New Opioid Pain Management Regulations Pharmacists Should Know

http://www.drugtopics.com/article/new-opioid-pain-management-regulations-pharmacists-should-know

As federal and other regulations on opioid pain relievers are changing, NCPA presented a panel discussion on “Opioid Pain Management and Your Pharmacy” on October 9 at the group’s Annual Convention in Boston.

The discussion centered on three aspects of opioid pain management: federal regulatory updates, work flow best practices for filling opioid prescriptions, and evaluating the abuse prevention policies in the community pharmacy.

Presenter Ronna Hauser, PharmD, vice president, Pharmacy Policy and Regulatory Affairs, NCPA, says the group has several recommended solutions for the opioid crisis, including establishing limits on maximum day supply for certain drugs, expanding electronic prescribing for controlled substances, encouraging alternatives to opioids for pain management, enhancing prescription drug monitoring programs (PDMPs), and increasing use and access to medication-assisted treatment for opioid abuse and addiction.

Policy Changes Coming

The presentation occurred within days of Congress’ passage of sweeping changes to federal rules related to the opioid crisis in Medicaid and Medicare programs. Many changes will start in 2019, though some won’t come into effect until 2021. “The main thing, I think, for our members is we’re going to move to a mandated system of electronic prescribing for controlled substances in [Medicare] Part D starting in 2021,” Hauser told Drug Topics prior to her presentation. Electronic prior authorization will be required for Part D drugs starting then as well, she adds.

Another change is that there will be a new drug management program or “lock-in program,” for Part D patients, where plans lock patients into using one or more specific pharmacies or healthcare providers for their prescriptions of frequently abused drugs, Hauser says. However, she adds, “It’s really the discretion of the [HHS] Secretary to determine what a frequently abused drug is. And then it’s up to the discretion of the Secretary to determine how you identify patients eligible for a lock in.”

There will also be hard safety edits for opioids, with seven-day limits on initial opioid prescriptions for acute pain under Part D. There will also be a real-time safety edit at 90 morphine milligram equivalents (MME) per day, which could be triggered when a beneficiary reaches a cumulative level of 90 MME per day across all their opioid prescriptions, she notes. Patients in hospice care, long-term care facilities, who are receiving palliative or end-of-life, or are being treated for cancer-related pain will be exempt from these rules.

NCPA believes that only a small number of patients will be affected by the 90 MME per day requirement, she says. “Nevertheless it’s going to be in existence and, I think, potentially grow in scope and size over time.” More federal legislation on opioids is expected in 2019, Hauser says.
 

How to Respond

After Hauser’s talk, Jordan Ballou, PharmD, BCACP, clinical assistant professor of pharmacy practice at the University of Mississippi School of Pharmacy, discussed policies that pharmacies should have in place when dealing with controlled substances. Policies should include what information to require from the patient; whether there should be a geographic limit to prescriptions, such as not filling those from providers outside a given distance from the pharmacy; when the PDMP should be checked; and what to do when patients request refills too early or too often.

Then Zach Forsythe, PharmD, a pharmacist with Hurricane Family Pharmacy in Hurricane, UT, looked back on how his pharmacy changed some of its practices after an armed robbery of the store. In southern Utah, where his pharmacy is located, there have been more than 20 night burglaries of pharmacies in 2017 and 2018. One independent store was hit three times in two months.

His pharmacy has added cameras, increased its employee training and counseling, put defined protocols in place, and added GPS trackers. It also added a sign in the window stating that the store was monitored by cameras and that Oxycontin and oxycodone are kept in a time-locked safe.

Our Illinois advocate representative, Sally Balsamo, is helping to find Illinois patients for a potential story that NPR is considering.

ILLINOIS RESIDENTS:

Our Illinois advocate representative, Sally Balsamo, is helping to find Illinois patients for a potential story that NPR is considering.

The reporter is seeking Illinois residents who were or are being weaned off of opioids. If you would like more information or this applies to you, and you are interested, please private message – Sally Balsamo through her FB page.

Thank you for your help.

