Florida Controlled Substance Prescribing

Chronic pain and opioid use and abuse is a significant problem in the United States and in Florida. Over one-quarter of United States citizens suffer from chronic pain. It is among the most common complaints seen in an outpatient clinic and the emergency department. The failure to manage chronic pain, as well as the possible complication of opioid dependence related to treatment, can result in significant morbidity and mortality. One in five patient complaints in an outpatient clinic is related to pain, with over half of all patients seeing their primary care provider for one pain complaint or another. It is paramount that providers have a firm grasp on the management of patients with chronic pain. As a country, the United States spends well over 100 billion dollars a year on healthcare costs related to pain management and opioid dependence. Pain-related expenses exceed those for the costs of cancer, diabetes, and heart disease combined. How a patient's chronic pain gets managed can have profound and long-lasting effects on a patient's quality of life. The International Association for the Study of Pain defines chronic pain as any pain lasting longer than three months. There are multiple sources of chronic pain. Combination therapy for pain includes both pharmacological therapies and nonpharmacological treatment options. There is a more significant reduction in pain with combination therapy compared to a single treatment alone. Escalation of pharmacological therapy is in a stepwise approach. Comorbid depression and anxiety are widespread in patients with chronic pain. Patients with chronic pain are also at increased risk for suicide. Chronic pain can impact every facet of a patient's life. Thus learning to diagnose and appropriately manage patients experiencing chronic pain is critical. Unfortunately, studies have revealed an inherent lack of education regarding pain management in most professional schools and training programs. Many schools have committed to opioid-related education and training by incorporating the Centers for Disease Control and Prevention guidelines for prescribing opioids for chronic pain into the medical school curriculum. Appropriate opioid prescribing includes prescribing sufficient opioid medication through regular assessment, treatment planning, and monitoring to provide effective pain control while avoiding addiction, abuse, overdose, diversion, and misuse. To be successful, clinicians must understand appropriate opioid prescribing, assessment, the potential for abuse and addiction, and potential psychological problems. Inappropriate opioid prescribing typically involves not prescribing, under prescribing, overprescribing, or continuing to prescribe opioids when they are no longer effective. The American Society of Addiction Medicine describes addiction as a treatable chronic disease that involves environmental pressures, genetics, an individual's life experiences, and interactions among brain circuits.Individuals that become addicted to opioids or other medications often engage in behaviors that become compulsive and result in dangerous consequences. The American Society of Addiction Medicines notes that while the following should not be used as diagnostic criteria due to variability among addicted individuals, they identify five characteristics of addiction: 1. Craving for drug or positive reward. 2. Dysfunctional emotional response. 3. Failure to recognize significant problems affecting behavior and relationships. 4. Inability to consistently abstain. 5. Impairment in control of behavior. Unfortunately, for most health providers, understanding of addiction is often confusing, inaccurate, and inconsistent due to the broad range of perspectives of those dealing with patients suffering from addiction. While a knowledge gap is present among healthcare providers, it is equally prevalent in politicians writing laws and law enforcement attempting to enforce the laws they write. Payers are responsible for the expenses associated with the evaluation and treatment of addiction. Persistent lack of education and the use of obsolete terminology continue to contribute to a societal lack of understanding for effectively dealing with the challenges of addiction. In the past, the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders defined "addiction," "substance abuse," and "substance dependence" separately. The result was provider confusion contributed to the under-treatment of pain. Over time, the manual has eliminated these terms and now uses "substance use disorder," ranging from mild to severe. Unfortunately, there are numerous challenges in pain management, such as both underprescribing and overprescribing opioids. The concerns are particularly prominent in patients with chronic pain and have resulted in patients suffering from inadequately treated pain while at the same time there has been a development of concomitant opioid abuse, addiction, diversion, and overdose. As a result, providers are often negatively influenced and fail to deliver appropriate, effective, and safe opioids to patients with chronic pain. Providers have, in the past, been poorly trained and ill-informed in their opioid prescribing. To make the challenges even worse, chronic pain patients often develop opioid tolerance, significant psychological, behavioral, and emotional problems, including anxiety and depression related to under or overprescribing opioids.  Clinicians who prescribe opioids face challenges that involve medical negligence in either failure to provide adequate pain control or risk of licensure or even criminal charges if it is perceived they are involved in drug diversion or misuse. All providers that prescribe opioids need additional education and training to provide the best patient outcomes and avoid the social and legal entanglements associated with over and under prescribing opioids. Physicians (DOs/MDs). Physician Assistants. Podiatrists. Dentists. Optometrists. Advanced Practice Registered Nurses. Veterinarians. There are substantial knowledge gaps around appropriate and inappropriate opioid prescribing, including deficits in understanding current research, legislation, and appropriate prescribing practices. Providers often have knowledge deficits that include: Understanding of addiction. At-risk opioid addiction populations. Prescription vs. non-prescription opioid addiction. The belief that addiction and dependence on opioids is synonymous. The belief that opioid addiction is a psychologic problem instead related to a chronic painful disease. With a long history of misunderstanding, poor society, provider education, and inconsistent laws, the prescription of opioids has resulted in significant societal challenges that will only resolve with significant education and training. Unfortunately, the misuse of controlled substances resulting in morbidity and mortality is rampant. According to the National Survey on Drug Use and Health,2016, performed by the U.S. Department of Health and Human Services, over 10 million people misuse prescription pain medications, and over 2 million misuse sedatives, stimulants, and tranquilizers each year. The same study found that the most common reason for misuse is for the treatment of physical pain. The Center for Disease Control estimates more than 40,000 people die each year die from an opioid overdose.  