• N g h i e n C L P U - K y t h u a t
G i a i p h a p m u a t h u d c k h a n g s i n h t h e o t e n g d c
Dat v d n de
Theo thdng ke cua Cue quan ly dupe Bd Y td ndm 2008, thuoc san xudt trong nude dat 715,435 tridu USD dap Ceng 50,18% nhu cau sir dung thuoc trong nudeI 2 J.
Vdi trdn 300 co so san xuat thuoc trong nude, la mdt lyc luang du ldn de gdp phdn vdo sy phat trien cua ngdnh cdng nghiep dirac Vidt Nam trong thdi ky hoi nhdp WTO[2l Tuy nhidn chung ta dang phai doi mdt vdi ton tai bat cap dd la sy dau tir triing Idp, dap gid nhau trdn thi trirdng l 6 ], trong khi nguon nguydn lieu ddu vdo chu ydu phai nhdp ngoail2', gid nguydn lieu mdi nhdm nirdc cd khdc nhau, din den thuoc san xuit trong nirdc cung hoat chit, hdm luang, dang bdo che tirang duang nhau nhirng cd gia khdc biet nhau.
De cd giai phdp lya chon mua thuoc san xuit trong nude theo tdn goc cung cip cho mang ludi bdn le, ddi hoi phai cd tidu chuin ddnh gia vd lya chpn cho phu hyp.
Trong bdi bdo ndy, chiing tdi trinh bdy ket qua nghien ciru : "Mua thuoc san xuit trong nude theo ten goc bing phuang phdp phdn
Nguyen Van Sinh1, Tir Minh Koong2 'Cong ty Co phdn Duoc phdm Bde Giang,
2Trudmg Dai hoc Duoc Hd Noi nhdm dya vdo tieu chuan nguydn lieu dau vdo"
Nhim dat dirac muc tidu sau:
Thuoc theo tdn goc cd ciing nong dp, dang bdo chd vd ca sd san xuit thuoc dat tidu chuin tuang duang nhau, cd gia bdn le nhu nhau.
D d i tu'cvng va p h i r a n g p h a p n g h i e n CLPU
Dja diim va thdi gian nghien cu>u
- Dja diim: Cdng ty Co phin dupe phim Bic Giang
- Thdi gian: Tu 1/2010 din 6/ 2010.
Ddi tupng nghien cuu
- Chpn 2 khdng sinh san xuit tai Viet Nam:
cefalexin 500mg vd amoxicillin 500 mg cd trong danh muc mua bdn ndm 2010 tai Cdng ty C i phin duac phim Bic Giang;
- Loai tru nhirng thuoc cefalexin 500mg vd amoxicillin 500 mg mua bdn khdng theo diing chinh sdeh phdn phii cua ca sd san xuit.
Phiromg phap nghien CLPU
- Nghidn ciru can thidp khdng doi chung.
- Cdc budc nghidn ciru can thiep dupe triin khai theo trinh ty sau:
He so K phan theo nhom nirdc san xuat nguyen lieu
Xac djnh gia danh gia (GDG)
GDG = [gia ban buon - Chiet khau (giam gia neu cd)] x K
Chpn mua thuoc cd GDG thip nhat
Hinh 2: Qui trinh xac dinh gia danh gia cho tung loai thudc Cac tieu chi danh gia
* Tidu chi chung :
+ Thuoc ciing hoat chit, hdm lupng, dang bdo chi, ca sd san xuit dat tidu chuin tuang
duang nhau.
Tidu chi khdc biet:
+ Tidu chuin nguydn lidu diu vdo.
+ Gid bdn.
TAP CHI DUQC HQC - 5/2011 (S6 421 NAM 51) 11
N g h i e n C L F U - K y t h u a t Phirang phap xiV ly sd lieu
- Thu thdp s6 lieu theo phuong phap hdi ciru va tien cuu.
- Phan tich sd lidu: Su dyng phan mem Excel
va phuong phap thdng ke md ta.
K i t q u a
Danh gia thyc trang vide mua, ban khang sinh cung loai theo nhieu gia khac nhau.