New Joint Commission Pain Standards Take Effect January 1, 2019

http://www.ciproms.com/2018/12/new-joint-commission-pain-standards-take-effect-january-1-2019/

New and revised Joint Commission pain assessment and management standards will be effective January 1, 2019, for accredited ambulatory care facilities, critical access hospitals, and office-based surgery practices. These updates continue a Joint-Commission initiative that required new and revised pain assessment and management standards for accredited hospitals to be implemented beginning January 1, 2018.

As with the hospital standards, the new standards going into effect in 2019 are reflected in the Leadership; Medical Staff; Provision of Care, Treatment, and Services; and Performance Improvement chapters of The Joint Commission hospital accreditation manual.

Joint Commission pain assessment and management standards are designed to strengthen organizations’ practices for pain assessment, treatment, education, and monitoring. They were established based on literature review, public field review, and several expert panels.

Based on the new and revised standards, Joint Commission–accredited organizations will be required to do the following:

  • Provide staff and licensed independent practitioners with educational resources and programs to improve pain assessment, pain management, and the safe use of opioid medications based on the identified needs of their patient populations
  • Involve patients in developing their treatment plans and setting realistic expectations and measurable goals
  • Facilitate clinician access to prescription drug monitoring program databases
  • Conduct performance improvement activities focusing on pain management and safe prescribing to increase safety and quality for patients
  • Ensure that the critical access hospital organized medical staff take an active part in pain assessment, pain management, and safe opioid prescribing through participating in the establishment of protocols, quality metrics, and reviewing performance improvement activities
  • Monitor high-risk patients in critical access hospitals

Not all requirements apply to all settings in the ambulatory care program. The Joint Commission has a grid indicating which requirements are applicable, as well as documentation by setting showing which requirements are new, which are deleted, and which have been revised.

For more information about the new pain requirements, review the Joint Commission Prepublication Standards – Revisions for Pain Assessment and Management.

— All rights reserved. For use or reprint in your blog, website, or publication, please contact us at cipromsmarketing@ciproms.com.

Consumers Still Prefer Independent Pharmacies, CR’s Ratings Show

https://www.consumerreports.org/pharmacies/consumers-still-prefer-independent-pharmacies-consumer-reports-ratings-show/

When it comes to filling prescriptions, consumers still prize the friendliness, courtesy, and expertise of the local drugstore.

That’s according to Consumer Reports’ most recent ratings of walk-in pharmacies based on survey responses from more than 78,000 CR members. Independent pharmacies earned high scores on such measures as courtesy, helpfulness, and speed of checkout and filling prescriptions, as well as pharmacists’ knowledge and accuracy.

At the bottom: large national chain pharmacies.

Daniel Holt, 53, a CR member from New York City, calls his local independent pharmacy a “neighborhood gem,” and notes that “I’d rather give my money to small, local businesses who are part of my community.” 

But the big business of retail pharmacy is changing fast and could threaten some of the nation’s 22,000 independent pharmacies. And that may make it more difficult—and expensive—for you to get medications at your neighborhood drugstore.

Take Amazon, which recently entered the $453 billion prescription drug business by purchasing PillPack, an online pharmacy, posing a new challenge to walk-in pharmacies.

And CVS Health and Aetna recently merged, combing the nation’s largest retail drugstore and pharmacy benefits manager company (a “middleman” in the drug business that works behind the scenes) with one of the country’s biggest health insurers.

The new combined company says that people insured through Aetna will still be able to fill prescriptions at other pharmacies, and that people with other insurance plans will continue to have access to CVS pharmacy and ther services.

But some experts remain worried that the mergers could make it harder for some people to fill prescriptions at independent pharmacies. People insured by Aetna may be steered—by lower copays, for example—to a CVS for their prescription drugs or even one of the chain’s in-house clinics for vaccinations and other basic healthcare needs, says Douglas Hoey, president and CEO of the National Community Pharmacists Association.

A separate merger in the works, between the pharmacy middleman company Express Scripts and the insurer Cigna, could similarly restrict consumers’ pharmacy options. 

And there’s another potential obstacle to finding an independent pharmacy: Last year some 4,000 of them refused to join “preferred networks” of pharmacies in Medicare Part D drug plans, says Adam Fein, CEO of the Drug Channels Institute, a market research and consulting firm.

