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Monday, March 4, 2013
Ed Silverman Pharalot Blog: FDA Begins Crackdown On "Risky" Compounders
In the wake of the scandal over the fungal meningitis outbreak, the FDA last month began a new crackdown on compounding pharmacies that is targeting about 30 so-called ‘high risk’ operations in nearly a dozen states and late last week disclosed that inspections reports were issued for four compounders for a variety of serious manufacturing violations.
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Sunday, March 3, 2013
Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred By Derrick Gingery / Email the Author / Mar. 1, 2013 Word Count: 1023 / Article # 14130301008 / Posted: March 1 2013 5:55 PM
Sequestration Day: FDA Will Manage For Now, But Could Suffer Later If Hiring Deferred
By Derrick Gingery / Email the Author / Mar. 1, 2013
Word Count: 1023 / Article # 14130301008 / Posted: March 1 2013 5:55 PM
Word Count: 1023 / Article # 14130301008 / Posted: March 1 2013 5:55 PM
Executive Summary
As the across-the-board cuts go into effect, not allowing FDA to add the hundreds of new employees that will be needed to meet the goals of user fee and other programs could damage the agency for years to come; NIH and CMS also will see significant effects.
Compounding effort Quality control, costs drive hospitals to mix drugs By Jaimy Lee Posted: March 2, 2013 - 12:01 am ET Read more: Hospitals turn to compound drugs because of quality, cost | Modern Healthcare http://www.modernhealthcare.com/article/20130302/MAGAZINE/303029974#ixzz2MVZZFUiR ?trk=tynt
As public officials and providers fret over the safety and cost of drugs bought from compounding pharmacies, more hospital systems are working on plans to mix and package the drugs themselves.
The multistate meningitis outbreak last year that led to 48 deaths and sickened another 714 people was caused by contaminated steroid injections produced by the New England Compounding Center.
Hundreds of hospitals in the U.S. purchased compounded drugs from NECC and Ameridose, a national compounder that shares ownership with NECC.
The outbreak triggered calls for stronger federal and state oversight of compounding pharmacies, especially for companies such as NECC and Ameridose that were operating more like drug manufacturers than traditional compounders before they closed last year.
“The tipping point for people who were close to making that decision was probably the Ameridose closure,” said Erin Fox, director of the drug information service at the University of Utah Hospitals and Clinics. “It was a wake-up call. They certainly trusted NECC and they trusted Ameridose.”
Read more: Hospitals turn to compound drugs because of quality, cost | Modern Healthcare http://www.modernhealthcare.com/article/20130302/MAGAZINE/303029974#ixzz2MVZmyUCe
?trk=tynt
The multistate meningitis outbreak last year that led to 48 deaths and sickened another 714 people was caused by contaminated steroid injections produced by the New England Compounding Center.
Hundreds of hospitals in the U.S. purchased compounded drugs from NECC and Ameridose, a national compounder that shares ownership with NECC.
The outbreak triggered calls for stronger federal and state oversight of compounding pharmacies, especially for companies such as NECC and Ameridose that were operating more like drug manufacturers than traditional compounders before they closed last year.
“The tipping point for people who were close to making that decision was probably the Ameridose closure,” said Erin Fox, director of the drug information service at the University of Utah Hospitals and Clinics. “It was a wake-up call. They certainly trusted NECC and they trusted Ameridose.”
Read more: Hospitals turn to compound drugs because of quality, cost | Modern Healthcare http://www.modernhealthcare.com/article/20130302/MAGAZINE/303029974#ixzz2MVZmyUCe
?trk=tynt
Lobbyist Efforts Grow for Stricter Regulations of Compounding Pharmacies
Drug companies have ramped up lobbying efforts in Congress to force specialty pharmacies to either stop mass-producing drugs or face stricter regulation.
Commercial drug makers are also trying to prevent these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.
This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.
Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations are pressing their interests.
Veterinary groups, for instance, are warning that any legislation requiring patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.
Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.
And the compounders, while agreeing that tighter federal enforcement of safety standards is needed for the large firms, are vigorously resisting the drug companies’ bid to limit competition.
The Senate Health, Education, Labor and Pensions Committee is working on draft legislation directed at compounders and is expected to begin circulating it to interested groups as soon as next month. The House Energy and Commerce Committee, meanwhile, is investigating whether lax oversight of NECC by the FDA contributed to illnesses and deaths.
Since Congress and other federal officials began investigating NECC last fall, the number of groups lobbying on issues related to compounding pharmacies has more than doubled, records show.
“Some are making blatant copies of FDA-approved products,” said Ron Phillips, who is lobbying for the Animal Health Institute, which represents drugmakers. “You can go to any trade show or to their websites and they are openly promoting this. A clear line needs to be drawn.”
Over the past two decades, many compounders — who custom-mix medications — have moved from a traditional practice of filling individual prescriptions to mass producing drugs, often without a prescription. Sometimes the drugs are similar to those made by drug manufacturers. Today, compounding is about a $2 billion-a-year industry.
Compounders supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. Veterinary groups estimate that 20 percent of the medications they prescribe are compounded products.
Read more: http://www.voxxi.com/lobby-stricter-compounder-regulation/#ixzz2MVVPHL00 - See more at: http://www.voxxi.com/lobby-stricter-compounder-regulation/#sthash.3EHWqSVW.dpuf
Niels Erik Hansen: Automation can make compound medicine safer
Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened nearly 700 people in 19 states, and killed more than 40.
Michigan was particularly hard-hit and had the most cases in the nation. One of only two states with more than 100 cases of illness linked to the contaminated injections (the other is Tennessee with 150 cases), Michigan has seen 250 cases to date, and 13 deaths.
Although this outbreak is an egregious example of medication compounding gone awry, it is hardly an isolated incident. In December, the journal American Health & Drug Benefits reported that medication errors from injectable drugs harm more than 1 million patients annually in U.S. hospitals. Adverse drug events (ADEs) due to injectable medications cost U.S. healthcare payers between $2.7 billion to $5.1 billion annually, an average of $600,000 per hospital.
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