Abuse-Deterrent OxyContin Tied to Spike in Hepatitis C

https://www.medscape.com/viewarticle/908645

The introduction of abuse-deterrent OxyContin in 2010 may have played a key role in the rapid increase in hepatitis C infections because some drug abusers switched from the prescription opioid to injectable heroin, new research suggests

While hepatitis C infection rates increased broadly across the United States in the years after reformulated OxyContin became available, investigators found that states with above-average rates of OxyContin misuse prior to the reformulation saw hepatitis C infections increase three times as fast as in other states.

The results suggest efforts to deter misuse of opioids can have “unintended, long-term public health consequences,” David Powell, lead investigator and senior economist at RAND Corporation, told Medscape Medical News.

“Policies that limit the supply of opioids are a great idea but they may cause more problems than they actually solve. Supply-side interventions, which is kind of how we are currently attacking the opioid crisis, may have limited impact when you have a readily available substitute like heroin out there,” Powell added.

The study was published online February 4 in the journal Health Affairs.

“Alarming” Increase

In the United States, acute new hepatitis C infections declined during the 1990s, plateaued starting around 2003, but have been rising at an “alarming” rate since 2010, the authors point out.

Prior studies suggest abuse-deterrent OxyContin may have led some nonmedical users of the drug to switch to injectable heroin, which then led to a sharp increase in heroin overdoses after 2010.

Because injection drug use is the predominant risk factor for hepatitis C, Powell and colleagues sought to determine whether the opioid epidemic might be one driver of the recent rise in new infections.

They examined rates of hepatitis C infections in each state from 2004 to 2015, examining differences between states based on the level of misuse of the drug before the reformulation occurred.

Results showed that states with above-median OxyContin misuse before the reformulation had a 222% increase in hepatitis C infections in the post-reformulation period, while states with below-median misuse of OxyContin had a 75% increase in hepatitis C infections over the same period.

Before the reformulation, there was almost no difference in hepatitis C infection rates across the two groups of states. The rise in hepatitis C infection rates was not associated with initial rates of abuse of other pain relievers, which suggests that the source of the differential rise in hepatitis C infection rates was unique to reformulated OxyContin, the authors say.

“It is important that strategies that limit the supply of abusable prescription opioids are paired with polices to ease the harms associated with switching to illicit drugs, such as improved access to drug treatment and increased efforts to identify and treat diseases associated with injection drug use,” study co-author Rosalie Liccardo Pacula, co-director of the RAND Opioid Policy Tools and Information Center and the RAND Drug Policy Research Center, said in a news release.

Interpret With Caution

Reached for comment on the study, David Murray, PhD, senior fellow at the Hudson Institute, cautions against concluding that reformulation of OxyContin alone is to blame for the rise in hepatitis C infections.

“The issue is very complicated and teasing out what exactly the abuse-resistant formulary did against the backdrop of several major policy changes is very difficult,” he noted in an interview with Medscape Medical News. “You will find a correlation, obviously, with an opioid crisis surging forward and increased injection drug use and therefore exposure to hepatitis C. The linkage to reformulation of Oxycontin, however, is a little weaker,” said Murray.

“There is no clear signal that reformulation was sufficient to drive hepatitis C when you consider the policy changes happening at the time and the stunning rise in heroin availability and use itself. Reformulation of OxyContin is a factor, but it is not the factor when you consider all the other contributing factors. That is a bridge too far in my sense,” Murray added.

Support for the study was provided by the National Institutes on Drug Abuse. The authors have disclosed no relevant financial relationships. Murray served as chief scientist at the Office of National Drug Control Policy (ONDCP) from 2006 to 2009 and as associate deputy for supply reduction in the ONDCP until 2014.

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‘Extreme’ Opioid Use And Doctor Shopping Still Plague Medicare

http://www.wnpr.org/post/extreme-opioid-use-and-doctor-shopping-still-plague-medicare

In Washington, D.C., a Medicare beneficiary filled prescriptions for 2,330 pills of oxycodone, hydromorphone and morphine in a single month last year – written by just one of the 42 health providers who prescribed the person such drugs.

In Illinois, a different Medicare enrollee received 73 prescriptions for opioid drugs from 11 prescribers and filled them at 20 different pharmacies. He sometimes filled prescriptions at multiple pharmacies on the same day.

