P H A R M A C Y P R A C T I C E ( M P P ) S c o p e C L I N I C A L P H A R M A CY P R A C T I C E ( M PP 1 0 1 T ) T h i s c o u r s e i s d e s i g n ed t o i m pa r t the b a s i c kn o w led g e and s k i l l s that a r e req u i r ed to p r a c t i c e p h a r m a c y in c l u d i n g the p r ov i s ion of p h a r m a c e u t i c a l c a r e s e r v i c e s t o b o t h h e a l t h c a r e p r o f e s s i o n a l s a n d p a t i e n t s in c l i n i c al s e tt i n g s O b j ec t i v e s Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e to : U n d e r s t a n d t h e e l e m e n t s of p h a r m a c e u t i c a l c are an d p r o v i d e c o m p r e h e n s i v e p a t ient c are s e r v i c e s Int e rp r et t h e l a b o r a t o r y r e s u l t s to a i d t he c l i n i cal d i a g n o s i s of v a r i o u s d i s o r d e r s P r o v i d e i n t eg r a t ed, c r i t i c a l l y a n a l y z e d m e d i ci n e a n d poison i n f o r m a t i o n to e n a b l e h e a l t h c a r e p r of e s s i o n a l s i n the e f f i c i e nt p a t i e nt m a n a g e m e n t THE O RY 60 H r s 1. I n t r o du c t i o n to Cli n i c al P h ar m a c y : Def i n i t i o n, e v o l u t i on a nd s c o pe of c l i n i c al p h a rm a cy, I n t e rna t i on a l and na t i o n a l s c e n a r i o o f c l i n i c al p h a rm a c y p r a c t i c e , P h a r m a c e u t i c a l c a r e Cli n ical P h arma c y Se r v ic e s: W a r d r o u nd p a rt i c i p a t i on, D r ug t h e r a p y r e v i e w (Drug t h e r a p y m o n i t o r i n g i n c l u d i ng m e d i c a t i o n o r der r ev i e w , c h a r t e n d o r s e m e n t , c l i n i cal r e v i e w and p h a r m a c i s t i n t e r v e n t i o n s ) 12 H r s 2 Cli n ical P h ar m a c y Ser v i c es: P a t i e n t m e d i c a t i o n h i s t o r y i n t e r v i e w , B a s i c c o n c e p t of m edic i n e and p o i s on i n f o r m a t i o n s e r v i c e s , B a s i c c o n c e p t of pha r ma c o v i g i l a n c e, H e m o v i g i l a n c e , M a t e r i o v i g il a n c e and A E F I, P a t i e n t m e d i c a t i o n co u n s e ll i ng, D r u g ut il i s a t i on e v a l u a t i o n , D o c u m e n t a t i o n of c l i nical p h a r m a c y s e r v i c e s , Q u a li t y a s s u r a n c e o f c li n i c al p h a rm a c y s e r v i c e s 12 H r s 3 Pa t ie n t Da t a A n a l y s i s : Pa t ie n t Da t a & Prac t ice S k il l s : P a t i e n t ' s c ase h i s t o r y - i t s s tructu r e a n d s i g n i f i c a n c e s in d r ug t h e r a p y m a n a g e m e n t , Co mm o n medical a b b r e v i a t i o n s a n d te r m i n o l o g i es u s e d i n c li n i c a l p r a c t i c e , C o m mun i c a t i o n s kil l s : v e r bal and n o n - v e r b a l c o mmu n i c a t i o n s , its a p p l i c a t i o n s in p a t i e n t c are s e r v i c e s 12 H r s 188 Lab Da t a I n t e r p r e t a t i o n : H e m a t o l o g i c a l t e s t s , R e n a l f u n c t i o n t e s t s , L i v e r f u n c ti o n t e s t s 4 Lab Da t a I n t e r p r e t a t i o n : T e s t s a s s o c i a t e d w ith c a r d i a c d i s o r d e r s, P u l m o n a r y fu n c t i o n t e s t s , T hyro i d f u n c t ion t e s t s , F l u i d and e l e c t r o l y t e b a l a n c e , M i c r o b i ological c u ltu r e s e n s itivity t e s t s 12 H r s 5 M e d i c i n e s & P o i s o n I n f o r m a t i on S e r v i c e s M e d i c i n e I n f o r m a t i on S e r vi c e: Def i nition and n eed for m e d i c i n e i nformation s e r v i c e , M e d i c i n e i nf o r m a ti o n resou r c e s , S y s t e m a t i c ap p ro a c h i n a n s w e ri ng m e d i ci ne i n fo r m a t i o n q u e r i e s, P r e p a r a t i o n of v e r b a l a nd w r itt e n r e s p o nse, E s t a b li s h i ng a d r u g i n f o r m a t i o n c e n t r e P o i s o n I n f o r m a t i on Ser v i c e : Def i niti o n, n eed, org a n i zat i on a n d fu n c t i o n s o f p o i s o n i n f o r m a t i o n c e n t r e 12 H r s R E F E R E N C E S 1. A T e x tb o ok of Cl i n i c al Ph a rm a c y P r a c t i c e – E s s e n t i a l c o n c e p t s a n d s k i l ls – P a r t h a s a r a t h i G, Karin N y f o r t - H a n s e n a n d M i lap N a h a t a 2. P r a c t i c e S t a n d a r d s a n d De f i n i t i o n s - T he S o c i e t y of H o s p i t a l P h a r m a c i s t s of A u s t r a l i a 3. B a s i c skil l s i n i n t erpr e t i n g l a b o r ato r y d a t a - S c o tt L T , A m e r i c an S o c i e t y o f H e a l t h S y s t e m P h a r m a c i s t s I n c 4. R e l e v a n t r e v i e w a r t i c l e s f r om r e c e n t m e dical a n d p h a r m a c e u t i c a l l i t e r a t u r e 189 S c o p e P H A R M A CO T H E R A P E U T I C S - I ( M P P 1 0 2 T ) T h i s c o u r s e a i m s to e n a b l e t he s t u d e n t s to u n d e r s t a n d t h e d i f f erent t r e a t m e n t ap p ro a c h es i n m a n a g i ng v a r i o us d i s e a s e con d i t i o n s A l s o, it im p