Is This A Treatment For The Opioid Crisis The DEA Doesn’t Want You To Know About?

Is This A Treatment For The Opioid Crisis The DEA Doesn’t Want You To Know About?

DEA gives some of Pfizer’s injected narcotics allotment to competitors as production issues intensify shortages

https://www.fiercepharma.com/manufacturing/dea-gives-some-pfizer-s-injected-narcotic-allotment-to-competitors-to-alleviate

Pfizer, the largest U.S. producer of injected narcotics, said Wednesday it has resumed production of some of the prefilled syringes that have been in short supply and expects to have the first shipments to wholesalers in July.

But Pfizer will have a smaller allotment to send after the DEA recently gave some of its narcotics quota to competitors because of ongoing problems that have left hospitals scrambling and Pfizer unable to meet demand.

Over the last year, a series of manufacturing issues at Pfizer have exacerbated a shortage of hospital-administered painkillers. With pressure building from healthcare providers, the DEA—which controls narcotics quotas—took steps to fix the situation.

Last month, the agency asked Pfizer to surrender some of its narcotics allocation, then turned around and gave the valuable supply allotments to three other drugmakers that could actually produce the essential drugs.  

Without naming Pfizer, the DEA said in an announcement explaining its action that the largest U.S. manufacturer of the injectables had to slow production of the drugs while it made “required upgrades” to its McPherson, Kansas, plant where the drugs are made and filled. It said the company voluntarily surrendered a portion of its allotment, which the DEA reallocated to three other drug companies.

Pfizer acknowledged Wednesday it was the subject of the action, saying that after it was notified by the DEA, it reassessed how much product it was likely to produce this year and “responded quickly to relinquish some of our DEA API allocation.”

One of the companies to get the extra allotment is West-Ward, which in an email confirmed it had gotten some but not nearly enough.

“In the U.S., there is currently a shortage of injectable opioids used in hospitals for the management of pain, due to the dominant supplier in the market temporarily ceasing manufacturing,” West-Ward said in a statement. “We, and the manufacturers who remain in the marketplace, are trying to make up for a nearly 60% drop in supply that is currently affecting patient care.”

“While the DEA recently granted some additional quota for us to purchase the active pharmaceutical ingredient (API), we continue to submit requests for further quota to meet our customer needs,” the company said.

The shortage of these hospital-administered pain medications, including morphine and fentanyl, started a year ago when Pfizer reduced output of prefilled syringes as part of an upgrade at its troubled sterile drug manufacturing site in McPherson, Kansas. Last fall, Pfizer told customers that because upgrades were taking longer than expected, “full recovery dates of prioritized prefilled syringes” had moved to Q1 2019 and deprioritized syringes to Q2 2019.  

Then earlier this year, the problem worsened when the contractor that makes a key component of the Carpuject and iSecure injectors Pfizer uses with those drugs ran into its own production issue. To ensure safety, Pfizer said it had to put a quality hold on the injectors, again interrupting production.

The company said that it has been working closely with its supplier to fix the “root cause” of the injector problem and get a handle on the impact on its existing inventory and product supply moving forward. Additionally, Pfizer said it is “exploring the feasibility of increasing capacity within the global Pfizer manufacturing network and potential third party suppliers.”

Wednesday Pfizer spokesman Steven Danehy said in an email that the company has resumed production of its Carpuject prefilled syringes and that the first shipments are expected to reach wholesalers in July 2018, “and we will work to expedite the process where possible.”

“We recognize the importance of these medications to patients and physicians and are committed to resolving these shortages as quickly as possible. We continue to work toward full recovery across the opioids product line in 1Q – 2Q 2019.”

Medical care .. rationed by corporate policies and bottom line ?

