Pharmacies may not stock naloxone, despite statewide orders

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(Reuters Health) - More than three years after Pennsylvania issued a statewide order expanding access to the life-saving opioid antidote naloxone, the product was still hard to purchase in Philadelphia pharmacies, researchers found.

In 2017, two-thirds of pharmacies in Philadelphia either did not stock naloxone, or they still insisted on a physician’s prescription, which the law said was no longer required.

In the wake of the opioid addiction crisis that has claimed thousands of lives, many U.S. states have passed laws like Pennsylvania’s, which allow the drug to be dispensed without a prescription and mandate that every drugstore carry it.

Laws that let pharmacists sell naloxone without prescription have been associated with a nearly 30% drop in the number of opioid overdose deaths, a separate team of researchers reported last month. (reut.rs/2WM3qMa)

Yet this study is not the first to find that drugstores are slow to comply. Research has shown that most pharmacies in California and Texas, for example, do not carry the drug or make it readily available.

The new results add to the growing body of evidence that these laws are not being enforced, experts said.

“While policy can be put in place, it’s not sufficient and has to be followed up with education, and reinforcement at the county and pharmacy level, and not just assume that the policy itself will ensure access to anyone who needs it,” Dr. Michael Lynch, a toxicologist and emergency medicine physician who was not involved in the study, told Reuters Health.

For the current study, Dima Qato of the University of Illinois, Chicago and colleagues contacted 418 drugstores in Philadelphia between February and August 2017 and found that only about 34% had naloxone in stock - and 38.5% of those drugstores required a physician’s prescription to dispense the drug.

People living in communities with elevated rates of opioid overdose deaths were the least likely to have access to naloxone without a prescription and had to pay more to buy the drug, the researchers wrote in JAMA Network Open.

“Areas that need this policy enforced the most are areas that lack it and that’s a concern,” Qato told Reuters Health by phone.

An overdose of opioids like morphine or heroin slows breathing, reducing the supply of oxygen to the body. Naloxone helps reverse the effects of an overdose and saves lives.

Lynch, who is also the medical director of the Pittsburgh Poison Center at the University of Pittsburgh Medical Center, notes that the high importance of naloxone may not necessarily translate to high demand.

“If patients or individuals are not coming in and asking for it, pharmacies, especially a local independent pharmacy with pretty narrow margins, may not continue to stock a medication that isn’t being dispensed,” he added.

However, Mel Brodsky, executive director of PARD, an association of community pharmacies in Philadelphia, disputes the study’s findings.

“It is from 2 years ago - a lot has changed. Philadelphia mandates that every pharmacy have 2 doses of naloxone in stock. As I travel to my stores, I see 95% having naloxone in stock,” he told Reuters Health by email.

Dr. Michael Fingerhood, of Johns Hopkins Bayview Medical Center in Baltimore, Maryland, told Reuters Health that the low numbers in the study may be partly due to a shortage of naloxone in 2017.

“I would do a similar study now, (when) we don’t have a shortage of naloxone, and see if there has been any difference, two years later,” he said.

SOURCE: bit.ly/2IEd5LZ JAMA Network Open, online June 7, 2019

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Many epinephrine self-injectors still potent long after expiration date

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(Reuters Health) - EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a new study that concludes patients might need expensive refills less often.

These autoinjectors contain a pre-set dose of epinephrine, a life-saving drug used by people at risk of experiencing anaphylaxis, a severe allergy attack. Untreated, anaphylactic shock can be fatal because blood pressure can drop suddenly and airways can narrow, making it difficult to breathe.

Patients who need these life-saving devices must carry at least one with them at all times and have access to one everywhere they go. Soaring prices and out-of-pocket costs for the autoinjectors have made it increasingly difficult for many patients to keep throwing out and replacing unused devices when they expire, researchers note in the Journal of Allergy and Clinical Immunology: In Practice.

The U.S. Food and Drug Administration (FDA) requires autoinjector expiration dates to ensure that the devices never contain less than 90% of the original dose of epinephrine, the study team notes.

For the study, researchers tested the contents of 46 different autoinjectors to see how much epinephrine remained after the expiration dates on the labels. Half of the devices were tested at least two years after their labeled expiration date. At this point, 80% of the devices still retained 90% or more epinephrine, indicating they were still effective under the FDA rules.