That could be a problem because preferred pharmacies typically offer lower copay prices to consumers. And while independent drugstores have among the highest overall scores in CR’s pharmacy ratings, they don’t do best at cost, landing between Costco (with the lowest prices) and big chain drugstores (with the highest) on that measure.

Chris Antypas, Pharm.D., co-owner of independent Asti’s South Hills Pharmacy in Pittsburgh, says his pharmacy was among those that opted out of being a preferred pharmacy. While he acknowledges that people on Medicare may now have to pay more for their drugs at his pharmacy, he hopes the personal care and extra services, including same-day home delivery and individualized prescription packaging service will still set him apart from the big chains.

“People want to be treated as individual as possible,” he says, “so independent pharmacists are focused on the relationship.”

That seems to be important for more than half of those CR members who fill their prescriptions at an independent and who said their pharmacists knew them by name. By contrast, only 14 percent of people said pharmacists at chain drugstores knew them by name.

Working with your pharmacist should never be a chore, says Antypas. “If your pharmacist doesn’t know you, get a new one,” he says. “Consumers should hold their healthcare providers accountable, and that includes pharmacists.”

Oregon: 67K Medicaid pts told to say goodbye to their opiate pain management

https://katu.com/news/local/oregon-task-force-backs-controversial-opioid-plan

BEND, Ore. (AP) — An Oregon proposal to expand alternative treatments for certain chronic pain conditions while limiting the use of opioids has moved forward with minimal changes, despite outcries from chronic pain patients and criticism from pain experts across the country.

The Bulletin reports that the state’s Chronic Pain Task Force, an ad hoc committee providing recommendations on treatments for chronic pain under Oregon’s Medicaid program, backed a proposal Wednesday to provide coverage for five chronic pain conditions currently not covered by the Oregon Health Plan.

That would allow patients to receive services such as physical therapy, acupuncture and other types of treatment. Opioids would be covered in limited doses for some of the chronic pain conditions, but not for fibromyalgia or centralized pain syndrome, a central pain processing disorder that can heighten the response to painful stimuli.

The task force concluded that opioids are not beneficial and can be harmful for those conditions.

Overprescribing of prescription opioids has been blamed for the ongoing overdose epidemic nationwide.

Patients who are already taking doses above the opioid limits would be required to begin a taper of their medications at rate determined in conjunction with their doctor. Patients with fibromyalgia or centralized pain syndrome would be required to taper off opioids completely.

“This is basically more extreme and draconian than any approach in the country. It goes against all of the guidelines,” said Kate Nicholson, a civil rights attorney from Colorado and a chronic pain advocate. “And importantly, it does so without regard for any attempt to measure potential harms or benefits to patients.”

The proposal is the second try by the task force to craft the chronic pain coverage guidelines.

A previous proposal would have limited opioid coverage to 90 days and required patients to taper off painkillers within a year. After hearing from patients and providers, Oregon Health Authority staff reworked the proposal to soften the language and provide patients and their doctors more flexibility in the rate of tapering.

“We at OHA believe that health care delivery is really dependent on the trusting relationship between a patient and provider,” Dr. Dana Hargunani, chief medical officer at OHA, told the task force. “All of the proposal elements, particularly addressing the opioid tapers . including the timelines, the rates and the ultimate success in getting to zero, are intended to be flexible and to meet individual patient needs based on the patient and doctor relationship.”

Oregon Health Authority officials estimated that about 67,400 people would gain coverage to alternative pain treatments under the proposal and that between 600 to 1,200 patients would need to have their opioid treatments re-evaluated by their providers.

