Policy and Law
Feldschreiber P. Public Health Issues with Counterfeit Medicines. Clin. Med. 2009;9(1):63-4.
Clinicians who prescribe medicines in the UK at primary care and at hospital level are facing the possibly disastrous consequences of a global crime wave – the supply and distribution of counterfeit medicines and healthcare products.
[...]Nsimba SE. Problems Associated with Substandard and Counterfeit Drugs in Developing Countries: A Review Article on Global Implications of Counterfeit Drugs in the Era of Antiretroviral (ARVs) Drugs in a Free Market Economy. East Afr J Public Health. 2008;
OBJECTIVES: To review the global implications associated with the use of substandard and or counterfeit drugs in developing and may be developed countries. The focus of this review is particularly on antiretroviral (ARVs), antimalarials and other drugs. METHODS: Review of various literatures through Pub-Med, Medline, Google and Internet search to retrieve and download published materials…
[...]Liang BA.* Pigs, Drugs, and Terrorists. Patient Safe Qual Healthcare. 2008 Nov 1:10-12
Abstract. Making drugs is messy. Take heparin.You raise pigs and then slaughter them. You isolate the pig intestines and cook them. Then you scrape the intestinal insides, dry them, and get them to a factory to undergo more processing (Harris, 2008). Making drugs is also expensive. Outsourcing this messy activity to countries such as China…
[...]Liang BA.* Safety Issues in Regulating Follow-On Biologic Drugs. J BIolaw Bus. 2007;10(4):44-49.
Biologic drugs are expensive, and hence policymakers are considering accelerating copies, or "follow on" biologic products to market using abbreviated pathways. However, important concerns relating to biologic products may have implications for follow on product regulation. The information gaps regarding biologic science, clinical issues associated with product excipients and active ingredient, and supply chain issues…
[...]Shepherd MD.* Impact of Drug Importation on Community Pharmacy and Patient Care. J Am Pharm Assoc. 2007 May-Jun ;47:319-20, 323-4, 327
Abstract. With the political powers shifting in both congressional houses, many pharmaceutical issues have resurfaced in the 110th Congress. One of these is legalization of drug importation. Many Democrats and Republicans have already stated that this is a high-priority item. In the first 60 days of the First Session, two bills were introduced that would…
[...]Theriault J. Counterfeit Pharmaceuticals: Understanding the Threat. J Biolaw Bus. 2006;9(4): 46-50.
The manufacture and distribution of counterfeit medicines is big business. Counterfeits threaten the health and safety of patients around the world, who depend upon authentic medicines prescribed by their doctors to save or improve the quality of their lives. The sale of counterfeit medicines not only funds criminal enterprises and terrorist organizations, but also undermines…
[...]Liang BA.* Structurally Sophisticated or Lamentably Limited? Mechanisms to Ensure Safety of the Medicine Supply. Albany Law J Sci Technol. 2006;16(3):483-524
Abstract. The use of medicines is ubiquitous. The benefits of pharmaceuticals are sought by virtually all citizens around the world to assist in sustaining life, treating illness, and preventing disease. As such, they represent a significant tool in promoting the quality of human existence. Because of this extensive demand for drugs for these purposes, there…
[...]Liang BA.* Parallel Trade in Pharmaceuticals: Injecting the Counterfeit Element into the Public Health. NC J Int Law Com Reg. 2006;31(4):847-900
Abstract. Varying prices for medicines create incentives to move products from one market to another in an effort to arbitrage the difference; this is known as parallel trade. Nevertheless, this situation allows nefarious individuals to introduce counterfeits into the drug supply due to weaknesses in detection. Both developed and developing countries around the world experience…
[...]Liang BA.* The Scourge of Counterfeit Drugs: No Easy Answers. J Biolaw Bus. 2006;9(2):3-7.
Counterfeit drugs are a scourge known throughout the world, and patients have been harmed and killed because of their presence. Regulation and penalties are weak against purveyors of fake medicines, yet entering and profiting from this illicit business is low cost with high returns. The Internet has fueled the sale of these counterfeits, while the…
[...]Liang BA.* Fade to Black: Importation and Counterfeit Drugs. Am J Law Med. 2006 Feb 1;32(2-3):279-323
Abstract. Importation of medicines from Canada and other countries has been proposed to provide relief from high drug prices in the US and greater access for underserved patients. Yet importation necessarily raises the issue of counterfeit drugs. The latter are a worldwide problem that have affected even the US closed regulatory and supply system. Counterfeit…
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