{"id":5017,"date":"2019-03-18T20:32:20","date_gmt":"2019-03-18T13:32:20","guid":{"rendered":"https:\/\/www.hmm88i.com\/drug\/?p=5017"},"modified":"2019-03-19T00:52:52","modified_gmt":"2019-03-18T17:52:52","slug":"thanh-kien-tran-va-to-giay-huong-dan-su-dung-cua-vaccine","status":"publish","type":"post","link":"https:\/\/hmm88i.com\/drug\/thanh-kien-tran-va-to-giay-huong-dan-su-dung-cua-vaccine\/","title":{"rendered":"Th\u00e1nh Ki\u00ean Tr\u1ea7n v\u00e0 t\u1edd gi\u1ea5y H\u01b0\u1edbng D\u1eabn S\u1eed D\u1ee5ng c\u1ee7a vaccine"},"content":{"rendered":"<p>H\u1ed3i c\u00e1ch \u0111\u00e2y h\u01a1n n\u1eeda n\u0103m th\u00e1nh Ki\u00ean Tr\u1ea7n hay c\u1ea7m c\u00e1i t\u1edd gi\u1ea5y H\u01b0\u1edbng D\u1eabn S\u1eed D\u1ee5ng c\u1ee7a vaccine, m\u00e0 ti\u1ebfng Anh g\u1ecdi l\u00e0 Package Insert, \u0111\u1ec3 d\u00ed v\u00e0o m\u1eb7t t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi r\u1ed3i ch\u1ec9 v\u00e0o c\u00e1i ph\u1ea7n Adverse Reactions (Klq, nh\u01b0ng m\u00e0 ch\u1eb3ng bi\u1ebft th\u1ebf qu\u00e1i n\u00e0o th\u00e1nh l\u1ea1i ngh\u0129 r\u1eb1ng Adverse Reactions \u0111\u01b0\u1ee3c c\u00e1c b\u00e1c s\u0129 d\u1ecbch sang ti\u1ebfng Vi\u1ec7t l\u00e0 shock ph\u1ea3n v\u1ec7 n\u1eefa). L\u00fd do l\u00e0 v\u00ec trong ph\u1ea7n \u0111\u00f3 c\u00f3 li\u1ec7t k\u00ea t\u1ea5t c\u1ea3 nh\u1eefng tai bi\u1ebfn c\u00f3 th\u1ec3 g\u1eb7p sau khi ti\u00eam. Trong s\u1ed1 nh\u1eefng tai bi\u1ebfn \u0111\u00f3 c\u00f3 H\u1ed9i Ch\u1ee9ng \u0110\u1ed9t T\u1eed \u1edf Tr\u1ebb S\u01a1 Sinh v\u00e0 \u0111i\u1ec3m \u0111\u1eb7c bi\u1ec7t l\u00e0 c\u00f2n c\u00f3 c\u1ea3 nh\u1eefng b\u1ec7nh do ch\u00ednh vaccine \u0111\u00f3 ph\u00f2ng ch\u1ed1ng n\u1eefa. V\u00ed d\u1ee5 nh\u01b0 vaccine s\u1edfi th\u00ec s\u1ebd c\u00f3 adverse reaction l\u00e0 s\u1edfi. V\u1eady l\u00e0 th\u00e1nh c\u01b0\u1eddi r\u1ea5t \u0111\u1eafc th\u1eafng tr\u01b0\u1edbc b\u1ecdn b\u00e1c s\u0129 t\u00e2y y gi\u00e1o Vi\u1ec7t Nam ngu d\u1ed1t.<\/p>\n<p>Tuy nhi\u00ean, (m\u00ecnh xin l\u1ed7i t\u1ea5t c\u1ea3 nh\u1eefng th\u1ea7y c\u00f4 gi\u00e1o d\u1ea1y Anh V\u0103n ch\u00e2n ch\u00ednh tr\u01b0\u1edbc, m\u00ecnh kh\u00f4ng c\u00f3 mu\u1ed1n n\u00f3i \u0111\u1ebfn c\u00e1c b\u1ea1n), tr\u00ecnh \u0111\u1ed9 c\u1ee7a m\u1ed9t \u00f4ng th\u1ea7y gi\u00e1o d\u1ea1y Anh V\u0103n nh\u01b0 th\u00e1nh th\u00ec ch\u1ec9 c\u00f3 \u0111\u1ebfn \u0111\u01b0\u1ee3c m\u1ee9c \u0111\u00f3: d\u1ecbch t\u1eeb ti\u1ebfng Anh sang ti\u1ebfng Vi\u1ec7t, kh\u00f4ng h\u01a1n kh\u00f4ng k\u00e9m. T\u1ea5t c\u1ea3 nh\u1eefng g\u00ec th\u00e1nh l\u00e0m ch\u1ec9 l\u00e0 d\u1ecbch l\u1ea1i nh\u1eefng b\u00e0i vi\u1ebft ti\u1ebfng Anh c\u1ee7a c\u00e1c b\u1ea1n anti vaccine n\u01b0\u1edbc ngo\u00e0i sang ti\u1ebfng Vi\u1ec7t v\u00ec l\u1eadp lu\u1eadn c\u1ee7a th\u00e1nh y chang c\u00e1c b\u1ea1n \u1ea5y v\u00e0 th\u1eadm ch\u00ed c\u00f2n c\u00f3 ph\u1ea7n s\u01a1 s\u00e0i h\u01a1n.<\/p>\n<p>C\u00e1c b\u1ea1n anti vaccine \u1edf n\u01b0\u1edbc ngo\u00e0i c\u0169ng ch\u1ec9 v\u00e0o ph\u1ea7n Adverse Reactions trong t\u1edd Package Insert \u0111\u1ec3 t\u1ea5n c\u00f4ng vaccine. V\u00e0 gi\u1edbi y khoa n\u01b0\u1edbc ngo\u00e0i h\u1ecd ng\u1ea5y \u0111\u1ebfn t\u1eadn c\u1ed5 chuy\u1ec7n n\u00e0y t\u1edbi m\u1ee9c \u0111\u1eb7t cho n\u00f3 lu\u00f4n m\u1ed9t c\u00e1i t\u00ean: l\u1ed7i ng\u1ee5y bi\u1ec7n Package Insert, hay c\u00f2n g\u1ecdi l\u00e0 \u201cargumentum ad package insert.