there was no way the urine test could have been wrong

Hi, my name is Tom, I am using my wife’s account to write you. My wife, Jane, has been advocating for a long time now. Unfortunately, she fell during a doctor’s off, face first off of the exam table. That was the beginning of the nightmare that I now find her in today. She is unable to contact you herself, or she would be the one contacting you about my question(s) . I want you to know that she is not only a pain patient advocate, but also she is a medical researcher and was working for a large hospital system here in mid-west. She has POTS (Postral Orthostatic Tachycardia Syndrome) initial fall came during an appointment with a new cardiologist. She fell off the exam table, after the doctor asked her to stand up to see how orthostatic she was at the time. She also had Chiari, and has had multiple surgeries, none of which has helped her. During the hospitalization, She was put into an induced coma, it was to help her because she had major brain swelling due to the trauma caused by the fall. She fought hard and she was completely off of the ventilator for three days, then she developed pneumonia, she was put back onto the ventilator immediately. While in the coma, a doctor decided that she needed to have a routine urine test, and they also did a urine drug screening. They tried to say that she didn’t have the right levels of medication in her system. They forced me to leave her side for 4 days as they went through the cameras in the ICU. (I guess they thought I could have somehow get into the locked pump? Impossible, right?) After they re-tested, the results were the same, but she supposedly tested positive for “Norco.” The entire situation is ridiculous! How would they know what medication in that group it was specifically, and how in the world could she have taken it with a trachea in? Then things got worse. Suddenly, her palliative care provider decided that she was “too complex” and they dropped her. Then, her pain doctor (doctor that writes her prescriptions) was raided and all patients were dropped, if complex or needed high doses. And now she is still in the hospital without a pain management doctor to follow her after she gets home. I believe in my heart that she is a fighter, and will pull through this. But I don’t know how to fight this. I have talked to patient advocates, her close relative spoke with the president of the hospital (Her relative is an attorney and retired from the deanship at a Law School) and the hospital keeps maintaining that they cannot help, and there was no way the urine test could have been wrong. They are so corrupted! We requested an immediate blood test when we were told that she had “Norco” in her system, but it never happened. Then, yesterday, the head of the anesthesia department came to see her to see how she was doing. During this visit she informed her father and I that as of June or July of 2019, there will not longer be a diagnosis code for chronic pain. And that they will be placing a number of pills needed for any surgery someone may have. For example, they will only allow three days of low level opiates for a same day surgery. Possibly up to 7 days for back surgery, etc. I asked for any paperwork that she may have regarding this, and she said that she would bring it to me when she comes back next time. I was in such shock, I failed to ask if it was going to be a state or federal law. Jane would have known what to ask, but it comes naturally because of her training in medical school, and working for the hospital (different hospital system than where she is currently inpatient.)I apologize for my lack of all of the correct medical terminology, I am learning in the moment and I may have misspelled some or many of the medical terms. Do you have any advice you can offer me? Have you heard anything about this change in chronic pain diagnosis codes? She basically said that there will no longer be a classification for chronic pain. If you have any advice or information that may be helpful, please message me back! I have lost trust in anyone working in the hospital, they all join together as a corrupt group that will never correct anything that another doctor has said or done. I have heard over and over again that “If Dr. X said that, then it must be correct.” I have also been informed that the only medication that she will be able to go home with is Suboxone or Subutex. (sorry if I butchered the spelling) I have reached out to other people in the chronic pain community that knows her personality, and 4 out of 5 told me that you were the one to contact for advice and guidance. I apologize for reaching out to you on this platform, I wasn’t sure how to best contact you. I look forward to hearing from you! Happy Holidays!

“as of June or July of 2019, there will not longer be a diagnosis code for chronic”

A year or two ago the diagnosis coding system ICD9 was replaced with a new and revised ICD10 codes and the number of diagnosed codes were DRAMATICALLY INCREASED.  Here is an example of the number of ICD10 codes referencing pain https://www.icd10data.com/ICD10CM/Codes/G00-G99/G89-G99/G89-/G89

Putting a pt on Suboxone or Subutex will virtually automatically have someone put a ICD10 code of  “opiate use disorder” on her list of health issues.  Would almost guarantee that a pt will not get a opiate for pain in the future.

Here is a article that I authored about the reliability of urine tests http://nationalpainreport.com/when-the-urine-test-lies-8833834.html

No blood/urine test is guaranteed absolutely accurate and reproducible, it is claimed that with a urine test that you can expect a 20% +/-  false positive/negative.  And urine tests are defined as “qualitative test” the substance that you are looking for is either there are not… it is like a pregnancy test – you are either pregnant or you are not based on the presence or absences of a single hormone. For the hospital to say that “the right quantity” did not show up in a urine test is  PURE BULL SHIT !

Blood tests are “quantitative tests… the come back with “how much” of a substance is in the blood. They can also vary from one test to another.. it just depends on what you are looking for because the body has numerous biological cycles and values can/will vary given the time of day that the sample is taken, taken on empty stomach or not … etc…etc…

The best non-medical reference I can give is to ask a person to take out their driver’s license and ask them to make a comment on the pic on their license and is it a good reflection of how you look or have looked in other photos ?

