22 Days into Implementing KY’s “Emergency” Narcotic Regulations

(This is the second of my blog series on KY’s “Pill Mill Bill”. Please access the first blog post here)
At some point in the discussion of the perfect storm created by Kentucky’s new narcotic-prescribing bill someone asked “How can regulations that aren’t going to be enforced until October be considered emergent?” I have no clue what the answer to that is but I can give an update into my office’s attempt at implementing the regs. Let me start by describing it as chaotic, confusing, time-consuming, and utterly frustrating.

We have patients calling from other doctors’ offices who want to switch their care because those physicians have thrown their hands up in frustration and are simply refusing to prescribe any controlled substances. We are not accepting any new patients on controlled substances until the dust settles. I spoke with an ER doctor a couple of days ago who told me it is taking 15 more minutes per patient who needs a controlled substance prescription. I was unable to find any statistics on how many patients leave an ER needing a narcotic or other scheduled medication, but given that it is an acute care environment, one could assume at least 25%. Emergency Departments are already over-crowded, so imagine the issue with increasing the waiting time due to these ill-conceived, burdensome regulations added to a law already over-reaching in its original form, now with many more medications than originally intended.

I try to explain the regulations to patients, including the need to have urine drug testing because of their Ambien (a sleep aid of mild abuse potential) or testosterone prescriptions. Their expressions and questions are of disbelief and frustration.

  • Question: Will my insurance pay for the drug tests?  Answer: I have no clue. 
  • Question: Why am I being treated like a drug abuser? Answer: Call your governor. 
  • Question: Am I going to have to be seen every three months? Answer: As long as I have to run a KASPER report on you every three months–yes.
  • Question: Will my insurance pay for those visits? Answer: I have no clue.
  • Question: Who thought this up? Answer: I’m not sure but I’d recommend asking Governor Beshear that one too.
  • Question: I’ve heard some doctors are just not prescribing controlled substances. Are you going to do that too? Answer: No, uh, let me qualify that. I don’t think so.
Despite Governor Beshear’s reassuring words “For doctors who worry their ability to prescribe will be compromised, you have nothing to fear”, it is taking my associates and me an average of twenty minutes per patient to explain the regulations, have patients sign informed consent papers, obtain drug tests, and run KASPERS. We only have fifteen minutes slots for patients so this is, of course, making us run behind all day long. And we are about average in the number of patients we have who take a controlled substance. The bill in its original form, covering only Schedule II meds (drugs like Oxycontin, morphine, amphetamines) and Schedule IIIs with hydrocodone would only have been an inconvenience during flu season with cough meds. But with the medications added in the emergency regulations, it’s a nightmare).
So far I have run maybe fifty KASPER reports. How many have had any surprises on them? ZERO. Let me repeat that number–ZERO. Not one of my patients have had any controlled substances that they have obtained in this state over the last year that I didn’t know about. Let me repeat that number–not one. When I asked the ER doctor what he thought of the law, he said, “This is a waste of time. None of the KASPERs we are running have anything of significance on them. The people that come in here who are drug-seekers we know about and we don’t get KASPER reports on them because we don’t give them controlled substances. Everyone else have clean reports. And the people from out-of-town we can’t get a report on anyway.” Then he said, “Oh here’s your patient’s KASPER. It has one entry.” I guessed, “The 20 Valiums I gave her last February?” His response? “Yep. That’s it. A real abuser, this one.” She’s 75 years old and her family begged me to prescribe something to help when she is completely overwrought with caring for her demented, terminally-ill husband. So far she’s taken two of them. Yep, a real abuser there! 
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Even Non-Kentucky Doctors need to examine Kentucky’s Narcotic Bill

Kentucky has had a well-documented problem with narcotic diversion and over-prescribing for some time. In recent years, particularly in the eastern part of the state, prescription drug abuse has flourished and killed an estimated 1000 Kentuckians yearly. In the legislative session this year a “Pill Mill Bill” was passed, aiming to crack down on over-prescribing of schedule II controlled substances and hydrocodone. “Pill Mills” are loosely defined as any clinic or doctor’s office where controlled substances are recklessly prescribed. In Kentucky the issue often centered around pain clinics that were not owned by physicians and were operated for the purpose of generating cash, not treating patients[1]. Physician groups lobbied to keep the bill from becoming over-burdening in its effect and not punish legitimate use of prescription pain-killers. HB1 passed and was signed into law on April 24. Most physicians felt a satisfactory compromise had been made that would protect patients without being over-reaching in its effect.

