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)

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.

Cheaper heroin showing up in Eastern Kentucky as crackdown on pain pills makes that trade less attractive

About 60 grams of heroin, worth about
$8,000. (AP photo)

It was only few months ago that Northern Kentucky law enforcement officers and substance abuse clinics began expressing grave concern that heroin was fast becoming the go-to drug in their region. Today, there are signs that the drug is already moving swiftly east, into the already drug-ravaged mountains of Eastern Kentucky. The reason for the uptick in heroin use? Because pain pills aren't as available anymore.

Federal and state law enforcement have been cracking down on the prescription pain-pill drug trade for years in these parts. They've created electronic prescription-tracking systems, staked out pain management clinics and shut down a drug pipeline that starts in Florida. Some argue that last year's passage of House Bill 1 has discouraged even legitimate doctors from prescribing pain drugs. All these things make heroin usage an unintended consequence of their success, officials fear.

 "There's always some type of drug to step up when another gets taken out," Dan Smoot, law enforcement director of Operation UNITE, which handles drug investigations in 29 Eastern Kentucky counties, told Brett Barrouquere of The Associated Press. "We didn't know it was going to be heroin. We knew something was going to replace pills."

Officials say the heroin is trafficked from Mexico into the U.S., where it first goes to Illinois, Michigan and Ohio. Northern Kentucky counties have been the epicenter of heroin abuse in the state, but law enforcement officials in Louisville, Lexington and Appalachian counties are reporting "a dramatic rise in the number of arrests and seizures related" to heroin. Kentucky State Police seized 11 doses of heroin and other opiates in 2008 in the eastern half of the state; they have seized 395 doses there so far this year.

Users are attracted to heroin's low cost compared to pain pills, Barrouquere reports. A single oxycodone pill can cost from $80 to $100, but heroin can cost as little as $15 to $20 for an amount that will produce the same level of intoxication as one pain pill for 24 hours, Kentucky Office of Drug Control Policy Director Van Ingram said. (Read more)

Medical licensure board changing rules to focus more on painkillers; fewer urine tests for patients, fewer reports for doctors

Patients in long-term treatment with controlled substances won't have to have their urine tested for drugs unless they are on painkillers, and doctors will have wide discretion over how often to do the tests, under new rules being drafted by the Kentucky Board of Medical Licensure.

That is just one example of the changes that the board is making in regulations authorized by the "pill mill bill" the General Assembly passed this year, reports Mike Wynn of The Courier-Journal. Other changes will put more focus on medicines with the painkiller hydrocodone and exempt some medicines that have only small amounts of painkillers.

"While the bill focused largely on pain pills, the board’s regulations covered a wider range of medications, including the sleep aid Ambien and the anti-anxiety drug Xanax," Wynn notes. "The regulations also called on doctors to perform a much broader array of administrative tasks to determine the appropriateness of prescriptions and a patient’s risk for abuse or diversion." Now they will have to do less, making follow-up reports to the state drug-tracking system only when prescribing painkillers.

The board's director, Michael Rodman, told Wynn it is responding to complaints by physicians and lobbying interests who say the the rules are too complex and go too far. The board filed the new rules last month for approval by legislative committees, but says it is already using them to make enforcement decisions. House Speaker Greg Stumbo, who sponsored the bill, has endorsed the changes.

The doctors' lobby, the Kentucky Medical Association, has voiced its pleasure with the changes but says others are needed, such as parts of the law that require specific medical practices such as standards for prescribing. (Read more)

State officials appear to be overstating successes of new prescription-drug law, The Courier-Journal reports

There's new criticism from Kentucky's doctors in an analysis of the state's four-month old prescription drug law, showing that a lot of what state officials have touted as the law's successes were already in the works before the law went into effect.

