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THE FUTURE OF PHARMACY

INTERNATIONAL PHARMACY JOURNAL

Consid e r in g a ll fo ur SINAMM cycl e s , a tot a l of 1 ,7 0 0 ph a r m a - c i e s ha v e a lr e a d y b e e n me mb e r s wit h t h e pr o g r a m , a numb e r UIBUBDDPVOUTGPSBCPVUPGUIFUPUBMPGDPNQPVOEJOH p h a r m a c i e s e s t im a t e d by ANVISA to b e in op e r a t i o n in Br a z il . Again , in a co unt r y wh e r e t h e go v e r n m e nt a ge n c y f a c e s ser i o u s dif fi c ul t i e s v isit in g a ll ph a r m a c i e s a n d enfo r c in g a he a v y a n d e x t e n s i v e le g i s l a t i o n , e v e n t h e 2 01 1 numb e r s a r e in fa c t e x t r e m e l y p o sit i v e .

As a nat ur a l re sult of t h e e v o lu t i o n of t h e SINAMM monit o r in g s y s t e m , we ha v e re c e nt l y a d o pt e d t h e us e of a sig n a t ur e , or s e a l , t h at id e nt ifi e s me mb e r ph a r m a c i e s . The se a l is aw a r d e d to a ll ph a r m a c i e s t h at co n si s t e nt l y p a r t i c ip a t e in a ll SINAMM act i v it i e s (s e e fi v e pill a r s de s c r ib e d a b o v e) a n d t h at p a s s t h e au dit , i . e . , t h o s e sh o w in g a low or mo d e r a t e r isk of no n c o m p li - a n c e wit h b e s t co mp o un din g pr a c t i c e s (a n d co n s e q u e nt l y wit h a ll ma n d a t o r y it e m s of t h e a p p li c a b l e le g i s l a t i o n) . S o , t h e SINAMM sea l is a way ph a r m a c i e s ha v e to ma ke t h e co mm u - ni t y aw a r e of t h e ir co mmi t m e nt to qua li t y a n d co nt in u o u s imp r o v e m e nt , a s we ll a s of t h e ir a b ili t y to co mp l y wit h te c hni - c a l a n d ot h e r le g i s l a t i o n re quir e m e nt s .

S o m e simil a r init i a t i v e s ha v e lat e l y b e e n ob s e r v e d wo r l d - w i d e . For e x a mp l e , t h e 2 0 0 8 Gl o b a l Confe r e n c e on t h e Futur e of Hospit a l Phar m a c y de v e l o p e d a co n s e n s u s s t at e m e nt , na m e l y The B a s e l St at e m e nt s , a im e d at refl e c t i o n a n d ac t i o n wit hin t h e co mm uni t y of ho sp i t a l ph a r m a c i s t s . 6 Wh at t his init i a t i v e ha s in co mm o n wit h t h e Br a z ili a n SINAMM monit o r- in g s y s t e m is t h at qua li t y imp r o v e m e nt pr o c e s s e s re l y on t h e we ll - e s t a b li s h e d c y c li c a l pla n - d o - c h e c k - a c t a p p r o a c h , i . e . , t h e y a r e b a s e d on co r e v a lu e s or pill a r s a n d a r e me a nt to pr o v i d e ph a r m a c i e s wit h to o l s to co nt in u o u s l y re v i s e a n d imp r o v e t h e ir pr a c t i c e s . 6

Afte r e a c h ne w c y c l e , t h e SINAMM sys t e m is e v a lu a t e d a n d f ur t h e r imp r o v e d at me e t in g s he l d by ANFARMAG regi o n a l co o r din a t o r s , wh o co n du c t a cr it i c a l a n a l y s i s of t h e pr e v i o u s c y c l e a n d id e nt if y op p o r t uni t i e s fo r imp r o v e m e nt . B e c a u s e SINAMM is a qua lit y pr o g r a m r un by a vo lunt a r y me mb e r s hip a s s o c i a t i o n , it c a n onl y ge n e r a t e sig nifi c a nt re sult s in t h e Br a - z ili a n s ce n a r i o of co mp o un din g in t h e lo ng te r m . The s e lo ng - t e r m re sult s a r e , how e v e r, de p e n d e nt on t h e co mmi t m e nt of f ut ur e b o a r d s at ANFARMAG to ke e p t h e s y s t e m r unnin g .

