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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Medication Moments in Family Practice

Yes, that her “out” during
freshman orientation.

My younger daughter has a condition known as narcolepsy (she OK’d this post by the way). Because of it, she has a tendency to fall asleep any where and any time, but it is worse in the mid-afternoon. During college she was prescribed a medication called Provigil, which improved her ability to function in the real world, particularly in afternoon classes. Her classmates were a little disappointed at how well the medication worked as they could no longer tease her with drooling photographs taken during lectures. Due to the cost of the medication, she quit taking it while doing her present research job in Panama. Recently, she realized that her tendency to fall asleep in the middle of writing was interfering with her ability to finish her research paper. I’d heard that Provigil was now generic so I looked to see how much that would cost us, expecting some improvement in price. Nope it is still $26/pill if you pay without insurance (that is NOT a typo, with a prescription but no insurance coverage, thirty days of the drug will cost in excess of $788). WITH our Humana insurance, it would be a little more than $100/month, IF we could get a Prior Authorization on it. She bought it in Panama for $2 a pill. She did not need a prescription. I suggested that she stock up while she’s down there. Maybe she can get enough to last through graduate school.

Following that personal medication moment, I received a fax from RightSource, the prescription company owned by Humana. They wanted to know if a patient of mine who is taking a blood pressure drug called Bystolic was using insulin. Insulin, as you probably know, is a hormone important in diabetes and can be given in injectable form to diabetics. Bystolic is a type of blood pressure drug that can mask the symptoms of a low blood sugar in diabetics. The weird thing is, this patient is not a diabetic. Humana has yet to answer my request as to why they were asking me the question.

Vagifem

On Friday a patient came to me who is post-menopausal and having some vaginal dryness which is making intercourse uncomfortable. I suggested using a topical estrogen, specifically a drug named Vagifem. Many women prefer this form of topical because it is in a small pill that is much less messy than creams. Now here is where it gets weird. First of all, I could not tell the patient how much this prescription would cost her in the pharmacy because it is a “third tier” listed drug with Humana. She can look it up on line on the MyHumana site but I have no way of knowing. I do know it costs about $68/month if you don’t use insurance to buy it. There are no “generic” estrogen creams BUT Humana lists Premarin estrogen cream as second tier which typically is a $30-40 monthly copay. Here’s the kicker–if you buy Premarin cream without insurance it will cost you $150/tube (a tube will last anywhere from two to four months).

My medication frustrations this week were multi-fold–why do drugs cost so much more in the US than other countries (here’s a link to an interesting article in the New York Times that is old but still rings true regarding this question); why do I have to spend my time answering ludicrous questions for drug coverage companies in order to get my patients’ drugs refilled; and why isn’t there more transparency in medication costs for me and my patients?

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KY Pill Bill

Today the doctors in the office had our yearly meeting with the regional medical director of my group. He explained what he understood about the newly passed KY law for prescribing controlled substances. Here are some details on the law:

Every patient prescribed controlled substances such as hydrocodone (a common synthetic codeine that is given for moderate pain and an ingredient in many cough medications) must have something called a KASPER query done on them. This involves obtaining information on the patient regarding prescribing of narcotics by other physicians from a website. This typically takes ten to fifteen minutes to do. We must discuss the risks and benefits of using a controlled substance including tolerance and drug dependence and get written consent for giving the patient that drug. 
I can only imagine what that written consent is going to look like. Some estimates suggest that it will be a seven page document. The timeline for implementation of these new rules is July 12. This may not sound like that big a deal, so let me give a couple of circumstances that are not uncommon to me. A patient presents to my office with a persistent moderate viral respiratory infection who I have known for fifteen years. She doesn’t like to take any type of narcotic or other addictive substance but hasn’t slept for three nights due to the coughing. It’s late afternoon and she is my last patient of the day, I’m already behind and need to be at a meeting on the other side of town in fifteen minutes. She’s allergic to codeine. Guess who’s probably not going to get her cough medication? Or my neighbor who is also my patient, sprains her ankle on the weekend. She doesn’t need to be seen immediately but she would like some pain medication in order to sleep tonight and I’ll see her in the morning. With this bill in place, I cannot relieve her pain. I’ve been in practice for more than 25 years. It is my job to know my patients. I know who has a tendency to overuse their pain meds. I wasn’t born yesterday and can spot a drug-seeker at ten feet. However, because Kentucky allowed “Pill Mills” to run rampant in our fair state, my patients and thousands of other Kentucky citizens will be held hostage to this new state law HB1. Here’s a link to one legal firm’s interpretation of the bill. I suppose the good news is that I can always prescribe oxycodone, since it is hydrocodone that is targeted in the bill. (What?!?!!?)

So now in addition to the insurance company, the lawyer, the employer, and the federal government in my examining room, please welcome the state of KY. It’s getting mighty crowded in there, so much so that many days it’s really hard to hear the patient. And that’s unfortunate since that’s the only way I can treat her.

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