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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 It's been a long and bumpy road for the multiple sclerosis therapy that was withdrawn from the market only three months after its introduction due to a serious side effect that affected three patients and killed two of those three.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.

Humira (adalimumab, Abbott) now comes in a pen form for easier one-touch administration by patients. Until now, patients with rheumatoid or psoriatic arthritis had to administer Humira as a subcutaneous injection via a prefilled syringe.

Arcadia Resources, a provider of home care and staffing services and respiratory and durable medical equipment, has formed a partnership with Physicians' Organization of Western Michigan, a 570-member independent physicians' coalition based in the state. Through POWM's partnership with Meijer, plans are moving forward to open walk-in medical clinics inside select Meijer stores in Indiana.

Dispensing Solutions Inc. (DSI), a Santa Ana, Calif.-based leader in repackaged pharmaceuticals, has launched a drug pedigree program. The program will be implemented nationally for all DSI product lines.

Until now, Novartis Corp.'s Exelon (rivastigmine tartrate) was approved to treat mild to moderate dementia associated with Alzheimer's disease. Now the drug has gained a new indication-to treat mild to moderate dementia related to Parkinson's disease.

The Healthcare Distribution Management Association (HDMA) is partnering with RxPatrol to combat the theft and illegal trafficking of prescription medications and further enhance supply chain security. RxPatrol is an information clearinghouse designed to collect, analyze, and share information on pharmacy robberies, burglaries, and theft of controlled substances.

After being shot down by the state commission on higher education last year, the University of South Alabama (USA) is reworking plans for a new pharmacy school. USA is in talks with Auburn University officials about some type of satellite collaboration on its campus in Mobile.

Saddle River Marketing Concepts has earned the Verified-Accredited Wholesale Distributors accreditation offered by NABP to secure the integrity of the nation's drug supply. The New Jersey-based firm fulfills Rx samples to physicians and trade pack orders for patient assistance programs.

ASHP and the ASHP Research and Education Foundation unveiled plans to establish a center for health-system pharmacy leadership by the end of this year. The center will be a division of the ASHP Research and Educational Foundation and will be located in the organizations headquarters in Bethesda, MD.

ASHP has issued broad recommendations to protect healthcare workers and patients from exposure to known carcinogens and other hazardous substances. The guidelines can be used to develop and implement safety programs that cover all aspects of the handling of hazardous drugs, from receipt to disposal.

The pharmacy at a Kmart in Helena, Mont., is launching its first Coumadin (warfarin sodium, Bristol-Myers Squibb) clinic. Pharmacists at the store have been certified to test the blood of patients who are taking the blood-thinning medicine.

The American Pharmacy Cooperative (APCI), a Bessemer, Ala.-based independent community pharmacy buying group with more than 1,200 members in 20 states, has entered into a cooperative marketing agreement with Vital Care, Meridian, Miss. The purpose of the agreement is to make it possible for members of APCI to evaluate the practicality of getting into the home infusion and specialty market with a Vital Care franchise.

The FDA is warning consumers not to use the Triaminic Vapor Patch marketed by Novartis Consumer Health due to reports of serious adverse events associated with accidental ingestion by children. The patch contains camphor, eucalyptus oil, and menthol.

More people initiated nonmedical use of narcotic pain relievers in the past year than initiated use of marijuana or cocaine. This finding comes from a new report from the Substance Abuse & Mental Health Services Administration (SAMHSA) that extracted data from the 2004 National Survey on Drug Use and Health.

A total of 185 Web sites now sell controlled substances, up from 154 in 2004, according to a survey by the National Center on Addiction & Substance Abuse (CASA). Only 11% of the sites require a prescription. Of the 165 sites that don't require an Rx, 30% advertised that no script was needed, 60% offered on-line consultations, and 10% didn't mention a prescription.

Pharmacists dialing the dedicated Medicare Part D help line will now be redirected to the 1-(800) MEDICARE interactive voice response system instead. CMS pulled the plug on the R.Ph.-only help line after daily calls fell by 80% since Jan. 1.

A study conducted by S/T Health Group, an independent healthcare consulting firm, found that McKesson customers experience the lowest percentage of contract price errors in the industry. McKesson officials asserted that the study data affirmed that the San Francisco-based drug wholesaler continues to lead the pharmaceutical wholesale industry in contract price accuracy.