High-five for Mandy Reece

A big shout-out to GPhA member Mandy Reece of Gainsville, whose letter advocating for step therapy reform was published in the Gainsville Times. Way to go, Dr. Reece!

(Shameless plug: We love the bill she wrote about — GPhA testified in favor of it earlier this year.)

“No other country allows pharmaceutical companies to charge any price they want for any reason they want”

Two U.S. senators are introducing a bill they say can cut medication costs in the country by more than 40 percent. The idea is simple: Prohibit Medicare and Medicaid from paying more for a drug than the median price in five major countries: Canada, the United Kingdom, France, Germany, and Japan.

And if the drugmakers refuse? By law, Medicare has to pay for every FDA-approved drug, so…

If pharmaceutical manufacturers refuse to lower drug prices below that level, the federal government would approve cheaper generic versions of those drugs, regardless of any patents or market exclusivities in place.

Fido lives

The FDA wants to cut the use of dogs in veterinary drug trials. Among other goals, the agency wants to stop euthanasia and autopsies necropsies and instead have “one single study involving a small number of dogs where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial.”

Nothing is simple

Having pharmacists ready and allowed to dispense naloxone is an easy call, but even using the nasal spray requires at least some training. That makes the issue a bit more complicated.

And then there’s the fact that some pharmacists don’t carry it. Some won’t dispense it without a prescription even when they can. And who should train patients on how to use them?

Stat News looks at the issue … and what comes next.

You had one job

“Alleviate PTSD symptoms.” But it seems Prazosin may do just the opposite.

Joe Kennedy changes his mind

The Massachusetts congressman used to be anti-marijuana legalization. But now, with “patchwork legislation” among the states — most have legalized it to some extent, but some, like Georgia, have not — he says it’s time for nationwide legalization.

“My concerns about the public health impact of marijuana remain. But it has become clear that prohibition has wholly failed to address them. I believe legalization is our best chance to actually dedicate resources toward consumer safety, abuse prevention, and treatment for those who need it,” he wrote.

The long read: “Will we ever cure Alzheimer’s?”

The will is there. The money is there. The researchers are there. So why is this such a tough nut to crack?

Elsewhere: NY legislator goes after mail-order pharmacies

A New York state assemblyman — who’s also a pharmacist — is tired of seeing tens of thousands of dollars in meds go unused.

A lot of the blame, he says, belongs to mail-order pharmacies, and he wants a law…

…that would mandate pharmacies that deliver or mail prescriptions get consent from patients before making each delivery.

Should the pharmacies continue to send unneeded medication, they would be held responsible for retrieving the medication, reversing the insurance claim and disposing of the medication.

PCOM gets dressed

A hearty congratulations to the new student pharmacists from the Philadelphia College of Osteopathic Medicine, who donned their white coats for the first time!

Silence is golden (but Beethoven is a fine choice)

If you’ve been thinking “My patients and customers probably don’t get enough holiday music,” and started playing your own … stop. Too much holiday music is bad for you — so says science.

[T]he brain becomes oversaturated, triggering a negative response. If you’re already worried about money, work, or seeing family during the holidays, the constant inundation of cheerful tunes may reinforce your stress instead of relieving it.

Oh, and it’s not good for you, either:

“People working in the shops [have to tune out] Christmas music, because if they don’t, it really does stop you from being able to focus on anything else…You’re simply spending all of your energy trying not to hear what you’re hearing.”

Drug price moratorium is over

Pfizer, and presumably the rest of the pharmaceutical industry, is preparing to raise list prices on its drugs in January.

The drug giant will increase the list price of about 10 percent of its drugs Jan. 15, the company announced Friday. Most of the increases will be 5 percent, though Pfizer will raise three drugs’ list prices by 3 percent and one drug’s by 9 percent.

But won’t raising prices make drugs less affordable? No, says the company:

“We believe the best means to address affordability of medicines is to reduce the growing out-of-pocket costs that consumers are facing due to high deductibles and co-insurance, and ensure that patients receive the benefit of rebates at the pharmacy counter,” Pfizer’s outgoing CEO Ian Read said in a statement.

