Formulary Watch |

Safety of testosterone products being investigated by FDA

FDA said it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.

Holes in the drug market place: How do we overcome these obstacles?

Complex diseases present complex challenges for researchers, clinicians, drug manufacturers, and FDA for a variety of reasons. The impact, however, is felt at the patient level, particularly when there are no FDA-approved treatments. In some cases, such as myalgic encephalomyelitis, commonly known as chronic fatigue syndrome (ME/CFS), the devastating effects of the disease are exacerbated by the huge deficit in the drug application and approval pipeline. This leaves the patient population with little hope.

The high cost of acute otitis media

Researchers recently determined that acute otitis media is associated with an incremental increase in outpatient health care costs of $314 per child per year in the United States, which translates into approximately $2.88 billion in added health care expense annually.

Postnatal test for developmental delays approved

FDA recently approved a unique test that can diagnose developmental delays and intellectual disabilities in babies postnatally.

Drugs in Perspective: Oxytrol goes over-the-counter

Anti-muscarinic drugs are an option in the treatment of overactive bladder which is defined as urinary urgency with or without urge incontinence, usually accompanied by frequency and nocturia, in the absence of a urinary tract infection or other obvious pathology.Oral oxybutynin has been available by prescription for over 40 years, initially marketed as Ditropan® and Ditropan XL® although now generically availably, in addition to the transdermal patch Oxytrol and transdermal gel Gelnique. As an antagonist at muscarinic receptors, oxybutynin leads to relaxation of the smooth muscle of the bladder which leads to increased bladder capacity, decreased involuntary contractions and decreased urgency and frequency of both voluntary and incontinent episodes. The suggested dose is one patch applied for 4 consecutive days, after which the patch should be removed and a new one applied.

Adding evolocumab in combination with statins can help reduce high cholesterol

Adding evolocumab (Amgen) to statin therapy may help patients control their low-density lipoprotein cholesterol (LDL-C) levels when high doses of statins are not sufficient, according to results from a recent phase 3 study.

Displayed commitment from doc could reduce unnecessary antibiotic prescribing by 20%

"Nudging" doctors with signed commitment letter in exam rooms lowered inappropriate antibiotic prescriptions for cold symptoms by nearly 20%, according to a study in JAMA Internal Medicine.

Single-payer healthcare system endorsed by oncologists

Two oncologists are calling on fellow oncologists and the American Society of Clinical Oncology (ASCO) to support a single-payer healthcare system, according to an article published in the January issue of the Journal of Oncology Practice.

Low vitamin D levels can predict multiple sclerosis progression

For patients in the early stages of multiple sclerosis (MS), low levels of vitamin D were found to strongly predict disease severity and hasten its progression, according to a study online January 20, 2014 in JAMA Neurology.

FDA approves higher dose, less-frequent dosing regimen for Copaxone

FDA approved a 40 mg/mL dose of glatiramer acetate injection (Copaxone, Teva Pharmaceutical Industries Ltd.) to be used three times a week for patients with relapsing forms of multiple sclerosis (MS). This new higher-dose formulation will allow for a less-frequent dosing regimen.

Teen asthma outcomes better with quality improvement initiative

A quality improvement initiative, conducted in a primary care setting, dramatically improved asthma control and outcomes for high-risk adolescents, according to a study published online in Pediatrics.

Another Ranbaxy facility stopped from making APIs for United States

Ranbaxy Laboratories is being prohibited by FDA from manufacturing and distributing active pharmaceutical ingredients (APIs) from its Toansa, India, facility in order “to prevent substandard quality products from reaching U.S. consumers,” according to a news release.

State of Union address: Obama praises healthcare reform progress

More than 3 million Americans under aged 26 years have health insurance through their parents’ health plans. More than 9 million Americans have signed up for private health insurance or Medicaid coverage. And no American can be dropped or denied health insurance because of a pre-existing condition, said President Barack Obama about the Patient Protection and Affordable Care Act (PPACA) during his fifth State of the Union address on January 28th.

Study backs giving flu vaccine to adults with diabetes

Working-age adults-aged 18 to 64-with diabetes appear to have an increased risk of being hospitalized for influenza compared to similar-aged adults without diabetes, according to a study in Diabetologia.

Omega-3s may help lower risk of type 2 diabetes

High concentrations of serum long-chain omega-3 fatty acids may help reduce the risk of type 2 diabetes, according to a University of Eastern Finland study published recently in Diabetes Care. The sources of these fatty acids are fish and fish oils.

