Princess Health and Painkillers appear to increase risk of deaths other than overdoses, according to new study of Medicaid patients in Tennessee. Princessiccia

Princess Health and Painkillers appear to increase risk of deaths other than overdoses, according to new study of Medicaid patients in Tennessee. Princessiccia

cardiac care cardiovascular disease heart health narcotics pain pain management prescription drug abuse research

Gusty 07:28 Add Comment

"Accidental overdoses aren't the only deadly risk from using powerful prescription painkillers," The Associated Press reports. "The drugs may also contribute to heart-related deaths and other fatalities, new research suggests."

A study of of more than 45,000 Medicaid patients in Tennessee from 1999 to 2012 found that "those using opioid painkillers had a 64 percent higher risk of dying within six months of starting treatment compared to patients taking other prescription pain medicine," AP reports. "Unintentional overdoses accounted for about 18 percent of the deaths among opioid users, versus 8 percent of the other patients."

"As bad as people think the problem of opioid use is, it's probably worse," said Vanderbilt University professor Wayne Ray, the lead author of the study report. "They should be a last resort and particular care should be exercised for patients who are at cardiovascular risk."

The report in the Journal of the American Medical Association noted that opioids can slow breathing and worsen the disrupted breathing associated with sleep apnea, which could lead to irregular heartbeats, heart attacks or sudden death.

The patients in the study "were prescribed drugs for chronic pain not caused by cancer but from other ailments including persistent backaches and arthritis," AP reports. "Half received long-acting opioids including controlled-release oxycodone, methadone and fentanyl skin patches. . . . There were 185 deaths among opioid users, versus 87 among other patients. The researchers calculated that for every 145 patients on an opioid drug, there was one excess death versus deaths among those on other painkillers. The two groups were similar in age, medical conditions, risks for heart problems and other characteristics that could have contributed to the outcomes."

Princess Health and Doctors trying to reverse course on opioid prescriptions can find it difficult because of addiction, shortage of good alternatives. Princessiccia

Princess Health and Doctors trying to reverse course on opioid prescriptions can find it difficult because of addiction, shortage of good alternatives. Princessiccia

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Gusty 08:37 Add Comment

The epidemic of opioid overdoses, 60 percent of which are blamed on abuse or misuse, "is changing prescribing habits, but there's still a lack of other pain medications, access to alternative therapies and knowledge among primary-care providers about multidisciplinary approaches to pain management," Modern Healthcare reports.

"The medical community turned to opioid prescriptions to address a condition many believed had been ignored or undertreated," Steven Ross Johnson writes. "And the dependence on fee-for-service payments also made it easier for providers to whip out their prescription pads rather than spend the time to help patients find alternatives. But experts now say the over-reliance on opioids for chronic pain, despite a lack of evidence on their efficacy and impact, was misguided and has distorted the public's concept of what pain is and what it means to be treated."

But reversing course can be difficult because many patients "have built up resistance to opioids and seek treatment while addicted or at risk of addiction," Johnson reports. He quotes Dr. Neel Mehta, medical director of Weill Cornell Medical College's Pain Medicine Center, which specializes in treating long-term pain as saying many come there because their doctor won't write them another prescription: �So we're sort of left with them expecting to get prescribed an opioid and we have to then calmly redirect that.�

In March the federal Centers for Disease Control and Prevention "recommended doctors prescribe alternative treatments such as over-the-counter medications, cognitive behavioral therapy and exercise before resorting to opioids. Weeks later, the Joint Commission [which accredits health-care facilities] clarified its 2001 standards for pain management and treatment to stress that opioid use was neither required nor specified for treating pain."

Other alternative treatments chiropractic care and the use of anti-inflammatory and neuropathic medications and even vitamin supplements, Johnson notes. "The problem is that few carry the punch or, for some, the pleasure of opioids. . . . The use of medical marijuana, meanwhile, has increased in several parts of the country. It's approved in 38 states and the District of Columbia for patients with illnesses such as cancer and HIV. But only some of those states allow the use of marijuana to relieve chronic pain." Kentucky does not.

Princess Health and In many people, OxyContin doesn't give 12-hour pain relief as advertised, and that can cause an addiction problem. Princessiccia

Princess Health and In many people, OxyContin doesn't give 12-hour pain relief as advertised, and that can cause an addiction problem. Princessiccia

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Gusty 09:50 Add Comment

Oxycontin tablets (Los Angeles Times photo by Liz Baylen)

Why have so many people become addicted to the painkiller OxyContin? We know about the overselling of the drug by its manufacturer, Purdue Pharma, which cost the company $635 million in 2007 to settle an investigation by the Department of Justice. Now the Los Angeles Times reports on another big reason, which the settlement didn't address: In many people, OxyContin doesn't last as long as advertised, and "Patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug," Harriet Ryan, Lisa Girion and Scott Glover report.

Purdue Pharma "launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications," the writers report. "On the strength of that promise, OxyContin became America�s bestselling painkiller, and Purdue reaped $31 billion in revenue."

However, the Times reports, "Even before OxyContin went on the market, clinical trials showed many patients weren�t getting 12 hours of relief," as the company claimed. "Since the drug�s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research. The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin�s market dominance and its high price � up to hundreds of dollars per bottle � hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers."

In the late 1990s, when doctors began telling patients to take OxyContin at shorter intervals, "Purdue executives mobilized hundreds of sales reps to [refocus' physicians on 12-hour dosing. Anything shorter 'needs to be nipped in the bud. NOW!!' one manager wrote to her staff," the Times reports. "Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn�t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death. More than half of long-term OxyContin users are on doses that public-health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times."

More than 7 million Americans have abused OxyContin in the last 20 years, according to the National Survey on Drug Use and Health, and a disproportionate number have been in Appalachia and Eastern Kentucky, where the drug has been called "hillbilly heroin." OxyContin "is widely blamed for setting off the nation�s prescription opioid epidemic, which has claimed more than 190,000 lives from overdoses involving OxyContin and other painkillers since 1999," the Times reports.

