TRUNG TAM Y TE HUY~N TIEN YEN

P. LY THUONG KI:E:T-TT.TIEN YEN - H TIEN YEN -T.QUANG NINH.

QUYTRINHGIAM SAT PHAN UNG eo H~I eVA .muoc "ADR"

NGUmVIET

BS.Le Due HQ'pDS. Chu Thi Anh

NHitNG THAY DOl DA.CONgay thang N{>idung thay dBi L§n ban

hanh--20103/2017 Ban hanh Ifm dfm 01

------------------ ------- - -

-- I---

8

Trung tam y t€ QUY TRINH GIAM SAT PHAN UNG co L§.n ban hanh : 01huyen'I'ien Yen H~I CVA THunC "ADR" Ngay ban hanh:

20103/20] 7

1.MVC otcn YEU cAu- Phat hien va su ly kip thoi phan irng co hai cua thuoc gay ra, dam baa sfr dung thuocan toan trong Trung tam.

2. PHAM VI A..p DUNG-T~t cit cac loai thu~e sir dung dieu tri cho benh nhan tai Trung tam y tS Huyen TienYen

3. DOl TUQNG A..p DVNG-HQi dong thu6c va diSu tri-Khoa duoc-Can bQ y tS tai cac khoa lam sang va c?n lam sang- Nguoi benh sir dung thuoc4. GIAI THicH TU NGU-HDT&DT: H9i dong thuoc va dieu tri- K1S, CLS: khoa lam sang, can lam sang-BOB: Ban giam d6c-BS-BD-DS: Bac sy -BiSu duong- Duoc sy-TK: Truong khoa-TTYT: Trung tam y tS

5. NQI DUNG QUY TRINH5.1. cs:yeu cau Co' him*NgtrO'i bao eao:Tc1t ca cac can bQ y tS, baa gem:- Bac si'- Duoc SI - Dieu duong, nir hQ sinh- Cac can bo y tS khac*Cae trU'O'ng hQ'p e~n bao eao-Baa caa tat ca cac biSn c6 bat lqi xay ra trang qua trinh diSu tri, nghi nga la ADRgay ra boi: - Thu6c h6a dUQ'c - v~c xin

- Thu6c dong y, dUQ'cli~u - Sinh phcim y tS.*Uu tien bao eao:

- Cac ADR nghiem trQng- ADR cua cac thu6c m6i dua vaa sir dvng tc;tiTrung tam.- ADR m6i chua tUng duqc biSt dSn cua thu6c- ADR xay ra lien tvc v6i mQt thu6c ha~c mQt 10 thu6c trong mQt thai gian ng~n.

*Khuy€n khieh can bQ y t€ bao eao cae vdn d~ v~ ehdt IU'Q'IlgthuBe va sai sottrong sir d1J.ng thuBe.

5.2.Quy trioh giam sat phao rrog co h~i ella thuBe" ADR"

9

..----~-----..'..

-Voi cac ADR nghiern tn.mg: gQi sOm nh~t co th~toi BS TK (trong gia hanh chinh) d~ ph6i hQ'p voiBS,DD va cac nhan vien y tS khac xu 1y, r6i ghinh~n ADR vao s6 thea d6i phc'mung co h(;li .Bcthea mfiu (PL 6)-Voi ADR thong thuang: BS,DD, DS va cac nhanvien y tS khac t\1'ghi chep vao s6 thea d6i phanung co h(;lit(;likhoa .Bc theo mfiu (PL 6)- DS duQ'c phan cong tlmang xuyen xu6ng khoaphong:+ Ki~m tra cac b~nh an co ADR

