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Pharmacists can soon offer to women an extended-use oral contraceptive (OC) regimen that contains low-dose ethinyl estradiol tablets in place of placebo pills. The Food & Drug Administration recently approved levonorgestrel/ethinyl estradiol and ethinyl estradiol (Seasonique, Barr Laboratories) 0.15 mg/0.03 mg and 0.01 mg tablets for the prevention of pregnancy. Seasonique will be available through retail pharmacies and physicians' offices before the end of the summer.

FDA has completed its safety assessment of Sanofi Aventis' Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks. Ketek is the first FDA-approved antibiotic of the ketolide class.

Merck announced that the CDC Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend that children four to six years of age receive a second dose of varicella vaccine for the prevention of chickenpox. Merck's Varivax (varicella virus vaccine live, Oka/Merck) and Proquad (measles, mumps, rubella, and varicella virus vaccine live, Oka/Merck) are the only vaccines to protect against chickenpox in the United States.

FFF Enterprises, Temecula, Calif., a national distributor of flu vaccine, has a new service available at MyFluVaccine.com. The service allows customers to place orders on-line and to select their delivery dates.

Pharmacists were rated the best at healthcare customer service, according to a survey of 7,479 consumers by BIGresearch, a market intelligence firm. Two-thirds of those surveyed think pharmacists provide a good or excellent level of customer service.

Planned Parenthood of the Rockies plans to give out free morning-after contraceptives at its clinics in Colorado to protest the Governor's veto of a bill that would have allowed pharmacists to prescribe and dispense Plan B. Gov. Bill Owens opposed spreading prescriptive authority beyond doctors and specialized nurses because it was outside the norms of medicine. Eight states permit trained R.Ph.s to prescribe and dispense Plan B.

IVAX Pharmaceuticals is recalling certain lots of 500-mg acetaminophen tablets and capsules because there's an error on the product label. The label incorrectly states, "Do not exceed 12 tablets or capsules in a 24-hour period," when it should have said, "Do not exceed 8 tablets or capsules in 24 hours."

The dental supply company Pascal is recalling the company's anticavity fluoride rinses because they could be contaminated with bacteria that may cause pneumonia, including Burkholderia cepacia and Pseudomonas ?ruginosa. The recall affects all lots and all flavors of NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse, and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse.

Walgreens announced that it has agreed to acquire Pittsburgh-based Medmark Specialty Pharmacy Solutions. Medmark is a leader in specialty pharmacy services and care, including injectables, infusibles, and advanced oral medications to patients with unique or chronic medication needs for conditions such as hepatitis, multiple sclerosis, HIV, infertility, hemophilia, organ transplants, and cancer.

Walgreen Co. has acquired C&M Pharmacy, LLC, a 10-year-old Chicago-based specialty pharmacy. C&M Pharmacy serves patients with HIV/AIDS, hepatitis C, and behavioral health conditions.

The New Jersey budget impasse that shut down non-essential government services has hit pharmacies. All claims for Medicaid and PAAD scripts filled up to and including June 30 will be paid, but claims after that date will not be reimbursed until a new budget is adopted.

Purdue Pharma has filled the first orders for its electronic customer ordering system for controlled substances. The system provides secure, paperless real-time access to information about the movement of controlled substances in the supply chain in accordance with DEA requirements, according to the drug company based in Stamford, Conn.

More than seven out of 10 people who responded to a Drug Topics Instant Poll in June are in favor of a New Hampshire law that would ban pharmacies and data-mining companies from selling their prescription data for commercial purposes. They feel the law has merit since it would stop drug reps from getting access to data on what drugs physicians prescribe and using the information to influence prescribing.

PhRMA has revamped its Spanish-language Web site. The new site, found at www.phrma.org/espanol or www.nuestraphrma.org, includes patient-friendly information on health topics and issues of concern to Hispanic audiences.

The FDA announced that Baxter Healthcare Corp. and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with the FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices.

