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Nghiencuuduoc SThong tin thudc

JOURNAL OF PHARMACEUTICAL RESEARCH AND DRUG INFORMATION

DANG CONG SAN VIET NAM QUANG VINH MUON NAM

T R l / C f N G D A I H O C D l / O C H A N O I

Oiachi: 13-15 LeThanh Tong Website: http://hup.edu.vn

Hoan Kiem - Ha Noi ISSN 1859-364X

Nghien cuU dtfcfc & Thong tin thuoc 2017, Tap 8, So 2 Journal of pharmaceutical Research and Drug information 2017, Vol 8, N°2

M U C L U C So 2, 2017

BAI NGHIEN CUU

C O N T E N T S No 2, 2017

RESEARCH

2 Khaosat phan ung co hai phong tranh dirgetircosoduflieu baocao ADR 6 Viet Nam

DoanThi PhuongThao, TranThuThuy, Vu D'mh Hoa, Nguyen Hoang Anh

Identify preventable adverse drug reaction from pharma­covigilance database of Viet Nam

DoanThi Phuong Thao,TranThu Thuy, Vu Dinh Hoa, Nguyen Hoang Anh

7 Xay dung cong thufc vien nen venlafaxin 75 mg giai phong keo dai dang bum tham tha u to tao 16 xop

Nguyen Van Ha, Nguyen Van Khanh, Vu Thi Thu Giang, Doan Cao Son

Formulation of controlled porosity osmotic pump tablets containing venlafaxine hydrocloride 75 mg

Nguyen Van Ha, Nguyen Van Khanh, Vu Thi Thu Giang, Doan Cao Son

13 Xac dinh methylendioxymethamphetamin trong toe bang sackykhikhoipho

Pham Quoc Chinh, Nguyen Thi Sinh, Pham Le Minh, Tran Viet Hung, Nguyen Tien Vtfng

Determination of methylendioxymethamphetamine in hair by gas chromatography mass spectrometry

Pham Quoc Chinh, Nguyen Thi Sinh, Pham Le Minh, Tran Viet Hung, Nguyen Tien Vung

19 Nghien cUu tac dung ha acid uric cua Man dia tren dong vat thUcnghiem

Nguyen Thuy Duong Phan Thi Anh Thu, Nguyen Quynh Chi, Nguyen Hoang Anh

Hypouricemic action of Archidendron clypearia in Mice Nguyen Thuy Duong, Phan Thi Anh Thu, Nguyen Quynh Chi, Nguyen Hoang Anh

24 Xay dung phuong phap phan tich doncj thdfi cephalexin, cefixim, cefdinir bang dien di mao quan vung

Nguyen Thi Thuy Linh, LeThj Hue, Le Dinh Chi

Developing a method for simultaneous determination of cephalexin, cefixime and cefdinir by capillary zone electrophoresis

Le Thi Hue, Le Dinh Chi, Nguyen Thi Thuy Linh

29 Xay dung phuong phap dinh lUOng dong phan quang hoc Simultaneous determination of atenolol enantiomers by cua atenolol bang phuong phap UPLC/DAD UPLC/DAD

Nguyen Thi NgptVan, Nguyen Huynh Kim Ngan, Nguyen Thi Kieu Anh Nguyen Thi Ngoc Van, Nguyen Huynh Kim Ngan, Nguyen Thi Kieu A

35 THONG TIN THUOC - CANH GIAC DUOC

Phan ufng tren da lien quan den thuoc Nguon: ktualites pharmaceutiques, so 543, thang 02/2015

Ngitdi dich va tong hop: Duong Thj Thanh Mai, Hoang Ha Phuong

39 DIEM TIN HOAT DONG

Le trao Huy hieu 30 nam tuoi Dang

40 Tin Dai hoi dai bieu Doan thanh nien cong san Ho Chi Minh truOng Dai hoc Duoc Ha Npi

Nghien cufu dtfcrc & Thong tin thuoc 2017, Tap 8, So 2, trang 2-6

BAI NGHIEN CLfU m

Khdo sat phdn ung co hgi phong trdnh duoc tir co so du lieu bdo cdo ADR d Viet Nam