Another close friend of mine with an uncurable chronic condition also had Walmart refuse her pain medication after going to that exact pharmacy 2 years! I refuse to go go Walmart, CVS or anywhere that will hurt me or other pain patients. I contacted Walmart and will again on Monday. I’m calling the corporate complaint number. There are too many suicides over scared doctors and now we have to deal with judgemental businesses!
Here’s what was shared:
Found out a couple of weeks ago that my husband has cancer. Today I had a fight with the walmart pharmacist on the phone because “they” didn’t want to fill the full prescription of liquid hydocodone. I asked who “they” were that know so much better than my husband’s doctor. She said it was Walmart’s policy. I said The man has cancer & cries every time he tries to swallow! Oh, she didn’t know he had cancer, that changes everything.

She called his doctor to verify the diagnosis. My son wrote this as his status after my pit bull fight with the pharmacist. He put it into words I could never find.
“My dad has cancer. Possibly 2 types of cancer. Rant follows:
There is some truly messed up stuff going on in this country. People were shouted down when they made comments about “death panels” in relation to Obamacare. That’s where a licensed medical doctor and all the knowledge and experience they’ve gained, studied and paid for are overruled by a group of people with no medical training or certification. Let that sink in. A licensed person with intimate knowledge of your medical history and condition orders a test or procedure in your best interest. Well, some panel at an insurance company somewhere decides that you don’t need that test or procedure because it’s too expensive and your doctor must have had a lapse in judgement and didn’t order the cheaper tests first. Even though those tests won’t show what your doctor needs to know to effectively treat you. So when my father’s doctor ordered a PET scan, of course the insurance company balked. Fast forward through an arduous 3 months of daily fighting with the insurance company, useless tests and back and forths with the doctors office and the random person of the day at the insurance company as to who’s lying when they say the appropriate paperwork hasn’t been correctly filled out and submitted, dad finally gets the PET scan. Guess what? That educated, licensed medical doctor was right. It’s cancer. Cancer that’s been allowed to grow unchecked for 3 months with all the added stress of everything listed above.

Fast forward to today:

Dad had a biopsy on a spot in his throat. It’s cancer too. The man can’t swallow now. Reduced to tears every time he takes a pill or tries to stay hydrated because I won’t let him run that risk. The doctor gives a prescription for a liquid – wait for it – opioid. That’s right. We have an opioid “epidemic” in this country and we all know that just one taste of a medically prescribed pill for a legitimate reason will reduce you to a heroin addict overnight. We must protect you from yourself. And in that light,

Walmart has a policy about just how much of that opioid you can have. Again, your doctor must have had a lapse of judgement and almost condemned you to a life of shooting heroin. But here comes Walmart to the rescue! They know what’s best for you.

Ignore your doctor and his uneducated, misguided ways. During an argument with the pharmacy it slips that dad is a cancer patient. Walmart immediately back pedals. “Oh! We didn’t know he was a cancer patient! That changes everything.” Well no shit you didn’t know! You’re not a medical professional with a right to that information according to HIPPA. How does that knowledge change anything? Oh because Walmart’s policy allows them to fill the full prescription for cancer patients. But the rest of you opioid dependent, heroin overdose waiting to happen people can only have what Walmart thinks you need.”

 

Medicare compounds the (Opiate) epidemic by funding needed opioids that can be abused

https://www.washingtonpost.com/news/powerpost/wp/2018/05/25/unseen-face-of-the-opioid-epidemic-drug-abuse-among-the-elderly-grows/

The face of the nation’s opioid epidemic increasingly is gray and wrinkled.

But that face often is overlooked in a crisis that frequently focuses on the young.

Consider this: While opioid abuse declined in younger groups between 2002 and 2014, even sharply among those 18 to 25 years old, the epidemic almost doubled among Americans over age 50, according to the Substance Abuse and Mental Health Services Administration.

Because of information like that, the Senate Special Committee on Aging convened a hearing Wednesday on opioid misuse by the elderly.

“Older Americans are among those unseen in this epidemic,” said Sen. Robert P. Casey Jr. (Pa.), the top Democrat on the panel. “In 2016, one in three people with a Medicare prescription drug plan received an opioid prescription. This puts baby boomers and our oldest generation at great risk.”

Unwittingly, Medicare compounds the epidemic by funding needed opioids that can be abused, but, generally, not funding the care and medicines needed to fight opioid addiction.

