What to Know

OTC hearing aids get closer

We told you a while ago that the FDA was totally OK with OTC hearing aids. Now a bill’s been introduced to make that a reality: “The Over-the-Counter Hearing Aid Act of 2017.”

Court rules for Rite Aid in the Case of the Needlephobic Pharmacist

The Second Circuit Court ruled that yes, Rite Aid could fire a pharmacist who was afraid of needles, and that it didn’t violate the Americans With Disabilities Act.

The bottom line: The ADA doesn’t supercede the need to perform the essential functions of their job, and giving vaccinations was such a function.

Accountants looking to get all up in FDA’s business

The Government Accounting officeis apparently looking into how drug companies are using the FDA’s Orphan Drug Program — and the possibility that ‘regulatory changes’ might be needed.

The sense of scents

Ladies, do you need smell training? It could be — being able to smell better apparently leads to a more active social life. Who knew?

Pharma’s bad rap means bad rep

Shocker: Pharmaceutical companies’ reputations have suffered lately. Patient groups surveyed have a much less positive view than they did just a couple of years ago.

Counting on it

If you thought your smartphone couldn’t be used (“with a few phone accessories”) to track sperm counts, you were wrong.

—Andrew Kantor • Mar. 23, 2017

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Congress considers letting Americans buy drugs in Canada

Trump pledges to lower prices, so…

[A]n old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

But wait, here’s an important tidbit: “The bill allows not only individuals but drug wholesalers and pharmacies to buy from Canada.”

Read all about it.

It’s time to head to DC

The National Community Pharmacists Association is holding its annual “Congressional Pharmacy Fly-In” — that’s when it gathers a few hundred pharmacists for a day of putting the pressure on Congress.

In case you missed it, there’s been some talk of changing the healthcare landscape. You might want to, you know, help shape that process.

Check it out, make your reservations, and give ’em what-for.

Macho, macho men

Men, it seems, really go for those ‘is your testosterone low?’ ads on TV.

What goes up doesn’t always go up

Eli Lilly did the math. It seems that the amount it raises list prices doesn’t correlate with the amount its profits increase. That’s because rebates have gone up so much and pharma pricing is complicated — kind of like a three-body problem but with dollars instead of planets.

Last chance for some free CPE in March

Don’t forget, tomorrow — Thursday the 23rd — is our free CPEasy webinar, “Pharmacy-EHR Integration and More.” It’s 1.5 hours of CPE, you can take it from home, and it’s free thanks to Alliant Quality. Check it out!

Hall County drug bust

Perhaps someone should tell these teachers that “Breaking Bad” was fiction‘.

What could YOU do with $300 million?

Yikes: Just looking at the “tip of the iceberg,” researchers found that Americans pay at least $730 million a year to treat gunshot injuries — and almost $300 million of that comes from taxpayers.

—Andrew Kantor • Mar. 22, 2017

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Fast start, long-term use

According to new CDC data, one in five people who receive a 10-day prescription for opioids will still be taking them a year later.

(That does not necessarily mean that their becoming addicted, of course. Some of those people are prescribed a 10-day supply because of chronic pain, so of course some of them will still be taking the meds a year later.)

But the data are still scary:

  • One-day supply: 6 percent chance of still using opioids a year later
  • Five-day supply: 10 percent chance
  • Six-day supply: 12 percent chance
  • 10-day supply: 20 percent chance

Convention registration is open!

Just a reminder that registration for the 2017 Georgia Pharmacy Convention is open. It’s the biggest even for Georgia pharmacy pros all year. You’ll be hearing plenty more, but for now head over to GPhAconvention.com for the details and to register.

Tell us what you really think

Useless” and “pathetic” read the tweets about PhRMA, the drug manufacturers trade group. But they didn’t come from where you think — they came from doctors, entrepreneurs, and the former head of R&D at Pfizer.

Repatha passes big test

It can have a significant effect on lowering cholesterol and reduce heart attacks and strokes. Downside? Come on, guess. If you said “the price,” you win.

The company is offering discounts of 30 to 35 percent on the treatment, though.

In case you’re wondering about the trial of the owner of that compounding center in Massachusetts…

… the jury asked the judge to clarify the definition of “murder.”

—Andrew Kantor • Mar. 21, 2017

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Fast start, long-term use

According to new CDC data, one in five people who receive a 10-day prescription for opioids will still be taking them a year later.

(That does not necessarily mean that their becoming addicted, of course. Some of those people are prescribed a 10-day supply because of chronic pain, so of course some of them will still be taking the meds a year later.)

But the data are still scary:

  • One-day supply: 6 percent chance of still using opioids a year later
  • Five-day supply: 10 percent chance
  • Six-day supply: 12 percent chance
  • 10-day supply: 20 percent chance

Convention registration is open!