Doan Thi Phudng Thao, Tran Thu Thuy, Vu Dinh Hoa, Nguyen Hoang Anh Trtidng Dai hoc Dupe Ha Ngi

(Ngay gtii dang: 10/12/2016 - Ngay duyet dang: 24/3/2017)

SUMMARY This study aimed to initially investigate preventable adverse drug reactions (pADRs) from Vietnamese pharmacovigilance

(PV) database. Spontaneous ADR reports in two months were firstly identified for medication errors (ME) using P-method (developed by World Health Organization - WHO), which is currently known as the only validated tool designed for this purpose in PV database. The preventability was assessed afterwards by consensus between two clinical pharmacology experts. Total 152/763 (19.9%) reports evaluated were suspected as having ME, of which 85 (11.1 %) were suspected as pADRs. These results show that PV database is an important source to detect pADRs that may guide interventions to improve the appropriate use of drugs.

TCtkhoa: cdnh gidc dupe, phan ting co hgi cua thuoc, phong trdnh dugc, sai sot lien quan den thuoc, phuong phap P.

Dot van de Phan dng co hai cua thuoc (ADR) co the de lai hau

qua nang ne cho benh nhan, la van de ludn can dugc lUu y khi sir dung thuoc. Nhieu nghien cdu tren the gidi cho thay mot ty le Idn ADR co the co lien quan den viec sit dung thuoc khdng hop ly va cac ADR nay ddoc coi la ADR phong tranh dude (pADR) [12]. Viec xac dinh cac pADR se giup ich trong viec ngan ngda nhufng trddng hop tuong t d xay ra trong thdc hanh lam sang.

Co sd dur lieu (CSDL) Canh giac duqc (CGD) cua cac quoc gia ddpc coi la mot nguon dQ lieu quan trpng va tiem nang de phat hien cac pADR [12].Tai Viet Nam, bao cao ADR gdi t d cac co sd kham, chda benh ddqc thu thap, tham djnh va Idu trd tai Trung tarn Quoc gia ve thong tin thuoc va theo ddi phan dng cd hai cua thuoc (Trung tarn DI&ADR Qudc gia). Cac nghien cdu tren CSDL bao cao ADR nay cung budc dau phat hien dupe mot so sai sot lien quan den thuoc (medication errors- ME) nhd t d dung thuoc ke don, dung lai thuoc da cd tien sd dj dng [6]. Tren the gidi, mot so nghien cdu ve ME va pADR tren CSDL bao cao ADR da ddpc thdc

hien thong qua nhieu each tiep can khac nhau. Gan day, Trung tarn dieu phoi cua WHO dat tai Ma-roc da de xuat phuong phap P dda tren 20 tieu chi ve cac yeu to nguy co/loai sai sot thddng lien quan den ADR ddpc bao cao [3]. Day cung la phddng phap duy nhat da ddpc tham dinh nham phat hien pADR t d CSDL bao cao ADR cho den thdi diem hien tai. Dda tren co sd cua phdong phap P, nghien cdu nay ddpc thdc hien de bddc dau xac djnh ty le va khao sat mot so dac diem cua cac ADR cd kha nang phdng tranh dupe trong CSDL bao cao ADR tai Viet Nam.

Doi tvong va phuong phdp nghien cuu Dot ttigng nghiin ctiu

Bao cao ADR td nguyen ddpc giri ve Trung tarn DI&ADR Quoc gia trong thdi gian 2 thang (td 16/12/2013 den 16/02/2014).Th6ng tin cua mot bao cao ADR sau khi hoan tat qua trinh xif ly tai Trung tarn bao gom: dac diem benh nhan, thuoc sd dung, ADR va mdc dp nghiem trpng cua ADR, moi quan he nhan qua gida thuoc va ADR. Loai trd cac bao cao ve phan dng sau khi thCr man cam vdi thuoc; thieu thong tin ve ADR; thieu thong tin ve thuoc nghi ngd;

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Nghien cuu dirge & Thong tin thuoc 2017, Tap 8, So 2, trang 2-6

BAI NGHIEN CQU

mdi quan he nhan qua giura thuoc - ADR dupe chuyen gia tham dinh xep d mdc "khdng chac chan" "chda phan loai" hoac "khdng phan loai dupe"; thieu ly do sd dung thuoc; hoac khdng cd thong tin ve thuoc sir dung trong cac tai lieu tham chieu trong nghien cud.