+ KSt hQ'pvoi BS,DD lam dftu rn6i ki~m trava hoan chinh cac bao cao ADR

Trach nhiem Cac bmrc thuc hi~nthuc hien

Mo ta/Tai Ii~u lien quan

- Can cir chirc nang nhiem vu cua HDT &DT theaTT s6 21/2013/TT-BYT cua BQ y tS.- Xac dinh nguy co xu~t hien ADR la hau quakh6ng th~ tranh khoi cua viec dung thu6c.Hftu nhtrt~t ca cac thuoc co hieu lire, du duoc dung khonkheo dSn m~y cling co th~ gay ra ADR. Khi chongiroi benh dung thuoc phai thea doi d~ phat hienva su ly kip thai ADR cua thuoc gay ra.nham dambao an toan cho nguoi benh trong qua trinh dibutrt~----------+-------~~------~-TK khoa lam sang phan cong BS,DD lam dftumoi trong cong tac theo doi ADR- DS duoc phan cong p1Wtrach t~p hu~n cong UlCthu thap, bao cao ADR cho cac khoa lam sang- BS,DD uu tien thea doi ADR tren d6i tuongbenh nhan thea phu luc PLI va thuoc thea PL2,- BS,DD phat hi~n cac bi~u hi~n ADR theo PL3- BS,DD ki~m tra cam quan ch~t luqrrg cua cacthu6c nghi nga gay ADR (nSu can mfiu), twanghQ'p nghi nga do ch~t 1uQ'ngthu6c thi bao cao theamfiu " Bao cao b~t thuang vb ch~t lUQ'ngthu6c"theo PL 5- Niem phong vo bao bi thu6c, vi thu6c cua thu6cnghi nga gay ra ADR (n€u can). Ghi r6 ten thu6c,ten b~nh nhan dung thu6c, co ten va chft ki euaBS,DD tren to niem phong va luu mfiu t(;likhoa.~----------+------------------+~~~~~~~~~~~~~~~~~=-~---Nguai phat hi~n phan 10(;liADR thea mtfC dQnghiem tr<.mg+ ADR nghiem tr9ng (PL 4)+ ADR thong thuang

HDT&DT

-BS-DD-DS-Can b<)y tSkhac

Bac sy,Di~u du5ng

-BS-DD-DS- Nhan vien ytS khac

Xac dinhmuc tieu

Thvc hi~n giam satADR va cae sai sot

trong di~u td

1

Khi co ADRPhan lo:;ti

Ghi chCpADR

1

10

-- - - - ---------

Nh6m thamdinh(HUT&UT)

ThAm djnhtai co so

-Thfim dinh ADR nghiem trong thee thang di~mWHO(PL 7) < 3 ngay sau khi nhan duoc bao cao.-Ghi k~t qua tharn dinh vao muc D cua bi~u mftu(PL 6)

DS chuyentrach vSADR

DS chuyentrach vSADR

Khoa DuQ'c

DS chuyentnich ADRDS thong tinthu6c

DS chuyenTnichADRDS thong tinthu6c

, ~Tong hop soluong ADR

Gui bao cao ADRd~n trung tam DIva ADR quoc gia.

1

Nh?n phc'm h6i

Gui cac cfmhbao t6i cackhoaphong

Luu bao caoADR

- Hang thang DS chuyen trach ve ADR lam baocao sa b9 ADR (theo khoa, thee thuoc, cac ADRnghiem trong), bao cao Ban Giam doc TTYT,-DS chuyen trach tong hop s5 hrong ADR trongtoan benh vien thee thang truce ngay 03 ella thangk~ tiep dS giri Sa y t~ va Trung tam DI&ADRQuoc gia thee quy dinh,- Gtri bao cao ADR den trung tam Dr va ADRquoc gia-Hinh thirc giri: gtri qua mail di.pvcenter@vnn.vn ,hoac gui biru dien, fax (04.3.9335642), dien thoai(04.3.9335618).-Thai gian giri+Voi cac ADR nghiem trong gay nr vong va dedoa tinh mc;tng:gui v~ trung tam trong vang 03ngay ill khi thu th~p ADR.+V&i cae ADR nghiem trQng khong gay tu vongho~e de dQa tinh mc;tng: gui v~ trung tam trongvang 05 ngay ttr khi thu th~p ADR.+V&i cae ADR thong thuang: gui v~ trung tamhang thang tru&e ngay 03 cua thang k8 ti~p

V&i cae ADR nghiem trQng: nh~n phan h6i tutrung tam ADR va DI qu5c gia.- V&i cae ADR thong thuang: nh~n bao cao t6ngk8t nam til trung tam ADR va DI qu5e gia

- DS chuyen trach ADR gui phan h6i cua trungHim ADR va DI qu5c gia d8n Dan vi Thong tinthu5c-DS thong tin thu5c c~p nh~t thong tin canh baot&i cae khoa lam sang trong Trung tam y t8

-DS chuyen traeh lUll cae bao cao ADR 5 nam.- DS thong tin thu6c luu cae phim h6i tu trung tamADR va DI qu5e gia dSn Trung tam 5 nam.