Purdue Pharma issued statement calling the Times story �long on anecdotes and short on facts� and said it was based on a �long-discredited theory.� Times spokeswoman Hillary Manning replied, �Our editors see nothing in Purdue�s statement that casts doubt on our reporting or our findings.� For details, click here.

Princess Health and Stanford hospital is first in Kentucky to go back to laughing gas, or nitrous oxide, to relieve the pain of childbirth. Princessiccia

Princess Health and Stanford hospital is first in Kentucky to go back to laughing gas, or nitrous oxide, to relieve the pain of childbirth. Princessiccia

babies pain pain management pregnancy rural hospitals

Gusty 09:43 Add Comment

Photo: Abigail Whitehouse, Interior Journal

Ephraim McDowell Fort Logan Hospital's Birthing Spa in Lincoln County is the first in Kentucky to offer nitrous oxide, often called laughing gas, as an alternative pain relief measure for women during childbirth, Abigail Whitehouse reports for The Interior Journal in Stanford.

Dr. James Miller, the unit's medical director, told Whitehouse that the Birthing Spa aims to provide support and comfort to mothers during labor and that nitrous oxide, which was commonly used for this purpose in the 1950s until epidural anesthesia became popular, provides another option to help decrease anxiety and pain during childbirth.

"We in our unit found, when we started hearing again about the nitrous oxide, that it just fit really well with our philosophy of trying to offer choices to moms," Miller told Whitehouse.

Miller said that while epidurals continue to be used most often during labor for pain management, the procedure comes with some risk and are expensive.

"Epidurals cost a lot and haven't shown the benefits. And they changed labor from a low-risk setting to a high-risk setting," Miller told Whitehouse. "With an epidural, we know that it drops the mom's blood pressure, so they have to have an IV ahead of time and load up on fluids to try to prevent the drop in blood pressure, and then it can still happen. Then you have to monitor the baby's heart tones."

In addition to nitrous oxide, the Birthing Spa also offers alternate options for pain management during childbirth, including: water births, which he said have been proven to lower cost and shorten the length of labor, showers big enough for two with multiple shower heads, a nursing staff trained to "almost function as a doula," a beautiful garden to walk in, and massage chairs. The unit also offers epidurals or an alternative intravenous medication for pain.

Miller noted that nitrous oxide, which is delivered through a mask, allows laboring mothers control over their pain management because they can put it on and remove it as needed; it can also be used earlier in the process than an epidural.

Miller told Whitehouse, "It's very fast acting so when the pain is starting to contract, they start breathing the medicine and within seconds it takes effect and then as the pain resolves, they take the mask away and the medicine wears off that quickly too."

Princess Health and Obama joins Rogers at National Rx Drug Abuse and Heroin Summit, says it's time to focus on treatment over incarceration. Princessiccia

Princess Health and Obama joins Rogers at National Rx Drug Abuse and Heroin Summit, says it's time to focus on treatment over incarceration. Princessiccia

conferences drug abuse drug treatment heroin pain pain management prescription drug abuse prescription drugs president public health

Gusty 19:41 Add Comment

By Melissa Patrick
Kentucky Health News

The fifth annual national summit on prescription drug abuse, started by U.S. Rep. Hal Rogers of Kentucky, was the largest, broadest and highest-profile yet.

A non-prescription drug was added to the title of the four-day event, making it the National Rx Drug Abuse and Heroin Summit. It drew more than 1,900 to Atlanta, including President Barack Obama, who joined an hour-long panel to talk about new ways to deal with a growing opioid and heroin epidemic.

U.S. Rep. Hal Rogers

"The rapid growth of this summit is truly a testament to the power of unity. Everyone here has one common goal - to save lives from the dark clenches of drug abuse," Rogers, a Republican from Somerset, said in a news release.

The summit was hosted by Operation UNITE, a Kentucky non-profit created by Rogers that leads education, treatment and law enforcement initiatives in 32 counties in Southern and Eastern Kentucky. The acronym stands for Unlawful Narcotics Investigations, Treatment and Education.

According to the federal Centers for Disease Control and Prevention, in the U.S. someone dies every 20 minutes from an opioid overdose and Kentucky has one of the nation's highest rates, with more than 1,000 deaths a year from it.

(On Monday, April 4, KET's "Kentucky Tonight" will have a report on the summit and a look back at the network's coverage of drug addiction issues. For a preview from host Bill Goodman, click here.)

The University of Kentucky and UK HealthCare, which helped sponsor the summit, sent a delegation of executive, clinical and research leaders, including President Eli Capilouto as one of the keynote presenters, according to a UK news release.

�Too many Kentucky families are too often confronted by the dark and painful scourge of prescription drug abuse and opioid addiction," Capilouto said. "It�s an epidemic that penetrates communities across the nation, both urban and rural, but has especially intractable roots in Appalachia and the regions served by the University of Kentucky.�

Obama opened his remarks on the panel by thanking Rogers,who is also co-chair of the Congressional Caucus on Prescription Drug Abuse, and UNITE, "the organization that has been carrying the laboring oar on this issue for many years now. We are very grateful to them."

Obama focused some of his comments on broadening access to medication-assisted treatments for addiction, most successfully with counseling and behavior therapy.

"What we do know is that there are steps that can be taken that will help people battle through addiction and get onto the other side, and right now that's under-resourced," the president said.

Obama's administration recently proposed doubling the number of patients a health-care provider can treat with buprenorphine, one of the drugs used to fight addiction, to 200 from 100.

He said the opioid and heroin epidemic is a public-health issue and not just a criminal-justice problem, which is the only way to reduce demand. "In this global economy of ours that the most important thing we can do is to reduce demand for drugs," he said.

Because the opioid and heroin epidemic is touching everybody and not just poor people and minorities, there is now more emphasis on treatment over incarceration, Obama said: "This is not something that's just restricted to a small set of communities. This is affecting everybody -- young, old, men, women, children, rural, urban, suburban."

