Pain is a very common patient complaint, and a frequent reason for a visit to the doctor. Pain is the main reason for emergency room visits in more than 50% of cases. Pain, as defined by the International Association for the Study of Pain (IASP), is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage”.
There are three kinds of pain, inflammatory, nociceptive and neuropathic. Many examples exist of each type, but common complaints include arthritic, degenerative joint and back pains. There are more than 3 million US cases of back pain reported per year. Fortunately, most pains resolve over a short time, but some persist chronically. There are many effective pain treatments, from simple OTC remedies to home remedies and topical applications. Additionally, physical therapy and medications are important for improved function and activities of daily living. Medications may be of different classes, anti-inflammatory, opioid, and adjuvant. More complicated treatments may need a doctor’s expertise. Where interventional techniques are indicated, they include nerve blocks, steroid injections, spinal injections, nerve ablation and more. Medical marijuana is now being used for chronic non-malignant pain.
Pain can be a complicated problem that requires a multimodal physician-directed management approach. For those suffering, pain is a difficult problem and self-medicating is a concern. According to Health and Human Services, in 2016 11.5 million people have misused prescription opioids.
In 2017, HHS declared the opioid epidemic a public health emergency. HHS demographic data shows more than 42,000 opioid overdose deaths in 2016. From 1999 to 2016, more than 630,000 people have died in the US from a drug overdose per the CDC.gov data. HHS data also showed 2.1 million people had an opioid use disorder at an economic cost of over 500 billion dollars. 116 people died every day from opioid related drug overdose.
In response to the crisis, the Florida legislature proposed new regulations in opioid prescribing. Governor Rick Scott signed House Bill/ HB 21 into law on March 19, 2018. Many other states have similar legislation. Most of the 205-page document imposes a number of legal requirements on healthcare practitioners that carry penalties for noncompliance. The law is effective July 1, 2018. There are several key factors that will affect patients.
What does this mean to patients?
HB 21 adds a new statute governing the prescribing of controlled substances for “acute pain”. Acute pain is defined as “the normal, predicted physiological and time limited response to an adverse stimulus associated with surgery, trauma, or acute illness”. HB 21 provides that a prescription for an opioid for the treatment of acute pain may not exceed a 3-day supply. The legislation does allow for a 7-day supply if several criteria are met and include medical documentation and lack of alternative treatments. The Florida Medical Association attempted to add major surgery as an exemption to “acute pain”, but the governor’s office refused any changes to HB 21.
Florida Prescription Drug Monitoring Program
Several other criteria must be met prior to prescribing a controlled substance.
Every controlled substance prescription must be reported to the database PDMP. Doctors must query the Florida Prescription Drug Monitoring Program prior to every prescription of a controlled substance. Further, doctors must participate in a mandatory continuing education course on prescribing controlled substances every 2-year license renewal period. HB 21 requires clinics prescribing controlled substances and previously exempt from registering with the DOH to obtain a certificate of exemption. Doctors may opt to no longer prescribe controlled substances in light of the new requirements, making patient availability a concern.
In addition to the prescribing recommendations from the FDA Risk Evaluation and Mitigation Strategy of 2012, prescribers have a lot of guidelines to address. REMS recommendations for ER/LA opioid analgesics include completing a REMS compliant education program, obtaining a patient counseling document, patient prescriber agreements, and addiction risk assessment instruments, including urine drug screening.
HB 21 requires the medical board to adopt rules establishing guidelines for prescribing controlled substances.
Guidelines are to include evaluation of the patient, obtaining informed consent, agreement to treatment contracts, and periodic review of the treatment plan, consultation and compliance with current laws.
The opioid epidemic is a real public health emergency and HB 21 is necessary legislation toward helping reduce opioid
abuse. Will patients who rely on controlled substances medications after surgery or injury be adversely affected by these regulations? Will these regulations deter physicians from prescribing controlled substances? These are challenging issues for patients, doctors and the legislature to address.