Just a reminder that registration for the 2017 Georgia Pharmacy Convention is open. It’s the biggest event for Georgia pharmacy pros all year. You’ll be hearing plenty more, but for now head over to GPhAconvention.com for the details and to register.

Tell us what you really think

Useless” and “pathetic” read the tweets about PhRMA, the drug manufacturers trade group. But they didn’t come from where you think — they came from doctors, entrepreneurs, and the former head of R&D at Pfizer.

Repatha passes big test

It can have a significant effect on lowering cholesterol and reduce heart attacks and strokes. Downside? Come on, guess. If you said “the price,” you win.

The company is offering discounts of 30 to 35 percent on the treatment, though.

In case you’re wondering about the trial of the owner of that compounding center in Massachusetts…

… the jury asked the judge to clarify the definition of “murder.”

—Andrew Kantor • Mar. 20, 2017

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Our bill passes!

Our patient protection bill has passed both houses of the Georgia legislature and is now on the way to Governor Deal for, we hope, his signature.

While compromises had to be made to pass the bill, what emerged is still one of the strongest pharmacy patient protection bills in the country. It’s a bill we are extremely proud of.

Specifically, this bill gives the commissioner of insurance the authority to create rules and regulations to enforce the specific provisions of the PBM chapter of the law. We can’t overstate how important this is. PBMs are licensed with the commissioner of insurance and, while pharmacies may often be bound to private arbitration, the commissioner is not. This provision alone would be a significant victory.

But there’s much more in the bill. It would specifically prohibit several practices that have adversely impacted patients and pharmacies.

  • PROHIBITED: Restricting pharmacies from providing patients with information about less costly prescription drugs (and selling them those less-costly drugs).
  • PROHIBITED: Restricting pharmacies from offering direct-delivery services to their patients as an ancillary service.
  • PROHIBITED: Charging patients copays that are higher than what the pharmacy is paid (i.e., copay clawbacks).
  • PROHIBITED: Charging pharmacies fees related to the adjudication of a claim (transaction fees).
  • PROHIBITED: Recouping money from a pharmacy outside of the audit process, unless otherwise authorized or required by law.
  • PROHIBITED: Penalizing or retaliating against a pharmacy for seeking to enforce their rights under the law.
  • PROHIBITED: Mandatory mail order under group, blanket, and individual accident and sickness policies. (There are several large swaths of the mail-order market that this bill will not directly impact due to federal law and other considerations.)

These protections are vast and would typically take years and years to obtain legislative codification. However, thanks to the support of Senator Mullis, Representative Knight, the many cosponsors, and the work of pharmacists who have been tirelessly fighting for these bills, we are one signature away from seeing this bill become law.

The AJC covers drug thefts

The Atlanta Journal-Constitution has a feature story on how the opioid epidemic is leading to more crime — specifically pharmacy robberies.

Celebrate

While you’re busy celebrating St. Patrick’s Day, don’t forget that March is Colorectal Cancer Awareness Month. What, did we spoil the mood?

Not everyone supports legalizing marijuana

Attorney General Jeff Sessions calls marijuana use a “life-wrecking dependency” that’s only “slightly less awful” than heroin addiction.

What, you worry? (Yes)

The title: “Cross-sectional Comparison of the Epidemiology of DSM-5 Generalized Anxiety Disorder Across the Globe.”

The conclusion: People in high-income countries are significantly more anxious than people in low- and middle-income countries.

Trump’s budget and healthcare

We waited to mention the proposed budget until we found a source/commentary that was focused on the pharma side of it (and less likely to raise partisan hackles).

It took a day, but we did it. Presenting BioPharma Dive’s look at Trump’s budget proposal, which, obviously, is only a starting point.

Gesundheit

More people are suffering from allergies, but more of them are turning to OTC solutions rather than going to see a physician. Why? Easy: Meds that used to be prescription-only are now off the shelf.

About 60 percent of allergy sufferers took the OTC route in 2015 — up 20 percent from just eight years previously.

—Andrew Kantor • Mar. 20, 2017

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Get out

The UGA College of Pharmacy was rated as one of the best colleges for outdoor enthusiasts by Pharmacy Times:

Certainly one of the most respected school in the United States, the student recreational activities available here have been ranked number one in the country for 10 years straight , and the competition isn’t even close.

Good bill, awful name

A bill introduced by U.S. Senator Ron Wyden — the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act” (seriously) — would require PBMs to disclose at least some of the rebates and discounts they receive from drug makers when Medicare Part D or Advantage plans are involved.

The effects of high U.S. drug prices

Hospitals are cutting back on their formularies, rejecting new, expensive drugs unless there’s a compelling reason to use them… but that’s spurring some sparring with various departments.

Meanwhile some cancer patients are skipping or delaying their medications because they can’t afford them.