Phiidng phap nghien cdu Nghien cud cat ngang mo ta thong qua hoi cud

dd lieu bao cao ADR. Bddc 1: Phat hien cac bao cao co sai sot lien quan

den thuoc (ME) bang phuong phap P. De phu hop vdi dd lied san cd trong bao cao ADR d Viet Nam, nhdm nghien cdu da sddung phien ban cd dieu chinh cua phdong phap R PhdOng phap P gom 20 cau hoi, cung chinh la 20 loai ME cd the gap trong sd dung thuoc, cu the nhd sau:

1. Lieu dung khdng phu hop? 2. Dddng dung khdng phu hop? 3. Thdi gian dung khdng phu hop? 4. Sddung sai dang thuoc? 5. Thudc het han? 6. Bao quan thuoc khdng dung? 7. Cach dung khdng phu hop? 8. Chi djnh khdng phu hop? 9. Khdng phu hop vdi dac diem cua benh nhan? 10. Khdng phu hop vdi tinh trang benh ly cua

benh nhan? 11. Cd tien sir qua man vdi thuoc/nhdm thudc? 12. Tddng tac thudc? 13. Trung lap dieu trj? 14. Khdng sddung thudc can dung? 15. Hoi chdng cai thudc? 16. Theo ddi dieu trj khdng phu hop? 17. Thudc kern chat Idpng? 18. Thudc gia? 19. Tuan thu dieu trj chda hop ly? 20. Benh nhan td dung thudc ke don? Vdi mdi tinh hudng trong bao cao ADR, nghien

cdu vien sir dung tai lieu tham chieu de tra Idi Ian Iddt 20 cau hoi nay d 3 mdc "cd", "cd the", "khdng/ khdng ap dung ddpc". Tai lieu tham chieu ve thudc sd dung trong bao cao ADR dddc lay du tien theo thd td: (l)Vidal 2014-2015 Viet Nam/Mims Online cua biet dupe trong bao cao hoac biet ddpc gdc tdong dng theo"Danh muc cdng bo biet ddpc gdc tddpt 1 - dot 11 BYT (2013-2014)"; (2) Ddgc thd quoc gia Viet Nam 2009; (3) Tom tat thong tin san pham (SPC) tai Anh,

Phap va My cua biet ddpc cung hoat chat, dang bao che; (4) Micromedex 2.0.

So vPi nguyen ban cua phuong phap P, tieu chi 12 "tdong tac thudc-thudc ddpc ghi tren nhan" ddpc lam ro bao gdm tPOng tac thudc-thudc, thudc-thdc an va thuoc-xet nghiem, t d do sd dung phan mem Stockley's drug interaction checker de danh gia. Tieu chi nay se ddpc tra Idi "cd" neu cd tdong tac mdc dp cao nhat "de dpa tinh mang/chong chi djnh" va "cd the" neu cd tuong tac mdc dp thd 2 "can chinh lieu/theo ddi chat che". Ddi vdi cac khang sinh, tieu chi 8 ve chi djnh chi ddpc danh gia tren kha nang bj nhiem khuan va chdng chi djnh. Trong tieu chi so 20, cac thudc ke don ddpc xac djnh la cac thudc khdng nam trong "Danh muc thudc khdng ke don" ban hanh kern theo thong tP 08/2009 cua Bp Y Te, la danh muc thudc cd hieu Idc cung thdi diem vPi cac bao cao ADR dupe chpn trong nghien cdu.