arts k n o w l e d g e and s k ills i n o p t i mi z i ng d r ug t h e r a p y of a p a t i e n t by i n d ividu a li z i ng t h e t r e a t m e n t p l an t h ro u gh e v i d e n c e - b a s e d m e d i c i n e s O b j ec t i v e s Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e t o : D e s c r i b e a nd e x p l a i n t h e r a t i o n a l e for dr u g t h e r a p y S u m m a r i z e the t h e r a p e u t i c ap p ro a c h for m a n a g e m e n t of v a r i o u s d i s e a s e c o nd i t io n s i n cluding r e f e r e n c e to the l a t e s t a v a i l a b l e e v i d e n c e D i s c u s s the c l i n i c al c o n t r o v e r s i e s i n dr u g t h e r a p y and e v i d e n c e b a s e d m e d i c i n e P r epa r e i n d i v i du a l ized t h e r a p e u t i c p l a ns based o n d i a g n o s i s Ide n t i fy the pa t i ent s p e c i f i c p a r a m e t e r s r e l e v a n t i n i n i t iat i n g d r ug t h e r a p y , a n d m o n i toring t h e r a p y ( i n c l u d i n g a l t e r n a t i v e s , t i m e - co u r s e o f c l i n i c al a nd l a b o r a t o r y i n dic e s of t h e r a p e u t i c r espo n s e a n d a d v e r s e e f f e c t / s ) THE O RY 60 H r s E t i o p a t ho g e n e s i s a n d p harm a co t h era p y o f d i s e a s e s a s s o c i a t e d w ith f oll o w i n g s y s t e m s 1. Cardi o v a s c u lar s y s t e m : H y p e r t e n s i o n , C o n g e s t i v e c a r d i a c fa il u r e, A c u t e c o r o n a ry s y n d r o m e, A rr h y t h m i a s , H y p e r li p i d e m i a s 12 H r s 2 Res p ira t o r y s y s tem: A s t h m a , C h r o n i c obstru c t i v e a i r w a y s d i s e a s e , D rug i n d u c e d p u l m o n a r y d i s e a s e s En d ocrine s y s t em: D i a b e t e s , T h y r o i d d i s e a s e s 12 H r s 3 G a s t r o in t es t i n al s y ste m : P e p t i c u l cer d i s e a s e s , R e f l u x e s o p h a g i t i s , I n f l a mm a t o r y b o w el d i s e a s e s , J a u n d i c e & h e p a t i t i s 12 H r s 4 G a s t r o in t es t i n al s y s t em: C i rrho s is, D i a r r h e a a nd C o n s t i p a t i o n , D r ug - i n d u c e d l i v er d i s e a s e He m atol o g ical d i s e a s e s : A n e m i a , Deep ve i n t hromb o s i s , D r ug i nd u c ed h e m a t o l o g i c a l d i s o r d e r s 12 H r s 190 5 Bone a n d j o i n t d i s o r d e r s : R h e u m a t o i d arthrit i s , O s t e o a r t h r i t i s , G o u t , O s t e o p o r o s i s Derma t ol o g i cal Di s ea s e s : P s o r i a s i s , Ecz e m a a n d s c a b i e s , im p e t i g o , d r u g i n du c ed s k i n d i s o r d e r s O p htha l mo l o g y : C o n j u n c t i v i t i s , G l a u c o m a 12 H r s R E F E R E N C E S 1. Rog e r a nd W a l k e r Clin i c al P h a r m a c y a n d T h e r a p e u t i c s - C hu r c h i l l L i v i n g s t o n e p u b l i c a t i o n 2. J o s e p h T Di p iro et a l P h a r m a c o t h e r a p y : A P a t h o p h y s i o l o g i c A p p r o a c h - A pp l e t o n & L an g e 3. R o b i n s SL. P a t h o l o g i c b a s i s o f d i s e a s e - W B S a u n d e r s p u b l i c a t i o n 4. E r i c T Herf i n d a l C l i nical P ha rm a c y and T h e r a p e u t i c s - W i l l i a m s a n d W i lk i ns P u b li c a t i o n 5. L l oyd Y o u ng a n d K o d a - K i m b l e MA A p p l i ed T h e r a p e u t i c s : T he c l i nical U s e of D r ug s - Lippi n c o t t W i l li a m s a nd W il k i n s 6. C h i s h o l m - Bu r ns W e ll s S c h w i ng h a m m e r M a l o n e a n d J o s e p h P D i p i r o P h a r m a c o t h e r a p y P r i n c i p l e s a nd p r a c t i c e - – M c G r a w H i ll P u b l i c a t i o n 7. C a r o l M a tt s o n P o r t h P r i n c i p l e s of P a t h o p h y s i o l o g y - L i ppin c ott W i l l i a m s and W il k i n s 8. Ha r ri s o n's. P r i n c i p l e s o f I n t e r n a l M e d i c i n e - M c G r aw H i ll 9. R e l e v a n t r e v i e w a r t i c l e s f r om r e c e n t m e dical a n d p h a r m a c e u t i c a l l i t e r a t u r e 191 S c o p e H O S P I T A L & CO MM U N I T Y P H A R M A C Y ( M P P 1 0 3 T ) T h i s c o u r s e is d esig n e d t o im p a r t b a s i c k no w l ed g e a nd s ki l l s th a t a r e r e q u ired t o p r a c t i c e p ha r m a c y i n b o t h hosp i tal and c o m m u n i ty s e t t i n g s O b j ec t i v e s Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e t o : U n d e r s t a n d the o r ga n i zat i o n a l s tructu r e of h o s p ital p h a r m a c y U n d e r s t a n d drug poli c y a n d d r ug c o m m i tt e e s K n o w a b o u t p r o c u r e m e n t & d r ug dist r i b u t i on p r a c t i c e s K n o w t h e a d mi x tu r es of r a d i o p h a r m a c e u t i c a l s U n d e r s t a n d the c o mm u n i ty p h a rm a cy m a n a g e m e n t K n o w a b o u t v a l u e a d d e d s e r v i c e s i n c o mm u n i ty p h a r m a c i e s THE O RY 60 H r s 1. I n t r o du c t i o n t o Hos p ita l s – De f in i t io