The Courier-Journal of Louisville reviewed state records after Gov. Steve Beshear released figures last month that showed the Kentucky Board of Medical Licensure had disciplined 33 physicians for violating professional prescription standards. Reporter Mike Wynn writes that he "found that 16 of the cases were resolved before the new law took effect on July 20, and 13 others involved investigations or actions that were well under way before the law’s implementation. The administration also reported last month that 18 of the 44 known pain-management clinics in Kentucky have closed or discontinued pain management services, including 10 after House Bill 1. Still, state records are unclear if all the clinics were suspected of illegal prescribing."

“They’ve taken a situation that required a scalpel to cut out the disease and instead they have used a machete,” Gregory Hood, governor of the Kentucky chapter of the American College of Physicians, told Wynn.

Beshear's announcement last month about the bill's almost overnight success also included crediting it for drops in prescriptions being written for pain killers, most notably for oxymorphone, which had a 38 percent falloff.  But, writes Wynn, "Critics of the law say that at least part of those declines are due to doctors denying needed prescriptions to patients because of problems with HB 1." Experts told the paper that oxymorphone, commonly prescribed as Opana, was not readily available in the market during the applicable period because of a reformulation by its manufacturer. (Read more)

Democratic ads accuse Republicans of supporting pill mills by voting against bill that all agree needs work

A bipartisan group of Kentucky lawmakers are looking ahead to fixing the much complained about "unintended consequences" of last spring's hastily passed bill aimed at curbing prescription drug abuse. Still, the House Democratic Caucus Committee has paid for political ads criticizing at least three Republican House members for not supporting the measure though they may have raised concerns about the very issues that now need legislative surgery.

Ryan Alessi of cn|2's "Pure Politics" reports that Rep. Mike Harmon of Boyle County and Rep. David Floyd of Bardstown are being targeted for not supporting the expansion of the use of the prescription monitoring system, KASPER, and requiring pain clinics to be run by physicians. Rep. Kim King of Harrodsburg has also been targeted; there may be othesr. Here is the ad:

Republican Floor Jeff Hoover of Jamestown, a supporter of HB 1, told Alessi that that need for changes in the bill now "vindicates lawmakers like Floyd and Harmon, who raised questions about whether the law would be overly restrictive for law abiding Kentuckians." (Read more, see more videos)

Board of Medical Licensure to amend pill-mill regulations to address concerns of doctors and some patients

The Kentucky Board of Medical Licensure wants to change some of the more controversial requirements for urine screenings and digital monitoring in the state’s new prescription-drug regulations under the law aimed at fighting doctor shopping and "pill mills" that dispense painkillers indiscriminately.

Mike Wynn of The Courier-Journal reports that Dr. Preston Nunnelley, the board’s president, told state lawmakers Wednesday that the board plans to submit amendments to the regulations by Nov. 1 to address the concerns of doctors that the new law is proving too burdensome, and because patients are being charged for urine tests that insurance companies are refusing to cover. Nunnelley said the amendments would provide more flexibility on when patients must receive those screenings. He said "chronic pain patients would not face regular screenings unless they are considered high risk for abuse or diversion," Wynn reports. "The amendments are also likely to exempt certain patients, such as children, from checks through the Kentucky All Schedule Prescription Electronic Reporting system, or KASPER, he said."

Nunnelley called the changes “tune-ups." “This is a new experience for the board of licensure,” he testified. “This is the first time we’ve done anything on this scale and obviously we didn’t do it perfect.” Or perfectly. (Read more)

Governor lauds HB 1 for closing 10 of the state's worst pain clinics, reducing the number of controlled-substance prescriptions

Gov. Steve Beshear gave credit this week to House Bill 1 for reducing the number of prescriptions written for frequently abused controlled substances and for closing the doors on 10 of the state's worst pain-management clinics. He also said the bill had promoted investigations into what he called "suspicious prescribing practices." Beshear, in a prepared statement, said: "We knew that this bill would have an immediate impact on thwarting the abuse and diversion of prescription drugs in our state, and the statistics over the last few months are already showing progress."