The president also noted that there has been a significantly increase in opioid abuse in rural areas, which often suffer from an under-resourcing of treatment facilities and mental health services.

"And that's why, for all the good work that Congress is doing, it's not enough just to provide the architecture and the structure for more treatment. There has to be actual funding for the treatment," he said.

The president has proposed $1.1 billion in his upcoming fiscal year 2017 budget request to fund drug-treatment programs in counties all across the country.

Agriculture Secretary Tom Vilsack announced two rural initiatives at the summit: town hall meetings in rural areas hit hardest by drug abuse, including Appalachia, "to raise awareness of the issue and discuss possible solutions," and an extension of the Rural Health and Safety Education competitive grant program to include $1.4 million in grants that will now be available to rural communities to fight heroin and painkiller abuse, according to a press release.

The president also announced several other new initiatives: establishing a Mental Health and Substance Disorder Parity Task Force; implementing mental health and substance use disorder parity in Medicaid; releasing $11 million for the purchase and distribution of the opioid-overdose reversal drug, naloxone; expanding an initiative that improves local partnerships between law enforcement and public health; a $7 million investment for community policing to address heroin; and providing guidelines for the use of federal funds to implement or expand needle-exchange programs.

Princess Health and Trying to stop overdose epidemic, CDC tells docs to limit most opioid prescriptions to 3-7 days, use low doses and warn patients. Princessiccia

Princess Health and Trying to stop overdose epidemic, CDC tells docs to limit most opioid prescriptions to 3-7 days, use low doses and warn patients. Princessiccia

addiction drugs federal government health insurance Medicaid Medicare narcotics pain pain management prescription drug abuse prescription drugs

Gusty 20:35 Add Comment

Graphic from CDC guideline brochure

Kentucky Health News

Doctors who prescribe highly addictive painkillers for chronic pain should stop and be much more careful to thwart "an epidemic of prescription opioid overdoses" that is "doctor-driven," the federal Centers for Disease Control and Prevention said Tuesday, March 15.

"This epidemic is devastating American lives, families, and communities," the CDC said. "The amount of opioids prescribed and sold in the U.S. quadrupled since 1999, but the overall amount of pain reported by Americans hasn�t changed."

Kentucky ranks very high in use of opioids and overdoses from them, and Louisville reported a big increase in overdoses this month, Insider Louisville reports.

The agency said doctors should limit the length of opioid prescriptions to three to seven days, use "the lowest possible effective dosage," monitor patients closely, and clearly tell them the risks of addiction.

It said most long-term use of opioids should be limited to cancer, palliative and end-of-life treatment, and that most chronic pain could be treated with non-prescription medications, physical therapy, exercise and/or cognitive behavioral therapy.

The guidelines are not binding on doctors, but Dr. Thomas Frieden, the CDC director, "said state agencies, private insurers and other groups might look to the recommendations in setting their own rules," the Los Angeles Times reported.

However, Modern Healthcare reported that the guidelines are unlikely to change physicians' practices. "One current hurdle to curbing the number of prescriptions is that it's much easier for a busy clinician to prescribe a 30-day supply of oxycodone or Percocet to treat a patient's chronic pain than it is to convince him or her to do physical therapy," Steven Ross Johnson writes. "The time constraints affecting physicians' practice has never been more acutely felt than in this era of health-care reform that emphasizes quality and value-based payment."

Money could be a key in making the guidelines effective. Sabrina Tavernise of The New York Times writes, "Some observers said doctors, fearing lawsuits, would reflexively follow them, and insurance companies could begin to us them to determine reimbursement." The federal Centers for Medicare and Medicaid Services could also play a role.

Johnson notes that physicians are trained to "reserve opioids for severe forms of pain . . . but in the 1990s, some specialists argued that doctors were under-treating common forms of pain that could benefit from opioids, such as backaches and joint pain. The message was amplified by multi-million-dollar promotional campaigns for new, long-acting drugs like OxyContin, which was promoted as less addictive."

Purdue Pharma, maker of OxyContin, agreed to pay $600 million in penalties to settle federal charges that it over-promoted the drug to doctors, prompting the epidemic, especially in Central Appalachia.

"When reports of painkiller abuse surfaced, many in the medical field blamed recreational abusers. In recent years, however, the focus has shifted to the role of doctors," Harriet Ryan and Soumya Karlamangla report for the Times, noting that a 2012 analysis "of 3,733 fatalities found that drugs prescribed by physicians to patients caused or contributed to nearly half the deaths."

Doctors, insurers, drug companies and government agencies "all share some of the blame, and they all must be part of a solution that will probably cost everyone money," Caitlin Owens writes for Morning Consult, which also notes prescribers' complaints and CDC's responses.

Princess Health and Paducah Sun looks at two local doctors who write many prescriptions for painkillers; such local data are easily available.Princessiccia

Princess Health and Paducah Sun looks at two local doctors who write many prescriptions for painkillers; such local data are easily available.Princessiccia

doctors drug abuse narcotics pain pain clinics pain management physicians pill mills prescription drug abuse

Gusty 11:52 Add Comment

The Paducah Sun has used some easily available information about two local doctors to shine a local light on their heavy prescribing of opioids.

The story by Laurel Black begins, "As narcotic painkiller abuse has drawn more public attention, two Paducah physicians � who have been ranked high among prescribers of such drugs � have found themselves defending their practices."

The story cites The Courier-Journal's analysis of 2012 Medicare data that showed Dr. Yogesh Malla of Paducah was "the No. 3 prescriber of narcotic painkillers in the commonwealth. A USA Today article listed Dr. Riley Love, also of Paducah, as 20th in the nation. Both reports used information the news organization ProPublica obtained under the Freedom of Information Act."

The Sun offers a quick retort from the medical director of the pain-management center where Malla practices, paraphrasung him as saying "the reports omit or minimize important factors, such as the specialty of the physicians and the morphine equivalence of the drugs they prescribe."

Dr. Laxmaiah Manchikanti also said in his written statement that his group emphasizes drugs with lower abuse potential and that more than 92 percent of patients at such centers "are already on long-term opioids; consequently, the best we can do (at these centers) is reduce the dosage."

