Formulary Watch |

FDA approves oritavancin for skin infections

FDA has approved oritavancin (Orbactiv, The Medicines Company) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Drugs in Perspective: Tasimelteon (Hetlioz)

Hetlioz (tasimelteon) is a melatonin receptor agonist, similar to Rozerem (ramelteon) that was approved by FDA in January 2014 for the treatment of N24HSWS caused by a completely blind person’s inability to regulate their internal clock.

FDA approves empagliflozin tablets for type 2 diabetes

FDA approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Whooping cough vaccine safe in pregnancy

Pregnant women given pertussis vaccination in their third trimester to prevent infections in newborns, should be reassured that the vaccine is safe, and in fact, may be beneficial, according to a study published in The BMJ online July 11, 2014.

FDA approves Striverdi Respimat to treat COPD

FDA has approved olodaterol (Striverdi Respimat, Boehringer Ingelheim) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

New AAP guidance for RSV drug spurs manufacturer reaction

The American Academy of Pediatrics (AAP) revision of its recommendations for use of palivizumab (Synagis, MedImmune Specialty Care Division of AstraZeneca) for respiratory syncytial virus (RSV) in infants has fueled a reaction from the drug’s manufacturer.

[BLOG]: The compounding challenge: A solution for all sides

Every patient’s condition and specific needs are different. Whether it’s due to an allergy, need for a special dosing, or just a lack of success with traditional options, often a personalized medication approach is the only solution that can provide effective treatment.

[BLOG]: Intravenous drug cost management and the regulatory environment

Spiraling drug costs, drug shortages, and increasingly complex and demanding regulations are making the intravenous (IV) services business more challenging than ever. Pharmacies providing IV compounding must comply with USP 797 (and soon USP 800) and state compounding regulations requiring detailed documentation. The financial impact is obvious. Increased workloads often have required staff additions. USP 797 regulations have prompted costly remodeling to provide buffer rooms and ante rooms.

FDA drug approvals-August 2014

FDA actions in brief, complete response, fast-track designation, priority review, orphan drug designations, first-time generic approval

A data-driven approach to minimizing diversion

As prescription drug abuse in the United States escalates, diversion of controlled substances is becoming an increasingly critical issue for hospitals and health system executives to monitor. In hospitals, diversion of controlled substances not only negatively impacts staff and places liability on the facility but it also affects patient safety, satisfaction, and in most cases, the hospital’s bottom line. As such, hospital executives are looking to pharmacy leaders to provide creative solutions to proactively prevent diversion and better control this evolving public health issue.

Recommend HPV vaccine with other routine shots in teens

Human papillomavirus (HPV) vaccination is cancer prevention and the healthcare industry needs to do a better job of providing the HPV vaccine to all adolescents, according to a survey conducted by the U.S. Centers for Disease Control and Prevention.

FDA approves hard-to-abuse opioid pain drug

FDA approved oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER, Purdue Pharma), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

AAP: Meningitis shots recommended for vulnerable children

For selected infants and children with increased risk for meningococcal disease, there will be a new recommended vaccine in their immunization schedule, according to updated recommendations from the American Academy of Pediatrics (AAP).

Paracetamol doesn’t speed recovery from acute low back pain: Study

Paracetamol did not improve recovery time for people with low back pain, compared to placebo, according to a study published in The Lancet.

4 ways to manage prescription drug misuse

While there are signs of progress in the epidemic of prescription drug misuse, everyone is at risk of misuse, according to a new study.

FDA approves drug to treat 3 types of blood cancers

FDA approved idelalisib (Zydelig, Gilead Sciences) to treat patients with 3 types of blood cancers.

AbbVie acquires Shire amid looming Humira biosimilar competition

The AbbVie purchase of Shire for about $54 billion will create one of the biggest deals so far this year.

Treatment for rare genetic disease approved by FDA

FDA has approved C1 Esterase Inhibitor [Recombinant] (Ruconest, Salix and Pharming Group) for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Multidisciplinary approach key to reducing medication errors in kids

Multidisciplinary efforts, including physicians, nurses, pharmacists, and families all working together, are needed to eliminate pediatric medication errors, according to a study published recently in Pediatrics.

Clinicians under-prescribing flu antiviral drugs, maybe overprescribing antibiotics

Clinicians are still more likely to prescribe antibiotics rather than antiviral medications to outpatients with flu, including to high-risk patients who would benefit from early empiric antiviral treatment, according to a study published in Clinical Infectious Diseases.

Antibiotic use increases worldwide

Global antibiotic use has risen 36% over the last decade, according to a study published in the July 10 issue of The Lancet Infectious Diseases.

Orphan drugs: Patients facing access issues

As the numbers of orphan drugs increase as well as their costs, patients are facing growing challenges accessing orphan drugs, according to a study from the Tufts Center for the Study of Drug Development (CSDD) at Tufts University.

Heart risk raised in women regularly using NSAIDs

Women who are regular users of non-steroidal anti-inflammatory drugs (NSAIDs) should be aware that these medications may increase the risk of adverse cardiovascular events, according to a study published in the July issue of Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.

Secukinumab clears skin in psoriasis patients: Studies

Psoriasis patients treated with interleukin-17A (IL-17A) inhibitor secukinumab demonstrated statistically significant skin clearance, according to in 2 pivotal phase 3 studies published in The New England Journal of Medicine.

Opioid deaths among young adults on the rise

Rates of opioid overdose in Ontario, Canada, have increased more than 3-fold over the past 2 decades, according to a study online in Addiction. Furthermore, deaths are clustered among younger Ontarians; in 2010, 1 in 8 deaths among those aged 25 to 34 years were related to opioids.

MI risk not increased in older men receiving testosterone therapy

Older men treated with intramuscular testosterone did not appear to have an increased risk of myocardial infarction (MI). For men with high MI risk, testosterone use was modestly protective against MI, according to a study published in Annals of Pharmacotherapy

Class III obesity linked with substantially elevated rates of total mortality: Study

Otherwise healthy, non-smoking adults with BMI values within the class III obesity range may considerably extend their life expectancy by avoiding additional weight gain, according to a study published in PLOS Medicine.

Drugs in Perspective: Aptiom (eslicarbazepine acetate)

Aptiom (eslicarbazepine acetate) is an oral antiepileptic tablet that was approved by FDA on November 8, 2013, as an add-on medication to treat seizure disorders that can be associated with epilepsy.

FDA approves Kerydin topical solution for onychomycosis of the toenails

FDA approved tavaborole (Kerydin, Anacor Pharmaceuticals) topical solution, 5%, which is the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.

FDA approves NovoSeven RT for Glanzmann's thrombasthenia

FDA approved coagulation factor VIIa [recombinant] (NovoSeven RT, Novo Nordisk), for the treatment of Glanzmann’s thrombasthenia, a rare genetic bleeding disorder.