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Authorized generics. Patent reform. Biodefense legislation. Funding for the Office of Generic Drugs (OGD). These are some of the challenges, opportunities, and issues that the Generic Pharmaceutical Association will continue to tackle in 2006 in order to lead America into a healthy future. This message was delivered by Kathleen Jaeger, GPhA president/CEO, to attendees of the association's annual meeting held recently in Boca Raton, Fla.

Many enrolled in two Part D plans

BioScrip has acquired Intravenous Therapy Services, a specialty infusion company located in Burbank, Calif. BioScrip, Elmsford, N.Y., provides pharmaceutical care solutions. The company is focused on two core areas: specialty medication distribution and clinical management services, and pharmacy benefit management services.

NSF International, an independent organization that develops standards and certifies products, has launched a new athletic banned substances certification program for dietary supplements and sports nutrition products. The new program has been recommended by key athletic organizations, including Major League Baseball and the Major League Baseball Players Association

Medicare beneficiaries should be wary of phone callers asking them for bank account information in order to help them enroll in a Part D plan, CMS warned. The scheme is called the "$299 ring" for the amount of money beneficiaries are typically scammed into withdrawing to pay for the fictitious drug plan.

The Government Accountability Office is recommending that Congress consider establishing a uniform payment update to the DME fee schedule for 2008 for class II and III DME devices. GAO conducted a study and found that manufacturers of class III devices, with limited exceptions, have higher premarketing costs than manufacturers of class II devices that are similar to class III devices.

Admissions to treatment for methamphetamine abuse have increased nationally, moving across the country from west to east. States in the Midwest and South that had few admissions to treatment for methamphetamine/amphetamine abuse in 1993 are now experiencing high rates of admissions.

BioScrip has acquired Intravenous Therapy Services, a specialty infusion company located in Burbank, Calif. BioScrip, Elmsford, N.Y., provides pharmaceutical care solutions. The company is focused on two core areas: specialty medication distribution and clinical management services, and pharmacy benefit management services.

Palm Beach Atlantic University Lloyd L. Gregory School of Pharmacy has received a $500,000 grant from the Quantum Foundation.

The National Nutritional Foods Association (NNFA) reacted to the House Committee on Government Reform's hearing on the regulation of dietary supplements, stating that anabolic or "designer" steroids, even if they are labeled as "dietary supplements," are illegal drugs that are masquerading as legitimate supplements in the face of inadequate enforcement. The industry also contends that the typical consumer who purchases vitamins, minerals, or other nutritional supplements is not at risk of inadvertently ingesting anabolic steroids.

There could be no retail pharmacies left in 11 rural North Carolina counties as a result of proposed cuts to Medicaid and Medicare reimbursement, according to the state pharmacy board. The board's confidential survey of most of the retail pharmacies in 40 rural counties also showed that an additional 14 counties would feel substantial impact with only one or two pharmacies left to serve a county's entire population.

The Albertson's chain is preparing to switch its pharmacy network to ARx, a software application it developed with RMTG Inc. to automate or simplify many pharmacy functions normally performed by hand, over the phone, or by multiple employees. RMTG is also preparing to offer the product to other chains as an enterprise pharmacy system named SuccessRx.

Physicians using the GE Centricity electronic medical record (EMR) can now electronically send prescriptions via the SureScripts e-prescribing network, which includes more than 90% of U.S. pharmacies. Kryptiq Corp. will provide the connectivity services that link physicians and pharmacies.

NSF International, an independent organization that develops standards and certifies products, has launched a new athletic banned substances certification program for dietary supplements and sports nutrition products. The new program has been recommended by key athletic organizations, including Major League Baseball and the Major League Baseball Players Association

The Partnership for Safe Medicines coalition's SafeMeds Alert System has become part of the FDA's Counterfeit Alert Network. The SafeMeds system broadcasts e-mail alerts about counterfeit drugs from government health agencies.