11

6.PHl} Ll}C:

STT Noi dung Ghi chuI D6i nrong benh nhan co nguy co cao g~pADR Phu luc 12 Thuoc co nguy co cao gayADR Phu luc 23 MQts6 bieu hien LS,CLS b~t tlurong co th~ lien quan d~n ADR Ph\l luc 34 Cac phan irng co hai nghiem trong Phu luc 45 Bao cao b~t thuong ve chat luqn_g thuoc Phu luc 56 Miu bao cao ADR Phu luc 67 ThAmdinh bao cao ADR thea thangWHO Phu Iuc 7

PhI} luc 1

DOl TVQNG B$NH NHAN CO NGUY CO CAO GAP ADR1. Nguoi benh cao tuoi, benh nhi2. Nguoi benh duoc diSu tri bing thuoc c6 nguy co cao xay ra phan irng c6 hai(duoc dinh kern phia duoi)3. Nguoi benh duoc diSu tri bang thuoc c6 khoang diSu tri hep4. Nguoi benh c6 r6i loan chirc nang gan, thanS. Nguoi benh c6 y~u t6 co dia suy giam miSn dich hoac mac cac benh tv miSn6. Nguoi benh c6 tiSn su di Ung, di lmg thu6c, di Ung thtrc an ho~c di Ungkh6ng ranguyen nhan7. Ph\! nil mang thai, cho con bu

Phu luc 2THU6c CO NGUYCO CAO GAYADR

(Thea hu6ng dfin t~i ph\l l\le 8 di~u 8 "Giam sat phan lrng eo h~i eua thu6e va eae sai sot trang di~utri" ban hfmh kern thea thong tu s6 21/TT-BYT ngay 08/8/2013 eua BQtru6ng B(1y tS)

Nhom thu6c Ten ho~t chat Ten bi~t dU'Q'c DU'o-ngdung

Adrenalin Adrenalin 1mg TMNoradrenalin Levonor Img, 4mg ™Noradrenalin Aguetant 4mg

Chli v~n adrenergic Dopamin Dopamin 200mg TMDobutamin Cardiject 2S0mg TM

Dobutamin 2S0mg ...Chyn ~ adrenergic Propranolol Avlocardyl Smg/Sml TM

Anepol 1% 20ml TM

12

Gay me Propofol Fresofol 1% 20ml TMPropofol 1% 20ml TM

c-------

Ketamin Ketamin 500mg TMLidocain Lidocain 10% 2mI, lOml TM

Chong loan nhip Amiodaron Cordaron I50mg TMAcenocoumarol Sintrom 4mg UongWafarin Wafarin sodium 5mg UongHeparin Heparin 25 OOOUI TM

Tac dong len qua Enoxaparin Lovenox 0,2 ; 0,4; 0,6 ml TMtrinh dong mau Fraxiparin Fraxiparin 0,3ml TM

Fondaparinux Arixtra 2,5mg ™Streptokinase Durakinase 1.5 MUT TMAlteplase Actilyse 50mg/50ml TM

Dextrose uu truong Dextrose 20% Glucose 20% 500ml TM--Dung dich IQcmau DTPPM 1,5 %,2,5 DTPPM 1,5 %, 2,5 %, 4,25 TM

%,4,25 %Gay te ngoai mang Bupivacain Marcain 20mg, 100mg TMcUngTang co b6p co tim Digoxin Digoxin 0,5mg TM