Early-bird convention registration ends Friday

See the headline? Good. Just a reminder that you’ll get the best rate for the 2017 Georgia Pharmacy Convention (Amelia Island!) if you register before the end of the day Friday, March 17. St. Patrick’s Day. Go to GPhAconvention.com.

Merck sued over shingles vaccine

It seems people are complaining that Merck’s Zostavax shingles vaccine is causing problems: rashes, seizures, chickenpox, and even one case of liver failure.

An idea so crazy it just… might… work

What if — now hear this out — what if, when you made a mistake, you admitted it, apologized for it, and did your darnedest to make things right? Crazy, huh?

Apparently, it’s working for some hospitals better than “deny and defend.”

[P]rograms to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular.

NCPA: End PBM pick pocketing

Doug “CEO of NCPA” Hoey has an op-ed in Morning Consult on the evil that is DIR fees — and how Congress is — and should be — working to eliminate them.

IMPORTANT NEWS

Hershey’s Easter chocolate products — including the new Carrot Cake Kisses — are now hitting shelves.

—Andrew Kantor • Mar. 16, 2017

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Live long(er) and prosper

Your kids aren’t killing you, despite what you may think. They’re actually helping you live longer.

Medicaid and addiction in Georgia

In case you were wondering (and simply because we stumbled on this fact while scouring the news), Medicaid pays about 6.5 percent of Georgia’s addiction-treatment bills.

A bold (and frightening) experiment to combat malaria in West Africa

Scientists working in Burkina Faso, West Africa, are considering a plan to eradicate a species of mosquito that has caused millions of deaths by malaria. But it’s a very different kind of experiment.

You may have heard of the idea of tweaking the genes in male mosquitoes to make them infertile, thus reducing the population where they’re released; they outcompete the fertile males and reduce the population. This has been done successfully in South and Central America, and may even be used in the U.S.

The Burkina Faso plan is a very different experiment. In this case, scientists would use a gene drive. (That is a phrase you’ll want to know for the future.)

A gene drive not only makes a change to an animal’s DNA, it also includes the mechanism to push that change into future generations.

Normally a gene has a 50-50 chance of being passed on (you know, from either mom or dad). A gene drive essentially forces a gene to be passed on, skewing that 50-50 chance — and it passes that skewing mechanism on as well.

The experiment being considered in Burkina Faso would create Anopheles gambiae mosquitoes that only produced male children… and whose children only produced male children.

It has the potential to save untold millions of lives… but a gene drive has never been released in the wild, and its long-term effects aren’t known.

Know a great pharmacist?

Maybe you should nominate her or him for a GPhA award. The deadline is coming up — head over to GPhA.org/awards to get info and nominate someone!

A startling gap in cystic fibrosis survival

Cystic fibrosis patients in Canada live an average of 10 years longer than they do in the U.S. The likely causes (plural): differences in diet recommendations, more lung transplants in Canada, and better access to healthcare in Canada.

—Andrew Kantor • Mar. 16, 2017

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Legislative update: week 8

Following crossover, GPhA’s priority patient protection legislation — SB 103 and HB 276 — enjoyed a good week. Both bills were favorably reported in their respective committees; SB 103 passed the House Insurance Committee unanimously on March 8 and HB 276 passed the Senate Insurance and Labor Committee unanimously on March 9.

We’re hoping for floor votes this week or next.

Vitamin C might slow cancer stem cells

Study: Early results seem to show that vitamin C might inhibit the growth of cancer cells — “it is a promising agent for clinical trials.”

Headline coming soon: “Vitamin C cures cancer!!!”

Artful tax dodging?

Could pharma companies be abusing the Orphan Drug Act? The intent of the law was to give drug makers incentives — tax breaks and exclusive rights — for developing drugs to treat rare diseases. Instead, pharmaceutical companies have been resubmitting existing drugs for treating those diseases … and reaping the benefits.

Botox, stocked in most dermatologists’ offices, started out as a drug to treat painful muscle spasms of the eye and now has three orphan drug approvals. It’s also approved as a mass market drug to treat a variety of ailments, including chronic migraines and wrinkles.

Now three GOP senators want the Government Accounting Office to look into the practice.

Last chance coming up

If you want to nominate yourself or someone else for a seat on the upcoming GPhA Board of Directors, those nominations close on March 31.

That may seem like a long way off, but the form asks a lot of questions, so you want to get started ASAP.

Get more info and apply at GPhA.org/board2017.

Isakson says marijuana should be rescheduled

In a town hall meeting, Georgia GOP Senator Johnny Isakson said he believes marijuana ought to be rescheduled. (It’s currently Schedule I, implying that it’s more dangerous that heroin.)