“Overall, one in three older Americans with Medicare drug coverage are prescribed opioid painkillers. However, while Medicare pays for opioid painkillers, Medicare does not pay for drug and alcohol treatment in most instances, nor does it pay for all of the medications that are used to help people in the treatment and recovery process,” William B. Stauffer, executive director of the Pennsylvania Recovery Organizations Alliance, in Harrisburg, Pa., said at the hearing. “Methadone, specifically, is a medication that is not covered by Medicare to treat opioid use conditions.”

Offering scary statistics and practices involving older folks, Gary Cantrell, a deputy inspector general at the Department of Health and Human Services, said “our nation is in the midst of an unprecedented opioid epidemic.”

He focused on Medicare Part D beneficiaries. Part D is the prescription drug section of Medicare, the government health insurance program covering older people. About a half-million Part D recipients “received high amounts of opioids” in 2016, Cantrell said. Almost 20 percent of that group are at “serious risk of opioid misuse or overdose,” he warned, placing the high risk in two categories — those receiving “extreme amounts of opioids” and some “who appeared to be ‘doctor shopping.’ ”

Doctor shoppers “each received high amounts of opioids and had four or more prescribers and four or more pharmacies for opioids,” Cantrell explained. “While some of these beneficiaries may not have been doctor shopping, receiving opioids from multiple prescribers and multiple pharmacies may still pose dangers from lack of coordinated care. Typically, beneficiaries who receive opioids have just one prescriber and one pharmacy.”

Many elderly get hooked on opiates through prescriptions, rather than street drugs like heroin.

“Older adults are at high risk for medication misuse due to conditions like pain, sleep disorders/insomnia, and anxiety that commonly occur in this population,” said Stauffer, who is in long-term recovery. “They are more likely to receive prescriptions for psychoactive medications with misuse potential, such as opioid analgesics for pain and central nervous system depressants like benzodiazepines for sleep disorders and anxiety. One study found that up to 11 percent of women older than age 60 misuse prescription medications. The combination of alcohol and medication misuse has been estimated to affect up to 19 percent of older Americans.”

Sixty-one-year-old Denise Holden is in long-term recovery, too, but she became addicted as a young woman seeking a heroin high. She’s been in recovery for almost 25 years, after first using drugs when she was 19. She got clean, then relapsed, as is common, then got clean again. Staying that way, even after decades clean, is not easy.

“I recently had back surgery,” the West Melbourne, Fla., resident said in an interview. “I had a spinal fusion and so I had been taking opiates for a period of time. You know, the older we get the more aches and pains we get. … We injure ourselves, we have surgeries. So, for people in recovery it’s a slippery slope because when you reintroduce that opiate to your system, your mind starts playing all kinds of tricks on you — ‘Oh you should take more, oh you should take less, oh you should throw them out. Oh no, take them all at once.’ It’s very difficult, like it’s a mind game. It is very challenging I would say, but it’s not impossible.”

Holden urged seniors to take medicines only as prescribed, and if they have suffered drug abuse to “work a very strong program of recovery.”

Addiction isn’t the only risk with opioids. Sen. Susan Collins (R-Maine), chairwoman of the committee, said, “Older adults taking opioids are also four to five times more likely to fall than those taking nonsteroidal, anti-inflammatory drugs.”

That points to a vicious cycle. Taking opioids can lead to falls, falls can lead to pain, pain can lead to opioids and opioids can be abused. On top of that, doctors might not even realize the source of an elderly patient’s problem.

“Regrettably,” Collins added, “health-care providers sometimes miss substance abuse among older adults, as the symptoms can be similar to depression or dementia.”

MO Cops… breaking state law… stealing money from kids and schools.. enabled by AG Session ?

Missouri Cops are Diverting School Funding and Making a Joke of State Law

https://stopthedrugwar.org/chronicle/2018/may/23/missouri_cops_diverting_school_funds

Responding to myriad tales of abuses, like many other states, Missouri has reformed its asset forfeiture laws to require a criminal conviction before cash or property is seized and, in a bid to prevent “policing for profit,” to require that money seized by state law enforcement agencies goes solely to the state’s schools.