Acarbose Glucobay 50mg UongGliclazide Diamicron MR 30mg Uong

Diamicron MR 60mgThu6c dieu tri dai Glimepirid Amaryl2mg Uongthao duong uong Metformin Glucophage 500mg, 1000mg Uong

Glucophage XR 500mgMeglucon 850mg

Metformin/ glibencla Glucovan 500/2,5-r-r

Uongmid

Thuoc bao che dang Amphotericin B Amphotericin B TMliposom liposom ---r-An than Midazolam Midazolam 5mg TM

Morphin Morphin 10mg TM TMPethidin Dolcontral 100mg TMFentanyl Fentanyl O,lmg; 0,5mg TM,

Opioid Durogesic Mi~ngdan

Sufentanyl Sufentanil 250 mcg TMIobitriol Xenetic TM

Can quang duong Iohexol Omnipaque TMtiem Iopamidol Topamiro TM

Iopromide Ultravit ™13

Ioxitalamat Telebrix TMAlvesin 250,500ml TM

H6n h9'P acid amin Amigold 250, 500mlNuoi duong ngoai Aminosteril N hepa ........tinh mach Dam mo Lipovenous 250, 500ml TM

Smoflipid 100, 250 m1...Dang phoi h9'P Kabiven TM

NutriflexSuxamethonium Suxamethonium 100mg ™PhOI;gb~ dftn Pipercuroni urn Arduan 4mg TM

truyen Rocuronium Esmeron 50mg TMth~n kinh Vecuronium Norcuron 4mg TM

Insulin Mixtard 1000UI TM,Insulin Actrapid 1000UI TDD

Insulin Insulin Latard 1000UI KhacInsulin Lantus 1000UI

Humulin ....Khac Magie sulfat Magiesulfate 15% 10 TM

Methotrexat Methotrexate 2,5mg UongOxytocin Oxytocin 5UI TMKaliclorid dam d~c Kaliclorid 10% 5ml TMNatriclorid >0,9% Natriclorid 10 % 5ml, 250ml TMNurre vo khuan pha Niroc cat pha tiern 500ml TMtiern

Ph\l luc 3

MOT so BIEU HI$N LAM SANG, CAN LAM sANG BAT THU'ONG coTHE LIEN QUAN DEN pRAN UNG CO HAl eVA THUOC

(Theo quyet dinh "V~ viec ban hanh huang dftnhoat dong giam sat phan img co haicua thuoc tai cac co sa kham chua benh)

1 BiSu hien chungSot, Dau dau, Buon ngu

STT Ten ADR Bieu hien ADR~---+----~~==~----4-~----~--~~~~'-------------- _

NgatTang can nhanh

May day, Phil mach, Ban do, Ban xuat huyet

2 Phan irng ngoai da

Tang nhlilY cam anh sang=---.----------------~Ban noi 1TI9ng:Hong ban etadang, hoi chCmgStevens -Johnson, hoai t11bieu bi nhiem doc, ban c6dinh

14

--Mun tnrng ca, Rung toeNhiem khuan, nhiem namYang da, vang mat, phu

3 R6i 10~mchirc nang Tang AST, ALT, phosphatase kiem,gan bilirubin mau

Giam hong cau .Giam tieu cauGiam bach cau, giam bach cau da nhan

4 KSt qua xet nghiem trung tinhhuyet hoc b~t Tang bach cau ua eosin, Tang lympho baothuong Thieu mau tan mau

Phan irng Coombs duong tinhGiam prothrombinNgay sau khi tiep sue voi di nguyen hoac muon hanxuat hien cam giac khac thuong (B6n chon.hothoang, so hai. ...) tiep do co cac bieu hien sau:- M§.n ngira ban do, may day, phu quincke

5 Phan irng phan v~ va -Mach nhanh nho kho b~t,huySt ap tut co khi khongs6c phan v~ do duoc.

-Kho tho (kieu hen thanh quan, nghet tho)-Dau quan bung .ia dai khong tv chu.-Dau d~u chong mat, doi khi hon me.-Choang vang, v~t va,gifiy gi\la, co gi~t, .....