\u201d<\/p>\n<p>Tuy nhi\u00ean, \u0111\u1ec3 gi\u00fap c\u00e1c b\u1ea1n hi\u1ec3u \u0111\u01b0\u1ee3c l\u1ed7i ng\u1ee5y bi\u1ec7n Package Insert n\u00e0y l\u00e0 nh\u01b0 th\u1ebf n\u00e0o, m\u00ecnh ph\u1ea3i gi\u1ea3i th\u00edch t\u1eeb \u0111\u1ea7u.<\/p>\n<p>Package Insert l\u00e0 m\u1ed9t m\u1eabu gi\u1ea5y nh\u1ecf v\u00e0 m\u1ecfng, chia ra l\u00e0m nhi\u1ec1u trang v\u1edbi font ch\u1eef nh\u1ecf \u0111\u01b0\u1ee3c g\u1ea5p l\u1ea1i r\u1ea5t g\u1ecdn g\u00e0ng \u0111\u1ec3 b\u00ean trong c\u00e1c h\u1ed9p thu\u1ed1c v\u00e0 nh\u1eefng lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m kh\u00e1c. N\u1ed9i dung c\u1ee7a n\u00f3 bao g\u1ed3m t\u1ea5t c\u1ea3 nh\u1eefng th\u00f4ng tin chuy\u00ean m\u00f4n m\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 n\u00f3i v\u1ec1 lo\u1ea1i thu\u1ed1c n\u1eb1m b\u00ean trong h\u1ed9p.<\/p>\n<p>T\u1ea1i M\u1ef9, c\u01a1 quan qu\u1ea3n l\u00fd Package Insert l\u00e0 FDA (Food and Drug Administration, hay C\u1ee5c Qu\u1ea3n L\u00fd Th\u1ef1c Ph\u1ea9m v\u00e0 D\u01b0\u1ee3c Ph\u1ea9m). FDA quy \u0111\u1ecbnh trong Lu\u1eadt Qu\u1ea3n L\u00fd Li\u00ean Bang (Code of Federal Regulation, hay CFR) r\u1ea5t kh\u1eaft khe v\u1ec1 nh\u1eefng g\u00ec \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o v\u00e0 nh\u1eefng g\u00ec kh\u00f4ng \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o Package Insert.<\/p>\n<p>Khi thu\u1ed1c tr\u1ea3i qua c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng phase I, II, v\u00e0 III, c\u00e1c d\u1eef li\u1ec7u v\u00e0 th\u00f4ng tin khoa h\u1ecdc v\u1ec1 n\u00f3 s\u1ebd \u0111\u01b0\u1ee3c thu th\u1eadp l\u1ea1i. Trong \u0111\u00f3 bao g\u1ed3m c\u00f3 d\u01b0\u1ee3c \u0111\u1ed9ng h\u1ecdc, th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng cho \u0111\u1ebfn k\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c th\u1eed nghi\u1ec7m.<\/p>\n<p>Sau \u0111\u00f3 th\u00ec ph\u00f2ng ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n v\u1ec1 y khoa c\u1ee7a c\u00f4ng ty s\u1ebd b\u1eaft tay v\u00e0o vi\u1ebft package insert d\u1ef1a theo m\u1eabu c\u00f3 s\u1eb5n \u0111\u00e3 \u0111\u01b0\u1ee3c FDA quy \u0111\u1ecbnh. \u1ede c\u00e1c n\u01b0\u1edbc kh\u00e1c, nh\u1eefng quy \u0111\u1ecbnh n\u00e0y do c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd d\u01b0\u1ee3c \u0111\u01b0a ra nh\u01b0ng ch\u00fang th\u01b0\u1eddng gi\u1ed1ng nhau \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh th\u1ed1ng nh\u1ea5t trong n\u1ed9i dung c\u1ee7a t\u1edd package insert tr\u00ean to\u00e0n th\u1ebf gi\u1edbi.<\/p>\n<p>M\u1ee5c \u0111\u00edch c\u1ee7a package insert l\u00e0 gi\u00fap cho b\u00e1c s\u0129 v\u00e0 nh\u00e2n vi\u00ean y t\u1ebf d\u1ef1a v\u00e0o \u0111\u00f3 \u0111\u1ec3 s\u1eed d\u1ee5ng thu\u1ed1c h\u1ee3p l\u00fd tr\u00ean b\u1ec7nh nh\u00e2n. Tuy nhi\u00ean, tr\u00ean m\u1ed9t th\u1ebf gi\u1edbi \u0111\u1ea7y r\u1eaby nh\u1eefng v\u1ee5 ki\u1ec7n t\u1ee5ng nh\u01b0 ng\u00e0y nay th\u00ec package insert c\u0169ng ch\u00ednh l\u00e0 c\u00e1i khi\u00ean \u0111\u1ec3 c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c