The governor also noted that Kentucky All Schedule Prescription Electronic Reporting (KASPER) accounts have increased from 7,911 in April to 21,542 in October. Account users are physicians, dentists, optometrists, advances practice nurses and podiatrists who then use those accounts to check on the drug records of patients daily. Beshear, responding to frequent criticism that the reporting of KASPER results is time-consuming, remarked that "the vast majority of those requests are processed in less than 15 seconds."
 
John Cheves of the Lexington Herald-Leader also reported that state regulators said this week that "they're working with private insurance companies and Medicaid managers to make sure health insurance plans help cover the cost of urine tests required under HB 1." Cheves had written earlier about consumer complaints that the costs of those tests, now required by the bill, were being borne by the patient. The
Kentucky Department of Insurance is communicating with insurers to guarantee that urine tests under HB 1 are classified as a medically necessary expense, Insurance Commissioner Sharon Clark told Cheves. The Kentucky Cabinet for Health and Family Services is doing the same for Medicaid clients.
(Read more)

Doctor complaints about bill aimed at reducing prescription drug abuse largely based on misconceptions, health officials say

State health officials say doctors' complaints about House Bill 1, which cracks down on pill mills and doctors who supply the illegal prescription pill trade, result from misunderstandings and misconceptions about the law's language and intent, Mike Wynn of The Courier-Journal reports. Doctors say the bill's regulations are excessive and restrict their ability to write common prescriptions.

Assistant deputy inspector general Stephanie Hold, of the Cabinet for Health and Family Services, said doctors have at least 19 misconceptions about the state's drug tracking system, Kentucky All Schedule Prescription Electronic Reporting, and said checking KASPER before writing prescriptions "should not impede them in any way," Wynn reports. Mike Rodman, director of the Kentucky Board of Medical Licensure, said there's nothing in the law that prevents doctors from prescribing controlled substances. He said many doctors have for years practiced prescription standards similar to those in the bill, but feel uncomfortable with them being written as law.

The co-chair of the state oversight committee, Democratic Rep. John Tilley, said there are some legitimate concerns about the bill "that need discussion after we can distill what is fact and what is myth," but lawmakers could likely address all of them without changing the statute. (Read more)

In wake of pill-mill regulation fight, Beshear has chance to craft a medical licensing board more to his liking

Gov. Steve Beshear

Gov. Steve Beshear is in a position to reshape a state medical board that has played a central and controversial role in recent efforts to crack down on prescription drug abuse. Mike Wynn of The Courier-Journal  reports that the terms of three members of the Kentucky Medical Licensure Board expired Aug. 31, and two other members’ terms await action after ending last year.

The licensure board drew criticism in 2011 "for not taking more aggressive action against so-called pill mills and corrupt doctors who supply Kentucky’s drug epidemic," Wynn writes. "The medical industry also has criticized the board in recent months for writing what doctors view as overly complex and excessive prescription regulations under HB 1, a landmark bill from the 2012 General Assembly that takes aim at abuse of drugs."

Beshear spokeswoman Kerri Richardson said the appointments are under review but did not indicate how the governor might proceed other than noting that he will consider qualifications and recommendations. Current board members serve until Beshear makes any new appointments. (Read more)

Comprehensive series looks at new angle of prescription pain pill epidemic: addicted newborns

The Courier-Journal's health reporter, Laura Ungar, is again delving into the prescription pain-pill epidemic in Kentucky, this time focusing on babies who are born addicted. For any reporter interested in writing stories about prescription pill addiction and the scope of the problem — stories that could be localized in every county in the state — Ungar's award-winning work is the place to start researching.

In a four-page piece, Ungar looks at:
• the limited options available to addicted moms
• the lack of funding available to fix the problem
• what to do for loved ones with a prescription drug problem
• the causes, symptoms and treatment for newborn addicts

There are also links to more recent stories pertaining to the issue here.

