It wants them to be down to a ‘non-addictive level.’ We would make a snide comment here about what constitutes a ‘non-addictive level,’ but some people frown on those.
Congress and the White House have agreed not to pursue a border adjustment tax (a tax on all imported goods from certain countries). Retailers were happy with the news, and our friends at NACDS are certainly pleased.
Texas reports its first case of mosquito-transmitted Zika virus this year.
So repealing/replacing Obamacare/ACA is dead for now. What comes next? A bi-partisan effort to fix it? Congressional efforts to make it work as-is (say, by paying insurers their risk-corridor money)? What’s the White House gonna do? (Will it withhold those cost-sharing payments?) Should we just wait and see?
We’ll go with “wait and see.”
Arkansas, Arizona, Indiana, Kentucky, and Wisconsin are looking for ways to cut Medicaid spending by raising the bar for enrollees.
—Andrew Kantor • Aug. 01, 2017
You can dispense naloxone without a prescription, but you have to keep the standing order from the DPH commissioner on file. That used to be Brenda Fitzgerald, but since she’s gone on to greener pastures the new version is signed by J. Patrick O’Neal.
Click here to get your copy — print it and file it. (Yes, it still has Dr. Fitzgerald’s name at the top ’cause DPH hasn’t printed up its new letterhead yet. The signature at the bottom is what’s important.)
The VA clinic in Statesboro allows patients there to consult with a pharmacist 146 miles away, near Atlanta.
“The Statesboro clinic is too small to put an actual pharmacist in to do these kinds of appointments. Also, because Statesboro is so rural, it would have been difficult to recruit in that area.”
Might affect your patients: If they’re paying their premiums directly to SHBP, the agency has a new processor: WageWorks. “All references to ADP will be replaced with WageWorks. WageWorks will appear on: the Benedirect website, printed materials (letters, invoices, etc.), email notifications, and phone greetings (for COBRA participants only).”
* Because insurers originally backed ACA’s limits in exchange for the individual mandate — it effectively guarantees them a mix of sick and healthy people.
Democrats would appreciate some news coverage of their plan to reduce high drug prices.
[T]he Democrats’ plan, part of party leadership’s new economic agenda launched ahead of the 2018 elections, would create an independent, Senate-confirmed “price gouging” enforcer to identify medicines with “unconscionable” price increases and impose fines on manufacturers that are proportional to the size of the price hike. Money paid will be given to NIH to further its work on new drug development.
The U.S. military spends $84 million per year on erectile dysfunction drugs — including $41.6 million on Viagra alone.
Researchers in Oregon have, despite warnings from a heck of a lot of scientists, edited the genes of viable, single-cell human embryos using everyone’s favorite gene-editing technique, CRISPR/CAS-9.
They used embryos that carried a gene for an inherited disease (they didn’t reveal which one) and successfully edited that gene so the disease wouldn’t manifest.
What’s different about this research team’s experiment is that 1) it used viable human embryos — not damaged ones that have previously been used (in China) for this kind of research, and 2) the team repeated the technique without causing damage to other genes.
What’s particularly notable is that these are germline modifications, meaning the changes the team made — if the embryo was carried to term — would be passed down to children.
If you’re thinking, “Holy wow, they could change the course of human evolution!” you’d be correct. If you’re thinking, “Couldn’t this lead to ‘designer babies’?” you’d also be correct. That’s what makes this research both exciting and terrifying.
—Andrew Kantor • Jul. 27, 2017
The idea that high drug prices (in the U.S. anyway) are needed to fund the pharma companies’ research and development has been debunked before, but here’s another bit of proof: They spend more paying dividends and buying back their own stock than they do on R&D.
But it’s easy to verify that “high prices = innovation” argument. Just look at the numbers. And some researchers did just that. Turns out the real reason for high U.S. drug prices is something else:
In the name of “maximizing shareholder value” (MSV), pharmaceutical companies allocate the profits generated from high drug prices to massive repurchases, or buybacks, of their own corporate stock for the sole purpose of giving manipulative boosts to their stock prices.
Or, as Stat News put it:
From 2006 through 2015, the 18 drug makers in the Standard & Poor’s 500 index spent $516 billion on buybacks and dividends, outpacing the $465 billion spent on R&D.
Drug Store News has released its annual profile of the top 50 pharmacy chains in the country, which account for 80 percent of retail pharmacy sales. No real surprises, but the 50 individual profiles are interesting reading.