Revenge on Montezuma

The FDA has approved Aemcolo (generic: rifamycin) “for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli.”

Up to 40 percent of travellers are affected by this. Zoiks!

ID that pathogen for less than a buck

A new 72-cent test (yes, you read that right) can detect any of dozens of diseases, from dengue, Ebola, hepatitis, and malaria to various cancers. It fits in the palm of your hand, needs no equipment, and requires little training to use.

You have to know what you’re testing for, but tests for dozens of diseases are already available and more are being developed. Health workers can test several patients at once for one disease, or can test one patient for several. It’s all cartridge-based. (Above link to the U.S. news story. Click here for the press release from the National University of Singapore.)

60 Minutes targets Kaleo

It’s the company that makes a naloxone injector, and in the midst of the opioid crisis, it jacked the price of its injector from $575 in July 2014 to $4,100 by January 2017.

Kaleo complemented its price increases with a strategy focusing on getting doctors’ offices to sign paperwork declaring Evzio medically necessary to ensure coverage by Medicare Part D through a formulary exception.

Nuts to you!

The good news is that a treatment for peanut allergies looks to be doing well in its phase-three trials. The less-than-good news: “Desensitization was not easy on the patients.”

When one size doesn’t fit all*

When you see someone in that section looking a little confused, you can be prepared to help with this useful article from — as always — Medical News Today.

Don’t forget the swine flu in China

If you want to keep track of the coming apocalypse, you could do worse than reading “Emerging Infectious Diseases.” In the latest issue: “Multidrug-resistant Salmonella emerges in US.”

Elsewhere: Anti-Science Edition

The biggest chickenpox outbreak in 20 years is hitting a North Carolina private school, where a large number of families claim “religious” exemptions from vaccination.

Wondering what various religions actually have to say about vaccination? Check this out.

“Horrific numbers”

The South continues to be the nation’s center for the ongoing HIV epidemic — it has the highest death rate from HIV/AIDS, and Georgia has the third highest number of infections in the region. The reasons? “[A] social stigma surrounding the disease; poverty; lack of insurance and access to care; and no Medicaid expansion in most Southern states.”

“We in the South have these horrific numbers,’’ said Dr. David Malebranche of Morehouse School of Medicine. “The HIV epidemic is squarely based in the South.’’

Georgia currently has more than 58,000 people living with HIV.

Give yourself a gift

A gift of immunization certification from APhA! It’s your last chance this year: Sunday, December 2, from 8:00 a.m. – 5:00 p.m at the GPhA Education Headquarters in Sandy Springs.

GPhA members get a huge discount — it’s only $349 for the course, which gets you not only the APhA certification, but (if you complete both the self-study and classroom work) a whopping 20 hours of CPE credit.

Check out GPhA.org/2018immunization for the details and sign up today!

Community pharmacy: Ready for your close-up

The good folks at the National Community Pharmacy Association have released their 2018 Snapshot of Community Pharmacy — in the form of a two-minute video.

How many offer MTM services? Home delivery? Hospice? Find out in the snapshot at NCPAnet.org. (The full digest is available to NCPA members.)

When seconds count

Got patients who want fast pain relief? Turns out that regular Tylenol pills actually dissolve faster than “Rapid Release gels.” (Johnson & Johnson says that the gelcaps are “rapid release” compared to conventional gelcaps, not to tablets.)

“A horrific illness”

A cure for sleeping sickness was approved by the European Medicines Agency, meaning it will finally be deployed in Africa.

The disease, also called human African trypanosomiasis, is transmitted by tsetse flies. The protozoan parasites, injected as the flies suck blood, burrow into the brain. Before they kill, drive their victims mad in ways that resemble the last stages of rabies.

Medicare, pharmacies, and formularies

From CMS, it’s the annual guide to “How Medicare Drug Plans Use Pharmacies, Formularies, & Common Coverage Rules.” Click here to download your PDF copy today!

Dems want Medicare to negotiate, but….