Ungar found hospitalizations for addicted newborns increased from 29 in 2000 to 730 last year, when there was a big jump. "It's a silent epidemic that's going on out there," said Audrey Tayse Haynes, secretary of the state Cabinet for Health and Family Services. "You need to say: 'Stop the madness. This is too much.'"

Nurse Tonya Anderson, an infant development/touch therapist at Kosair Children's Hospital, said she's seen as many as 14 of 26 babies in the special-care nursery where she works suffer from symptoms of withdrawal. "They are just agitated," she said. "They are screaming. They have tremors. Their faces — you have to grimace. They're in pain."

Those close to the problem say there is not enough treatment for addicts who are pregnant. But it's an investment worth making, Ungar suggests. One study showed the health-care costs for addicted newborns was $720 million in 2009, up from $190 million in 2000. Babies with addictions stay about 16.4 days in the hospital, which costs an average of $53,300 per infant. In 80 percent of those cases, Medicaid pays the bill.

Researchers estimate that more than 13,5000 babies were born addicted in 2009. "We knew that it was common, but we would not expect this problem would have tripled in the last decade," said Dr. Matthew Davis, an associate professor at the University of Michigan and one of the study's authors. "There are not many medical problems that have tripled in a decade — not obesity, not heart disease, not diabetes." (Read more)

Some doctors find law to fight pill mills confusing and overreaching, and some say they will stop writing prescriptions

Dr. Kathy Nieder, with patient charts
(C-J photo by Michael Clevenger)

Dr. Ralph Alvarado’s medical practice in Winchester has prescribed controlled substances to 1,800 patients in Central Kentucky over the past three years. But he and other doctors in the practice decided to put down their pens four weeks ago. That’s because, Mike Wynn of The Courier-Journal reports, "The standards imposed under a new Kentucky law designed to crack down on prescription drug abuse are so strict and complex that he would go bankrupt in a month -- or worse -- if he were to continue prescribing controlled substances."

Alvarado, who has made two unsuccessful campaigns for the state Senate, told Wynn, "I’m not going to be threatened with jail time or criminal charges and lose my career." He said he would refer patients to specialists to get pain-pill prescriptions.

Proponents argue that the new prescribing standards in House Bill 1, passed by the 2012 General Assembly "in hopes of combating an epidemic of drug abuse that kills nearly 1,000 Kentuckians each year were intended only to root out pill mills and crooked doctors and should not hamper legitimate physicians or prevent patients from receiving needed drugs," Wynn writes. However, "Some doctors contend the legislation is excessive, confusing and time-consuming, and across Kentucky, many have been seeking advice from attorneys about following the law, and warning patients about potential cutbacks to common drugs for pain, anxiety and other conditions. Some doctors are even talking about leaving the state. . . . Others say they have sent patients home in tears or in pain because they lack the time and resources to comply with the law."

"Patients who have never been a problem are bound up in all of this," Greg Hood, Kentucky chapter governor of the American College of Physicians, told Wynn. "There are so many unintended consequences." Hood's group and the Kentucky Medical Association are trying to determine how many clinics are declining to write prescriptions, but neither is advocating that approach. According to state offices of the Drug Enforcement Administration, only three in-state doctors have voluntarily surrendered their DEA registration — required for prescribing controlled substances — in recent weeks for reasons related to the new law. Still, the Greater Louisville Medical Society held a meeting with about 200 members recently in which attorneys tried to explain the law’s details. Doctors cited nearly two dozen areas of concern stemming from what they call vague and ambiguous legal language, the group reported. (Read more)

Legitimate pain patients having trouble getting prescription drugs because of 'pill mill bill,' some doctors say; hearing Wednesday

With lawmakers set to review the regulations of the "pill mill bill" Wednesday, doctors are saying some legitimate patients are having trouble getting access to prescription drugs as a result of the legislation. 

The law is aimed at cracking down on illegal pain-management clinics and curbing prescription-drug abuse. It requires physicians to use the state's prescription-drug monitoring system, KASPER, before prescribing certain drugs. 