n , c l a s s i f i c a t i o n , o r gan i z a t i o n al s t r u c t u r e Hos p ital P h ar m a c y : D e f i n i t i o n, R e l a t i o n s h i p of h o s p i t a l ph a r m a c y d e p a r t m e n t w i th o t her d e p a r t m e n t s , O r g a n i z a t i o n a l s tructu r e, le g al r e q u i r e m e n t s , w o r k load sta t i s t i cs, I n f r a s t r u c t u r a l r e q u i r e m e n t s , H o s p i t a l Phar m a c y B u d g e t a n d H o s p i t a l P h a r m a c y m a n a g e m e n t Hos p ital D r ug P o li c y : Pha rm a c y & T h e r a p e u t i c s C o m m i tt e e , In f e c t i on C o nt r ol c o mm i t t e e , Re s e a r ch & E t h i c s C o m m i tt e e , M a n a g e m e n t of M e d i c i n e s as per N A B H 12 H r s 2 H o s p i t a l Formul a r y G u i d e li n e s a n d i t s d e v e l o p m e n t , D e v e l o p i n g T h e r a p e u t i c guidelin e s , Dr u g p r o c u r e m e n t p r oce s s , and m e t h o d s of I n v e n t o r y c o nt r ol, M e t h o d s of Drug di s tr i b u t i on, I n t r a v e n o u s ad m i x tu r e s , H o s p i t a l W a s t e M a n a g e m e n t 3 Ed u ca t ion and t r a i n in g : T r a i n i n g of t e c h n i c a l s t aff, tr a i ni n g a n d c on t i nuing e d u c a t i o n f o r p h a r m a c i s t s , P h a r m a c y s t u d e n t s , M e d i c a l s ta f f and s t u d e n t s , Nu r s i n g s ta f f and s t u d e n t s , F o r m a l and i n fo r m al m e e t i n g s a n d l e c t u r e s , Dr u g a n d t h e r a p e u t i c s n e w s l e tt e r Com m uni t y P h arma c y P rac t ic e : De f ini t i o n , rol e s & re s p o n s i b i l i ti e s of commu n i ty p h a r m a c i s t s , a nd t h e i r r e l a t i o n s h i p w ith oth e r h e a l t h care p r o v i d e r s 12 H r s 12 H r s 192 Com m uni t y Phar m a c y m a na g e m e n t: L e g a l r e q u i r e m e n t s t o s ta r t c o mm u n i ty pha r m a c y, s i t e s e l e c t i o n , l a y o ut & d e s i gn, d r ug d i s p l ay, su p er dr u g s t o r e m o d e l, a cc o u n t s a nd a u d i t s , Good d i s p e n s i ng p r a c t i c e s , D i f f e r e nt s o f t w a r e s & d a t a b a s e s u s ed i n c ommu n i ty p h a r m a c i e s E n t r e p r e n e u r s h i p i n c o mmun i t y p h a r m a c y 4 Presc r ipti o n – L e g a l r e q u i r e m e n t s & i n t erpr e tatio n , p r e s c r i p t i o n r e l a t e d p r o b l e m s Res p on d i n g to s y m ptoms o f mi n or a i l m en t s: He a d a c he, pyre x i a, m e n s t r u a l pain s , food and d r ug a l l e r g y , O T C m e d icat i o n: R a t i o n a l u se of over t he c o u n t e r m e d i c a t i o n s M e d i c a t i o n c o unse l i ng a nd u s e o f p at i e nt infor mation l e a f l e t s M e d i c a t i o n a d h e r ence – Def i n it i o n , f a c t o r s i nf l u e n c ing a d h e r e n c e be h a v i o r , s t r a t e g i e s to im p r ove m e d i c a t i o n a d h e r e n c e P a t i e n t r efe r r als t o t he d o c t o r s ADR m on i t o r i n g i n c o m mun i ty p h a r m a c i e s 12 H r s 5 Hea l th P ro m o t ion – De f i n i t i on a n d h e a l t h p r o m o t i on a c t i v i t i e s , fa m i l y p l a n n i n g , H e a l t h s c r e e n i ng s e r v i c e s , f i r st ai d , p r e v e n t i o n o f c ommu n i c a b le a n d n o n - c o mm u n i c a b l e d i s e a s e s , s m o k i n g c e s s a t i o n , C h i l d & mot h er c a r e Na t ional H ea l th P r o g r a m s - R o l e of C o m m u n i t y P h a r m a c i s t i n M a l a r i a a n d T B c o nt r ol p r o g r a m s Home M e d i c i n e s re v i e w p r o gram – Def i n i ti o n, o b j e c t i v e s , G u i d e l i n e s , m e t h o d a n d o u t c o m e s Res e arch in c o m mu n i t y p harma c y P r ac t i ce 12 H r s R E F E R E N C E S 1. H o s p i t a l P h arma c y - H a s s a n W E L e a a n d F e b i g e r p u b l i c a t i o n 2. T e x tbo o k o f h o s p i t a l p h a r m a c y - A ll w o o d M C a n d B l a c k w e ll 3. Av e r y ’ s Drug T r e a t m e n t , A d i s I nte r n a t i o n al L i m i t e d 4. C o mm u n i t y P h ar m a cy P r a c t i c e – R a m e s h Ad ep u , B S P P u b l i s h e r s , H y d e r a b a d 5. R e m i n g t o n P h a r m a c e u t i c a l S c i e n c e s 6. R e l e v a n t r e v i e w a r t i c l e s f r om r e c e n t m e dical a n d p h a r m a c e u t i c a l l i t e r a t u r e 193 S c o p e C L I N I C A L R E S E A R C H ( M P P 1 0 4 T ) T h i s c o ur s e a i m s t o p r ov i d e the s t u d e n t s a n o p p o rt u n i ty to l e a r n d r ug d e v e l o p m e n t p r o c e ss e s p e c i a ll y the p hases of c l i n i c al t r i a l s a n d a l s o the e t h i c a l i ss u e s i n v o l ved in the c o n d u c t of c l i nical resea r c h. A l s o, i t a i m s to i m p a r t s k no w l ed g e a n d dev e l op s k il l s on c o n c e p t u a li z i n g , d e s i g n i n g , c ondu c t ing a n d m an a g i n g c l i n i c a l t r i a