Bang 1: Mua khang sinh theo ten thuong mai hay kem theo fen cua nha san xuit
(TQ: Tmng Qudc; AD: An Do; CA: Chau Au) TT Ten hoat chat Ten thuoc Don vi, Ham Iwong, Nguon goc Dang bao che nguyen lieu Gia
bin
Chiet khau (%)
Gii bin da giam trw
(V (2) (3) (5) (6) (7) (8) (9)
1 Amoxicillin Amoxicillin Vien nang, 500mg TQ 580 3 562,6 Amoxicillin Amoxicillin Vien nang, 500mg AD 472 3 463,7 Amoxicillin Hagimox Vien nang, 500mg CA 1232 20 985,6 Amoxicillin Amoxicillin Vien nang, 500mg TQ 562 2 550,8 Amoxicillin Amoxicillin Vien nang, 500mg TQ 772 4,5 737,3 2 Cephalexin Cephalexin Vien nang, 500mg TQ 735 3 713,0 Cephalexin Cephalexin Vien nang, 500mg AD 635 3 616,0 Cephalexin Hapenxin Vien nang, 500mg CA 1540 20 1232,0 Cephalexin Cephalexin Vien nang, 500mg TQ 693 3 672,2 Cephalexin Cefacyl Vien nang, 500mg CA 1840 25 1380,0 Nhan xet:
Amoxicillin 500mg cd ten thuong mgi la Hagimox 500mg do Cdng ty cd phan dugc Hdu Giang (DHG) san xudt c6 gia la 1232 ddng/vien, trong khi d6 amoxicillin 500mg do Cdng ty cd phdn dugc hoa my phdm Mekophar ( Z2 4) san xudt cd gid Id 472 ddng/vidn. Hai co sd san xuat
Bang 2: Ban le khang sinh theo tdn gdc vdi nhiiu
Ngudn: Cong ty co phan duoc phim Bic Giang ndy deu dat tidu chudn " Thyc hdnh tdt san xudt thudc" ( GMP) . Nguydn nhdn cd sy chdch Idch gid Id do nguydn lidu ddu vdo cd sy khdc nhau cy the hagimox 500mg DHG cd ngudn gdc nguydn lidu san xuat tu Chdu Au vd amoxicillin 500 mg do Z2 4 san xuat cd ngudn gdc nguydn lidu san xudt tu An DO.
mire gid khdc nhau
(TQ: Tmng Quoc; AD: An DQ; CA: Chau Au) TT Ten hoat chat Ten thuoc -
Noi san xuat Don vj, Ham Iwong,
Dang bao che Nguon goc
nguyen lieu Gii
mua vio Gii bin le
(V (2) (3) (5) (6) (7) (8)
1 Amoxicillin Amoxicillin- Zi Vien nang, 500mg TQ 562,6 703 2 Amoxicillin Amoxicillin- Z24 Vien nang, 500mg AO 552,9 700 3 Amoxicillin Hagimox - DHG Vien nang, 500mg CA 985,6 1.232 4 Amoxicillin Amoxicillin- VPC Vien nang, 500mg TQ 550,8 688 5 Amoxicillin Amoxicillin- DHG Vien nang, 500mg TQ 737,3 922 6 Cephalexin Cephalexin- Z1 Vien nang, 500mg TQ 713,0 890 7 Cephalexin Cephalexin - Z24 Vien nang, 500mg AO 616,0 770 8 Cephalexin Hapenxin- DHG Vien nang, 500mg CA 1232,0 1.540 9 Cephalexin Cephalexin- Domesco Vien nang, 500mg TQ 672,2 840 10 Cephalexin Cefacyl- VPC Vien nang, 500mg CA 1380,0 1.725
Nh$n xdt:
Khdng sinh mang tdn gdc cd gid bdn le khdc nhau khao sdt 2 khdng sinh mang tdn gdc Id
Ngudn: Cong ty c6 phin dupe phim Bic Giang amoxicillin 500mg vd cephalexin 500 mg tu 10 co sd san xudt cho thay mdi co sd Id mdt loai gid.
