Quality of Medicines:Introduction

Tuesday, 17 November 2009

Dr Lembit Rägo, CoordinatorQuality Assurance and Safety: Medicines (QSM), Department of Essential Medicines and Pharmaceutical Policies (EMP)World Health OrganizationGeneva, Switzerlandragol@who.int

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• 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-INH-Rifampicin 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)

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

Can we rely on essential medicines against TB? (2)

WHO study planned on the use and quality of TB medicines with NDRAs in Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan

Quality failures

The Daily Star, 2008-11-19

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• 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)

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2006 2007 2008 2009 (I-IX)

Trainings organized or supported by PQP

PQP supported

PQP organized

Biennial International Conference of Drug Regulatory Authorities (ICDRA) – forum for 100+ nations