t\u1ef1 b\u1ea3o v\u1ec7 m\u00ecnh tr\u01b0\u1edbc t\u00f2a. V\u00ed d\u1ee5 nh\u01b0 n\u1ebfu b\u00ean trong t\u1edd package insert c\u00f3 vi\u1ebft l\u00e0 \u201cKh\u00f4ng \u0111\u01b0\u1ee3c k\u00ea toa lo\u1ea1i thu\u1ed1c n\u00e0y cho nh\u1eefng ng\u01b0\u1eddi nghi\u1ec7n r\u01b0\u1ee3u\u201d v\u00e0 b\u00e1c s\u0129 l\u1ea1i k\u00ea toa cho m\u1ed9t ng\u01b0\u1eddi nghi\u1ec7n r\u01b0\u1ee3u r\u1ed3i sau \u0111\u00f3 c\u00f3 x\u1ea3y ra v\u1ea5n \u0111\u1ec1 li\u00ean quan \u0111\u1ebfn ph\u00e1p l\u00fd th\u00ec c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c s\u1ebd \u0111em t\u1edd package insert ra \u0111\u1ec3 b\u00e0o ch\u1eefa.<\/p>\n<p>Sau khi b\u1ea3n ph\u00e1c th\u1ea3o \u0111\u1ea7u ti\u00ean c\u1ee7a package insert \u0111\u01b0\u1ee3c ho\u00e0n th\u00e0nh th\u00ec n\u00f3 s\u1ebd \u0111\u01b0\u1ee3c truy\u1ec1n qua kh\u1eafp c\u00e1c ph\u00f2ng ban kh\u00e1c nhau c\u1ee7a c\u00f4ng ty \u0111\u1ec3 review v\u00e0 ch\u1ec9nh s\u1eeda. V\u00ed d\u1ee5 nh\u01b0 b\u1ed9 ph\u1eadn s\u1ea3n xu\u1ea5t c\u00f3 th\u1ec3 s\u1ebd kh\u00f4ng \u0111\u1ed3ng \u00fd v\u1edbi nh\u1eefng m\u00f4 t\u1ea3 v\u1ec1 c\u00e1ch s\u1ea3n xu\u1ea5t thu\u1ed1c \u0111\u01b0\u1ee3c vi\u1ebft trong package insert v\u00e0 \u0111\u1ec1 ngh\u1ecb ch\u1ec9nh s\u1eeda l\u1ea1i.<\/p>\n<p>T\u00f9y theo c\u00f4ng ty, c\u00f3 th\u1ec3 c\u00f3 \u0111\u1ebfn 10-12 ph\u00f2ng ban review m\u1ed9t package insert. Qu\u00e1 tr\u00ecnh n\u00e0y c\u00f3 th\u1ec3 k\u00e9o d\u00e0i \u0111\u1ebfn v\u00e0i tu\u1ea7n, th\u1eadm ch\u00ed l\u00e0 v\u00e0i th\u00e1ng, tr\u01b0\u1edbc khi t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi th\u1ecfa m\u00e3n. Kh\u00f4ng ch\u1ec9 c\u00f3 v\u1eady, khi c\u1ea7n ch\u1ec9nh s\u1eeda, thay \u0111\u1ed5i, ho\u1eb7c c\u1ee7ng c\u1ed1 m\u1ed9t th\u00f4ng tin g\u00ec \u0111\u00f3 b\u00ean trong t\u1edd package insert, nh\u1eefng ng\u01b0\u1eddi tham gia review ph\u1ea3i \u0111\u00ednh k\u00e8m theo \u0111\u00f3 nh\u1eefng t\u00e0i li\u1ec7u, data, hay gi\u1ea5y t\u1edd ch\u1ee9ng minh r\u1eb1ng nh\u1eefng ch\u1ec9nh s\u1eeda c\u1ee7a m\u00ecnh l\u00e0 \u0111\u00fang. Tr\u01b0\u1edbc khi chuy\u1ec3n sang ph\u00f2ng ban kh\u00e1c, ng\u01b0\u1eddi review ph\u1ea3i k\u00fd t\u00ean x\u00e1c nh\u1eadn. C\u00e1i ch\u1eef k\u00fd \u0111\u00f3 ch\u00ednh l\u00e0 b\u1eb1ng ch\u1ee9ng ph\u00e1p l\u00fd cho r\u1eb1ng ng\u01b0\u1eddi review \u0111\u1ed3ng \u00fd v\u1edbi nh\u1eefng g\u00ec \u0111\u01b0\u1ee3c vi\u1ebft ra.<\/p>\n<p>Sau \u0111\u00f3, t\u1ea5t c\u1ea3 s\u1ebd \u0111\u01b0\u1ee3c g\u1eedi l\u00ean FDA \u0111\u1ec3 \u0111\u01b0\u1ee3c duy\u1ec7t cho s\u1eed d\u1ee5ng tr\u00ean th\u1ecb tr\u01b0\u1eddng M\u1ef9. FDA sau \u0111\u00f3 s\u1ebd review l\u1ea1i to\u00e0n b\u1ed9 nh\u1eefng g\u00ec li\u00ean quan \u0111\u1ebfn lo\u1ea1i thu\u1ed1c \u0111\u00f3, bao g\u1ed3m package insert, nh\u00e3n hi\u1ec7u, c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t v.v.. tr\u01b0\u1edbc khi quy\u1ebft \u0111\u1ecbnh c\u00f3 \u0111\u1ed3ng \u00fd ph\u00ea duy\u1ec7t hay kh\u00f4ng.