Nghien CCFU - Ky thuat
vDanh gia thu-c trang hoat flong Canh giac Dirge cua mot so benh vien tai Viet Nam
• • • • •
Pham Thi Thuy Vdn', Nguyen Tfi Sm\ Tran Thi Lan Anh^ Nguyin Hoang Anh^"
'BQ mon Duac ldm sdng
^Bo mon Qudn iy vd Kinh te Dupc
^Trung tdm DI & ADR Quoc gia. Truomg DH Duac Hd Npi 'E-mail: anh90tk@yahoo com Summary
On the purpose to contribute to furtfier development and improvement of ttie management of ptiarmacovigilance in iiospitals, the Indicator-based Pharmacovigllance Assessment Tool (IPAT) developed by the Strengthening Pharmaceutical System in 2009 was used to describe the actual pharmacovigllance activities in the year 2012 at 12 selected hospitals. The private hospitals achieved over 70% total performance score; all the sun/eyed public hospitals achieved less than 50%. Ail the sun/eyed hospitals got absolute score on the following indicators: Unit responsibility for monitoring safet/of medicines, personal dedication to pharmacovigllance, availability of pharmacovigilance budget, ADR form and collection of pharmacovigllance data from the National Dl & ADR center. Hovi/ever, still remained under development the risk assessment and evaluation activities.
Keywords: Indicator-based Pharmacovigllance Assessment Tool, hospitals, 2012.
Dat van de
Theo thong k& gan day tai c^c nirac phat trien, cfi 10 benh nhan dieu tri npi tnj ed mdt benh nhan xuat hi$n b i l n co bat Igi. Con so nay con eao hon a cac nu'dc dang phat trien, gdy ton kem hang chuc ty do la m6i nam'^°i. De han e h l v l n de nay, vi^c trien khai h$ t h i n g Canh giac Du'gc (CGD) trong benh vipn dang ia u'u tien hang dau trong chinh sach y t l cua nhieu nudc trong do cd Viet Nam i"i. Quyet djnh s6 68/QD-Ttg cOa Thu tu'dng Chfnh Phu ban hanh ngay 10/1/2014 phe duyet C h i l n iupc q u i c gia phat trien ngdnh Dugc d i n nam 2020 vd tam nhin 2030 da neu ro 1 trong nhung quan d i l m phat triln la "Sfi dung thulc hgp ly, an toan, hieu qua; day manh hoat dong Dugc lam sang va Cdnh giac Dugc". Trung tam Qudc gia ve Thong tin thudc va theo doi phan fing cd hpi cua thulc (Trung tam Dl & ADR) du^gc thanh lap tfi nam 2009, da gop phan lfing budc trien khai cac hoat dpng theo doi an toan thuoc trong cdng ddng va b$nh vi6n, t u van xSy dyng cac van ban va hudng dan chuyen mon cung nhu trien khai dao tao ve CGD '"'. Tuy nhieu b§nh vien da trien khai cac don vj lign quan d i n an toan thulc trong bpnh vi#n nhung mfic dp thyc hidn con chua dong bd ''^. V6i myc dich cung cap bang chfing ve thyc trgng hoat ddng Canh giac Dugc, xae djnh nhfing diem tdn tai, tren co sd dd de x u i t giai phap ndng cao hieu qua hoat dong, chung
toi sfi dung bd cdng cu danh gia hoat dpng Cdnh giac Dugc dya trSn cdc chi so (Indicator-based Phannacovigilanee Assessment Tool- IPAT) d l danh gia c^u tnic hp t h i n g Canh giac Di/gc, hoat ddng phat hien, danh gia va quan ly nguy ca Ii6n quan den thuoc tai mpt so bSnh vien.
