Global Update on Pharmacovigilance and

its Importance

WHO, Geneva

WHO Pharmacovigilance (PV)

Programme
World Health Assembly
Resolution 16.36
INVITES Member States to
arrange for a systematic
collection of information
on serious adverse drug
reactions observed during
the development of a
drug and, in particular,
after its release for
general use.

Could we have reliably predicted

phocomelia ahead of market
authorization

WHO definition of pharmacovigilance

The science and activities relating to
the
detection, assessment, understanding
and prevention of adverse effects or
any
other possible drug-related problems

The importance of pharmacovigilance, WHO, 2002

Situation in Indonesia (1)

(As on 17 March 2015)

Situation in Indonesia (2)

Situation in Indonesia (3)

What is the urgency for

PV in LMIC?
More than 300
products in the
pipeline for neglected
diseases, HIV AIDS, TB
and malaria
At least half of them
will be launched in the
coming years in those
very settings where
there is little or no
capacity for post
approval monitoring
Developer Analysis, BVGH, 2012

If we do not have a PV plan, it

could affect the introduction of
those new products
Lack of PV will affect
Availability
Affordability
Acceptability

Global TB Drug Pipeline

Discovery1

Preclinical Development

Diarylquinoline
CPZEN-45
DprE Inhibitors
DC-159a
GyrB inhibitors
Q201
InhA Inhibitors
SQ609
LeuRS Inhibitors
SQ641
MGyrX1 inhibitors
Mycobacterial Gyrase
Inhibitors
Pyrazinamide Analogs
Riminophenazines
Ruthenium (II) complexes
Spectinamides
Translocase-1 Inhibitors

BTZ043
TBA-354

Clinical Development

AZD5847
Bedaquiline (TMC207)
Linezolid
Novel Regimens2
PA-824
Rifapentine
SQ-109
Sutezolid (PNU100480)

Delamanid (OPC67683)
Gatifloxacin
Moxifloxacin
Rifapentine

www.newtbdrugs.o
rgJune 18,
Updated:
2012

WHO Interim guidance on

bedaquiline availability
To invest in PV
To include active monitoring of
bedaquiline
Not having a PV plan in place
will become a barrier to
making new medicines
available in LMIC

Acceptability: the case of

amodiaquine-artesunate
rare, temporary, but frightening
dystonia
could cause reluctance to using this
medicine.
Assessment of actual risks
Dedicated resources to manage
those risks
A pharmacovigilance plan

Affordability: models of
success
The WHO Prequalification of Medicines Programme
(PQP) brings safe and effective medicines of good
quality to LMIC at affordable price
80% of people on HIV treatment today are taking
PQP-certified ARVs produced in India.
The price of a 'brand' ARV in 2002 was about US
$ 12 000 for one years treatment for one person
An Indian generic manufacturer could offer an
equivalent product for US $ 360600 for developing
countries.

Availability
HIV treatment market has rapidly
expanded since 2005
By 2011: Five fold increase in donor
funding
By 2013: 8 million on treatment
By 2015: to have 15 million on
treatment

Is PQP efficient without PV?

Cost of ADRs add to cost of treatment:
Hospital costs annually for all ADEs are
estimated to be as much as $5.6 million
per hospital.(Bates, JAMA, 1997)
India: The total cost to the hospital due
to ADRs was found to be Rs. 1,567,397 in
6 mo (US$36 451).
The average cost per patient hospitalized
with an ADR was Rs. 4,945 (US$115).

Without PV, we are likely to

advocate the wrong medicine: the
case of stavudine

Hepatotoxicity and acidosis

Not used in resource rich settings
But stockpiled in LMIC
Being phased out while we look to
replace with other drugs
Wasted resources

The available medicine is unacceptable.

No money left for the better medicines.

Affordability and the impact of

substandard medicines
Poor quality products: one of the ten
leading causes of inefficiencies in
healthcare spending (World Health
Report, 2010).
Collaborative reporting and learning
systems are required to assess and
quantify the problem of poor quality
products

To summarize
Market
shortcoming

Underlying
reason

outcome

Impact

Absence of
safety
monitoring
systems

Lack of
resources for
Post marketing
activities

In the absence
of PV, countries
may not be
eligible to
register new
products

New priority
medicines not
available

Lack of PV data
in LMIC

No post
marketing
follow up in
LMIC.

Limited LMICspecifc
information /
knowledge on
right dose,
regimens.

Reduced
product
acceptability,
compatibility,
relevance to
LMIC.

Reduced safety
and efficacy of
medicines

Lack of quality
assurance
systems
(product quality
and product

Circulation of
poor quality
medicines,
irrational use

Wasted
resources,
inefficiencies in
healthcare
spending

Solutions
Remove barriers to availability by
Building functional PV systems
PV methods to monitor new products

Improve acceptability by
Characterizing specific risks
Developing & supporting risk management plans

Optimize affordability through

collaborations between quality detection and PV
networks
reduced cost-inefficiencies

Next, support those systems

UMC

Accra
WHO

Rabat

Oslo
Nether
lands

Detecting poor quality products

to reduce cost inefficiencies
Algorithm that detects clusters of
reports within the WHO Individual
Case Safety Reports database
for lack of effect
may reflect cases of substandard
medicinal products

Certain prerequisites to be in place

for algorithm to be useful

PV centres to receive and respond to medications

errors: additional value for money

Reports of medication errors in

WHO ICSR database

PV system that :
Records errors
Analyses
Learns
Implements checks
Prevents errors

Going forward
Point of Care

Operationalising
managed market
entry

PreMarketing
Safety
Data

Decisio
n
Making

National
PV Centre

Data
Analysis

Decisio
n
Making

Thank you

http://www.who.int/medicines/areas/quality_safety/safety_efficacy/en/
email: pvsupport@who.int