Under Missouri law, seized cash is supposed to go to the schools, but the cops have found an end-around. (Wikipedia)

Somebody needs to tell the cops. As Kansas City TV station KMBC reported, state and local law enforcement agencies seized more than $19 million in the past three years, but only some $340,000 has actually made it to the schools. That’s a measly 2% of the cash seized.That’s because police, with the help of the Trump Justice Department, are doing an end run around the state law. Under the Justice Department’s Equitable Sharing Program, which was suspended late in the Obama administration but reinstated last year by Attorney General Jeff Sessions, state and local law enforcement agencies can hand their cash-laden cases over to federal prosecutors instead of turning them in to local district attorneys. And when they do, the reporting agency gets to keep 80% of the seized cash, with the Justice Department getting the rest.

The scheme not only subverts state law by diverting much-needed funding for schools to police agencies, but also by allowing state and local cops to seize cash and goods under the federal law, which does not require a criminal conviction first. In this manner, Missouri’s cops are not only ripping off the schools, they are also giving a big middle finger to the state’s democratically elected representatives who passed the asset forfeiture reform law.

The cops like things just as they are.

“We can immediately put that back in our tool belt if you will,” said Major Derek McCollum, the head of the Kansas City Police Department’s Asset Forfeiture Squad. The money buys “computer type equipment, covert surveillance type equipment,” McCollum told KMBC, adding that he didn’t feel like law enforcement was taking money from the schools.

The Missouri School Board Association begs to differ.

“Absolutely, the constitution says it is,” said association attorney Susan Goldammer of the forfeiture money. “We still have school districts that don’t have air conditioning or have concerns about asbestos. We’ve got many, many school buildings in the state that are way more than 100 years old,” she added.

Instead of turning forfeitures over to the state’s school system, the state Highway Patrol spent $70,000 on new weapons. And in Phelps County, which sits astride the east-west throughway Interstate 44 and which profited the most from asset forfeiture, the sheriff spends the money on the department’s buildings — not school buildings.

State Rep. Shamed Dogan (R-St. Louis) is working on a partial fix. He has authored House Bill 1501, under which only cases involving more than $50,000 could be handed over to the feds. (He had originally pegged the figure at $100,000, but has now halved it after “pushback from law enforcement.”)

Dogan told KMBC that cases over $50,000 account for about 20% of asset forfeiture cases statewide and that he believes many smaller seizures are from innocent victims or involve rights violations.

“We can eliminate that incentive for them to just take money or take property,” Dogan said. “The government seizes their money and says, “we think you’re a suspected drug dealer. The government never produces any drugs, never charges you with a crime and then you have to spend more than they’ve actually seized trying to get your property back. That’s unfair.”

The $100,000 version of Dogan’s bill is currently stalled in the legislature. Facing law enforcement opposition, the House Crime Prevention and Public Safety Committee voted in February to postpone action on it, and the bill has no hearings scheduled and is not on the House calendar.

Perhaps he can get the $50,000 version moving. In the meantime, Missouri’s cops continue to perversely profit from prohibition, while the state’s schools are out of luck.

When the health system’s protecting their profit is more important than readily available services to pts ?

Declining number of rural pharmacies ‘a worrisome trend’

www.news.wsu.edu/2018/05/25/rural-pharmacies/

Small-town pharmacists dispense medication, of course. But they might also provide clinical services like immunizations and blood pressure screenings; consult on health issues; or even act as a de facto benefits or case manager for customers.

Pharmacies clearly are important to health care in rural communities. Yet nearly 500 rural communities in Washington lost their only retail pharmacy between 2003 and 2013.

Janessa M. Graves, an assistant professor at the Washington State University College of Nursing, is studying the issue.

“It’s a worrisome trend, and yet this is something that hasn’t been looked into very closely,” she said.