But some doctors worry they may face criminal charges or penalties for prescribing the drugs or making clerical errors, reports Scott Wartman for the Kentucky Enquirer, an edition of The Cincinnati Enquirer. As a result, "There are already doctors saying no more prescriptions on green prescription pads," said Dr. Gregory Hood, a Lexington internist and governor for the Kentucky chapter of the American College of Physicians. The legislation also "adds layers of more work they or their staffs already have to do," said Dr. Elmer Martin, a Covington pediatrician who is the medical director of HealthPoint Family Care.

But state officials say the only criminal penalties in the bill would result only "from someone operating a pain clinic without a doctor's license and for intentional failure to input data into the state's prescription drug tracking system," Wartman reports. Since July 20, the number of KASPER reports requested by doctors has grown to 20,000 per day from 3,000. The reports show a patient's prescription history to indicate "doctor shopping."

The number of drugs prescribed has increased exponentially in Kentucky. "Last year there was enough doses of hydrocodone prescribed "to treat every man, woman and child in the state with 50 doses," said Van Ingram, executive director of the Kentucky Office of Drug Control Policy. Still, even physicians who supported the bill, like Dr. Robert Klickovich, say it needs to be tweaked. "Specialists may not be present in rural communities and if primary care physicians fear prescribing, even though in the appropriate case, for fear of a punitive action, they may hesitate to treat a patient," he told Wartman. (Read more)

Four pain clinics already closed as 'pill mill' bill takes effect; Beshear says nine more haven't applied, will be investigated

By Tara Kaprowy
Kentucky Health News

Just days after new legislation has taken effect to combat prescription drug abuse, four pain clinics in Kentucky say they will close, Gov. Steve Beshear announced today. "The word is out. Kentucky is deadly serious about stopping this scourge of prescription drug abuse and now we have some of the strongest tools in the country to make that happen," the governor said, adding that nine other pain-management clinics have not applied for licenses and will be investigated.


The law puts more restrictions on pain clinics to prevent so-called "pill mills" from setting up shop in the state. To be licensed, pain clinics must be owned by a licensed medical practitioner, and the law requires licensing boards to investigate complaints immediately.

It also requires doctors who prescribe controlled substances to refer to the state's drug-monitoring system known as KASPER before they write a prescription so they can see if a patient appears to be doctor shopping. The licensing boards have been charged to set up standards to increase oversight and spell out how doctors should be using KASPER (Kentucky All Schedule Prescription Electronic Reporting).

Though changes are still possible, the licensing boards issued those regulations last week, which were more expansive than originally required in the new law. The boards indicated they wanted KASPER to track all Schedule II and III drugs and 15 more Schedule IV drugs. The statute originally only required tracking of Schedule II and Schedule III drugs that contain hydrocodone.

Cracking down on actual pill mill owners, drug abusers and dealers had been difficult up until now since law enforcement couldn't see the data in KASPER without already having a case file opened. In his first four years in office, Attorney General Jack Conway said repeatedly he never got a referral from the Kentucky Board of Medical Licensure saying an investigation should be conducted.

Now when a complaint about prescription drug abuse is lodged with any investigative agency — the attorney general's office, Kentucky State Police, any of the licensing boards or the Cabinet for Health and Family Services — it must be shared with the other agencies within three days. However, the six licensing boards (medical licensure, nursing, dentistry, pharmacy, podiatry and optometry) don't have to share among each other. "This alleviates concerns that the professional organizations would be forced to report information to other boards that have no jurisdiction over the complaint," Beshear said.

If the Kentucky State Police sees there has been a complaint made by another agency, its officers do still need to open "a bona fide specific investigation on that designated individual" before they can request their own KASPER report or see the one used to prompt the complaint, said CHFS spokeswoman Jill Midkiff.

Some critics have said the legislation interferes with the care doctors provide for their patients and threatens confidentiality. To that end, Beshear said people who legitimately need prescription drugs "have nothing to fear. You'll get your medicine." For doctors who are concerned they won't be able to prescribe as they wish, Beshear said provisions have been built into the law to prevent that from happening.

