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Opioid overdoses: NOT A PRESCRIBING CRISIS – an addiction crisis
Posted on April 9, 2019 by Pharmaciststeve
An ‘Interview’ With Dr. Andrew Kolodny
Posted on April 9, 2019 by Pharmaciststeve
An ‘Interview’ With Dr. Andrew Kolodny
By Josh Bloom — April 1, 2019https://www.acsh.org/news/2019/04/01/interview-dr-andrew-kolodny-13921
Dr. Andrew Kolodny, one of the world’s premier experts on addiction and drugs was kind enough to sit down with me to discuss some very tough questions regarding the ongoing opioid crisis in the US. We all owe Dr. Kolodny much gratitude for sharing his wisdom and insight. It is quite revealing.
JB: Good morning, Dr. Kolodny, and thank you so much for finding time in your very busy schedule to speak with me. I’m terribly sorry for being late but some guy pushed me in front of a subway train – again – and I had to stop off at the ER so I could get a Tylenol pill for my crushed femur. I begged for two pills but they called me a junkie and threw me out into the street. Landed on the same leg, which really sucked. Too bad I couldn’t get that second pill.
AK: You have to be careful with that stuff. Too much Tylenol can give you lung cancer. Or, is it liver damage? Can’t remember. I suppose that if it’s absolutely necessary you could add some acetaminophen to the Tylenol. They work synergistically.
JB: But Andrew, Tylenol, and acetaminophen are identical.
AK: This cannot be true. Look here, I have both. One has a red shiny coating but the other is white.
JB: Of course. People make that mistake all the time. But, the active ingredients in the two pills are the same. The company who made the red ones just added the red shell, perhaps to make the pill easier to swallow.
AK: Gee. So *that’s* why they act synergistically. I had no idea.
JB: Andrew, that’s not really possible. It takes two different drugs for synergy to be possible. Basic pharmacological principles.
AK: Pharma… what? I don’t know what that means.
JB: It’s OK. No one would expect a psychiatrist to know these things. Pharmacology is the study of the effect of drugs on the body.
AK: Thank you! That is *so* informative. It’s really hard to keep up with all these new technical terms that keep popping up.
JB: But the term “pharmacology” was coined in the 19th century.
AK: See what I mean!
JB: I apologize in advance because this may be a very sensitive topic, but some people contend that your educational background does not make you qualified to have input into American drug policy. How do you respond to this?
AK: Utter nonsense! I finished in the top 95% of my graduating class at Queens College. My career options were unlimited. To this day I remember exactly what my bocce coach told me at graduation: “It would be a shame if you went into any other field.” I’ll never forget the tears in his eyes when I told him that I’d be going to… what’s that place called?
JB: Do you mean medical school?
AK: Yeah, that’s it.
JB: I don’t need to tell you that you are a very polarizing figure in drug policy today. Some contend that you have stepped up at the perfect time to save America from the ravages of opioid addiction while others criticize your policies as wrong-headed and counterproductive. Putting aside these points of view for a moment, I think it is fair to say that your name and “opioid expert” are almost synonymous. It is nothing short of astonishing that a bocce major from Queens College has become the go-to person on all matters opioid. How did you begin this remarkable journey?
AK: I read an article in TV Guide. It changed my life.
JB: You already have accomplished more in a decade than most of us will ever do in our entire lives. Now that the opioid crisis is over what’s next on the agenda?
AK: That’s a timely question. As we speak, my colleague Jane Ballantyne, who knows almost as much about drugs as I do, and I have begun studying what we believe will trigger the next addiction crisis in the country – Flintstones Vitamins. Another product of big pharma, of course.
JB: How’s that going so far?
AK: We’re off to a bit of a rough start. Jane and I both agree that Fred and Wilma are safe enough, provided that they are classified as Schedule II drugs by the DEA. But Jane maintains that Barney, although he should be monitored closely, is safe and effective. To me, Barney is simply a heroin pill. There is no difference. The jury is still out on Dino.
JB: Andrew, I can’t thank you enough for allowing me to conduct this fascinating and revealing interview, especially since you undoubtedly headed for the nearest TV camera. I have learned so much and will share your wisdom with all ACSH readers and the pain patients who follow me.