These are among the examples cited in a sobering report released Thursday by the inspector general of the U.S. Department of Health and Human Services. The IG found that heavy use and abuse of painkillers remains a serious problem in Medicare’s prescription drug program. The program, known as Part D, serves more than 43 million seniors and disabled people. Among the report’s findings:

• Of the one-third of Medicare beneficiaries in Part D (or roughly 14.4 million people) who filled at least one prescription for an opioid in 2016, some 3.6 million received the painkillers for at least six months.
• There were wide geographic differences in prescribing patterns, consistent with data released last week by the Centers for Disease Control and Prevention. Alabama and Mississippi had the highest proportions of patients taking prescription painkillers — more than 45 percent each — while Hawaii and New York had the lowest — 22 percent or less.
• More than half a million beneficiaries received what the report defined as high doses of opioids for at least three months — meaning they got the equivalent of 12 tablets a day of Vicodin 10 mg. The figure does not include patients who have cancer or those who are in hospice care, for whom such high doses may be appropriate.
• Almost 70,000 beneficiaries received what the inspector general labeled as extreme amounts of the drugs — an average daily consumption for the year that was more than 2 1/2 times the level the CDC recommends avoiding. Such large doses put patients at an increased risk of overdose death. Extreme prescribing could also indicate that a patient’s identity has been stolen, or that the patient is diverting medications for resale.
• Some 22,000 beneficiaries seem to be doctor shopping — obtaining large amounts of the drugs prescribed by four or more doctors and filled at four or more pharmacies. All states except for Missouri operate Prescription Drug Monitoring Program databases that allow doctors to check, before writing a prescription, whether their patient has already received the drug or similar drugs from other doctors.
• More than 400 doctors, nurse practitioners and physician assistants had questionable prescribing patterns for the beneficiaries most at risk, meaning those who took extreme doses of the drugs or showed signs of doctor shopping. One Missouri prescriber wrote an average of 31 opioid prescriptions for each of 112 patients on Medicare. And four doctors in the same Texas practice ordered opioids for more than 56 beneficiaries who seemed to be doctor shopping. “The patterns of these 401 prescribers are far outside the norm and warrant further scrutiny,” the inspector general said.

To be sure, many seniors suffer from an array of painful conditions, and some opioids are seen as less harmful and addictive than others. Tramadol, often used to treat chronic osteoarthritis pain, for example, was the most frequently prescribed opioid and carries a lower risk of addiction than other opioids, according to the Drug Enforcement Administration.

Moreover, last week’s report from the CDC shows that painkiller use is ticking downward after years of explosive growth.

Still, officials in the inspector general’s office said more can and should be done to combat the problems they observed, even if opioid prescribing is beginning to subside overall.

“I think what we’re saying here is this is still a lot of Medicare beneficiaries,” says Jodi Nudelman, regional inspector general for evaluation and inspections in the New York regional office, who supervised the report. “Regardless of if you are turning a corner, you’re still at these really high levels.”

The inspector general previously has called for Medicare to use its data to focus on doctors who are prescribing drugs in aberrant ways.

The inspector general’s numbers differ somewhat from an April report from the Centers for Medicare and Medicaid Services, which runs Medicare. The CMS report said that 29.6 percent of Part D enrollees used opioids in 2016, down from 31.9 percent in 2011. The inspector general pegged the 2016 figure at 33 percent, and did not offer any historical comparisons. It was unclear why the two agencies came up with different figures.

In a written statement, CMS said opioid abuse is a priority for the Trump administration. “We are working with patients, physicians, health insurance plans and states to improve how opioids are prescribed by health care providers and used by patients, how opioid use disorder is diagnosed and managed, and how alternative approaches to pain management could be promoted,” the agency said.

Officials have known for years that opioid prescribing has been a problem in Medicare. ProPublica first highlighted the problem in 2013, by publishing data on the drugs prescribed by every physician in the Part D program. Following that report, CMS put in place what it called an Overutilization Monitoring System, which tracked beneficiaries at the highest risk for overdoses or drug abuse. It asked the private insurance companies that run the drug program on its behalf, under contract, to review the cases and provide a response.

In a memo released in April, CMS said its monitoring system has been a success. From 2011 to 2016, it said, there was a 61 percent decrease in the number of beneficiaries who were labeled as “potential very high risk opioid overutilizers.” People were flagged that way if they were taking high doses of opioids for 90 consecutive days and received prescriptions from three or more doctors at three or more pharmacies. But the agency also said it would be implementing changes in January to better target those at highest risk of abuse.

Separately, in 2014, CMS told health providers they would have to register with the Medicare program in order to prescribe medications for beneficiaries. That way, the government could screen them and take action if their prescribing habits were deemed improper. Up to that point, doctors could prescribe drugs to Medicare patients even if they weren’t registered Medicare providers. Delay after delay has pushed back the registration requirement until 2019.