• N g h i e n e l m - K y t h u a t Do dp khi cOng vdi thdng so ban le theo qui dinh se din tdi hien tuang bit cap la khang sinh mang ten goc cd nhieu loai gia ban le khac nhau nhu amoxicillin 500mg c6 gia ban le tu1 688 dong/vien den 1.232 ddng/vidn.
Ndi dung can thiep
He so k img voi nhom nu&c sin xuit nguyen lieu dau vao (ban thanh pham) duyc xac dinh nhw sau
- Nhom 1: la nguyen lieu (ban thanh phim) dirac san xuit tai cac nirdc Chau Au, My, Nhdt irng vdi hd so k duoc xdc djnh: Liy gid bdn budn tinh theo don vj ddng gdi nho nhit cua cdc thuoc theo tdn thuong mai hay biet duoc cd trong danh muc lira chpn mua lin lupt thuoc thir nhit cd gid Id XL thuoc thir 2 cd gid Id x2, thudc thir 3 cd gia Id x3 .. thuoc thir n cd gid Id xn. Vd tinh gid mua trung binh Id X= (x1+x2+x3+xn): n. Ddt he so k cho nhdm 1, k phu thudc theo X khi do hd so dirpc xdc dinh: k = X:X = 1.(1)
- Nhdm 2: Id nguyen lidu (bdn thdnh phim) dupe san xuit tgi cdc nude cdn lai irng vdi hd so k dupe xdc dinh: Lay gid bdn budn tinh theo don vj ddng gdi nho nhit cua cdc thuoc theo tdn thuong mai hay bidt dupe cd trong danh muc
Ket qua can t h i e p
Bang 4: Kit qui thuc hi&n giii phip can thidp phin nhdm...
lya chpn mua lin lupt Id thudc thir nhit cd gid Id y,, thudc thir 2 cd gid Id y2, thudc thir 3cd gid Id y3 .. thudc thir n cd gid Id y„. Vd gpi gid mua trung binh Id Y, khi dd Y= (yi+y2+y3+yn): n. Hd sd k cua nhdm 2 phy thudc theo X khi dd hd sd dupe xdc dinh: k = X:Y.(2).
Theo cdch xdc djnh tai (1), (2) ta cd:
Nhdm 1: Cd gid trung binh Id: (985,6 + 1232,0 + 1380,0): 3 = 1.199,2 ; vdy cd hd sd k cua nhdm 1 Id: 1.199,2:1.199,2 = 1.
Nhdm 2: Cd gid trung binh la: (562,6+
552,9+550.,8+737,3+713,0+616,0+672,2):7=
629,2; vdy cd hd sd k cua nhdm 2 Id 1.199,2:629,2 = 1,9.
Bang 3: Hi sd k tuong ung vOi nhdm 1 vi nhdm 2
STT Nhdm nw&c san xuat nguyin lipu Gia trj he so k 1 Nhom 1: Chdu Au, My ;z Nhat 1,0 2 Nhom 2: Cac nirdc cbn lai 1,9
* Xdc djnh gid ddnh gid = [gid bdn budn - Chiet khau (giam gid ndu cd)] x k
* Gid mua: Ld thudc cd gid dupe xdc djnh d gid ddnh gid thip nhit.
