CO lien quan den stn tang nguy ca tim mach dirge ding bo ngay cang nhieu Tir d6, HSA dua ra met so khuyen cao ye viec sir dung diclofenac danh cho can be y to a tang cuOng de an toan khi sir dung thuoc nay

Ca quan Quan ly DuVc philm Canada (Health Canada):

Nam 2013, Ca quan Quan Dugc pham Canada (Health Canada) da den hanh met tong quan phan tich ve de an toan cua diclofenac dung duang Wing va d4t true trang Ket Juan cua cu()c ra soat nay cho thay viec sir dung diclofenac ca, lien quan den sv tang nguy ca xuAt hien hien co bat lgi lien quan den tim va clot quy De

giam thieu nguy ca ten tim mach lien quan den sir dung diclofenac, nhan thu6c va

to HDSD cua cac thu6c nay & Canada da &lac cap nhit thOng tin ten Tiep theo hoat chit diclofenac, Health Canada cling lien hanh mot phan tich tong quan du li8u ve dc) an town cua Ca celecoxib Health Canada ding cho rang khi celecoxib

&rot dung theo khuyen cao, hi8u qua cila thuoc nay hi8n yin vuot trOi nguy ca

Health Canada cling da ra soat ca dO an town ten tim mach lien quan den vi'ec sir dung lieu cao ibuprofen Ket qua cho thay vi8c sir dung cac thuOc k8 don chira ibuprofen lieu cao (lieu hang ngay > 2400 mg) ca lien quan den tang nguy ca bier' c6 bat lqi lien quan den tim va dOt quy, dac bit ten b8nh nhan co tien sir hoac c6 cac yeu to nguy ca xay ra benh tim ho4c dOt quy Hi8u qua dm ibuprofen hilen van vuat trOi nguy ca do thuoc gay ra

Dua tren quyet dinh cua cac Ca quan Quan ly Dirac phdm tren the gieri, de dam bao dO an town ten tim mach, cac can 1)0 y to can luu y cac van de sau khi sir dung NSAIDs:

Cac thu6c ch6ng viem khong steroid (NSAIDs) c6 the lam tang nguy ca xuat

hi8n bien c6 huyet kh6i tim mach, bao gom ca nh6i mau ca tim va dOt quy,

co the an, den tir vong Nguy ca nay co the xuat hi8n sam trong vai Win dau dimg thuoc va co the tang len theo theyi gian dung thu6c Nguy ca huyet khoi tim mach dirge ghi nhi.n chu y6u ajiL cao

Bac si can clank gia dinh kS, su xuat hi8n cua cac bien c6 tim mach, ngay ca khi benh than khong co cac tri8u chimg tim mach truarc do Wenh nhan can duot canh bao ve cac tri8u chirng cua bien c6 tim mach nghiem tong va can tharn kham bac si ngay khi xuat hi'en cac tri'eu chimg nay

De giam thieu nguy ca xuat hi8n bien c6 bat lqi, an sir dung NSAIDs a lieu hang ngay thdp that co hi8u qua trong thai gian ngin nhat c6 the

Cac thin nghi8m lam sang va dich to duoc hoc cho thy viec sir dung diclofenac c6 lien quan den tang nguy ca xuat hi8n bien CO huyet khi tim mach (nhu nhoi mau ca tim hoac dOt quy), dac bit khi sir dung diclofenac lieu cao (150 mg/ngay) va keo dai Vi vdy, rieng doi vai diclofenac, chOng chi dinh diclofenac a benh nhan suy tim sung huyet (tir d6 II den dO IV theo phan d6 chirc Wang cua suy ti.m theo H6i Tim New York - NYHA), benh tim thieu mau cue b6, benh dOng mach ngoai vi, benh mach mall, nag Can rat than tr9ng khi str dung diclofenac cho cac benh nhan co cac yeu to nguy co r6 rang xuat hien cac bien co tim mach (n.hu tang huyet ap, tang lipid huyet thanh, dai thao duimg, nghien thaw la).1

BO Y TE CONG BOA XA HOI CHI) NGHIA VIET NAM

PH1J LVC II Cfic nOi dung thay d6i, bO sung tren nhan, htroug clan sir dung ctia cac thmic chtmg viem khong steroid, khong phai aspirin va diclofenac dung duong toan

than

(Dinh kern theo tong van so Slin /QLD-DK ngay cita Cyc Quan ly

[Doi v6i tat ca cac thu6c ch6ng viem kh6ng steroid, khong phai aspirin va

A

diclofenac dUng duong town than, thong tin tren than thuoc va t6 HDSD can b6 sung de phan anh cac thong tin &roc cung cap duai day]