I do not know if this hospital is just one large hospital in the mid-west or a teaching hospital, if the all the healthcare professionals are independent practitioners or JUST EMPLOYEES of this corporate healthcare system… but I don’t think that this story and this pt’s issues concerning her pain management will have some more things coming to light.


Kolodny: in favor of taxes on legal pharma opiates – to reduce their use

Why states might start taxing opioids

The next wave of state actions against the opioid crisis may focus on taxing them — depending on the outcome of an industry lawsuit against New York, the first state to try it.

Between the lines: Most of the bills that have been proposed would tax opioid painkillers and use the money for addiction treatment and prevention. But the health care industry argues that they’re bad policy and, at least in the New York law’s case, illegal. That case will be tested when oral arguments in the lawsuit begin Monday.

More than a dozen states saw the introduction of bills to tax opioids last year, but only New York’s made it into law.

  • The New York law will collect $600 million over six years from drugmakers and distributors and use it to fund addiction treatment and prevention. These industry groups have responded with three different lawsuits arguing that the law is unconstitutional. Oral arguments for each lawsuit will be heard on Monday.
  • Some groups are also arguing that the law is bad policy. “The fee itself could force a generic company, which is making a very low margin, to leave the market. And so a potential policy consequence is that patients are only left with the brand-name, high cost opioids when they have medical needs,” said Jeff Francer of the Association for Accessible Medicines, one of the plaintiffs.

Why it matters: If the industry is successful in its attempt to kill the law, that could influence whether other states follow New York’s lead or how they write legislation.

  • “I think that the states see what’s going on in litigation,” Francer said. “No legislator wants to pass a law that a court finds to be unconstitutional.”

One state to watch is Minnesota, where Governor-elect Tim Walz has said he’s supportive of a fee on opioid prescriptions to help pay for treatment and prevention.

  • Legislation that would have created such a fee failed to pass last year, but lawmakers have said they want to try again, per Kaiser Health News.
  • Other states to watch include California, Delaware, Iowa, Kentucky, Maine, Massachusetts, Montana, New Jersey, Tennessee and Vermont, per KHN.
  • Here’s a list of state opioid tax legislation that was introduced in 2018, as compiled by the National Conference of State Legislatures.

Proponents of opioid taxes argue that their value goes beyond just raising money. “If the actual price for these products reflected their true costs, I think we’d see a greater emphasis on reducing opioid use and encouraging use of pain treatments that are much safer and more effective,” said Andrew Kolodny of Brandeis University.

The other side: Opponents say these taxes could make it harder for people to get the pain medication they need. “We do not believe levying a tax on prescribed medicines that meet legitimate medical needs is an appropriate funding mechanism for a state’s budget,” said a spokeswoman for Pharmaceutical Research and Manufacturers of America.

The bottom line: It’s a unique new approach to the fight against the opioid crisis — but a ruling against New York could easily shut it down.

Next crisis: Americans eat more French fries than any other country in the world

Americans eat more French fries than any other country in the world and now a Harvard professor is saying you should not eat more than six fries at a time. Professor Eric Rimm at the Harvard T.H. Chan School of Public Health told The New York Times, “I think it would be nice if your meal came with a side salad and six French fries.” Potatoes, especially those cooked in oil, have been linked to obesity, diabetes, and heart disease.

what does this actually mean: “we do not choose to get involved with this issue at this time.”

We’ve also contacted every civil rights attorney & organization here in Oregon & across the country. Their answers have been, across the board, via phone, snail mail, email, & in person, “we do not choose to get involved with this issue at this time.”

There is a lot going on in Oregon, for those not paying attention that local bureaucrats are hell bent on taking away all opiate pain management … initially from Medicaid pts.

Could the above response from the various law firm be for several reasons:

  1.  those that have approached them, want them to take the case on … on a contingency basis and there is really no financial upside for a law firm in preventing laws, regulations, interpretations from being implemented.
  2. It will be easier to challenge the constitutionality of whatever they implement after the fact.. because then it gets into the court system and in theory they can get an injunction promptly upfront and then move on with challenging its constitutionality
  3.  They may never consider any of these actions because their is no financial upside to the law firm taking on such a legal challenge and until some group comes forward with a “boat load of $$$” to finance the legal challenge.