Medications vary during and after tonsillectomy care

While same-day tonsillectomy may be one of the most common and cumulatively costly surgeries for children in the United States, there is substantial variability in the quality of care and outcomes, reports a study in Pediatrics.

Bariatric surgery demonstrates cost recovery in less than 2 years: Study

A recent study confirms cost recovery and long-term savings for morbidly obese patients undergoing bariatric surgery procedures. - See more at: http://formularyjournal.modernmedicine.com/formulary-journal/news/bariatric-surgery-demonstrates-cost-recovery-less-2-years-study#sthash.gdmwiTok.dpuf

Online patient portal boosts diabetes medication adherence

Diabetic patients who used an online patient portal to refill medications increased their medication adherence and improved cholesterol levels, according to a Kaiser Permanente study published in a recent issue of Medical Care.

Drug shortages have big impact on patient care

Drug shortages remain a serious problem for patient safety, according to newly published results from a survey of pharmacy directors. Nearly half of the responding directors reported adverse events at their facilities resulting from drug shortages - including patient deaths.

BLOG: Vitamins: Supplement at a detriment?

Complementary alternative medication (CAM) including vitamins, herbals, supplements, homeopathy, and extracts seems to be as polarizing a topic as politics these days. Given that more than half of the US adult population uses at least 1 CAM, you can easily find passionate opinions on either side of the isle from the Herbal Tea Party and Abstinence Only factions.1 Children’s Hospital of Philadelphia (CHOP) recently fueled the debate by publically declaring they would no longer provide CAM.2 Families wishing to continue these agents during hospitalization have to sign a waiver and provide the product. Some hospitals have long held this abstinence policy (perhaps sans waiver), but were less vocal in their withdrawal. The motivation for disallowing use is based on risks to the patients due to the inherent unknowns of CAM. Patients seem to be increasingly motivated to continue consuming, however, as self-management with CAM skyrockets.

Delirium in critically ill patients can be reduced with statins

Continued use of statins may help prevent delirium in critically ill patients who received statins before hospital admission, according to a study published online ahead of print in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

Online patient portal boosts diabetes medication adherence

Diabetic patients who used an online patient portal to refill medications increased their medication adherence and improved cholesterol levels, according to a Kaiser Permanente study published in a recent issue of Medical Care.

Antibiotic misuse problematic for adult emergency room patients

An analysis of emergency department (ED) visits over a 10-year period found that while inappropriate antibiotic use is decreasing in pediatric settings, it continues to remain a problem in adults, according to a study published ahead of print in Antimicrobial Agents and Chemotherapy.

Fulyzaq improves noninfectious diarrhea in patients with HIV on ART therapy

Noninfectious diarrhea in patients with HIV on antiretroviral therapy showed improvement after treatment with 125-mg delayed-release crofelemer (Fulyzaq, Salix Pharmaceuticals) tablets, according to a study in HIV Clinical Trials.

PBMs to limit availability of branded drugs on formularies

Express Scripts and CVS Caremark are expected to expand their list of non-covered drugs for the 2015 plan year, leading to challenging pricing negotiations between branded pharmaceutical companies and PBMs.

Optimal adherence to meds prescribed post-heart attack lowers hospital readmissions

Optimal medication adherence is important for patients who have had a heart attack in order to get maximum clinical benefit, according to a study published in the January 2014 issue of the American Heart Journal.

FDA: Prescribers, dispensers should stop use of combination painkillers with more than 325 mg of acetaminophen

FDA is recommending healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.

Gestational diabetes screening should take place at 24 weeks

All pregnant women should be screened for gestational diabetes mellitus at 24 weeks gestation, even if they have no symptoms, according to new recommendations from the U.S. Preventive Services Task Force (USPSTF).

Aetna weight-loss program to include Belviq, Qsymia

Aetna is launching a pilot program to test the benefits of FDA-approved, prescription weight-loss drugs combined with lifestyle support.

Obinutuzumab with chlorambucil helped patients with blood cancer live longer without disease worsening compared to rituximab

In elderly patients with chronic lymphocytic leukemia (CLL) taking obinutuzumab (Gazyva, Genentech), also known as GA101, in combination with chlorambucil lived nearly 1 year longer without worsening of their disease compared to rituximab in combination with chlorambucil, according to a study published online ahead of print in the New England Journal of Medicine.