There are three common classes of controlled substances commonly misused: opioids, depressants, and stimulants.  Opioids are prescribed for pain control by binding to mu-opioid receptors in the central nervous system reducing pain signals to the brain as well as receptors in the GI tract and respiratory system, and are used to treat pain, diarrhea, and cough. One of the most commonly taken opioid medications. It is at the center of the opioid addiction problem in the United States and thus is highly regulated. Its main indication is for pain and cough. FDA-Approved Indication Pain Codeine plays a role in the treatment of mild to moderate pain. Its use is recognized in chronic pain due to ongoing cancer and palliative care. However, the use of codeine to treat other types of chronic pain remains controversial. Chronic pain, defined by the International Association for the Study of Pain, is pain persisting beyond the standard tissue healing time, which is three months.[1] The most prevalent causes of non-cancer chronic pain include back pain, fibromyalgia, osteoarthritis, and headache. Non-FDA Approved Indications Cough Codeine is useful in the treatment of various etiologies producing chronic cough. Also, 46% of patients with chronic cough do not have a distinct etiology despite a proper diagnostic evaluation. Codeine produces a decrease in cough frequency and severity in these patients. However, there is limited literature demonstrating the efficacy of codeine in chronic cough. The dose can vary from 15 mg to 120 mg a day. It is, however, indicated in the management of prolonged cough (in specific populations like lung cancer) usually as 30 mg every 4 to 6 hours as needed. Restless Leg Syndrome Codeine is effective in treating restless leg syndrome when given at night time, especially for those whose symptoms are not relieved by other medications. Persistent Diarrhea (Palliative) Codeine and loperamide are equally effective, and the choice between them has its basis in the assessment of the physician evaluating the small but undoubted addictive potential of codeine versus the higher cost of loperamide, and an individual difference in patient's vulnerability to adverse effects. Transdermal patch and IV, commonly abused and used in mixture with other drugs. Fentanyl is a synthetic opioid that is 80-100 times stronger than morphine and is often added to heroin to increase its potency. It can cause severe respiratory depression and death, particularly mixed when mixed with other drugs or alcohol. It has a high addiction potential. Hydrocodone is a schedule II semi-synthetic opioid medication used to treat pain. Immediate-release (IR) hydrocodone is available as a combination product (combined with acetaminophen, ibuprofen, etc.) and is FDA approved for the management of pain severe enough to require an opioid analgesic and for which alternative (non-opioid) treatments are inadequate. Single-entity hydrocodone is only available in extended-release (ER) formulations. It is FDA approved to treat persistent pain severe enough to require 24-hour, long-term opioid treatment, and for which alternative treatments are inadequate. Hydrocodone is also an antitussive and indicated for cough in adults. FDA-approved usage of morphine sulfate includes moderate to severe pain that may be acute or chronic. Most commonly used in pain management, morphine provides significant relief to patients afflicted with pain. Clinical situations that benefit significantly by medicating with morphine include managing palliative/end-of-life care, active cancer treatment, and vaso-occlusive pain during sickle cell crisis. Morphine is widely used off-label for almost any condition that causes pain. In the emergency department, morphine is given for musculoskeletal pain, abdominal pain, chest pain, arthritis, and even headaches when patients fail to respond to first and second-line agents. Morphine is rarely used for procedural sedation. However, clinicians will sometimes combine a low dose of morphine with a low dose of benzodiazepine-like lorazepam for small procedures. An opioid agonist prescription medication. The oxycodone immediate-release formulation is FDA-approved for the management of acute or chronic moderate to severe pain for which other treatments do not suffice, and for which the use of opioid medication is appropriate. The extended-release formulation is FDA-approved for the management of pain severe enough to require continuous (24 hours per day), long-term opioid treatment, and for which there are no alternative options to treat the pain. The oxycodone to morphine dose equivalent ratio is approximately 1 to 1.5 for immediate-release and 1 to 2 for extended-release formulations. Tramadol is an FDA approved medication for pain relief. It has specific indications for moderate to severe pain. It is considered a class IV drug by the FDA. Due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication. There are two forms of tramadol: extended-release and immediate release. The immediate-release is not for use as an "as needed" medication; instead, it is for pain of less than a week duration. For pain lasting more than a week, extended-release is the therapeutic choice — the indication for extended-release is for pain control under 24-hour management or an extended period. Off-label, the drug is useful for premature ejaculation and restless leg syndrome refractory to other medications. For the off-label use of tramadol for premature ejaculation, both sporadic and daily use is effective for the treatment of the condition. Patients indicate a preference for "as needed" therapy for premature ejaculation due to the lack of side effects compared to the daily use of tramadol. While each of these terms is similar, providers should be aware of the differences. Addiction - the constant need for a drug despite harmful consequences. Pseudoaddiction - constant fear of being in pain, hypervigilance; usually, there is a resolution with pain resolution. Dependence - physical adaptation to a medication where it is necessary for normal function and withdrawal occurs with lack of the medication. Tolerance - lack of expected response to a medication increasing dose to achieve the same pain relief resulting from CNS adaptation to the medication over time.