Manchikani is CEO of the American Society of Interventional Pain Physicians, a lobbying group that advocates monitoring of painlkiller prescriptions, and a leading contributor to a wde range of political causes. The Sun doesn't note the latter point, but focuses on the issues of painkiller abuse, a major problem in Kentucky.

"With more than 1,000 deaths per year, Kentucky in 2013 had the third-highest drug overdose mortality rate in the United States, according to the Trust for America's Health," Black notes.

As for the other doctor, the Sun reports, "ProPublica's data on Love, who practices at the Lourdes Pain Management Center, reports that 59 percent of his 1,141 patients filled one or more prescriptions for a Schedule 2 drug and 51 percent filled for a Schedule 3 drug. Both figures are above the average of 45 percent and 41 percent, respectively, for his specialty in Kentucky.

"A spokeswoman for Love said Lourdes center represents the only location in the region where Medicaid patients receive inpatient pain consultations," the Sun reports, quoting her: "The patients we see are often very sick, and the treatments and medications we provide are the last resort comfort measures so the patients can spend quality time with family" as they near death.

The story is behind the Sun's paywall.

Princess Health andChiropractors cite research recommending 'conservative treatments' for low-back pain before prescribing painkillers.Princessiccia

Princess Health andChiropractors cite research recommending 'conservative treatments' for low-back pain before prescribing painkillers.Princessiccia

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Gusty 09:07 Add Comment

Recent research has questioned the effectiveness of acetaminophen for the treatment of spinal pain. In response, the American Chiropractic Association recommends that patients and health-care providers take a conservative approach to back pain. According to a study published in the British Medical Journal, the commonly administered painkiller isn't helpful for diminishing low-back pain.

According to a report released by the federal Centers for Disease Control and Prevention, Kentucky ranks among the top five states for opiate painkiller prescriptions written per 100 people, Deborah Highland reports for the Bowling Green Daily News.

"Research supports the use of more conservative treatments as a first-line defense against pain," said ACA President Anthony Hamm. "This sensible approach not only reduces healthcare costs but may also help some patients avoid riskier treatments altogether," he said in a news release that has exercise tips, posture recommendations and injury prevention techniques to help people maintain healthy backs throughout life.

Princess Health andPain and fever reducer acetaminophen, most-used drug in U.S., is found to reduce positive emotions and reduce psychological pain.Princessiccia

Princess Health andPain and fever reducer acetaminophen, most-used drug in U.S., is found to reduce positive emotions and reduce psychological pain.Princessiccia

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Gusty 19:56 Add Comment

Ohio State University researchers discovered a new side effect of acetaminophen, a leading over-the-counter pain reliever: it also blunts positive emotions. Other research revealed that it helps reduce psychological pain. The drug has been used in the U.S. for more than 70 years and is best known by the brand name Tylenol.

In the Ohio study, participants took Tylenol or a placebo, then looked at very pleasant or very disturbing photos. Those in the experimental group reported weaker emotions than those in the control group. On average, those who took the placebo rated their level of emotion when viewing the photos at 6.76 on a scale of 10, while people who took the pain reliever averaged 5.85.

"Rather than just being a pain reliever, acetaminophen can be seen as an all-purpose emotion reliever," said Geoffrey Durso, the lead author of the study and a doctoral student in social psychology.

Balwin Way, an assistant psychology professor who conducted the study with Durso, said those who took Tylenol didn't seem to be aware they were reacting differently. "Most people probably aren't aware of how their emotions may be impacted when they take acetaminophen," he said.

Acetaminophen, found in more than 600 medicines, is the most common drug in the U.S., according to the Consumer Healthcare Products Association. Every week approximately 52 million American adults, 23 percent of the population, use a medicine with acetaminophen in it. Durso said researchers don't know if other pain relievers like ibuprofen and aspirin have similar effects, but they plan to study that question.

Princess Health and Princess Health andRogers, other drug-caucus chair file bill to reverse FDA's approval of new painkiller; competing company has alternative.Princessiccia

Princess Health and Princess Health andRogers, other drug-caucus chair file bill to reverse FDA's approval of new painkiller; competing company has alternative.Princessiccia

Congress drug abuse drug companies drugs Opana Oxycontin pain pain management prescription drug abuse

Gusty 18:51 Add Comment

Illustration from PainAndDepression.com

U.S. Reps. Hal Rogers of Somerset and Stephen Lynch of Massachusetts have introduced a bill to withdraw federal approval of a new formulation of hydrocodone that is highly addictive and produced in crushable pills, which they say threatens to start a new wave of prescription drug abuse. They are the Republican and Democratic co-chairs, respectively, of the Congressional Caucus on Prescription Drug Abuse.

But the Food and Drug Administration might act against Zohydro ER on its own, because Purdue Pharma LP has completed testing of a competing, non-crushable drug and will ask for "a priority review that would cut two to three months off the 10 months the agency sets as a goal to examine applications" for regulatory approval, Drew Armstrong of Bloomberg News reports. "Purdue�s pill is hard to crush and snort or inject."

That is important to the FDA. �If and when they, or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market,� FDA pain-drug director Bob Rappaport said in his Oct. 25 review of Zohydro�s approval.

Zohydro ER is an extended-release hydrocodone medication made by Zogenix Inc. for patients who need round-the-clock, long-term pain treatment and have found other treatments to be inadequate. Unlike recent formulations of the popular painkillers OxyContin and Opana, is not crush-resistant, but the company has said it is working on a crush-resistant version.

Citing concerns about abuse, the FDA's scientific advisory panel voted 11-2 against approving Zohydro ER, and a coalition of more than 40 health, consumer and other organizations urged the FDA to revoke its approval. Attorney General Jack Conway was among 28 attorneys general who sent the FDA a letter asking it to reconsider. Sen. Joe Manchin, D-W.Va., has introduced a companion bill to the one filed by Rogers and Lynch.

