Global PV Update and Importance

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Global Update on Pharmacovigilance andits Importance

WHO, Geneva



• World Health AssemblyResolution 1!"

• I#$I%&' (ember 'tates toarrange )or a systematic

collection o) in)ormationon serious adverse drugreactions observed during

the development o) adrug and, in particular,

a)ter its release )orgeneral use!

WHO Pharmacovigilance *P$+Programme



ould -e have reliably predictedphocomelia ahead o) mar.et

authori/ation



WHO de0nition o) pharmacovigilance

%he science and activities relating tothe

detection, assessment, understanding

and prevention o) adverse eects orany

other possible drug2related problems

The importance of pharmacovigilance, WHO, 2002



'ituation in Indonesia *1+

*As on 13 (arch 4516+



'ituation in Indonesia *4+



'ituation in Indonesia *"+



• (ore than "55products in thepipeline )or neglecteddiseases, HI$ AI7', %8

and malaria• At least hal) o) them

-ill be launched in thecoming years in those

very settings -herethere is little or nocapacity )or postapproval monitoring

7eveloper Analysis, 8$GH, 4514

What is the urgency forPV in LMIC?



I) -e do not have a P$ plan, itcould aect the introduction o)

those ne- products• 9ac. o) P$ -ill aect

– Availability

–Aordability

– Acceptability



7elamanid *OP23:"+

Gati;o<acin

(o<i;o<acinRi)apentine

A=76:>3

8eda?uiline *%(2453+

9ine/olid#ovel Regimens4

PA2:4>

Ri)apentine

'@215

'ute/olid *P#U2155>:5+

P=&#2>6

7216a

@451

'@5

'@>1

Preclinical 7evelopment7iscovery1 linical 7evelopment

7iaryl?uinoline

7pr& Inhibitors

Gyr8 inhibitors

InhA Inhibitors9euR' Inhibitors

(GyrB1 inhibitors

(ycobacterial Gyrase

Inhibitors

Pyra/inamide Analogs

Riminophena/ines

Ruthenium *II+ comple<es

'pectinamides

%ranslocase21 Inhibitors

Global %8 7rug Pipeline

Updated: June 18,2012

8%=5>"

%8A2"6>

---!ne-tbdrugs!o

rg



WHO Interim guidance on

beda?uiline availability

• %o invest in P$

• %o include active monitoring o)beda?uiline

Not having a PV plan in placewill become a barrier tomaking new meicines

available in LMIC



AcceptabilityC the case o)

amodia?uine2artesunate

• rare, temporary, but )righteningdystonia

• could cause reluctance to using thismedicine!

Assessment o) actual ris.s

7edicated resources to managethose ris.s

A pharmacovigilance plan



AordabilityC models o)success

• %he WHO Pre?uali0cation o) (edicines Programme*P@P+ brings sa)e and eective medicines o) good?uality to 9(I at aordable price

• :5D o) people on HI$ treatment today are ta.ing

P@P2certi0ed AR$s produced in India!

• %he price o) a EbrandE AR$ in 4554 -as about U'

F 14 555 )or one years treatment )or one person

– An Indian generic manu)acturer could oer an

e?uivalent product )or U' F "555 )or developingcountries!



Availability

• HI$ treatment mar.et has rapidlye<panded since 4556 – 8y 4511C ive )old increase in donor

)unding

– 8y 451"C : million on treatment

– 8y 4516C to have 16 million on

treatment



Is P@P eJcient -ithout P$K

– ost o) A7Rs add to cost o) treatmentC

– Hospital costs annually )or all A7&s areestimated to be as much as F6! million

per hospital!*8ates, LA(A, 13+ – IndiaC %he total cost to the hospital due

to A7Rs -as )ound to be Rs! 1,63,"3 in mo *U'F" >61+!

– %he average cost per patient hospitali/ed-ith an A7R -as Rs! >,>6 *U'F116+!



Without P$, -e are li.ely toadvocate the -rong medicineC the

case o) stavudine• Hepatoto<icity and acidosis

• #ot used in resource rich settings

•

8ut stoc.piled in 9(I – 8eing phased out -hile -e loo. to

replace -ith other drugs

– Wasted resources

%he available medicine is unacceptable!#o money le)t )or the better medicines!



Aordability and the impact o)

substandard medicines

• Poor ?uality productsC one o) the tenleading causes o) ineJciencies inhealthcare spending *World Health

Report, 4515+!

• ollaborative reporting and learningsystems are re?uired to assess and

?uanti)y the problem o) poor ?ualityproducts



%o summari/eMarketshortcoming

!nerlyingreason

outcome Impact

Absence o)sa)etymonitoringsystems

9ac. o)resources )orPost mar.etingactivities

In the absenceo) P$, countriesmay not beeligible toregister ne-

products

#e- prioritymedicines notavailable

9ac. o) P$ datain 9(I

#o postmar.eting)ollo- up in9(I!

9imited 9(I2speci)cin)ormation M.no-ledge onright dose,

regimens!

Reducedproductacceptability,compatibility,relevance to

9(I!

Reduced sa)etyand eJcacy o)medicines

9ac. o) ?ualityassurancesystems*product ?uality

and product

irculation o)poor ?ualitymedicines,irrational use

Wastedresources,ineJciencies inhealthcare

spending



'olutions

• Remove barriers to availability by – 8uilding )unctional P$ systems

– P$ methods to monitor ne- products

• Improve acceptability by

– haracteri/ing speci0c ris.s

– 7eveloping N supporting ris. management plans

• Optimi/e a"orability through

–

collaborations bet-een ?uality detection and P$net-or.s

– reduced cost2ineJciencies

#e<t support those systems



#e<t, support those systems

Accra

Oslo

U(

Rabat

WHO

#etherlands



#etecting poor $uality prouctsto reuce cost ine%ciencies

• Algorithm that detects clusters o)reports -ithin the WHO Individualase 'a)ety Reports database – )or lac. o) eect

– may re;ect cases o) substandardmedicinal products

• ertain prere?uisites to be in place)or algorithm to be use)ul



PV centres to receive an respon to meicationserrors& aitional value for money

Reports o) medication errors inWHO I'R database

PV system that &'ecors errors(nalyses

LearnsImplements checksPrevents errors

G i ) d



#ationalP$ entre

Pre)Marketing*afety#ata

7ecision

(a.ing

Point o) are

#ata(nalysis

7ecision

(a.ing

+perationalisingmanage market

entry

Going )or-ard



%han. you

http&,,www-who-int,meicines,areas,$uality.safety,safety.e%cacy,en,

email& pvsupport/who-int

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