An 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.
Ever 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.
Sanofi-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.
Specialty pharmaceutical company Santarus has received FDA approval for immediate-release proton pump inhibitor Zegerid. The new product contains omeprazole and sodium bicarbonate in 40 mg/1100 mg and 20 mg/1100 mg combinations.
Hanford 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.
Coverage for psychotropic drugs under Medicare Part D is under fire. The goal of covering all or substantially all products and providing appropriate care for all patients is not being met.
As 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.
Nearly all persons enrolled in Medicare Part D prescription drug plans (PDPs), except those with the most generous subsidies or those in high-end plans, are subject to co-pays and deductibles. CMS has provided for a central reporting mechanism for recording these out-of-pocket expenditures. The amount a beneficiary must spend on Part D drugs to reach the catastrophic coverage provision is being called "true out-of-pocket," or TrOOP, expenditure. In 2006, persons covered by a PDP are eligible for catastrophic coverage after they have paid $3,600 in TrOOP cost. The threshold can change annually as provided by the Medicare Modernization Act (MMA).
Lou 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.
The 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.
In an attempt to eradicate hepatitis B virus (HBV) from the United States, the Centers for Disease Control & Prevention Advisory Committee on Immunization Practices (ACIP) issued updat-ed guidelines for vaccination against the disease.
The American Heart Association (AHA) estimates that approximately 6.6 million Americans are affected with chronic angina.
Pharmacies 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.
Pharmacies that want to pull out of Medicare Part D should check the fine print of their drug plan network contracts.
In remarks about his proposed 2007 budget and deficit reduction, President Bush said, "People talked about how the decision to reform Medicaid was immoral. Well, it's not immoral to make sure that prescription drug pharmacists don't overcharge the system.... It turns out that there was inflated markups for people who had government help to buy drugs. That doesn't make sense, so we reformed that. The people are still going to get their drugs, but the taxpayers aren't going to pay inflated prices." Bush's accusation about pharmacy overcharging came the same day HHS secretary Michael Leavitt repeated his praise of R.Ph.s for their "heroic" efforts to help patients get their Medicare Part D drugs.
The HealthWell Foundation, a nonprofit organization that assists indigent patients in meeting their cost-sharing obligations for Rx medications, has launched four new programs to help patients afford the medical treatments they need. The new programs will assist patients with colorectal cancer, moderate to severe asthma, non-small cell lung cancer, and non-Hodgkin's lymphoma.
NCPA has urged CMS to not allow drug plans and drugstore chains to co-brand Part D identification cards. Independent pharmacists contend that the co-branded Rx cards confuse beneficiaries into mistakenly thinking they can get their medications only at the drugstores shown on their ID cards.
Charfoos & Christensen has filed a lawsuit against Walgreens on behalf of Michael Wells in U.S. District Court, Eastern District of Michigan. Attorney Douglas Peters of Charfoos & Chistensen told Drug Topics that Wells' surgeon prescribed the antibiotic Duricef (cefadroxil/cefadroxil hemihydrate, Warner Chilcott) to prevent the development of postsurgical wound infection.
First DataBank has introduced the OrderView Med Knowledge Base CPOE-ready drug database designed to be physician-friendly by reducing mouse clicks and drug pick lists, according to the San Diego technology firm. One component of the system is Orderable Meds, which focus only on data necessary for ordering, not for dispensing, administration, research, or billing.
The American College of Apothecaries (ACA) has created the American College of Hospice Pharmacists for R.Ph.s interested in strengthening their knowledge and skills in hospice care and pain management. Programs being developed for the specialty college include separate newsletters for pharmacists, prescribers, and patients/caregivers, as well as a 20-hour didactic certificate program to be offered during ACA's annual meeting and a lab-based 16-hour certificate program to be offered at ACA's Research & Education Center.
Physicians will be able to securely access patient medication histories through pharmacies that belong to the SureScripts electronic prescribing network. Physicians will be able to see a patient's medication records and pharmacy data, such as allergies and when drugs were dispensed, across all prescribers.
CMS has ruled that prescription niacin products, such as Niaspan and Niacor, are prescription vitamins and are, therefore, excluded from Part D coverage. After May 31, the two products cannot be included in Part D formularies.
A group of pharmacists has launched USGenerics, an on-line pharmacy offering patients FDA-approved generics for 30-day and 90-day scripts. To keep prices low, the Wisconsin-based firm does not accept any insurance plans.
The iPLEDGE program, a risk management plan to prevent pregnancy during isotretinoin therapy, is being called too cumbersome and difficult to manage by dermatologists. The program's start date is set for March 1.
Parents of infants suffering with fungal-infected diaper rash will now have a new form of treatment available. Vusion ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum has been approved by the FDA and is the first product for diaper dermatitis complicated by candidiasis.
The March of Dimes applauded the new FDA iPLEDGE program. The March of Dimes urged the agency to monitor the program's effectiveness and to create comparable programs for other oral retinoid medications.
Forty-four states will participate in a CMS program to reimburse them for drugs and administrative costs associated with dual eligibles in the Part D benefit. CMS will reconcile each state's drug payments with Part D plans and pay the difference between the plan reimbursement and the state's Medicaid costs, as well as the administrative tab.
Since its home state has no pharmacy school, Community Pharmacies is offering a one-year scholarship to a Maine resident attending the Massachusetts College of Pharmacy and Health Sciences in Boston. The scholarship covering the winner's final year of tuition is currently worth about $25,000.
The Commission for Certification in Geriatric Pharmacy (CCGP) will switch to computer-based testing beginning March 15. Candidates will be able to take the certification test at the nearest H&R Block Premium Center and receive immediate exam results.