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

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 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

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

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

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.

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

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

SUPPLY CHAIN VULNERABILITIES Source: Pew Health Group

DRUG DISTRIBUTION SYSTEM

WSJ: AFRICA’S MALARIA BATTLE

WWARN ONLINE DRUG QUALITY MAP

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

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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