<\/p>\n<p>FDA th\u01b0\u1eddng s\u1ebd y\u00eau c\u1ea7u thay \u0111\u1ed5i m\u1ed9t v\u00e0i ch\u1ed7 n\u00e0o \u0111\u00f3 t\u00f9y tr\u01b0\u1eddng h\u1ee3p. C\u00f3 nhi\u1ec1u tr\u01b0\u1eddng h\u1ee3p c\u00e1c h\u00e3ng d\u01b0\u1ee3c mu\u1ed1n th\u00eam v\u00e0o m\u1ed9t v\u00e0i ch\u1ec9 \u0111\u1ecbnh m\u1edbi cho s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd. Ch\u1ec9 \u0111\u1ecbnh l\u00e0 nh\u1eefng l\u00fd do ch\u00ednh \u0111\u00e1ng \u0111\u1ec3 s\u1eed d\u1ee5ng thu\u1ed1c. V\u00ed d\u1ee5, \u201ch\u1ea1 s\u1ed1t\u201d l\u00e0 m\u1ed9t ch\u1ec9 \u0111\u1ecbnh c\u1ee7a paracetamol. Tuy nhi\u00ean, FDA s\u1ebd b\u00e1c \u0111\u01a1n cho \u0111\u1ebfn khi n\u00e0o c\u00f3 \u0111\u1ee7 d\u1eef li\u1ec7u ch\u1ee9ng minh \u0111\u01b0\u1ee3c c\u00e1c ch\u1ec9 \u0111\u1ecbnh \u0111\u00f3 l\u00e0 \u0111\u00fang. C\u00f2n c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c kh\u00f4ng th\u1ec3 t\u1ef1 \u00fd thay \u0111\u1ed5i c\u00e1c ch\u1ec9 \u0111\u1ecbnh cho \u0111\u1ebfn khi n\u00e0o \u0111\u01b0\u1ee3c s\u1ef1 cho ph\u00e9p c\u1ee7a FDA.<\/p>\n<p>B\u00ean trong package insert c\u00f3 r\u1ea5t nhi\u1ec1u m\u1ee5c nh\u1ecf bao g\u1ed3m th\u00f4ng tin chung, ng\u00e0y \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t, m\u00f4 t\u1ea3, d\u01b0\u1ee3c l\u00e2m s\u00e0ng, ch\u1ec9 \u0111\u1ecbnh v\u00e0 c\u00e1ch d\u00f9ng, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh v.v..<\/p>\n<p>Tuy nhi\u00ean, c\u00e1c b\u00e1c s\u0129 th\u01b0\u1eddng s\u1ebd ch\u00fa \u00fd c\u00e1c m\u1ee5c sau \u0111\u00e2y:<\/p>\n<p>1) CLINICAL PHARMACOLOGY (d\u01b0\u1ee3c l\u00e2m s\u00e0ng): cung c\u1ea5p th\u00f4ng tin gi\u00fap b\u1ea1n hi\u1ec3u \u0111\u01b0\u1ee3c v\u1ec1 nh\u1eefng t\u00e1c \u0111\u1ed9ng c\u1ee7a thu\u1ed1c tr\u00ean c\u01a1 th\u1ec3 ng\u01b0\u1eddi. N\u1ebfu hi\u1ec3u \u0111\u01b0\u1ee3c ph\u1ea7n n\u00e0y, c\u00e1c b\u1ea1n s\u1ebd hi\u1ec3u \u0111\u01b0\u1ee3c thu\u1ed1c \u0111i\u1ec1u tr\u1ecb b\u1ec7nh nh\u01b0 th\u1ebf n\u00e0o. V\u00e0 n\u1ebfu hi\u1ec3u \u0111\u01b0\u1ee3c ph\u1ea7n n\u00e0y, c\u00e1c b\u1ea1n s\u1ebd hi\u1ec3u \u0111\u01b0\u1ee3c t\u1ea1i sao vaccine kh\u00f4ng th\u1ec3 t\u1ef1 nhi\u00ean chui l\u00ean n\u00e3o m\u00e0 l\u00e0m t\u1ed5n th\u01b0\u01a1ng c\u00e1c t\u1ebf b\u00e0o n\u00e3o g\u00e2y t\u1ef1 k\u1ef7 \u0111\u01b0\u1ee3c. Tuy nhi\u00ean, D\u01b0\u1ee3c L\u00e2m S\u00e0ng l\u00e0 m\u1ed9t m\u00f4n kh\u00f3 nh\u1ea5t trong tr\u01b0\u1eddng Y. C\u00e1c sinh vi\u00ean ph\u1ea3i h\u1ecdc tr\u1ea7y vi tr\u00f3c v\u1ea3y m\u1edbi qua \u0111\u01b0\u1ee3c. Ch\u1ee9 kh\u00f4ng c\u00f3 \u0111\u01a1n gi\u1ea3n theo c\u00e1i ki\u1ec3u \u201ckh\u00e1ng th\u1ec3 \u0103n g\u00ec \u0111\u1ec3 s\u1ed1ng\u201d theo nh\u01b0 l\u00fd thuy\u1ebft c\u1ee7a c\u00e1c th\u00e1nh.<\/p>\n<p>2) CONTRAINDICATION (ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh): nh\u1eefng tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng thu\u1ed1c.<\/p>\n<p>3) WARNING (c\u1ea3nh b\u00e1o): Nh\u1eefng tai bi\u1ebfn do thu\u1ed1c g\u00e2y ra \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh b\u1eb1ng c\u00e1c nghi\u00ean c\u1ee9u khoa h\u1ecdc nghi\u00eam t\u00fac v\u00e0 c\u00f3 gi\u00e1 tr\u1ecb. FDA c\u00f3 th\u1ec3 bu\u1ed9c c\u00e1c h\u00e3ng d\u01b0\u1ee3c ch\u1ec9nh s\u1eeda package insert \u0111\u1ec3 th\u00eam v\u00e0o c\u00e1c c\u1ea3nh b\u00e1o m\u1edbi n\u1ebfu nh\u01b0 c\u00f3 c\u00e1c b\u1eb1ng ch\u1ee9ng khoa h\u1ecdc m\u1edbi ch\u1ee9ng minh nh\u1eefng t\u00e1c \u0111\u1ed9ng c\u00f3 h\u1ea1i c\u1ee7a n\u00f3.