"But if you're doctor-shopping, buying extra pills for recreational use, or prescribing pills for cash, you'd better change your vocation or change your location, because we're coming after you," he said.

As for arguments that checking with KASPER to see if a patient has a questionable prescription history will be too time consuming for providers, "nine times out of 10, it will take as much time as measuring a patient's blood pressure or recording their insurance information," said Mary Begley, CHFS inspector general. CHFS reports 90 percent of KASPER reports are completed within 15 to 30 seconds.

A prescriber or pharmacist can also choose delegates — like a nurse or an aid — to run reports on their behalf, Midkiff said.

The licensing boards have allowed a grace period until Oct. 1 to allow practitioners to time to learn how the new policies will work, according to Beshear's press release.


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.

To implement law aimed at prescription drug abuse, licensing boards issue regulations that some say are too expansive

Ambien and Ritalin are among the drugs that will be tracked through the state's drug monitoring system, with medical licensure boards issuing emergency regulations that are more expansive than originally required in a law aimed at curbing prescription drug abuse and so-called pill mills.

Rep. John Tilley, D-Hopkinsville, said "there's an honest debate" about why the Cabinet for Health and Family Services and the boards wish to track all Schedule II and III drugs and 15 more Schedule IV drugs. "The statute only called for tracking Schedule II drugs and those Schedule III drugs that contain hydrocodone," reports Ronnie Ellis for Community Newspaper Holdings Inc.

Among the 15 listed Schedule IV drugs are Ambien, Valium, Librium, anorexic drugs and Soma. Ritalin, usually used to help with Attention Deficit Disorder, is a Schedule II drug and will be tracked for patients who are prescribed it for more than 30 days. Lloyd Vest, the Kentucky Board of Medical Licensure's general counsel, said some parents "doctor shop" to get the drug. The new regulations have prompted "some prescribers to cease prescribing the drug, causing parents and children to scramble for prescriptions before school begins next month," Ellis reports.

Dr. Steven Sack, an emergency room doctor from St. Joseph East in Lexington, said the regulations "have gone well beyond the initial intent" of the legislation and will "result in unnecessary suffering in the commonwealth with patients not getting the care they need."

He said running a report in the drug-monitoring system known as KASPER takes an "enormous" amount of time. He asked why doctors must run reports on, say, an 80-year-old with chronic pain. Ellis reports the average KASPER report can be electronically transmitted in 15 seconds, and Tilley said running a report might "prevent prescriptions which might adversely interact with other medication the patient is taking."

Changes can be made to the regulations before the September deadline and they can be revised in the 2013 General Assembly. Physicians had until last week to sign up for a KASPER account. As of last Friday, there were 17,048 master accounts. In 2011, there were just 879.  (Read more)

Tensions mounting as implementation of prescription drug bill nears on July 20

House Speaker Greg Stumbo, D-Prestonsburg,
sponsored the prescription drug bill.
(Courier-Journal photo)

A controversial bill aimed at curbing prescription drug abuse, which was considered by many as the hallmark of the 2012 General Assembly, is creating tension as its implementation draws nearer. It takes effect July 20.

House Bill 1 puts more restrictions on pain clinics to prevent so-called pill mills from setting up shop in the state. It also requires doctors who prescribe controlled substances to use the state's drug-monitoring system known as KASPER. It further requires licensing boards to set up standards to increase oversight and spell out how doctors should be using KASPER. "But many of the details remain uncertain — including how frequently doctors must run searches of patients — and several areas are poised to drive a wedge between the medical industry and lawmakers in the coming months," reports Mike Wynn for The Courier-Journal.

The Kentucky  Board of Medical Licensure has written a draft proposal with dozens of new rules that have prompted confusion and anger among physicians. House Speaker Greg Stumbo, the bill's sponsor, has questioned the move. "What it appears to me they are doing is almost making it over burdensome to practitioners, and one might argue that is an attempt to make the entire system fail," he said.