AK: No problem. I sure hope your arm feels better.
JB: Uh, the femur is a bone in the leg.
AK: Whatever.
(HAPPY APRIL FOOL’S DAY!)
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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
Posted on April 9, 2019 by Pharmaciststeve
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm
[4-9-2019] The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.
While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.
Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.
Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).
Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.
We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our
Disposal of Unused Medicines webpage.
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving opioids or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
Contact FDA
Report a Serious Problem to MedWatch
Complete and submit the report Online.
Download form or call 1-800-332-1088 to
request a reporting form, then complete
and return to the address on the
pre-addressed form, or submit by fax to
1-800-FDA-0178.
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How the CDC Guidelines effected me – Part Two
Posted on April 8, 2019 by Pharmaciststeve
This covers how the CDC Guidelines directly effected and further permanently injured me back in 2016 when they were misapplied to Intractable Pain and Chronic Pain Patients across the country. I had been on the same medication at the same dosage for 6 years without them being increased, and was stable with my pain well managed at the time when my doctor was forced to start tapering my dosage down by nearly 50% for NO MEDICAL REASON, And just simply because management was forcing their physicians to adhere to the new CDC Guidelines which were only supposed to be voluntary and not be used as mandatory regulation
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PBM executives are heading to Capitol Hill this week. Here are 4 things to watch
Posted on April 8, 2019 by Pharmaciststeve
PBM executives are heading to Capitol Hill this week. Here are 4 things to watch
https://www.fiercehealthcare.com/payer/pbm-executives-head-to-hill-4-things-to-watch
Pharma CEOs went before the Senate last month, and now it’s PBMs’ turn to be on the hot seat.
Executives at five pharmacy benefit managers will testify before the Senate Finance Committee on Tuesday in the latest hearing on solutions to drive down drug prices. Express Scripts, CVS Caremark, Humana, Optum and Prime Therapeutics will be represented on the panel.
Drug rebates—and the Department of Health and Human Services’ plan to eliminate them—are likely to be center stage in the discussion around the role that PBMs play in rising drug prices. PBMs play a shadowy role in the pharmaceutical supply chain and have been a prime target for criticism, especially from drug companies, in the price debate.
Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., said in a statement upon inviting the PBMs to testify that “middlemen in the healthcare industry owe patients and taxpayers an explanation of their role.”
RELATED: Pharma CEOs go after familiar target in drug hearings—insurers
“There’s far too much bureaucracy and too little transparency getting in the way of affordable, quality healthcare,” Grassley and Wyden said. “We’ve heard from pharmaceutical companies, and it’s only fair that the committee has the opportunity to ask questions of other players in the healthcare supply chain.”
Here are a few things to watch at Tuesday’s hearing:
1. Breaking into the drug rebate ‘black box’
As Grassley and Wyden made clear in their invitation to the PBMs, one of policymakers’ key concerns about drug rebates is the lack of transparency around the negotiations and who gets a cut of the discounts.
Azar echoed this concern when HHS announced the rebate rule, saying that shining light on this “hidden system of kickbacks to middlemen” is driving up drug costs.
The central criticism lobbed at PBMs by drug companies is that, because these negotiations happen behind closed doors and are not provided directly to consumers, insurers use the savings to line their own pockets instead of driving down costs for plan members.
RELATED: Express Scripts hits back at criticisms of PBMs, says it ‘would do just fine’ without drug rebates
PBMs have hit back at this criticism. The Pharmaceutical Care Management Association launched an ad campaign called #OnYourRxSide to dispute the idea that pharmacy benefit managers are the key driver behind rising drug costs.
“PBMs have an established and successful track record of implementing consumer-friendly, market-based tools, such as negotiating with drug manufacturers, to lower costs for consumers,” PCMA President J.C. Scott said.
2. Will eliminating rebates bring down drug costs? Depends on who you ask
HHS argues that its rule—which would eliminate the anti-kickback protections for rebates and instead provide those legal safeguards to point-of-sale consumer discounts—will drive down drug prices. Drug companies have said the same.
However, insurers, as one might expect, have disputed that claim. PCMA issued a report on Thursday that analyzes the costs that might be associated with the end of rebates, and it suggests that it could drive up overall drug spending by nearly $200 billion over the next decade.