New cha ll e n ge s will a lw a y s b e pr e s e nt , but we a r e confi d e nt t h a t t h e b e n e fi t s of eng a g in g B r a z ili a n co mp o un din g ph a r m a c i e s in t h e co n s t a nt mo nit o r in g of t h e ir pr a c t i c e ha s en a b l e d t h e s e co mp a ni e s to b et t e r s e r v e t h e ir t a r ge t pub li c , i . e . , pr e s c r ib e r s a n d , mo s t imp o r t a nt l y, p at i e nt s . Obje c t i v e me a s ur e m e nt of t h e b e n e fi t s e x p e r i e n c e d by p a r t i c ip a t in g ph a r m a c i e s is a m o n g our f ut ur e pr o j e c t s , a n d a co mp a r i s o n of t h e re sult s obt a in e d by SINAMM memb e r s v s . no nm e m - b e r s wh e n au dit e d by Br a z ili a n he a lt h a ge n c i e s wo ul d b e e x t r e m e l y us e f ul to b et t e r un d e r s t a n d a n d co nfir m our ro l e in t h e Br a z ili a n co mp o un din g co mm uni t y a s wh o l e . In th e me a nt im e , we will co nt in u e to refl e c t , pla n , do , ch e c k , a n d ac t , a lw a y s t a r ge t in g e xc e ll e n c e a n d ke e p in g t r u e to our v a lu e s , s o t h at s o m e day we c a n co ng r e g a t e a hig h e r numb e r of

fa c ili t a t e d su c c e s s f ul co mp l e t i o n of s a nit a r y insp e c t i o n s . The ro l e of au dit o r s a s a d v i s o r s (r at h e r t h a n a s insp e c t o r s) ce r t a in l y acc o unt s fo r a ma j o r p a r t of t h e imp r o v e m e nt ob s e r v e d . Not wit h s t a n din g , t h e s e re sult s pr o v i d e un e qui v o - c a l e v i d e n c e of t h e vo lunt a r y co mmi t m e nt of t h e s e ph a r m a - c i e s to e xc e ll e n c e .

D i s c u s s i o n ANFARMAG is a vo lunt a r y me mb e r s hip a s s o c i a t i o n a n d t h e r e - fo r e it re p r e s e nt s co s t s to p a r t i c ip a t in g pha r m a c i e s . St ill , ANFARMAG and SINAMM-relat e d co s t s a r e mu c h low e r t h a n a ny ot h e r qua li t y pr o g r a m cur r e nt l y av a il a b l e in Br a z il , a n d we a r e co nfi d e nt t h at t h e b e n e fi t s of t h e s y s t e m out w e ig h it s co s t s . We st r o n g l y b e li e v e t h at our co n si s t e nt wo r k on SINAMM’s five pill a r s , na m e l y co nt in uin g e du c a t i o n , qua li t y co nt r o l , s y s t e m a t i z e d dat a co ll e c t i o n (in c lu din g t h e re g ul a r a s s e s s m e nt of r aw mat e r i a l sup p li e r s) , ac t i v e disp e n s in g a n d au dit s , 3 ha s b e c o m e a v a lu a b l e ins t r um e nt fo r ph a r m a c i e s t h at t a r ge t co nt in u o u s imp r o v e m e nt , re g a r dl e s s of comp a ny s i z e (m o s t of t h e ph a r m a c i e s cur r e nt l y p a r t i c ip a t in g in t h e pr o g r a m do not ha v e br a n c h e s) . B y r unnin g a u dit s , at t e n din g c o ur s e s /s e m in a r s , p e r fo r m in g la b o r a t o r y a n a l y s e s , or eng a g in g in s e v e r a l ot h e r e v e nt s , ph a r m a c i e s enr o ll e d in t h e SINAMM sys t e m ha v e a cha n c e to ch e c k t h e ir pro c e s s e s a n d get mo r e a d e qu a t e l y pr e p a r e d to fa c e le g i s l a t i o n re quir e m e nt s . Phar m a c i e s out si d e t h e pr o g r a m , in tur n , pro b a b l y f a c e gr e a t e r dif fi c ult y me e t in g su c h re quir e m e nt s , a n d ha v e to de a l wit h t h e co n s e q u e n c e s t h e r e a f t e r (e . g . clo sin g n o n c o m p li a nt de p a r t m e nt s or dis c o nt in uin g t h e pr o du c t i o n of ce r t a in dr ug s) .