Dr. Cheryl Phillips, senior vice president for public policy and health services at LeadingAge, an association of nonprofit service providers for older adults, says managing pain in seniors is complex. Seniors are more likely to have conditions such as orthopedic problems, cancer or degenerative joint disorders that result in chronic pain. They sometimes don’t react well to nonprescription pain relievers, such as Tylenol, aspirin or nonsteroidal anti-inflammatory medicines. And health care providers at nursing homes are still evaluated in part on how well they manage pain, creating an incentive to turn to drugs.

“We have to challenge the notion that being pain-free is a goal,” Phillips says. “It’s not that I want to see people suffering, but being pain-free is perhaps a myth that not only society has been seduced with, but physicians have as well.”

Phillips says she encourages physicians to explore nondrug alternatives, including meditation, mindfulness, moist heat and exercise.

This story was produced by ProPublica, an independent nonprofit newsroom based in New York. Charles Ornstein is a senior reporter. You can compare your doctor’s medication prescribing to his or her peers using ProPublica’s Prescriber Checkup tool.

With 44 million people getting their meds paid for by Medicare Part D…  This article focuses on 22,000 potential substance abusers… that is 0.000023% of the Medicare population.  IS THIS EXTREME  and this article would have you to believe ?

If this was true, why didn’t the Medicare PBM reject payment for these frequent opiate Rxs  or where they paid for by cash… it was only after the fact data mining of the various PMP’s databases to uncover these facts .

Do we know – other than what was retrieved from the various PMP’s  – that the person(s) filling these prescriptions were in fact the actual person whose name was on the prescription and the driver’s license that was presented.

Do we know.. if many/most/all of these prescriptions were valid prescriptions or forged on counterfeit  prescription blanks and the prescriber had no idea that there name/DEA/NPI was being used without their consent ?

Do we know if these prescriptions were actually obtained by people who intended to DIVERT these opiates and that is there BUSINESS PLAN ?

Maybe drilling down to get all the FACTS … rather than just piling similar data into one data pile… to make it sound like something was really bad going on.

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Limiting opioid prescriptions will do little to reduce overdose deaths, study says

https://www.bostonglobe.com/metro/2019/02/01/limiting-opioid-prescriptions-will-little-reduce-overdose-deaths-study-says/DX9nHWdUWaLcP4DjdgLafJ/story.html

When the death toll from opioid overdoses began to soar a few years ago, the evidence was clear how it all started: Painkiller prescriptions had tripled in a decade, exposing millions of people to the risk of addiction. Policy makers naturally sought to put a lid on opioid prescribing.

But a study published Friday in JAMA Network Open finds that reducing opioid prescriptions will have little effect on the death rate over the next few years, now that the epidemic is dominated by heroin and illicit fentanyl.

The study offers a countervailing view at a time when authorities are warning or even prosecuting high-prescribing doctors and numerous state and local governments are suing over the conduct of opioid manufacturers, including whether Purdue Pharma deceptively marketed the popular painkiller, OxyContin.

A team that included researchers from Massachusetts General Hospital and Boston Medical Center employed mathematical modeling to project what could happen over the next several years. They predicted that opioid-related mortality nationwide would double or triple from 2015 levels, reaching around 82,000 a year in 2025.

The projections showed that restrictions on prescription opioids — such as a Massachusetts law requiring prescribers to consult a database that can flag doctor-shopping, and another that limits the length of new prescriptions — would reduce opioid deaths by only 3 percent to 5 percent in the near future.

“You can’t just cut off the spigot and expect things to get better,” said Dr. Marc R. Larochelle, a Boston Medical Center addiction researcher and one of the study’s authors. “The nature of the threat has changed and we haven’t caught up with it.”

In many states, the vast majority of opioid-related deaths involve heroin or fentanyl, and prescription drugs account for only a small number. In Massachusetts in 2018, fentanyl was found in 90 percent of people who overdosed, while prescription opioids are present in only 17 percent of cases.

And opioid prescribing, although still high, has been decreasing since 2010. Larochelle said that restricting access to pills can drive people to more dangerous street drugs.

The research, however, failed to persuade two prominent advocates of limiting opioid prescribing. One said it contained errors and the other said it overlooked the fact that taking prescribed opioids can lead to heroin use.

Dr. Andrew Kolodny, a Brandeis University researcher and executive director of Physicians for Responsible Opioid Prescribing, said the study contained errors and he was surprised JAMA published it.

