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FDA Lacks Authority to Protect Public Health from Drug Shortages Says the GAO
In a report by the Government Accountability Office, the director said Congress should consider establishing a requirement for drug manufacturers to report to FDA any changes that could affect the supply of drug products. (The question is what happens after the FDA is informed? Actually, FDA actions result in some of the drug shortages we are currently experiencing.)
http://www.gao.gov/assets/590/586979.pdf
12 Million Motrin Bottles Recalled from Shelves by J&J
Johnson & Johnson has been plagued by product recalls in the past two years and just announced that it is voluntarily asking retailers to remove about 12 million bottles of Motrin pain relievers from store shelves.
The reason given is that as they approach their expiration dates, the coated caplets may not dissolve as quickly as intended; the company determined this when testing product samples.
Although J&J said there is no safety concern if consumers continue taking the product in accordance with its label, it is possible there may be a delay in experiencing relief.
http://www.reuters.com/article/2011/12/22/us-jnj-motrin-idUSTRE7BL03F20111222
Ketoconazole-loaded Lollipops Could Boost Oral Thrush Compliance
Oral thrush can commonly occur in bottle-fed babies and is also a problem for older children and adults. Antifungal compounds can treat the disorder but, especially among children, a pleasant delivery form is desirable. A current study in the International Journal of Life Sciences Biotechnology and Pharma Research states:
"Attractive, taste masking formulations are the need of the hour. In the present study ketoconazole sweetened lollipops were designed for the effective treatment of oral thrush in children".
The 3g lollipops each contained 15 mg of ketoconazole. A hydrophilic polymer was added to increase the retention time of the drug in the mouth.
"Stability studies at ambient temperatures show that the formulations were found to have uniform drug content up to 3 months", the researchers wrote.
(Editor's Note: Compounding pharmacists have known this for many, many years!!!!)
http://www.in-pharmatechnologist.com/Materials-Formulation/Drug-loaded-lollipops-could-boost-oral-thrush-compliance
National Drug Shortage Takes Toll on Billings Montana Child
Richard and Dawn Grayson's son, Tanner, suffered chemical burns when he had to receive alternative supplements because of a national drug shortage of a calcium product. Tanner was born 11 weeks premature at St. Vincent Healthcare and developed necrotizing enterocolitis, a serious and sometimes fatal bowel infection, which required emergency surgery at Primary Children's Medical Center in Salt Lake City.
During the surgery, Tanner received his nutrients, including calcium, through Total Parenteral Nutrition. However, there was a national shortage of the type of calcium needed, so physicians mixed a substitute that had devastating consequences. The alternative substance caused chemical burns and permanent scarring on his arm and foot.
"I was furious, flat livid about it," said Richard Grayson, 33, Tanner's father. "These drug manufacturers know how vital calcium is. Why they don't have enough on hand is beyond me. It's insane and uncalled for."
http://billingsgazette.com/news/state-and-regional/national-drug-shortage-takes-toll-on-montanans/article_ca67ee54-032d-5ef1-8679-a4c7da1f4c86.html?oCampaign=hottopics
U.S. Treasury Benefiting from Pharmacy Fraud
The Department of Justice is boasting about recovering lots of money from prosecuting healthcare fraud, which has become an annual pastime. For the second year in a row, the agency recovered more than $3 billion under the False Claims Act, and the total since January 2009 is $8.7 billion.
Of the $3 billion recovered this past fiscal year, which ended September 30, $2.4 billion in recoveries involved fraud committed against federal healthcare programs. As for drugmakers, the feds say that enforcement actions involving the pharmaceutical industry were, once again, the source of the largest recoveries this year; DOJ recovered nearly $2.2 billion in civil claims against drugmakers last fiscal year, including $1.76 billion in federal recoveries and $421 million in state Medicaid recoveries.
http://www.pharmalot.com/2011/12/pharma-fraud-continues-to-fill-the-us-treasury/
European Union Again Tightens Control on Drugs Used in Executions
The European Union (EU) has set new controls on drugs and other products used in executions that are being exported to the U.S. and other countries with capital punishment. Starting immediately, exports of sodium thiopental (Pentothal) and other short- and medium-acting barbiturate drugs must have prior approval of the EU member nations' regulatory agencies when they are destined for "countries that have not yet abolished the death penalty," The commission is responding to a request from Amnesty International. "I wish to underline that the European Union opposes the death penalty under all circumstances," said Catherine Ashton, a top Commission official, in a statement.
When another barbiturate product, pentobarbital, was substituted by prison authorities, the drug's supplier-the Danish firm Lundbeck A/S-said it would only ship the product to U.S. distributors and pharmacies that promised not to sell the drug to prison authorities in death-penalty states. The European Commission said that if its new rules failed to stop use of European products in executions, it would consider additional regulations and/or the addition of "other goods...identified as needing particular surveillance."
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