6 Suy th~n cap Tang creatilin mauNon, buon nonKho nuot, Roi lo~n vi giacTang san l<)'i

7 Kho mi~ngR6i lo~n tieu hoa Loet mi~ng Loet th\Xcquan

Bau thuQ'llg vi Soi m~t,Viem t\ly,Tao bonTieu chay va viem d~i trang gia m~cXu~t huySt tieu hoa .....

8 Kho th6R6i lo~n ho h~p Co that phe quan

Vi em phoi ke--

9 Gia tri glucose mau Tang glucose huyStb~t thucmg H~ glucose huySt --

10 Suy giapR6i 10~n nQi tiSt Tang nang tuySn giap

Tang prolactin mauLupus ban do do thu6c

15

11 Benh ly than kinh ngoai bien.Chong mat.Co gi~.t

R6i loan than kinh coRei loan tnrong hrc cO,R6i loan ngoai thapTang ap lire noi so.Cac dong tac bat thuongDau co, Tieu co van capLeang xuong.Hoai nr xuongHa huyet ap

12 Huyet ap b~t thirong Ha huyet ap tu th~ dirngTang huyet apLoan nhip hoac bieu hien bat thuong tren dien tamd6,Ch~m nhip

13 R6i loan tim Viern ngoai mang timHuyet kh6i/dQt quyBenh co tim.Benh van tim, Suy timKich dQng,Uc che tam than

R6i loan tam th~nThay d6i tam tinh: tram cam, hung cam

14 R6i loan giac ngu.Roi loan hanh vi an uong,R6i loan tri nhoThay d6i nhan thirc, Loan thanHQi chirng cai thuoc

15 Tat ca cac bieu hienb~t thuong khac

Phu luc 4

cAe pRAN UNG co fL:\_INGHIEM TRQNG1. Tu vong2. De doa tinh mang3. C~n phai nhap vien4. Keo dai thai gian nim vi~n5. D~ lc;tidi chUng n~g nS ho~c vInh viSn6. Gay di t~t b~m sinh & thai nhi7. Dugc can bQ y t~ nh~n dinh la gay h~u qua nghiem trQng vS m~t lam sang8. ADR xay ra thanh chu6i v6i cung mQt thu6c, san ph~m

16

Phu luc 5Ten khoa phong: ..

BAo eAo BAT THUONG VE eRA T LUONG THUOC(Theo m~u bao cao b~t thuong v~ chM luong thuoc cua BQ Y tS)

1. Ten thucc va ham hrong: .2. S6 lo: H9.n dung: .3. S6 dang ky (Khoa Duoc di~n thong tin nay): .4. Dang bao chS:Dung dich 0 BQt pha tiem 0 Vien nen 0Vien nang 0 B9t uong 0 Khac: .5. Ten nha san xu~t (Khoa Duoc diSn thong tin nay): ................................................................................................................................6. Ten nha cung c~p (Khoa Duoc di~n thong tin nay): .................................................................................................................................7. Ten va dia chi nha cung c~p true tiSp (Khoa Duoc dien thong tin nay): ........................................................................................................................................8. Ng,ay linh thu6c tai khoa DU9·c: .I .I ..9 D ·~ ki ~ b' , . kh 1 '. leu ien ao quan tar oa p long: ..10.Mo ta d~y du, chi tiSt cac b~t thuong v~ chat luong thuoc (NSu thieu ch6xin ghi mat sau): (D6i mau, von C\lC, kSt tua ....)..........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................11.Thu6c do da duoc xu tri nhu thS nao: ................................................................................................................................................................................................................................................................l ZNguoi bao cao (ky, ghi ra ho ten, chirc vu): .................................................................................................................................13.Xac nhan cua thu tnrong dun vi (ky, ghi ra ho ten, clnrc vu): ...............................................................................................................................................................................................................................................................

Bao cao xin gui v~T6 thong tin thu6c, DLS - Khoa DuQ'c

Trung tam y tS huy~n Tien Yen

17

Phu luc 6BAo cAo PHAN LrNG CO'HAI CUA THUOCTHONG TIN v~ NGU'al BAD CAD, BENH NHAN vA f)ON VI BAD CAD

SE oiroc BA 0M~ T .