Doi tu'O'ng va phiporig phap nghien CU'U
Ooi t u ^ n g nghien c f i u
Nghien cfiu d u g c t r i l n khai tai 12 b#nh vifn (BV) da khoa, lya chpn dya tren tmh dal di?n cho cae vCing theo dja ly va eac t u y l n b f n h vipn cQng nhu hinh thfic sd hfiu: cdng ldp va t u nhan. Bfnh vipn trung uong bao gom; Benh vien Hfiu nghj, Benh vien Vi6t Nam-Thuy Dien Uong B(, B?nh vien C Da Ngng, Benh vien Da khoa Trung uong Can Tho. Benh vien tinh bao gom: Benh vifn fia khoa tinh Quang Ninh, Bgnh vien Da N i n g , Bfnh vien Thanh pho C i n Tho. Benh vien huypn bao gom: Benh vien huyen Ddng Trilu, Bpnh vifn qu§n Hai Chau, Bpnh vipn huyen 6 Mon. Bfnh vien t u nhan bao gom: Bpnh vign Vinmec, B§nh vign Da khoa Hoan My Da Nang.
Phu'O'ng phap nghien cu-u
Nghien cfiu mo ta ck ngang, thu thap s l iifu bdng Bg cau hdi va cdc tai liSu, van ban dd dupc ban hanh tai moi bpnh vien.
TAP CHI D i r o c HOC -10/2015 rSO 474 NAM 55)
• Nghien ciru - Ky thuat
Bp cSu hdi d u g c t h i l t k l theo bd cdng cg danh gia hoat dgng Canh giac Duge d y a trdn cdc ehi so (Indicator-based Pharmacovigilance Assessment Tool- IPAT)'^'. De phu hgp vdi mo hinh t l chfic va hoat ddng cua cac c o s d kham, chfia bpnh tai Vidt Nam, chung tdi da tien hanh Viet hda va khao sat thfi Bp cau hdi nghien cfiu tai 2 benh vidn tren dja ban TP Ha Ngi. Bg cau hdi ehinh thfic de cap tdi 4 ngi dung cCia CGD trong bdnh vidn, bao gdm 34 chi s l trong do 21 chi so chinh (Core - C) va 13 chi s l phu (Supplement - S), trdn cac ITnh vyc:
- Cau trUc hd thong CGD, s y tham gia cua can bp y t l va cac bg phan trong he thong.
- Ph^l hidn nguy co, thu thgp d f i lipu trong thyc hanh CGD.
- D^nh gia nguy co trong thye hanh CGD.
- Quan ly nguy c o , t n j y i n thong an toan t h u l c trong t h y c hanh CGD.
Quy trinh thu thap dirlieu
Bd Cciu hdi d u g c gfii cho ngudi d u g c phdng van qua t h u dien l f i bao gom bg cau hdi va cac iai lieu can chuan bj tiong khoang thdi gian t f i 2-7 ngay t r u d c khi nhom nghien cfiu t i l n hanh thu thap so lieu lai Ihyc dja. Khi phdng van, ngudi d u g c phdng van tra Idi cac eau hdi, d i n g thdi cung cap cac tai lieu c§n t h i l t lien quan den eau hdi nghidn cfiu.
T/)d7g/anf/}uf/Tapdu'//eu; thang 6-8/2013.
Phan tich /ref qua
Tinh kit qua bing tinh diem: Moi cau hdi trong bd cdng cu duge Ira Idi la "ed" hogc "khong". Moi cau tra Idi "cd" d u g c tinh 2 diem vdi chi so chinh va 1 diem vdi chi s l phu. D l i vdi cac chi s l ydu c l u cd t^i lidu chfing minh, cau tra Idi d u g c xac
dinh la "ed" khi cd b i n g chfing d u g c nhdm nghien cfiu xac nhan tpi thdi d i l m phdng van. Diem s6 cua tfing bdnh vien d u g c tinh bang each I l y t i n g so diem cua cac chi so. So lieu d u g c nhap vd lfnh loan bang phan m i m Microsoft Office Excel 2010.