Graves’ research is specifically looking at retail pharmacies that serve people covered by Medicaid, the state-federal insurance program for low-income children and adults and people with disabilities. More children are covered by Medicaid in Washington’s “nonmetro” counties than by private insurance, and statewide, 91 percent of community pharmacies accept at least one Medicaid insurance plan.

Laura Forman, a WSU College of Nursing Honors student, assisted Graves on the first part of the research. They presented initial findings at a rural health conference in Spokane recently.

Janessa-Graves
Graves

Graves said access to a community pharmacy is especially important in rural areas, which have trouble attracting health care providers.

“Where there’s a dearth of health care, a pharmacy can play an important role,” she said.

But some large counties have only a handful of retail pharmacies. Ferry County, for example, has a total area of more than 2,200 square miles, but has only a couple of retail pharmacies that accept Medicaid reimbursement. There are three in Lincoln County and two in Pend Oreille County. Spokane County has 93 such pharmacies, according to preliminary research by Graves and Forman.

Rural counties are sparsely populated, so the number of pharmacies per 10,000 residents is higher in Ferry and Lincoln counties than in Spokane County.

But those numbers don’t reflect challenges like driving long distances, over sometimes dangerous roads, to get to a pharmacy. And while mail-order pharmacies might be an answer for medications used to treat chronic conditions, they aren’t useful for filling prescriptions needed immediately, like an antibiotic.

The research is ongoing. Graves would like to know whether people in rural areas are driving long distances to fill prescriptions, and what the decline in rural pharmacies means about access to health care. She said the research could suggest potential solutions, like targeted policies to raise Medicaid reimbursement rates in rural areas, or other measures to encourage rural pharmacies to continue to accept Medicaid.

Graves was drawn to the subject because her research tends to focus on health systems and data. Plus, she grew up in a rural community and lives in one now and said, “I care a lot about rural communities.”

What are copay accumulator programs… or how the PBM’s get their “pound of flesh” from the pt

http://exclusive.multibriefs.com/content/what-are-copay-accumulator-programs/pharmaceutical

Retail pharmacists and specialty pharmacists working in the trenches may have heard whispers about something called “copay accumulator programs.” But with long lines at the register, phones ringing off the hook, 65 medication therapy management (MTM) consultations to do, 30 more flu shots to give and a jammed printer…I can understand why you haven’t had time to read up on them.

I’m a front-line pharmacist myself, and I understand your dilemma. Let me take a moment to explain this issue.

By way of introduction, let me express that this really is a big issue in my opinion. It was a major topic of discussion at the recent Asembia conference held in Las Vegas earlier this month.

Scott Dulitz of TrialCard, who attended the conference, posted on LinkedIn that “if this topic was hot last year, it was on fire by comparison at Asembia18.” Copay accumulator strategies by pharmacy benefit managers (PBMs) and health plans may be impacting some of your patients already.

At the heart of the copay accumulator program is the fact that pharma companies are actively involved, and have been for some time, in helping patients afford their medications when copays are beyond their financial reach. They do so through copay assistance programs and charitable foundations.

Thus, when a patient is confronted with an expensive copay, many pharmacies (in particular, specialty pharmacies), look for financial assistance for these patients.

This financial assistance covers the patient copay, often getting them through a high deductible or through the Medicare “donut hole,” to the point where the health plan now is responsible for the majority of the cost. And that is where the problem, from the health insurer perspective, begins.

A high deductible, copay or coverage gap period are, to put it bluntly, a mechanism to reduce utilization.

These large out-of-pocket oceans are simply too big for many patients to cross. But manufacturer assistance programs act like a lifeboat, safely helping patients cross the depths of these high-deductible seas.

The copay accumulator program, to continue the illustration, effectively shoots a hole in the bottom of the patient lifeboat.

These plans are designed to identify when patients receive financial assistance and not count such assistance toward their deductible, out-of-pocket limits or coverage gap. The result?

The benefit derived from these manufacturer programs, even if they amount to thousands of dollars, may be exhausted in several months and the patient is left facing the same high copay as before.

