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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Prosecutors drop Flint, Michigan water charges over 'flawed' probe

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(Reuters) - Michigan prosecutors on Thursday dropped all criminal charges over the deadly contamination of the city of Flint’s water, saying a more thorough investigation was needed before they could proceed with the case.

FILE PHOTO: Volunteers distribute bottled water to help combat the effects of the crisis when the city's drinking water became contaminated with dangerously high levels of lead in Flint, Michigan, March 5, 2016. REUTERS/Jim Young/File Photo

The charges were brought by the Office of Special Counsel (OSC), a federal prosecutorial agency, and were based on an investigation that state prosecutors described as “flawed.”

“Dismissing these cases allows us to move forward according to the non-negotiable requirements of a thorough, methodical and ethical investigation,” Michigan’s Solicitor General Fadwa Hammoud and Wayne County Prosecutor Kym Worthy said in a statement.

Eight former state and city officials, including Michigan’s chief medical officer Eden Wells, faced criminal charges for their roles in the water crisis which killed 12 people and sickened over 70, one of the worst man-made environmental disasters in U.S. history.

According to the prosecutors, the OSC made agreements that gave law firms representing state agencies and officials a role in deciding what information would be turned over to law enforcement during their investigation. As a result, not all evidence was pursued, they said.

Additional investigation by the prosecution team has already identified more individuals of interest in the case, they said.

Flint’s troubles began in 2014 after the city switched its water supply to the Flint River from Lake Huron to cut costs. Corrosive river water caused lead to leach from pipes, contaminating the drinking water and causing an outbreak of Legionnaires’ disease.

Prosecutors said they dropped charges “without prejudice,” meaning they could be brought again once a new investigation is completed.

“Justice delayed is not always justice denied,” Michigan Attorney General Dana Nessel said in a statement.

But Michigan Senate Minority Leader Jim Ananich, a Democrat who represents Flint, expressed his disappointment.

“Months of investigation have turned into years, and the only thing to show for it is a bunch of lawyers who have gotten rich off the taxpayers’ dime,” he said in a statement. “The people of Flint believe that they will never see justice, and sadly, so far they’ve been proven right.”

The U.S. Supreme Court in March allowed two class-action lawsuits filed by Flint residents, who are pursuing civil rights claims against local and state officials.

Reporting by Andrew Hay in Taos, New Mexico; Editing by Bill Tarrant and James Dalgleish

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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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New review suggests proven ways to cut back on sugary drinks

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(Reuters Health) - With sugary sodas and other sweetened drinks considered a key driver of the obesity epidemic worldwide, a new research review evaluates how well various measures work to reduce consumption of these calorie laden drinks.

Strategies including limited availability of sodas in schools, removal from children’s menus at restaurants and better labeling could help reduce consumption, according to the analysis published in The Cochrane Database of Systematic Reviews.

The authors of the new report did not respond to requests for an interview. Study coauthor Hans Hauner said in a statement, “Rates of obesity and diabetes are rising globally, and this trend will not be reversed without broad and effective action.” Hauner, a professor of nutritional medicine at the Technical University Munich, added, “Governments and industry in particular must do their part to make the healthy choice the easy choice for consumers. This review highlights key measures that can help accomplish this.”

The researchers pored through the literature seeking studies that evaluated so-called environmental strategies for reducing sugary drink consumption - meaning interventions that change the physical or social setting in which a person chooses what drink to consume or buy. Fifty-eight studies involving a total of more than 1 million adults, teens and children met their criteria. Most lasted about a year and were done in schools, stores or restaurants.

Some of the studies were less well designed, the researchers allowed, simply asking participants how much sugary soda they consumed, for example.

Ultimately, the researchers found moderate-to-low-certainty evidence supporting a number of measures that appeared to help people cut back on sugary drinks. These included: labels that were easy to understand and that rated the healthfulness of beverages; limits on availability of sugary sodas in schools; price increases on sugary sodas in restaurants, stores and leisure centers; inclusions of healthier beverages in children’s menus; and promotion of healthier beverages in supermarkets.

Strategies that raise the price of sugar-sweetened drinks were also supported by moderate-quality evidence while lowering prices on low-calorie drinks was not as well supported.

The new study “lays out evidence that there are things that actually do work,” said Dr. Bruce Y. Lee, executive director of the Global Obesity Center and an associate professor at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.

What makes these sugary beverages especially bad for health is the fact that they represent “empty calories,” said Lee, who was not involved in the review. “So you’re essentially drinking sugar.”

While these strategies may not be the entire solution, “we are clearly having an obesity and diabetes epidemic,” said Dr. Robert Rapaport, a professor of pediatrics and director of the division of pediatric endocrinology and diabetes at the Kravis Children’s Hospital at Mount Sinai in New York City. “Anything that can be done to improve that would certainly be welcome.”

Rapaport welcomes strategies such as removing sugary drinks from schools and making labels easier to read. In general, he said, it makes sense to “tell children to drink water. If they want it with carbonation and flavors that’s fine. All are preferred to having drinks that contain high calories.”

The new study highlights the importance of education, especially for kids, said Shelly Kendra, clinical nutrition manager at the Magee-Womens Hospital of the University of Pittsburgh Medical Center, who also wasn’t involved in the review. “What we learn as kids is what we’re going to carry with us into adulthood,” Kendra said. “Having an environment to help support that is potentially creating the building blocks to healthier choices.”

SOURCE: bit.ly/2IbuoVp The Cochrane Database of Systematic Reviews, online June 12, 2019.

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Comedian Jon Stewart assails Congress for ignoring 9/11 first responders fund

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WASHINGTON (Reuters) - Jon Stewart, the popular former host of the late-night comedy program The Daily Show, criticized members of Congress for not attending a hearing on Tuesday on renewing funding for a program that provides health care to first responders who were sickened responding to the Sept. 11 attacks.

“Sick and dying, they brought themselves down here to speak and no one,” Stewart said, pointing to a mostly empty dais. “Shameful, it’s an embarrassment to the country and a stain on this institution. You should be ashamed of yourselves for those who aren’t here but you won’t be because accountability doesn’t appear to be something that occurs in this chamber.”

Stewart was testifying before the Judiciary Committee’s Subcommittee on the Constitution, Civil Rights and Civil Liberties about a renewal of the 9/11 first responders health care fund. Most of the panel’s 14 members were not in attendance.

“Where are they? It would be one thing if their callous indifference and rank hypocrisy was benign, but it’s not,” Stewart said. “Their indifference cost these men and women their most valuable commodity, time, one thing they’re running out of.”

The fund, originally approved for five years in 2010, provides medical treatment for emergency responders sickened by toxic dust inhaled at the World Trade Center site in New York in the days following the attack.

Republicans had balked at the price of the original legislation and as a compromise at the time, Democrats agreed to authorize the fund only for five years and cover the cost with an excise tax. That has set up a fight every five years to get Congress to renew the program.

Stewart criticized Congress for continuing to require the fund be renewed every five years - pointing to the panel’s top Republican, Representative Mike Johnson, for saying that Congress has to balance other emergencies as well.

“I’m pretty sure what’s going to happen five years from now, more of these men and women are going to get sick and they are going to die and I am awfully tired of hearing that it’s a 9/11 New York issue,” Stewart said. “Al-Qaeda didn’t shout death to Tribeca.”

Reporting by Ginger Gibson; Editing by Dan Grebler

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