Ket qua
Danh gia chung ve hoat dpng CGD tgi cac BV du'gc khao sat
Diem so toi da khi danh gia eae bpnh vipn theo 34 chi s l la 54. Ket qua long hgp diem cua cdc bpnh vipn khao sal d u g c t h i hidn d hinh 1.
Hinh 1: Danh gia chung ve hoat dpng CGD t cac BV dirpc khao sat Tong so diem Irung binh cua 12 benh vien la 24, dal 44,4% so vdi diem tuyel doi. Trong do, cac BV khoi l u nhan dat s6 diem TB cao nhat {38 d i l m ) luong fing 70,4% diem tuyet doi) Irong khi khdng benh vien cong lap nao dat tren 50%.
Cau true he thong CGD, s y tham gia cua can bp y t l va cac bp phan trong hd thong
Hd thong CGD dugcthen khai d mdi benh vipn dya vao s y thanh lap cac don vj, phan cdng edng vide cho cac ca nhan, ban hanh cac van ban co lidn quan va co s d vat c h i l cho hogi dpng nay.
Bang 1 : Tong hgp diem danh gia cau true he thdng CGD
Chi ... . Npi dung
. Co quyet dinh ttianh lap dffn vi CGD hay bg ptian dim trach nhiem giam sat an toan thuoc tiDngBV
„ „ Cd van bSn chinh thirc quy dinh ro nhiem vg, ca cau to ch^c, vai tro, trach nhiem va phirang liiOc bSo cao cua dOT vi CGD
2.3 Cd danh mgc quy trinh thao tac chuan trong kiem soat chat luong thuoc
„ . Cdh§ thong dii'lieu [uu tnj thdngtintraioicauhdiveADRvSthSngtnantoSn cOa thuoc
Cd ban ptl3n cdng ding vi^c cda nhan i^en chiu trach nhi^m ve CGO hoac an toan Hiucc trong BV
Loai Chis6
C C
s c c
ei/ftjyen tfunguOTig
2 0 0,25
1 1,5
Biem danh giii BVluySn BV bjyen
tinh huyin
2 0 0,33
0,67
0,67 2 0 0,67
0 1,33
BV twntm
2 2 1 2 2
TAP CHI DU'PC HOC -10/2015 (SO 474 NAIM 55)
• Nghien ciru - Ky thuat
2.6 Co nguon lai chinii dio ho?t flpng CGD trong BV 2,7 06 tiif6ng dan quoc gia ve CGD dirac cap nhgt 5 namilln
„ „ Cd quy trinh chuan cho thtfc hien boat ddng CGD (vi du nhif quy tnnh bao cao
^ ' ADR)
2 9 Cd thanh lap va tnen khai hdat dqng cda Hdi ddng thudc va dilu tri , , Co san t^c phirong ti^n cdng nghe thdng bn de cap nhat va cung cap thdng tin ve
thucc
2,11 Cd cac tai lieu tham khae ccr ban ve Tiidng fin thudC va CGD 2.13 C^n bd da tham gia tap hu^n ve CGD hdac an toan thudc
Cd van ban ve vtec phdi hpp cac ben lien quan traig BV de triln khai hdat dpng CGD
Tdng so ^m(ty If % dat so voi t6ng so diim toi da) C C C S S C
0 0 1.5 1 0 0
0,67 0 2 1 0 0,67
0 2 0,67 2 1,33 2 0,67 1 0 0 0 2 23(100) S,3140,2) 10(43,5) 8,7(37,7)20(17,111 100% cac BV khao sal dat duoc diem toi da
d 2/14 chi so, la chi s l v l q u y l t dmh thanh lap don vi; nhan s y chiu tr^ch nhipm va ngan sach benh vien cho hoat dpng CGD. Nhdm BV t u nhan CO tong diem so Imng binh (87%) cao hon cac benh vien cong (khoang 40%) do cdc bpnh vien nay da cd kha day du cac van ban quan trgng trong vipc thiet lap hd thong, phan cong trach nhiem va quy trinh hoat dgng. Trong do, cac chi tieu ma bpnh vien cong khdng dat dugc chii yeu la thieu cac quy trinh chuan cho Ccic hoat dpng lidn quan den CGD, Ihieu van ban quy djnh trach nhidm rd rang, so do p h l i hgp giua cac bg phan Bang 2: Tong hpp diim d^nh gia hoat
va t h i l u ghi chep v l hoat ddng CGD trong b§nh vien. Ngoai ra, 2 lidu chf khong cd bpnh vi0n khao sat nao dal dugc, bao gom lidu chf co liru trfi hudng d i n quoc gia v l CGD cap nhgt trong vong 5 nam va s l nhan vien y t l dugc dao tao v^
CGD > 5% long so CBYT trong BV.