<\/p>\n<p>C\u00f2n m\u1ee5c \u0111\u01b0\u1ee3c c\u00e1c b\u1ea1n anti vaccine ch\u00fa \u00fd nhi\u1ec1u nh\u1ea5t l\u00e0 m\u1ee5c ADVERSE REACTIONS.<\/p>\n<p>\u0110\u1ec3 hi\u1ec3u \u0111\u01b0\u1ee3c nh\u1eefng u\u1ea9n kh\u00fac trong chuy\u1ec7n n\u00e0y, tr\u01b0\u1edbc ti\u00ean c\u00e1c b\u1ea1n ph\u1ea3i bi\u1ebft hai kh\u00e1i ni\u1ec7m Adverse Reaction v\u00e0 Adverse Event.<\/p>\n<p>Theo FDA \u0111\u1ecbnh ngh\u0129a th\u00ec Adverse Event l\u00e0 nh\u1eefng d\u1ea5u hi\u1ec7u, bi\u1ec3u hi\u1ec7n, tri\u1ec7u ch\u1ee9ng c\u00f3 li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c, b\u1ea5t k\u1ec3 l\u00e0 n\u00f3 c\u00f3 m\u1ed1i quan h\u1ec7 causation hay kh\u00f4ng.<\/p>\n<p>Adverse Reaction l\u00e0 nh\u1eefng d\u1ea5u hi\u1ec7u, bi\u1ec3u hi\u1ec7n, tri\u1ec7u ch\u1ee9ng c\u00f3 m\u1ed1i quan h\u1ec7 causation \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c.<\/p>\n<p>Nh\u01b0 c\u00f3 l\u1ea7n m\u00ecnh \u0111\u00e3 gi\u1ea3i th\u00edch v\u1ec1 s\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa correlation v\u00e0 causation. Hai s\u1ef1 vi\u1ec7c \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 correlation khi c\u00f3 v\u1ebb nh\u01b0 l\u00fac n\u00e0o ch\u00fang c\u0169ng x\u1ea3y ra g\u1ea7n nhau. Hai s\u1ef1 vi\u1ec7c \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 causation khi s\u1ef1 vi\u1ec7c x\u1ea3y ra tr\u01b0\u1edbc g\u00e2y ra s\u1ef1 vi\u1ec7c x\u1ea3y ra sau.<\/p>\n<p>V\u00ed d\u1ee5, s\u00e1ng h\u00f4m nay tr\u01b0\u1edbc khi \u0111i l\u00e0m b\u1ea1n u\u1ed1ng m\u1ed9t ly n\u01b0\u1edbc v\u00ec tr\u1eddi n\u00f3ng l\u00e0m b\u1ea1n kh\u00e1t n\u01b0\u1edbc. Nh\u01b0ng c\u0169ng v\u00ec tr\u1eddi n\u00f3ng, b\u1ea1n c\u1ea3m th\u1ea5y kh\u00f3 \u1edf trong ng\u01b0\u1eddi n\u00ean tr\u00ean \u0111\u01b0\u1eddng \u0111i l\u00e0m, b\u1ea1n nh\u00ecn th\u1ea5y th\u1eb1ng ch\u1ea1y xe k\u1ebf b\u00ean c\u00e1i m\u1eb7t th\u1ea5y gh\u00e9t, b\u1ea1n quay sang ch\u1eedi n\u00f3: \u201c\u00ca, \u0110MM !\u201d N\u00f3 n\u1ed5i kh\u00f9ng \u0111\u1ea1p b\u1ea1n t\u00e9 ch\u1ed5ng v\u00f3.<\/p>\n<p>C\u00e1i s\u1ef1 vi\u1ec7c h\u00f4m nay tr\u1eddi n\u00f3ng v\u1edbi c\u00e1i s\u1ef1 vi\u1ec7c b\u1ea1n u\u1ed1ng m\u1ed9t ly n\u01b0\u1edbc n\u00f3 c\u00f3 m\u1ed1i quan h\u1ec7 causation v\u00ec h\u00f4m nay tr\u1eddi n\u00f3ng n\u00ean b\u1ea1n m\u1edbi u\u1ed1ng n\u01b0\u1edbc.<\/p>\n<p>C\u00e1i s\u1ef1 vi\u1ec7c h\u00f4m nay tr\u1eddi n\u00f3ng v\u1edbi c\u00e1i s\u1ef1 vi\u1ec7c b\u1ea1n th\u1ea5y kh\u00f3 \u1edf trong ng\u01b0\u1eddi n\u00f3 c\u00f3 m\u1ed1i quan h\u1ec7 causation v\u00ec h\u00f4m nay tr\u1eddi n\u00f3ng n\u00ean b\u1ea1n m\u1edbi th\u1ea5y kh\u00f3 \u1edf trong ng\u01b0\u1eddi.<\/p>\n<p>C\u00e1i s\u1ef1 vi\u1ec7c b\u1ea1n th\u1ea5y kh\u00f3 \u1edf trong ng\u01b0\u1eddi v\u00e0 c\u00e1i s\u1ef1 vi\u1ec7c b\u1ea1n ch\u1eedi th\u1eb1ng \u0111\u00f3 c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation v\u00ec b\u1ea1n th\u1ea5y kh\u00f3 \u1edf trong ng\u01b0\u1eddi n\u00ean b\u1ea1n m\u1edbi ch\u1eedi c\u00e1i th\u1eb1ng \u0111\u00f3.