Hal Rogers (Associated Press photo)

Rogers said in a press release, "�While the FDA continues to send mixed signals to drug companies about the need to invest in abuse deterrent technologies, the Act to Ban Zohydro will make it abundantly clear � life saving measures are critical to the development of powerful painkillers like Zohydro. . . . In Southern and Eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths."

Kentucky ranks third in the nation for overdose deaths, with more than 1,000 Kentuckians dying each year from prescription drug overdoses. The number has leveled off following passage of laws that target pill-pushing clinics and doctors, and put stricter regulations on painkillers.

Zogenix has said it is committed to exceeding FDA requirements to make sure the drug is used appropriately, will monitor for misuse, and will allow an outside group to monitor and analyze its data. It noted that Zohydro ER will be regulated as a Schedule II drug, which means it can only be dispensed through a physician�s written prescription, with no refills, and does not contain acetaminophen, longtime use of which can cause liver failure.

Princess Health and Deadly, recalled pills still circulating in Pennyrile Region.Princessiccia

Princess Health and Deadly, recalled pills still circulating in Pennyrile Region.Princessiccia

drug companies drugs food and drug administration pain pain management

Gusty 18:52 Add Comment

A pain reliever that has been recalled and declared dangerous by the Federal Drug Administration is still circulating around southern Kentucky.

The drug marketed under the name Reumofan Plus is being distributed in Elkton and the broader Pennyrile Region, despite being recalled, and a local doctor's office says patients on the drug have had dangerous side effects, reports Nick Tabor of the Kentucky New Era.

Dr. Keith Toms of Generations Primary Care told Tabor three of his patients have taken the drug and had bad side effects. One patient had dangerous elevations of liver enzymes, and two diabetic patients had dangerous spikes in blood sugar.

The Food and Drug Administration has received reports of deaths, strokes, severe internal bleeding, dizziness, insomnia, high blood sugar and other problems associated with the drug since June. The manufacturer, operating under the names Reumofan Plus USA, LLC and Reumofan USA, LLC, announced a voluntary product recall last month, reports Tabor.

According to the FDA, undeclared ingredients in the drug, which is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, could result in serious illness. Tabor reports a FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug, and methocarbamol, a muscle relaxant.

Tabor reports the FDA has issued an alert telling consumers to stop taking the drug immediately and consult a health-care professional. The agency also said it may follow up on the Reumofan recall with warning letters, seizure, injunction requests or criminal charges. (Read more)

Princess Health and House sends Senate pill-mill and Medicaid managed-care fixes.Princessiccia

Princess Health and House sends Senate pill-mill and Medicaid managed-care fixes.Princessiccia

doctor shopping legislation legislature managed care Medicaid pain management pill mills prescription drug abuse prescription drugs state government; General Assembly

Gusty 10:38 Add Comment

The state House yesterday approved without dissent two bills aimed at improving Kentucky's health care.

House Bill 217 addresses some "unintended consequences" of last year's "pill mill bill" by easing some of the bills regualtions. The bill also tightens restricitions on prescription drugs, reports Ryan Alessi of cn|2.

The other measure, House Bill 5, deals with payment problems of the Medicaid managed care system. Itl would apply the prompt-payment laws to managed-care organizations and would move Medicaid late-payment complaints and disputes to the insurance department; those are now handled by the Cabinet for Health and Family Services, which administers Medicaid.

Both bills are expected to see action in the Senate.

Princess Health and With crackdown on pill abuse, will legitimate patients be able to get the prescriptions they need?.Princessiccia

Princess Health and With crackdown on pill abuse, will legitimate patients be able to get the prescriptions they need?.Princessiccia

pain clinics pain management pill mills prescription drug abuse prescription drugs

Gusty 11:23 Add Comment

The crackdown on prescription-pill abuse has some patients worried they won't be able to get the medicine they need because doctors are fearful of over-prescribing. "It's a huge concern in a nation where chronic pain afflicts 116 million American adults and is associated with up to $635 billion in health care costs," reports Laura Ungar in an ongoing series for The Courier-Journal.

"Pain patients feel ashamed or weak that they have to take these medications ... (and) shy away from being treated," said Dr. James Murphy, a pain specialist in Louisville. 

But there is little evidence that pain patients who really need medicine are unable to find treatment. Ungar reports: "It may take longer for them to find a doctor, experts said, and they may be subjected to urine tests and pill counts to ensure they're not abusing their medicines. But most eventually are able to get the medication they need."

"I don't see any decrease in the amount of opioid prescribing in any jurisdiction," Dr. Nathaniel Katz, president and chief executive officer of the Masschusetts-based consulting firm Analgesic Solutions, told Ungar. "So it's difficult to justify a position that legitimate opioid prescribing is being chilled."

Some worry that making physicians use the state's prescription drug monitoring system � commonly known as KASPER � for new patients could create that chilling effect. A survey of controlled-substance prescribers made to use KASPER found about half didn't change their prescribing habits and about 13 percent said they actually prescribed more opioids. But 35 percent, or 190 prescribers, said they had decreased the amount of controlled substance they subscribed because of "media coverage of abuse, increased law enforcement activity related to prescription-drug abuse and fear of investigations by law enforcement or the medical board," Ungar reports.

Some are concerned that "if more doctors make that choice, desperate pain patients may feel forced to seek relief at unscrupulous pain clinics," Ungar reports. (Read more)

Princess Health and Couple shares 'horrible journey' of prescription drug abuse.Princessiccia

Princess Health and Couple shares 'horrible journey' of prescription drug abuse.Princessiccia

health journalism newspapers pain management pill mills prescription drug abuse prescription drugs

Gusty 08:20 Add Comment

Recovering pill addict Stacy Pennington
of Ashland is due to give birth next month.
(Courier-Journal photo by Matt Stone)

Stacy and James Pennington had to lose everything, including their children and home, before they were able to face their prescription drug abuse problem. Now in recovery at The Healing Place in Louisville, they spoke to The Courier-Journal's Laura Ungar of their downward spiral.