NO'ibao cao: B$nh vien 8KKV Tien Yen

Mil s6 bao cao cua donV!: .Mil s6 bao cao (do Trung tam qu6c gia quanIy): .

Xin enh/ch! My bso ceo k~ ca khi kMng cMc cMn vEl san ph lim ofJ sev ra pMn (fng va/ho~c kMng c6 o,gyou esc tMngtin

A. THONGTIN VE BeNH NHAN

1 Ho va ten: .Ngay 3. Gi&i tfnh

D Nam D NO>4. Canni;ing

B THONGTIN VE PHAN lrNG c6 HAl (ADR) I

2.sinh: .1 .1. .Hoac tuOi: ...kq

5. Nqay xuat hien phan Lmg: / .1. ..20 .

7. M6 ta bieu hien ADR:

11. Muc dO nqhiern tronq cua phan ungD TLYvongD £)e doa tfnh mGlng

D Nhap vien/Keo dai thai gian narn vienD Tan t$t vTnhvien/ni;ing n~

o Di tat thai nhio kh6ng nghiem trong

6. Phan ung xuat hien sau bao lau (tfnh tLf Ian dung cuoi cungcua thu6c nghi nga): .

s6Ian

dungtrongngayltu~nlthang.

8. Cac xet nqhiern lien quan den phan ung

9. Ti~n SLY(di (fng, thai nghen, nghi~n thuoc la, nghi~n nrou,benn gan, benn th(Jn... )

~~~~~~~~------------------.--------~10. Cach XLYtrl phan ung

12 Ket qua sau khi XLYtrf phan ungD TLYvong do ADRD TLYvong kh6ng lien quan den thu6c

o ChlJ'a hoi phuc D Hoi phuc c6 di chungD£)ang hoi phuc nHoi phuc kh6ng c6 di chung~~ -L~~~ __ ~ ~ ~

C. THONGTIN VE THU6c NGHI NGO'GAY ADR

D Kh6ng ro

Ngay di~u tri(Ngayithangln{Jm)

iv

DGlngbao che,

ham1lJ'Q'ng

STT

13.Thu6c (ten g6c vaten thlJ'O'ngmGli)

Nhasan xuat S616

Li~udungmotIan

£)lJ'angdung

Ly do dungthuoeBat

dau Ket thuc

iii

STT14.Sau khi ngLfng/giam li~u cLla thuQe bi nghi nga, phi3n ungc6 dlJ'Q'ccai thien kh6ng?

C6 Kh6ng Kh6ng ngLfng/giam li~u Kh6ng c6 th6ng C6 Kh6ng Kh6ng tai SLYdung Kh6ng cotin th6nq tin

in 0 DOD 0 D D

(TlJ'cyngting 13.)

15.Hi SLYdl,Jngthuoc bi nghi nga c6 xuat hien IGliphanunq kh6nq?

ii D DOD DOD Diii DOD D 0 -:D::::--f--__ ~D~-_+--~D~___liv D D DOD D D D

Ten thu6c D~ng bao ch~,ham luc:mg

16. Cae thuoc dung dong thai (Ngoi;Ji tn) cac thu6c dunq oieu tril kMc phl.,1ch(Ju qua cua AOR)Ngay dieu tri . D~ng bao

_.(!lgay/)~an_gl!l~m) _ Te!n thu6c ch~, hamB~t dau K~t thuc IUQ'ng

18

Ngay di~u tri(ngay/thang/nam)

B~t d~u K~t thuc

D. PHAN THAM D!NH ADR eOA DO'N V!17. Danh gia moi lien quan giCl'athuoc va ADRo Ch~c chan 0 Khong chac chano Co kha nang 0 Chua phan lo~io Co th~ 0 Khong th~ phan 10<;1i

o Khac

18. Don vi th m dlnh ADR theo thang nao?o Thang WHO 0 Thang Naranjo

........................... :_:_.:..:.:_:_:_:_:_:_---

o Thangkhac

19. Phan blnh luan cua can bo y te (neu co)

E. THONG TIN V~ NGU'O'I sAo eAo20. Ho va ten: .

£lien thoai lien tac..Nghe nghiep/ChLl'c VI) .

Email: .

21. ChCl'ky i 22. Danq bao cao:I sun

o L~n d~ul 0 86 23. Nqay bao cao......... 1 120

Xin chan thanh cam an!----------- -------- -----------

