PUBLIC HEALTH Stacy Kancijanic, MA DEFINITIONS Counterfeit - - PowerPoint PPT Presentation

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Jan 10, 2023 23 likes •173 views

QUALITY OF MEDICINES IN PUBLIC HEALTH Stacy Kancijanic, MA DEFINITIONS Counterfeit medicine is one that infringes on a registered trademark. Substandard drugs fail to meet the specifications outlined by an accepted pharmacopeia or the

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QUALITY OF MEDICINES IN PUBLIC HEALTH

Stacy Kancijanic, MA

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DEFINITIONS

 Counterfeit medicine is one that infringes

n a registered trademark.

 Substandard drugs fail to meet the

specifications outlined by an accepted pharmacopeia or the manufacturer’s dossier.

 Falsified drugs are those that carry false

representation of identity or source.

IOM Report, Countering the Problem of Falsified and Substandard Drugs, 2013

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SUBSTANDARD MEDICINES

 30-60% of the medicine supply in Africa

and SE Asia is substandard*

 Failure to adhere to GMPs root cause  an astonishing number of bad drugs

reach patients through legitimate supply chains

 degraded through bad storage  once a manufacturer has obtained

quality certification, it is relatively easy to sell the drug at a lower quality in countries with weak regulations

*International Policy Network

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COUNTERFEIT RX

 antimicrobials and antiparasitics are the 2

types of pharma products most counterfeited in developing countries

 Estimated 80% of counterfeit drugs come

from overseas

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PUBLIC HEALTH CONSEQUENCES

 Lack of therapeutic effect may lead to

prolonged illness or death

 May include toxic or adverse reaction  Encourages drug resistance  Wastes money  Causes consumers to lose confidence in

health care system and national regulatory agencies.

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CAUSES OF POOR OUTCOMES IN PHARMA PRODUCT INTEGRITY

 below-standard supply chain or cold chain processes,  production or handling (substandard medicines),  deliberate mislabeling (counterfeit products), or  from poor storage conditions or inappropriate distribution

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Upstream Supply Chain Security

Source: Rx-360 Upstream Supply Chain Security White Paper, 2013.

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SUPPLY CHAIN VULNERABILITIES

Source: Pew Health Group

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DRUG DISTRIBUTION SYSTEM

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WSJ: AFRICA’S MALARIA BATTLE

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WWARN ONLINE DRUG QUALITY MAP

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GENERIC DRUGS LANDSCAPE

 Around 80% of the drug substances and 40% of the

drug products sold in the US are imported, most from India and China

 All antibiotics sold in the US are imported  FDA’s ability to inspect outside the US is limited

 Some require advanced warning vs. unannounced

inspections in the US – India now has unannounced inspections

 Some countries like China make obtaining visas for

FDA inspectors very difficult – FDA now stationing people in China

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INTL STANDARDS

 WHO

 http://apps.who.int/prequal/  developing a system for the global

surveillance and monitoring of falsified and substandard drugs.

 International Conference on

Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

 Q10, Pharmaceutical Quality System

 Pharmacopeias (USP, European)

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