August 24, 2009
Ensuring the quality of prescription drugs has become a tougher job than ever before, now that the vast majority of medicines contain imported ingredients, increasingly obtained from suppliers in India and China, says the New England Journal of Medicine.
"Our biggest challenge right now in quality assurance is globalization," said Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).
Many factors can result in a product that does not meet specifications or perform as it should, explains the Journal -- including problems with the active ingredient (as in the case of an adulterated heparin product that caused serious illnesses and deaths in U.S. patients in early 2008); problems with bulking agents, preservatives, coatings, or other ingredients; contamination or shelf-life instability; or glitches in the manufacturing process.
- In general, generic drugs that are sold in the United States are a high-quality, reliable alternative to brand-name drugs -- and a critical component of efforts to contain health care costs.
- Yet generic drugs prompt the majority of complaints, since they account for 70 percent of U.S. prescriptions.
- The FDA lists 8800 approved generic drugs, as compared with 4131 brand-name ones; once a brand-name drug goes off patent, there are often several generic versions.
- In addition, consumers who are switched from a brand-name to a generic product are apt to notice when a familiar pill is replaced with an unfamiliar-looking one -- and may ascribe any unexpected symptom to the new pill.
Manufacturers of brand-name drugs, too, have been cited by the Food and Drug Administration (FDA) for manufacturing or quality-control problems in recent years and have been forced to recall medicines -- the adulterated heparin, marketed by Baxter Healthcare, was a dramatic example. Brand-name companies sometimes produce generic versions of their own drugs or contract with generic manufacturers to make the medicines that they market. Both types of companies have complex supply chains and increasingly rely on foreign suppliers.
In the United States, information on the source of ingredients in prescription medicines is considered proprietary, and the details of manufacturing deficiencies cited by the FDA are closely guarded. Thus, it is difficult or impossible for consumers to discover the origins of their pills or for a physician to find out in detail what was wrong with a recalled drug, says the Journal.
Source: Susan Okie, "Multinational Medicines -- Ensuring Drug Quality in an Era of Global Manufacturing," New England Journal of Medicine, Vol. 361, No. 8, August 20, 2009.
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