<\/p>\n<p>C\u00e1i s\u1ef1 vi\u1ec7c b\u1ea1n ch\u1eedi th\u1eb1ng \u0111\u00f3 v\u00e0 c\u00e1i s\u1ef1 vi\u1ec7c b\u1ea1n b\u1ecb n\u00f3 \u0111\u1ea1p t\u00e9 ch\u1ed5ng v\u00f3 c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation v\u00ec b\u1ea1n ch\u1eedi n\u00f3 n\u00ean n\u00f3 m\u1edbi \u0111\u1ea1p b\u1ea1n.<\/p>\n<p>Nh\u01b0ng b\u1ea1n kh\u00f4ng th\u1ec3 n\u00f3i r\u1eb1ng t\u1ea1i v\u00ec b\u1ea1n u\u1ed1ng n\u01b0\u1edbc n\u00ean b\u1ea1n m\u1edbi ch\u1eedi c\u00e1i th\u1eb1ng \u0111\u00f3 \u0111\u01b0\u1ee3c. Ch\u00fang tuy l\u00e0 c\u00f3 m\u1ed1i li\u00ean h\u1ec7 correlation v\u00ec c\u00f3 v\u1ebb nh\u01b0 c\u1ee9 m\u1ed7i khi b\u1ea1n u\u1ed1ng n\u01b0\u1edbc l\u00e0 b\u1ea1n l\u1ea1i mu\u1ed1n g\u00e2y s\u1ef1 v\u1edbi ng\u01b0\u1eddi kh\u00e1c. Tuy nhi\u00ean, ch\u00fang kh\u00f4ng c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation v\u00ec trong c\u1ea3 hai s\u1ef1 vi\u1ec7c, kh\u00f4ng c\u00f3 s\u1ef1 vi\u1ec7c n\u00e0o g\u00e2y ra s\u1ef1 vi\u1ec7c n\u00e0o c\u1ea3. Th\u1eadt ra, s\u1ef1 vi\u1ec7c b\u1ea1n u\u1ed1ng n\u01b0\u1edbc v\u00e0 s\u1ef1 vi\u1ec7c b\u1ea1n ch\u1eedi c\u00e1i th\u1eb1ng \u0111\u00f3 \u0111\u1ec1u c\u00f3 c\u00f9ng m\u1ed9t nguy\u00ean nh\u00e2n: h\u00f4m nay b\u1ea1n th\u1ea5y kh\u00f3 \u1edf trong ng\u01b0\u1eddi v\u00ec tr\u1eddi n\u00f3ng.<\/p>\n<p>N\u00f3i theo to\u00e1n h\u1ecdc th\u00ec Adverse Reaction l\u00e0 t\u1eadp h\u1ee3p con c\u1ee7a Adverse Event. Adverse Event l\u00e0 t\u1ea5t c\u1ea3 nh\u1eefng d\u1ea5u hi\u1ec7u, bi\u1ec3u hi\u1ec7n, tri\u1ec7u ch\u1ee9ng c\u00f3 m\u1ed1i li\u00ean h\u1ec7 correlation v\u1edbi vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c. Tuy nhi\u00ean, trong s\u1ed1 \u0111\u00f3, ch\u1ec9 c\u00f3 nh\u1eefng lo\u1ea1i c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation m\u1edbi \u0111\u01b0\u1ee3c x\u1ebfp v\u00e0o nh\u00f3m Adverse Reaction th\u00f4i.<\/p>\n<p>Nh\u01b0 v\u1eady th\u00ec m\u1ecdi vi\u1ec7c r\u00f5 r\u00e0ng qu\u00e1 r\u1ed3i, \u0111\u00fang kh\u00f4ng b\u1ea1n?<\/p>\n<p>Ch\u00ednh FDA c\u0169ng \u0111\u00e3 c\u00f3 khuy\u1ebfn c\u00e1o r\u1eb1ng c\u00e1c h\u00e3ng d\u01b0\u1ee3c kh\u00f4ng n\u00ean gom h\u1ebft t\u1ea5t c\u1ea3 c\u00e1c adverse event \u0111\u1ec3 \u0111\u01b0a v\u00e0o m\u1ee5c ADVERSE REACTION.<\/p>\n<p>C\u00e1c b\u1ea1n c\u00f3 th\u1ec3 \u0111\u1ecdc quy \u0111\u1ecbnh n\u00e0y \u1edf \u0111\u00e2y:\u00a0<a href=\"https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm075057.pdf\" rel=\"noopener\">https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm075057.pdf<\/a><\/p>\n<p>Ho\u1eb7c c\u00e1c b\u1ea1n c\u0169ng c\u00f3 th\u1ec3 xem ph\u1ea7n \u0111\u01b0\u1ee3c t\u00f4 \u0111\u1eadm \u1edf trong h\u00ecnh \u0111\u00ednh k\u00e8m theo b\u00e0i vi\u1ebft n\u00e0y.<\/p>\n<p>Tuy nhi\u00ean, cu\u1ed9c \u0111\u1eddi kh\u00f4ng ph\u1ea3i l\u00fac n\u00e0o c\u0169ng m\u00e0u h\u1ed3ng nh\u01b0 v\u1eady.<\/p>\n<p>Vi\u1ec7c x\u00e1c \u0111\u1ecbnh, nh\u1eadn di\u1ec7n \u0111\u00e2u l\u00e0 Adverse Reaction v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c c\u00e1c nh\u00e0 qu\u1ea3n l\u00fd quy \u0111\u1ecbnh r\u00f5 r\u00e0ng v\u00e0 r\u1ea5t d\u1ec5 l\u00e0m m\u1ecdi ng\u01b0\u1eddi l\u1ea7m l\u1eabn.