Drug Topics - September 29, 2008 - (Page 5) DRUG TOPICS 5 Of Interest to Pharmacists Heparin incident underscores how badly FDA is underfunded David Work medicines now have foreign sources beyond the reach of FDA. When I entered pharmacy a long time ago, a major drug company had an advertising campaign using the phrase “The dose you take is never tested,” and that is true today. Federal law does require that batches be tested, and that should ensure the quality of individual doses. But when serious problems arise, as they have with heparin, and quality shortcuts are discovered, it is only after many injuries and deaths. While in widespread use, heparin is not included in the top 200 drugs consumed in the United States. Other drugs, such as the anticholesterol drugs and antacids, are used by many millions of people daily. Inserting a toxic ingredient in any of these products would be an effective means of overwhelming our healthcare system by sending millions of people into hospitals in a few days. FDA has been underfunded for many years, and every indicator points to more transnational trade. The next Administration and Congress must address the need for full support of FDA if we expect to prevent future incidents of the kind caused by substandard heparin. It should also be a priority for presidential candidates. DAVID WORK is the executive director emeritus of the North Carolina Board of Pharmacy. T here have been rethe flawed drug was cent reports of inproduced prior to the juries and deaths injuries and deaths. due to the use of hepaThis is not the first inrin, which is marketed cident of patients ingestby Baxter Laboratories, a ing poisonous products large manufacturer with from China. In 1996 at a good reputation. The least 100 children died product was contaminatin Haiti from medicine David Work ed with a toxic substance laced with diethylene from China and hundreds of patients glycol, an impurity produced in the have been injured, with more than manufacturing of glycerin which is 80 deaths attributed to the tainted used in many liquid medicines. drug. The known toxic products This event caused the World were recalled from the market. Health Organization in Geneva, The incentive for using in- Switzerland, to convene a group gredients from China appears to from more than a dozen countries be a lower price, but the motive that met over three days in May in this case is not known with 1998. I was privileged to be an certainty. The choice was between invited observer at that conferraw material at $900 a pound for ence, which adopted international good quality compared with $9 a standards for the control and safe pound for the ingredient actually trade of starting materials for pharused. One could expect that any maceutical products.A reading of reasonably competent purchasing that document reveals that these agent should be suspicious of a standards were disregarded during competitive bid at 1 percent of the manufacture of the heparin. another supplier’s price. Diethylene glycol as a contaminant With the globalization of the is a well-known hazard in the makeconomy, including pharmaceuti- ing of drug products, as it caused cals, we find that some drugs or more than 100 deaths from elixir raw materials are obtained from sulfanilamide in 1937. This caused foreign countries. a complete rewrite of the federal Standards require that drugs drug laws and led to the creation of obtained from these sources must the FDA. come from locations inspected by The fact is that FDA relies on the Food and Drug Administra- manufacturers to meet federal stantion (FDA). Neither FDA nor Bax- dards, and that policy certainly needs ter had inspected the site where review, particularly when many FDA relies on manufacturers to meet federal standards and that policy certainly needs review.
Table of Contents Feed for the Digital Edition of Drug Topics - September 29, 2008 Drug Topics - September 29, 2008 Walgreens Sues San Francisco Over Tobacco Ban Heparin Incident Underscores How Badly FDA is Underfunded Drug Topics - September 29, 2008 Drug Topics - September 29, 2008 - Drug Topics - September 29, 2008 (Page 1) Drug Topics - September 29, 2008 - Drug Topics - September 29, 2008 (Page 2) Drug Topics - September 29, 2008 - Walgreens Sues San Francisco Over Tobacco Ban (Page 3) Drug Topics - September 29, 2008 - Walgreens Sues San Francisco Over Tobacco Ban (Page 4) Drug Topics - September 29, 2008 - Heparin Incident Underscores How Badly FDA is Underfunded (Page 5)
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