Atlanta: Come for the emissions, stay for the brake dust

A Georgia Tech study finds that a “cloud of tiny metal particles” from automotive brakes and tires is a major source of air pollution and respiratory distress.

What makes this interesting: This stuff isn’t going away even as more low- and zero-emissions cars hit the road.

—Andrew Kantor • Mar. 13, 2017

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Neanderthal pharmacists

Looking at DNA in dental plaque of Neanderthals,researchers found that they may have self-medicated with aspirin (from poplar bark) and penicillin (from mold).

“Apparently, Neanderthals possessed a good knowledge of medicinal plants and their various anti-inflammatory and pain-relieving properties, and seem to be self-medicating.”

Life 2.0

Scientists are five steps closer to creating an artificial yeast — that is, building the organism from scratch with chromosomes designed and built in the lab.

They’ve created six of a yeast’s 16 chromosomes so far, and they expect to complete the job by the end of the year. If successful in combining the chromosomes in a cell, it will be the most complex form of artificial life ever created. “Nothing can possibly go wrong.”

Spring cleaning your medication

U-Save-It pharmacist — and GPhA member — Betsy Urick of Albany offers WALB viewers advice on cleaning out their medicine cabinets for spring.

Study links pot smoking to heart disease and stroke… sort of

Now that marijuana is becoming legal (to different degrees) in more places, researchers are finally able to, you know, do research on it.

One new study, based on reviewing medical records, finds there may be an increased risk to cardiovascular health — in fact, a tremendous increase: a 26 percent increase in the risk of stroke and a 10 percent increase in the risk of heart failure.

Two big caveats, though. First, the study was based on hospital discharge records, so patients were already sick (“the findings may not be reflective of the general population”). Second, it was only based on patients who admitted to marijuana use.

Bill would allow employers to demand genetic testing

A bill quietly moving through Congress would allow employers to demand their employees’ genetic information and test results — and fine them if they refuse to submit to testing.

The idea is that employers can, under the ACA, charge employees up to 50 percent more on their health insurance premiums (or simply charge them a fine) if they decline to participate in workplace wellness programs. This new bill would effectively include genetic testing as part of those programs.

If you’re getting medical advice from celebrities…

stop.

—Andrew Kantor • Mar. 13, 2017

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Two critical victories for our bill

Our patient-protection bill took two seemingly small but important step forward: It got through both the house and senate insurance committees (“insurance and labor” in the senate).

These may seem like easy wins because both chambers already passed identical versions, but in politics nothing is guaranteed. So we’re happy to have passed these hurdles and gotten two steps closer to the endgame.

Next: The bills are voted on by the full chambers, where they passed handily once before. Assuming that happens again, the final bill will go to the governor.

Report: R&D doesn’t justify high U.S. drug prices

Pharma companies have said that a major reason for high drug prices is the cost of research and development (although that doesn’t explain why they raise prices).

But now a new study finds that turns out not to be the case.

Looking at the 15 drug companies that manufactured the 20 top-selling drugs in 2015, the researchers found that…

  • List prices of drugs in the U.S. were 144 percent higher than in other developed countries.
  • Those higher prices earned drug makers $116 billion more (i.e., $166 billion more than if U.S. prices were on par with other countries’).
  • Those drug makers only spent $76 billion on R&D worldwide.

So, they concluded, the U.S. markup isn’t justified by the cost of R&D.

I saw a werewolf drinking a piña colada at Trader Vic’s

Apparently taking Propecia — and other drugs based on finasteride or dutasteride — can cause erectile dysfunction and other such side effects.

Janssen sheds some light on its drug pricing and profit

Johnson & Johnson’s Janssen released its “transparency report” on its pricing, and it’s actually interesting. For example, while the company’s list prices rose 8.5 percent in 2016, when you take into account rebates and discounts the net increase (i.e., what goes to the company’s bottom line) was only up 3.5 percent that year.

What isn’t clear, though, is how much the cost to insurance companies and individuals changed. (Which is something Janssen can’t provide, anyway.) Why? Because that would tell us how much is being taken in by middlemen — e.g., PBMs.

Put another way, Janssen’s take only went up 3.5 percent — but if the average co-pay went up 6 percent… well, you can figure out who’s pocketing the difference.

This could be interesting

Two congressmen said Trump is on their side when it comes to a bill that would overturn existing law and allow Medicare to negotiate drug prices directly with manufacturers.

Perspective 1: Other developed countries (where the government pays for most/all drugs) negotiate prices, and they pay a lot less than the U.S. does. Ergo, if Medicare negotiated prices they would come down considerably.

Perspective 2: It wouldn’t make that much of a difference because Medicare prescription benefits are usually handled by private companies, and they (or their PBMs) already negotiate prices.

File under “We shall see.”

—Andrew Kantor • Mar. 10, 2017

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