Ho^t d p n g phdt hien n g u y co', thu thap 6Qf lidu t r o n g t h y c hanh CGD
Khao sal cac n g u i n thu Ihap d f i lieu s i n cdvl sfi dung t h u l c Irong bdnh vidn cd Hen quan din hoat ddng phat hien nguy co, k i t qua dugc trinh bay d bdng 2.
ddng phat hi$n nguy ca va thu thpp du- lieu
Chi so Noi dting
, Benh vi^n cd ket n6i vai nguon co s& du' lieu v l CGD tif ben ngoai (nhu Trung tam DI&ADR)
3.2 Co mlu bao cao ADR danh cho ngu'&i blnh 3.3 C6 mau bao cao phan irng bat lai cda thuoc (ADR) 3.4 Cd mau bao cao lien quan lai chat luang thuoc 3.5 Cd mlu bao cao sai sdt lien quan ain sir dung thulc 3.6 Cd mau bao cao that bai dieu tri
T6ng so diem (tylf%d^tso voi tong s6 diem toi da) Loiii chi so
C S C
c c c
11 (100) BVtuyen tning uvng
2 0 2 0 0,5
0 4,5(40,3)
Biem danh gia BVtuyen
dnh 2 0 2 0,67 0,67 0 5,3(43,2)
BVtuyen huyen
2 0 2 0 0,67
0 BVtir nhan 2 0 2 2 2 0 4,7(42,7) 8,0(72,7) 2/6 chl so ma tai ca cac BV deu dat dugc bao
gom i) ed mau bao cao ADR tai cac khoa phong lam sang va lai khoa Dugc sfi dung m i u bao Ccio do Bg Y te ban hanh va ii) cac benh vign d i u cd k i t n i i trao doi thdng tin vdi Tmng lam Dl & ADR Q u i c gia. Tuy nhidn, khdng bdnh vien nao trong s l BV dugc khao sat cd mau bao cao ADR danh cho
ngudi bdnh va m l u bao cao that bai dieu bi, co thi do chua cd van ban hudng d i n cy the v l vln d^
nay. K i t qua khao sat v l sy s i n cd cac mau bdo cao khac lidn quan d i n thuoc nhu chat lugng thufic va sai sdt Irong sfi dung thulc dugc ghi nhan khdc nhau gifia cac bdnh vidn cong lap, trong khi dd, cdc BV l u nhdn l^i dat dug'c l i t ca cac tieu chi nay.
TAP CHI Diroc HOC - 10/2015 (S6 474 NAM
Nghien ciru - Ky thuat
Hoat d p n g danh gia nguy cat trong thiJc hanh CGD
vide thye hien cac nghidn cfiu, bao cao lien quan d i n ADR, chat lugng t h u l c , sai sol trong s f i dung t h u l c va danh gia sfi dung t h u l c .