VPi moi bao cao ADR cu the, neu khong cd cau tra IPi nao la "cd" hoac "cd the" thi bao cao se dupe quy ket la "khdng phat hien ddpc ME". Ngdpc lai, bao cao co it nhat mot cau tra IPi la "cd" hoac "cd the" ddpc gpi chung la "bao cao nghi ngd cd ME" va ddpc dda vao danh gia d bddc 2. Mdi cad tra Icri "cd" dng vPi mot "ME" va moi cad tra Idi "cd the" dng vdi mot "cd the la ME". Nhd vay mot "bao cao nghi ngded ME"cd the cd nhieu hon mot ME.

Bddc 2: Td cac "bao cdo nghi ngd cd ME", danh gia kha nang phdng trdnh ddoc cua cac ADR. Trddc tien, hai thanh vien trong nhdm nghien cdu (chuyen nganh Ddpc ly- Ddpc lam sang) danh gia cac "bao cao nghi ngp cd ME" de loai di cac trddng hop ME lien qdan den chi djnh khdng ddpc phe duyet (off-label) nhdng ddpc coi la chi djnh hpp ly. Hai chuyen gia danh gia rieng biet kha nang phong tranh ddpc cua cac ADR theo ba mdc dp: "phong tranh ddpc"(neu cd moi lien he gida ME va ADR),"cd kha nang phdng tranh ddpc" (neu cd the cd mdi lien he gida ME va ADR) va "khdng phdng tranh ddpc" (neu khdng cd mdi lien he gida ME va ADR). Cac trddng hpp cd sp khac biet, hai chuyen gia se thao luan de dat ddpc dong thuan eddi cung cho cac trddng hpp nay. Cac bao cao ADR ddpc xep loai la "phong tranh" hoac"co kha nang phdng tranh dPpc" se dPpc md ta mot sd dac diem ve thudc, ADR, loai ME trong cac bao cao.

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Nghien oiudifoc & Thong tin thuoc 2017, Tap 8, So 2, trang 2-6

BAI NGHIEN OJU

Nhap lieu va xu1 ly so lieu bang phan mem Microsoft Excel.

Ket qua nghien cuv Soldgng va ty le bao cao cd pADR

1013 BC*

Loai BC

763 BC

Budc 1 (phuang phap P)

Loai 250 BC

164 BC nghi ngd co ME

Bode 2 (chuyen gia)

599 BC khdng phat hien ME

152 BC

Bode 2 (chuyen gia) K:

12BC co chi dinh off-label hdply

85 BC cd/cothela pADR

127 BC "co ME" 25 BC "co the la ME"

•60 BC "co pADR" •25 BC "co the la pADR"

*BC: bao cao Hinh 1. So do phat hien bao cdo nghi ngdeo ME va bdo cdo

co/co the la pADR

trong do 5 tracing hpp khdng hieu chinh lieu phu hpp vdi dac diem benh nhan (dp tuoi, can nang). Hau het sai sot ve each dung thuoc lien quan den so Ian dung thuoc trong mot ngay. Mot trPdng hpp nghi ngp la pADR lien quan den each dung la phan ufng run, kfch thich va tim nhanh tren tre 14 kg, dupe tiem tinh mach ceftriaxon 2000 mg.Theo y kien chuyen gia, lieu 2000 mg cd the dPOc dung trong cap cdu nhUng phai truyen tinh mach, tiem tlnh mach lieu cao cd the dan den phan ting gidng phan ve. Hai trudng hpp tPOng tac thudc lien quan den pADR la khd thd, run, nhjp tim nhanh khi dung metronidazol cung vdi rupu va run chan tay (cd the la dau hieu cua hpi chdng gia Parkinson) khi sd dung phoi hpp 2 thuoc an than kinh la haloperidol va olanzapin. Hai trudng hpp trung lap trj lieu lien quan den pADR la viec stidung ddng thdi hai thudc cung nhdm giam dau khdng steroid, dan den mot trUdng hpp xuat hien phu va loet dPdng tieu hoa trong trPdng hpp con lai.

