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FDA starting drug safety audio broadcasts
The Food and Drug Administration has alerted health care professionals and consumers to availability of audio broadcasts providing emerging drug safety information. The broadcasts, commonly known as "podcasts," can be transmitted to personal computers and personal audio players. Agency officials said the service is part of an ongoing effort to broaden and speed communications on the safety of marketed medications when unexpected adverse events are reported to FDA. They will be produced in addition to the existing print- and Web-based public health advisories. Anyone can subscribe to them at http://www.fda.gov.
FDA said that since the service was launched in February 2007, it has alerted listeners to the potential hazards of skin-numbing products used in hair removal, the voluntary market withdrawals of drugs to treat the symptoms of Parkinson's disease and irritable bowel syndrome, and to serious adverse events associated with agents that reduce need for blood transfers in cancer patients.
Pharmacist's license revoked for fatal mistake
The Ohio Board of Pharmacy has revoked the license of a hospital pharmacist who failed to catch a technician's mistake that led to the death of a two-year-old girl at Cleveland's Rainbow Babies and Children's Hospital. The technician testified she warned pharmacist Eric Cropp that something wasn't right with a saline solution prepared for Emily Jerry. The little girl died March 1, 2006, three days after receiving a lethal dose of salt along with chemotherapy. Instead of a saline solution with 1% chloride, the girl received a mixture with concentrated sodium chloride, a 23.4% solution.
Cropp cried as he testified before the board that "it was a bad day, the computer was down, and the technicians were way behind. It was nuts.... I should have caught it.... I wish I could go back in time and fix it. I wish it were me instead of her. I'll have to live with this the rest of my life." The hospital fired Cropp one week after the incident and the technician resigned. There have been calls for legislation in Ohio to regulate pharmacy technicians.
Patient cost-sharing cuts statin adherence
Requiring patients to partially pay for their statin medications has a negative effect on adherence to the cholesterol-lowering therapy, according to a new Harvard Medical School study published in the April 10, 2007 issue of Circulation. Lead investigator Sebastian Schneeweiss told Heartline that although treatment guidelines and health plan performance measures recommend statin therapy after acute myocardial infarction, adherence to therapy is often less than 60% six months after initiation, even among patients with comprehensive drug plans.
Researchers studied 51,561 patients who initiated statin therapy in the Canadian province of British Columbia. The provincial health plan had provided full coverage for the elderly until January 2002, when a $25 (Canadian) co-payment was implemented ($10 for low-income seniors). In May 2003, the co-payment was replaced with a 25% coinsurance, in which patients pay a percentage of the cost, plus an income-based deductible policy. The changes in payment policies allowed researchers to study the effect of the different cost-sharing interventions on adherence to and initiation of statin therapy after a heart attack.
Relative to full-coverage policies, adherence to new statin therapy, measured after nine months of follow-up, was reduced 5.4% under a fixed co-payment policy and 5.4% under the coinsurance policy. The proportion of new heart attack patients starting statin therapy increased steadily over the study period, similar to a Pennsylvania control population with full coverage.
"It is known, and frequently described, that medication cost-sharing by patients out of pocket is associated with less drug use and sometimes adverse health outcomes," Schneeweiss said. "We wanted to specifically look at statins because statins are a preventive medication, and we're not treating symptoms that patients feel, making the adherence issue worse with statins than with other medications. Also, statins are expensive, so paying 25% of the cost out-of-pocket is quite a bit for these drugs. With fixed cost-sharing and coinsurance, we saw a 5% reduction in adherence, in the proper use of these medications. Adherence is already bad with statins, but if you reduce this further, we end up with only about 50% of people taking their medication. This is quite poor and will result in many outcomes that could have been avoided. Also, if you turn this around, if you think in terms of interventions on how to improve adherence, this costs a lot of money to boost adherence by 5%."
ESA safety information is strengthened
FDA has issued a public health advisory with new safety information, including revised product labeling, for erythropoiesis-stimulating agents (ESAs), used for treating anemia. The drugs involved are Amgen's Aranesp (darbepoetin alfa) and Epogen and Procrit (epoetin alfa). ESAs are genetically engineered forms of erythropoietin, a naturally-occurring human protein that is made by the kidney and increases the number of red blood cells.
FDA and Amgen agreed on revised product labeling with updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor hemoglobin levels and adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the risk of blood transfusions. Physicians and patients should carefully weigh the risks in using ESAs against the risk of blood transfusions, FDA says.
Recent studies have described an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received higher doses of ESAs. In studies where ESAs were given at recommended doses, an increased risk of death was reported in cancer patients who were not receiving chemotherapy, and an increased risk of blood clots was observed in patients following orthopedic surgery.
The three drugs are approved for treating anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit also are approved for patients scheduled for major surgery to reduce potential blood transfusions and for treating anemia due to HIV treatment with zidovudine. ESAs are not approved for treating anemia symptoms in cancer patients, surgical patients, or those with HIV.