Trong t h y c hanh CGD, danh gia nguy c o la
Bang 3: Tdng hgp diim danh gia hoat dong danh gia nguy co
Chi J . Ngi dtmg
4.1 So iifong bao cao tir nguyen tai B V ^ t yeu cau 4.3 O i Uiyc hien va bao cao kiem soat ctllt iirpng thudc 4.4 Co ttlirc hien nghien ctjru cac sai sot lien quan ten sD dung thudc 4.5 Co thlfc h ^ nghiSn dm ya bao cao danh gia si> dgng thudc
. g B^o cao hoat dpng giam sat tich cut an toan thudc d u ^ thyc hien trong 5 nam tnj lai day tai BV
.J TJ le benh nhan duprc ghi nh§n gap blln cd bat loi lien quan din thudc (bao gom ca tiuong hpp n5ng)
Tong s6 diim (tylf%datsov6il6ngs6 diim toi da)
Loai ctii so C S S S C C 3(100)
BVtuyen tmng uong
0 0,25 0.25 0 0 0 0,5(3,6)
Biem danh gia BVtuyen BVtuyen
tinh huyen 0 0,33
0 0.33
0 0 0,7(7,4)
0 0,33
0 0 0 0
BVtir ntian 0 0,5 1 1 0 0 0,3(3,3) 2,5 (27,8J Ddy la nhdm tidu chf cd ty ip dal d u g c t h i p
nhai d t i t ca cac bpnh vien. T i l ca 3 tieu chi chfnh Irong nhdm tidu chf nay deu khong dat d u g c d tat ca cac bgnh vidn khao sat. Dac biet, so lugng bao cao ADR va ty le BN ghi nhgn b i l n e l cd hai thap han nhieu so vdi khuyin cao (da dieu chinh so vdi s l the bao hiem BV quan ly vd 1 % so BN dieu lri npl tru) phan anh mfic do bao cao thap (under-reporting) cua he t h i n g bao cdo l g nguyen lgi cac BV. Trong nhom BV cong.
Bang 4: Ting hi^tp diim danh gia hoat dong
BV luyen linh dat ly le 6\em so Imng binh cao n h i t la 7,4% t i n g d i l m t l i da cho nhom hoat dpng nay Irong khi BV l u nhan dal 27,8%.
Hoat d o n g quan ly n g u y co*, truyen t h o n g an toan t h u o c t r o n g t h i r c hanh CGD
Cac v l n de an loan thuoc trong benh vien can t r i l n khai kjp thdi va tmydn tai thong tin den cac d l i tugng cd lien quan bao g i m can bg y t l va bdnh nhan. Vide thuc hien cac hoat dgng nay tai cac bdnh vien khao sat du'oc trinh bay d bang 4.
quan ly nguy ca, truyen thong an toan thudc
ctii so Npi dung
5.1 So luong yeu cau thdng tin ve an toan thudc da ti§p nhan va xir ly 5.2 S6 lucmg ban tin ve an toan thuoc duoc phd blln trong BV 5 3 06 thuc hien vd ban hanh Hirang din mua, chinh sach mua tiiudc 5.6 C^hiRjng din sudung cac thudc cd nguy CO cao tiong BV 5.7 TJ IS Ccic canh bao an toan ve tiiuoc trong BV va cac ngudn ben ngoai c a Ktioing thai gian tre tiung binh ke tif khi xac dinh duoc cac van de
an todn tiiuoc cho bfn luc tiiong tin cho can bo y t l
Q Co thyc hi|n chucmg trinh giao duo benh nhan ve van d l ADR va an toan tiiuoc
Co Ihuc hipn cac boat dpng an toan ttiudc nhu: ttidng bao cho bd 5.10 phqin lamsang, xay dung guideline, ra quyet dinh quanly hoac
chuong tiinh dao tao nhan vien y te. benh nhan
