FDA has approved a combination of the generic drugs naltrexone and bupropion (Contrave) for chronic weight management in obese adults (body mass index [BMI] >30 kg/m2). This combination agent has also been approved for use in those patients who are overweight (BMI >27 kg/m2) and have at least one weight-related comorbid condition such as diabetes, hypertension, or dyslipidemia.
Medication-related problems (MRPs) can be a significant patient safety risk, particularly in hospitalized patients. One method used to minimize this safety concern is through medication reconciliation, or the process of documentation of a patient’s outpatient medication list at the time of hospital admission. Medication reconciliation can be performed by any trained health care professional (i.e. nurses, pharmacy technicians, physicians, etc.), however improved patient safety outcomes have been demonstrated when pharmacists perform this process.
In 1983, the United States enacted the Orphan Drug Act (ODA). An analogous law was passed in Europe in 2000. Both pieces of legislation are considered major successes in terms of spurring the development of orphan drugs. To illustrate, in the decade prior to 1983 only 34 orphan products were marketed, whereas in the past year alone 9 orphan drugs were launched. In the past 5 years, 39 orphan drugs were launched in the US across numerous therapeutic categories, including multiple myeloma, chronic myeloid leukemia, metastatic non-small cell lung cancer, hemophilia, tuberculosis, homozygous familial hypercholesterolemia, and cystic fibrosis.1
Nursing home residents with advanced dementia often receive medications of questionable benefit with costly consequences, according to a study published online September 8 in the Journal of the American Medical Association Internal Medicine.
FDA has approved Ferric Citrate (Keryx), an oral, iron-based therapy for the control of serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis.
An investigational extended-release oral formulation of hydrocodone and acetaminophen the treatment of moderate to moderately severe acute pain was more effective than placebo at providing rapid and consistent pain relief in patients 48-hours post-surgery, according to a recent data presented at PAINWeek 2014 in Las Vegas.
Nationwide Children’s Hospital is one of 13 medical centers nationwide participating in the Pediatric Regional Anesthesia Network, a collaboration designed to support the collection of highly audited data on practice patterns and complications and to facilitate collaborative research in regional anesthetic techniques in infants and children. Participating institutions report the number of regional anesthesia procedures they do each month. Researchers conducted this study at Nationwide Children’s Hospital in Columbus, Ohio, publishing its results in the Journal of Pediatric Orthopaedics in June.
The US Preventive Services Task Force (USPSTF) published a final recommendation statement recommending that women at high risk for preeclampsia use low-dose aspirin (81 mg/day) after 12 weeks of pregnancy to prevent the condition and its related health problems.
FDA actions in brief, fast-track designations, priority review, orphan drug designations
Dalvance (dalbavancin) is the first and only intravenous antibiotic was approved on May 2014 to treat ABSSSIs with a 2-dose regimen of 1,000 mg once week and later on a 500 mg that is given over a 30-minute time span
Patients with heart failure and reduced ejection fraction (HF-REF) treated with an investigational angiotensin receptor neprilysin Inhibitor (ARNI) are more likely to reduce cardiovascular death and heart failure hospitalization than those given ACE inhibitors or ARBs as first-line therapy in heart failure, according to data presented at the European Society of Cardiology congress in Barcelona, Spain, and published simultaneously in the New England Journal of Medicine.
FDA has approved pembrolizumab (Keytruda, Merck) for treatment of patients with advanced or unresetable melanoma who are no longer responding to other drugs.
Medical marijuana laws are associated with significantly lower state-level opioid pain reliever mortality rates, according to a study published online August 25 in JAMA Internal Medicine.
About one-third of people with depression derive benefit from adding cognitive therapy to treatment with antidepressant medication, according to a study published in JAMA Psychiatry.
PerformRx, a member of the AmeriHealth Caritas family of companies, is a pharmacy benefits manager covering more than 3.5 million lives. In partnership with two affiliated Pennsylvania-based Medicaid managed care organizations (MCOs) ? a large Philadelphia-based Medical Assistance managed care health plan and AmeriHealth Caritas Pennsylvania-PerformRx implemented a collaborative drug therapy management (DTM) program for patients with diabetes treated with polypharmacy.
FDA has approved a new indication for the once-daily use of eltrombopag (Promacta, GlaxoSmithKline) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
Stroke patients are 70% more likely to continue taking their stroke prevention medications 1 year later if they are given a prescription when discharged, and 40% more likely after 2 years, according a study published in the Journal of Stroke and Cerebrovascular Diseases.
Teens who received the collaborative care intervention in primary care had significantly greater improvements in depressive symptoms than teens who were receiving treatment as usual.
FDA has approved abacavir 600 mg, dolutegravir 50 mg (Tivicay) and lamivudine 300 mg (Triumeq, ViiV Healthcare) as as a first-line therapy to treat HIV.
Zorvolex was the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. By using this technology, the dose can be lowered without delaying absorbtion.
Almost half of disabled workers enrolled in Medicare’s prescription drug program fill a prescription for opioids each year, and more than 1 in 5 were chronic users, filling 6 or more opioid prescriptions each year, according to a study in the September issue of Medical Care.
Precedex, dexmedetomidine hydrochloride, is approved to sedate patients with breathing tubes in an intensive-care setting, as well as patients without breathing tubes before and during surgeries and other procedures. Hospira’s patent that covers the use of Precedex in an intensive-care setting in due to expire in 2019, however other patents have already expired. On Monday, the FDA approved the sale of generic copies of the drug as long as the companies leave out information from the prescribing labels about uses that are covered under Hospira’s patent, including “intensive-care unit sedation.”
FDA has approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE.
FDA has approved fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older.
FDA has approved peginterferon beta-1a (Plegridy, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis (MS).