RELATED: Winners and losers under bold Trump plan to slash drug rebate deals
The Centers for Medicare & Medicaid Services Office of Actuary does, to some degree, back up this assertion. An analysis from the actuaries on the rule estimates (PDF) that if the rule were implemented it could drive up overall drug spending by $137 billion by 2029, and Part D spending by $196.1 billion.
Expect this debate to be a hot topic during the hearing. Coincidentally, the comment period on HHS’ proposed rule ends Monday, so the rule could take effect in short order following the PBMs’ testimony.
3. The blame game
Finger-pointing has been the name of the game in this debate, and Tuesday’s hearing is likely to include more of that. At their hearing, drug companies deflected blame for rising drug costs by targeting insurers and PBMs.
Expect PBMs to return the favor on Tuesday. Industry groups, including PCMA, America’s Health Insurance Plans and the American Hospital Association have had harsh words for drug companies and say that they—not PBMs and payers—are the source of rising costs.
RELATED: CVS looks to begin rollout of new PBM contracting model in 2019
“The drugmakers have a long tradition of finger-pointing,” said Erik Rasmussen, AHA’s vice president of advocacy and public policy. “They’ll say it’s everyone’s fault but mine.”
Of note in this cross-sector blame game is that the hearing panel will be entirely made up of PBM executives, so drug companies will not have the opportunity to respond directly to criticisms of them made at the hearing, paralleling their own hearing where PBMs were unable to counter their claims.
4. Expect the grilling to be bipartisan
As evidenced by the joint statement, addressing drug prices is of bipartisan interest, and in the Senate Finance Committee’s series of hearings so far, both Democrats and Republicans have been tough on industry players who may have a role in rising costs.
Though a divided Congress is not likely to undertake a major legislative overhaul, industry experts have noted that action on drug prices is one issue that draws interest from both sides of the aisle.
It’s an issue that’s also of particular interest to Grassley, who became chairman of the committee this year, as evidenced by the hearings.
In the statement, the two senators said that “every part of the industry” has a role to play in driving down drug prices, and said they hope PBMs come to the hearing armed with “real information” and will discuss “real solutions.”
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The Legislature is taking a “ready, fire, aim” approach
Posted on April 8, 2019 by Pharmaciststeve
By CHRIS HOLBROOK
April 05, 2019 – 6:16 PM
April 05, 2019 – 6:16 PM
A conference committee in the Minnesota Legislature, and/or Gov. Tim Walz, should kill a pair of companion bills on opioid use (SF 751/HF 400) — before the legislation kills victims of chronic pain.
This feels-like-we’re-doing-something-good effort to combat a manufactured crisis will hurt more than it helps. The Legislature is taking a “ready, fire, aim” approach guaranteed to create suffering for Minnesotans who need prescriptions to manage their real pain to sustain a real life.
We are talking about the lives of cancer patients, burn and trauma victims, amputees, and other major surgery patients.
It’s arrogant and ignorant for politicians to say no one needs these pills, they shouldn’t be made, or that one pill is the start of heroin addiction. People turn to street drugs for problems that government ignores, like pain and suffering. Prohibition and taxation do not stop illicit drug use anymore than they stop pain and suffering. Actually, they create it.
Mark Twain popularized the saying that there are “three kinds of lies: lies, damned lies, and statistics.” Quoted numbers from the Centers for Disease Control and Prevention say that 64,000 Americans die annually from drug overdoses. That is all drugs, legal and illegal. Of that, roughly half are by opioids, legal and illegal. Of that 32,000 — close to 90 percent are overdoses of the opioids heroin and fentanyl, leaving around 5,000 deaths per year from solely misusing prescription pills.
By comparison, more than 6,000 people a year commit suicide due to unmanageable pain; 6,000 die riding bicycles; 40,000 in cars; 88,000 from alcohol; and 480,000 from tobacco.
The last report in Minnesota said that 422 state residents died from opioid overdose in a year, legal and illegal. The authorities said that 91 percent of those were fentanyl or heroin. The 38 other deaths were attributed to misused authentic prescriptions.
