Mark McClellan, M.D., Ph.D., chief administrator of CMS, will leave the agency in early October. McClellan had run the agency since March 2004 and has been both lauded and criticized for his management during implementation of the Medicare Part D drug plan this year.
DEA is designating six pharmaceutical products as exempt anabolic steroids under the Controlled Substances Act. The reason is that these six products are similar to other preparations that have already been exempted.
DEA has issued a final rule regarding new registration fees. As of Nov. 1, pharmacies applying or renewing their DEA registration must pay an annual fee of $184.
On Sept. 5, U.S. marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advance Arthritis Support capsules distributed by Advantage Nutraceuticals LLC of Fort Walton Beach, Fla., valued at about $55,000. The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
PhRMA is introducing a multimedia national health education campaign to promote cancer awareness. The effort stresses the importance of patients consulting with their healthcare providers.
How will new travel rules affect OTC/HBC sales?; How will new travel rules affect OTC/HBC sales?
As the saying goes, two are better than one. And that's just what Takeda Pharmaceuticals is saying about its new combination drug recently approved by the Food & Drug Administration. Duetact takes pioglitazone (Actos, Takeda)-a thiazolidinedione-and adds glimepiride-a sulfonylurea-in an effort to offer Type 2 diabetes patients a new, once-daily alternative.
As the saying goes, two are better than one. And that's just what Takeda Pharmaceuticals is saying about its new combination drug recently approved by the Food & Drug Administration. Duetact takes pioglitazone (Actos, Takeda)-a thiazolidinedione-and adds glimepiride-a sulfonylurea-in an effort to offer Type 2 diabetes patients a new, once-daily alternative.
Paul Duncsak, a pharmacist who was employed by Franklin Lakes, N.J.-based Medco Health Solutions, was found shot to death in his Ramsey, N.J., home on Aug. 23. According to newspaper reports, Duncsak was involved in a bitter divorce and child-custody battle with his ex-wife.
There are several important things that all Medicare Part D beneficiaries can do to avoid falling in the Medicare Part D "donut hole," according to the Academy of Managed Care Pharmacy. Recommendations from the organization include make use of generic drugs whenever appropriate; talk to your doctor or pharmacist about alternative drugs; don't stop taking your medications to save money; talk to your doctor or pharmacist about cutting tablets in half; and remember to use your Medicare card each time you purchase drugs, whether or not you have reached the donut hole.
Seventy-nine percent of drugs and medical devices are approved by the FDA's outside advisory panels, according to a study conducted by National Research Center for Women & Families. The Washington-based nonprofit research group termed the committees as little more than "rubber stamps" for drug companies.
After a computer glitch sent out more than $50 million in reimbursements to approximately 230,000 Medicare recipients, CMS plans to ask for the money back. Some Medicare beneficiaries also received letters from the Social Security Administration http://www.ssa.gov/ that erroneously said the agency will no longer deduct their monthly prescription drug benefit premiums from their Social Security checks.
The March of Dimes medical director, Nancy Green, has testified before the FDA Reproductive Health Drugs Advisory Committee on the benefit of injectable progesterone for pregnant patients at risk of delivering premature infants. The drug, known as 17-P, or 17 alpha-hydroxyprogesterone (Gestiva), is currently under priority review by the FDA for the prevention of preterm birth in women with a history of early delivery.
Consumers should not purchase medications from Web sites that have prescription orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, warned the FDA. Apparently the sites are selling counterfeit drugs to U.S. consumers that include versions of Lipitor, Actonel, Nexium, Hyzaar, Ezetrol (sold as Zetia in the U.S.), Crestor, Celebrex, Arimidex, Propecia, and Diovan.
Sudafed PE, Pfizer's OTC decongestant that replaced Sudafed on drugstore shelves, is not "sufficiently absorbed into the bloodstream to make it an effective oral medication," according to pharmacists at the University of Florida. A Pfizer spokesman said the drug is effective, but consumers also can ask for the original Sudafed, which is now kept behind pharmacy counters to prevent criminals from buying it to make methamphetamine.
CheckUps, formerly known as Quick Quality Care, will open 20 new clinics inside Wal-Mart stores in the Southeast by the end of the year. The new clinics will be located in New Orleans; Jackson, Miss.; and Alabama.
Gov. Arnold Schwarzenegger (R, Calif.) is expected to sign a compromise bill passed by the Democrat-controlled state legislature that would create a prescription drug discount program for many residents lacking drug coverage or with inadequate drug coverage. The compromise allows the drug companies three years to negotiate discounts or risk exclusion from the Medi-Cal list of approved drugs.
How will new travel rules affect OTC/HBC sales?; How will new travel rules affect OTC/HBC sales?
Remember this bit of advice: "Take your medicine; it's good for you"? Well, it appears that a lot of people haven't been following that counsel. It is estimated that 80% of patients don't take their medications as prescribed, and about 20% of all prescriptions are never filled. Patient noncompliance not only poses serious health consequences but can also result in significant losses of revenue.
More companies are in favor of carving in their prescription benefits with their overall health plans than carving them out, according to the results of the 2006 Arxcel Prescription Benefit Research Survey.
With some programs enjoying a resurgence and others on the wane, here's a look at what's out there
There were many unknowns as Medicare Part D rolled out. However, some answers are now available, including how many of those who were eligible enrolled and which plans they chose.
It seems to me the age of the independent drugstore is rising. I mean it! I know that many privately owned pharmacies are being bought by chains. I know older owners can get worn down. After countless seasons of six days a week, they want some of the goodies that a life of hard work promised. The chain closes the store. The owner works a little relief for the chain and gets some rewards for all those decades in the trenches. What's so bad about that?
How much written drug information is enough for consumers? Is there such a thing as too much information?
The American Association for Geriatric Psychiatry (AAGP) recently released a position paper to affirm that a minimal set of care principles now exists for those with Alzheimer's disease (AD) and their caregivers, and to articulate these principles. "Principles of care for patients with dementia resulting from Alzheimer disease" was published in the July 2006 issue of the American Journal of Geriatric Psychiatry and on the AAGP Web site at http://www.aagponline.org/prof/position_caredmnalz.asp.
A subdermal implantation of a single etonogestrel-containing rod can prevent pregnancy for up to three years. Does this sound too simple to be true? The manufacturer of Implanon, Organon Inc., is hoping women will be intrigued. The Food & Drug Administration approved the new 68-mg implant just last month. It contains the same component that's in the company's vaginal contraceptive, NuvaRing.
An Electronic Drug Registration and Listing System (EDRLS) has been proposed by the FDA that would include a complete list of drug products marketed in the U.S. A change from the current paper system, the new electronic list would be available to healthcare providers, government agencies, and healthcare payers and would include specifics such as dosage forms, ingredients, strengths, labeling, and manufacturing information.
On Aug. 17, the U.S. Court of Appeals for the Tenth Circuit in Denver upheld the FDA final rule declaring all dietary supplements containing ephedrine alkaloids adulterated and, therefore, illegal for marketing in the U.S., reversing a decision by the District Court of Utah. Commenting on the Denver court's ruling, the FDA said, "The Tenth Circuit Court of Appeals' ruling demonstrates the soundness of FDA's decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Arcadia Resources, a provider of home care, staffing services, and related home care equipment, is opening health clinics in seven Meijer stores in Michigan. Arcadia announced in June that it will operate health clinics in nine Meijer stores in Indiana.