E na b le rs a nd b a rrie rs to me a suring impa c t pa tie nt - PowerPoint PPT Presentation

E na b le rs a nd b a rrie rs to me a suring impa c t – pa tie nt a nd he a lthc a re pro fe ssio na l e ng a g e me nt 3.1 BRE AK OUT SE SSI ON – PART OF : ME ASURING T HE IMPACT OF PHARMACOVIGIL ANCE ACT IVIT IE S

Sta rting po ints fo r this se ssio n  09.00 De fining e ngage me nt – awar e ne ss and pe r c e ption of public he alth me asur e s own - Unive rsity o f Amste rda m, Ne the rla nds Patr ic k Br  Do we know what we ar e me asur ing? Is the ir (br oad) agr e e me nt ar ound c onc e pts?  09.20 ISPE pape r “E valuating the E ffe c tive ne ss of Additional Risk Minimisation Me asur e s via Sur ve ys in E ur ope : Challe nge s and Re c omme ndations” Rac he l Sobe l - Pfize r I nc .; I SPE BRACE SI G i Madison - Ma pi; I SPE BRACE SI G T e r r  Do we have the data to unde r stand e ngage me nt and do the se have use ful me asur e s?  09.40 Patie nt r e por ting in E udr aVigilanc e – a me asur e of patie nt e ngage me nt? in Banovac - E uro pe a n Me dic ine s Ag e nc y, E U Mar  How muc h do available me asur e s te ll us muc h about e ngage me nt ?  As a b a sis fo r wide r a nd de e pe r disc ussio ns…

'De fining e ng a g e me nt - a wa re ne ss a nd pe rc e ptio n o f pub lic he a lth me a sure s'  Wha t is e ng a g e me nt?  Who is b e ing e ng a g e d – a nd do e s this ma tte r fo r o ur unde rsta nding s o f e ng ag e me nt ?  Ca n we me a sure e ng a g e me nt? And if no t, wha t a re the mo st use ful pro xie s? And wha t a re the pro b le ms/ da ng e rs with suc h pro xie s?

Diffe re nt c o nc e ptua lisa tio ns o f e ng a g e me nt?  Co mmunic a tio n, c o nsulta tio n, pa rtic ipa tio n (a ll thre e ? ) (Ro we a nd F re we r 2005:255)  T he mo st a ppro pria te le ve l o f e ng a g e me nt de pe nds o n na ture o f risk – simple / line a r, c o mple x, unc e rta inty, a mb ig uity (Re nn e t a l 2011)  ‘ …mo re inc lusio n do e s no t e q ua l b e tte r risk g o ve rna nc e . T he de g re e a nd type o f inc lusio n ma y va ry de pe nding o n the pha se a nd c o nte xt. I n e a c h pha se a nd c o nte xt, it ha s to b e tho ug ht thro ug h wha t kind a nd de g re e o f inc lusio n is ne e de d. So diffe re ntia tio n is no t a n e xc e ptio n, b ut ra the r the rule ’ (va n Asse lt & Re nn 2011: p. 441 )

Cha ins o f kno wle dg e flo w a c ro ss me dic ine re g ula tio n c o nte xts Ma nufa c ture r Re g ula to r Othe r flo ws Pro fe ssio na ls (a s individua ls a nd via (e g Me dia ) o rg a nisa tio ns) Me dic ine -use rs

So urc e : Britte n N (2012)‘ Adve rse Drug Re a c tio ns: So c ia l Co nside ra tio ns’ in: Ste phe ns’ De te c tio n and E valuatio n o f Adve rse Drug Re ac tio ns ; p. 578

So me dime nsio ns o f e ffe c tive e ng a g e me nt with pub lic s  Ma ximise re le va nt pa rtic ipa nts (Ro we a nd F re we r 2005: 265)  K no wle dg e , mo tiva tio n, trust in re g ula to ry a utho rity  Ma ximise re le va nt info rma tio n fro m pa rtic ipa nts  Co mpe te nc e , c o nfide nc e a nd ‘ tra ining ’  Ma ximise tra nsfe r, pro c e ssing a nd a g g re g a ting o f info rma tio n  E ffe c tive ne ss o f to o ls o f e ng a g e me nt/ syste ma tic use o f info ?  ‘ I nc lusio n ha s de e p implic a tio ns. Co ntra ry to the c urre nt sta te o f a ffa irs in whic h risk to pic s a re usua lly ide ntifie d b y e xpe rts, pub lic va lue s, a nd so c ia l c o nc e rns ma y a c t a s the driving a g e nts fo r ide ntifying risk to pic s. I nc lusio n do e s no t just me a n tha t va rio us a c to rs a re inc lude d, b ut tha t the y pla y a ke y ro le in fra ming (o r pre -a sse ssing ) the risk’ (va n Asse lt a nd Re nn 2011)