A gr a du a l de c r e a s e ha s b e e n ob s e r v e d ov e r t h e ye a r s in t h e numb e r of ph a r m a c i e s enr o ll e d in SINAMM and in t h e numb e r of ph a r m a c i e s sub mi t t e d to au dit s – a fin din g t h at co ul d pot e nt i a ll y b e s e e n a s a n ob s t a c l e to t h e gr o w t h of our pro g r a m . From t h e 1 , 3 0 0 ph a r m a c i e s enr o ll e d in 2 0 0 8 , we ha v e gr a du a ll y dr o p p e d to 9 0 0 in 2 0 0 9 , 70 0 in 2 01 0 , a n d 49 6 comp a ni e s re g i s t e r e d in t h e 2 01 1 c y c l e f r o m May to S ept e m b e r 2 01 1 (t h e c y c l e en d s in April 2 01 2 ; a g a in , pl e a s e not e t h at t h e numb e r s of p a r t i c ip a t in g ph a r m a c i e s a r e low e r t h a n t h e numb e r s of au dit e d ph a r m a c i e s a s pr e s e nt e d in Table 1 , in v ie w of t h e pr e s e n c e of br a n c h e s t h at a r e in d e - p e n d e nt l y sub mi t t e d to au dit s) . One po s sib l e e x p l a n a t i o n fo r su c h de c r e a s e co ul d b e t h e hig h e r le v e l s of e xc e ll e n c e s et fo r t h by t h e pr o g r a m at e a c h c y c l e . Anot h e r e x p l a n a t i o n co ul d b e t h e fa c t t h at t h e fir s t c y c l e , in 2 0 0 8 , wa s re l e a s e d s o o n af t e r pub li c a t i o n of t h e RDC 67/ 2 0 0 7, s o pr o b a b l y a gr e a t numb e r of ph a r m a c i e s ent e r e d SINAMM at the t im e to re c e i v e fo r m a l a s si s t a n c e in t h e pr o c e s s of imp l e m e nt in g a n d co mp l y in g wit h t h e ne w le g i s l a t i o n . Howe v e r, f r o m a dif fe r e nt QFSTQFDUJWF GSPNUIFDVSSFOUNFNCFST  PWFS h a lf of t h e m) ha v e p a r t i c ip a t e d in a ll fo ur SINAMM cycl e s , TJODF0GUIFSFNBJOEFS   QBSUJDJQBUFEJO UISFFDZDMFT   JOUXP BOEPOMZQIBSNBDJFT  BSFJOUIFJSmSTUDZDMF5IFGBDUUIBUTPNBOZQIBSNB - c i e s ha v e b e e n p a r t i c ip a t in g in t h e s y s t e m e v e r sin c e it s fir s t e dit i o n s e e m s to reinfo r c e t h e re c o g ni t i o n of t h e pr o g r a m a s a to o l to imp r o v e pr a c t i c e .