“If the expiration dating on these devices was changed, this means that patients would not need to replace their auto-injectors as frequently, limiting cost to them, their insurance, and the healthcare system, while still feeling secure that they have access to adequate treatment for anaphylactic reactions,” said lead study author Lynn Kassel of Drake University College of Pharmacy & Health Sciences in Des Moines, Iowa.

Devices six months past their labeled expiration date in the study still had 100% of the original epinephrine dose. One year after the labeled expiration date, devices still had 95% of the original epinephrine dose.

And all of the autoinjectors tested that were up to 30 months beyond their labeled expiration date still had 90% of the dose remaining.

The study tested far too few devices to help determine with certainty whether all epinephrine autoinjectors in the U.S. might be safely used past their expiration dates, Kassel said by email.

The authors also note that they did not test the expired injectors’ effectiveness in stopping an anaphylaxis episode.

“Until the FDA changes the expiration dating guidance for these devices, patients with anaphylactic allergies should carry auto-injectors that have not yet expired,” Kassel advised.

“The greatest risk of using an expired auto-injector is that the epinephrine is no longer potent enough to combat the anaphylactic reaction, and this could result in death or critical illness.”

Right now, the expiration date is 18 months from the time the product is manufactured, a duration that is shorter than the expiration date for most other medications, said Dr. Kao-Ping Chua of the C.S. Mott Children’s Hospital and the University of Michigan Medical School in Ann Arbor.

While the study results build on a growing body of evidence suggesting that expiration dates for epinephrine autoinjectors could be extended, in the meantime, patients should use the devices as labeled, Chua, who wasn’t involved in the study, said by email.

“I don’t think anyone should postpone refilling an epinephrine auto-injector if they can afford it,” Chua said. “In a life-or-death situation, you want to have as much certainty as possible that the rescue medication is going to work.”

SOURCE: bit.ly/2F7WrTT Journal of Allergy and Clinical Immunology: In Practice, online May 28, 2019.

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IBM, Walmart, Merck in blockchain collaboration with FDA

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FILE PHOTO: The Walmart logo in New York, U.S., May 1, 2018. REUTERS/Brendan McDermid/File Photo

(Reuters) - IBM, Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution.

The companies said they would work with consultancy KPMG to create a shared blockchain network that will allow real-time monitoring of products in the pharmaceutical supply chain.

The project has been authorized under the U.S. Drug Supply Chain Security Act (DSCSA) that was set up to increase regulatory oversight of counterfeit, stolen, contaminated or otherwise harmful drugs.

The FDA has previously used the DSCSA to issue a warning letter to drug distributor McKesson Corp for violations involving opioid medications.

Opioids have been tied to thousands of overdose deaths and state and local governments across the United States have filed lawsuits seeking to hold pharmaceutical companies responsible for the epidemic of abuse.

The new project is aimed at reducing the time needed to track and trace prescription drugs, improving access to reliable distribution information and ensuring products are handled appropriately and stored at the right temperature while being distributed, the companies said in a statement.

Blockchain technology, originally conceived a decade ago as the basis for the cryptocurrency bitcoin, will help stakeholders establish a permanent record and can be integrated with existing systems used to trace products while they are distributed.

The project is scheduled to be completed in the fourth quarter of 2019 and results will be published in a report, the companies said.

Reporting by Tamara Mathias in Bengaluru; Editing by Shinjini Ganguli

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U.S. pet doctors steel themselves for online pharmacy challenge

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(Reuters) - A David and Goliath battle is brewing in the business of selling prescription medicines for pets, pitching veterinarians against online giants moving into this lucrative corner of the growing market for animal supplies.

Destiny Brown, Dr. Katie Buss, and Kingsley family pose with puppies at the Kings Veterinary Hospital in Loveland, Ohio, U.S., on April 26, 2019. Picture taken on April 26, 2019. Courtesy Jennifer Blodgett/Kings Veterinary Hospital/Handout via REUTERS

Americans spent $72.56 billion last year on their pets, according to American Pet Products Association. Prescription drugs were expected to account for over $10 billion, according to an estimate here from the Federal Trade Commission, and overall pet product sales are expected to keep growing by 4% a year. (Graphic:tmsnrt.rs/2KfxTvy)

With deep discounts and online convenience, Walmart Inc, soon-to-be listed Chewy.com and Amazon.com Inc’s Wag brand have effectively conquered the market for pet food, care products and other supplies, but until now veterinary practices, which both prescribe and sell drugs, have been a major source of prescription medication.

