Bowel-prep products can lead to kidney failure
March 13th 2006Consumer 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.
Alert, information sheets issued for Tequin
March 13th 2006Following 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.
New labeling for inhalers warns of death risk
March 13th 2006Findings 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.
Shipping of generic Flonase resumes
March 13th 2006A 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.
Oklahoma bill allows Rx reimportation
March 13th 2006The 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.
CMS warns of Part D phone scams
March 13th 2006Medicare 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.
States mull tightening wholesaler regulation
March 6th 2006Legislators 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.
Long-awaited insulin inhaler approved
March 6th 2006For 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.
Pharmacists aid Latino brown bag reviews
March 6th 2006The 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.
Specialty pharmacy teams with compounder
March 6th 2006The 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.
Feds seize supplements containing ephedrine
March 6th 2006At 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 mulls changing Part D enrollment date
March 6th 2006CMS 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.
Help desks must match business hours
March 6th 2006CMS has updated the Part D performance standards for 2007 to require drug plans to operate a toll-free pharmacy technical help call center that is open for the entire period during which network pharmacies in their service areas are open. Thus, if a network includes pharmacies open 24 hours, the plan's technical help desk must also be open round-the-clock.
Pfizer tops in early Part D help
March 6th 2006Long-term care pharmacy providers and consultants rated Pfizer as the drug company with the promotional activities that best met their needs with regard to Medicare Part D prior to implementation of the drug benefit. Johnson & Johnson, Forest, Novartis, and Amgen rounded out the top five in Verispan's Fall 2005 nursing home promotional audit.
States mull tightening wholesaler regulation
March 6th 2006Legislators 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.
Group calls for propoxyphene phase-out
March 6th 2006A citizen's petition has been filed with the FDA calling for a phased withdrawal of propoxyphene-containing drugs due to their toxic side effects. The group responsible for the move, Public Citizen, said that the risks associated with the painkiller—including the conversion of the drug to a toxic metabolite that leads to cardiac depression—far outweigh the benefit.
Most think Tysabri should be restored
March 6th 2006An Instant Poll on Drug Topics' Web site, posted in February, found that most respondents think that Tysabri (natalizumab, Biogen Idec) should be brought back to the market. Out of 145 people who voted, 68% said the multiple sclerosis agent should be brought back but with new warnings added, 16% said it should be restored with no new restrictions added, only 10% said it should not be returned to market, and 6% said they didn't know whether FDA should let it come back.
New VZIG product available under IND
March 6th 2006Ever since the sole U.S. manufacturer of varicella zoster immune globulin (VZIG) discontinued its production in October 2004, supply has dwindled to the point of depletion. This February, however, an investigational VZIG product, called VariZIG, has become available under an investigational New Drug Application (IND) for patients who have been exposed to varicella and are at increased risk for severe disease and complications.
Prandial insulin analog now available
March 6th 2006Sanofi-Aventis has announced that Apidra (insulin glulisine [rDNA origin] injection) is now available for the control of hyperglycemia in adult patients with Type 1 and Type 2 diabetes. Apidra is a rapid-acting insulin with an onset and duration of action that are faster and shorter than those of regular human insulin.
Nationwide recall of cefazolin vials issued
March 6th 2006Hanford Pharmaceuticals is voluntarily recalling four lots of Cefazolin for Injection, USP, 1 gm/10 ml vials due to contamination of the active ingredient by Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus. The affected vials were distributed by Sandoz (lots C4650, C4537) and Watson Pharmaceuticals (lots C4689, C4665) and should be promptly returned to Hanford.
Punch & Judy: Thanks a lot, Mr. President!
March 6th 2006As if the cash flow problems many pharmacists are experiencing lately due to Medicare Part D aren't bad enough, President Bush just delivered another sucker punch to the nation's drug professionals. He signed the budget reconciliation bill, which cuts Medicaid reimbursement to pharmacies for generic drugs by a whopping $6.3 billion over the next five years.
Part D chaos causes cash flow crisis
March 6th 2006Lou Spadafora, co-owner of Midland Pharmacy on Staten Island, N.Y., bounced a check for $51,000 last month. The pharmacy's bank account was $2,000 short of covering the check. It wasn't the first check he bounced, because he serves a lot of dual eligibles in group homes who were switched from Medicaid to Medicare Part D.
This drug kills two birds with one stone
March 6th 2006The Food & Drug Administration recently approved sunitinib (Sutent, Pfizer) for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib (Gleevec, Novartis). Sunitinib was also granted accelerated approval for the treatment of metastatic renal cell carcinoma (MRCC). This is the first time that the agency has approved an oncology drug for the treatment of two indications simultaneously.
Pharmacy faces Medicaid cuts in billions of dollars
March 6th 2006Pharmacies already reeling from the botched implementation of Medicare Part D took another body blow Feb. 1, when Congress narrowly approved federal Medicaid reimbursement cuts of $3.6 billion over the next five years. Just five days later, the Bush Administration's new budget proposed lopping an additional $1.3 billion from Medicaid reimbursement.