l s O b j ec t i v e s Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e t o : K n o w t h e n ew d r ug d e v e l o p m e n t p r o c e s s U n d e r s t a n d the r egulat o ry a n d e t h i c a l r e q u i r e m e n t s A p p r e c i a t e a n d c o n d u c t t h e cli n i c a l t r i als a c t i v i t i e s K n o w s a f e t y m o n i to r i ng a n d r e p o rt i n g in c l i nic a l t r i a l s M an a ge the t r ial c o o r d i n a t i o n p r o c e ss THE O RY 60 Hrs 1. D r u g de v el o p m ent p r o c e s s : In t rod u c t i o n , v a r i ous a pp r o a c h es t o d r ug d i s c overy, I n v e s t i g a t i o n a l new d r ug a p p l i c a t i on s u b m i s s i o n E t h i c s in B i o m e d i c a l R e s e a rch: E t h i c a l I s s u e s in B i o m e d i c a l Re s earch – P r i n c i p l e s of e t h i c s in b i o m e d i c al r e s e a r c h , E t h i c a l c o mm i t t ee [ i n st i t ut i o nal r e v i e w boa r d] - i ts c o n s t itu t i o n and fu n c t i o n s, C h a l l e n g e s i n i m p l e m en t a t i o n of e t h i c a l gu i d e l i n e s , I C H G CP gu i d e l i n e s and IC M R gu i d e li n es in c o n d u c t o f C li n i c a l t r i a l s , Drug S a f e t y R e p o r t i n g 12 H r s 2 T y pes and D e s i gns u sed i n C l i n ical R e s e ar c h: P l a nn i n g and e x e c u t i o n of c l inic a l tr i a l s , V a r i o u s P h a s es of c l i n i c al t r i a l s , B i o a v a i l a b i l i t y a n d B i o e q u i v a l e n c e s t u d i e s , R a n d o m i z a t i o n t e c h n i q u e s ( S i m p l e ra n do m i z a t io n , r e s t r i c t e d r a n d o m i z a t i o n , b l ocking m e t h o d and st r a tifi c at i o n ) , Ty p e s of resea r c h d e s i g n s ba s e d on C o n t r o ll i n g M e t h o d ( E x p e r i m e n t a l , Q u a s i e x p e r i m e n t a l , and O b s e r v a t i o n a l m e t h o d s ) T im e S e q u e n c es ( P r o s p e c t i v e and R e t r o s p e c t i v e ) , S a m p li ng m e t h o d s ( C o h o r t s t u d y , c a s e C o n t r o l s t u d y a nd c ross s e c t i o n a l s t u d y ) , H e a l t h o u t c o m e m e a s u r e s (Cl i nical & P h y s i o l o g i c a l , H u m a n i s t i c and e c o n o m i c ) Cli n ical T r i a l S t u d y t ea m : R o l e s and r e s p o n s i b il i t i e s o f : I n v e s t i g a t o r , S t u d y C o o r d i n a t o r , S p o n s o r , M on i tor, C o n t r a c t Re s earch O r g a n i z a t i o n 12 H r s 194 3 Cli n ical t r i a l Doc u m e nts: G u i d e l i n e s to t h e p r e p a r a t i o n o f fo ll o w i ng d o c u m e n t s : P r o t o c o l s , I n v e s t i g a t o r ’ s B r o c h u re, I n f o r m e d C o n s e n t For m , Case r epo r t fo rm s , C o n t r a c t s a n d a g r e e m e n t s , Da i ry C a r d s Cli n ical Tr i al S t art u p a c ti v i t ies: S i t e F e a s i b i l i t y S t u d i e s , S i t e / I n v e s t i g a t o r s e l e c t i o n , P r e - s t u d y v i s i t , I n v e s t i g a t o r m e e t i n g , Cl i nica l tr i a l a g r ee m e n t e x e c u t i o n , E t h i c s c o m m i tt e e d o c u m e n t p r e p a r a t i o n a n d s u b m i s s i o n 12 H r s 4 I n v e s t i g a t i o n a l Pro d uc t : P r o c u r e m e n t and S t o r a g e o f i n v e s tiga t i on p r o d u c t Fil i ng p r o c e du r e s : E ss e n t i a l d o c u m e n t s f o r c l i n i c a l t r i a l , T r i a l M a s t e r F i l e p r e p a r a t i o n a n d m a i n t e n a n c e , I n v e s t i g a t o r S i t e F il e , Pha rm a cy F i l e , S i t e in i t i a t i o n v i s it, C o n d u c t , R e p o r t and F o l l o w up Cli n ical T r ial M on i t o r i ng a n d C lose ou t : Prepara t i o n a n d c o n d uct o f m o ni t oring vi s i t : R e v i e w of s o u r c e d o c u m e n t s , CRF, ICF, I P s t o r a g e , a c c o u n t a b i l i t y and re c o n c i l ia t i on, S t u d y P r o c e d u r e , E C c o mmun i c a t i o n s , S a f e t y rep o rt i n g , M on i toring vi s i t r ep o r t i ng and f o l l o w - u p Clos e - O ut v i s i t : S t u d y r e l a t e d d o c um e n t s c o ll e c ti o n, A r c h i v al req u i r e m e n t , I n v e s t i g a t i o n a l P r o d u c t re c o n c i li a t i o n and de s tr u c t io n , C l o s e - O u t v i s i t r e p o r t 12 H r s 5 Q u ali t y A ss u r a n ce a n d Q u a l i t y Co n t r o l in Cli n ical T r i a l s : Ty p e s of a u d i t s , Au d i t c r i te r i a , A u d it pr o ces s , R e s p o n s i b il i t i e s o f s t a k e h o l d e r s i n a ud i t p r oces s , Aud i t f o l l o w - u p a n d d o c u m e n t a t i o n , Aud i t r eso l u t ion a n d P r e p a r i n g for FDA i n s p e c t i o n s , F r aud a n d m i s c o n d u c t m a n a g e m e n t Da t a M a n a g e m e n t I n f r a s t r u c t u r e a n d S y s t em Req u ir e m ent for D a t a M a n a g e m e n t: E l e c t r o n i c d a t a c a p t u r e s y s t e m s , S e l e c t i o n a n d im