Small Doses: 6 Stories You Need to Know in January

Saying that pharmacists are busy is like saying that water is wet. In the middle of all the craziness you go through every day, are you really taking the time to sit down and read all the latest pharmacy news?

We thought not.

But there are some things you should know. Things like Amazon’s entry into the pharmaceutical business, how the U.S. government is cracking down on illegal ovoid withdrawal supplements, and how hospitals are handling the ongoing IV saline shortage are all important issues that impact pharmacists’ daily business.

In these six “Small Doses” articles, Drug Topics gives you easy-to-swallow bits of information that could make a huge impact on you and your patients. 

Up next: FDA cracks down on false claims

FDA, FTC Warn Opioid Cessation Supplement Makers

The FDA and the Federal Trade Commission warned the marketers and distributors of 12 opioid cessation products for illegally marketing unapproved products with claims about their ability to help treat opioid addiction and withdrawal.

The marketers include Opiate Freedom Center; U4Life, LLC; CalmSupport, LLC; TaperAid; Medicus Holistic Alternatives LLC; NutraCore Health Products, LLC; Healthy Healing, LLC; Soothedrawal, Inc.; Choice Detox Center, Inc.; GUNA, Inc.; and King Bio, Inc. 

All of them use online platforms to make illegal claims about their products' ability to cure, treat, or prevent a disease, according to FDA. Examples of claims include: “#1 Selling Opiate Withdrawal Brand” and “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”

If the companies don’t correct violations, they could face law enforcement actions, such as seizure or injunction.

Publix Pharmacies Feature Walk-In Care Centers

Lakeland, Florida-based Publix and BayCare Health System teamed up to provide Telehealth systems at 26 in-store Publix Pharmacy locations by the end of this year.

The “Walk-In Care” telehealth centers at Publix, which operates 1,168 stores, feature a private room where shoppers can receive non-urgent medical care from board-certified physicians through teleconferencing and medical diagnostic equipment.

“The kiosk, which is interactive and user-friendly, allows patients to easily enter their symptoms and work with medical tools such as thermometers, otoscopes, blood pressure cuffs, and high definition cameras to help doctors make an accurate diagnosis,” BayCare Health said in a statement.

Publix Pharmacy support staff are available to assist patients, if needed. 

“Pharmacists are a part of many patients’ wellness plans, and our Publix Pharmacists have been serving our communities through a variety of services like vaccinations, health screenings, free and discounted medications, and more,” said Maria Brous, Publix’s director of media and community relations. “This Walk-In Care clinic takes our partnership with physicians to a new level. Together, we’ll help keep our community feeling well.”

Amazon’s Pharmacy Team Expands

Amazon’s exploratory pharmacy business leadership team has expanded to between 30 and 40 people, according to a report from financial research firm Leerink.

Amazon also held exploratory talks in November with generic drug manufacturers such as Sandoz and Mylan, leading analyst to speculate that Amazon will sell generic drugs.

Leerink believes that Amazon’s entry into the pharmaceutical business is a matter of “when” not “if.” CNBC reported. "Amazon saw the inclusion of pharmaceutical drugs as a natural add-on to its existing product offerings,” Leerink’s report stated.

Amazon’s latest high-profile health care hire is Martin Levine, a doctor who specializes in new models of patient care, CNBC said.

The Flu’s Impact on IV Saline Shortages

This year’s severe flu season may continue to further impact the IV saline shortage, which worsened last fall after Hurricanes Maria and Irma struck Puerto Rico. “The tight supply of saline products has been exacerbated by an increased demand for saline we’re seeing as a result of the worse-than-typical flu season. ... As such, we encourage healthcare organizations and hospitals to contact FDA directly if they aren’t receiving the products they need,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

Related article: Pharmacy Supply Lines Are Still Shaking After Storm Passes

FDA is also asking IV saline manufacturers to submit data to extend expiration dates for products. “If expiration dates can be safety extended, it would allow some near-expiry product that remains at the hospital level to be used,” Gottlieb said.

Updates, including new supply sources and extensions of expiration dating, will be posted on the FDA’s drug shortage website as soon as they’re available.

Cannabidiol Drug for Epilepsy Expected Later This Year

A cannabidiol therapy-the first in a new category of antiepileptic drugs-is expected to launch in the second half of this year, after its manufacturer’s New Drug Application was accepted by FDA.

Epidiolex, manufactured by GW Pharmaceuticals, demonstrated a reduced monthly drop in seizure frequency compared to placebo in highly-treatment-resistant patients with Lennox-Gastaut syndrome (LGS), a rare form of epilepsy, according to a study published in The Lancet. Over a 14-week treatment period, 44% of patients taking Epidiolex saw a significant reduction in seizures, compared with 22% of the placebo group.

"LGS is one of the most difficult types of epilepsy to treat, and the majority of patients do not have an adequate response to existing therapies," said Elizabeth Thiele, MD, PhD, a professor of Neurology at Harvard Medical School, and lead author of the Lancet study. "These results show that Epidiolex may provide clinically meaningful benefits for patients with LGS."

FDA accepted the NDA for Epidiolex to treat LGS and Draven syndrome, another rare childhood-onset epilepsy, in December.

Publix Launches Low-Cost Generics Program

Publix Pharmacy’s new low-cost generic program will provide up to a 90-day supply of some of the most commonly prescribed generic drugs for $7.50.

The Lakeland, FL-based chain of 1,168 stores will offer 29 generic medications with a total of 85 dosage options for $7.50 each. They include highly-prescribed treatments for heart health and cardiovascular conditions, diabetes, high cholesterol, mental health, seizure disorders, Parkinson’s disease, Alzheimer’s disease, osteoporosis, and several other medical conditions.

 “Healthcare costs continue to rise, so sometimes people have a hard time filling their prescriptions as regularly as they should. We believe this low price will help encourage customers to follow their doctor’s orders, so they can experience better health outcomes,” said Maria Brous, director of media and community relations for Publix.