FDA investigation finds widespread problems at compounding pharmacies
SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency’s website Thursday.
The agency inspected 31 pharmacies that were known to have engaged in sterile compounding of sterile drugs. At all but one of the pharmacies, inspectors found problems such as mold and rust in clean rooms, black particles floating in supposedly sterile drugs, technicians using their bare hands to handle products that require latex gloves and wearing nonsterile lab coats. In at least two instances, FDA officials had to get administrative warrants to obtain access to pharmacies’ records, and U.S. Marshals had to accompany the agency’s investigators to one pharmacy.
In traditional pharmacy compounding, a pharmacist mixes drugs according to a physician’s prescription, usually oral solids, liquids, ointments and suppositories, which can be done from a pre-made kit or with an existing drug, such as the common practice of using capsules of Genentech’s Tamiflu (oseltamivir) to create a drinkable liquid formulation for children. But sterile compounding usually involves mixing drugs for injection, such as chemotherapy and biotech drugs, and it requires strict adherence to sterilization practices.
Hamburg has called for giving the FDA increased authority over compounding pharmacies in the wake of a nationwide outbreak of fungal meningitis linked to the New England Compounding Center of Framingham, Mass. An inspection by health officials of that pharmacy found widespread disregard for sterile practices as the pharmacy, according to officials, had effectively become a drug manufacturer.
According to the Centers for Disease Control and Prevention, the meningitis outbreak has sickened 733 and resulted in 53 deaths.
Study finds wide disparities in antibiotic prescribing rates between South, Midwest
NEW YORK — Research has indicated that about half of antibiotic prescriptions are unnecessary, raising concerns about the growth of bacteria resistant to them, but a new study by researchers at the Centers for Disease Control and Prevention also finds that prescriptions are highest in several states in the South and Midwest.
The study, published Thursday in the New England Journal of Medicine, was based on a database maintained by IMS Health that includes a sample of more than 70% of U.S. prescriptions.
The study found 258 million courses of antibiotics prescribed in 2010, or 833 prescriptions per 1,000 people. Prescribing rates in the South were 936 per 1,000 people, compared with 639 in the West.
The highest rates — ranging from 996 to 1,237 prescriptions per 1,000 people — were found in Alabama, Mississippi, Louisiana, Arkansas, Tennessee, Kentucky and West Virginia, as well as the Midwestern states of Indiana and North Dakota. The lowest rates were found in Washington, Oregon, California, Alaska, Hawaii, Colorado, Vermont and New Hampshire.
Reports: Alberta government to give pharmacists allowance in preparation for generic pricing changes
NEW YORK — The government of Canada’s Alberta province will pay pharmacists C$1 for each prescription filled as part of a one-year transition program for which it will spend $24 million, according to published reports.
The Calgary, Alberta, Herald reported Wednesday that the program was designed to help pharmacists transition to a new business model. The newspaper also reported that provincial health minister Fred Horne said the province was "committed" to offering generic drugs to residents of the province for 18% of the cost of branded drugs, but that pharmacists had historically objected to efforts to lower generic drug prices.
Under provincial regulations, pharmacies buy drugs at a price, capped by the government, that suppliers can charge. Pharmacists are then reimbursed for the cost when prescriptions are filled and can charge the government a dispensing fee of $10.93 per prescription.
At the same time, many pharmacists have arranged volume deals, but the Herald reported that they said such deals, which provide an additional source of income, were under threat due to lowering of generic drug prices. The government plans to pay the current price for generic drugs until the end of May, the newspaper reported.
C$1 = 99 U.S. cents.