FDA requires OxyContin pills to be non-crushable to deter abuse

The Food and Drug Administration announced Tuesday that it would block generic, crushable versions of OxyContin from coming to the market and approve the reformulated, non-crushable OxyContin, which deters abuse of the powerful painkiller.

U.S. Senate Republican Leader Mitch McConnell applauded the move. “Given the public health epidemic of prescription drug abuse and the ravaging effects it has on families all across Kentucky, this announcement is great news and will prevent an influx of crushable, generic OxyContin from coming to market,” McConnell said in a release.
 
OxyContin is a potent drug designed to treat severe pain. Without abuse-deterrent formulas, addicts can crush the pills to get an immediate heroin-like high. The reformulated product has properties that make the tablet harder to crush, break, or dissolve and that prevent it from being injected in order to achieve a quick high, an FDA press release said.

Drug overdoses are now the leading cause of death in Kentucky, and law enforcement, lawmakers and health providers have expressed their concerns that crushable, generic versions would worsen the problem.

The FDA decision came on the same day manufacturer Purdue Pharma’s patent on the original drug was set to expire, and McConnell has been actively meeting with federal officials on behalf of those concerned. Rep. Hal Rogers, R-5th, also lobbied for it. (Read more)

In an editorial, the Lexington Herald-Leader points out that the move means a continued OxyContin monopoly and more profits for Purdue Pharma, which "paid $600 million in fines in 2007, and three of the company's executives paid a total of $34.5 million, after they pleaded guilty to misleading doctors and the public about OxyContin's addictiveness. . . . We wonder why Rogers and McConnell aren't calling for Purdue to voluntarily share its new formulation."

National Rx Drug Abuse Summit, a Kentucky product, seeks to make the nation face up to its problem

The second annual National Rx Drug Abuse Summit, organized by Eastern Kentucky's Operation UNITE, called for a national commitment to combating the country's drug-abuse problem

U.S. Rep. Hal Rogers, R-5th District

"People of great passion and perspective are here wanting to make an impact in their communities," said U.S. Rep. Hal Rogers, who first funded Operation UNITE. "The first step is we have to admit there is a problem. I don't think the country is there yet. We've got to face up to it. We've got to make this known ... and that we're not going to hide from it." Rogers was quoted in a news release.

UNITE (Unlawful Narcotics Investigations, Treatment and Education) serves 32 counties in Eastern Kentucky. It was created to fight illegal drug use through a comprehensive approach that includes educating youth and the public and coordinating substance abuse treatment while providing support for families affected by abuse.

In Kentucky, drug overdose is the leading cause of death and is more fatal than motor vehicle accidents, and the number of Kentucky drug-overdose deaths nearly quadrupling from 2000 to 2010. The nation has seen a similar trend, with the number of overdose deaths more than tripling over the decade.

“We can stop this epidemic,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said at the summit. “But we need everyone working together in an all-hands-on-deck approach.”

Themes highlighted at the summit included the need to provide better education about drug abuse, the need for greater use and seamless integration of state prescription-monitoring programs, the need to facilitate effective treatment and recovery programs, and the need for abuse-deterrent narcotic formulations.

“We were extremely pleased that so many individuals representing such a broad cross-section of interests shared their knowledge and expertise,” said Karen Kelly, who is leaving Operation UNITE to become district director on the Rogers congressional staff. To read more about the summit, click here.

Most Kentucky adults don't know that drug overdose is the leading cause of death in the state, but those in the east do

Drug overdoses, driven largely by prescription drug abuse, overtook motor vehicle accidents as the leading cause of unintentional deaths in Kentucky back in 2010 and remain the state's leading cause of death. From 2000 to 2010, the number of drug-overdose deaths in Kentucky rose a staggering 296 percent, highlighting the state's drug abuse epidemic that now kills more than 1,000 Kentuckians a year. But a recent poll suggests many Kentuckians are not fully aware of the state's drug problem.

In an effort to gauge awareness of the problem, the Kentucky Health Issues Poll asked Kentucky adults whether traffic accidents, falls, firearms or unintentional drug overdoses resulted in the highest dumber of deaths in the state each year. Only 44 percent of Kentucky adults correctly indicated that drug overdose is the leading cause of unintentional Kentucky deaths; 43 percent incorrectly identified traffic accidents as the leading cause.