As they prepare to take control of the House in January, Democrats want to allow Medicare to negotiate drug prices — something they and candidate Donald Trump agree on. But, in order to be able to negotiate prices, Medicare also needs the power to refuse to pay for certain drugs, the way other countries can. (Without that power, it can’t really negotiate, can it?) And that is going to face opposition from those who want Medicare to have to cover every FDA-approved treatment.

The show premieres January 3.

Ticked off

Tick-borne diseases — “Lyme disease, Powassan virus; spotted fever rickettsiosis, including Rocky Mountain spotted fever, anaplasmosis, ehrlichiosis, babesiosis and tularemia” — hit record numbers in the U.S. last year, says the CDC, and are expected to increase thanks to warmer weather. And that’s just what’s reported. The actual number is probably 10 times higher. Yay.

What, a news report not good enough for you? You want charts, maps, references to the Pope, and really disgusting photos of what the diseases look like*? Fine. Click here for the full 108-page report from HHS’s Tick-Borne Disease Working Group.

Some like it hot (and that’s probably a little better)

“Case closed” reads the headline. The healthiest coffee you can drink, it claims, is …well, it isn’t really answered. All it says is that hot-brewed coffee looks to have more antioxidants than cold brew. (Actually, hot-brewed coffee has more “antioxidant capacity,” whatever that means.)

So don’t close any files just yet.

While we’re looking at dubious claims…

Someone found a nutritionist who says that pizza is a better breakfast food than most cereals. (“Most” in this case meaning the likes of Chocolate Frosted Sugar Bombs, not shredded wheat.)

That’ll do, pig

Admit it, “xenotransplantation” sounds so much cooler than “getting human organs from pigs.” But either way, the result could be the same: saved human lives, and more delicious bacon.

E-cigs in the news

As the FDA prepares to limit where electronic cigarettes can be sold, agency head Scott Gottlieb was getting criticism from conservatives for trying to limit sales. Gottlieb (who used to work for the very conservative American Enterprise Institute*) shot back:

“My former friends in the libertarian community who think this is emblematic of nanny-state government intervention and denying adults access to legal pleasures — I hope that when they sit and think about the data we’re seeing they’re willing to accept modest speed bumps in terms of the access adults will have to these products to hopefully close off the access of these products to kids.”

Meanwhile, e-cig maker Juul is shutting its Facebook and Instagram accounts in an effort not to market to kids. (It’s a bit late to close that barn door, say critics.) It’s also getting rid of its sweeter flavors that appeal to kids.

And elsewhere, other e-cig companies are touting — I kid you not — vaping to get vitamins, with names like “VitaminVape” and “Vitamin Air.”

Congrats to PharmD on Demand

It was just named one of the UGA Alumni Association’s 10th annual Bulldog 100!

Rural Georgia, wired

With some help from Mercer, telehealth services are coming to Jimmy Carter’s hometown — and potentially the rest of rural Georgia.

Ups and downs in Carrollton

Carrollton police say they’ve seized a record amount of oxycodone — 900 pills, plus nearly 100 alprazolam and 81 Vyvanse. They speculate it was likely stolen from area residents.

Tip your hat to the new institution

Having laws and regs keep up with medical advances is tough stuff. One molecular change, for example, and something goes from C-I to unregulated. So UGA’s College of Pharmacy is launching a new institute to teach and explore the issues: the Institute for International Biomedical Regulatory Sciences.

American exceptionalism

The U.S. leads the world in overdose deaths — we have more than twice the rate other modern countries*. Worse, we have the second-highest increase in that death rate (only Estonia’s is increasing faster).

Quitting: No time like the present

It can take 16 years after quitting for heavy smokers not to be at a higher risk for cardiovascular disease.

Antibiotics as nutrition

One way to fight resistant antibiotics is to remove them from the environment. How do we do that? By creating bacteria that eat them, of course.

[Researcher Gautam] Dantas had exposed one group of soil microbes to a dose of antibiotic, which he figured the bacteria wouldn’t eat. A week later, a group grown on a diet of plant matter — and exposed to no antibiotics — had grown only a little. In the dishes filled with antibiotic, however, most of the microbes were having a picnic. Instead of proving deadly, the antibiotics were providing sustenance.

