New Law Governing Prescribing of Controlled Substances in Florida July 1

There is an ongoing epidemic of addiction to prescription pain medications in our country. The death toll from opioid drug overdoses on a daily basis is now higher than loss of life through motor vehicle accidents and violence.

This spring the Florida Legislature passed Hb21, a new law that is meant to keep oral pain medications off the streets. Hb21 requires that when you are prescribed a controlled substance, the prescriber must first access the states Prescription Drug Monitoring Program website (Known as E-FORCSE) and review the recipient’s history of receiving prescribed controlled substances in the state of Florida. It is designed to make sure that drug seeking patients are not able to doctor or clinic hop to obtain narcotics.

Dispensers of the controlled substance such as pharmacies and pain clinics with dispensaries will be required to list the prescription on E-FORCSE within 24 hours. There are fines and penalties by the state for physicians and dentists failing to comply with access to E-FORCSE before writing the script. It is expected the Florida Board of Medicine will add penalties, license suspensions and revocations for noncompliance as well.

The law defines “acute pain” from an injury, medical procedure or dental procedure. Practitioners may prescribe three days of controlled substances for pain relief with no refills after accessing E-FORCSE. If they believe the procedure or injury are so severe that it requires more than a three day supply, they must write “Acute Pain Exception” on the prescription and they may request a 7 day supply with no refills. The prescriber will be required to document in the medical record why controlled substances are being prescribed and why there is an exception

The law additionally requires dispensers to complete a state mandated two hour course on safe prescribing of controlled substances. The course must be given by a recognized and accredited statewide professional association for a fee. The course will need to be retaken every two years before your license comes up for renewal. This course is separate and distinct from the course required to prescribe medical marijuana.

Our office has been registered with and has used E-FORSCE for several years now. It is helpful in tracking a patient’s ability to obtain controlled substance medications. It clearly adds additional time and labor to a doctor’s visit to comply with the new state regulations. Once again the Legislature has chosen to treat every patient as an addict and every dispenser as a criminal.

There is talk that in the near future we may be required to prescribe controlled pain substances electronically as opposed to the current requirement that a patient present a legible hand written or typed script. We have been told by our computer software maintenance vendors that there will be a significant charge to set up this service along with a monthly maintenance fee.

The law goes into far more detail than this synopsis permits me to go into. I suspect that, as we move forward, pharmaceutical chains may find it cost prohibitive to stock controlled substances and designate only certain locations as prescribing centers. This is what happened when the Legislature passed a 2011 law to deal with chronic pain and eliminate the “pill mills.”

If you have any questions or concerns feel free to call or email me and we will review your individual situation.

The American Cancer Society and Colorectal Cancer Screening

Colorectal cancer is the fourth most common cancer with 140,000 diagnoses in the nation annually. It causes 50,000 deaths per year and is the number two cause of death due to cancer.

Colorectal cancer screening guidelines have called for digital rectal examinations beginning at age 40 and colonoscopies at age 50 in low risk individuals. An aggressive public awareness campaign has resulted in a marked decrease in deaths from this disease in men and women over age 65.

The same cannot be said for men and women younger than 55 years old where there is an increased incidence of colorectal cancer by 51% with an increased mortality of 11%. Experts believe the increase may be due to lifestyle issues including tobacco and alcohol usage, obesity, ingestion of processed meats and poorer sleep habits.

To combat this increase, the American Cancer Society has changed its recommendations on screening suggesting that at age 45 we give patients the option of:

  • Fecal immunochemical test yearly
  • Fecal Occult Blood High Sensitivity Guaiac Based Yearly
  • Stool DNA Test (e.g., Cologuard) every 3 years
  • CT Scan Virtual Colonoscopy every 5 years
  • Flexible Sigmoidoscopy every 5 years
  • Colonoscopy every 10 years.

Their position paper points out that people of color, American Indians and Alaskan natives have a higher incidence of colon cancer and mortality than other populations.  Therefore, these groups should be screened more diligently. They additionally note that they discourage screening in adults over the age of 85 years old. This decision should be individualized based on the patient’s health and expected independent longevity.

As a practicing physician these are sensible guidelines. The CT Virtual Colonoscopy involves a large X irradiation exposure and necessitates a pre- procedure prep. Cologuard and DNA testing misses few malignancies but has shown many false positives necessitating a colonoscopy. Both CT Virtual Colonoscopy and Cologuard may not be covered by your insurer, and they are expensive, so consider the cost in your choice of screening.