On July 20, 2012, the day the bill was scheduled to take effect, “emergency” regulations were signed into law by Governor Beshear. These ten pdf’s worth of regulations went FAR beyond the intent of the legislation. As of this writing physicians must get KASPER reports every time they initially prescribe any schedule II or schedule III drug and some schedule IVs (see below for an explanation of how controlled drugs are classified). KASPER is defined as

The Kentucky All Schedule Prescription Electronic Reporting System (KASPER) tracks controlled substance prescriptions dispensed within the state. A KASPER report shows all scheduled prescriptions for an individual over a specified time period, the prescriber and the dispenser.” 

This includes ADHD stimulants in adults, testosterone, and Ambien, tramadol, alprazolam, lorazepam, clonazepam, diazepam, soma, Librium, and phentermine. Patients must see their physician MONTHLY until the physician determines that this is a medication that they should remain on. This must be repeated EVERY THREE MONTHS for as long as the patient is on the drug. In addition we must discuss and have the patient sign an “informed consent”. This covers their understanding that the drugs are addictive, reminds them to stop the drug when they no longer have the problem they are taking it for, and how to destroy the medications they do not use. After the initial three months the physician must do random drug urine screens on ALL patients using these medications, discuss if there has been any history of drug abuse in any first degree relative or themselves, ask if the patient has had any legal problems with drug abuse and revisit the issue every three months ad infinitum.

How appropriate is it that I ask my 88 year old patient to submit to a urine screen for the hydrocodone she takes some nights for her severe spinal stenosis? Oh, and if you follow the letter of the law, if that drug screen is NEGATIVE I am supposed to stop prescribing the hydrocodone and send her to a drug treatment program!  Then again there is the patient who calls in for a couple of Xanax to take for an eight-hour plane ride, usually someone who’s been a patient of mine for years. They have to come in first for a COMPLETE physical exam (which their insurance will not pay for unless it been more than a year from the last and it is a two month wait to get a physical in my office) and be counseled regarding use and abuse of narcotics including signing the informed consent. Same for cough medications–so how many doctors will be prescribing cough medications with controlled substances do you think? How much time does the governor think we primary care doctors have?

Despite Governor Beshear’s comforting remark “Let me be very clear, if you need a prescription, you will get your medicine”, he will not be opening up the governor’s mansion to prescribe medication. Last time I checked he didn’t have an MD behind his name. In a time when primary care doctors are already over-extended, to enact over-reaching regulations of this magnitude reveals an ignorance of monumental proportions. It is not that it is far easier to say “no” than to spend the time necessary to prescribe the “offending” medications, it is that there are not enough hours in the day to support the implementation of this bill. It’s important to understand that these regulations go far beyond the intent of the legislature to stop Pill Mills and over-prescribing of narcotics by physicians. These regulations will reduce the access of necessary controlled substances to ordinary citizens of the state of Kentucky because of the administrative burden placed upon offices already reeling from insurance and other governmental regulations. In addition, they will make the ordinary individual feel like they are requesting “street” drugs, when all they want is relief from their insomnia, their cough, the symptoms of low testosterone, their pain or their anxiety.

Let ME be clear. The 93% of patients in Kentucky that don’t have a controlled substance problem will suffer, and suffer unjustly because of the regulations enacted by our governor and attached to this bill.

Defining “Scheduled” Drugs or Controlled Substances:
In 1970 the Controlled Substances Act (CSA) was enacted which placed drugs into categories based on their abuse potential. There are five “schedules”
Schedule I
-high potential for abuse and no accepted medical use for treatment in the US. Instances include heroin, marijuana, or LSD
Schedule II
-high potential for abuse. Patient must have a written paper script to fill. Cannot be refilled by phone. Instances include morphine, methadone, Adderal, or cocaine
Schedule III
-potential for abuse is less. Instances include combination products with hydrocodone such as Vicodan, codeine, or testosterone. 
Schedule IV
-potential for abuse is lower than Schedule III drugs. Instances include valium, ambien and xanax. Tramadol is NOT a scheduled drug under the CSA Act and is only considered controlled in a minority of states, including KY.
Schedule V
-This schedule primarily contains combination products containing very limited amounts of narcotics used for cough suppression or diarrheal control.

References
1. http://www.kentucky.com/2012/02/01/2051727/beshear-said-shutting-pill-mills.html
2. http://www.deadiversion.usdoj.gov/schedules/index.html

This blog post was updated on July 31, 2012 to better explain the schedule of controlled substances as well as clear up grammar mistakes in the body of the blog. The opinions and content were not appreciably affected.
It was further updated on September 10, 2012 to update the fact that 93% of patients DON’T have a controlled substance problem.


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