FDA safety efforts target counterfeiting, unapproved products, and confusing abbreviations; enrollment in Medicare Part D rises above 38 million

In a report from its Counterfeit Drug Task Force, FDA stated that drugs entering the market after December 1, 2006, will be subjected to regulatory requirements pertaining to tracking a medication's "pedigree"-a trail of documentation that provides further evidence of the drug's chain of custody once it enters the supply chain.

"A new system would give companies the support and flexibility they need to continue working on different innovative approaches, including RFID technology, to prevent counterfeiting," said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Enforcement of the pedigree regulations during the first year would initially concentrate on the medications most commonly counterfeited or diverted in the supply chain. FDA intends to list these medications in a future draft guidance to be published in the Federal Register.

Other issues raised by the Counterfeit Drug Task Force regarding implementation of track-and-trace technologies include:

TARGETING CARBONIXAMINE

FDA also issued a guidance targeting products containing the antihistamine carbonixamine that are marketed without FDA approval for purposes outside their indications.

Two products containing carbonixamine have received FDA approval for the treatment of allergic symptoms. However, products containing carbonixamine are being marketed under labels for the treatment of cough and cold symptoms, an area outside of the approved FDA indication. Of particular concern is a potential safety risk for children younger than 2 years, as carbinoxamine has not been studied in very young children, who are more susceptible to drug-related adverse events.

"Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said acting FDA Commissioner Andrew von Eschenbach, MD. "These unapproved drugs have bypassed the agency approval process through which FDA ensures, based on reliable scientific data, that marketed drugs are safe, effective, properly manufactured, and accurately labeled."

CUTTING OUT ABBREVIATIONS

In an effort to prevent deaths from medication errors, which according to the Institute of Medicine of the National Academies exceed 7,000 per year, FDA and ISMP started an educational campaign targeting the pharmaceutical industry and other medical professionals in multiple settings.

"Some abbreviations, symbols and dose designations are frequently misinterpreted and lead to mistakes that result in patient harm," Dr von Eschenbach said. "This joint campaign will promote safe practices among those who communicate medical information to help avoid serious and even potentially fatal consequences of medication errors."

Error-prone abbreviations as identified by ISMP include the following:

Materials to be distributed in the campaign include brochures, a public-service ad that will appear in industry publications, posters, an online toolkit, and a video. The materials are available at: http:// http://www.fda.gov/cder/drug/MedErrors/. ISMP's listing of abbreviations may be found at:http:// http://www.ismp.org/PDF/ErrorProne.pdf.

PART D UPDATE

Health and Human Services Secretary Michael Leavitt released the department's latest report on enrollment in the Medicare Part D prescription drug plan.

A sharp increase in enrollment of >2 million people during the 2 weeks prior to the May 15 deadline pushed the total number of Part D enrollees to 38.7 million Americans.

Leavitt noted that >3.5 million prescriptions per day are currently filled through Medicare Part D coverage. He touted better-than-expected cost savings that, according to the Centers for Medicare and Medicaid Services (CMS), resulted in average premiums for 2006 that are <$24 (excluding retiree benefits). This figure is 40% lower than original estimates, even though 87% of beneficiaries chose plans other than the standard benefit that provide coverage with no deductibles or coverage for the so-called "donut hole" between regular and catastrophic coverage.

"Thanks to Medicare beneficiaries making informed choices to meet their needs, the costs of Medicare drug coverage are way down," CMS Administrator Mark McClellan, MD, PhD, said.

According to the new report, California, Florida, and Texas have the largest number of Medicare Part D enrollees with >8 million beneficiaries combined.

Stand-alone prescription drug plans have the largest number of beneficiaries with 10.4 million people, while 6 million receive benefits through Medicare Advantage's prescription drug plan, which encompasses Medicare recipients who also receive coverage through managed care plans, preferred provider organization plans (PPO), private fee-for-service plans, and specialty plans.

SMALL EXTENSION

The number of enrollees in Medicare Part D will likely continue to grow. CMS in mid-June announced that certain Medicare beneficiaries would still have a chance to enroll in a prescription drug plan without penalty thanks to a demonstration program that lasts until December 31.

The program waives late-enrollment penalties for beneficiaries who receive approval for the low-income Medicare subsidy and also those who lived in parishes or counties that qualified for "individual assistance" from the Federal Emergency Management Agency following Hurricane Katrina in August 2005.

In addition to the extension, CMS will maintain its outreach efforts toward lower-income beneficiaries, estimated to be about 3.2 million Americans, by:

"It's imperative that we reach as many of them to make sure that they are able to get the drugs they need," Dr McClellan said.

SOURCES: FDA announces new measures to protect Americans from counterfeit drugs [press release]. Washington, DC: US Food and Drug Administration; June 9, 2006. Available at: http:// http://www.fda.gov/bbs/topics/NEWS/2006/NEW01386.html. Accessed June 26, 2006.

FDA issues recommendations to fight counterfeit drugs [press release]. Washington, DC: PhRMA; June 9, 2006. Available at: http:// http://www.phrma.org/news_room/press_releases/fda_issues_recommendations_to_fight_counterfeit_drugs/. Accessed June 26, 2006.

FDA acts to improve drug safety and quality [press release]. Washington, DC: US Food and Drug Administration; June 9, 2006. Available at: http://www. fda.gov/bbs/topics/NEWS/2006/NEW01384.html. Accessed June 19, 2006.

FDA and ISMP launch campaign to reduce medication mistakes caused by unclear medical abbreviations [press release]. Washington, DC: US Food and Drug Administration; June 14, 2006. Available at: http:// http://www.fda.gov/bbs/topics/NEWS/2006/NEW01390.html. Accessed June 26, 2006.

Over 38 million people with Medicare now receiving prescription drug coverage [press release]. Washington, DC: United States Department of Health and Human Services; June 14, 2006. Available at: http:// http://www.hhs.gov/news/press/2006press/20060614.html. Accessed June 26, 2006.

Medicare announces special election period for low-income beneficiaries and those affected by Katrina [press release]. Washington, D.C.: Centers for Medicare and Medicaid Services; June 15, 2006. Available at: http:// http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1880/. Accessed June 26, 2006.