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.
Just a week after Apotex Corp. announced that it was going to market the first generic version of clopidogrel bisulfate (Plavix) 75-mg tablets, the innovator companies-Sanofi-Aventis and Bristol-Myers Squibb-filed a request for an injunction in the U.S. District Court for the Southern District of New York, in an attempt to block Apotex from selling clopidogrel.
"Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events" is the statement that's been added to GlaxoSmithKline's dextroamphetamine sulfate sustained-release capsules and tablets (Dexedrine Spansules) labeling. The revision comes in response to an FDA request to all manufacturers of CNS stimulants used to treat ADHD for additional and standardized language based on recommendations made by members of two different advisory committees, according to Glaxo.
New York State Attorney General Eliot Spitzer is informing New Yorkers that his Web site has been expanded to enable consumers to search and compare the prices for 150 commonly prescribed drugs that state law requires pharmacies to disclose to them upon request.
Pharmacies in New Jersey will soon be required to submit price information for the 150 most frequently prescribed prescription drugs as part of the New Jersey Prescription Drug Retail Price Registry. The recently signed law calls for drug prices to be available on a state-run Web site and a toll-free hotline in English and Spanish.
Independent pharmacy cooperatives United Drugs and Partners in Pharmacy Cooperative (PIPCo) recently announced a new agreement to expand cooperation between the two organizations. "This new relationship lets us continue to preserve and strengthen our members' independence but allows them to do business on a chain level," explained Gene Brah, executive director of PIPCo.
With the Food & Drug Administration's approval of Atripla (efavirenz/emtricitabine/tenofovir, Bristol-Myers Squibb and Gilead Sciences), HIV patients will have access to a once-daily single-tablet regimen. The new product combines three agents from two classes of antiretrovirals: Efavirenz (600 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and emtricitabine (200 mg) and tenofovir (300 mg) are nucleoside reverse transcriptase inhibitors (NRTIs). All three work by blocking reverse transcriptase, an enzyme required for HIV replication.
The Pharmacist Services Technical Advisory Coalition, founded in 2002 to improve the coding infrastructure required for billing of pharmacist services, has successfully gained revisions in the Health Care Provider Taxonomy Code List for pharmacy service providers and pharmacy suppliers. Among the new categories are geriatric, oncology, and compounding pharmacy. Changes in definitions for existing pharmacist categories include nuclear, nutrition support, pharmacotherapy, and psychiatric. The code review was performed in preparation for implementation of a National Provider Identifier (NPI), as mandated by HIPAA. According to PSTAC, providers may have one or more taxonomy codes, depending on their areas of specialization, and providers that have already completed the NPI application may need to update the code(s) in their NPI record. The new changes were announced in July by the National Uniform Claims Committee and will go into effect on Oct. 1. For a complete list of taxonomy codes, visit..
Pharmacists will continue to assume a gatekeeper role in individualized oncologic therapy, according to experts participating in an American Medical Association-sponsored media briefing, "Revolutionary Cancer Treatments," held in New York City recently. The event addressed the issue of unmet needs in cancer therapy. Carolyn D. Runowicz, president of the American Cancer Society, was the moderator for the meeting.
Specialty pharmacy Caremark was been chosen by Shire Human Genetics Therapies to participate in a limited distribution network for idursulfase (Elaprase), the orphan drug recently approved to treat Hunter Syndrome, or mucopolysaccharidosis II.
The cost of training providers and physicians who are reluctant to give up their old ways continue to be major obstacles to the adoption of e-prescribing. Andrew Morgan, an insurance specialist at CMS' Office of E-Health Standards & Services (OESS), said that some doctors don't want to spend a lot of time being trained.
The newly formed Coalition for Community Pharmacy Action (CCPA), a group representing 55,000 community pharmacies, is urging the House-Senate Conferees of the National Defense Authorization Act (H.R. 5122/S. 2766) to give military families enrolled in TRICARE a choice when filling Rxs. Catherine Polley, co-president of CCPA, said, "Congress is considering legislation that raises co-pays at community pharmacies and could force millions of military families to fill their maintenance medications through mail order."
GPhA has announced the results of an independent study that disputes a recent PhRMA report endorsing the use of authorized generics. The new study, An Assessment of Authorized Generics: Consumer Effects and Policy Issues, by Aidan Hollis, M.D., and Bryan A. Liang, M.D., concluded that the practice of authorizing generics significantly reduces incentives for independent generic firms to challenge invalid brand-name patents and develop non-infringing processes.