"It had gotten to the point where my prescription drugs were my everything. As long as I had them, I was OK," said James, 40, of Ashland. "Before, we had everything we could want. In the end, we were just feeding an addiction. We had lost everything."

Stacy Pennington said she took her first painkillers in 2002 after she cut her finger on a glass candle jar and needed two surgeries. "A year later, she was diagnosed with cervical cancer, then severe endometriosis, and she required several more surgeries," Ungar reports. "Each of her 14 operations brought another prescription for pain pills."

James Pennington took prescription drugs for the first time at age 14 after he dislocated his shoulder. After he broke his shoulder in a motorcycle accident when he was 25, he got a 30-day supply for Percocet and, later, was prescribed more of the drug after a knee injury. "Pain medications became my drug of choice from there on out," he said.

Soon, he was traveling to "pill mills" in Florida to fuel his addiction, pills he sold and shared with his wife. When Stacy gave birth to their daughter, she was heavily addicted and eventually lost custody of her. James' older daughter was also taken from the home. 

Before Stacy Pennington checked in to The Healing Place, she had sold her engagement ring, the Penningtons sold their home before they lost it, and they were spending $100 to $500 a day to feed their addiction. Now, Stacy is expecting another child and the couple is fighting for their sobriety. "It's a horrible journey. I had to absolutely lose everything. But I see that as a blessing," said James Pennington. "I'm so glad I'm on the other side today." (Read more)

Princess Health and Improvements to Rx monitoring systems worth the expense, study finds; using systems influence doctors' prescribing decisions.Princessiccia

Princess Health and Improvements to Rx monitoring systems worth the expense, study finds; using systems influence doctors' prescribing decisions.Princessiccia

pain clinics pain management pill mills prescription drug abuse state government

Gusty 07:22 Add Comment

A plan for an ideal prescription drug monitoring system was published today in the New England Journal of Medicine, with its authors concluding spending more money to improve systems is worth the expense.

To improve databases, the paper's authors recommended "standardization of the type of information submitted to the databases, and a move toward the use of bar-coded prescription paper to more quickly log entries, or a robust e-prescribing system that would eliminate paper and the resulting prescription fraud and 'doctor shopping' that contributes to illicit use of these controlled substances," reports research-reporting service Newswise. (Read more)

Forty-three states, including Kentucky, now have databases to monitor prescriptions for pain relievers and another five states have passed laws to create them, reports Mary Wisniewski for Reuters. Part of the reason for the push is prescription drug abuse is an increasingly big problem, with more people dying from prescription drug overdoses each year than cocaine and heroin combined. Kentucky is a hot spot, with nearly 1,000 people dying from prescription drug overdoses in 2010.

On July 12, a new law will take effect in Kentucky that will make it mandatory for a physician to consult the state drug-monitoring system before writing a prescription for certain drugs for a new patient. Doing so can influence how a doctor chooses to prescribe. A study by the emergency department of the University of Toledo's College of Medicine found "doctors or pharmacists who reviewed state prescription data changed how they managed cases 41 percent of the time," Wisniewski reports

The study found 61 percent of prescribed either no opioid medicine, or less than originally planned, while 39 percent decided to prescribe more. (Read more)

Princess Health and Major newspapers publish reflections, reactions and details (including videos) on new law that will fight 'pill mills'.Princessiccia

Princess Health and Major newspapers publish reflections, reactions and details (including videos) on new law that will fight 'pill mills'.Princessiccia

attorney general doctor shopping doctors General Assembly legislation legislature pain clinics pain management physicians privacy

Gusty 04:22 Add Comment

Reflections on the new law to fight "pill mills" are in both of Kentucky's major metropolitan newspapers today.

The Courier-Journal, which rightly takes partial credit for focusing attention on the issue, has a story by Laura Ungar that summarizes what the bill will do and not do. In the Lexington Herald-Leader, Kentucky Medical Association President Shawn Jones has an opinion piece defending his organization's lobbying against key parts of the bill.

"Unfortunately, in a desire to pass something, many did not consider the details of proposed legislation, and many of the details were extremely troublesome," writes Jones, right. "Most troubling were the proposed infringements on patient privacy through access to the state's Kentucky All Scheduled Prescription Electronic Reporting, or KASPER, system, which contains what is essentially a log of all of the controlled substances an individual has bought. A controlled substance is not just what many people have characterized as 'pain medicine.' It also includes prescriptions for medicines for anxiety, depression or attention deficit disorder." (Read more)

Jones is among the people featured in videos posted with The Courier-Journal's story. Others include Dr. Greg Cooper of Cynthiana; attorney Fox DeMoisey, who represents physicians accused of malpractice; and Dr. Patrick Murphy, a pain-management physician, talking about the various responsibilities of doctors in his field.

Princess Health and Pill-mill bill passes; attorney general won't get drug-monitoring system but narcotic-prescribing doctors will have to use it.Princessiccia

Princess Health and Pill-mill bill passes; attorney general won't get drug-monitoring system but narcotic-prescribing doctors will have to use it.Princessiccia

attorney general doctor shopping doctors General Assembly legislation legislature pain clinics pain management physicians pill mills state government

Gusty 16:25 Add Comment

House Speaker Greg Stumbo, center, walks
with House budget committee chair Rick
Rand and House Majority Floor Leader
Rocky Adkins. (Courier-Journal photo).

Legislators have sent Gov. Steve Beshear a bill to curb prescription drug abuse and crack down on rogue pain clinics, ending the special session of the General Assembly.

The final version left the state's prescription drug-monitoring system under the control of the Cabinet for Health and Family Services and the doctor-controlled Kentucky Board of Medical Licensure rather than move it to the attorney general's office, as the last version in the regular session would have. But in another significant change, it will require doctors and pharmacists who prescribe or dispense Schedule II and III drugs, such as oxycodone and morphine, to use the Kentucky All Schedule Prescription Electronic Reporting system. Only about 25 percent of Kentucky physicians now use KASPER.

