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.

The Need to Blame the Doctor, not the System

Maureen Dowd wrote a thoughtful and thought-provoking article in the New York Times this morning entitled "The Boy Who Wanted to Fly". I had read about the incident in a twitter-linked article earlier in the week and my heart ached for everyone involved--the boy, the parents, the pediatrician, the ER docs and the staff treating him at the hospital. I know from professional experience how gut-wrenching this outcome is to the doctors and staff involved. As a parent I prefer not to imagine what the personal experience would be. It was hard enough to have stood beside friends as they moved through it.

Many of the comments below the article demonize the physicians involved in the care of this boy. That is an easy thing to do and seems to be a particularly American way of approaching a problem--find someone to blame and sue them. Unfortunately, this will do nothing to fix what is an increasingly common problem in our healthcare system today.

I don't know the specifics of what happened in this case. On the surface of it, the article and remarks about it emphasize many of the issues of our broken healthcare system. The comments engendered begin with 'hard-hearted doctors" and "sue the jerks". Perhaps the most thoughtful was the comment by Infectious Disease specialist Dr. Jonathan Rosenthal who said: "The average physician will never see a case of florid Group A Streptococcal septic shock such as this one in her entire career. One of the reasons these rare cases can be so lethal is that is can be enormously difficult to pick them out from among 10000 cases of viral illness in a Pediatric ER. Herculean efforts are made every day not to miss early sepsis. We can learn from cases like this but not if we are distracted by looking for the person to blame. This poor child was seen by a number of physicians - were they all incompetent?"

As a primary care physician some of my thoughts are: How busy was the pediatrician? How busy was the ER? Did they have the time and experience to pick up on those "soft signs" of sepsis that Sully Sullenberger alluded to? As an aviation safety expert he understands the importance of fixing the SYSTEM that is causing the problem, rather than placing blame on the individuals involved.

Patients live in a world where physicians are pushed to see more and more of them to pay the bills; where technology substitutes for stopping and really "seeing" a patient as more than a disease state; where the patient is seen only as a dollar sign by the healthcare administrators, insurance executives, employers, lawyers and politicians who crowd into the examining room as if they had a sacred right to be there; and where time, the most important commodity for good patient care, is stripped from those on the front lines because it is not valued highly by their own peers.

This case should be a rallying cry for patients (and we are all patients) to fix a badly broken, fragmented healthcare system where volume and technology substitute for care. Since this involves a political fix from a system equally broken and fragmented, a fix that must involve compromise from both sides of the aisle, I fear for the future health of my patients and my profession.

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?