<\/p>\n<p>N\u00f3 th\u01b0\u1eddng \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n ra d\u1ef1a v\u00e0o nh\u1eefng nghi\u00ean c\u1ee9u v\u1ec1 d\u01b0\u1ee3c h\u1ecdc v\u00e0 \u0111\u1ed9c h\u1ecdc tr\u00ean c\u00e1c con v\u1eadt c\u0169ng nh\u01b0 c\u00e1c nghi\u00ean c\u1ee9u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng tr\u01b0\u1edbc khi thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. Nh\u1eefng ph\u1ea3n \u1ee9ng n\u00e0y th\u00ec ch\u1eafc ch\u1eafn l\u00e0 c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation v\u1edbi thu\u1ed1c r\u1ed3i.<\/p>\n<p>Tuy nhi\u00ean, ngo\u00e0i nh\u1eefng ph\u1ea3n \u1ee9ng c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation r\u00f5 r\u00e0ng \u0111\u00f3 th\u00ec danh s\u00e1ch trong ph\u1ea7n ADVERSE REACTION c\u1ee7a package insert c\u0169ng s\u1ebd \u0111\u01b0\u1ee3c k\u00e9o d\u00e0i ra th\u00eam sau khi thu\u1ed1c \u0111\u01b0\u1ee3c \u0111\u01b0a ra ngo\u00e0i th\u1ecb tr\u01b0\u1eddng d\u1ef1a v\u00e0o c\u00e1c post market studies. L\u00fac n\u00e0y th\u00ec m\u1ecdi vi\u1ec7c b\u1eaft \u0111\u1ea7u r\u1ed1i. L\u00fd do l\u00e0 v\u00ec n\u00f3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng tr\u00ean m\u1ed9t l\u01b0\u1ee3ng ng\u01b0\u1eddi r\u1ea5t l\u1edbn.<\/p>\n<p>FDA c\u00f3 l\u1eadp ra h\u1eb3n m\u1ed9t h\u1ec7 th\u1ed1ng \u0111\u1ec3 cho m\u1ecdi ng\u01b0\u1eddi v\u00e0o b\u00e1o c\u00e1o c\u00e1c Adverse Event m\u00e0 h\u1ecd g\u1eb7p ph\u1ea3i khi s\u1eed d\u1ee5ng thu\u1ed1c. H\u1ec7 th\u1ed1ng n\u00e0y g\u1ecdi l\u00e0 Medwatch v\u00e0 h\u1ec7 th\u1ed1ng c\u01a1 s\u1edf d\u1eef li\u1ec7u l\u01b0u tr\u1eef c\u00e1c adverse event c\u1ee7a thu\u1ed1c l\u00e0 FAERS (FDA\u2019s Adverse Event Reporting System). Tuy nhi\u00ean, t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi \u0111\u1ec1u \u0111\u01b0\u1ee3c quy\u1ec1n b\u00e1o c\u00e1o l\u00ean h\u1ec7 th\u1ed1ng n\u00e0y, bao g\u1ed3m b\u00e1c s\u0129, d\u01b0\u1ee3c s\u0129, b\u1ec7nh nh\u00e2n, v\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t. D\u1ef1a v\u00e0o \u0111\u00f3 m\u00e0 FDA s\u1ebd \u0111\u01b0a ra nh\u1eefng quy\u1ebft \u0111\u1ecbnh c\u1ea7n thi\u1ebft bu\u1ed9c c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t thu\u1ed1c ph\u1ea3i thay \u0111\u1ed5i n\u1ed9i dung package insert cho ph\u00f9 h\u1ee3p.<\/p>\n<p>V\u1ea5n \u0111\u1ec1 \u0111\u01b0\u1ee3c \u0111\u1eb7t ra l\u00e0 ai s\u1ebd l\u00e0 ng\u01b0\u1eddi quy\u1ebft \u0111\u1ecbnh t\u00ednh ch\u00ednh x\u00e1c c\u1ee7a c\u00e1c Adverse Event n\u00e0y khi m\u00e0 t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi \u0111\u1ec1u c\u00f3 th\u1ec3 g\u1eedi b\u00e1o c\u00e1o l\u00ean h\u1ec7 th\u1ed1ng?<\/p>\n<p>Ngo\u00e0i ra, c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c c\u0169ng s\u1ebd nh\u1eadn c\u00e1c b\u00e1o c\u00e1o v\u1ec1 adverse event t\u1eeb ng\u01b0\u1eddi s\u1eed d\u1ee5ng \u1edf kh\u1eafp n\u01a1i tr\u00ean th\u1ebf gi\u1edbi g\u1eedi v\u1ec1.