chQn khing sinh theo tdn gdc bdng phuong phip
TT Ten
hoatchat Ten thuoc Don vi, Ham Iwong, dang bao
che
Nguon nguyen goc li$u
ban Gia Chiet khau (%)
Gia bin da giam
trw
dinh Gia gii
Chpn mua
(V (2) (3) (4) (5) (6) (7) (8) (9) (10)
1 Amoxicillin Amoxicillin- Zi Vien nang, 500mg TQ 580 3 562,6 1068,9 Amoxicillin Amoxicillin- Z2 4 Vien nang, 500mg AO 570 3 552,9 1050,5 Amoxicillin Hagimox - DHG Vien nang, 500mg CA 1232 20 985,6 985,6 X Amoxicillin Amoxicillin- VPC Vien nang, 500mg TQ 562 2 550,8 1046,5 Amoxicillin Amoxicillin- DHG Vien nang, 500mg TQ 772 4,5 737,3 1400,8 2 Cephalexin Cephalexin- Zi Vien nang, 500mg TQ 735 3 713,0 1354,7
Cephalexin Cephalexin - Z2 4 Vien nang, 500mg AO 635 3 616,0 1170,4 X Cephalexin Hapenxin- DHG Vien nang, 500mg CA 1540 25 1232,0 1232,0 Cephalexin Cephalexin.Domesco Vien nang, 500mg TQ 693 3 672,2 1277,1 Cephalexin Cefacyl- VPC Vien nang, 500mg CA 1840 25 1380,0 1380,0 Nh$n xdt:
- Nhdm thudc amoxicillin 500mg edgid ddnh gid thip nhit Id 985,6 dong/vien dupe lya chpn mua; dd Id amoixicillin 500mg cd tdn thuong mai hagimox gid mua Id 1232 ddng/vidn cd chiet
Nguon: cua Cong ty c6 phin diryc phim Bic Giang khau thuong mgi Id 20% P 1; V$y nhdm thudc ndy dupe chpn mua thu0c nhdm 1 do cdc ca sd san xuit cd nguydn lidu diu vdo cua cdc nude Chdu Au, My vd Nh$t.
TAP CHI DUQC HQC - 5/2011 (S6 421 NAM 51) 13
• N g h i e n c i m - K y t h u a t - Nh6m cephalexin 500mg dang vien nang c6 gia danh gia thap nhat la 1108,8 dong/vien dirge lira chon mua; d6 la cephalexin 500mg co gia mua la 635 dong/vien co chiet khau thuong
Bang 5 thdng nhit
mai la 3% [3l.Vdy nhom thuoc nay dugc chpn mua thudc nhdm 2 trong cac co so san xuat cd nguydn lidu dau vdo cua tat ca cac nude tru Chdu Au, My va Nhdt.
Bah le khang sinh san xuat trong nude theo ten gdc duoc qui dinh theo mot mire gid (TQ: Trung Quoc: AD: An DQ; CA: Chau Au)
TT Ten hoat chat Ten thuoc -
Noi san xuat Don vi, Ham Iwong,
Dang bao che Nguon goc
nguyen lieu Gia
mua vao Gia ban le
(V (2) (3) (5) (6) (7) (8)
1 Amoxicillin Hagimox - DHG Vien nang, 500mg CA 985,6 1.232 2 Cephalexin Cephalexin - Zn Vien nang, 500mg AD 616,0 770 Nhdn xdt:
Khdng sinh ban le theo ten goc chi co mdt gid cho nhom thuoc da lira chpn, nhu amoxillin500mg chpn mua nhung khang sinh d nhom 1 vd co gid
bdn le dupe qui dinh thong nhat Id 1.232 ddng/vidn, tuong tir cephalexin 500mg chpn mua nhu'ng khdng sinh d nhdm 2 va cd gia ban le dupe qui djnh thong nhat Id 770 ddng/vidn.
Bang 6: So sdnh sis khdc bidt trudc can thiep va sau can thidp
So TT Chi tieu so sanh Trw&c can thiep Sau can thiep
1
Mua khang sinh cung cap cho
mang liroi ban le Mua theo ten thirong mai hoac
ten nha san xuat Mua theo ten goc 2 Gia ban le thuoc theo ten goc Theo nhieu mire gia Theo mot mdc gia Nhan xet:
Lira chpn mua khang sinh trudc can thiep mua theo ten thuong mai, ten biet dupe hodc ten thudc kdm ten nha san xudt, vdi cac mire gid khdc nhau ( theo bang 1), khi bdn le cdng vdi thdng sd bdn le 25% da ddn ddn sir bat cdp thudc cd ten gdc co nhieu loai gia bdn le khdc nhau (theo bang 2);
Sau can thiep viec lua chpn mua khang sinh theo ten gdc voi tieu chi cu thd, dd chpn dupe thudc theo ten gdc trong nhPm thudc co gid mua theo mdt gia thap nhdt (theo bang 4), khi bdn le cpng vdi thdng sd ban le 25% da dat dupe kdt qua khang sinh co ten gdc co mdt mdc gid bdn le nhu nhau (theo bang 5).
