News

The Society of Thoracic Surgeons has updated its clinical practice guidelines on use of antiplatelet drugs during heart surgery. The new guideline, published in the November 2012 issue of The Annals of Thoracic Surgery, takes into account newly available antiplatelet therapies, new scientific information, and a broader use of antiplatelet drugs such as before lung and vascular procedures, according to Newswise.

FDA has fast-tracked etirinotecan pegol (NKTR-102) (Nektar Therapeutics) for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC).

James D. Coffey, RPh, director of the Massachusetts Board of Registration in Pharmacy, has been removed from his position after allegedly failing to follow up on a complaint about the New England Compounding Pharmacy (NECC) from the Colorado Board of Pharmacy in July. In addition, Susan Manning, the Massachusett’s Board attorney has been placed on administrative leave, according to a statement from the Massachusetts Department of Public Health.

Investigators from the Tennessee Department of Health and the Centers for Disease Control and Prevention (CDC) provided an aggressive public health response following a single case of Aspergillus fumigatus meningitis in an immunocompetent adult who had received an epidural injection of preservative-free methylprednisolone acetate at a clinic in Tennessee, according to a report published Nov. 7 in the New England Journal of Medicine.

With President Obama’s re-election, implementation of the Affordable Care Act (ACA) will move forward, full speed ahead, according to one industry expert.

FDA has approved tofacitinib (Xeljanz, Pfizer) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

Plans expect rules now that election is over

An automated online self-management program may help employees with prehypertension or hypertension achieve adequate blood pressure control, according to a study published in the October issue of American Heart Journal.

Bleeding rates associated with new use of dabigatran (Pradaxa, Boehringer Ingelheim) do not appear to be higher than bleeding rates associated with new use of warfarin, according to an FDA safety review of post-market reports of serious bleeding events.

Two recalled products manufactured by the New England Compounding Center (NECC), Farmingham, Mass., have tested positive for bacterial contamination, according to an FDA update.

Congressman Edward J. Markey (D-Mass.) plans to introduce legislation that he believes will strengthen FDA's authority to oversee compounding pharmacies. The New England Compounding Center, located in Rep. Markey's congressional district, is the source of contaminated injectable steroids that led to a national meningitis outbreak, claiming 28 lives and sickening more than 300 people in 19 states, according to a press statement from Markey's office.

MA plans must dig deeper for data and collaborate with providers

Ameridose, LLC, is voluntarily recalling all of its unexpired products in circulation, according to an FDA press release Oct. 31. Ameridose, based in Westborough, Mass., is managed by the same parties that manage the New England Compounding Center (NECC), of Framingham, Mass. Injectable drugs produced by NECC are linked to the fungal meningitis outbreak, which has resulted in 377 fungal meningitis cases, 9 cases of peripheral joint infections and 29 deaths.

Patients taking long-term warfarin who had GI bleeding should probably resume warfarin once the bleeding episode is under control to reduce their risk of thrombosis.

Recent FDA action (through October 2012) related to, Treprostinil diethanolamine extended release tablets, Lomitapide, Mipomersen sodium, Xilonix, Ponatinib, Trospium chloride extended-release capsules

Bariatric surgery reduces the incidence of type 2 diabetes, according to a recent observational study.

Dimethyl fumarate is an investigational drug being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS).

FDA has warned patients of TTP, a serious blood disorder that results from misuse of Opana ER.

New combination: FDA approved the combination tablet of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada, Gilead Sciences) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 in adults at high-risk in combination with safer sex practices.

Recent FDA Approvals (through October 2012) related to (Perampanel, Eisai, Ocriplasmin, ThromboGenics, Paclitaxel protein-bound particles for injectable suspension, Celgene, tocilizumab, Genentech, Cysteamine ophthalmic solution, Sigma-Tau Pharmaceuticals, APTIMA HPV 16 18/45 Genotype Assay, Hologic, Adalimumab, Abbott, Regorafenib, Bayer HealthCare, Onyx)

Health system payment reform is on the minds of just about everyone involved in healthcare delivery, financing, and analysis.

New data demonstrating the safety and tolerability profile of tivozanib versus sorafenib in the first-line setting for patients with metastatic renal cell carcinoma (RCC), was presented at ESMO's 2012 Congress.

Although general guidance exists for medication reconciliation, there is a need for more thorough studies and stronger guidelines.

Depressive symptoms are associated with use of opioids for non-pain symptoms, according to researchers

A study of Medicare data suggests there is substantial variation in the use of antibiotics across regions after adjusting for population characteristics.

The world of formulary management is changing and organizations must work on education initiatives.

Screening practices for multidrug-resistant organisms (MDROs) in intensive care units (ICUs) vary widely from hospital to hospital, according to a study published in October.

Multiple sclerosis (MS) is a neurologic disorder of chronic inflammation and demyelination of the central nervous system. Several additional agents, including oral products, are now under investigation for the future treatment of MS.

New molecular entity: FDA approved icosapent ethyl (Vascepa, Amarin Pharmaceuticals Ireland Limited), an ethyl ester of eicosapentaenoic acid (EPA), as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

New standards released by the USP seek to reduce medication compliance issues.