Given the anticipated impasse, some expect Gov. Steve Beshear "to sign emergency regulations that will achieve at least some of the goals of HB 1, but those would expire within six months and wouldn't be subject to a prior review process," Wynn reports. (Read more)

Prescription pill abuse 'a holocaust' in Kentucky, hitting 1 in 16; big drug firms and even well-meaning doctors are to blame

Another in-depth look at Kentucky's prescription drug abuse problem hit the pages of The Courier-Journal yesterday, this time exploring the history of OxyContin and how well-meaning doctors started over-prescribing opioids in the 1990s in response to vigorous marketing campaigns. 

The problem continues to be gargantuan, with Laura Ungar reporting about one in 16 Kentuckians misused prescription painkillers in the past year. Kentucky ranks "as the fourth-most-medicated state in a nation that fills enough painkiller prescriptions each year to keep every American adult medicated around the clock for a month," Ungar writes.

A review published in the journal Pain Physician last year found evidence is lacking for how effective opioids are in treating long-term pain. "They're not M&Ms," said Dr. Lee Tannenbaum, founder of the Bel Air Center for Addictions in Maryland. "As physicians, we need to be really, really, really careful as to when we put someone on these drugs. Cancer pain may need opioids, but someone out shoveling snow who hurt his back doesn't. We have created so many addicts."

A C-J investigation found physicians fuel the problem in three ways. First, they do not screen patients adequately. They prescribe powerful pills for moderate pain. And they do not use the state's monitoring program, Kentucky All Schedule Prescription Electronic Reporting, known as KASPER.

The problem started in the 1990s when "medical organizations, concerned that pain wasn't being treated adequately, encouraged doctors to do more to relieve suffering," Ungar reports. OxyContin was approved by the Federal Food and Drug Administration in 1995, with OxyContin prescriptions for noncancer pain increasing by tenfold between 1997 and 2002. A report found the drug's maker, Purdue Pharma "directed its drug representatives to focus on physicians in their sales territories who were high opioid prescribers, while also issuing OxyContin 'starter coupons' for patients and distributing promotional items, such as fishing hats and plush toys," Ungar reports.

In October 2007, Kentucky and Pike County sued Purdue Pharma for its deceptive marketing campaign, alleging it misled doctors about the potency of the drug, which is twice as powerful as morphine. U.S. Rep. Harold "Hal" Rogers, R-5th District, called OxyContin "the guilty party that got this epidemic going." In Kentucky, the retail distribution of oxycodone grew from 83,000 grams in 1997 to 950,000 grams in 2010.

Part of the problem is that doctors do not have the time they need to properly assess patients for potential abuse. "You've got an awful lot of doctors prescribing not out of ill intents. They've got a limited amount of time, and pain patients require a lot of time," said Robert Walker, assistant professor of behavioral science at University of Kentucky's Center on Drug and Alcohol Research. "The easiest solution is the opioid."

While easy, they are not necessarily effective for all pain. Evidence is "very, very mixed" on whether the drugs work in the long term on chronic pain and "the evidence is pretty scant" that they are effective against treating chronic lower back pain, said Dr. Timothy Ives of the University of North Carolina.

Though the problem is never expected to be solved completely, there are steps being taken to combat the issue. In 2010, the FDA approved a reformulation of OxyContin which makes it more resistant to being cut, chewed, crushed or dissolved — methods that make the drug more powerful. The Kentucky Board of Medical Licensure has spelled out "the steps physicians need to take as they seek to help patients control pain unrelated to terminal illness," Ungar reports. And the Kentucky General Assembly passed a comprehensive bill that requires doctors to use KASPER when prescribing certain drugs and take a full medical history of patients to whom they are considering prescribing drugs. (Read more)

With crackdown on pill abuse, will legitimate patients be able to get the prescriptions they need?

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)