Is the solution to increase costs on the 99.998 percent who don’t misuse their drugs and who are alive because of these pills?
State Sen. Julie Rosen, R-Vernon Center, authored SF 1098 to force pharmaceutical companies to provide transparency on how they arrive at such high drug prices. Then she authored SF 751 to raise the costs of drugs with $20 million in new annual fees for manufacturers and wholesalers of opioids. This money is slated to create a new government advisory board, with a portion going toward law enforcement. To see how that will work, consider marijuana (which by the way is a gateway off opioids).
No pain patients have been involved in any advisory council or task force making these recommendations. Under the legislation, you would need a state ID to get your prescription (but not for the more dangerous act of voting). Your doctors would be allowed half the number of days to treat pain, or could lose a license and have assets seized, including your private medical records. Several doctors have announced they will no longer treat chronic pain because of the risk of government. In a related story, several heroin dealers have just announced that they will expand their products and services to fill that void.
Let’s use our heads and not just our hearts for once. Urge your legislator and Gov. Walz to stop this illogical, expensive, regressive, misdirected overreaction that will hurt real Minnesotans with real medical pain.
Chris Holbrook is chair of the Libertarian Party of Minnesota.
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Epidural Steroid Injections / APDU’s Warning Letter to Pfizer
Posted on April 8, 2019 by Pharmaciststeve
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War on opioid abuse is striking the wrong target
Posted on April 7, 2019 by Pharmaciststeve
War on opioid abuse is striking the wrong target
Prescription drugs help people in pain. They aren’t to blame for the rise in opioid deaths.
http://www.aei.org/publication/war-on-opioid-abuse-is-striking-the-wrong-target/
Patients in pain have become collateral damage in the war on opioids.
That’s the message of a letter from more than 300 medical professionals, including three former White House drug czars, to the Centers for Disease Control. In 2016, the CDC issued guidelines to discourage doctors from overprescribing opioids. The signatories believe that those guidelines are being misapplied in a way that keeps many patients in agony.
Among policymakers, however, the focus is still on cracking down on prescriptions. Thirty-three states had imposed some type of limit on opioid prescriptions by last October. Democratic Senator Kirsten Gillibrand of New York and Republican Senator Cory Gardner of Colorado are pushing for a federal limit. Under their legislation, initial prescriptions for acute pain could cover no more than seven days and include no refills.
In the senators’ press release, Gardner says: “As I’ve met with Coloradans impacted by the opioid epidemic, the recurring story is clear. Oftentimes, the first over prescription spurs the devastating path of addiction.”
Gillibrand concurs: “One of the root causes of opioid abuse is the over-prescription of these powerful and addictive drugs.”
The bipartisan pair of senators have the same mindset that led then Attorney General Jeff Sessions to recommend last year that people in pain “tough it out” with aspirin rather than opioids. President Donald Trump, too, has called for reducing opioid prescriptions. “It’s so highly addictive,” he has said. “People go into a hospital with a broken arm; they come out, they’re a drug addict.”
This understanding of the opioid crisis has less and less grounding in reality. Illicit drugs, rather than prescription medications, have accounted for an increasing proportion of deaths from opioids.
The CDC reports 47,600 opioid overdose deaths for 2017. Heroin was involved in 15,500 of them. A drug category that mainly represents manufactured fentanyl and similar drugs was involved in 28,500.
Pain medications, meanwhile, were involved in 14,500: too many, but a minority of all cases. In some of these cases, illicit substances were also present. (The numbers for each category add up to more than the total because many overdoses include more than one drug.) The heroin- and fentanyl-related deaths have been rising much faster than the medication-related ones.
Other research suggests that prescription opioids are acting less and less as a “gateway drug” for opioid abuse. More and more opioid abusers are starting with heroin. Between 2005 and 2015, the percentage of opioid abusers who started with heroin grew from 9 percent to 33 percent.
Pain patients, contrary to a common view, have a low rate of addiction to opioids when you look closely at the research. A study of nearly 570,000 people who took opioids after surgery received attention when it was published last year for concluding that prescription refills were associated with a “large increase” in rates of misuse.
But the overall rate was low, including less than 1 percent of the sample. My American Enterprise Institute colleague Sally Satel reviewed some of the other research for Politico last year.