Respondents from Eastern Kentucky, where the problem is most prevalent  were more likely to correctly identify it as the leading cause of death, at 69 percent. However, only 29 percent of Louisville-area respondents did.

“Experts have reported significant prescription pain reliever abuse in eastern Kentucky,” said Susan Zepeda, presient of the Foundation for a Healthy Kentucky, which co-sponsored the poll.  “It is no surprise that the Kentuckians most aware of this issue are those who are living in this region.  Awareness is the first step towards curbing this trend – it is up to all of us to get involved and take action to reduce the toll of this health crisis.”

The poll was conducted for the foundation and The Health Foundation of Greater Cincinnati from Sept. 20 through Oct. 14 by the Institute for Policy Research at the University of Cincinnati. A random sample of 1,680 adults throughout Kentucky was interviewed by land line and cell telephones, and the poll's margin of error is plus or minus 2.5 percentage points.

Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant

Generic versions of popular pain relievers must be made harder to abuse, in order to curb prescription drug abuse that is epidemic in many states, Attorney General Jack Conway and 47 other attorneys general said in a letter sent to federal officials Monday.

The National Association of Attorneys General letter encourages the Food and Drug Administration to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper- and abuse-resistant versions of their products, because the attorneys general are concerned that non-medical users are shifting to non-tamper-resistant formulations of generic opioids.

“Prescription drug abuse is an epidemic that kills more than 1,000 Kentuckians each year,” Conway, who co-chairs NAAG’s Substance Committee, said in a news release. “The development of tamper-resistant and abuse-deterrent opioid drug products is a valuable aid to the law enforcement, legislative and public awareness initiatives many of us have implemented in our states to combat prescription drug abuse.”

Prescription drugs can be deadly when abused, and fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States and Kentucky, exceeding even motor vehicle deaths, according to the Centers for Disease Control and Prevention. Federal data show that U.S. drug overdose deaths totaled 38,329 in 2010, rising for the 11th straight year, and accidental deaths involving addictive prescription drugs overshadow deaths from illicit narcotics.

In Kentucky, the number of drug-overdose deaths in Kentucky rose a staggering 296 percent from 2000 to 2010, according to the Kentucky Injury Prevention and Research Center. Kentucky is one of the most medicated states in the country, and has the sixth highest overdose rate. Last year, 220 million doses of the highly addictive painkiller hydrocodone were dispensed in the state -- that’s 51 doses for every man, woman and child in the state, says the AG release.

The news release from Conway's office said he led the effort to reach out to the FDA, along with Attorneys General Luther Strange of Alabama, Pam Bondi of Florida and Roy Cooper of North Carolina. Click here to read the letter; for a news release, click here.

Legislature sends fix of last year's pill-mill bill to Beshear

"After more than a year of debate, a bill that would revamp Kentucky’s prescription-drug law to more strictly focus on pill abuse and ease requirements on patients is heading to the governor’s desk," Mike Wynn reports for The Courier-Journal. On a 36-0 vote, the Senate sent House Bill 217 to Gov. Steve Beshear, who said he will sign it tomorrow.

The chief lobbyist for the Kentucky Medical Association said the physicians' group did not get all the changes it requested in last year's law but is satisfied with the bill. It "would exempt hospitals and long-term care facilities from many of the requirements that doctors must follow before prescribing drugs," Wynn writes. "It also creates a 14-day exemption for surgery patients and gives doctors more discretion in examining patients before a prescription is given." (Read more)

House sends Senate pill-mill and Medicaid managed-care fixes

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.

House panel approves bill easing rules of 2012's pill-mill bill

They could call it the pill they're taking to fix the pill-mill bill.

A state House committee approved a bill Tuesday that would tweak last year's legislation aimed at cracking down on prescription drug abuse through doctor shopping and "pill mills" where painkiller prescriptions are easily available for a fee.

House Speaker Greg Stumbo told the House Judiciary Committee that House Bill 217 would fix “unintended consequences” of 2012's House Bill 1 while still requiring that health-care providers use the Kentucky All Schedule Prescription Electronic Reporting system to track painkiller prescriptions.

The bill "would exempt hospitals and long-term care facilities from HB 1’s per-unit patient dosing restrictions and ensure that physicians decide when physicals are needed," the Kentucky Press News Service reported. "It would limit restricted access to narcotic pain medication for surgery patients, end-of-life patients, cancer patients and a few other categories of patients who may need increased pain management, Stumbo said." (Read more)

Deaths by overdose, mainly of prescription drugs, hit a new record in U.S. in 2011; a huge problem in Kentucky

Drug overdose deaths in the U.S. rose for the 11th straight year and accidental deaths involving addictive prescription drugs overshadow deaths from illicit narcotics, new federal data show.

