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Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes. The loss-leader strategy used by big-box, chain, independent, and online pharmacies has boosted the mean cost of branded diabetes medications by up to 113% since 2008.

David D. Pope, PharmD, CDE, editor-in-chief of CreativePharmacist.com, has developed and directs an innovative, web-based program titled HealthyHeartClub.com, which offers accountability, encouragement, and education to help patients adopt healthier lifestyles and decrease cardiovascular risk.

FDA has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap); GlaxoSmithKline Biologicals] for use in adults aged 65 years and older for active booster immunization against tetanus, diphtheria, and pertussis (whooping cough). This approval makes Boostrix the first Tdap vaccine approved for use by this age group.

Dronedarone (Multaq, Sanofi), which is approved for nonpermanent atrial fibrillation (AF), was being tested on patients with permanent AF. However, that trial, PALLAS (Permanent Atrial fibrillation outcome Study using Dronedarone on top of standard therapy) phase 3b, has been terminated because it was causing increased cardiovascular events.

FDA has approved the first and only fentanyl nasal spray (Lazanda, Archimedes) in the United States for the management of breakthrough pain in cancer patients aged 18 years and older who are already receiving opioid therapy to which they are tolerant, for their underlying persistent cancer pain.

In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life in patients with painful diabetic neuropathy, a broad literature review was conducted and new guidelines were published online May 17 in Neurology and were presented at the American Academy of Neurology Annual Meeting in Honolulu.

FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.

An FDA advisory panel recommended in late June that Avastin should no longer be used to treat breast cancer.

Passing the MTM Empowerment Act and expanding Medicare Part D coverage should be Congress?s focus this session, says the National Association of Chain Drug Stores.

From Drug Topics staff reports Generic manufacturer Qualitest recently recalled several lots of drugs, including hydrocodone bitartrate and acetaminophen tablets, because of a labeling mixup.

The National Association of Chain Drug Stores (NACDS) is urging FDA to streamline patient medication information.

The first Senate Community Pharmacy Caucus was established in late June. Senator Jerry Moran (R-KS) and Senator Jon Tester (D-MT) created the caucus, which is meant to serve as an advocate for community pharmacy issues and as a clearinghouse of information for senators, staff, and other interested parties.

FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.

The American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) last week issued a serious medication alert about colistimethate.

In the face of dozens of pink-clad demonstrators at the gates of FDA and many heartfelt pleas from women with metastatic breast cancer, an advisory committee to the agency voted unanimously at the end of June to hold firm in its recommendation that approval for Avastin (bevacizumab) for breast cancer be withdrawn.

Professional pharmacy organizations and U.S. Congressional leaders lauded the decision announced today by the Centers for Medicare and Medicaid Services (CMS) to delay the agency's change in Medicare billing rules governing infusion pump solutions for pain medications.

Diabetic kidney disease has become more prevalent in the United States over the last 2 decades due to the expansion of the diabetes population, concluded a study published in the June 22/29 issue of JAMA.

Crizotinib, an investigational drug, demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer (NSCLC) with an anaplastic lymphoma kinase (ALK) positive genetic alteration, according to the results of an early-phase study presented at the 2011 annual meeting of the American Society of Clinical Oncology.

FDA has issued a warning that smoking-cessation aid varenicline (Chantix, Pfizer) may be associated with a small, increased risk of certain adverse events in patients who have cardiovascular disease.

Compared with moderate-dose therapy, intensive-dose statin therapy appears to be associated with increased risk of new-onset diabetes, concluded a meta-analysis of data from 5 statin trials published in the June 22/29 issue of JAMA.

Pfizer?s second attempt at an abuse-resistant formulation of oxycodone (Remoxy) recently received a complete response letter (CRL) from FDA. Just a week earlier, FDA approved another of the drug maker?s abuse-resistant products ? immediate-release Oxecta (oxycodone HCl) ? for the management of acute and chronic moderate-to-severe pain.

Walgreens announced last week that it is ending its relationship with pharmacy benefits manager Express Scripts as of January 1, 2012.

FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.

CVS/pharmacy's new Care 1on1 program aims to make patient and pharmacist counseling more a part of the chain's culture.

Retail pharmacies are behind in testing software systems for HIPAA?s NCPDP Telecommunication Standard D.0, according to a new survey from the National Council for Prescription Drug Programs.

Local pharmacists can reduce Medicaid costs by helping millions of patients take their medication properly, said B. Douglas Hoey, RPh, MBA, in a prepared statement of response to a recent ad campaign sponsored by the Pharmaceutical Care Management Association.

Legislators and pharmacists are working to convince the Centers for Medicare and Medicaid Services???????????????????????? to halt its rule change on infusion pumps for pain medications.

FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of increased risk of cardiovascular events such as stroke, thrombosis, and death.

Kaiser Permanente pharmacists in Southern California have finally agreed to a new 3-year contract. The new terms were reached after an extended battle that saw pharmacists vote to strike, then reject what Kaiser called a final offer.

FDA published an online safety communication on June 15, informing prescribers and patients that pioglitazone (Actos, Takeda Pharmaceuticals America Inc., Deerfield, Illinois) use may be associated with a 20% to 40% increased hazard of new bladder cancer.