Consumer advocacy group Public Citizen is warning that bowel-cleansing products containing sodium phosphate are an underreported cause of kidney failure. Specifically, products such as Salix Pharmaceutical's Visicol tablets, sold by prescription, and OTC solutions like Fleet Phosphosoda, both containing sodium phosphate and used the day before colonoscopy procedures, can damage the kidneys.

Following the "Dear Healthcare Professional" letter that Bristol-Myers Squibb distributed in February providing updated labeling for gatifloxacin (Tequin), the FDA has now issued an alert along with information sheets for patients and healthcare professionals as serious reports of hypo- and hyperglycemia continue to occur in both patients with and without diabetes. The new sheets remind patients that the drug should not be used by diabetics and lists other risk factors for developing changes in blood sugar levels: older age, abnormal kidney function, and taking other medications that affect blood sugar concomitantly with gatifloxacin.

Findings from a study of 26,000 patients, showing that long-acting beta 2-adrenergic agonist salmeterol may increase the risk of asthma-related death, has led to revised labeling for GlaxoSmithKline's Serevent Diskus and Advair Diskus. The new prescribing information states that salmeterol is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta-agonists or for patients whose asthma can be successfully controlled with low- to medium-dose inhaled corticosteroids or other controller medications along with occasional use of inhaled short-acting beta 2-agonists.

A Maryland U.S. District Court has denied GlaxoSmithKline's motion for a preliminary injunction to set aside the FDA's decision to approve fluticasone propionate nasal spray, the generic version of Flonase. The court also lifted the suspension of the FDA's approval of a generic version of the spray, and the temporary restraining order previously granted to Glaxo was allowed to expire.

The Oklahoma Senate passed a bill to allow state pharmacies and wholesalers to reimport drugs from Canada, Switzerland, and European Union countries. The bill also requires the pharmacy board to certify foreign suppliers that meet certain conditions such as allowing board inspections and reviews of their safety protocols.

Medicare beneficiaries should be wary of phone callers asking them for bank account information in order to help them enroll in a Part D plan, CMS warned. The scheme is called the "$299 ring" for the amount of money beneficiaries are typically scammed into withdrawing to pay for the fictitious drug plan.

Legislators in Kansas and Nebraska have introduced bills to tighten regulation of drug wholesalers, a move supported by pharmacy associations and state pharmacy boards. The Kansas legislation would require licensure of the nearly 700 wholesalers doing business in the state and institute other drug supply safeguards.

For diabetic patients reluctant to use insulin for fear of daily injections, their prayers may have been answered. Following years of setbacks and delays, the first new insulin delivery option in more than 80 years, Exubera (insulin human [rDNA origin]) Inhalation Powder from Pfizer Inc., received Food & Drug Administration approval in late January for the treatment of adults with Type 1 and Type 2 diabetes.

The American Association of Colleges of Pharmacy joined Univision and the American Association of Colleges of Nursing to sponsor a free brown bag review and health screening for Latinos in San Antonio. Pharmacists and pharmacy students conducted the drug reviews and helped nurses screen for glucose, cholesterol, body mass index, and blood pressure.

The specialty pharmacy Assured Pharmacy has teamed with AnazaoHealth Corp. to offer its customers compounded drugs with overnight courier delivery. Based in Tampa, Fla., AnazaoHealth specializes in nuclear and pain management drugs, as well as drugs for clinical trials, using USP's Chapter 797 sterile compounding standards.

At the request of the FDA, U.S. marshals seized dietary supplements containing ephedrine alkaloids at facilities operated by Hi-Tech Pharmaceuticals in Norcross, Ga. The marshals seized more than 200 cases of finished product sold as Lipodrene, Stimerex-ES, and Betadrene, more than 200 boxes of bulk tablets, and nine 25-kilo drums of ephedrine alkaloid raw material.

CMS is considering changing the date when new Part D enrollments received late in the month become effective. Beneficiaries who sign up late in the month may not have an Rx card or be entered in the eligibility database, causing delays and confusion at the pharmacy counter.