Hypertension med recall, again

Sandoz’s Iosartan potassium hydrochlorothiazide is being recalled again for possible contamination. Note: “The voluntary recall only involves the 100 milligram/25 milligram tablets, it does not involve the other versions of the drug, sometimes sold under the brand names Hyzaar.”

Tomorrow is yesterday

Yesterday the report was that it’s not clear whether fish oil or vitamin D really help people live longer. Pshaw — that was yesterday.

Today the report is “Fish oil cuts heart attack risk, vitamin D lowers odds of cancer death.” (And a different study also found that “Insufficient vitamin D levels [are] tied to earlier death in older men.”

See you tomorrow!

Home Depot and Walmart fight prescription costs

Home Depot and Walmart are turning to “copay accumulator” strategy for their employees’ prescription coverage. In short, if an employee uses a prescription discount card at a pharmacy, the discounted price is charged to the patient’s deductible, not the full price.

Burning rubber

When it comes to approving generics, the FDA is setting records. In October 2018 it bested its previous record of total approvals (set way back in July).

Cancer moving to #1 killer

It seems that cancer is about to take over from heart disease as the number-one cause of death in the U.S.

Try to keep up

Quinoa is so 2014. Today healthy eaters are looking at spelt.

The long read: What happened to U.S. drug prices?

In the 1990s, we were on par with the rest of the world. Today we pay more than any other modern nation. As Jerry Seinfeld might say, “What’s up with that?” The New York Times looks for the answer(s).

New BP guidelines: Forget the targets

Instead of focusing on broad targets (e.g., 120/80), each patient should be evaluated individually for CV risk. So says major new cholesterol management guidelines from the American Heart Association.

Statins are still key, but the idea is to put patients in ‘treatment categories’ depending on their risk, rather than try to get everyone to a specific blood pressure target.

JD Power rates pharmacy chains

Wegman’s tops the list.

Sing out loud, sing out strong

Singing in a group can reduce the effects of Parkinson’s.

[M]otor symptoms significantly improved, which was driven mostly by improvements in upper extremity bradykinesia, tremor, and walking. These results suggest that singing may have benefits beyond improving respiratory control and swallow in persons with PD, improving mood and motor symptoms as well as reducing physiological indicators of stress.

Fish oil, vitamin D: a whole lotta maybe

Two new studies were just released about two popular supplements. Despite the coverage in some mainstream press, the actual results were, well, nothing new.

Fish oil: This research found that it doesn’t seem to do much to protect against heart attack or cancer… but then other researchers found some notable flaws with the study — the placebo wasn’t really a placebo. (Highly concentrated doses of omega-3 fatty acids, like those found in Amarin’s prescription Vascepa, do seem to show a significant risk reduction.)

Vitamin D: A new study finds that it might help reduce cancer rates, but — because cancer can take a long time to develop — it needs more study. Previous studies have shown that Vitamin D “decreases all-cause mortality in adults and older people.”

Bottom line: Nothing has changed.

More power from ya

How about an implanted blood-glucose monitor that uses the glucose itself as a power source? Science*, baby!

Do patients dream of electric pharmacists?

Like so many other industries, there are parts of pharmacy that can be automated. The idea isn’t to put anyone out of a job, but to free humans to do what humans do best. (Hint: Patient interaction.) Prepare to meet your new electronic partners.

Cook the bird

As Thanksgiving approaches, the CDC would like to remind you to cook your turkey — not in the least because there’s a 35-state drug-resistant salmonella outbreak still going on.

Elsewhere: Cannabis-law edition

Confused about where marijuana or any of its derivative oils are legal* in the U.S., post-midterms? Quartz has you covered.

Insert platypus headline here

Are you worried about the duck-billed platypus? Of course you are, and for good reason. Apparently just eating a normal diet (bugs, mostly) means each one ingests half a human’s dose of antidepressants each day. And more.

The types of drugs detected included muscle relaxants, antihistamines, paracetamol, beta-blocking agents and small amounts of medication for Parkinson’s disease.

For some drug classes, such as antidepressants, researchers estimated that trout and platypus could be consuming as much as half the daily therapeutic dose for humans.