g ^ . BienbancuOchpiiCuahdiadngthudcvadilutiivetiiuchienhoat ddng canh giac duoc hoac giai quyet van de an toan thudc
Tong so diem (t/l^%d^t so voi tong so diem toi da) Loai chi
so S S S S S
c s s
C ) ) (fOO)
BVtuyen tnjng uong
0 0 1 0 0 0,5 0
1
0.5 3(27,3;
Biem danh gia BVtuyen BVtuyen
Snh huyen 0 0,33
1 1 0 2 0
1
0,67 6(54,5)
0 0 1 0,67
0 1,33
0
0,67
1.33 5(45,5)
BVbr nhan 1 0 0.5 1 1 1 0
1
2 7,5(68,2J TAP CHl Diroc HQC - 10/2015 (SO 474 NAM 55)
• Nghien CIFU - Ky thuat
Cac hoat ddng quan 1;^ nguy co va Imyen thdng ve nguy co rat da dang va co s u dao dpng r i t Idn gifia eac benh vien v l mfic do thgc hidn cdc hogt dpng nay. Nhdm BV Imng uong cd diem trung binh thap nhat do cd 5/9 chi so khdng dal diem nao, khdng ed chi so chfnh nao dat diem toi da dan tdi d i l m trung binh dat t h i p nhat (27,3%
long d i l m t l i da dgt d u g c cho nhdm hoat dgng nay). Cac nhdm BV deu Ihuc hidn viec Ihdng tin cac van de an toan t h u l c ldi CBYT, song chf cd nhdm BV luyen lfnh dat d i l m t l i da do dam bao v l khoSng Ihdi gian thuc hien. Khao sal bidn ban hgp cCia HOi dong Thuoc va d i l u In cho thay, ngi dung chu y l u lien quan den qua trinh lap danh muc thuoc va xel thau cac t h u l c Irong danh muc t h u l c bdnh vidn, chi cd nhdm BV t u dal tieu chf cd giai q u y l t eac van d l ve an toan t h u l c va CGD Irong cugc hgp. Doi vdi hoat dgng Iruyen thdng nguy co lidn quan d i n thulc, chi duy n h l t 1 benh vien luyen linh trong so 12 BV khao sat co xuat ban ban tin An loan thuoc hang Ihang do da nam trong k l hogch hogt ddng cua D o n vi thdng tin thulc (chl so 5.2); khong cd BV nao cd chuong trinh dao tgo ndi dung nay cho benh nhan.
Ban iuan
Trong nghien cfiu nay, chiing toi s u dung bg edng cy ddnh gia hoat dgng CGD (IPAT) la bg cong cu dau tidn Irdn the gidi da d u g c t h i m djnh vd dp dung danh gid hoat dgng CGD mpi s6 nude Irong khu vgc vd tren t h i gldi '^•''. Khong chf d u g c dp dyng de xac dinh thuc Irang, bo cdng cy con giup de xuat cac giai phdp lang cudng hogt dong cho he t h i n g tren tfing ITnh vgc va danh gia hidu qua can thidp tang cudng cac hogt dgng CGD i^'.
Mgt hg t h i n g CGD chi co the hogt dgng hieu qud khi dugc xay dung tren mgi c i u true vung chac. Ben cgnh do, s g p h l i hgp chat che gifia cac ben lien quan trong hp thong canh giac dugc giup phdt hidn nhanh nhung han c h l de co giai phap khac phuc cung nhu dam bao tan dung tot eac nguon Igc lai don vj. Mac du 100% BV khao sal deu d u g c xdc dinh la co thanh lap don vj vd nhdn s u chju traeh nhiem cho CGD, song k i t qud nay chiJ y l u dga vao quyet dinh thanh lap Don vj Thdng tin Ihuoc cua BV ma chua cd don vi ehuyen Irach ve CGD va An toan t h u l c