I still believe Flexible Sigmoidoscopy must be combined with the Fecal Occult Blood High Sensitivity Testing and prepping.  Looking at only part of the colon makes little sense to me in screening.

Colonoscopy is still the gold standard for detecting colorectal cancer.

Controlled Substances and Schedule Drugs

The right to prescribe narcotics and controlled substances is regulated by the Federal Government. Physicians, dentists and health care providers apply for licensing with the Drug Enforcement Agency and request the right to prescribe medication from the different “schedules.” State legislatures and state medical boards regulate this further. Most people are unaware which medications and drugs are in which schedules or categories.

Schedule I – For the most part, these are substances which have no current accepted medical usage and are easily abused.

Examples are: Heroin, LSD, Ecstasy (methylenedioxymethamphetamine), Quaaludes          (methaqualone) and peyote.

Schedule II – These are substances with high potential for abuse with a risk of physical and psychological dependence.

Examples are: Vicodin, cocaine, methamphetamine, methadone, hydromorphone (dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, Ritalin

Schedule III – these are drugs with moderate to low potential for physical and psychological dependence.

Examples are: Products with < 90 milligrams of codeine per dosage unit such as Tylenol with codeine, ketamine, anabolic steroids and testosterone.

Schedule IV – These are drugs with a lesser risk for abuse and dependence.

Examples are: – Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, and AmbienTramadol.

Schedule V drugs have lower potential for abuse than Schedule IV drugs and contain limited amounts of narcotics. This would include antidiarrheal medications, antitussives, and mild analgesics. Cough medications with less than 200 milligrams of codeine per 100 milliliters such as Robitussin AC, Lomotil, Lyrica and Parapectolin.

All the medications on these schedules must be reported to E-Forcse, the Prescription Drug Monitoring Program, within 24 hours of dispensing by pharmacies. They all require the prescribing doctor to check E-FORSCE before prescribing.

Prostate Cancer, Digital Rectal Exams, PSA and Screening

The PSA blood test, to detect prostate cancer, clearly has saved lives according to numerous studies. The United States Preventive Task Force (USPTF) recognizes this but has decided that screening for prostate cancer is not a great idea in men aged 55-69. They point out the PSA can be elevated from an enlarged prostate, an inflamed or infected prostate, a recent orgasm while having sex and other causes.

Elevated PSAs led to trans-rectal ultrasound views of the prostate and biopsies of the prostate. These biopsies were uncomfortable, even painful, and often followed by inflammation and infection of the prostate. Many times the prostate biopsy was benign with no cancer detected. The USPTF felt the cost, worry, and potential side effects were a risk far outweighing the benefits of screening. They consequently came out against screening men in this age group.  Naturally this position produced a tidal wave of criticism from urologists and other.

So, the USPTF has produced new recommendations calling for patient education and making a shared decision whether or not to obtain a PSA measurement before you send it out. This is a bit confusing because we always discuss the pros and cons of a PSA before we draw it. Adult men are entitled to hear the pros and cons so they can make their own informed decision.

To complicate matters, a study out of McMaster University in Canada reveals physicians are poorly trained in performing a digital rectal exam. They cite the lack of experience coming out of school and going into training and cite numerous research studies showing a rectal exam is a low yield way to detect prostate cancer. They do not recommend performing digital rectal exams for prostate cancer screening.

This received much media hype and the blur between the efficiency of detecting prostate cancer via a rectal exam and the use of the rectal exam to detect rectal and colon disease has been lost. We perform digital rectal exams to detect prostate cancer and look at the perirectal area for disease. We test the strength and performance of the anal sphincter muscle. We feel for rectal polyps and growths and, in certain situations, test the stool for the presence of blood.

During my internal medicine training my teachers always required a digital rectal exam, stool blood test and slide of the stool as part of the exam. As trainees, we realized the invasiveness of the exam and did our best to be polite, gentle and caring. I always asked for permission first, and still do. How can you tell if something is abnormal if you haven’t performed normal exams?

Last but not least, Finesteride, a medicine used to shrink an enlarged prostate by inhibiting male hormones, has finally been shown to be protective against developing prostate cancer. A study published in the journal of the National Cancer Institute found that men taking it for 16 years had a 21 % lower incidence of prostate cancer.