“The projections have already been disproven,” he said, pointing to federal data that show the number of opioid-related deaths leveling off nationwide in 2018. The JAMA Network Open study instead projects the death toll to continue rising. Kolodny also said the researchers based their work in part on a “misleading” study that suggested an increase in the number of people whose first opioid is heroin. In fact, the number is decreasing, he said.

The research team gathered data on the trajectory of the opioid crisis from 2002 to 2015, and used that data to project numerous scenarios for the years 2016 to 2025. No matter how the epidemic played out in the different projections, including an optimistic scenario where deaths leveled off, reducing the misuse of prescription opioids still showed minimal impact, they said.

“Our study does not devalue the efforts to reduce misuse of prescription opioids, [but] these efforts in isolation will not bend the overdose death curve,” said Jagpreet Chhatwal, senior scientist at MGH’s Institute for Technology Assessment and the study’s co-lead author.

The researchers acknowledge imperfections in their models.

“It’s really hard to predict the future,” Larochelle said. But they say none of the limitations undercut the study’s fundamental conclusion that lowering the misuse of prescriptions won’t make much of a difference.

The authors argue that policy makers need to focus on increasing access to effective treatment, especially with medications such as buprenorphine and methadone, and reducing deaths among those not in treatment, by expanding the use of the overdose drug naloxone, needle exchanges, and creating safe places to use drugs.

Dr. Adriane Fugh-Berman, professor of pharmacology and physiology at Georgetown University Medical Center, agreed that such measures are critical. But the study, she said, doesn’t address the fact that prescription opioids “can start people down the path to heroin.”

“Overprescription of opioids continues to feed this epidemic,” said Fugh-Berman, who directs PharmedOut, a Georgetown-based project that promotes evidence-based prescribing. “Opioids are still being prescribed at too high a rate to patients for whom the risks outweigh the benefits.”

Dr. Scott Hadland, a Boston Medical Center addiction specialist who was not involved in the study, agreed with the study authors that “limiting the supply of prescription opioids is not going to be the primary answer” to reduce deaths in the short term.

But Hadland, a pediatrician who recently published a study showing a connection between marketing efforts by opioid maker and fatal opioid overdoses, added that opioid prescribing still requires attention for the long term.

In national surveys, about 4 percent of high school seniors report using opioids without a medical reason, and high schoolers are 10 times less likely to use heroin, he said. Looking ahead to these teens’ lives after 2025, Hadland said, it remains important to prevent young people from misusing prescription opioids.

Felice J. Freyer can be reached at felice.freyer@globe.com. Follow her on Twitter @felicejfreyer.

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Retail-induced panic attack?!!

https://www.reddit.com/r/pharmacy/comments/alyudx/retailinduced_panic_attack/

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Combating the opioid crisis one doctor at a time

https://www.washingtonpost.com/national/health-science/combating-the-opioid-crisis-one-doctor-at-a-time/2019/02/01/9d11c1a0-1a71-11e9-8813-cb9dec761e73_story.html

GLENSIDE, Pa. — Sandeep “Sonny” Bains pulled up to Lyons Family Medicine in the pre-dawn dark armed with coffee, doughnuts and glossy brochures about pain treatments.

“What can I help you with for acute pain?” he inquired of ­father-and-son primary-care doctors Michael and Zachary Lyons as he was ushered into a wood-paneled back office.

Bains’s quick drop-ins are modeled on those used by pharmaceutical sales reps to pump up sales. The similarity ends there, though: Bains, a pharmacist, is part of a fledgling movement co-opting the drug industry’s tactics to deliver a different message to doctors — that narcotics are not only addictive but also often no better at managing pain than safer, over-the-counter medicines.

“I’m cold-calling them, picking up the phone: ‘I’m Sonny . . . a pharmacist providing free education,’” Bains said. “It does sound like a drug rep’s pitch.”

The opioid crisis and a series of high-profile lawsuits against drugmakers, including Purdue Pharma and Insys, have put a national spotlight on aggressive pharmaceutical marketing campaigns to persuade doctors to prescribe their drugs, sometimes with scant attention to safety issues — a $20 billion-a-year effort for all drugs sold in the United States, according to a recent study. It has also given new energy to a countermovement that borrows the style, if not the substance, of that outreach.

Late last year, Aetna invested nearly $7 million in the counterprogramming strategy, partnering with a nonprofit, Alosa Health, to bring its pain treatment education to doctors in Pennsylvania, Maine, Illinois, Ohio and West Virginia — states hit hard by opioid overdose deaths. The health system Kaiser Permanente and the Department of Veterans Affairs also use the approach.