trong BV. K i t qua khao sat tgi mOt so nudc dang phdt Irien cung cho t h i y , chi tieu nSy chl dgt 40% 1^'^. Tgi cac BV deu chua cd hudng din q u i c gia ve CGD egp nhdt Irong vdng 5 ndm v^
so cdn bg y te d u g c dao tgo ve CGD > 5%. Thyt trgng nay d u g c ly gidi Id do Bp Y te van chua ban hdnh d u g c hudng dan q u i c gia v l CGD dong thdi cdc hoai ddng dao tgo Canh gidc Dugc m i ^ b l l d i u d u g c Irien khai mpi each hp thing Eai cac benh vipn l f i nam 2012. K i t qud nghien cfiu thgc hien d 5 nude chau A khdc eho Ihay, da c6 25% cac CO s d y t l khao sat cd hudng dan quoc gia ve CGD cdp nhgt trong vong 5 nam '^. Mau bao cao d u g c coi Id cdng ey de lhu thgp dfi li^u v l an loan t h u l c (phdn fing ed hgl eua thuoc, chat lugng thuoc, sai sdt trong s f i dyng thuoc, t h i t bgi dieu trj) t f i cdc n g u i n khde nhau trong h$
t h i n g CGD. Tai Viel Nam, hidn mdi chl c6 mlu bao cao ADR d u g c ban hdnh s f i dyng d d p dg quoc gia va he t h i n g thu Ihdp dfi ligu CGD t|p trung vao viec tiep nhdn vd qudn ly d f i lidu v l c^c bao cao nay. Cac BV d u g c khdo sdt deu dang thgc hidn mau ndy nhung chua ehu trpng den cdc loai m i u bdo cdo khdc, chang hgn nhu 100%
cdc BV khao sdt ehua ban hanh m i u bao cdo thai bgi d i l u trj. K i t qua khao sat thgc hign d cic nudc cd dieu kign CGD ban dau luong ty Viet Nam cho thay ly lp eac co s d cd mau bdo cao thai bai dieu trj lan l u g l la 0% va 6% ^^'^K Mgf h§
t h i n g CGD loan dien khong the t h i l u cdc hogt dong ddnh gia thudng xuydn d f i lidu bao c^o ADR t u nguyen (he t h i n g theo ddi thy dgng) vd cde hogi ddng nghien cfiu, gidm sdt chCi dgng nhung v l n d l an loan t h u l c nghiem trgng, dgc thu. Tuy nhidn p h i n Idn cdc bdnh vign khao s^t chua thgc hidn cac hoat ddng ddnh gid nay (cao n h i t la 27,8% d nhdm BV t u nhan vd Ihap nhlt Id 3,3% d nhdm BV t u y l n huypn). Mac du 100%
BV khao sat cd D o n vj Thdng lin t h u l c song cac van de hen quan d i n qudn ly va t m y l n thdng v l an loan thuoc cdn kdm. H l u h i t cdc BV khao sdt deu chua Ihuc hidn ghi chdp eac ydu c i u vd xi> I:?
Ihdng tin, s l lugng bdn tin v l an todn t h u l c dugc xuat ban khdng dat tidu chl de ra. Hon nfia, nOi dung cac cudc hgp cOa Hdi dong thuoc va dilu tri cung chua lap Imng vao gidi q u y l l cdc vln d l CGD ndi Chung va an todn thuoc ndi ridng.
T^PCHID-^-^
• Nghien CIFU - Ky thuat
Nhu vdy cae BV chua quan tdm dung muc tdi hoat dgng CGD va an toan t h u l c ; tuy nhidn van d l ndy cd the edn phu thupe vdo quan diem cua mdi nha lanh dao khac nhau bdi vi cae BV t u nhan dal diem t l i da d tieu ehi nay (5.11).
