Bank Counterfeit Workshop

7/29/2019 Bank Counterfeit Workshop

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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
http://www.usp.org/volunteershttp://www.usp.org/volunteers


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Good Quality: Definition

Good quality medicines meet officialstandards for identity, strength, purity,

quality,packaging, and labeling.


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Legal basis: United States

A drug or device shall be deemed to beadulterated if it purports to be or isrepresented as a drug the name of which is

recognized in an official compendium, and itsstrength differs from, or its quality or purityfalls below, the standards set forth in suchcompendium (Section 501(b) of the FederalFood, Drug, and Cosmetic Act).


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Standards for drug quality

Internationally recognized pharmacopoeias- e.g., IP, USP, EP, JP, and BP

Official national pharmacopeias

Standards and analytical methods developed bythe manufacturer

Public standards needed for new products with

high public health importance, e.g.,antiretrovirals, artemisinin-derived


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An Early USP Monograph


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Isoniazid Monograph

Isoniazid


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Dissemination of Standards


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Poor quality products

Fake/counterfeit deliberately mislabeled foridentity and/or source. (Usually no activeingredient or a different active ingredient thanon the label)

Substandard legally registered innovator orgeneric product, but does not meet officialstandards for identity, quality, purity, strength,

packaging and labeling.


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Why be concerned about drug quality?

Because counterfeit and substandard drugs areprevalent worldwide

People living in countries with limited regulatorycapacity 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-savingtherapies


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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-allergy8%

Hormones &

steroids 18%


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Whats 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, suchas contamination,weight variation,

unusual appearance,incorrect labeling

No activeingredient

Incorrect amount ofActive ingredient


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Availability of poor quality medicines

Fig. 1. Percentage failure -chloroquine tablets (content)

0

20

40

60

80

100

% Failure

Source: Maponga and Ondari. The quality of antimalarials: A study in selected African countries. WHO/EDM/PAR/2003.4


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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


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Repeated exposure to sub-lethal doses allowsparasite to adapt

Chloroquine-resistant P.

falciparum malaria isnow widespread inAfrica.

Increasing drug resistancein Southeast Asia, Africa,and South America

Drug Resistance - Malaria


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Antibiotics

Substandard antibiotics can increase globalproblem of antimicrobial resistance

Poor response to substandard narrow-spectrum

antibiotics may lead to unnecessary prescription ofnewer and more expensive broad-spectrumantibiotics.

Wider exposure to these drugs creates opportunity

for more kinds of bacteria to develop resistance.


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Build local capacity

Drug regulatory authorities- evaluate andapprove drugs legally in the country

Drug Quality control laboratories testproducts at registration and postmarketingsurveillance

Local industry improve compliance to goodmanufacturing practices

Storage and distribution ensure facilities andsystems preserve stability and purity

Law enforcement confiscate counterfeits,work with DRA, MOH, customs, inspectors


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Opportunities:

Countries should share data on substandardand counterfeit products

USP working with USAID and others toincrease regional surveillance and

information sharing in Mekong region

Collaborations/partnerships are important:

Research: authoritative data on drugquality problems can put pressure on

governments to do more.


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Tools development

Operational Guide for Drug Quality Assurancein Resource-limited Settings

In development in collaboration with:

WHO

RPM Plus

PATH

Drug Regulatory Authorities of Zimbabwe,Malaysia, Vietnam and Uganda.


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Counterfeit Drugs are dangerous

Substandard and counterfeit drugs cankill

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 withno antigen

Niger 1995: around 2500 deathsSource: World Health Organization


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MCH clinic in Mozambique


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Nancy Blum, M.P.H., M.A.Director, Global Assistance Initiatives

United States Pharmacopeia

12601 Twinbrook Parkway

Rockville, MD 20852

www.usp.orgwww.uspdqi.org

[email protected]
http://www.usp.org/http://www.uspdqi.org/mailto:[email protected]:[email protected]://www.uspdqi.org/http://www.usp.org/

Documents

Bank Counterfeit Workshop