Putting the drug-monitoring system in the hands of the attorney general was considered a linchpin of efforts to help law enforcement to proactively identify suspicious prescribers; law enforcement officers can access the database only if they have a case opened, and say they need the data to open cases. But the Kentucky Medical Association called giving law enforcement oversight of information with prescription-drug information a violation of personal privacy. "You are essentially legislating medical care," said Shawn Jones, president of the KMA.

Beshear, who repeatedly pressured legislators to pass a bill pertaining to the issue, issued a statement this evening expressing his delight. "Even though the prescription drug bill doesn't include every element we had hoped, it is an enormous bipartisan accomplishment, and it restores Kentucky as a leading state in innovative tactics in battling prescription drug abuse," he said. "The elements of the bill also help prevent Kentucky from becoming a source state for prescription pills.

House Speaker Greg Stumbo, who sponsored the bill, called its passage "a step forward" though he "would have preferred a stronger version." He told reporters that he did not feel this would be the last time lawmakers would be changing laws to fight the problem, and noted that Beshear could use his gubernatorial reorganization powers to change the administration of the system: "I think the governor, in the days ahead, will continue to take aggressive action on addressing this problem."

The measure will require pharmacists to submit information to KASPER within 24 hours of dispensing a narcotic and doctors must check the system before prescribing one to a new patient. They then would be required to check a KASPER report every three months during a patient's treatment.

As before, the measure will require most pain clinics be owned by at least one doctor; 33 of Kentucky's 77 pain clinics are owned by people with no medical background. Those who already own clinics and haven't had run-ins with the law will be "grandfathered" and be allowed to continue operating. "That really waters it down. A lot!!" Operation UNITE Director Karen Kelly said on Facebook.

Lawmakers also passed the transportation budget bill, which was the main reason why they were called in for a special session by Beshear. They reached an impasse last week when the Senate would not approve the budget, a move Beshear and Senate President David Williams blamed on each other.

There were suggestions that the road and drug issues, the only items that the legislature could consider under Beshear's call of the session, were related. "As the Senate receded on the amendment to put back $50 million of [road] money into Senate President David Williams' district, word went out that the House would compromise on the pill bill and let the Senate keep KASPER [where it is] as long as a funding change took place," Ryan Alessi reports for cn|2. "The Senate sprang into action amended the pill bill and leaders from the two chambers worked together to pass legislation before supper time."

Princess Health and Fighting prescription drug abuse back on legislative agenda.Princessiccia

Princess Health and Fighting prescription drug abuse back on legislative agenda.Princessiccia

legislation legislature pain clinics pain management pill mills state government; General Assembly

Gusty 19:31 Add Comment

As expected, finding a way to fight prescription drug abuse was back on the legislative agenda as lawmakers gathered for Day 1 of their special session. House Speaker Greg Stumbo introduced a bill today that will make it "mandatory for doctors to use the state's electronic reporting system for prescriptions, which would be moved from the Cabinet for Health and Family Services to the attorney general's office," report Jack Brammer and Beth Musgrave for the Lexington Herald-Leader.

Filed as House Bill 1, Stumbo said it "will correct damages caused by lobbyists for the Kentucky Medical Association in the final days of the regular session, when KMA inserted last-minute language that prevented mandatory use of this basic tool."

The bill also makes it possible for doctors who teach pain and addiction medicine at the University of Kentucky and University of Louisville to be appointed by the governor to the boards that license doctors and nurses. "The KMA's lobbyists can no longer argue that such experts do not exist or, if they do, that they should not be on the licensing boards," Stumbo said. "It is unfortunate that KMA lobbyists sought to obscure this provision."

The bill, slightly altered from House Bill 4 that did not pass before the end of the legislative session Thursday, is considered by experts to be the cornerstone of this legislative session. (Read more)

Princess Health and Need for painkillers and social support, shortage of treatment programs, feeds prescription drug abuse in Appalachian Ky..Princessiccia

Princess Health and Need for painkillers and social support, shortage of treatment programs, feeds prescription drug abuse in Appalachian Ky..Princessiccia

addiction drugs pain clinics pain management prescription drug abuse prescription drugs rural health

Gusty 09:04 Add Comment

By Ivy Brashear
Kentucky Health News

Taking opioids is still the best way to treat patients with pain, but the drugs are addictive because they do more than just alleviate physical suffering � they cause patients to feel good too. That's causing big problems in Kentucky, the state with the highest rate of opioid use and overdose.

In Perry County, for example, prescription medicines are the drugs of choice, second only to marijuana, and users may get more of them from relatives than from doctors. And their drug use appears to be part of a social support system.

Those were the findings of three separate studies presented at the second annual Appalachian Health Summit in Lexington last week.

Prescription-drug abuse is "an epidemic" that "seems to have started in rural Appalachia," Jennifer Havens, an associate professor in the University of Kentucky Department of Behavioral Science, said in presenting a study showing how disease spreads through the region.

Havens� study of Hazard and Perry County found that prescription drug abuse in the county is second to marijuana use, and that painkiller abuse among high school seniors is at the same rate as in adults.

Though it�s not clear why prescription drug abuse is so rampant in the region, Havens speculated that lack of availability of other �hard� drugs, like heroin and cocaine, has led Appalachian drug users to turn to prescription medicine to get high. There are few drug-treatment options for users in the region, and many hospitals aren�t �financially viable� to care for drug abusers, she said.

An earlier study in which Havens was involved revealed that rural adults use more �alternate� methods to take drugs, including snorting and injecting. The study compared drug users in Perry County to those in Louisville and found that more than 40 percent of adults in the Hazard area were injecting prescription drugs to get high, and youth there were 25 percent more likely than those in Louisville to abuse such drugs.

The study found high rates of sharing drug-taking instruments, which increases risk for diseases such as hepatitis and HIV, Havens said. Almost 90 percent of participants said they shared snorting straws, and almost 1 in 3 said they shared syringes. No cases of HIV were found among the participants, but almost 43.7 percent of the 500 interviewed had hepatitis-C, and 11.5 percent had herpes-2.