p l eme n ta t ion of n e w s y s t e m s , S y s t e m v a l i d a t i on a n d t e s t p r o c e d u r e s, C o d ing d i c t i o n a r i e s , D a t a m i g r ati o n and a r c h i v a l Cli n ical Trial Data M a n a g e m e n t: S t a n d a r d O p e r a t i ng P r o c e d u r e s , D a t a m a n a g e m e n t p l an, CRF & D a t a b a s e d e s i g n c o n s i d e r a t i o n s , S t u d y s e t - u p , D a t a ent r y , CRF t r a ck i ng and c o rr e c t i o n s , D a t a c l e a n i n g , M a n a g i ng l a b o r a t o r y a n d ADR d a t a , D a t a tra n s fer a n d d a t a b a s e loc k , Q u a l i t y Con t r o l a n d Q u a l i t y A s sur a nce in CD M , D a t a m ining a n d w a r e h o u s i n g 12 H r s 195 R E F E R E N C E S 1. P r i n c i p l e s a nd p r a c t i c e of p h a r m a c e u t i c a l m e d i cin e , S e c ond e d i t i o n A u t h o r s : L i o n e l D. E d w a r d , A a d r e w J F l e t h e r A n t h o n y W Fos , P e t e r D S l o a i e r P u b l i s h e r : W i l e y ; 2. Han d b o ok of c l i n i cal r e s e ar c h J u l i a L l oyd and A nn Ra v en E d. C h u r c h il l L i v i n g s t o n e 3. P r i n c i p l e s of Cl i n i c a l Re s e a r ch e d i t e d by G i o v a n n a di I g nazi o , Di G i o v a n n a and Ha y n e s 4. C e n t r a l D r ugs S t a n d a r d C o n t r ol O r g a n i z a t i o n G o o d Cl i ni c al P r a c t i c e s - G u i d e l i n e s for C l inical T rials on P h a r m a c e u t i c a l P r o d u c t s i n In d i a. New De l h i : M in i stry of H e a l t h 5. In t e r n a t i o n a l C o n f e r e n c e on H a r m o n i s a t i o n of T e c h n i c a l r e q u i r e m e n t s f o r reg i stration of P h a r m a c e u t i c a l s for h u m a n use. ICH Ha r m o n i s e d T r i p a r t i t e G u i d e l i ne. Gu id e li n e for Go od C l inical P r a c t i c e E 6 ; M ay 1 9 9 6 6. E t h i c a l G u i d e l i n e s for B i o m e d i c a l R e s e ar c h on H u m an S u b j e c t s I n d i a n Cou n c i l of M e d i c a l R e s e a r ch, New D e l h i 7. T e x tbo o k of C l inic a l T ria l s e d i t e d by D a v i d M a c h i n , S i m o n D ay and S y l v a n G r een, J o h n W i l e y and S o n s 8. C l inical D a t a M a n a g e m e n t e d i t e d by R K R o n d e l s , S A V a r l e y , C F W e b b s S e c o n d E d i t i o n , J a n 2 0 0 0, W i l e y P u b l i c a t i o n s 9. Goo d m a n & G i l m a n : J G H ar d m an, LE L i m b a r d, M c G raw H i ll P u b l i c a t i o n s 10. R e l e v a n t r e v i e w a r t i c l e s f r om r e c e n t m e dical a n d p h a r m a c e u t i c a l l i t e r a t u r e 196 P H A R M A CY P R A C T I C E P R A C T I C A L – I ( M P P 1 0 5 P ) Pha rm a cy P r a c t i c e p r a c t i c a l c o m p o n e n t i nclu d es e x p e r i m e n t s c o v e r i ng im po r t a nt to p i c s of t h e co u r s e s Cl i n i c al P h ar m a cy P r a c t i c e , P h a r m a c o t h e r a p e u t i c s - I , H o s p i t a l & C o mmu n i t y Ph a r m a c y a nd C li n i c a l R e s e a r c h Li st o f E x peri m e n ts ( 2 4 ) 1. T r e a t m e n t C h a r t R e v i e w ( on e ) 2. M e d i c a t i o n H i s t o r y I n t e r v i e w ( one) 3. P a t i e n t M e d i c a t i o n C o u n s e l ing ( t w o ) 4. Dr u g Inf o rm a t ion Que r y ( t w o ) 5. P o i s o n I n f o r m a t i o n Que r y ( o ne ) 6. Lab D a t a In t e r p r e t at i o n ( t w o ) 7. P r e s e n t a t i o n of c l i n i c al c a s e s of var i o u s d i s e a s e c o n d i t i o n s a d o p t i n g P h a r m a c e u t i c a l Ca r e P l a n M o d el ( e i gh t ) 8. A BC A n a l y s i s of a g i v e n l i s t o f m e d i c a t i o n s ( o ne) 9. P r e p a r a t i o n of co n te n t of a m edici n e, w i th prop e r j u stif i c at i o n , for t h e i n c l us ion i n t he h o s p i tal fo r m ula r y ( one) 10. F o r m u l a t i o n a nd d i s p e n s i n g of a g i v en IV a d mi x tu r es ( o n e ) 11. P r e p a r a t i o n of a p a t i ent i nf o rm a t ion l e a f l et ( t w o ) 12. P r e p a r a t i o n of S t u d y P r o t o c o l (one) 13. P r e p a r a t i o n of I n fo r med C o n s e n t Form ( o n e ) 197 P R I N C I P L E S O F Q U A LI T Y U S E O F M E D I C I N E S ( M P P 2 0 1 T ) S c o p e : T h i s c o u r s e is d esig n e d t o im p a r t b a s i c k no w l ed g e a nd s ki l l s th a t a r e r e q u ired t o p r a c t i c e q u a l i ty u s e o f m e dic i n es ( Q U M ) i n d i f f erent h e a l t h c a r e s e t t i n g s and a l s o to p r om o te q u a l i ty u s e of m e di c in e s , i n c l i n i cal p r a c t i c e , t hro u gh e v i d e n c e - b a s e d m edi c i ne a p p r o a c h O b j ec t i v e s : Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e t o : U n d e r s t a n d the p ri n c i p l es of q u a l i ty u s e of m e d i c i n e s K n o w t h e b e n e f i t s a n d r i s k s a s s o c i a t e d w i th u s e of m e d i c i n e s U n d e r s t a n d