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Quality Control Approaches for EssentialMedicines
“Good Intentions – Bad Drugs”
The World Bank
March 10, 2005
United States Pharmacopeia
Private, not-for-profit organization since 1820 Establishes official manufacturing standards
enforceable by the U.S. FDA and many other countries
Publishes USP/NF annually Distributes chemical reference substances used to
carry out tests for product identity, strength, quality, and purity
400 member organizations 650 volunteer experts, www.usp.org/volunteers Global Assistance Initiatives, Patient Safety, Dietary
Supplements Verification
Good Quality: Definition
Good quality medicines meet official standards for identity, strength, purity,
quality, packaging, and labeling.
Legal basis: United States
A drug or device shall be deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium (Section 501(b) of the Federal Food, Drug, and Cosmetic Act).
Standards for drug quality
• Internationally recognized pharmacopoeias - e.g., IP, USP, EP, JP, and BP
• Official national pharmacopeias
• Standards and analytical methods developed by the manufacturer
• Public standards needed for new products with high public health importance, e.g., antiretrovirals, artemisinin-derived
An Early USP Monograph
Isoniazid Monograph
Isoniazid
Dissemination of Standards
Poor quality products
Fake/counterfeit – deliberately mislabeled for identity and/or source. (Usually no active ingredient or a different active ingredient than on the label)
Substandard – legally registered innovator or generic product, but does not meet official standards for identity, quality, purity, strength, packaging and labeling.
Why be concerned about drug quality?
Because counterfeit and substandard drugs are prevalent worldwide
People living in countries with limited regulatory capacity and resources are most affected
Substandard drugs may be ineffective or toxic
Undermines trust in national disease programs
Waste of limited financial resources
Can lead to drug resistance and loss of life-saving therapies
What drugs are being counterfeited?
Reports of counterfeit drugs by therapeutic class received by WHO 1999-2002
Antibiotics, 28%
Other (14 therapeutic categories)
33%
Analgesics & antipyretics
6%Antimalarials 7%
Antiasthma & anti-allergy
8%
Hormones & steroids 18%
What’s wrong with the drugs?
68%
8%
24%
Failed Anti-tuberculosis and Antimalarial Samples (n=479) in Selected USAID-assisted Countries
(16 countries represented in 12 reports: 1997-2003)
Source: Carpenter J P, 2003. Drug quality report matrix of USAID-assisted countries by the USP DQI Program, www.uspdqi.org
Other deficiencies, such as contamination, weight variation, unusual appearance, incorrect labeling
No active ingredient
Incorrect amount ofActive ingredient
Availability of poor quality medicines
Fig. 1. Percentage failure - chloroquine tablets (content)
0
20
40
60
80
100
Gabon
Ghana
Mali
KenyaM
ozambique
Sudan
Zimbabw
e
% Failure
Source: Maponga and Ondari. The quality of antimalarials: A study in selected African countries. WHO/EDM/PAR/2003.4
Poor quality SP in Africa
Country Content failure Dissolution failure
Gabon 18% 97%
Ghana 45% 78%
Kenya 10% 55%
Mozambique 7% 70%
Zimbabwe 5% 79%
WHO Annual Report 2001
Repeated exposure to sub-lethal doses allows parasite to adapt
Chloroquine-resistant P. falciparum malaria is now widespread in Africa.
Increasing drug resistance in Southeast Asia, Africa, and South America
Drug Resistance - Malaria
Antibiotics
Substandard antibiotics can increase global problem of antimicrobial resistance
Poor response to substandard narrow-spectrum antibiotics may lead to unnecessary prescription of newer and more expensive broad-spectrum antibiotics.
Wider exposure to these drugs creates opportunity for more kinds of bacteria to develop resistance.
Build local capacity
Drug regulatory authorities- evaluate and approve drugs legally in the country
Drug Quality control laboratories – test products at registration and postmarketing surveillance
Local industry – improve compliance to good manufacturing practices
Storage and distribution – ensure facilities and systems preserve stability and purity
Law enforcement – confiscate counterfeits, work with DRA, MOH, customs, inspectors
Opportunities:
Countries should share data on substandard and counterfeit products
USP working with USAID and others to increase regional surveillance and information sharing in Mekong region
Collaborations/partnerships are important: Research: authoritative data on drug quality
problems can put pressure on governments to do more.
Tools development
Operational Guide for Drug Quality Assurance in Resource-limited Settings
In development in collaboration with: WHO RPM Plus PATH Drug Regulatory Authorities of Zimbabwe,
Malaysia, Vietnam and Uganda.
Counterfeit Drugs are dangerous
Substandard and counterfeit drugs can kill
Substandard: e.g., diethylene glycol• US 1938: 120 died• Nigeria 1990: 109 children died• Bangladesh 1992: 223 children died• Argentina 1992: 23 patients died• Haiti 1995/1996: 89 children died
Counterfeit: e.g., meningitis vaccine with no antigen
• Niger 1995: around 2500 deathsSource: World Health Organization
MCH clinic in Mozambique
Nancy Blum, M.P.H., M.A.Director, Global Assistance Initiatives
United States Pharmacopeia
12601 Twinbrook ParkwayRockville, MD 20852
www.usp.orgwww.uspdqi.org