In 2010, there were 38,329 drug overdose deaths nationwide, and prescription drugs were the cause of nearly 60 percent of them.  As in recent years, opioid drugs such as OxyContin and Vicodin were the biggest problem, contributing to three-fourths of medication-overdose deaths, report Lindsey Tanner and Mike Stoppe of The Associated Press.

Anti-anxiety drugs including Valium were involved in almost 30 percent of medication-related deaths.  Most were unintentional overdoses; 17 percent were rules suicides. The data were reported Tuesday in the Journal of the American Medical Association.

In Kentucky, drug abuse is epidemic and more than 1,000 Kentuckians a year die from prescription-drug overdoses, more than the number who die in car accidents, according to a 2012 Kentucky Justice & Public Safety Cabinet report. About 85 percent of Kentucky's drug-related deaths were accidental and approximately 2 percent were suicides, according to federal Centers for Disease Control and Prevention data.

The number of drug-overdose deaths in Kentucky rose a staggering 296 percent from 2000 to 2010. In 2010, the record number of deaths reflected the national trend and also involved opioid painkillers, according to a study by the Kentucky Injury Prevention and Research Center. The highest rates of overdose deaths during the study period were concentrated in Eastern Kentucky and among men, reports Bill Estep of the Lexington Herald-Leader.

Many doctors and patients don't realize how addictive these prescription drugs can be, and that they're too often prescribed for pain that can be managed with less risky drugs, said Dr. Thomas Frieden, head of the CDC. He said the data show a need for more prescription drug monitoring programs at the state level, and more laws shutting down "pill mills" -- doctor offices and pharmacies that over-prescribe addictive medicines, AP reports.

That was the aim of House Bill 1, passed in last year's legislative session. The Kentucky All-Schedule Prescription Electronic Reporting  (KASPER) system has undergone several changes since the bill's passage to help crack down on so-called pill mills.

Last month, a federal panel of drug safety specialists recommended that Vicodin and dozens of other medicines be placed in a more restrictive drug category, which would make them harder to prescribe. Refills wouldn't be allowed without a new prescription, and faxed or called-in prescriptions wouldn't be accepted; only a handwritten prescription from a doctor would be allowed.

Beshear calls for action to improve state's health, but says only that 'It's time for us to begin looking seriously' at a smoking ban

By Al Cross
Kentucky Health News

His priorities were education and tax reform, but Gov. Steve Beshear mentioned several health issues in his State of the Commonwealth speech tonight to a joint session of the General Assembly.

Beshear called for action to correct the state's "fundamental weaknesses," including "a population whose health ranks among the worst in the nation." Near the end of his speech, he said, "We need to continue improving the health of our people," but after about a minute of discussing tobacco and smoking he stopped short of endorsing a statewide ban on smoking in the workplace. (KET photo)

"It's time for us to begin looking seriously at doing this on a statewide level," he said to some applause, after noting that nearly half of Kentuckians live in jurisdictions where smoking is legally restricted, that the state has the highest or next-to-highest smoking rate overall and among teens and pregnant women, and that "Our smoking-related mortality rate is the worst in the nation. . . . Our addiction hurts productivity, jacks up health care costs and kills our people."

Beshear called for improving prenatal care and newborn screening, and for minor improvements in last year's bill to fight prescription drug abuse. He said the bill has caused a precipitous drop in abuse of prescription painkillers. "Kentucky at one time had the sixth highest rate in the nation, but . . . we improved 24 spots," he said. "Nearly half of the state's known pain management clinics have closed rather than submit to new rules that protect patients." He said use of the Kentucky All Schedule Prescription Electronic Reporting system "has increased nearly seven-fold . . . and prescriptions for some of the most abused drugs have dropped up to 14 percent from a year ago."

However, the problem of babies becoming addicted to drugs in their addicted mothers' wombs has skyrocketed in the last decade or so, Beshear said: "In 2000, reports showed 29 babies in Kentucky born addicted to drugs. But in 2011, there were 730 babies – more than 25 times as many. And that figure is thought to be under-reported." He did not say how he wants to improve screening.