Addition: Earlier in the week, we offered our congratulations to two Georgia pharmacists who won reelection this year. We also want to add our congratulations and thanks to Representative Butch Parrish (who ran unopposed). He’s been a one of our pharmacy champions year after year,
and we’re looking forward to continuing to work with him under the Gold Dome. Congratulations,
Butch!

Major e-cig limits are coming

Do you sell e-cigarettes? Be prepared for some “severe restrictions” as the FDA cracks down hard. (Yes, this is about convenience stores and gas stations. But do you really expect that rule not to spread?)

As soon as next week, FDA Commissioner Scott Gottlieb is expected to announce a ban on the sale of most flavored e-cigarettes in tens of thousands of convenience stores and gas stations across the country, according to senior agency officials.

Meanwhile….

Cigarette smoking by Americans is down to its lowest level evah. (But more among some people than others. Low-income undereducated and divorced/separated gays and lesbians living in the South or Midwest still have a ways to go.)

Reminder: Immunization for community pharmacists

Don’t forget about the Pharmacy Times dinner in Buckhead on November 13: Immunization Considerations for the Community Pharmacist. It’s a great way to get ideas for growing the immunization side of your practice

It’s at the South City Kitchen Buckhead (3350 Peachtree Road NE) from 6:00 to 8:00 pm. Click here for more info and to register — no robots allowed.

Pharma foe about to get a lot more power

When the Democrats take control of the House in January, Maryland’s Rep. Elijah Cummings is likely to chair the House Oversight and Government Reform Committee. As Stat explains…

“It’s a high-profile role […] that will give him the opportunity to haul in executives from drug companies or pharmacy benefit managers and demand explanations for their price hikes or murky rebate systems.

AMA considers endorsing drugs from Canada

The American Medical Association is deciding whether to endorse allowing patients to buy drugs in Canada to save money. (Before you get too angry, this would only apply to people physically going to The Great White North and buying those drugs in a brick-and-mortar Canadian pharmacy. No online sales.)

A roundtrip ticket from ATL to Toronto runs about $250, so this is probably more an issue for those northern states.

Should kratom be C-I?

HHS wants to make kratom a Schedule-I drug, like heroin, ecstasy, and LSD (and, amusingly, marijuana — but that’s another discussion).

The issue: Sure, kratom has abuse potential, but it also has use potential to combat addiction (people do use it as an alternative to heroin), and making it C-I means it’s harder to do research.

Read all about it.

Guess who’s back?

If you said “Primatene Mist OTC” you win 150 Internet Points!

Bonus cool science part: It was taken off the market because its propellent contained CFCs, which were ruining the ozone layer. Remember when those were banned? Well, the ban worked, and the ozone is getting a lot better.

This is NOT a path to fixing the opioid problem

The gods of economics will not be denied. And the result, as Stat News explains, is not good at all.

First, big production increases mean the price of street opioids like heroin is going down.

In the early 1980s, a gram of pure heroin cost about $2,200. Today that same amount costs less than $500, nearly an 80 percent decrease. A bag of heroin today will set you back about $5, the cost of a pumpkin spice latte.

Meanwhile increased demand has pharma companies raising the price of the overdose antidote, naloxone.

Given the ongoing devastation of the opioid crisis, you might expect that naloxone would be widely available at a low price. Not so. A decade ago, a lifesaving dose of naloxone cost $1. Today, that same dose costs $150 for the nasal spray, a 150-fold increase. A naloxone auto-injector, approved in 2016, costs $4,500.

This could be a path toward fixing the opioid problem

Turns out that most surgery patients use only a quarter of the post-op opioids they’re given. Even more interesting: The prescription size seems to have more effect on how many they take than any other factor; give them more pills and they take more pills.

“In what we tell patients about what kind of pain to expect after surgery, and how many pills we give, we set their expectations — and what the patient expects plays a huge role in their post-operative pain experience. So if they get 60 pain pills, they think they have to take many of them.”

The long read: When is a placebo no longer a placebo?

Here’s a really interesting idea: What if there’s actually a biological reason for the placebo effect?

