Drug Shortages Prompt Legislation to Help FDA Confront Problem
Sep 28, 2011
By Krystina Steffen, staff writer – September 28, 2011
Medicines that are critical to fighting cancer as well as anesthetics, electrolytes for intravenous drips, and emergency drugs are facing severe shortages in the U.S. The American Hospital Association surveyed 820 hospitals this summer and found that at least half experienced shortages with more than 20 drugs, and 75 percent started rationing drugs.  The problem stems from a harmful mix of drug quality concerns, manufacturing issues and delays of new drug approvals and foreign inspections. Without a serious combination of resolutions to tackle this problem, individuals, loved ones and friends could receive inadequate care and a shortened life.
“The last thing you want to hear is that we don’t have first-line medication to treat you; that the medication we have may not work as well and could cause heart damage, but it is all we have to offer; or that we are delaying your treatment until we are able to obtain drugs that are in short supply,” said Kevin Colgan, Corporate Director of Pharmacy at Rush Medical Center in
Chicago, Ill. 
Drug shortages have increased in 2011 and particularly for cancer patients, the problem has led to the disease spreading throughout their body and what many call a preventable death. What is even more alarming is that some medical centers, even in the same region, might have different levels of supply. Patients might not be able to afford to go to another facility that has the drug, or their insurance will not cover the doctor or hospital, or, even worse, might be too sick to transfer. For cancer patients, drugs such as Bleomycin, Doxil (doxorubicin), Paclitaxel and Fluorouracil (F5u) are critical to stave off the disease. Millions of people die across the globe from many forms of cancer. Cancer-related deaths will surpass 13 million by 2030 if global efforts are not in place, according to the National Cancer Institute. 
Take, for example, Brigham Robust – for weeks he waited to get Bleomycin at Pinellas County Hospital in Florida. As he waited, his lymphoma cancer spread to his chest, armpits, neck, and abdomen. His father ultimately sat down with the doctor and asked, “Why don’t you have it [cancer medicine]? He told me there’s a national shortage of it. I said are you trying to tell me my son is dying? He looked at me and said, ‘If we don’t get the medicine we need, yes.’” 
Cancer of the lymph tissue, also known as lymphoma, must be aggressively treated with six months of treatment and an arsenal of drugs. With a lack of medicines, patients must plead with their doctor and friends to find alternatives. “This [cancer] treatment is not something that you can interrupt at any time and assume the outcome is going to be the same,” said Tom Kornberg, a lymphoma cancer patient and a professor at the University of California-San Francisco.  “My oncologist told me, ‘I’m used to rationing hospital beds, but I’ve never had to ration drugs.'”
In an advanced economy and country of pharmaceutical giants, this crisis comes as a surprise to many in the U.S. For pharmaceutical insiders, it is a sign of the growing complexities to make drugs. Part of the problem is that the U.S. Food and Drug Administration (FDA) has no enforcement measures to make pharmaceutical companies or even raw materials manufacturers alert them about drug shortages well ahead of the actual crisis. Currently, the U.S. Senate and House of Representatives have companion bills actively being discussed to amend the Food, Drug, and Cosmetic Act to allow the FDA to take a multi-tiered approach to drug shortages. The bill, Preserving Access to Life-Saving Medications Act (S. 296, H.R. 2245) comes at a critical time to address this huge issue. 
The Preserving Access to Life-Saving Medications Act mandates that all drug makers must notify the FDA about manufacturing issues and discontinued drugs. Manufacturers must alert the FDA six months before the actual shortage occurs, or for raw materials issues, as soon as the problem is evident. The FDA will also maintain an online database of shortages and be able to inflict civil penalties of up to $10,000 a day for every violation that drug makers do not report. The penalties are capped at $1.8 million. 
The bill also requires the FDA to track drugs that are prone to shortages. For some medicines, the number of manufacturers, supply chain issues, ingredients, and alternatives inherently cause supply squeezes. The FDA would make this list available to the public. All of the FDA’s findings would also be documented by a yearly Congressional report and a five-year action plan.
Currently, without a penalty system in place and only encouragement by the FDA to force reporting of shortages, the United States faces an annual labor cost of $216 million to confront drug shortages.  The FDA’s growing list of drug shortages includes more than 10 percent of drugs for cancer patients.  Many are older injectable drugs that become low moneymakers for drug companies. Drug companies for generics lessen as many move to make profits off of different classes of drugs. Patients must switch treatments or stop altogether when a shortage occurs.
Cancer drugs are not like antibiotics where switching to a different drug could be just as effective. Donald Harvey, the director of the Emory Winship Cancer Institute’s Phase I Clinical Trials in Atlanta says that “…switching to a different cancer drug often means making a sacrifice. The substitute could be less effective, cause more side effects, or not be covered by medical insurance.” 
Shortages not only put patients’ lives in peril, but make medical centers sometimes resort to the “gray market” to buy medicines. As quality issues, delays, discontinuations, and raw material problems continue to hit record highs, buying from the gray market and foreign suppliers increases. Critical care, community, and university hospitals noted price gouging at 10 times or more the regular contract price for medicines.  The Institute for Safe Medication Practices conducted a survey this fall and found these gray market drugs were also susceptible to being tainted. Improper storage before a sale is made, counterfeit and placebo drugs, as well as recalled and stolen medicines caused patient health issues in 12 percent of the medical centers.  To remain a beacon of medical progress, the U.S. and the FDA face steep challenges. More government intervention in this instance will help the greater society and some of the most critical patients at a crossroads in their well-being.
 http://www.opencongress.org/bill/112-h2245/show, http://www.opencongress.org/bill/112-s296/show
 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm, http://www.cancer.org/Cancer/news/News/chemotherapy-drug-shortages-concern-doctors-and-patients
 http://www.ismp.org/pressroom/PR20110825.pdf, p.2
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