Who’s paying? Third-party insurance pays for just over half of prescriptions (51.3%), while Medicare (26.9%) and Medicaid (14.1%) make up the bulk of the rest — which is why pharmacists are keeping an eye on the Obamacare-replacement process. Cash payments account for 7.7% of sales.
APhA is soliciting candidates for its 2018 Board of Trustees, Academy of Pharmacy Practice and Management, and Academy of Pharmaceutical Research and Science.
Get more info at pharmacist.com/elections.
Heck, with all the U.S. cities and states (and the Cherokee Nation) suing opioid makers, our friends to the north might join in as well. Let’s be honest: Being sued by Canada is like being sued by Mr. Rogers. It just doesn’t look good.
Per the Congressional Budget Office: If the ACA is repealed without a replacement, 17 million Americans would lose coverage almost immediately (in 2018), and 10 million more would lose it within three years. Premiums for individual policies would go up 50 percent in two years and would double within a decade.
—Andrew Kantor • Jul. 20, 2017
Severe asthma isn’t just more severe — there’s a different immune response. And that means corticosteroids won’t work for those patients — we’re talking about 10 percent of asthma sufferers.
Here comes the science:
Researchers observed that the immune cells, called CD4 T-cells, in the airways of severe asthmatics secreted different inflammatory proteins than those in mild disease, particularly interferon gamma. (Emphasis ours.)
…keeps the skin cancer away. (Maybe.)
Is that — unlike a lot of recreational drugs — most of the people who become hooked on painkillers don’t start taking the drugs for fun. They get injured, get meds, and then end up chasing that dragon.
When Matt was little, [his mother] Kelly was a Head Start caseworker who patiently taught parents how to manage their autistic children. She loved hosting potlucks with friends and playing Barbie with Matt’s sister, Brianna. There was always music: Tchaikovsky when Kelly was at the piano, or Jimmy Buffett blasting through the speakers while she cooked. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”
Then Kelly had neck surgery and got addicted to OxyContin. By 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, letting the fridge go empty and the house lapse into a den of cigarette butts and dirty dishes. “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”
Georgia Insurance Commissioner Ralph Hudgens has said he won’t run for re-election in 2018.
Cindy Zeldin, the executive director of Georgians for a Healthy Future, is the first person to announce she will seek the office.
Not that you would ever tell your patients this, but just because a drug is “expired” doesn’t mean it doesn’t work. The expiration date is simply the date the manufacturer can guarantee its effectiveness.
You might think that the drug becomes less effective after that. Not necessarily. Drug makers only check whether a drug is good till that date — they don’t check to see how long it’s actually good for.
In fact, the federal government, which maintains stockpiles of drugs in case of emergency, doesn’t toss them after they “expire.” Instead, they test the drugs to make sure they still work.
Why is this a big deal? Well, imagine you’re in a country that’s spending billions and billions on healthcare and are looking for ways to cut costs….
China to drug makers: We have 1.4 billion customers. We’d like a discount.
Drug makers: How’s, oh, 44 to 70 percent sound?
China: That works.
But this time it’s because of mistakes they make at home — the wrong meds, the wrong dose, or taking something twice by mistake.
That’s the finding from a 13-year study of calls to poison control centers.
The most common medications involved were cardiovascular drugs such as beta blockers, calcium antagonists and clonidine; pain medications, including opioids and acetaminophen; and hormonal medications, including insulin.
What can help? A system for preventing multiple caregivers (e.g., parents) from accidentally doubling up. And a conversation with a pharmacist (that’s you!) about when and how to take them.
More opioid users turn to heroin. So what happens to all those needles they use? “They hide in weeds along hiking trails and in playground grass. They wash into rivers and float downstream to land on beaches. They pepper baseball dugouts, sidewalks and streets.”
*You’re right. That headline makes no sense.
A study from the American College of Allergy, Asthma and Immunology (published in the Annals of Allergy, Asthma and Immunology) found that barely more than a third of kids going into anaphylactic shock received epinephrine before they got to the ER.
“We found kids who had a reaction at home were less likely to receive epinephrine than kids who had a reaction at school,” says allergist Melissa Robinson, DO, ACAAI member and lead author of the study. “Treatment with epinephrine is often delayed or avoided by parents and caregivers. And sometimes antihistamines are used even though they are not an appropriate treatment.”