I nsig hts into e ffe c tive pro fe ssio na l e ng a g e me nt  ‘ T he spo nta ne o us re po rting syste m re lie s o n vig ila nt physic ia ns who g e ne ra te a suspic io n tha t a pa rtic ula r drug ha s c a use d a n a dve rse re a c tio n a nd who re po rt it’ (Ha sfo rd e t a l 2002: 945)  K e y c o mmo n fa c to rs in no n-re po rting (L o pe z-Go nza le z e t a l 2009:19):  ignoranc e (o nly se ve re ADRs ne e d to b e re po rte d) in 95% o f studie s;  diffide nc e (fe a r o f a ppe a ring ridic ulo us fo r re po rting me re ly suspe c te d ADRs) in 72%;  c onfide nc e - ‘ will it ma ke a diffe re nc e ’ a nd unc e rta inty in 67% o f studie s;  c omplac e nc y (o nly sa fe drug s a re a llo we d o n the ma rke t) in 47% o f studie s.  time pre ssure fa c to rs in 77% o f studie s;  ‘ Almo st 20% o f the physic ia ns a dmitte d to no t kno w[ing ] the spo nta ne o us re po rting syste m a nd 30% to no t kno w ho w to re po rt;’ 54% wo uld re po rt to a the ra pe utic a dvic e se rvic e (Ha sfo rd e t a l 2002: 945)

I f e ngage me nt is ha rd to o pe ra tio na lise a nd me a sure – wha t a re use ful pro xie s? E ng a g e me nt ‘e ffe c tive ne ss ma y be a sc e rta ine d by the e ffic ie nc y with whic h full, re le va nt informa tion is e lic ite d from a ll a ppropria te sourc e s’ (Ro we & F re we r 2005:251) K no wle dg e o f (the e xiste nc e o f) re g ula to rs a nd re po rting me c ha nisms (Ha sfo rd e t a l 2002: 525; Himme lste in e t a l 2011) Ove ra ll le ve ls o f ADR re po rting (va rio us so urc e s) Me a sure s o f the q ua lity o f re po rting (F ig ue ira s e t a l 2006) Me a sure s o f unde r-re po rting (Ha ze l & Sha kir 2006) T rust in re g ula to rs a nd in re po rting pro c e sse s (Wa lls e t a l 2004; E ng da hl & L idsko g 2014)

Re fe re nc e s  Britte n N (2012)‘ Adve rse Drug Re a c tio ns: So c ia l Co nside ra tio ns’ in: in: T a lb o t, J. & Aro nso n, J.(e ds.) Ste phe ns’ De te c tio n and E valuatio n o f Adve rse Drug Re ac tio ns . Oxfo rd: Wile y Bla c kwe ll.  E ng da hl, E . & L idsko g , R. (2014) Risk, c o mmunic a tio n a nd trust: to wa rds a n e mo tio na l unde rsta nding o f trust. Pub lic Unde rstanding o f Sc ie nc e 23(6):703-17.  F ig ue ira s A He rde iro M Po lo nia J (2006) An E duc a tio na l Inte rve ntio n to Impro ve Physic ia n Re po rting o f Adve rse Drug Re a c tio nsA Cluste r-Ra ndo mize d Co ntro lle d T ria l. JAMA 296(9):1086-1093  M Munte r K Ha sfo rd J Go e ttle r H Mülle r-Oe rling ha use n B (2002) Physic ia ns' kno wle dg e a nd a ttitude s re g a rding the spo nta ne o us re po rting syste m fo r a dve rse drug re a c tio ns. Jo urnal o f Clinic al E pide mio lo g y 55(9):945-50.  Ha ze l L Sha kir S (2006) Unde r-re po rting o f a dve rse drug re a c tio ns: a syste ma tic re vie w. Drug Safe ty 29(5):385- 396.  Himme lste in M Miro n-Sha tz T Ha no c h Y (2011) Ove r-the -c o unte r c o ug h a nd c o ld me dic ine s fo r c hildre n: A c o mpa riso n o f UK a nd US pa re nts' pa re nta l usa g e , pe rc e ptio n a nd trust in g o ve rnme nta l he a lth o rg a niza tio n. He alth, Risk & So c ie ty 13(5):451-68.  L o pe z-Go nza le z E He rde iro M F ig ue ira s A (2009) De te rmina nts o f Unde r-Re po rting o f Adve rse Drug Re a c tio ns: A Syste ma tic Re vie w. Drug Safe ty 32(1):19-31.  Re nn O K linke A va n Asse lt M (2012) Co ping with c o mple xity, unc e rta inty a nd a mb ig uity in risk g o ve ra nc e : a synthe sis. Amb io 40: 231. do i:10.1007/ s13280-010-0134-0  Ro we G F re we r L (2005) A typo lo g y o f pub lic e ng a g e me nt me c ha nisms. Sc ie nc e , T e c hno lo g y & Human Value s 30(2):251-290  va n Asse lt M Re nn O (2011) Risk g o ve rna nc e . Jo urnal o f Risk Analysis 14(4):431-449.  Wa lls J Pidg e o n N We yma n A Ho rlic k-Jo ne s T (2004) Critic a l trust: unde rsta nding la y pe rc e ptio ns o f he a lth a nd sa fe ty risk re g ula tio n. He alth, Risk & So c ie ty 6(2): 133-50.