Beshear did not mention perhaps the biggest health policy question facing the commonwealth, whether to use federal subsidies to expand the Medicaid program to people in households earning up to 138 percent of the federal poverty threshold. Now the program covers people in households earning up to 70 percent of the poverty line. The federal government would pay all the cost of the additional enrollees through 2016, when the state would start picking up part of the tab, up to 20 percent in 2020.

Some Republicans say the state can't afford the expansion, while some Democrats say it would be a good long-term investment in the state's health and economy. Beshear has said he wants to do it if the commonwealth can afford it, and expects to get cost estimates around the end of March -- about the time the legislature must adjourn.

For a PDF of the speech text, click here. For an audio recording, go here. For video from KET, here.

Prescription-painkiller epidemic is spurred by societal shift, experts say: People think every problem has a pill for an answer

By Molly Burchett
Kentucky Health News

The prescription-painkiller epidemic stems partly from an evolution of society's views toward pain and how to deal with it, said experts at "The Different Faces of Substance Abuse" conference in Lexington Jan. 23-24.

"The entire society's viewpoint of pain and the management of pain has completed shifted," said Dr. Ryan Stanton, an emergency physician and conference panelist.

Pain is considered the fifth vital sign, after temperature, pulse, blood pressure and respiratory rate, but it is the only sign that is subjective, which complicates the problem, said Stanton, because patient satisfaction is associated with the amount of drugs the provider prescribes. If an emergency-room doctor suggests exercise to combat back pain, he said the patient's reaction might be, "You might as well ask a man to deliver a baby."

The substance-abuse problem shouldn't be laid at the feet of prescribers because patients think there is a pill out there for every problem when sometimes the answer is non-prescription ibubrofen and an ice pack, said Van Ingram, executive director of the state Office of Drug Control Policy.

"This is a complicated issue," Ingram said. "It's easy to be against heroin, and it's easy to be against cocaine. But prescription opioids are things that many people need to live and need to improve their quality of life at the end of life."

Patients need to understand how much a doctor can or should do, said Dr. Helen Davis, conference panelist and chair of the Gov. Steve Beshear's KASPER Advisory Council. "Patients come in to the doctor's office expecting a silver bullet . . . but when looking at pain, the goal isn't to make the patient pain-free," she said. "The goal is to reduce the pain enough that they can have systematic and functional relief to go about their daily living."

Davis said doctors and nurses must change their culture to become more collaborative with the patient to address the non-pharmacological management of pain. There are some things that are the responsibility of the provider and there are some things that are the patients', families' and communities' responsibility, she said, adding that all professionals must look at their interdisciplinary responsibility to the people of the state.

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

Experts explain changes to state prescription-tracking system

By Molly Burchett
Kentucky Health News

The Kentucky All-Schedule Prescription Electronic Reporting system, the key to fighting doctor-shopping for painkillers in the state, has undergone several changes since the legislature passed House Bill 1 last year to crack down on so-called pill mills. An expert panel at "The Different Faces of Substance Abuse"conference last week in Lexington addressed the more recent changes to KASPER.

“The new legislation has brought prescription drug use into the medical arena when it had not been before,” said Dr. Michelle Lofwall, member of the KASPER Advisory Council, created last year by Gov. Steve Beshear.

Very soon Kentucky will be sharing KASPER data with all seven border states, which will be provided automatically in reports, and all agreements to enable this exchange have already been signed, said Van Ingram, executive director of the Kentucky Office of Drug Control Policy.

One important but little-reported change is that KASPER reports can now be included in patients’ medical records. Prior to the passage of HB1, this was a felony and created workflow problems for physicians.

Attorney General Jack Conway has steered money from a mortgage settlement to enable the necessary system upgrades to KASPER that will bring about additional changes, said Ingram. Starting in July, dispensers of drugs will be required to report data every 24 hours instead of the current weekly timeframe, improving the timeliness of the data.

Changes are also coming to the regulations associated with HB1, since medical licensure boards have “gotten an earful” and have revisited the regulations to make them more straightforward and common sense, KASPER program manager Dave Hopkins said.

Ingram said, “With any big policy change, there are going to be unintended consequences. . . . The legislature will take a look at the unintended consequences. If you want to make drastic changes, it’s going to be chaos for a while.”

“In a lot of things with government, great ideas are complicated by reality,” said Dr. Ryan Stanton, UK Good Samaritan Hospital emergency-room physician and medical director, as he painted a more realistic picture of KASPER from when he first created an account with the system in 2005.