—Andrew Kantor • Jul. 19, 2017
Augusta was ranked the 9th most-stressed city in the country by WalletHub (which does these kinds of rankings). It’s based on 30 figures including work stress (average work hours, unemployment, etc.), financial stress (income, debt, etc.), family stress (divorce rate, etc.), and health stress.
Of the other 149 cities in the study, Columbus ranked #34 and Atlanta ranked #74 — right in the middle. Newark and Detroit were at the top (or bottom, I suppose), while if you want to relax head to Fremont, Calif., or Plano, Tex.
Yesterday we told you how Medicare is considering cutting hospitals’ 340B reimbursements from six percent above the average price to 22.5 percent below it.
Hospitals that treat lower-income people and those without insurance — many in rural areas — are naturally up in arms.
But Adam Fein at Drug Channels explains the logic, and how it’s not as shocking as it sounds.
According to the Medicare Payment Advisory Commission, 340B hospitals get a minimum discount of 22.5 percent on drug prices. Thus, CMS is saying that its new payment scheme would at worst have hospitals break even on drugs. (Fein thinks most pay even less than that.)
Bottom line: 340B hospitals wouldn’t be losing money on these drugs, but they’ll no longer be making money on them.
Further — according to Fein — because Medicare Part B patients’ co-pay is based on what Medicare pays the hospital, the new reimbursement plan would mean lower out-of-pocket costs for them.
Oh, and of note: This would only affect hospitals, not outside contract pharmacies.
Just in case, though, because this involves both money and politics, here’s your grain of salt:
Even though Dr. Brenda Fitzgerald has left her post in Georgia to head the CMS, her standing order allowing pharmacists to dispense naloxone without a prescription is still in effect. Be sure to have a copy of that order on hand.
We can’t not point out this story, in case you missed it: Ophthalmologists doing a routine cataract surgery found a lump of 27 contact lenses in the woman’s eye, the result of wearing disposable contacts for 35 years.
(No, they were not all stacked up over her cornea. They had moved up, under the eyelid. But still.)
“She said she had felt an uncomfortable and gritty eye, ‘like something was inside,’ but she didn’t think it was anything to worry about.”
It’s doing its annual Community Pharmacy Impact Census — gathering info to use with legislators, regulators, the media, and patients. Click here to take it, so your data are included.
And don’t forget that NCPA’s annual convention is in Orlando on October 14 – 18. Early-bird registration ($15 discount!) ends July 31.
Merck sued Gilead for patent infringement. Merck won $200 million in 2016. But then it turned out that Merck’s former attorney… well, let’s just say he didn’t exactly uphold the standard of ethics expected of a lawyer. The verdict was overturned because of his “unclean hands”:
“Merck’s numerous unconscionable acts, including lying, unethical business conduct, and litigation misconduct, the doctrine of unclean hands barred Merck from asserting the patents against Gilead.”
And now Merck finds it not only lost the suit (after winning it), but it must also pay Gilead’s $14 million in attorney fees.
20 million sterile male mosquitoes are about to be released in Fresno as part of an eradication scheme. The bugs are sterilized with a bacterium so they can outcompete the existing males and reduce the number of offspring.
Missouri’s governor has had enough. He issued an executive order establishing a prescription drug monitoring program after the state’s legislature couldn’t do it. Missouri is — um, was, the only state without one.
—Andrew Kantor • Jul. 18, 2017
The FDA is going to require drug makers to have a Risk Evaluation and Mitigation Strategy (REMS) for all opioids, not just extended-release versions. That will include mandatory training for physicians, nurses, and pharmacists.
A REMS is “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”
In the case of opioids, the REMS includes additional education. The FDA will be requiring that for both extended- and immediate-release opioids — and for drug manufacturers to pay for it. In May, the agency released a suggested blueprint for that education (and invited industry comment). Check it out — it’s a 10-page PDF.
We’re gonna skip the marketing jargon here.
If you’re a GPhA member and have a student loan, we can save you a lot of money.
GPhA partners with SoFi, which offers student-loan consolidation. GPhA members get a lower rate than SoFi’s standard.
Here’s the news: From now till September 30, GPhA members who refinance with SoFi get a quarter-percent lower rate below SoFi’s rates.
Here’s the math:
And let’s be real — chances are, if you’re a new PharmD, you owe a bit more than that. (The average 2016 PharmD grad owed $157,425!)
SoFi’s stats show pharmacists save an average of $408 a month over 10 years when they refinance, and that’s without the extra GPhA discount.