Td 1013 bao cao nhan dupe d Trung tarn DI&ADR Quoc gia trong thdi gian nghien cdu, sau khi loai bao cao theo tieu chuan loai t rd con lai 763 bao cao dupe dUa vao danh gia. Sau khi danh gia theo phuong phap P cd chinh sda, 164 bao cao (21,5%) dupe phat hien la bao cao nghi ngd cd ME. Tuy nhien theo danh gia cua cac chuyen gia d budc 2, cd 12 bao cao dope xem la cd chi djnh ngoai phe duyet hpp ly va do do khdng dupe coi la ME. Tong so 152 (19,9%) bao cao con lai bao gom 127 bao cao "cd ME" va 25 bao cao "cd the cd ME". Trong cac bao cao nay, 85 (11,1%) bao cao dUOc xac djnh la cd pADR (n=60) hoac cd the la pADR (n=25).

Sai sot trong cac bdo cao cd/cd thecd pADR

Cac dang ME thudng gap nhat trong cac bao cao pADR la chi djnh khdng phu hpp (n=37; 43,5%), tU dung thuoc ke don (n=36; 42,3%), lieu dung khdng phu hpp (n=17; 20%), dung lai thudc cd tien sd dj dng (n=15; 17,6%) va each dung khdng phu hpp (n=11; 12,9%). Ca 17trUdng hpp lieu dung khdng phu hpp deu lien quan den lieu cao hon khuyen cao,

Loai sai sot

Khoang thai gian Theo doi

Trung lap trj li£u Tuang tac

TiAn si> di irng Oac didm benh nhan

Cach dung Tt/ dung Rx

Chfdinh L.eu

• pADR

• Co th i la pADR

• Nghi ngd la ME nhung khdng phai la pADR

0 20 40 60 80

S6 bao cao

H'inh 2. Cdc logi sai sot trong sddung thudc

Ode diem cua cac bdo cdo cd/cd thecd pADR

Cac bao cao pADR nghiem trpng chiem ty le Idn (n=52; 61,2%). Cac pADR thudng gap nhat la roi loan tren da/mo dudi da (n=57; 67,1 % ) , rdi loan tren dudng tieu hda (n=16; 18,8%) va rdi loan tren tre nhd vdi cung ty le. Khang sinh la nhdm thudc thudng gap nhat, trong do cao nhat la cephalosporin va cac beta-lactam khac (n=21; 24,7%) va penicillin (n=12; 14,1%). Trong cac bao cao nghi ngd la pADR, dp tuoi 18-64 chiem ty le cao nhat (58,8 % ) , tuy nhien dp tuoi tre em 0-18 tuoi cung chiem mot ty le dang lUu y (18,8%).Tong so cd 48,2% bao cao cd ADR dUOc ghi nhan ban dau ngoai benh vien va 34,1% bao cao ghi nhan tai co sd kham, chda benh (Bang 1).

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Nghien cuu dude & Thong tin thuoic 2017, Tap 8, So 2, trang 2-6

BAl n g h i e n c Q u

Bang 1. Mot so dgc diem cua cua bdo cdo co/co thi cd

pADR (n=85)

Tieu chi n (%) Tieu chi n (%) Mile do nghiem trong cua

phan ling

Cac nhom thuoc thudng gap

(ATC)

Nghiem trong 52 61,2. J01 D-Khang sinh beta-lactam Knac

21 (24,7)

Khong nghiem trong f i t ! 8) JOlC-Khang sinh nhom penicillin (14 1)

Ua fit m i , n ihifrtnn nan nc co guaii uiuuiig gap phan ilng (WHO-ART)

im P-M a/mli/i linm.a/niH i/a JU ll IVIdtlUIIU, NMlUSdIMIU Vd streptogramin

8 9 4)

Roi loan tren da va mo dudi da 57 (67,1) MOIA-NSAID 8 (9,4)

Roi loan tren he da day-ruot 16 (18,8) J01 E-Sulfonamid va trimethoprim 6 (7,1)

Roi loan tren tre nho 16 (18,8) JOIG-Khang sinh aminoglycosid 6 (7,1)