Stanton said recent changes have included timelier and more accurate reports that make the system easier to use. He said more such improvements are critical to catch those who "abuse in spurts," and are also important because physicians have minimal time and need to spend more time with patients instead of in front of a computer.

The use of KASPER has increased significantly since the passage of HB 1, with the number of reports requested increasing from 811,000 in 2011 to 2.69 million in 2012.

Medications containing the painkiller hydrocodone, including Lortab, Lorcet and Vicodin, remain the most-prescribed type of controlled substance in Kentucky, 41.5 percent of the total.

Click here for more information about KASPER.

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

FDA likely to make hydrocodone painkillers harder to prescribe

Prescription painkillers containing hydrocodone should be placed in a more restrictive federal category, a Food and Drug Administration advisory panel of experts voted on Friday. The changes would be an effort to stem the tide of prescription painkiller abuse and addiction in the U.S., much of it in rural areas, beginning in Central Appalachia. Painkillers containing hydrocodone are the most widely prescribed drugs in the country.

Sabrina Tavernise of The New York Times reports the FDA is likely to adopt the panel's recommendations, which include limiting access to hydrocodone drugs such as Vicodin by making them harder to prescribe. Refills wouldn't be allowed without a new prescription, and faxed or called-in prescriptions wouldn't be accepted. Only a hanwritten prescription from a doctor would be allowed, and pharmacists would be required to keep the drugs in special vaults.

Many said these changes would be a key step in reducing painkiller addiction. However, dissenters in the vote were concerned that this move wouldn't make a difference. Oxycodone, the main ingredient in the highly-abused painkiller OxyContin, has been classified in a restrictive category since it was first introduced on the market but it is still widely abused, dissenters said. They also said the change could create unfair obstacles for legitimate patients. (Read more)

Poll shows depth of prescription drug abuse in Kentucky

By Molly Burchett and Al Cross
Kentucky Health News

One-third of Kentucky adults have friends or relatives who have experienced problems from abusing prescription pain relievers, and 8 percent have used pain medicine when it wasn't prescribed or for the feeling it caused, according to a statewide poll conducted last fall.

The Kentucky Health Issues Poll found that in Eastern Kentucky, 45 percent reported that prescription drug abuse have caused problems for friends or family members. In the 17-county Bluegrass Area Development District, which includes some Appalachian counties, the figure was 37 percent. It was 32 percent in Northern Kentucky, 31 percent in the seven-county Louisville area and 25 percent in Western Kentucky.

The poll found that young adults are more likely to have the problem. Among those 18 to 29 years old, 13 percent said they had used pain medicine when it wasn't prescribed or for the feeling it caused, and 49 percent said they had a friend or relative who had been affected.

The Foundation for a Healthy Kentucky, which co-sponsored the poll, noted that drug-overdose deaths in Kentucky correspond to a steep increase in the sales of opioid prescription pain relievers, which include OxyContin, Vicodin, Percocet and codeine. More than half of Kentucky adults in the poll reported being prescribed such drugs.

“While these types of medications are important for controlling pain in patients who need them, opioids also carry the potential for abuse,” said Dr. Susan Zepeda, President and CEO of the foundation. “Our state ranks sixth in the nation for prescription pain reliever overdose deaths, and these data provide a window on how many Kentuckians are impacted – directly or indirectly – by prescription misuse.” (Read more)

The poll was conducted for the foundation and The Health Foundation of Greater Cincinnati from Sept. 20 through Oct. 14 by the Institute for Policy Research at the University of Cincinnati. A random sample of 1,680 adults throughout Kentucky was interviewed by landline and cell telephones. The poll's margin of error is plus or minus 2.5 percentage points.

Kentucky Health News is an independent service of the Institute for Rural Journalism and Community Issues at the University of Kentucky, with support from the Foundation for a Health Kentucky.

FDA could require tamper-resistant painkillers; without such action, prescription-drug abuse problem would worsen

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

Pike court will keep lawsuit county and attorney general filed against Purdue Pharma over damage done by its OxyContin

A state court will hear the Kentucky attorney general's 2007 lawsuit against OxyContin manufacturer Purdue Pharma, against the wishes of the company. The U.S. Court of Appeals for the 2nd Circuit affirmed a lower court's order returning the suit to Kentucky from New York's Southern District, where Purdue wanted the case heard. The suit was filed in Pike Circuit Court, in Kentucky's easternmost county.

