Oncology Times:
doi: 10.1097/01.COT.0000311433.90702.c7
Department: Eye on Washington

EYE ON WASHINGTON

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FDA Says Consumers Continue to Buy Risky Drugs Online

A yearlong FDA investigation into drugs mailed to the United States from foreign countries suggests that consumers are buying drugs online to avoid the need for a prescription from their physicians. And a sampling of these imported drugs indicates that consumers continue to spend money unnecessarily on potentially risky products, the agency said.

The investigation found that 88% of the 2,069 packages examined appeared to be prescription medicines available in this country. Of the remaining 12%, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the US.

More than half the products sampled have FDA-approved generic versions, likely sold at lower cost. In fact, approved generic versions of approximately half the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.

“The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription,” Randall Lutter, PhD, FDA Deputy Commissioner for Policy, said in a statement. “In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice.”

The surveys were conducted from September 2006 to August 2007 in international mail facilities across the country. At each city surveyed, a selection of parcels suspected by US Customs and Border Protection of containing pharmaceuticals were stopped. FDA then recorded data on the contents of the parcels before repacking and sending them on their way.

The FDA notes that a Web site may appear legitimate but in fact may be a front for an illegal operation. In addition, unregulated Internet drug sellers may sell products that might not contain the correct ingredients and possibly toxic substances. Several drugs found in the survey require special monitoring by physicians or other health professionals for potential adverse events and to ensure their effectiveness, including antibiotics, antidepressants, warfarin, and levothyroxine.

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Teamwork Breakdowns, Lack of Supervision Cause Errors by Medical Residents

A new study funded by the Agency for Healthcare Research and Quality indicates that medical residents are highly vulnerable to errors that stem from teamwork breakdowns, especially lack of supervision by experienced staff. A significant number of these errors occurred during patient handoffs.

The study (Arch Intern Med 2007;167:2030–2036) was conducted by researchers at the Michael E. DeBakey VA Medical Center, Baylor College of Medicine, University of Texas at Houston, and Harvard School of Public Health. Data were analyzed from a random sample of 889 closed malpractice claims that had been reviewed by specialist physicians between 2002 and 2004. The reviewers had determined whether injuries had occurred, and if so, whether they were due to errors involving residents.

Twenty-seven percent of the cases involved residents whose involvement in the error was considered at least moderately important. Adverse outcomes were serious: One-third resulted in significant physical injury, one-fifth in major physical injury, and one-third in death.

“We are continuing to learn about the critical role that effective teamwork plays in preventing medical errors and promoting patient safety,” said AHRQ Director Carolyn M. Clancy, MD, in a news release. “This study reminds us that we have a lot to do to ensure that hospitals are providing appropriate supervision to trainees and implementing team-training programs.”

Researchers also examined the role of residents attributable to cognitive factors (judgment and technical knowledge) and teamwork factors (supervision and patient handoffs). The former contributed to the majority of errors, 72% of which involved judgment, 58% of the rest a lack of technical knowledge, and 57% to failure of vigilance or memory.

Attending physicians' failure to oversee residents' work was a factor in 82% of the lack of supervision cases.

Errors stemming from handoff problems were due to a variety of communication breakdowns, especially incomplete or inaccurate transfer of information, and in 20% of the cases, more than two parties were involved.

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Payment Increases May Be Insufficient to Mitigate Drug Payment Cuts in Hopps Rule

The Centers for Medicare & Medicaid Services (CMS) has released the 2008 Final Hospital Outpatient Prospective Payment System (HOPPS) rule. Among the highlights:

• Reduced payment for separately paid drugs without pass-through status to average sales price (ASP) plus 5%. The agency said it believes that adequate payment for drugs is ASP+3%, but 2008 will be a transition year with payment at ASP+5%. Drugs with pass-through status will continue to be reimbursed at ASP+6%.

• For all drugs and biologicals with an average per day cost of less than $60, CMS will bundle the drug and administrative payment. Payment for antiemetics will continue to be made separately.

• Some administrative payments increased slightly while others decreased.

• The agency will not require hospitals to remove pharmacy overhead costs from drug acquisition costs and report them in an uncoded revenue line.

• Hospitals must report on seven quality measures in order to receive the full increase of 3.3% in 2008. Hospitals that do not report quality data will have their annual update reduced by 2%.

© 2008 Lippincott Williams & Wilkins, Inc.

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