Ban luan
Danh gia thuc trang viec lua chon mua thudc khang sinh theo ten thuong mai hoac ten thudc kem theo ten nha san xudt
Trudc thirc trang cac co sd san xudt thudc trong nude dau tu trung Idp din ddn thudc ciing hoat chat, ham lupng, dang bao chd vd tieu chuin ky thudt vd co sd san xuit tuong duong nhau nhung gia ca khac biet nhau dd din den hidn tupng dap gia nhau l 2 , 6' .
Ket qua tai bang 1 cho thiy khi khao sdt 2 loai khang sinh mang ten hoat chat amoxicillin
khdng sinh ciing tdn hoat chdt, hdm lupng, dang bdo chd, tieu chuan ky thudt ve ca sd san xudt tuang duang nhau nhung ddu cd gia khdc nhau; ddc bidt sir khdc biet vd gid hodn todn phu thudc vdo nguydn lieu san xudt thudc; dan cir cephalexin 500 mg; neu nguyen lieu diu vdo cd ngudn gdc do An Dp san xuat se cd gid thanh phim Id 635 dong/vien; ndu nguydn lieu ddu vdo cd ngudn gdc do Trung Qudc san xuat se cd gid thdnh phdm la 693 ddng/vidn; ndu nguydn lidu diu vdo cd ngudn gdc do cac nude Chau Au san xudt se cd gid thdnh phim la 1840 ddng/vidn.
Nhu vdy ciing mpt loai thudc ciing san xudt trong dieu kidn tidu chuin ky thudt nhu nhau nhung nguyen lieu cd ngudn gdc xudt xir khdc nhau, se cd gid thdnh pham khac nhau. "Cd nghTa Id thudc cd tdn gdc mang nhieu gid khdc nhau".Trong liic mpt tdn hoat chdt cd tdi 39 sd ddng ky [2\ cua nhidu ca sd san xuat, vdi nhieu loai gid bdn khdc nhau md vide lira chpn chi Id mdt logi thudc theo ten gdc Id mdt viec Idm rdt khd khdn cho cdc doanh nghidp dugc thyc hidn vide mua thudc de cung cip cho cdc ca sd bdn le trirc thudc. Do vdy hidn tuang phd bien hidn nay tai cdc ca sd bdn le thudc, thudc tdn gdc mang nhieu loai gid khdc nhau (theo bang 2)
• N g h i e n C L F U - K y t h u a t din den viec mua thuoc theo don thuoc ghi ten goc va viec ban le thuoc theo ten goc dang gdp nhieu bit cap.
Trong khi Luat dupe so 34/2005-QH11 Quoc hdi thdng qua ngay 14/6/2005 da qui dinh viec ke don thudc bit buoc phai thyc hien ghi don theo tdn goc '4'. Dong thdi Thdng tu so 11/2007/TTLT-BYT-BTC-BCT cua Bo Y te, Bo tdi chinh va Bo Cdng thuong qui djnh gid thuoc bdn le phai nidm yet tryc tidp tren bao bi cua thuoc m. Vdi thyc trang thuoc mang tdn gdc cd nhieu loai gia khac nhau cd the gdy nham lin ve gid Idm anh hudng tdi quyen loi cua ngudi tieu dung... De giai quydt nhung vin dd bit cap nay, budc diu chung tdi tidn hanh dua ra giai phap can thidp cho viec mua khdng sinh theo tdn goc thay cho vide mua khdng sinh theo ten thuang mai hodc tdn thudc kdm theo nha san xuit.
Thyc hien can thiep va danh gia hieu qua sau can thiep.
Thyc hidn giai phdp can thidp nhim dat duac muc tieu tong qudt: Mua khang sinh theo ten gdc bing phuang phdp phdn nhdm de cd gid bdn le thdng nhit cho thuoc cd ciing ten goc ciing nong dp, dang bdo chd.