"After years of delay tactics, Purdue will now answer to a Kentucky court and a Kentucky jury," Attorney General Jack Conway said. Purdue Pharma spokeswoman Libby Holman said the company is disappointed by the decision, but now it is "fully prepared to vigorously defend this action on its merits, and we expect to prevail."

Then-AG Greg Stumbo and Pike County sued Purdue Pharma in October 2007, alleging that the company's "aggressive and deceptive marketing campaign saddled taxpayers with millions of dollars in social, health care and other costs," Laura Ungar of The Courier-Journal in Louisville reports. The suit also alleges the company misled health-care providers, consumers and the government about the highly addictive nature of OxyContin. The suit is largely based on admissions of guilt made by the company and several top-ranking company officials in a May 2007 Virginia federal court settlement. Purdue Pharma, its president, chief legal counsel and former medical director pleaded guilty to misleading doctors, regulators and patients about OxyContin during that case.

The nation's prescription-drug epidemic apparently began in the region, largely because of the introduction and high rate of prescription of OxyContin. Kentucky has nearly 1,000 overdose deaths a year. Conway's office said the suit against Purdue Pharma seeks reimbursement for drug-abuse programs, law-enforcement actions and prescription payments through Medicaid and the Kentucky Pharmaceutical Alliance Program. (Read more)

Legislature likely to tweak, clarify and limit last year's 'pill mill bill'

State lawmakers could narrow the focus of last year's "pill mill bill" during the legislative session that begins tomorrow, to concentrate on adults with long-term prescriptions for frequently abused painkillers, John Cheves of the Lexington Herald-Leader reported yesterday. Doctors, hospitals and patients have complained that HB 1 in its current from "restricts too many drugs in too many clinical settings, needlessly complicating medical care in an effort to shut down storefront pain clinics that recklessly hand out prescriptions," Cheves writes.

Under the law, people with long-term prescriptions for controlled substances must submit to urine drug testing to determine if they are actually taking the drug rather than selling it, and if other unprescribed drugs are in their systems. Some patients complained they were being charges hundreds of dollars for urine tests because their insurance companies denied coverage of such testing. One couple was charged more than $900 for tests to get prescriptions for insomnia and anti-anxiety medication.

The new rules, being drafted by the Kentucky Board of Medical Licensure, would reduce the mandate for drug screening to pain medicine prescriptions of 90 days or more. Other medications would not require testing unless the doctor thinks it's necessary. The new rules will say that other types of testing which would be cheaper, including hair, could be used. The board is also restricting its focus to powerful painkillers, including hydrocodone and oxycodone.

The new regulations are subject to approval by the legislature, which could write its own restrictions into law, but the consensus appears to be that the law needs tweaking, not major changes. for example, House Speaker Greg Stumbo said it should be changed to clarify that hospitals don't have to run a new background check on a patient every time they give another dose of a controlled substance during his stay. (Read more)

Painkiller epidemic was driven in part by drug makers' financial relationships with researchers who discounted the risks

For almost a decade, medical officials and experts claimed OxyContin rarely posed problems of addiction for patients. The drug's label, which was approved by the Food and Drug Administration, said addiction risks were small. Research published in the New England Journal of Medicine also said OxyContin wasn't addictive; so did a study in another journal, which OxyContin manufacturer Purdue Pharma reprinted 10,000 times. Since the drug first hit the market, it has fueled a large-scale swath of prescription pain killer addiction, beginning in Central Appalachia, that has grown into a national epidemic, especially in rural areas.

The epidemic was driven in no small part by doctors' lack of knowledge about OxyContin, which was perpetuated by the drug's manufacturer through false claims that became scientific consensus. But now, "Many in the medical profession have rediscovered the destructive power of opiates," and are calling that consensus into question, Peter Whoriskey of The Washington Post reports. "A closer look at the opioid painkiller binge, in which retail prescriptions have roughly tripled in the past 20 years, shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice."

Doctors were wary of prescribing painkillers to any patient except those with cancer for years. But manufacturers and some pain specialists "helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain: bad backs, arthritis, sore knees," Whoriskey reports.