The campaign against over-prescription of opioids has succeeded in affecting medical practice. The prescription rate peaked in 2012 and has fallen steeply in recent years.
One might have hoped that by reducing the number of addicted patients and keeping excess medicines from being available for diversion into the street market, reducing prescriptions would dent the death toll from opioids. But during this period, the overdose-death rate has kept climbing: Those 47,600 deaths in 2017 set a new record.
It’s to Gardner and Gillibrand’s credit that their bill does not apply to prescriptions for chronic pain. The pleas of physicians and patients about the costs of the prescription crackdown may be starting to be heard.
But the record of recent years raises the question of whether a federal crackdown is a good idea in the first place. It misidentifies the root of the problem: It mostly has to do with people who are seeking out opioids for abuse, not who got addicted from prescriptions.
It is accompanied by a lot of counterproductive political rhetoric that discourages people from getting safe treatment for pain by telling them they will become addicts. And it does not seem to be succeeding in its fundamental aim of saving lives.
Each year, nearly as many Americans are dying from opioids as died in the entire Vietnam War. Increased interdiction of drugs at the border and funding for drug courts and treatment may help reduce those harrowing numbers. A continued bipartisan focus on prescriptions, though, will guarantee that too much of the war on opioid abuse will keep being fought on the wrong front.
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ED Dept: Helping pts with OUD to get therapy… believing they can put a dent in the opiate crisis – FAIRY TALE ?
Posted on April 6, 2019 by Pharmaciststeve
Emergency Department Program Aims At Reducing Opioid Use Disorder
https://www.news-line.com/PH_news28523_enews
Alabama hospital emergency departments have become all too familiar with patients suffering from opioid overdose.
The state leads the nation in opioid prescriptions, according to the Centers for Disease Control and Prevention, and Jefferson County alone saw 98 deaths from heroin and 104 from fentanyl use in 2017. Opioid abuse, whether street drugs or prescriptions, is rampant.
“Emergency departments are the tip of the spear where societal problems meet healthcare,” said Erik Hess, M.D., vice chair for research for the University of Alabama at Birmingham Department of Emergency Medicine. “The nation’s opioid epidemic plays out every day in our emergency departments.”
The UAB Department of Emergency Medicine is launching a new initiative to help patients with opioid use disorders get appropriate therapy and referral for further assistance in an effort to put a dent in the epidemic. The program, called the ED MAT, or Medication Assisted Treatment Protocol, is funded by a $1.5 million grant from the Substance Abuse and Mental Health Services Administration, part of the U.S. Department of Health and Human Services. Telehealth can provide individuals with a number of different services including: specialist referral services, patient consultations, and remote patient monitoring. Specialist referral services involve both a doctor and a specialist, who work together to come up with an accurate diagnosis for the individual. Patient consultations use video and audio in order to come up with a diagnosis and an effective treatment plan. Remote patient monitoring is where devices are used remotely to collect data that is sent to a monitoring station and is interpreted by a health professional. This helps professionals to come up with an effective treatment plan and to spot any changes in condition quickly. Telehealth can be used to measure and monitor and measure a number of different areas and these include: blood pressure, blood glucose levels, oxygen levels and weight. These systems can be beneficial because they can reduce the number of visits that an individual needs to make to their doctor or to the hospital. You can get more information about Telehealth.
Program partners include the UAB Center for AIDS Research and the Jefferson County Department of Health, which has undertaken a county-wide effort to coordinate care for persons with opioid use disorder.
The Jefferson County Department of Health helped establish the Recovery Resource Center, a referral hub at Cooper Green Mercy Health Services that assesses the severity of an individual’s opioid addiction, determines the intensity of treatment that is required, and coordinates referral to appropriate treatment centers, including the UAB Addiction Recovery Program, the Fellowship House, and the Beacon Addiction Treatment Center, among others.
The program has several components. The ED MAT program consists of the use of buprenorphine/naloxone in the ED to treat the symptoms of opioid withdrawal and to decrease cravings, followed by a short-term prescription of buprenorphine/naloxone if appropriate and a take-home naloxone kit.
Buprenorphine/naloxone, also known as Suboxone, is used to treat opioid use disorder. It can reduce withdrawal symptoms for 24 hours.