What we have seen over the last 2-3 yrs with these bureaucrats and their actions against chronic pain pts cannot be labeled as anything less than they are ZEALOTS.

From what I have read about the “going ons” in Oregon… these bureaucrats have their opinions and maybe they have reached the point where they believe that they are entitled to their opinions should actually be considered as FACTS.  Or they are basing their actions on “facts” from such entities like the CDC, which most realize that many are fabricated, embellished or just flat out lies.

Sooner or later… the chronic pain community is going to have to come to the conclusion that data/facts from some other entities than what the bureaucrats have formed their decisions from are most likely not going to be considered by the bureaucrats and they are going to move forward with their planned changes… they have devoted a lot of staffing time coming to their conclusions and perhaps no words or “other’s facts” are going to change their agenda and moving forward.

In the end, it may just boil down to the chronic pain community coming together FINANCIALLY and funding one or more law firms to challenge the constitutionality of what has been done against those suffering from chronic pain and their pain therapy is being reduced, stopped or not started in the first place to those new pts which are headed towards being a chronic pain pt.

Walmart Will Implement New Opioid Prescription Limits By End Of Summer

I filled my scripts last Wednesday at my mom & pops pharmacy. They were packed!!!!! Most people had come from Wal Mart…..

 

 

 

 

 

 

 

 

https://www.npr.org/sections/thetwo-way/2018/05/08/609442939/walmart-will-implement-new-opioid-prescription-limits-by-end-of-summer

Walmart announced Monday it is introducing new restrictions on how it will fill opioid medication prescriptions in all of its in-store and Sam’s Club pharmacies.

It is the company’s latest expansion of its Opioid Stewardship Initiative, intended to stem the spread of opioid addiction, prevent overdoses and curb over-prescribing by doctors. It follows a similar initiative by CVS that went into effect in February.

A March report by the Centers for Disease Control and Prevention found overdoses from opioids soared by nearly 30 percent between 2016 and 2017.

“We are proud to implement these policies and initiatives as we work to create solutions that address this critical issue facing the patients and communities we serve,” Marybeth Hays, executive vice president of Health & Wellness and Consumables said in a statement.

Over the next 60 days, the fourth-largest pharmacy chain will cap acute painkiller supplies to cover a maximum of seven days. It will also limit a day’s total dose to no more than the equivalent of 50 morphine milligrams. And, in states where prescriptions are restricted to fewer than seven days, Walmart will abide by the governing law.

Walmart said the new policies align with the Centers for Disease Control and Prevention recommendations established in 2016. Those rules were meant for doctors prescribing chronic pain medication and encourage primary care physicians to prescribe the “lowest effective dose.”

By the end of Aug. 2018, the company said its pharmacists will begin using NarxCare, a controlled-substance tracking tool with “real-time interstate visibility.”

Pharmacies will also carry naloxone, an opioid overdose antidote that has become instrumental in helping to decrease overdose deaths. The life-saving medicine will be offered over the counter, dispensed upon request, wherever it is legal.

As NPR has reported, “The medicine is now available at retail pharmacies in most states without a prescription.” Retail sales of naloxone, more commonly known by the popular brand name, Narcan, increased by tenfold between 2013 and 2015.

Dr. Steven Stanos, former president of the the American Academy of Pain Medicine told NPR the organization applauds “any action that seeks to limit the over-prescription of opioids.” But, he added, “That needs to be balanced with the very real need of patients.”

“Setting a mandatory limit without giving physicians the ability to explain why a patient might need a longer prescription, interferes with the relationship between that person and their physician, who knows them better than the pharmacist,” Stanos said.

He also explained requiring patients to obtain a new prescription after seven, or sometimes even three days, depending on the state, can become too costly because of mandatory co-pays.

Another of the company’s changes going into effect on Jan. 1, 2020, is a requirement that all controlled-substance prescriptions be submitted electronically. According to Walmart: “E-prescriptions are proven to be less prone to errors, they cannot be altered or copied and are electronically trackable.”