Roi loantoan than 13 05,3) Op tuoi benh nhan (tuoi)

Roi loan he thankinh 12 (14,1) < 2 tuoi 7 (8,2)

Ndixuat hien phan limg 2-11 tuoi 3 (3,5)

Trong cpng dong 2' (48,2) 12-17 6 (7,0)

Tai benh vien 2 9 (34,1) 18-44 30 (35,3)

Khongro 15 (17,7) 45-64

65-74

>75

20

4

5

(23,5)

(4,7)

(5,9)

Ban luqn Ty le bao cao co pADR trong nghien cub nay la

11,1%, cao hon nghien cdu d New Zealand (4,3%) [5], nhung thap hon nghien cdu tai Thuy Dien (14%) [7] va Phap (17%) [4]. Sp dao dpng nay bat nguon td sp khac biet ve CSDL bao cao ADR giCra cac quoc gia va phuong phap xac dinh pADR. Du vay, day la mot ty le khong nho, mot mat phan anh kha nang phong tranh dupe cua ADR trong thUc hanh lam sang, mat khac ghi nhan tiem nang cua CSDL bao cao ADR tai Viet Nam trong viec phat hien cac pADR nay.

Benh nhan dddi 18 tuoi chiem ty le 18,8%, trong cac bao cao pADR, cao hon nhieu so vdi ty le benh nhan dddi 20 tuoi trong nghien cdu cua Kunac (6,6 %) [5] va cuaTanti (7,3%) [11]. Benh nhi la doi tdpng nhay cam, von da chiem ty le cao trong CSDL bao cao ADR tai Viet Nam (20,4% [2]). Trong nghien cdu nay, da phan cac pADR tren benh nhi lien quan den lieu dung khdng phu hop. Dieu nay phan nao phan anh sd phut tap cua che dp lieu d tre em, vi vay can quan tarn hon khi sd dung thuoc tren doi tupng nay.

Ty le bao cao cd pADR nghiem trpng kha cao (61,2%), dac biet len den 83-100% d cac bao cao cd

ME ve theo ddi lam sang/can lam sang; dudng dung thuoc; trung lap trj lieu, tien sd di ring va t d dung thuoc ke don. Neu tinh den nhdpc diem cua CSDL bao cao ADR, bao gom hien tdpng chu trpng bao cao cac ADR nghiem trpng [9] va hien tupng bao cao ft hon thud te (under-reporting), ngay ca vdi nhdng trUdng hop nghiem trpng [8], so Idpng va tan suat xuat hien cac loai ME nay trong thdc hanh lam sang cd the con cao hon nhieu so vdi ket qua nghien cdu.

Tuong t d cac cdng bo trddc day trong y van, nghien cdu cung cho thay ty le cao cac pADR lien quan den chi djnh, lieu dung khong phu hpp va dung lai thuoc cd tien sd dj dng [5], [6], [7], [11].Tuy nhien, diem khac biet la ty le tu dung thuoc ke don (42,3 %), dac biet la cac khang sinh, cao hon dang ke so vdi the gidi. Nguyen nhan cd the do mang ludi ban le trong cpng dong d nUdc ta con chUa tuan thd nghiem ngat cac quy djnh ve thuoc ke don va viec giam sat thdc hanh nha thuoc tot con chUa chat che. Thud trang nay cung da dupe Do Thj Thuy Nga va cpng sUghi nhan trong mot nghien cdu khao sat cac nha thuoc tai Ha Npi, theo do khang sinh chiem t d 18-24% Idpt mua tai cac nha thuoc, trong do 88-91 % ddpc ban khong can don [10]. Khi sd dung thuoc khdng theo don, kha nang chi djnh, lieu dung, each dung thuoc khdng phu hpp cung tang len. Td do cho thay viec cai thien thUc trang t d mua, t d dung thuoc khong ke don la rat can thiet de han che xay ra ADR trong cpng dong.

