Legislative Affairs Feature - August 2009
Tex Med. 2009;105(8):37-39.
By Ken Ortolon
Are injections of jet fuel, natural gas, and mycotoxins acceptable treatments for allergies? At least one Dallas physician thinks so, but the Texas Medical Board (TMB) disagrees.
In a complaint filed against the physician in 2007, TMB concluded that the doctor's use of these substances was inappropriate, not based on any scientific evidence, nonsensical, and potentially harmful to patients.
The board labeled the physician's treatment methods "nontherapeutic prescribing." A complaint is still pending against him at the State Office of Administrative Hearings (SOAH).
While nontherapeutic prescribing makes up a relatively small percentage of complaints that come before the TMB - probably less than 5 percent, according to TMB officials - the issue has received a lot of attention lately, particularly in this year's session of the Texas Legislature.
TMB's critics sought passage of legislation to block the board from acting against physicians for nontherapeutic prescribing unless it could prove the practice harmed a patient. TMB Executive Director Mari Robinson, JD, says that bill, House Bill 3816 by Rep. Fred Brown (R-College Station), would have "lessened our ability to prosecute" cases in which patients are given drugs that have no beneficial effect, as well as the so-called "pill mills" that divert controlled substances for illegal use.
The Texas Medical Association strongly opposed the language regarding nontherapeutic prescribing. The measure cleared the House Public Health Committee but ultimately failed when it was caught up in the session's last-minute delaying tactics.
Representative Brown now says the nontherapeutic portion of his bill was not that important to him and he has no plans to bring it up again in the 2011 legislative session.
TMA President William H. Fleming III, MD, says patient safety was the bottom line for TMA.
"We don't feel that patients should be given prescription medications for nontherapeutic reasons, without adequate physical examinations, without adequate workups, and without adequate reasons," said Dr. Fleming, a former TMB president.
Where's the Evidence?
TMA consistently advocates a strong but fair TMB. But the association believes critics of the board's actions in nontherapeutic prescribing cases are hiding behind legitimate complaints about the fairness of some board processes to push their own agenda.
Dr. Fleming, who testified against HB 3816 and its companion bill, Senate Bill 2336 by Sen. Dan Patrick (R-Houston), says the bills would have seriously weakened the board's ability to protect patients.
"Medicine must rely on rigorous, scientific investigation to determine which therapies work, which don't, and what risks they may pose to the patient," he said. "In fact, the original Texas Medical Practice Act was written nearly 100 years ago to rid the profession of snake oil salesmen. Today's patients are indeed harmed, some fatally, if their physicians omit proven and appropriate treatments in favor of their own, unproven regimens. These bills would allow a physician to prescribe Laetrile or human urine for cancer treatment or injections of jet fuel as a cure for allergies. I would add that removing this ability to discipline for nontherapeutic prescribing would curtail the board's ability to sanction a physician for illegally diverting controlled substances."
Dan Finch, director of TMA's Legislative Affairs Department, says the efforts to block TMB enforcement against nontherapeutic prescribing actually hindered the association's attempt to address other process improvements at the board. These include doing away with anonymous complaints against doctors, increasing the time physicians have to respond to an initial complaint from 30 to 45 days, creating a statute of limitation on complaints of seven years except in the case of children, and binding the board to findings of fact and law issued by SOAH judges.
"All those provisions that we supported got dragged down with a lot of these other provisions," Mr. Finch said.
Another provision TMA opposed would have allowed physicians to set their own particular standard of care if they could demonstrate that they took a continuing medical education (CME) course on the subject. Dr. Fleming says that provision is a bad idea because the content of CME courses is essentially unregulated.
Representative Brown says the nontherapeutic prescribing provisions were not his main focus in the bill.
"The biggest issue was the anonymous complaints, especially complaints by insurance companies," he said. "In the past I've heard complaints from doctors all over the state that insurance companies will turn in complaints on doctors just to get out of having to pay them."
Representative Brown says nontherapeutic prescribing is "not a big issue for me, and in the next session it's not an issue for me, either."
TMA also opposes anonymous complaints against physicians from insurance companies.
Where's the Benefit?
Ms. Robinson says the board investigates two types of nontherapeutic prescribing.
The first is prescribing or administering a drug for which there is no demonstrated therapeutic benefit. "That's going to be things for which there is no therapeutic way to use it, at least as far as modern science is concerned," Ms. Robinson said.
The second is the use of legitimate drugs in nontherapeutic ways. The most common examples of these, she says, are improper diversion of pain medications and inappropriate use of thyroid hormones.
"Obviously there are plenty of pain medicines that are therapeutic in nature," she said. "You absolutely have to have them for the modern practice of medicine, particularly as it relates to surgeries and other types of things. However, they certainly can be prescribed in a nontherapeutic manner, such as all of the pill mills everybody's heard so much about in the Houston area where every person who walks in gets the same three drugs - hydrocodone, Xanax, and Soma - every single time no matter what is wrong with them."
Ms. Robinson says the board also sees a significant number of cases in which physicians prescribe thyroid hormones even though testing does not indicate they are necessary.
"A person's thyroid test will come back normal, and there's no real indication that the person needs thyroid, but the doctor prescribes it anyway and fails to do appropriate follow-up, then the patient suffers negative side effects from having too much thyroid in their system," Ms. Robinson said. "What we have been told is that they don't believe that the testing is accurate and that they have anecdotal evidence that this works to cure all ranges of illnesses or symptoms, so this is their treatment modality."
A TMA review of TMB sanctions issued between 2006 and 2008 found only 23 disciplinary actions for nontherapeutic prescribing. Of those, 15 were for pill mill operations, two for self-prescribing, one for a fat farm, and five others. Of those five, only one involved unorthodox use of medications. That was for "prescribing Adipex, Adderall, and Armour Thyroid to patients when such medications were not indicated."
The board has disciplined another eight physicians this year for nontherapeutic prescribing.
Getting It Right
TMB officials say they are working to help physicians ensure that their prescribing patterns do not violate regulations against nontherapeutic prescribing, particularly with regard to pain medications and scheduled drugs. The Spring 2009 issue of the TMB Bulletin includes guidelines for prescribing such medications.
Ms. Robinson says the issue also will be addressed through a new physician outreach and education program later this year. The legislature provided funding for that effort in this year's appropriations bill.
Ken Ortolon can be reached by telephone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by e-mail at Ken Ortolon .
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