“It helps to lessen withdrawal so that a person feels more like their usual self, more normal,” says Hess, who is principal investigator on the project. “As they return to normalcy, they become more capable and willing to engage in treatment, which is an important first step to recovery. Studies show that Suboxone is very effective in getting patients into treatment and getting them clean.”
Patients will also be connected face-to-face with a peer navigator while in the emergency department.
“This is a hard handoff to a peer navigator – an individual in sustained recovery from opioid use disorder who has ‘been there,’ who can help the patient understand the options for continued therapy and how to maneuver through the system to access those options,” Hess said. “The emergency department is our window of opportunity to treat these patients, as many don’t tend to see medical providers outside of emergency situations.”
The navigator will assist patients with referrals to follow up treatment through the Recovery Resource Center of Jefferson County at Cooper Green Mercy Services.
“I’m elated to see that Dr. Hess and his team are able to start this innovative program,” said Mark Wilson, M.D., health officer for the Jefferson County Department of Health. “It fills a critical gap for people who are desperately seeking effective treatment for their opioid addiction or who have just survived an overdose. It will definitely save lives. I hope it can become a model that other emergency departments can replicate.”
Another component of the program will be to increase the number of physicians licensed to administer Suboxone. The Drug Addiction Treatment Act of 2000 provides a waiver for physicians who have undergone the DATA 2000 training to prescribe Suboxone. The program goal is to have 75 percent of UAB emergency physicians receive DATA 2000 waiver training. Currently only about three percent of Alabama physicians have received that training.
Program administrators anticipate enrolling 550 patients with opioid use disorder over the three years of the program.
“We’ve set ambitious goals that we think are reachable,” Hess said. “We hope to have 75 percent of our MAT clients report abstinence from opioids at six months and we aim, along with our community partners, to decrease the number of deaths in Jefferson County from opioid overdose by 30 percent over three years.”
The UAB emergency department has extensive experience integrating public service programs into ED workflow, following the creation of universal testing for HIV and Hepatitis C virus in ED patients beginning in 2011.
“We already have the necessary systems in place to identify and track these patients while we link them to appropriate follow-up care,” said Ricardo Franco, M.D., an investigator in the UAB Center for AIDS Research and co-principal investigator. “There is considerable overlap between intravenous drug use and HIV or HCV infection. This program offers a unique opportunity to have an impact on reducing not only opioid use but also the incidence of HIV and HCV infection.”
According to SAMHSA, the number of admissions for heroin in Alabama increased 220 percent from 2014 to 2017. Jefferson County’s overdose rate of 48.75 per 10,000 population was significantly higher than the statewide average of 19.9 percent per 10,000. The Jefferson County Coroner’s office reports 269 illicit drug deaths in 2017.
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The insurance companies said we can funnel our profits through PBMs
Posted on April 6, 2019 by Pharmaciststeve
Pharmacists, state chamber at odds over prescription benefits
Independent pharmacists and the integrated behemoths that account for as much as 85 percent of the prescription drug business are fighting it out be proxy this week in the Oklahoma Legislature.
The pharmacists are hoping at least one of two similar bills — Senate Bill 841 and House Bill 2632 — survives this week’s committee deadline.
Pharmacy benefit managers — known as PBMs — and their powerful allies are doing all they can to stop the measures.
The bills would make PBM networks accept any pharmacy willing to meet their price and service requirements and to forego certain business practices others say have contributed to spiraling prescription drug prices.
The bills would also outlaw “gag rules” that prevent pharmacists from telling patients about cheaper alternatives to their prescribed drugs, and set in statute “access” minimums — that is, networks would have to have pharmacies within a reasonable distance of most policyholders.
The pharmacists say PBMs are running them out of business, particularly in rural areas, and costing patients millions in prescription costs.
PBMs say the opposite is true, that they save insurance providers — that is, employers — millions, and that the legislation sought by the pharmacists will cost state government and businesses millions more.
“These bills will negatively impact pharmacy bills,” said Fred Morgan, the chief executive officer of the Oklahoma State Chamber, which is among those lobbying against SB 841 and HB 2632. “They’re going to increase the costs of drugs.”