r e g u l at o ry a s p e c t s of q u a li ty u s e of m e d i c i n e s Ide n t i fy and r e s o l v e m e d i c a t i o n r e l a t e d p r o b l e m s P r o m o t e q u a l ity u se of m e d i c i n e s P r a c t i c e e v i d e n c e - b a s e d m e d i c i n e s THE O RY 60 H r s 1. I n t r o du c t i o n to Qual i t y use of me d ic i n es ( Q U M ): Def i nit i on a n d P r i n c i p l e s o f Q U M , Key p a r t n e r s a n d respo n s i b i l i t i e s o f t h e p a r t n e r s , B u il d i n g blo c k s i n Q M C, E v a l u a t i o n pr o cess i n Q M C, C o mm u n i c a t i o n i n QU M , C o s t e f f e c t i v e p r e s c r i b i n g 12 H r s 2 Conc e pts in Q UM Evi d e n c e b ased m e d ic i ne: Def i n i ti o n, c o n c e p t of e v i d e n c e ba s e d m e d i c i n e , App r o a c h a n d p r a c t i c e o f e v i d e n c e b a s e d m edi c i ne i n c l i n i c a l s e tt i n g s E ss e n t i a l dru g s: Def i n ition, ne e d, c o n c e p t of e s s e n t i a l d r u g , N a t i o n a l e s s e n t i a l drug p o l icy and l i s t Ra t ional d ru g u s e: Defin i t i on, c o n c e p t a n d n e ed f or r a t io n a l d r ug u s e, R a t i o n a l d r ug pr e sc r ibing, R o l e of p h a r m a c i s t in rat i o nal d r ug u s e. 3 Q UM in v ario u s s e tt i n g s : H o s p i t a l se t t i n g s , A m b u l a t o r y c a r e / R e s i d e n t i a l care, R o l e of h e a l t h c a r e pr o f e s sio n a l s i n p r o m o t i ng the Q U M , S t r a t e g i e s to p r om o te t h e Q U M , I m p a c t o f Q U M on E - h e a l t h , i n te g r at i v e m e d i c i ne a nd m u l t idisciplina r y c a r e Q UM in s p e c i a l pop u l a ti o n: P e d i a t r i c p r e sc r i b i n g, G e r i a t r i c p r e s c r i b i n g , P r e s c r i b i n g i n pr e gn a n c y and l actation, P r e s c r i b i ng i n im m u n e c o m p r o m i s ed and o r g an f a il u r e p a t i e n t s 12 H r s 12 H r s 19 8 4 Re g ula t o r y as p ec t s of Q UM in I n d i a : R e g u l a t i o n i n c l u d i n g s c h ed u l i n g , R e g u l a t i o n of c o m p l e m e n t a r y medic i n e s , R e g u l a t i o n of O T C m ed i cin e s , P r o f e s s i o n a l re s p onsibil i ty of p h a r m a c i s t , R o l e of i n du s t r y in QUM i n m edic i n e d e v e l o p m e n t 12 H r s 5 M e d i c a t i o n errors: Def i n i t i o n, c a teg o r i z a t i o n a nd ca u s e s o f m e d i c a t i o n e r ro r s , D e t e c t i o n a nd p r e v e n t i o n of m e d i c a t i o n e rr o r s , R o l e of p h a r m a c i s t i n m o n i tori n g a n d m a n a g e m e n t of m e d i c a t i o n e r r o r s Phar m ac o v i g i l a n ce: Def i n i t i on, a i m s a n d ne e d f o r ph a r m a c o v i g i l a n c e, Ty pe s , pr e d i sposing f a c t o r s a n d m e c h a n i s m of adve r s e d r u g r e a c t i o n s ( A DR s ), D e t e c t i o n , r e p ort i n g and m onito r i ng of ADRs, C a u s a li t y a s s e ss m e n t of A D R s , M a n a g e m e n t of A DR s , R o l e of p h a r m a c i s t in p h a r m a c o v i g il a n c e 12 H r s R E F E R E N C E S : 1. A T e x tb o ok of Cl i n i c al Ph a rm a c y P r a c t i c e – E s s e n t i a l c o n c e p t s a n d s k i l ls – P a r t h a s a r a t h i G, Karin N y f o r t - H a n s e n a n d M i lap N a h a t a 2. An d re w s EB, M oo r e N. M a n n ’ s P h a r m a c o v i g il a n c e 3. D i p i ro J T , T a l b e r t RL, Y ee G C. P h a r m a c o t h e r a p y : A P a t h o p h y s i o l o g i c A pp r o a c h 4. S t r a u s S E, R i c h a r d s o n W S , G l a s z i o u P, H a yn e s R B E v i d e n c e - B a s e d M e d i c i ne: H o w to p r a c t i c e a n d t e a c h i t 5. Coh e n M R. M e d i c a t i o n E r r o r s 6. O n li n e : h t t p : / / m e d i c i n e s a u s t r a l i a c o m a u / f i l e s / 2 0 1 2 / 0 5 / M A _ Q U M _ E x t e r n a l _ R e d u c e d p d f h t t p : / / c u r r i c u l um r a c g p o r g a u / s t a t e m e n t s / q u a l i t y - u s e - o f - m e d i c i n e s / h t t p : // w w w r ug n l / r e s e a r c h / p o r t a l / f i l e s / 1 4 0 51 5 4 1 / C h a p t e r _ 2. p d f 7. R e l e v a n t r e v i e w a r t i c l e s f r om r e c e n t m e dical a n d p h a r m a c e u t i c a l l i t e r a t u r e 199 S c o p e P H A R M A CO T H E R A P E U T I C S II ( M P P 2 0 2 T ) T h i s c o u r s e a i m s to e n a b l e t he s t u d e n t s to u n d e r s t a n d t h e d i f f erent t r e a t m e n t ap p ro a c h es i n m a n a g i ng v a r i o us d i s e a s e con d i t i o n s A l s o, it im p arts k n o w l e d g e and s k ills i n o p t i mi z i ng d r ug t h e r a p y of a p a t i e n t by i n d ividu a li z i ng t h e t r e a t m e n t p l an t h ro u gh e v i d e n c e - b a s e d m e d i c i n e s O b j ec t i v e s Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e t o : D e s c r i b e a nd e x p l a i n t h e r a t i o n a l e for dr u g t h e r a