Things are looking up in relation to Medicare Part D, according to Mark McClellan, head of the Centers for Medicare & Medicaid Services. In early March, he addressed an audience of 700 pharmacists from New England on the status of the drug benefit, as the program passed its 60th day in operation. The presentation was the keynote address at the 66th Howard L. Reed Conference, sponsored by the Massachusetts College of Pharmacy and Health Sciences.
Some pharmacies will not survive the next 12 months. The longer pharmacy waits to break longstanding links between pharmacy product and pharmacy reimbursement, the bleaker the prospects.
Innovative delivery of drugs that are already Food & Drug Administration-approved appears to be the way of the future. And, in many cases, the future is already here. While great strides have been made in the development of new drug entities, an often easier way for companies to maintain market share and compete with generics is to utilize newer delivery techniques with older drugs already proven effective. In many cases, the new developments will offer additional advantages such as ease of administration, fewer side effects, and increased patient compliance. Here are a few examples of products in the pipeline with unique formulations.
The Food & Drug Administration recently approved hepatitis B immune globulin [human] (HepaGam B, Cangene) for the treatment of acute exposure to blood containing hepatitis B surface antigens (HBsAg), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure to those with acute hepatitis B virus (HBV) infection.
Use of nonselective monoamine oxidase inhibitors (MAOIs) to treat depression has fallen from favor in recent years due to significant side effects and the development of newer agents with improved safety profiles.
Brandishing signs and chanting slogans, protesters gathered on the steps of the San Francisco convention center to urge the American Pharmacists Association to take a stand against the Medicare drug plan. Meanwhile, inside the convention hall, APhA conference attendees got the bad news that only 5% of Part D plans are using any community-based providers for medication therapy management (MTM) programs.
The "single most brutal issue" with Part D will occur this summer when enrollees hit the donut hole and start paying out-of-pocket for their medications, according to George Pillari, CEO of Copay Solutions.
Perhaps heeding the dire warnings that pharmacies will be drivenout of Medicaid by a new drug pricing formula, HHS issued a Roadmapto Medicaid Reform that reminds states that they can pay higherdispensing fees to independent pharmacies, pharmacies serving alarge number of low-income beneficiaries, or pharmacies in ruralareas to ensure access.
As the May 15 deadline approaches for Medicare Part D enrollment, CVS is continuing its efforts to educate and inform seniors about the new prescription drug benefit plan. Medicare Tuesdays returns to CVS pharmacies from April 11 to May 9, featuring a staff member who will answer questions and help patients review available drug benefit plans.
Crime Stoppers of Central Indiana is offering up to $1,000 cash reward for information leading to the arrest of suspect(s) responsible for pharmacy robberies in the central Indiana area. The robberies occurred at a Kroger Pharmacy in Carmel, a CVS in Westfield, and a CVS in Zionsville.
CVS/pharmacy Charitable Trust and CVS/pharmacy announced the creation of CVS All Kids Can, a five-year, $25 million commitment to making life easier for children with disabilities.
Independent dialysis facilities are getting paid by Medicare for darbepoetin alfa (Aranesp, Amgen) and other new end-stage renal disease drugs more than what they are paying to acquire them. That's the conclusion of a new report from the Office of Inspector General.
Conceding that there are too many Part D prescription drug plans for Medicare beneficiaries to choose from now, HHS is limiting the number of PDPs insurers can offer from three per region this year to two next year. Insurers that offer enhanced coverage may have more leeway to offer three plans.
Deep vein thrombosis (DVT) is responsible for 200,000 fatalities each year in the United States. Yet, according to the results of a recent study conducted by Premier Inc. and researchers from the University of California, Irvine, hospitals aren't doing such a great job of protecting patients from dangerous blood clots that form in veins.
Patients in the Asheville Project for asthma had improved outcomes over five years, including fewer ER visits and hospitalizations, according to researchers. In addition to better clinical outcomes through pharmacist interventions, annual direct cost savings averaged $725 per patient and annual indirect cost savings were estimated at $1,230 per patient, including less absenteeism.
Pharmacy First, a Nanuet, N.Y., firm giving a network of 3,500 independent pharmacies and regional chain drugstores access to manufacturer-sponsored programs, has acquired the PBM Beyond Rx and Third Party Station, a third-party contract administrator.
