Make sure to check out these not-to-be-missed pharmacy headlines from this week.
Migraine is the third most prevalent illness in the world, affecting 1 billion individuals worldwide. Current medications available for migraines have varying efficacy and significant potential for adverse effects. Research is ongoing to develop safe, effective treatments.
Vitamins B6, B9 (folic acid), and B12 are involved in homocysteine metabolism. Thus, a research team recently investigated the homocysteine-lowering effects of vitamin B supplementation and its subsequent effect on migraine control.
Their study, which was published in The Journal of Headache and Pain in June 2016, found that doses of 1 mg folic acid were less effective than 2 mg folic acid at reducing migraine symptoms. They randomly placed 200 patients on a daily regimen of 1 mg folic acid, 25 mg vitamin B6, and 400 mcg vitamin B12. They placed 100 patients on a placebo regimen.
After 6 months, there was no significant reduction in homocysteine levels or migraine symptoms in the treatment group compared with the placebo group. This suggests that folic acid yields a dose-dependent reduction in homocysteine levels and migraine symptoms.
You may have heard about direct and indirect remuneration (DIR) fees looming over the heads of independent community pharmacy owners. The Centers for Medicare and Medicaid Services (CMS) created DIR fees as a way to track the annual amount of drug manufacturer rebates and other price adjustments applied to prescription drug plans impacting the total cost of Medicare Part D medications. The savings from rebates received by the pharmacy benefit manager (PBM) are passed on to the payer, which in this case is CMS.
DIR fees morphed from the original definition of DIR to a myriad of meanings, including the cost a pharmacy pays to participate in a PBM/plan’s network, the adjustment of the maximum allowable cost and the contracted rate the plan reimburses the pharmacy for a medication, and the reimbursement or fee to a pharmacy for meeting or failing to meet certain quality measures.
A pharmacy could opt out of a preferred network, but this would increase co-pays for patients and limit the customer base. If the pharmacy opts into the PBM’s preferred network, it might have more foot traffic and fill more prescriptions, but also fill those prescriptions at only slightly above medication acquisition cost.
The FDA has approved Sanofi’s lixisenatide (Adlyxin), a new glucagon-like peptide-1 (GLP-1) receptor agonist to improve glycemic control, in conjunction with diet and exercise, in adults with type 2 diabetes.
Adlyxin will be available in a disposable prefilled injectable pen in a single dose of 20 μg. Patients will also receive a disposable prefilled pen in a single dose of 10 μg that they should initiate once daily for 14 days. On day 15, patients will increase the dosage to 20 μg once daily, according to the manufacturer.
The GLP-1 receptor agonist’s FDA approval was partially based on results from the GetGoal clinical program, which included 13 clinical trials involving more than 5000 subjects worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies successfully met the primary efficacy endpoint of hemoglobin A1C reduction.
Sanofi originally submitted a new drug application for lixisenatide in 2013, but the company pulled that application because the FDA was concerned about the cardiovascular safety of similar diabetes drugs. However, the subsequent ELIXA trial successfully addressed the FDA’s request to demonstrate that lixisenatide does not increase the risk of cardiovascular adverse events.
In addition to being a clinical assistant professor in the College of Nursing at Texas A&M Health Science Center, Matt Hoffman, DNP, APRN, FNP-C, is also somewhat of a Pokémon professor.
Dr. Hoffman earned the title after being a vocal advocate for Pokémon Go, a game where players use their smartphones and GPS to walk around in the real world catching Pokémon characters. With an influx of individuals getting outside, playing the game, and reaching out to others to find out where to catch certain Pokémon, Dr. Hoffman believes the game has led to the emergence of a new social community.
While walking around the A&M campus with some friends on one memorable weekend, he ran into a student who asked for tips on how to play the game.
In addition to the comradery, there are some actual health benefits to playing the game:
1. It encourages physical activity.
2. It could improve cognitive development.
3. It could potentially help reduce depression.
4. It may aid patients with autism.
Over a 3-day period in July, 130 individuals overdosed on K2 in New York City.
Health and law enforcement officials told The New York Times that they believe the hike in overdoses was linked to a tainted batch of the synthetic compound, rather than an actual increase in users.
However, the CDC reported last year that it was seeing an increase in calls to poison centers that were related to synthetic cannabinoid use. The most common complaints were agitation, tachycardia, lethargy, vomiting, and confusion, and among the nearly 3000 calls, 11.3% involved a major adverse event that could be life threatening.
For pharmacists who aren’t too familiar with K2, the following are 5 facts to know about it:
1. It’s a mixture of herbs and spices.
2. You can find it in head shops, bodegas, tobacco shops, some retail stores, and on the Internet.
3. It has several other street names.
4. There are generally 2 ways to use it.
5. It can have detrimental effects on both the mind and body.