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Pages 1-14

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From page 1...
... More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority)
From page 2...
... The other main category of illegitimate products is falsified drugs, those that carry a false representation of identity or source or both. Many countries also have problems with unregistered medicines, those not granted market authorization in a country.
From page 3...
... Such drugs not only put patients at risk but also encourage drug resistance, thereby threatening population health for future generations. Substandard antimicrobials often contain low and erratic drug doses, while falsified ones can be diluted.
From page 4...
... is developing a system for the global surveillance and monitoring of falsified and substandard drugs. Consistent use of this system, eventually linking it to national pharmacovigilance systems, would advance international action and give a more nuanced understanding of the type of falsified, substandard, and unregistered medicines in circulation and the extent of the trade.
From page 5...
... When a producer capable of meeting international standards fails to do so consistently and only in product lines sold to the poor, one may conclude that noncompliance is part of a more insidious system. Rich countries enforce high quality standards for medicines, and manufacturers recognize the need to use quality ingredients and good manufac
From page 6...
... Recommendation 4-2: Procurement agencies should develop a plan, within the next 3 to 5 years, to comply with the World Health Orga nization's Model Quality Assurance System for procurement agencies and work to remove any barriers to compliance. CAUSES OF FALSIFIED DRUGS In practice, one difference between falsified and substandard medicines is that the drugs regulator, having the authority to license manufacturers and register medicines, can act against unscrupulous or careless manufacturers.
From page 7...
... A more robust generic drug market could help prevent the drug shortages and price spikes that encourage the sale of poor-quality products. Regulatory authorities can work to better harmonize their procedures, thereby improving their own efficiency and reducing barriers to market entry for good-quality generics manufacturers.
From page 8...
... Strengthening the drugs regulatory system, building the inspectorate, enforcing quality standards, and licensing in accordance with international standards are essential to improving drug quality. Without a competent regulatory authority to inspect wholesalers, distributors, and manufacturers, opportunities to corrupt the drug supply abound.
From page 9...
... The first step on the drug distribution chain is the wholesale market. There are two kinds of drug wholesalers: primary wholesalers who have written distribution contracts with manufacturers and buy directly from them, and secondary wholesalers who buy from other intermediaries.
From page 10...
... Small thefts and large heists compromise the integrity of the drug distribution chain and confidence in the quality of medicines. In rich and poor countries alike, drugs often circulate outside of the main distribution channels without a drug pedigree, a record of a drug's every sale and owner.
From page 11...
... Unlicensed vendors may approach medicines dispensing as any other sales job and not want a customer to leave without making a purchase. In general, these vendors exploit the chaos inherent to street markets and dry goods shops in low- and middle-income countries and online drug stores in middle- and high-income ones.
From page 12...
... In the United States the NABP runs the Verified Internet Pharmacy Practice Sites (VIPPS) accreditation program to recognize safe online drug stores.
From page 13...
... Drug regulation, surveillance, and law enforcement are the necessary components of any national response to the problem. A voluntary soft law such as an international code of practice could encourage international action against falsified and substandard drugs.
From page 14...
... Eliminating falsified and substandard drugs from the market requires international cooperation. A voluntary soft law could help advance harmonized systems for surveillance, regulation, and law enforcement.


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