Sd dung CSDL bao cao ADR tu nguyen, han che cua nghien cdu nay la khong udc tinh dupe tan suat pADR do hien tdpng bao cao it hon thud te va cd the chUa phat hien dupe day du mot so loai ME khac do thieu thong tin trong bao cao. Cu the, trong bp 20 cau hoi cua phuong phap P, mot so cau hoi chUa that sd danh gia ddpc (cau 5,6,17,18,19), do dac thu dd lieu thUc te trong bao cao ADR. ThUc trang thieu thong tin va chUa thong nhat thong tin ve thuoc dang luu hanh tai Viet Nam trong cac tai lieu tham chieu [1 ] cung la trd ngai khong nhd trong qua trlnh nghien cdu. Viec cd them bade danh gia tinh hpp ly cda cac chi djnh off-label va moi lien quan ME-pADR mot each dpc lap, sau do lay y kien dong thuan da phan nao khac phuc dupe han che nay. Tuy nhien, tinh chd quan cua ngUdi danh gia va viec chUa cd bac si lam sang trong nhdm chuyen gia danh gia cung la mot han che cua nghien cdu.

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BAI NGHIEN CL/U

Mac du co sU khac biet Idn trong phuong phap gida cac nghien cdu ve pADR, nhieu nghien cdu da chon each tiep can pADR thong qua viec phat hien cac ME nhd la mot bddc trung gian. Cach tiep can nay giup phat hien cac ME chUa gay hai khong lien quan den ADR ddpc bao cao, von cung la mot nguon gay hai tiem tang cho benh nhan [12]. Nghien cdu khong ap dung hoan toan phdong phap P nguyen mau ma dieu chinh theo dac diem cda bao cao ADR tai Viet Nam, lam rd each danh gia tdng tieu chi, tao thuan Ipi cho ngudi danh gia. Neu ddpc phat trien, toi du hon theo dieu kien thuc te, day cd the la mot bp cdng cu toan dien va hdu ich trong xd ly bao cao ADR thddng quy de phat hien tin hieu ve cac pADR, t d do xac dinh nguyen nhan mot each he thong va de xuat bien phap han che ADR cho ngUdi benh.

Kef luan Nghien cdu da budc dau phat hien va mo ta dac

diem cua cac pADR td CSDL bao cao ADR tai Viet Nam.Ty le bao cao cd pADR la 11,1%, trong do 61,2% la ADR nghiem trpng. Cac ME lien quan den ADR thudng gap nhat bao gom chi djnh khong phu hpp, t u dung thuoc ke don, lieu dung khong phu hpp, dung lai thuoc cd tien sddj dng va each dung khdng phu hpp. Ket qua nghien cdu nay cho thay CSDL bao cao ADR la mot nguon dd lieu tiem nang de phat hien pADR va sd can thiet phai cd mot bp cdng cu de phat hien pADR trong quy trinh xd ly bao cao ADR thudng quy. Mat khac, bp cdng cu "P method" cua WHO va bp cdng cu cd chinh sda sd dung trong nghien cdu con nhieu diem chua thud su phu hpp vdi dac diem co sd dd lieu d Viet Nam va can dupe phat trien hoan thien them. Viec xac djnh pADR cd y nghia quan trpng trong xay dung khuyen cao va de ra bien phap can thiep phu hpp nham han che xay ra ADR, dam bao sd dung thuoc an toan, hpp ly cho benh nhan.

TAI L IEU T H A M K H A O

1. Phi Xuan Anh va cpng sd(2011), Nghien cdu danh gia mot so co sdddlieu thudng dung trong thUc hanh tra cdu thong tin thuoc tai Viet Nam. Tap chi Ddpc hoc, So 11, tr.12-16.

2. Tran Thuy Ngan, Lai Quang Phuong, Nguyen Hoang Anh (2014), Phan tich bao cao ADR tren doi tupng benh nhi ghi nhan trong co sd dd lieu Quoc gia trong giai doan 2010-2012. Tap chi Y hoc thdc hanh, So 924, tr. 9-13.

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ITTanti, A., et al. (2013), Medication errors through a national pharmacovigilance database approach: a study for Malta. The International journal of risk & safety in medicine. 25(1): pp. 17-27.

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