Xin hay bao cao t~t ca cac phan(J>ngc6 hal rna anh/ch] nghi ng6',d~c bi~t khi:

• Cac phan Ll'ng lien quan toithuoc rno:

• Cac phan Ll'ng khong mongmuon hoi;lc chU'a dU'O'c bietden

• Cac phan Ll'ng nghiem trong• TU'O'ngtac thuoc• That b<;1itrong dieu tri• Cac van de ve chat IU'O'ng

thuoc• Cac sai sot trong qua trlnh

su dl)ng thuoc.

Mau bao cao nay dU'Q'c ap dl:lngcho cac phan (J>nggay ra biYi:

• Thuoc va cac che phamsinh hoc

• V~c xin• Cac thuoc c6 truyen hoi;lc

thuoc co nguon goc dU'O'clieu

• Thl)'c pham chLl'c nang.

HU'aNG DAN LAM sAo cAoeach bao cao:

• £lien thong tin vao mau bao cao• Chi can dien nhCl'ngphan anh/chi co thong tin• Co the dlnh kern them mot vai trang (neu mau bao cao khong du khoanq

trong d~ dien thong tin hay co nhCl'ngxet nqhiern lien quan).• Xin hay gui bao cao ve Trung tam Quoc gia ve Thong tin thuoc va Theo diSi

phan Ll'ngco h~i cua thuoc theo cac dia chi sau:

ThU': Trung tam Qu6c gia vi! Thong tin thu6c va Theo doi phan (J>ngc6 h~i eua thu6e

TrLI'ang £l<;1ihoc DU'O'cHa NOi13-15Le Thanh Tong, Qu$n Hoan Kiem, Ha Noi

Fax: 04.3.9335642

£lien tho~i: 04.3.9335618

Website http://canhgiacduoc.org.vnEmail: di.pvcenter@vnn.vn

Anh/chi co th~ lay mau bile cao nay t<;li khoa DU'Q'c, ph6ng K€! hO<;lcht6ng hQ'p cua b$nh vi$n ho$c tai tu' trang web http://canhgiacduoc.org.vn. N€!u

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NgU'cYibao cao c6 th~ la:• Bac sl• DU'O'csl• Nha sl• Y tal di~u dU'cmg/nCY hOsinh• Cac nha cung cap dich VI)

cham s6c sue khoe khac.

""'Phirn mu1"" c'n"onung mnrnl"!: ..mR""th.Mc 1Tia-

co bat ky thac mac nao, anh/ch] c6 th~ lien h~ v&i Trung tam Ouoc gia v~ThOng tin thuoc va Thee d6i phan Lrng co hal cua thuoc thee so di$n thoai 0439335618 hoac thee dia chi email dLpvcenter@vnn.vn.

---------------------1. GCPixac nMn t&i don vi bao cao , 0 3. Phan ling da c6 trong y vanl SPCI CSDL 0,, +--2. Phanlo~i phan ling ,

4. Nhap dCYli$u vao h$ CO' so dCYli$u qu6c gia 0o Thu6c moi o Thu6c cO , 0•• o Nghiem tronq 0 Khong nqhiern tronq 5. Nhap dCYli$u vao phan rnern Vigiflow 0,6. Mlic dOnghiem tronq cua phan lingODe doa tinh m<;lnglgay tlf vong ONh~p vi~nl keodai thai gian nam o Gay di tW tan t~t LO quan toi lamdl,mglphu thuQc

vien thu6c,Ngay 9CPi0

,Ngay gCPi7. GCPibao cao t&i hoi d6ng th~m dinh , , 8. GCPibao cao cho UMC 0 ..../.....!, ..../.... ./. . ......., .........

9. Ket qua th~m djnh0 Chac chan 0 Khong chac chan 00 C6 kha nang 0 ChU'a phan lo~i Khac ... .................... .. .. . . . . . '" . .. ... .. . . ,. . . . ....0 C6 th~ 0 KhOng th~ phan lo~i

........................ ...... ... .. .. . .. . .. ... . . . ... ..