Take the two minutes to see what your SoFi rate would be if you refinance. Then the math is easy. (Click here for a loan calculator.
Currently, hospitals that treat a large number of lower-income people get deep drug discounts through the 340B program. Medicare reimburses those hospitals the average sales prices for the drugs, plus six percent.
A new proposal from the agency, though, would change that “plus 6%” to “minus 22.5%.”
The idea is to cut Medicare costs, but critics point out that the cost-cutting is going to be borne by hospitals that treat the poor, notably in rural areas.
Higher levels of vitamin D might protect from and repair sunburn, according to a study published in the Journal of Investigative Dermatology. (Admit it, that’s a cool title for a journal.)
Participants who consumed the highest doses of vitamin D had long-lasting benefits — including less skin inflammation 48 hours after the burn. Participants with the highest blood levels of vitamin D also had less skin redness and a jump in gene activity related to skin barrier repair.
Downside: The doses involved were up to 200,000 IU — way above the recommended dose of 400 IU per day.
The U.S. once again ranks last among modern Western nations when it comes to healthcare — we spend more and get less than anyone else.
The U.K. ranked first overall, but — despite some major gains lately — it still lags in “Health Care Outcomes”; only the U.S. is worse. (Austria ranks number two overall, and has the best outcomes.)
Where we’re good: preventative measures, and “wellness counseling […] shared decision-making with primary care and specialist providers, chronic disease management, and end-of-life discussions.”
Where we’re bad: access (we knew that already), affordability (ditto), “administrative efficiency” (no shock), and of course outcomes, especially for the money we spend.
A new study from the University of Houston suggests that only 15 to 25 percent of our genome might actually do anything useful. The rest is junk DNA.
The idea is simple: Considering the typical number of mutations, if more of our genome was critical we would see a lot more children born with life-threatening genetic defects.
“If 80 percent of the genome were functional, unrealistically high birth rates would be required to sustain the population,” but if only 25 percent is functional, because most deleterious mutations are in that (useless) 75 percent.
Here’s your guide to the colors of your phlegm — and what it means. (Bonus: It also covers textures!)
—Andrew Kantor • Jul. 17, 2017
The Novartis CAR-T cancer therapy — aka CTL019 — was unanimously approved by an FDA panel. What makes CAR-T interesting? It’s the first cancer therapy that’s custom made for each user, reprogramming his or her immune cells to fight a particular type of leukemia.
To use the technique, a separate treatment must be created for each patient — their cells removed at an approved medical center, frozen, shipped to a Novartis plant for thawing and processing, frozen again and shipped back to the treatment center.
CRISPR can potentially cure diseases and bring woolly mammoths back from extinction, but more importantly — it’s been used to store a movie in a bacteria’s genes. Science!
If you thought the pharma bureaucracy here was bad, imagine what they’re looking at in Britain post-Brexit. The word “chaos” keeps popping up.
If the voices in your head are saying you don’t need meds, [it ]mightbe OK to listen to them.
[T]here are now “hearing voices” support groups on all five continents, and over 180 in the U.K., alone, anchored by the Hearing Voices Network. The idea has been slower to take hold in the U.S., which has a strong medical model for treating mental illness, but is gaining steam there, too.
The Senate is considering the nuclear option to craft an Obamacare replacement: bipartisanship.
—Andrew Kantor • Jul. 14, 2017
GPhA President Liza Chapman told APhA how newly-minted CDC director Brenda Fitzgerald supported pharmacy in her role with the state’s Department of Public Health:
“Under the direction and leadership of Dr. Fitzgerald, the profession of pharmacy in the state of Georgia has advanced in providing immunization services and opioid overdose prevention measures to the citizens of the state.”
Yet Another Study — this one out of USC’s Keck School of Medicine — has found that “People who consumed a cup of coffee a day were 12 percent less likely to die compared to those who didn’t drink coffee.” Two or three cups raised that to 18 percent.
While that sounds like drinking coffee can make you immortal, sadly… no. Rather, the huge study (185,855 people) found that “drinking coffee is associated with reduced risk of several types of cancer, diabetes, liver disease, Parkinson’s disease, Type 2 diabetes and other chronic diseases.”
Georgia is the focus of this story on the impact of the proposed Medicaid cuts on rural areas. “Cuts now would cripple rural Georgia,” said Dr. Ben Spitalnick, president of the Georgia chapter of the American Academy of Pediatrics.