Eighty percent were lifetime users, and about half first abused Oxycontin through injection. Havens said 28 percent of users had overdosed, and 58 percent had witnessed an overdose.

The study also found that a person�s likelihood of continuing drug use correlated with higher levels of social support, which Havens said contradicts long-held assumptions that drug users continue to abuse prescription pills because of low social support.

�Most people in the study depended on people also using drugs for social support,� Havens said. �As you can imagine, that�s not a good idea.�

No good alternative to prescribing painkillers

Despite widespread opioid abuse in Appalachia, such drugs are �still the best pain therapy,� UK physiology professor Karin Westlund High reported.

The purpose of her study was to determine what effect a high-fat and alcohol diet would have on �visceral pain� in the pancreas, and then what effect opioid gene therapy would have on the organ.

There are clusters of Appalachian counties at high risk for pancreatitis, which can lead to pancreatic cancer. Severe abdominal pain is associated with both, and morphine is typically used to treat it. However, High said, patients usually develop a tolerance to the drug over time.

She and other researchers used rats to test an opioid gene therapy involving herpes simplex-1, which 90 percent of Americans already have, to see if it would reduce pancreatitis pain without building tolerance in the rats. After 10 weeks of treatment, there was no tolerance present and the therapy seemed to be reversing damaged sections of the pancreas caused by the disease.

While opioids are effective in alleviating pain, "There are lots of different kinds of pain, but most opioids act as if they treat the same pain,� said Michelle Lofwall, a UK psychiatry and behavioral science assistant professor. Lofwall set out to discover how pain affects prescription drug abuse, since that is the main reason such drugs are prescribed or first used.

Her study participants, who were all drug users, placed one arm in a cooler of ice to elicit pain, and then were asked about pain levels. The test was repeated after a dose of painkiller.  Researchers were attempting to give the drug to treat patients� pain only, and not to have the patient feel a high when the drug was in their system, but that failed.

�Unfortunately, in my patients I wanted to say, �Yes, let�s treat your pain and you won�t feel any good effects�,� Lofwall said. �I wasn�t able to say that to them.� She said they are now trying to help doctors better prescribe pain medication so that habits aren�t formed.

One of the biggest habit-forming painkillers is Oxycontin, which was introduced in 1996 but wasn�t abused on a large scale until doctors had to start documenting pain in 1999, Lofwall said. Sales of, treatment for, and death from prescription drug abuse have increased since then. She noted that Kentucky has the highest rates of opioid use and overdose.

The makers of Oxycontin have reformulated the drug to make it harder to crush, mix with water and snort, but a new drug has risen to take its place: Opana. Lofwall said researchers have been trying to study Opana use, but can�t get a study supply because it is in such high demand. She said she has seen more of a rise in heroin use by her patients because even heroin is easier to get than Opana.

Though legislators are grappling to curb the proliferation of "pill mills" in the state, Lofwall said "doctor shopping" may not be the problem it's been billed to be. According to the National Household Survey on Drug Use and Health, 56 percent of users get their supply from a relative, of whom 85 percent have a prescription from one doctor. The drug abuser may get the drug from the relative as a gift, by paying for it or by stealing it.

Asked about the Kentucky All Schedule Prescription Electronic Reporting system, which allows doctors to search a database for �doctor shoppers� before prescribing pain pills, Lofwall said KASPER is limited because it only covers Kentucky, but �I think the state�s ready to make it better.�

Kentucky Health News is a service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Telecommunications at the University of Kentucky, with support from the Foundation for a Healthy Kentucky.

Princess Health and Senate panel and House OK bills to tackle prescription-bill abuse.Princessiccia

Princess Health and Senate panel and House OK bills to tackle prescription-bill abuse.Princessiccia

pain clinics pain management pill mills prescription drug abuse state government; General Assembly

Gusty 15:34 Add Comment

Two bills aimed at attacking the state's prescription drug abuse problem made headway yesterday, with a major difference between the House and Senate measures, reflecting possible turf battles between state agencies and doctors' desire to maintain as much control over regulation as they can.

Senate Bill 2 would keep the state drug monitoring system � known as the Kentucky All Schedule Prescription Electronic Reporting, or KASPER � the responsibility of the Cabinet for Health and Family Services. House Bill 4 would give it to the attorney general's office.

The Senate Judiciary Committee approved Senate Bill 2 on an 8-to-1 vote. House Bill 4 passed the full House 81 to 7. The bills' low numbers reflect their importance to legislative leaders in both chambers.

Lawmakers feel the issue will ultimately be taken up near the end of the session in a conference committee, whose members represent the House and Senate and come together to come to an agreement between the two chambers, reports Jack Brammer for the Lexington Herald-Leader.

SB 2 originally required that doctors use KASPER when dispensing narcotics and get a KASPER report before issuing a prescription. At the request of the Kentucky Medical Association, bill sponsor Sen. Jimmy Higdon, R-Lebanon, changed that stipulation, requiring the Kentucky Medical Licensure Board, made up mainly of doctors, to issue regulations on how doctors should use KASPER. Higdon said he made the change in order to get the bill out of committee, a move that angered Sen. Ray Jones, D-Pikeville, who accused the KMA of trying to "gut the bill." (Read more)

HB 4 would still require the use of KASPER, used by only less than a third of doctors, and "would bolster regulation on pain clinics and call on coroners to perform mandatory drug tests in cases of deaths with an unknown cause," reports Tom Loftus for The Courier-Journal. "It also would give commonwealth's and county attorneys access to the data in KASPER and would require that pain clinics be owned by a licensed physician or an advanced practice registered nurse." SB 2 would allow only doctors to own pain clinics, but Sen. Brandon Smith, R-Hazard, said clinics with non-physician owners should be grandfathered in if they have not have previous problems with the law.

As for whether the KASPER should stay in the cabinet or go to the attorney general, Sen. Tom Jensen, R-London, said he doesn't has one strong feeling over the other. "We have to make sure the enforcement is there, whoever is doing it. properly," he told Ryan Alessi on CN|2's "Pure Politics."