Level 2 results of the National Institute of Mental Health's STAR*D trial show that 25% of patients who switched to a new antidepressant after having no response to the SSRI citalopram in Level 1 became symptom-free within 14 weeks. Of the 1,439 patients studied, 727 were switched to sertraline (Zoloft, Pfizer), bupropion-SR, or venlafaxine-XR (Effexor-XR, Wyeth) and the improvement of depression was similar for each of the three drugs.
After reviewing data on ADHD drugs and their propensity to cause psychosis, mania, aggression, or cardiovascular side effects in children, the FDA's Pediatric Advisory Committee told the agency that black box warnings are not necessary, but rather warnings should be rewritten in a language that is better understood. This decision follows a recommendation in February from the agency's Drug Safety & Risk Management Advisory Committee to add the strongest possible warning regarding cardiovascular risk.
GlaxoSmithKline is attaching radio frequency identification (RFID) tags to all bottles of its HIV drug Trizivir (abacavir/lamivudine/zidovudine) distributed in the United States as part of a patient safety pilot project. Glaxo chose Trizivir for the pilot because it's on NABP's list of the 32 drugs most susceptible to counterfeiting and diversion.
The Federal Trade Commission plans to investigate the likely short- and long-term competitive effects of authorized generic versions of brand drugs. FTC staffers have been authorized to subpoena about 80 drug companies, 10 authorized generic companies, and 100 independent generic manufacturers.
Previously approved in 1998 to treat bladder cancer and discontinued in 2002 by then-manufacturer Anthra Pharmaceuticals, valrubicin (Valstar) may make another debut, this time from Valera Pharmaceuticals. Valera has just completed its acquisition of the NDA for the drug, and the company said it hopes to have the product available by the end of 2006.
A new guide has been published by the CDC in part to aid clinicians with the difficult task of diagnosing tick-borne rickettsial diseases (TBRDs). According to the agency, the incidence of these diseases has risen in the past 10 years, causing severe illness and death in adults and children in the United States despite the fact that the conditions are easily treated with antibiotics in the early stages.
The National Comprehensive Cancer Network (NCCN) has announced new guidelines for the diagnosis, treatment, and prevention of venous thromboembolic (VTE) disease. According to the organization, cancer patients are at high risk for VTE, which could lead to a deadly pulmonary embolism if not recognized and treated appropriately.
Disetronic Medical Systems has announced a voluntary nationwide recall of faulty Accu-Chek Ultraflex insulin infusion sets following a recent increase in complaints of fully or partially separated luer lock tubing connections. The company is advising customers to examine their infusion sets at the luer lock tubing connection every three hours and before bedtime for possible insulin leakage.
A new survey that NCPA faxed to 5,000 pharmacies found that even though some Medicare Part D problems have moderated since the drug benefit started in January, many problems remain. Out of 525 pharmacies that responded to the survey, more than nine out of 10 respondents said their cash flow is worse than before the drug benefit started.
Cardinal Health has sold its pharmacy staffing business to Soliant Health. The wholesaler's pharmacy staffing unit provides temps and direct hires for retail and hospital pharmacies and other practice settings out of four locations?Boston; West Palm Beach, Fla.; Houston, Texas; and Irvine, Calif.
With an ear out for pharmacy owners hollering that allowing logos on Part D Rx cards tilts the playing field toward their big chain rivals, the Centers for Medicare & Medicaid Services has proposed tightening the rules for co-branding Medicare drug plans. And the agency also wants to hear whether co-branding should be outlawed altogether.
Pharmacists, patient advocacy groups, and drugmakers are trying to revive the latest unintended victim of Medicare Part D?patient assistance programs, or PAPs. Most manufacturers are cutting back on free or discounted pharmaceuticals distributed under PAPs because of potential conflicts with antikickback laws.
President Bush nominated acting FDA commissioner Andrew vonEschenbach, M.D., to permanently head the agency. Eschenbach, whoalso heads the National Cancer Institute, may faceconflict-of-interest charges at his confirmation hearings, andSenate Democrats have threatened to hold up his confirmation overFDA's inaction on OTC status for the emergency contraceptive PlanB. NCPA and NACDS had no comment on the Eschenbach nomination, butAPhA views him as an "excellent choice."
Wyeth is launching "Dialogues: Time to Talk," a nationwide program for Spanish-speaking patients with depression who are taking Effexor XR (venlafaxine HCl). Patients who enroll in the program will receive educational materials.
