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Hospira Recalls Some Cancer Medicines
Hospira has issued a nationwide recall of four types of cancer products because of a problem with the glass vials that contain the medicines. Hospira said the problem with the glass vials has been fixed by the company's glass-vial supplier and that production of the medicines continues. Some of the cancer drugs have been in short supply because of previous production problems at various manufacturers. A company spokesman said Hospira doesn't expect any new U.S. shortages of the medicines because of the recall.
The recall involves a total of 19 lots of carboplatin, cytarabine, paclitaxel, and methotrexate because of visible particles embedded in the glass located at the neck of the vial. There is the potential for the medicine to come into contact with the embedded particles and then be injected into a patient. Hospira said there have been no reports of this happening or any other side effects.
http://online.wsj.com/article/SB10001424052702304388004577531221263785262.html?mod=dist_smartbrief&_nocache=1342722276240&user=welcome&mg=id-wsj
Study Says Doctors Increasingly Fill Prescriptions
Doctors are increasingly filling prescriptions for workman's compensation patients in Pennsylvania and New Jersey, sometimes getting paid much more per dose than a pharmacy, according to a study to be released Thursday by a research group funded by insurers and state governments. The Workers Compensation Research Institute studied nearly 5.7 million prescriptions paid under workers' compensation for about 758,000 claims from 2007 to 2011 in 23 states, including Pennsylvania and New Jersey.
In Pennsylvania, 20 percent of the prescriptions for patients filing workman's compensation claims were filled by a doctor, up from the 17 percent over a three-year period used in the study. The percentage of payments to doctors for prescriptions rose from 15 percent to 27 percent during the same period.
The study found that prices paid to doctors for certain drugs, including some painkillers, were higher than those paid to pharmacies, both retail and mail order. "We rarely see a medical cost driver that has grown this rapidly," Dr. Richard Victor, WCRI's executive director, said in a statement.
Recently, the New York Times reported that some distributors help some doctors set up pharmacies within offices, buy drugs in bulk, and then repackage them. Repackaging has allowed those distributors and doctors to claim a higher reimbursement price than pharmacies get. California has closed that loophole.
http://www.philly.com/philly/business/20120719_Study_says_doctors_increasingly_
fill_prescriptions.html
CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams Withdrawn for Reasons of Safety or Effectiveness
The FDA has determined that CHLOROMYCETIN (chloramphenicol) capsules, 250 milligrams (mg), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol 250-mg capsules.
The FDA has determined that additional nonclinical and possibly clinical studies of safety and efficacy would be necessary before CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, could be considered for reintroduction to the market. Accordingly, the Agency will remove CHLOROMYCETIN (chloramphenicol) capsules, 250 mg, from the list of drug products published in the Orange Book. The FDA will not accept or approve ANDAs that refer to this drug product.
http://www.gpo.gov/fdsys/pkg/FR-2012-07-13/pdf/2012-17091.pdf
Bill Proposed to Deter Painkiller Abuse
House lawmakers are introducing legislation requiring most pain drugs to adopt abuse-deterring safeguards, the broadest congressional attempt at curbing the nation's prescription-drug problem. The bipartisan bill proposes to eventually require most of the nation's 137 million annual painkiller prescriptions to contain some form of abuse deterrence, including dosage forms that are more difficult for abusers to crush open or inject. The bill leaves vague the exact details of how drug makers could meet new standards. Currently, only a small number of branded products, such as Purdue Pharma LP's OxyContin or Endo Pharmaceuticals Inc.'s Opana, have in recent years been made with so-called tamper-resistant formulations. Most generics don't have such safeguards.
http://online.wsj.com/article/SB10000872396390444097904577535361145297688.html?_nocache=1342723281896&user=welcome&mg=id-wsj
Travelers Insurance Companies Have Paid for Thousands of Off-label Prescriptions
Cephalon Inc. has sued Travelers to stop the insurer from trying to recover millions of dollars it allegedly paid for off-label uses of Actiq. Travelers has demanded that Cephalon reimburse $17.4 million stemming from the off-label promotion of the drug; the promotions involve uses of a drug not approved by the FDA.
While Cephalon settled with U.S. federal and state regulators in 2008 over similar allegations, it said federal law entrusts the FDA with oversight of off-label promotion and does not give Travelers the right to bring its own case.
http://in.reuters.com/article/2012/07/13/teva-travelers-idINL2E8ID82Z20120713
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