Hogwash, says state Rep. T.J. Marti, R-Broken Arrow, and one of two active pharmacists in the Legislature.
“We need some parity in prescription drugs,” said Marti. “Anybody who can’t see that is looking out for somebody else.”
The House and Senate bills passed from their respective chambers without dissent, but must get through committee meetings in the opposite chambers this week to remain active. HB 2632, by Rep. Jon Echols, R-Oklahoma City, has 31 Senate and 21 House co-authors.
But a heavy-hitting lineup has come out in opposition. It includes such large employers as Boeing, Devon Energy, Continental Resources and the Muscogee Creek Nation. Several insurance companies and associations are against the bills, and so is Tulsa’s Fraternal Order of Police.
The debate over PBMs and their business practices is a national one, and it cuts across party lines. Congress is looking into them and so are several states.
PBMs manage just about all prescription plans, whether through commercial insurance, self-insurance or government plans such as Medicare Part D. In theory, they negotiate lower prices for their clients — the insurance providers, not the patients — while handling all administrative functions.
PBMs began as true third-party administrators that mostly processed claims and handled paperwork.
With the advent of managed care, however, they assumed more active roles in putting together provider networks and negotiating drug prices.
But as PBMs changed, their relationships to insurers, pharmacies and even drug companies became more complex. Marti says
the Affordable Care Act’s attempt to cap health insurers’ profit margins at 15 percent caused them to look to PBMs as a way to boost their bottom lines.
“PBMs have no such restrictions,” Marti said.
“The insurance companies said we can funnel our profits through PBMs.”
The three largest PBMs — Express Scripts, CVS Caremark and OptumRX — own or are owned by a combination of pharmacy chains and insurance companies.
Express Scripts, for instance, was recently acquired by the insurance company Cigna. CVS Caremark is under the same corporate banner as CVS pharmacies and Aetna insurance. OptumRX is owned by UnitedHealth Group, the largest health care company in the world.
According to a 2018 Health Affairs article, those three account for 85 percent of the prescriptions in the United States.
Marti, who operates four Tulsa-area pharmacies, said pharmacists like him have little leverage in dealing with the large PBMs and no recourse if they’re excluded from a network.
In some cases, pharmacists complain because they belong to networks they say don’t adequately reimburse them for the cost of drugs, or in some cases don’t allow them to advise patients of lower-cost alternatives to their prescriptions.
In other cases, pharmacists say they’re shut out of networks because they are independents.
“The little guys are trying to fight to stay alive,” Marti said.
Morgan and at least some employers see things differently. The proposed legislation, he said, is “trying to create a profit for someone and use the state government to do it. We don’t agree with that.”
He said the state chamber opposes all “any willing provider” legislation — that is, the requirement that anyone willing to meet the requirements of a provider network must be accepted by that network.
Morgan said PBMs are able to negotiate lower rates by promising higher volume to pharmacies. Expanding networks, he said, lowers volume to individual establishments.
Morgan said the state chamber is also concerned because the proposed legislation would apply to self-insured health and workers compensation plans.
Asked what he would tell independent pharmacists who say they’re being squeezed out, Morgan said, “That’s not my job, but the industry is evolving and businesses have to adjust to that.”
Still, the complaints about PBMs do not appear completely unfounded. A pending class action lawsuit against Mylan NV alleges it conspired with PBMs to dominate the epinephrine injector market by artificially raising the price of its EpiPens, then reimbursing the PBMs through rebates.
According to the suit,
the higher cost of the EpiPens was passed along to insurers, insurance providers and consumers, while the PBMs kept the rebates.
Critics, including Marti, say that as PBMs decline in number while becoming more entwined with insurers and pharmacies their financial incentives shift from keeping costs to clients and consumers down to keeping them up.
But, Morgan said, employers would not continue using PBMs if they weren’t cost effective. He noted that the State Chamber helped negotiate a truce between the two parties several years ago that brought in the state insurance department to arbitrate disagreements between PBMs and pharmacists.
The cease fire is coming apart, he said, because, “The insurance commissioner maybe needs more staff to handle the numerous challenges from the pharmacists. I think it’s not worked as well as the pharmacists had hoped.”
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