The whole issue of copay accumulator programs exposes the underlying tension going on in healthcare between pharma, and the insurer and PBM industry.

Payers point the finger at pharma for high drug prices. Pharmaceutical manufacturers point the finger at PBMs and high deductibles and copays which are not affordable without these coupon programs.

Neither side seems willing to admit that they are ultimately more concerned with their bottom line than with the patients they serve.

It’s pretty clear that while patients are not excited about the high cost of prescription drugs, they are equally unhappy with health plans stripping away their access through these copay accumulator plans.

A patient quoted in a recent Los Angeles Times article on the subject said, “It seems unfair. It shouldn’t matter to them who’s paying my deductible, as long as it’s being paid.”

As a pharmacist, I have to admit, I couldn’t agree more. While the ongoing battle over drug prices continue, I hate to see patients caught in the middle.

One cannot feel too sorry for either pharma or the PBMs, both of whom appear to be profiting pretty well in our healthcare system. But patients who work, pay premiums and now are stuck with unaffordable deductibles and copays are the ones who lose.

Personally, I’m not okay with that, and can only hope that employers will reject plans that offer such programs to them.

As seen on the web – time for the chronic pain community to SPEAK UP and become VISIBLE ?

As seen on web ….

“do gooders” alive and well in Louisville Kentucky/Jefferson County

Ordinance requires restaurants to offer healthy options for kids

https://www.whas11.com/article/news/local/ordinance-requires-restaurants-to-offer-healthy-options-for-kids/417-558544307

“We just want everyone on board to have the healthiest kids we can in our community,” one councilman said.

LOUISVILLE, Ky. (WHAS11) — Dining out with kids could be getting healthier. At least that’s what several Louisville metro council members hope after they passed an ordinance Thursday evening that will require Louisville restaurants to make sure children have healthy options in the menus.

“Nobody’s trying to play gotcha here,” Councilman Rick Blackwell, D.-District 12, said. “We just want everyone on board to have the healthiest kids we can in our community.”

The ordinance would require children’s meals at restaurants – defined as when several different items are bundled together – include either a whole grain product, a lean protein, a cup of fruits or vegetables.

If a drink is included in the meal, the default drink will now need to be listed on the menu as either water, milk (or a non-dairy alternative), fruit juice combined with water or a drink that has less than 25 calories per 8 ounces and no artificial sweeteners. Customers will still be able to request soda or another sugary drink.

“The hope is that an adult presented with that will more likely than not choose that option,” Blackwell said.

According to Blackwell, one of the co-sponsors of the bill, which passed with a 13-11 vote, the goal is to combat childhood obesity and the other health risks that come with it.

“We are looking for ways to make a dent in that,” he said. “So last night’s vote wasn’t a silver bullet. It wasn’t the one that’s going to make that all turn around, but it’s one thing that will make a difference, we believe.”

But not everyone believes the menu changes will lead to behavioral changes.

“I think that most people when they go into a restaurant have in mind what they’re going to get,” Kentucky Restaurant Association President and CEO Stacy Roof said. “As a parent, I think you know what you’re going to make available.”

Roof said she and other organizations and restaurant owners did talk with council members as they worked on the ordinance to give their opinions. She said while almost everyone can agree promoting childhood health is important, the ordinance could pose challenges for some restaurants.

“What is in print on restaurant websites, restaurant menus, the drive-thru boards that you see or the menu boards in the restaurant and quick-service operations, those will have to be changed,” she said.

Blackwell said the ordinance, if not vetoed by Mayor Fischer, will take effect in 120 days. Restaurants will then have one year after the ordinance begins to get everything in order before fines will be imposed.

If you don’t have your own vending machine, it’s probably worth getting a nice mobile phone and filling out the contact details to get a vending machine. The leading provide of vending machine Sydney is Royal Vending. Get in contact with them today for all your vending machine needs. After you get your machine, here royalvending.com.au are some basic instructions you might find helpful to follow.

Contact reporter Dennis Ting at dting@whas11.com. Follow him on Twitter (@DennisJTing) and Facebook.