Key among those concerns are prenatal care in rural areas. With a maternal mortality rate that is among the worst in the country, OB-GYNs are worried that the cuts would eliminate fragile solutions to doctor shortages that the state has implemented.
…vice chair and associate professor of pharmacy practice at PCOM’s Georgia Campus — she was just selected as a Fellow of the American Association of Diabetes Educators for “outstanding contributions to diabetes education through clinical practice, research, education or health policy.”
More than half of Americans’ debt is related to medical expenses, and now a change to credit reporting will give them (that is, us) a better chance to settle that debt before it hurts their (that is, our) credit ratings.
Starting Sept. 15, the three major credit reporting agencies — Experian, Equifax and TransUnion — will set a 180-day waiting period before including medical debt on a consumer’s credit report. The six-month period is intended to ensure there’s enough time to resolve disputes with insurers and delays in payment.
—Andrew Kantor • Jul. 12, 2017
Here comes “snortable chocolate” — yes, it’s exactly what you think (assuming you think it’s a chocolate powder you sniff like snuff that’s marketed as a stimulant). And here comes the first legislator to say that the FDA really needs to get involved.
Congrats to Georgia’s Dr. Brenda Fitzgerald, officially named to head the CDC (as if you didn’t know by now). You know her, of course, as the head of the Department of Public Health. She’s got a combination of medical chops, Republican connections, and a reputation as a moderate.
“Dr. Fitzgerald is more than prepared to face the health challenges of our time, including climate change, Zika, Ebola, and our growing burden of chronic disease,” said Dr. Georges Benjamin, executive director of the American Public Health Association.
If you’re looking to treat stomach acid, H2 blockers look to be a better choice than proton-pump inhibitors. Why? A study of 275,00 people found that PPIs lead to an increased risk of death.
“No matter how we sliced and diced the data from this large data set, we saw the same thing: There’s an increased risk of death among PPI users.”
A shocking study finds that handwritten prescriptions — notably for opioids — have more errors than electronic ones.
“Overall, the investigators found that 92 percent of handwritten prescriptions either failed to meet ideal practice standards, contained such errors as the absence of at least two patient identifiers, or failed to comply with federal opioid prescription rules.”
Could be worse, though. Could be a Russian prescription:
CDC: When you cook walrus, please make sure it’s well done.
The potential overhaul/replacement of the ACA is still up in the air. The Senate is back from its July recess no closer to an agreement — and it only has a few weeks before its August recess.
—Andrew Kantor • Jul. 10, 2017
Each year we ask GPhA members for their ideas on laws that need to be enacted or changed. And those member ideas get turned into results.
You get the picture.
We’re about to look at the issues we’ll be working on in the 2018 legislative session.
If there’s a law or policy issue you want to see changed — something that will improve patient care or the practice of pharmacy — tell us about it!
E-mail a brief explanation of the issue to our VP of public policy, Greg Reybold, at email@example.com. Yes, it’s that simple.
Deadline: Thursday, July 27 by 5:00 p.m.
Greg compiles all your ideas. The best ones — chosen by our legislative policy committee and board of directors — will become part of our 2018 legislative agenda.
GPhA is your association. Our legislative agenda needs to reflect your idea and your needs. We want your opinion heard. So get e-mailing!
Here’s the story of how Georgia and other states are trying to keep up with all the new opioids appearing on the streets.
At the Georgia Bureau of Investigation’s forensic lab outside Macon, [lab director Brian] Hargett assigned the tablets to one of his forensic chemists. She threw on her gown and gloves, weighed a pill, and dropped it in a skinny vial to soak in ethanol. Then she ran a test designed to separate and identify each substance in the pill. Two synthetic opioids showed up — including one never before seen in Georgia.
Their best guess: the little-known, and lethal, compound known as cyclopropyl.
The Georgia Board of Pharmacy passed an emergency rule regulating a new kind of synthetic opioid — tetrahydrofuran fentanyl — as a Schedule 1 substance. This is the kind that is quickly absorbed through the skin and is resistant to naloxone, too.
Kudos to the BoP for giving police the authority to seize it.
Oklahoma is the latest state to join the Sue the Opioid Manufacturers Club™.
In New Hampshire, opioid manufacturers argued (and won) that the state couldn’t hire outside contractors to sift through paperwork to look for deceptive marketing practices. But the state’s supreme court just overturned that ruling, saying the pharma companies have no say in the state’s contracts with contractors.
—Andrew Kantor • Jul. 05, 2017