K i t qua khao sat theo cdc ngi dung eho t h i y s g khdng dong bg trong cac hoat dgng CGD d cae bdnh vidn (ke ca benh vidn cCing t u y l n ) the hien qua d i l m s l khdc nhau tren cdng mgi chf so. Ly do ehu y l u d u g c cac benh vien dua ra la lien quan tdi v l n d l nhan luc d u g c hien nay khdng du de thuc hien mgi nhiem vu Iheo yeu c l u . D i l u ndy cQng d u g c tong k i t trong cac bdo cao chung cua hd thong y t l i^. Tuy nhien, v l n de chfnh v i n la viec khdng cd hudng d i n chung cho eac hoat dgng Canh giac Duge mang tinh chat qudc gia. Cho d i n nay da cd mgt s6 van ban phap quy cd lien quan tdi CGD dugc ban hanh song ngi dung ehua cd hudng d i n hay yeu c i u cu t h i d l i vdi hoat dgng nay f^'^'. Theo k i t qud nghidn cfiu, cae bdnh vidn deu dal diem t l i da d l l vdi edc chi s l da d u g c qui djnh trong cac van ban nay nhu: yeu c i u p h l i hgp va bdo cao ADR ldi Trung tam, dCing chung m i u bao cdo ADR Irong cd nudc, hudng d i n d i u t h i u Ihulc. Nam 2013, Bg Y te da ban hanh Hudng d i n hoai dgng gidm sal ADR P' nham tang cudng hoat dgng bao cao ADR Irong cac benh vien. Do vgy, yeu c l u e l p t h i l l Id c i n xdy dung hudng dan Quoc gia ve heal dgng CGD de giup cac benh vien djnh hudng t r i l n khai trong thdi gian tdi
Ket iuan
S u dung bg cdng cy IPAT dugc Viel hoa de khao sal thgc Irgng CGD lai 12 benh vien cho t h i y t i n g s l d i l m trung binh dal duge la 24, dgt 44,4% so vdi diem tuyel d l i , trong do BV t u nhan cd diem cao n h l t ( >70% t i n g s l diem luyet d l i ) . 100% cac BV khao sat ddu da co he t h i n g lien quan d i n CGD va an loan thuoc bao g i m : q u y l l djnh Ihanh lgp don vi Thdng tin t h u l c , nhan s g chju trdch nhidm va ngan sdch bdnh vidn cho hoat dgng CGD, mdu bao cao ADR, lien k i t
vdi Trung tam Dl & ADR quoe gia. Tuy nhien cac hogi dgng lien quan d i n ddnh gia va truyin thdng nguy co trong thgc hanh CGD cdn d mfic do han ehe.
Tai iieu tliam Itiiao
1. Bo Yte (2012), Thong tw31/2012/TT-BYTngay 20/12/2012, Hudng dan hoaf dong Dugc lam sang trong b^nh vien.
2. B0Ytl(2011), Thong tw 23/2011/TT-BYT ngay 10/6/2011, Huong din su diing thuoc trong cac co' so' y le CO giudng b$nh
3. Bp Y t l (2013), Quyet dtnh 1088/QB-BYT ngay 4/4/2013, Hu'O'ng dan hoat dong gl^m sat phan ung co hai cua thulc (ADR) tgi cac co" sd kham, chua b§nh
4. Trung tam DI& ADR quoc gia, Tong quan v§ Canh giac Duuc, duac trich din ngay 02/02/2014, tCp http.//
canhgiacduoc org vn/CanhGiacDuoc/tongquancgd aspx
5. Kabore L., et al. (2013), "Pharmacovigilance systems in developing countnes. an evaluative case study in Burkina Faso", Drug Saf.. 36 (5), p. 349-58.
6 Ministry-of-Health and Heaith-Partnership- Group, Joint Annual Health Review 2013, Towards universal health coverage, Hanoi.
7. USAID, Comparative analysis nf pharmacovigilance systems in five asian countnes, 2013 [cited 03/01/2014], Available from: http://
apps who int/medicinedocs/documents/s21335en/
s21335en.pdf.
8 USAID, Assessment of pharmacovigilance systems and performance in Asian countnes- Local consultant's Manual 2012
9 USAID, Strengthening Pharmaceutical Systems (SPS) Program (2009), Indicator-Based Pharmacovigilance Assessment Tool- Manual for Conducting Assessments in Developing Countries.
[cited 02/04/2014], Available from: httpV/pdf.usaid gov/
pdf_docs/PNADS167.pdf
{Ngay nhan bai: 22/05/2015 - Ngay duyet dang: 01/10/2015)
TJ^P CHI Diroc HOC - 10/2015 (SO 474 NAJVI55)