Through an examination of key scientific papers, court documents and FDA records, the Post found that many of the studies claiming OxyContin wasn't addictive were supported by Purdue Pharma. The conclusions those studies reached were sometimes not supported by data, and when the FDA needed to develop an opioid policy, it turned to a panel of doctors who had financial relationships with Purdue Pharma and other drug makers. (Read more)

Generic OxyContin and Opana, headed for market soon, could make fight against pain-pill abuse tougher, McConnell says

With generic versions of the two most commonly-abused painkillers, Opana and OxyContin, coming on the market next year, police, hospitals and health clinics in Kentucky have voiced concern that "these generic crushable drugs lack the tamper-resistant gel coating of the brand-name drugs," says a news release from U.S. Sen. Mitch McConnell.

"Without this technology, addicts crush the pills in order to achieve an immediate heroin-like high from sniffing or injecting the painkillers," the release says. "If these generics come to market without the tamper-resistant coating, much of the work that law enforcement and health care providers have done to stem the tide of pain pill abuse in Kentucky will be lost."

McConnell's news release said he has asked the Food and Drug Administration to keep the crushable drugs off the market "until a workable solution can be found." McConnell, the Senate Republican leader, met Wednesday with the Department for Health and Human Services’ acting general counsel, Bill Schultz, to discuss the issue. (Read more)

Deaths from drug overdoses in Kentucky hit new high in 2010; more than half involved prescription drugs

Deaths from drug overdoses in Kentucky jumped to a new high in 2010, and "rose a staggering 296 percent from 2000 to 2010," Bill Estep of the Lexington Herald-Leader reports. "A tidal wave of prescription-drug abuse drove the steep increase," with just over half of the deaths involving prescription drugs, according to a study by researchers at the University of Kentucky.

As usual, the problem is worst in Appalachian Kentucky, as illustrated by this Herald-Leader map:

"The increase in deaths might have been even greater because information was not available for Kentucky residents treated in neighboring states, and because some death certificates might not have listed an overdose as the cause of a person's death when in fact it was," Estep reports. "The report did not measure the impact of changes Kentucky lawmakers made this year aimed at confronting the prescription-drug problem, though it will provide a way to help measure the impact of the law."

Read more here: http://www.kentucky.com/2012/12/20/2451315/drug-overdose-deaths-up-296-percent.html#storylink=cpy

Read more here: http://www.kentucky.com/2012/12/20/2451315/drug-overdose-deaths-up-296-percent.html#storylink=cpy

Read more here: http://www.kentucky.com/2012/12/20/2451315/drug-overdose-deaths-up-296-percent.html#storylink=cpy

Managed-care doctor creates process to steer pregnant Medicaid recipients who are using dangerous drugs into treatment

When Dr. Jeremy Corbett of Lexington found that "nearly one in five pregnant women enrolled in the Medicaid managed-care program where he works were using narcotics or other harmful drugs," he tackled the problem. As medical director of the Kentucky Spirit Health Plan, "He designed a new program combining high-tech health information with case management to tackle the problem of addicted babies, which is exploding statewide," reports Laura Ungar of The Courier-Journal. (C-J photo by Tim Webb)

Ungar describes how Corbett's program works: "Employees examine patient records for pregnant Kentucky Spirit members. The pharmacy department uses an analytics report, coupled with the Kentucky All Schedule Prescription Electronic Reporting System, or KASPER, to cross-check for drugs that could be dangerous during pregnancy, including narcotics. Department employees also look at the pattern of prescriptions, which could point toward doctor-shopping for pills. . . . Kentucky Spirit sends letters to the prescribing doctor and the obstetrician the woman is seeing, letting them know she is pregnant and has received a prescription for dangerous drugs. Corbett said sometimes the prescribing doctor doesn’t know the woman is pregnant, and the obstetrician doesn’t know she’s taking narcotics. Corbett said they also send letters outlining the dangers of taking certain drugs during pregnancy, and case managers reach out to women at risk of giving birth to addicted babies."

The program started three weeks ago. Corbett said two women have asked to get substance-abuse treatment, for which Kentucky Spirit pays — "even residential treatment, which is not required by Kentucky law — because it saves money in the long run," Ungar reports. "Kentucky has seen its hospitalizations for addicted newborns climb from 29 in 2000 to 730 last year — a 2,400 percent increase that far outpaces the national increase." Corbett told her, “When these babies wind up in the neonatal intensive care unit, it’s a huge loss, emotionally, and it’s also a huge loss of state dollars.” (Read more)