<\/p>\n<p>Khi c\u00e1c c\u00f4ng ty n\u00e0y nh\u1eadn th\u1ea5y r\u1eb1ng c\u00f3 h\u01a1i nhi\u1ec1u b\u00e1o c\u00e1o v\u1ec1 m\u1ed9t ph\u1ea3n \u1ee9ng n\u00e0o \u0111\u00f3, v\u1edbi c\u00e1i ho\u00e0n c\u1ea3nh tranh t\u1ed1i tranh s\u00e1ng n\u00e0y c\u1ed9ng v\u1edbi vi\u1ec7c c\u00e1c lu\u1eadt s\u01b0 nh\u01b0 nh\u1eefng con s\u00f3i ch\u1edd m\u1ed3i \u0111ang \u0111\u1ee9ng \u0111\u1ea7y tr\u01b0\u1edbc c\u1eeda, h\u1ecd s\u1ebd ch\u1eadc l\u01b0\u1ee1i r\u1ed3i th\u00eam c\u00e1c ph\u1ea3n \u1ee9ng n\u00e0y v\u00e0o m\u1ee5c ADVERSE REACTION m\u00e0 b\u1ecf l\u01a1 l\u1eddi khuy\u1ebfn c\u00e1o c\u1ee7a FDA \u0111\u1ec3 l\u1ee1 c\u00f3 chuy\u1ec7n g\u00ec th\u00ec c\u00f2n c\u00f3 c\u00e1i \u0111\u1ec3 b\u1ea3o v\u1ec7 m\u00ecnh tr\u01b0\u1edbc t\u00f2a. L\u00fd do r\u1ea5t \u0111\u01a1n gi\u1ea3n, n\u1ebfu th\u00eam v\u00e0o danh s\u00e1ch m\u1ed9t c\u00e1i t\u00ean m\u00e0 ng\u01b0\u1eddi d\u00f9ng kh\u00f4ng b\u1ecb g\u00ec th\u00ec ch\u1eb3ng ai b\u1ecb l\u00e0m sao c\u1ea3. Nh\u01b0ng n\u1ebfu kh\u00f4ng th\u00eam v\u00e0o m\u00e0 ng\u01b0\u1eddi d\u00f9ng b\u1ecb \u0111\u00fang c\u00e1i ph\u1ea3n \u1ee9ng \u0111\u00f3 r\u1ed3i \u0111\u00e2m \u0111\u01a1n \u0111i ki\u1ec7n th\u00ec \u0111\u00f3 l\u00e0 m\u1ed9t th\u1ea3m h\u1ecda.<\/p>\n<p>Do \u0111\u00f3, theo \u0111\u00fang \u0111\u1ecbnh ngh\u0129a c\u1ee7a FDA th\u00ec nh\u1eefng g\u00ec \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o m\u1ee5c Adverse Reaction \u0111\u1ec1u ph\u1ea3i c\u00f3 m\u1ed1i li\u00ean h\u1ec7 causation v\u1edbi thu\u1ed1c. Tuy nhi\u00ean, trong th\u1ef1c t\u1ebf th\u00ec kh\u00f4ng h\u1eb3n nh\u01b0 v\u1eady. \u0110\u00f4i khi ch\u00fang ch\u1ec9 l\u00e0 nh\u1eefng Adverse Event c\u00f3 m\u1ed1i li\u00ean h\u1ec7 correlation, th\u1eadm ch\u00ed r\u1ea5t y\u1ebfu v\u1edbi thu\u1ed1c m\u00e0 th\u00f4i.<\/p>\n<p>C\u00e1i danh s\u00e1ch nh\u1eefng ph\u1ea3n \u1ee9ng v\u1edbi thu\u1ed1c trong m\u1ee5c Adverse Reaction th\u1eadt ch\u1ea5t ch\u1ec9 l\u00e0 \u0111\u00f2n \u0111\u00e1nh ph\u1ee7 \u0111\u1ea7u, bao v\u00e2y c\u1ee7a c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c \u0111\u1ec3 \u0111\u1ed1i ph\u00f3 v\u1edbi c\u00e1c v\u1ea5n \u0111\u1ec1 ph\u00e1p l\u00fd m\u00e0 th\u00f4i.<\/p>\n<p>V\u1eady hen. H\u1eb9n d\u1ecbp kh\u00e1c m\u00ecnh l\u1ea1i t\u00e2m s\u1ef1 v\u1edbi c\u00e1c b\u1ea1n antivaccine ti\u1ebfp.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>H\u1ed3i c\u00e1ch \u0111\u00e2y h\u01a1n n\u1eeda n\u0103m th\u00e1nh Ki\u00ean Tr\u1ea7n hay c\u1ea7m c\u00e1i t\u1edd gi\u1ea5y H\u01b0\u1edbng D\u1eabn S\u1eed D\u1ee5ng c\u1ee7a vaccine, m\u00e0 ti\u1ebfng Anh g\u1ecdi l\u00e0 Package Insert, \u0111\u1ec3 d\u00ed v\u00e0o m\u1eb7t t\u1ea5t c\u1ea3 m\u1ecdi ng\u01b0\u1eddi r\u1ed3i ch\u1ec9 v\u00e0o c\u00e1i ph\u1ea7n Adverse Reactions (Klq, nh\u01b0ng m\u00e0 ch\u1eb3ng bi\u1ebft th\u1ebf qu\u00e1i n\u00e0o th\u00e1nh l\u1ea1i ngh\u0129 r\u1eb1ng Adverse [&#8230;]\n","protected":false},"author":1,"featured_media":5018,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5017","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/posts\/5017","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/comments?post=5017"}],"version-history":[{"count":0,"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/posts\/5017\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/media\/5018"}],"wp:attachment":[{"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/media?parent=5017"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/categories?post=5017"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hmm88i.com\/drug\/wp-json\/wp\/v2\/tags?post=5017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}