While Amazon so far has shown no interest in that market, Chewy’s and Walmart’s forays into the online pet pharmacy business threaten to change that, prompting veterinary clinics to seek help in defending their turf. Enter Covetrus Inc, Vet Source, which partners with Patterson Companies Inc, and others that offer tools to help vets manage their practices and give customers the convenience they have come to expect from online shopping.

“We started to realize this is what our clients want,” said Stephanie Foster, practice manager at Kings Veterinary Hospital in Loveland, Ohio. “They want to be able to order things at 11 o’ clock at night. They’re used to the Amazon mentality.”

Foster says she began using Covetrus to order drugs and supplies for the practice after it began losing sales of pet food and other products to online retailers. Now, her hospital has a website run by Covetrus under the practice’s name that effectively acts as its online pharmacy.

With that comes software that helps the clinic manage its inventory and track prescriptions, so Foster knows when clients need a refill and for those Covetrus collects a service fee that is a percentage of sales.

Foster said partnering with Covetrus has helped boost overall sales by half over the past three years because it gives clients online convenience, timely reminders and, despite the fees, competitive prices.

“Covetrus now has more leverage with the manufacturers than I will ever have as a small business,” she said. “They’re able to get the manufacturers to agree to instant rebates and they can do flash sales on products and things that we just can’t compete with.” 

The company, formed by the combination of medical supply firm Henry Schein’s animal health unit and Vet’s First Choice and listed in February, represents some 100,000 veterinary practices globally. In the United States, 27,000 use some form of its services with over 8,000 - about a quarter of the market - signed up for prescription management, Covetrus says.

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PetSmart Inc-backed Chewy.com, whose sales soared from $26 million to $3.5 billion between 2012 and 2018, said in a filing ahead of its New York Stock Exchange debut this month it planned to expand its online pharmacy business launched last year.

The company has yet to update on the pharmacy’s performance and it would not comment for this article, citing the silent period ahead of its stock exchange debut.

Walmart joined the fray last month when it launched its online pet pharmacy WalmartPetRx.com and said it aimed to operate 100 in-store animal clinics by the end of the year.

Analysts say, however, the prescription pet medicine business could prove more challenging than other pet products.

Those who want to buy medication online still need a prescription from a vet and must either email or upload a copy or have the online retailer contact the practice first.

That, analysts say, offers the practices a chance to sell the first batch on site and then direct customers to their own online service.

Kristen Cook, a practice manager at the Belton Veterinary Clinic in Belton, Texas, says their doctors have no obligation to write a prescription for those shopping elsewhere and the clinic’s policy is to handle prescriptions internally.

“It’s not something like I am handing them a piece of paper to take it wherever they want to take it,” Cook said.

The stakes are high.

Cook said that at least half of the clinic’s revenue comes from prescription drug sales.

Nationally, pharmacy sales on average make up about a third of a practice’s revenue, according to Gary Glassman, partner at accounting and financial services firm Burzenski & Company, which serves veterinary practices across the country.

The American Veterinary Medical Association (AVMA) says, however, that 40 states have already adopted laws, regulations or guidelines that specifically or implicitly require veterinarians to provide a written prescription upon request in some circumstances.

To see the summary report from AVMA, please click here here

This means pet owners could fill those prescriptions with Chewy or other online providers, and the market is just too attractive to e-commerce players for the vets and their partners to get complacent, analysts say.

According to a 2018 TD Ameritrade online survey of U.S. millennial pet owners, they were willing to spend up to $2,000 on average if their pet got sick, with dog owners prepared to spend more on their pets than what they expected to spend on their own healthcare.

“People are treating their pets more like people,” William Blair analyst John Kreger said. “Historically ... you’d frankly euthanize the pet when they started to have some of these chronic conditions. That’s just not happening now.”

Reporting by Tamara Mathias and Manas Mishra in Bengaluru, Writing by Patrick Graham; Editing by Tomasz Janowski

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