Transcript 3rd Stakeholders - World Health Organization

Quality of Medicines:
Introduction
Tuesday, 17 November 2009
Dr Lembit Rägo, Coordinator
Quality Assurance and Safety: Medicines (QSM), Department
of Essential Medicines and Pharmaceutical Policies (EMP)
World Health Organization
Geneva, Switzerland
[email protected]

The Millennium
Development Goals
(MDGs) are eight
international
development goals
that 192 United
Nations member
states and at least 23
international
organizations have
agreed to achieve by
the year 2015
Is quality of medicines still Globally a
problem?
 Facts
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Diethylene glycol poisonings continue
Roche Viracept (nelfinavir) case
Heparin case
…
Can we rely on essential medicines
against TB? (1)
2008: South-Africa Drug Regulatory Authority withdraws
from the market two FDCs (Pyrazinamide-Ethambutol-INHRifampicin and INH-Rifampicin) produced in India.
"Substandard tuberculosis medicines are particularly worth
highlighting: there is little point in deciding optimum
treatment regimens for TB when the medicines the patients
actually use are not curative and/or encourage the spread
of drug resistance"
Paul Newton (BMJ
23.8.2008: 427)
Can we rely on essential medicines
against TB? (2)
Quality defects found in:
 Botswana: 4/13 FDCs
 Nigeria: 4/4 INH, 3/3 Pyr, 5/15 Rif and 10/19
Strep inj
 India: Amikacin, Etham (2x), Rif (2x), INH (2x),
Pyr
 Myanmar: Rifampicin
 Hong Kong, Pakistan, Germany: Ofloxacin
 Rifampicin: Poor bioavailability in FDCs and
monotherapy
WHO study planned on the use and quality of TB medicines with
NDRAs in Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan
Quality failures
 The Daily Star, 200811-19
 Drug marketed to
cure or kill?
 Foreign particle, circled,
is seen in a 500mg
ampoule of Amibac
(amikacin) intravenous
injection. Photo: STAR
Who in WHO are dealing with quality, safety,
efficacy and regulatory issues of medicines?
 Medicines and blood products/related
bilologicals – QSM/EMP
 Vaccines and other biologicals –
QSS/IVB
 … some other "pockets"
Quality Assurance and Safety: Medicines
(QSM) team
 One team, 7 inter-related programmes
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Quality Assurance (Dr Sabine Kopp)
International Nonproprietary Names (Dr
Raffaella Balocco)
Quality Assurance of Blood Products and
Realated Biologicals (Dr Ana Padilla)
Safety (Pharmacovigilance) (Dr Mary Couper)
Regulatory Support (Dr Samvel Azatyan)
Anticounterfeiting (Dr Sabine Kopp)
Prequalification of medicines (Dr Anthony Gould)
Trainings organized or supported by PQP
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14
4
12
4
10
PQP supported
8
1
6
11
9
4
6
2
4
0
2006
2007
2008
2009 (I-IX)
PQP organized
Biennial International Conference of Drug Regulatory
Authorities (ICDRA) – forum for 100+ nations