p y S u m m a r i z e the t h e r a p e u t i c ap p ro a c h for m a n a g e m e n t of v a r i o u s d i s e a s e c o nd i t io n s i n cluding r e f e r e n c e to the l a t e s t a v a i l a b l e e v i d e n c e D i s c u s s the c l i n i c al c o n t r o v e r s i e s i n dr u g t h e r a p y a nd e v i d e n c e b a s e d m e d i c i n e P r epa r e i n d i v i du a l ized t h e r a p e u t i c p l a ns based o n d i a g n o s i s Ide n t i fy the pa t i ent s p e c i f i c p a r a m e t e r s r e l e v a n t i n i n i t iat i n g d r ug t h e r a p y , a n d m o n i toring t h e r a p y ( i n c l u d i n g a l t e r n a t i v e s , t i m e - co u r s e o f c l i n i c al a nd l a b o r a t o r y i n dic e s of t h e r a p e u t i c r espo n s e a n d a d v e r s e e f f e c t / s ) THE O RY 60 H r s 1. Ner v ous s y s t em: E p il e p s y , P a r k i n s o n ' s d i s e a s e , S t r o k e , Hea d a c h e , A l z h e i m e r ’ s d i s e a s e , N e u r a l g i a s and P a i n p a t h w a y s and P a i n m a n a g e m e n t 2 P s y c h ia t ric d i s o r d e r s : S c h i z o p h r e n i a , D e p r e s s i o n , A n x i e t y d i s o r d e r s, S l e e p d i s o r ders, D r ug i n duced p s y c h i a t r i c d i s o r d e r s Re n al s y s t em: A c u t e r e n al f a i lur e , Ch r o n i c r e n al f a i lu r e, R e n a l d i a l y si s , D r ug i ndu c ed r e n a l d i s e a s e 12 H r s 12 H r s 3 I n f ec t i o u s d i s ea s e s : G e n e r a l gui d e l i n e s for t he ra t io n a l u s e o f an t i b i ot i c s a n d s ur g i c a l p r o phyla x i s , Urina r y tract i n f e c t i o n s , R e s p i r a t o r y t r a c t in f e c t io n s , G a s t r o e n t e r i t i s , T u b er c u l o s i s , M a l a r i a , B a c t e r i a l e n d o c a r d i t i s , S e p t i c e m i a 12 H r s 4 I n f ec t i o u s d i s ea s e s : M e n in g i t i s , HIV a n d o p po r t u n i s t i c i n f e c t i o n s , R h e u m a t i c f e v e r , D en g u e f e v e r , H1N1, H e l m e n t h i a s i s , F u n g a l i n f e c t i o n s G y ne c olo g ical d i s o r d e r s : D y s m en o rrh e a, H o r m o n e r e p l a c e m e n t t h e r a p y 12 H r s 200 5 O n col o g y : G e n e r a l p r i n c i p l es of c a n c er c h e m o t h e r a p y , p h a r m a c o t h e r a p y of b r e a s t can c e r , l ung c a n ce r , h ead & neck c a n ce r , h e m a t o l o g i c a l m a l i g n a n c i e s, M a n a g e m e n t of na u s ea and v o m it i n g, P a ll i a t i v e c a r e 12 H r s R E F E R E N C E S 1. Rog e r a nd W a l k e r Clin i c al P h a r m a c y a n d T h e r a p e u t i c s - C hu r c h i l l L i v i n g s t o n e p u b l i c a t i o n 2. J o s e p h T Di p iro et a l P h a r m a c o t h e r a p y : A P a t h o p h y s i o l o g i c A p p r o a c h - A pp l e t o n & L an g e 3. R o b i n s SL. P a t h o l o g i c b a s i s o f d i s e a s e - W B S a u n d e r s p u b l i c a t i o n 4. E r i c T Herf i n d a l C l i nical P ha rm a c y and T h e r a p e u t i c s - W i l l i a m s a n d W i lk i ns P u b li c a t i o n 5. L l oyd Y o u ng a n d K o d a - K i m b l e MA A p p l i ed T h e r a p e u t i c s : T he c l i nical U s e of D r ug s - Lippi n c o t t W i l li a m s a nd W il k i n s 6. C h i s h o l m - Bu r ns W e ll s S c h w i ng h a m m e r M a l o n e a n d J o s e p h P D i p i r o P h a r m a c o t h e r a p y P r i n c i p l e s a nd p r a c t i c e - – M c G r a w H i ll P u b l i c a t i o n 7. C a r o l M a tt s o n P o r t h P r i n c i p l e s of P a t h o p h y s i o l o g y - L i ppin c ott W i l l i a m s and W il k i n s 8. Ha r ri s o n's. P r i n c i p l e s o f I n t e r n a l M e d i c i n e - M c G r aw H i ll 9. R e l e v a n t r e v i e w a r t i c l e s f r om r e c e n t m e dical a n d p h a r m a c e u t i c a l l i t e r a t u r e 201 C L I N I C A L P H A R M A CO K I N E T I C S A ND T H E R A P E UT I C D R U G M O N I T O R I N G ( M P P 2 0 3 T ) S c o p e T h i s co u r s e is d e s i g ned to e n a b l e s t u d e n t s to u n d e r s t a n d the b a s i c s p r i n c i p l e s and a p p l i c a t i o n s o f p h a r m a c o k i n e t i c s i n d e s i g n ing t h e i n d i v i du a li z ed d o s a g e reg i men, t o i n t e rp r et t h e p l a s m a drug c o n c e n t r a t i o n p r o f i l e in a l t e r e d p h a r m a c o k i n e t i c s , d r ug i nt e ra c t i o n s and in t h e r a p e u t i c d r ug m o n i t o r i n g p r o c e s s es to op t i mi z e the d r ug d o s a ge r e g i m en. A l s o, i t e n a b l e s s t u d e n t s t o un d e r s t a n d t h e b a s i c c o n c e p t s o f p h a r m a c o g e n e t i c s , p h a r m a c o m e t r i c s f o r m od e li n g a n d s im u l a t i on of p h a r m a c o k i n e t i c d a t a O b j ec t i v e s Upon c o m p l e t i on of t h i s co u rs e i t is e x p e c t e d t h at s t u d e n t s sha l l b e a b l e t o : D e s i g n the d r ug