Bains is one of about 30 trained academic detailers, as they call themselves, who will be knocking on doctors’ doors for the next year, deploying their knowledge about drugs and their people skills to provide the best evidence about how to treat pain. Aetna will measure how well the intervention works and could expand it to other states — or to other health problems, such as overuse of antibiotics.

“What’s fascinating about this program is that . . . the cause of the opioid epidemic was inappropriate and aggressive marketing of opioids by these sales reps,” said Daniel Knecht, vice president of clinical strategy and policy at Aetna.

Holly Campbell, a spokeswoman for PhRMA, a lobby for the drug industry, said that ethical relationships between drugmakers and health care professionals were beneficial for patients and aided in the development of new medicines.

“An important part of achieving this mission is ensuring that health care professionals have the latest, most accurate information available regarding medicines,” Campbell said.

Policymakers often favor top-down approaches to change how doctors practice: Some states, for instance, set limits on pain prescriptions, or send doctors report cards on their prescribing habits in hopes of quelling a crisis that now kills more Americans each year than AIDS at the height of the HIV epidemic.

Bains’s approach, in contrast, adopts the very method of building relationships with doctors that helped seed the opioid crisis.

“The message is not: ‘Don’t use opioids,’ ” Bains said, after quizzing Michael Lyons on when he would consider using narcotics to treat pain. “It’s . . . be cautious. Use immediate-release and not necessarily long-acting drugs. Short course of treatment.”

He sees himself as peddling evidence, often championing treatments that may be too old or too unconventional, like Advil and Tylenol or acupuncture, to have a sales force dropping by to remind doctors to use them.

“The drug company is frankly much smarter about how to get into people’s heads,” said Jerry Avorn, a Harvard Medical School professor and critic of the drug industry’s influence. As a primary-care doctor, “I would definitely have sales reps trying to get to see me to talk about this amazing medication, [to] tell me that pain is undertreated, it’s the fifth vital sign and every patient should be asked if they are in pain.”

The idea of using the drug companies’ own playbook is familiar to Avorn, who first showed the strategy could work nearly four decades ago in a research project. But only recently has Avorn seen broader embrace of the idea that the drug industry’s outreach may drive up the use of expensive medicines and push physicians to use them inappropriately.

Bains makes these visits not just for opioids, but also to help physicians manage dementia, lung diseases, diabetes and other conditions, through an Alosa Health program supported by the Pennsylvania Department of Aging. In brief meetings that often take place off-hours, he builds relationships with doctors, listening to their questions and challenges.

The interactions are collaborative and respectful, even if doctors practice in ways that don’t conform with evidence. Bains said doctors are often dismissive when confronted with a new idea or evidence, but then they bring it up with greater interest next time he sees them.

These unconventional education efforts have often started as one-off contracts or experiments, but they are growing as studies show they work. Michael Courtney, director of physician engagement at the Capital District Physicians’ Health Plan, now deploys his experience as a pharmaceutical sales rep for companies such as Pfizer and Johnson & Johnson to dissuade doctors from unnecessary use of expensive drugs, drawing on relationships built over time.

“Even in the pharmaceutical industry, it wasn’t a one-time call,” Courtney said. “You were going in there because the data said you have to hear something six to eight times to make it change or resonate.”

A recent study in JAMA Network Open found a possible link between the number of office visits that drug reps made, building trust over time, and the number of overdose deaths — although the research couldn’t show that the visits caused the deaths.

For doctors, these visits amount to a different way to stay abreast of research in their fields. Normally, physicians learn about new findings piecemeal, at best, when they have time to read medical journals or to sit in darkened hotel rooms watching slides flash by. Or they get a highly selective version of the data from drug company representatives, along with free samples.

Bains, by contrast, comes with prescription pads already filled out for treatments like Tylenol or rest, ice and compression — and with warnings about risks and side effects of opioids.

“Being in primary practice, it would be very easy to be in isolation — to take the medical knowledge from the time you finish residency, really not bulk it up, or update it, and really veer off of what is the current evidence-based medicine,” said Zachary Lyons, the son.

The Lyonses, trained three decades apart, were both aware of the risks of opioids, but they debated with Bains about when to turn to steroids, which are not recommended for short-term pain relief for acute low-back pain.

“The wonderful thing about doing what we do is — you and I can disagree, but we’re all on the same side. We all want the patient to get better,” Michael Lyons said of their chats with Bains. “Drug salesmen come, but they have motivation — they’re trying to sell.”

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