To better serve the prescription drug needs of chronic-disease outpatient populations, one of the largest disease management companies is aligning its services with a pharmacy benefit manager in a 10-year collaboration. Medco Health Solutions, a PBM based in Franklin Lakes, N.J., and Nashville-based Healthways recently announced details of a newly formed alliance. The key advantage for patient members will be intervention by pharmacists and other clinical educators armed with more pertinent information earlier in the patient's plan of care. The companies project that the long-term results will be better compliance with clinical practice guidelines, a decreased risk of hospitalization, and ultimately a healthier lifestyle for each patient served by the program.

Prior to the implementation of Medicare Part D, many senior citizens depended on prescription assistance programs (PAPs) offered by pharmaceutical manufacturers. These programs provide free or low-cost prescription medicine to low-income people who meet the eligibility guidelines.

After almost three years, the Food & Drug Administration has approved Omnitrope (somatropin, Sandoz) as a follow-on version of Pfizer's Genotropin. "Its approval is beneficial for everyone. It also increases competition in the growth hormone market, which will hopefully reduce the price of growth hormones," stated Anita Siu, Pharm.D. and clinical neonatal/ pediatric pharmacotherapy specialist and assistant clinical professor at the Ernest Mario School of Pharmacy, Rutgers, the state university of New Jersey.

Affecting an estimated one million Americans each year, herpes zoster (shingles) is caused by the same virus that causes chickenpox: the varicella-zoster virus. After an initial infection with chickenpox (varicella), the virus lies dormant in the dorsal root or cranial sensory ganglia; however, the virus can reactivate later in life, causing shingles. Shingles is estimated to affect one in every five persons during their lifetime. The frequency and severity of the infectious disease increase with advancing age.

Pharmacists can soon offer to women an extended-use oral contraceptive (OC) regimen that contains low-dose ethinyl estradiol tablets in place of placebo pills. The Food & Drug Administration recently approved levonorgestrel/ethinyl estradiol and ethinyl estradiol (Seasonique, Barr Laboratories) 0.15 mg/0.03 mg and 0.01 mg tablets for the prevention of pregnancy. Seasonique will be available through retail pharmacies and physicians' offices before the end of the summer.

Recently, the Food & Drug Administration gave the green light to Biogen Idec and Elan's natalizumab (Tysabri) to return to the market through a restricted distribution program. It's been a long and bumpy road for the multiple sclerosis therapy that was withdrawn from the market only three months after its introduction due to a serious side effect that affected three patients and killed two of those three.

The pharmacy community appears to be solidly behind the Food & Drug Administration's recent announcement that it is planning to enforce its long-dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees.

Latebreakers

Walgreens to stop filling Rxs for Midwest Health

Until now, Lumigan (bimatoprost ophthalmic solution) 0.03% was used as a second-line treatment for glaucoma. Now the Allergan once-daily prescription eyedrop has been approved for first-line treatment of elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension.

A new combination therapy for late-stage cervical cancer has been approved by the FDA. Topotecan (Hycamtin, GlaxoSmithKline) and cisplatin together can now be used for women in stage IV-B with incurable, recurrent, or persistent cancer of the cervix that has spread to other organs and is not likely to respond to surgery or radiation.

Bevacizumab (Avastin, Genentech) has been approved by the FDA in combination with a 5-fluorouracil (5-FU)-based chemotherapy regimen as a second-line treatment for metastatic colorectal cancer. The phase III trial that led to the approval of the therapy evaluated 829 patients who received either bevacizumab plus FOLFOX4 (oxaliplatin, 5-FU, leucovorin) or FOLFOX4 alone and who were previously treated with irinotecan (Camptosar, Pfizer) and 5-FU as their initial therapy for metastatic disease or as adjuvant therapy. Results showed a 33% improvement in survival for the combination regimen. Median survival was 13 months versus 10.8 months.

A total of 46,527 students were enrolled in pharmacy schools last fall, compared with 43,908 in 2004, according to the 2005 Profile of Pharmacy Students compiled by the American Association of Colleges of Pharmacy. A total of 8,268 degrees were awarded, up from 8,158 in 2004.