d o s a g e re g im e n for i n d i v i du a l p a t i e n t s Int e rp r et a n d c o rr e l a t e t he p l a s m a dr u g c o n c e n t r a t i o n s w i th p a t i e n t s ' t h e r a p e u t i c o u t c o m e s R e c om m e nd d o s a ge a d j u s t m e n t for p a t i e n t s w ith r e n a l / h e p a t i c i m p a i r m e n t R e c om m e nd d o s a ge a d j u s t m e n t for p a e d i a t r i c s a n d g e r i a t r i c s M an a ge p h a r m a c o k i n e t i c d r ug i n t e r a c t i o n s A p p ly p h a r m a c o k i n e t i c p a r a m e t e r s i n c l i n i c al s e t t i n g s Int e rp r et t he i m p a c t of g e n e t i c p o l y m o r p h i s m s of i n d i v i du a l s on p h a r m a c o k i n e t i c s a n d o r p ha r m acodyn a m i c s of d r u g s Do p h a r m a c o k i n e t i c m o d e l i ng for the g i v en d a t a us i ng t h e p r i n c i p l e s o f p h a r m a c o m e t r i c s THE O RY 60 H r s 1. I n t r o du c t i o n t o C l i n i c al p h a r m ac o k ine t i c s: C o m p a r t m e n t a l a n d Non c o m p a r t m e n t a l m o d e l s , R e n a l and n o n - r e n a l c l e a r a n c e , O r gan e x t r a c t i on a n d m o d e l s of h e p a t i c c l e a r a n c e , E s t i m a t i o n and d e t e r m i n a n t s of b i oavailabil i t y , M u l t i p l e dos i ng, C a l c u l a t i o n o f l oa d i ng a n d m a i n t e n a n c e d o s e s Des i gni n g of d o s age re g i m ens: D e t e r m i n a t i o n o f d o se a n d do s ing i n t e r v a l s , C o n v e r s i o n from i n t r a v e n o u s to o r al d o s i n g , No m o g r ams a n d T a b u l a t i o n s i n d e s i g n i ng d o s age r e g i m e n 12 H r s 202 2 Phar m ac o k i ne t i c s of D r u g I n t e r a c t i o n : P h a r m a c o k i n e t i c d r ug i n t e r a c t i o n s , I n h i b it i o n a nd Ind u c ti o n o f Drug m e t a b o l i s m , In h i b it i o n of B i li a r y E x c r e t i o n P h a r m ac o g e n e t i c s : G e n e t i c p o ly m o r phism in Drug m e t a b o l i s m : C y t o c h r o m e P - 4 50 I s o e nz y m e s , G e n e t i c P o l y m o r p h i s m i n D r u g T r a n s p o r t a n d D r ug T a r g e t s , P h a r m a c o g e n e t i c s and P h a r m a c o k i n e t i c / P h a r m a c o d y n a m i c c o n s i d e r a t i o n s I n t r o du c t i o n t o P h arm a c o m etrics: In t r o d u c t i o n to B a y e s i a n T he o r y , A d a p t i v e m e thod or D o s i n g w ith f e e db a c k , A n a l y s i s o f P o p u l a t i o n p h a r m a c o k i n e t i c D a t a 12 H r s 3 Non Lini e r M i x ed Ef f e c t s M o d e l l i n g : T he S t r u c t u r a l or B a s e M o d e l , M o d e l ing R a nd o m E ff e c t s , M od e l i ng C o v a r i a t e R e l a t i o n s h i p s , M i x tu r e M o d e l , E s t i m a t i o n M e t h o d s , M o d e l B u il d i ng T e c h n i q u e s , C o v a r i a t e S c r ee n i ng M e t h o d s , T e s t i n g t h e m od e l a s s u m p t i o n s , P r e c i s i o n of the p a r a m e t e r e s t i m a t e s a n d c o n f i d e n c e i n t e r v a l s , M od e l m i ss p e c i f i c a t i o n a n d v i o l a t i o n of t h e m od e l a s s u m p t i o n s , M od e l V a li d a t i o n , S i m u l a t i o n of d o s i n g reg i me n s a n d d o s ing r e c o m m e n d a t i o n s , P h a r m a c o m e t r i c s s o f t w a r e 12 H r s 4 A ltered P h arma c oki n e t i c s: Drug do s i ng in t h e e l derl y , D r ug do s ing i n t h e p a e d i a t r i c s , Drug do s i ng in the obe s e p a t i e n t s , D r u g do s ing i n t he p r e gn a n c y a n d l a c t a t i o n , Drug d o s i ng i n t he r e n a l fa il u r e and e x t r a c o r p o r e a l remo v al of d ru g s , Drug d o s i n g i n t he i n h e p a t i c f a i l u r e 12 H r s 5 T h erape u t ic D r u g m oni t o r i n g : In t rod u c t i o n, I nd i v i d uali z a t i on o f d r ug d osage r egi m en ( V a r i a b il i t y – G e n e t i c , a g e, w e i g h t , d i s e a s e and I n t e r a c t i ng d ru g s ) , I n d i c a t i o n s f or T D M , P r o t o c o l for T D M , P h a r m a c o k i n e t i c / P h a r m a c o d y n a m i c C o r r e l a t i o n in drug t h e r a p y , T D M of d r u g s u sed in the f o ll o w ing con d i t i o n s : C a r d i o v a s c u l a r d i s e a s e : Di g o x i n, L i d o c a i n e , A m i o d a r o n e ; S e i z u r e d i s o r d e r s : P h e n y t o i n , C a r b a m a z e p i n e , S o d i um V a l p r o a t e ; P s y c h i a t r i c c on d i t i o n s : L i t h i u m , F l u o x e t i n e , A mi t r i ptyl i n e ; O r g a n t r ansp l a n tations: C y c l o s p o r i n e ; C y to t o x i c A g e n t s : M e t h o t r e x a t e , 5 - F U , C i s p l a t i n ; An t i b io t i c s: V a n c o m y c i n , G e n t a m i c i n , M e r o p e n e m 12 H r s 203 R E F E R E N C E S 1. L e on S h a r g e l , S usa n n a W u - P o n g , A n drew Y u. Ap p l i ed B i o p h a r m a c e u t