1 Canh bao va than trung

1 ]

Nguy co* huyit khoi tim mgch:

Cac thu6c ch6ng viem khOng steroid (NSAIDs), khong phai aspirin, dung duong town than, c6 the lam tang nguy co xuat hien bien c6 huyet khOi tim mach, bao gOm

ca nh6i mau co tim va dot quy, c6 the dan den tit vong Nguy co nay có the xuat hien sam trong vai ,tuan du dung thu6c va c6 the tang len theo thoi gian dUng thu8c Nguy co huyet kh6i tim mach duqc ghi nhan chu yeu a lieu cao

Bac si can danh gia Binh ky su xuat hien cua cac bien co tim mach, ngay ca khi benh than khong c6 cac trieu chimg tim mach truac d6 Benh nhan can duoc canh bao ve cac trieu chi:Mg cna bien c8 tim mach nghiem tong va can tham kham bac si ngay khi xuat hien cac trieu,chimg nay ,

De giam thieu nguy co xuat hien bien co bat lot, can six dung [ten thutic] lieu hang ngay thap nhat CO hieu qua trong th6i gian ngan nhat co the

1 ]

2 Tac dung khong mong man'

Nguy co huyet khoi tim mach (xem them phan Canh bao va than tong)

1-1

./

BO Y TE CONG HOA XA HO! CHU' NGHIA VIET NAM

CUC QUAN LY DUOC DOc lap - Tkr do — Hanh phut

PHU LUC III Csic nOi dung thay d i, be sung teen htr&ng dan sir dung ciia cac thuec china

diclofenac dung &thug town than

(Dinh kem theo tong van so SirrYg /QLD-DK ngiry cita Cue Quan ly Duoc)

,-A-1/1/ 4 4 7 z - • •

[Doi voi tat ca cac thuoc china diclofenac dungclueing toan than (du.64 uong, tiem va ddt trtrc trang), thong tin ten nhAn thu6c va t6 HDSD can bet sung de phan anh cac

thong tin throe cung cap dtrai day]

I Lieu dung va each thing

1 ]

• •

De giam thieu nguy co xuat hien bien c6 bAt loi, can sir dp—g [ten thu6c] 6 lieu hang

ngay thAp nhAt co hieu qua trong theri gian ngan nhAt có the (xem them phAn Canh bao

va then tong)

i ]

2 Chong chi dinh

Benh nhan suy tim sung huyet (tir de II den de IV theo phan de chi:re nang cUa suy tim theo Hei Tim New York - NYHA), benh tim thieu mau cut be, benh dOng mach ngoai

vi, benh mach mau ndo

3 Canh bio va thOn tryng

1.1

Nguy co buy& khdi tim mach:

Cdc thuoc chOng viem khong steroid (NSAIDs), khong phai aspirin, dung duemg town than c6 the lam tang nguy co xuat hien bien co huyet khoi tim mach, bao gom ca nhoi mau co tim va quy, có the clan den to vong Nguy co nay co the xuat hien sam tror$ vai.tuan dau dung thuoc va có the tang len theo thOi gian dung thuoc Nguy ca huyet khoi tim mach &roc ghi nhan chu yeu a lieu cao

Bac sT can danh gia dinh ky sun xuat hien cda cac bien co tim mach, ngay ca khi benh nhan kh6ng co cac trieu chirng tim mach tru4c do Besnh nhan can &roc canh bdo ve cac trieu chimg cira bien co tim mach nghiem trong va can tham kham bac si ngay khi xuat hien cac trieu chUng nay

De giam thieu nguy co xuat hien bien co bat Igi, can sir dung [ten thuOc] o lieu hang n4ay thap nhat co hieu qua trong thOi gian ngin nhat co the

Can can nhac can than khi sit dung diclofenac cho benh nhan có cac yeu to nguy co xuat hien cac bier' co tim mach ro net (nhu tang huyet ap, tang lipid huyet thanh, dai than duOng, nghien thuoc la)

[ ]

4 Tfic dung khong mong main

Nguy co huy6t khi tim mach: Cac thin nghiem lam sang va dich to clugc h9c cho thay viec sir dung diclofenac co lien quan den tang nguy ca xuat hieu hien co huyet Ichoi tim mach (nhu nhoi mau ca tim hoac d6t guy), dac biet khi sir dung diclofenac a lieu cao (150 mg/ngay) va keo dai (xein them phan Canh bao va than trong)

/