New research is zeroing in on a biochemical basis for the placebo effect — possibly opening a Pandora’s box for Western medicine.

Clarification: In Wednesday’s Buzz we said that Texas prohibits pharmacists from giving flu shots. In fact, points out the indomitable Tracie Lunde, Texas only prohibits pharmacists from administering flu shots to children under seven. We apologize for the error.

Medicaid expansion in 17 seconds

Idaho, Nebraska, and Utah voters chose to enact Medicaid expansion under the Affordable Care Act. That makes 36 states that have expanded to program that provides health insurance to more low-income people.

Georgia probable-governor-elect Brian Kemp has said he opposes expansion, which would provide coverage to about 726,000 more Georgians; the state currently has the third-highest rate of uninsured people in the country (behind Texas and Alaska).

Our number two story

The FDA has approved Experior, a drug designed to make cow manure smell better. “The product will likely be marketed as a benefit to the environment.”

It keeps going, and going…

Naloxone nasal spray apparently remains effective long after its expiration date.

• Current, official shelf life: 18 to 24 months.
• Actual tested shelf life: up to 19 months longer (i.e., 3 to 3 ½ years) … and maybe even more than that (testing is ongoing).

Community pharmacists: Looking to grow your immunization biz?

Have we got a dinner for you! Well, the folks at Pharmacy Times do: Immunization Considerations for the Community Pharmacist in Atlanta Buckhead on November 13.

It’s at the South City Kitchen Buckhead (3350 Peachtree Road NE) from 6:00 to 8:00 pm.

Click here for more info and to register — no robots allowed.

CVS über alles?

“CVS Lays Out Vision for Future as Aetna Merger Looms”

Aspirin, reconsidered (for some people)

Daily low-dose aspirin has been a mainstay to protect cardiovascular health, but new studies show that, for those over 70 without existing CV problems, it might do more harm than good.

The power of coffee explained

It’s not in the caffeine (although the caffeine ain’t bad). Much of coffee’s medicinal effect comes from phenylindanes — compounds created during the roasting process.

It is the phenylindanes, rather than any other coffee-related compounds, that seem to inhibit the amalgamation of tau and beta-amyloid. These are toxic proteins, of which the excessive buildup in the brain is a key factor in neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease.

Takeaways: 1) Decaf is as good as regular coffee when it comes to protecting your brain, and B) Darker roasts are better than lighter ones.

TLC and a teddy bear

When it comes to younger children, the best medicine — at least for a common cold — is probably no medicine at all. (That’s according to a review of studies in the British Medical Journal.)

Grain of, er, salt

Conventional wisdom says that too much salt isn’t good for your heart. But the actual data? It’s not nearly as clear.

This is why what you do is important

Texas law doesn’t allow pharmacists to give flu shots. One doctor had to wait more than two weeks to get his son a shot — and it was too long.

NDC countdown

Did you know the FDA is running out of NDC numbers? It’s holding a meeting to figure out what to do about it. (No worries: It has at least a decade, and it’s well aware of the pace of government change.)

No backsies

The drug industry is fighting to repeal a bipartisan law passed just this year — it mandates they give larger discounts to Medicare patients who fall into the “doughnut hole.”

The word to note is “could”

“Kroger could consider selling pharmacy business after Walgreens deal”

Do they have the bendy kind? With stripes?

How do you deliver precise medication doses to individual cells? How about nanoscale straws?

[Researchers] successfully delivered molecules into three human cell types as well as mouse brain cells, all of which had proved difficult to work with in the past.

What’s more, the method was more precise, faster, and safer than other methods. The nanostraw technique took just 20 seconds to deliver molecules to cells, compared with days for some methods, and killed fewer than 10 percent of cells, a vast improvement over standard electroporation.

There, there

Let’s all send thoughts of encouragement to AstraZeneca CEO Pascal Soriot, who bemoans the fact that he’s the lowest-paid pharma CEO in “the whole industry.”

“You know, it is annoying to some extent. But at the end of the day, it is what it is. I’m not going to complain, but me and Emma (Walmsley, chief executive of Glaxo Smith Kline) are the lowest-paid in Europe and the US.”