............... .... .. . .. ... . . .............. ..,"10. NgU'Criquan Iy bao cao

11. Ngay. .."J., ..,. I 12. ChCYky.....

........ ................................... .. .......... . ,. . . . . . . . .. ...

Ph\ll\lC 7

THAM DINH BAO CAO ADR THEO THANG WHO, ,*Moi lien quan gifra thuoe nghi nga va ADR se dUQ'edanh gia theo 1 trong 6 mue quikSt:

1. Ch~e eh~n2. Co kha nang3. Co thS4. Khong eh~e ch~n5. Chua phan IO(;li6. Khong thS phan IO(;li

KSt qua a 3 mue (1,2,3): co m6i lien h~KSt qua a 3 mue (4,5,6): khong co m6i lien h~

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*ThAm djnh bao cao theo thang WHO:

Chac chan(Certain)

-Phan irng duoc mo ta (bieu hien Him sang hoac cfm Him sang batthuong) c6 moi lien h~ chat che voi thai gian su dung thuoc nghingo,-Phan ung xciy ra khong thd giai thieh bang tinh trang benh ly cuanguoi b¢nh hodc cdc thu6e khac S~t'dung d6ng thai voi thu6e nghingo;-Cac bi~u hi~n cua phan t'fng dU'Q'ecai thien khi ngirng suo dungthudc nghi ngo',-Phan irng H, hie dung bfit IQ'id~e trirng da dU'Q'ebi~t d~n cuathudc nghi ngo--Phan t'fng l~p lai khi tal sir dung thuBe nghi ngo- (n~u co dunglai thuoc nghi ngo),

C6 kha nang(Probable/likely)

-Phan irng duoc mo ta c6 moi lien h~ hop ly voi thai gian sir dungthuoc nghi ngo,-Nguyen nhan gay ra phan img kh6ng chile ehlln au()'e li¢u co thdco lien quan din b¢nh If; eLLanguai b¢nh ho(1e cae thu6e khae sud1;ingd6ng thai hay kh6ng,-Cae bidu hi~n cua phiin irng tlu'(J'ceiii thi~n khi ngitng sii' dl:lngthuac nghi ngo~-Khong efin thi~t phai co thong tin v~ tai suo dung thuBe.

C6 the(Possible)

-Phan Ung c1uQ'cmo ta c6 moi lien h~ hQ'p ly v6i thai gian su d\lngthu6c nghi nga,-Phan irng co thd dw),c giai thieh bang tinh trgng b¢nh ly cuanguai b¢nh ho(1c cae thu6e khae sir d1;ingd6ng thai,-Thiiu thong tin vJ diin biin eua phiin u-ng khi ngitng sii' dl:lngthuac nghi ngo' ho{ic thong tin vJ vi~c ngirng sii' dl:lngthu6ckhon/( ro ding.

Khong chacch~n (Unlikely)

-Phan ung c1uQ'cmo ta c6 moi lien h~ khong ra nlng v6i thai giansu d\lng thu6c,-Phan ung co thd dw)'c giai thieh bang tinh trgng b¢nh If; eLLanguai b¢nh ho(1e cac thu6e khae sU:d1;ingd6nf!, thai.

Chua phan lo?i(Unclassified)

-Ghi nh~n vi~c xay ra phan ung, nbung can them thong tin de danhgia ho~c dang ti~p t\lC thu th~p thong tin b6 sung dS danh gia.

Khong the phanlo?i

(Unclassifiable)

-Ghi nh~n phan ung, nghi ngo' la phan ung c6 h?i cua thuoc, nhungkhong the danh gia duQ'Cdo thong tin trong bao cao khong d~y duho~c khong th6ng nb~t,va khong thS thu th~p them thong tin b6sung ho~c xac minh l?i thong tin.

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