Vdi qui djnh lya chpn mua khang sinh san xuit trong nude phan nhdm theo tieu chuin, chit lupng nguyen lidu diu vao cho tirng nhdm nude san xuat nguyen lieu cd dieu kien tieu chuin ky thuat nhu nhau.
Kdt qua sau can thiep theo bang 6 viec lya chpn mua khdng sinh theo ten goc vdi tieu chi cu the, de chpn dupe khdng sinh trong nhdm thuoc cd gid mua theo mpt gia thip nhit.Khi bdn le cpng vdi thdng sd bdn le theo qui dinh, da dat dupe ket qua thuoc cP tdn gdc cd mpt mire gid bdn le nhu nhau.
Ket luan
Thuoc san xuit trong nuoc cd cung hoat chit, nong dp va dang bdo che tuang duang nhau, dupe san xuit tai cdc ca sd san xuit deu dat tidu chuan GMP nhu nhau nhung gid ca cd sy chdnh lech nhau, sy chenh Idch gid phu thudc hodn todn vdo nguon goc nguyen lieu dau vdo.
Khi mua thuoc dupe lya chpn mua theo ten thuang mai, hay ten thuoc kdm theo ten nha san xuit, dd din den thyc trang cung mdt thuoc goc cd cung nong dp, dang bdo che nhu nhau nhung cd gia mua vdo khdc nhau. Tir cho gid
mua vdo khdc nhau dupe cdng vai thdng so bdn le nhu nhau dd din den thyc trang tai cac ca sd ban le thuoc, thuoc mang ten goc co nhieu loai gid khdc nhau cd the gay bit lpi cho ngudi tieu dung vd ca quan quan ly gia thudc.
Trong dieu kien chua cd the thyc hidn diy dii viec lya chpn thuoc theo tieu chi "Tuang duang sinh hpc" Giai phap can thiep mua thuoc san xuit trong nude theo ten goc bdng phuang phdp phdn nhom dya vdo tieu chuin nguyen lieu diu vdo da dat duac kdt qua budc diu nhu sau:
1. Lya chpn mua thuoc theo ten goc, theo mdt gia mua vao dupe xac dinh cho nhPm thudc vd thyc hien dupe gia bdn ra ( gid bdn le) thong nhit cho nhdm thudc cd cung ten goc.
2. Kiem soat vd quan ly dupe gia thuoc bdn le gdp phan bao vd lpi (ch hpp phap cho nguai tidu dung vd giir vung uy tin cho ca sd phdn phoi thudc.
S u m m a r y
A big problem is now widespread in Vietnam that selling prices of many antibiotics are so different although the drugs have the same principle, dose, formula, and manufactured by appropriate companies. In order to choose the domestic antibiotic drugs as preferential indication for the Vietnamese, the solution that buying one drug described by the generic name of the principle is approved. This will help patients purchase drugs with quality fitting the reasonable price. The result also suggests that this solution protects patients from devaluation price and improve the fair business environment for drugs' manufactories and enterprises.
Tai lieu t h a m k h a o
1. Bo Y te, Bp tai chinh, Bp cong thircmg, thong tir so 11/2007/TTLT-BYT-BTC-BCT hudng dan quan ly Nha nude ve gia thuoc diing cho ngu'di, (2007).
2. Cgc quan ly dirpc - Bp Y te, Tong ket cong tac dirac nam 2008 va trien khai ke hoach nam 2009, (2009).
3. Cong ty Cp duoc phim Bic Giang, Ke hoach kinh doanh nam 2010.
4.Qu6c hpi, Luat Diryc so 34/2005- QH11, (2006).
5.Bp Y te, Bp tai chinh, thong tu- lien tich so 10/2007/TTLT-BYT-BTC hirdng dan dau thau mua thuoc trong cac cc sd Y te cong lgp, (2007).
6. Cyc quan ly du-pc - Bp Y te, Nganh Dirpc Vipt Nam Ca hpi va thach thdc trudc them hpi nhgp WTO 2006.
