To appropriately manage patients while minimizing diversion and misuse, HCPs must stay abreast of the existing and evolving laws, regulations, and policies that govern CS prescribing and to comply with all requirements. 17 To improve patient outcomes and minimize misuse, HCPs should aim to recognize the signs and symptoms of appropriate medical indications for prescribed CS. 5,17 This activity is designed to educate HCPs about select controlled substances as required by the State of Tennessee. Introduction to Controlled Substances Drugs or medications with the potential for misuse and a high risk of resulting in substance- use disorder (SUD) are strictly controlled by the federal government. The aim is to protect access to drugs with a legitimate medical purpose while preventing the detrimental effects of illegal importation, manufacture, distribution, possession, and improper use. The Drug Enforcement Administration (DEA) enforces federal CS laws in all states and territories. In recent decades, the agency’s approach to curtailing drug misuse and diversion of pharmaceutical opioids has been to focus on traffickers and doctors who prescribe inappropriately rather than on individuals who illegally obtain opioids. 18 Drug Schedules The Controlled Substance Act (CSA), which took effect in 1971 regulates manufacture, distribution, and dispensing of CS with specifics laid out in the Code of Federal Regulations (CFR) Title 21, §§1300- 1316. Under the CSA, illegal and prescription drugs are classified into 5 schedules according to: 18,19 • Actual or relative potential for misuse • Known scientific evidence of pharmacological effects
Introduction Controlled substances (CS) are used to treat many medical conditions but are associated with risks to patients and society. 1-4 Research suggests that the potential for misuse of non-opioid medications is under appreciated by heath care providers (HCPs). 5-8 Although most overdose deaths still involve opioids, 9 polysubstance involvement is on the rise and includes prescription stimulants, benzodiazepines, and sedative-hypnotics. 6-8 Misuse of any prescription drug is a serious problem, and that includes opioid and non-opioid CS. 1-4,10 Actions aimed at containing the societal opioid crisis have paralleled increased prescription rates for non-opioid CS, 11,12 some of which are recommended as first-line agents for pain treatment. 13 Despite these efforts, reductions in opioid prescriptions 14 have not seen a corresponding drop in overdose drug deaths in the United States. 9 At the same time, interest in non-opioid CS has grown: prescriptions for stimulants have risen sharply, and benzodiazepines are among the most commonly prescribed CS (Figure 1). 4 An analysis based on a single commercial insurance provider found a “concerning” 5-fold rise in stimulant use over 15 years (2004-2019). 4 Opioid-use disorder (OUD) can develop with opioid medication use, significantly affecting quality of life. Yet, significant barriers prevent broad access to treatment for OUD, despite strong evidence that treatment with medications approved by the US Food and Drug Administration (FDA) for OUD reduces morbidity and mortality. 15 Fewer than a third of people with OUD receive treatment, and those who do often wait years to begin. 15,16 Additional barriers include stigma, lack of professional education and training related to the evidence base for using medication to treat OUD, and a fragmentary health care system that does not incentivize best care. 15
• Current scientific knowledge of the substance • History and current pattern of misuse • Scope, duration, and significance of misuse • Risk to public health • Psychic or physiological dependence liability • Whether the substance is an immediate precursor of an already-scheduled substance Two federal agencies, the DEA and the Food and Drug Administration (FDA), determine which substances are added to or removed from Schedules I-V. 12 Each schedule is defined as shown in Table 1. Schedule I drugs have the highest risk for substance use disorder (SUD) and misuse and no accepted medical uses. Cannabis, although legal in some states, is still a Schedule I drug at the federal level. It is the only Schedule I drug that is legal at the state level for medicinal and recreational uses. The DEA does allow research to be conducted with Schedule I drugs when an investigator is deemed to be qualified and the protocol is found to have merit. Schedule II medications do have accepted medical uses (some with restrictions), including opioids for acute or chronic pain severe enough to warrant an opioid prescription and stimulants used to treat attention deficit hyperactivity disorder (ADHD). Use of Schedule II drugs may lead to severe psychological or physical dependence. The medications in Schedule III may lead to a moderate or low degree of physical dependence or “high.” Schedule III opioids include products containing not more than 90 mgs of codeine per dosage unit. This is also the schedule that contains stimulants and anabolic steroids. Although Schedule IV drugs are considered to have low potential for SUD and misuse relative to Schedule III, cautions do apply. This schedule contains medications that are frequently prescribed for insomnia and anxiety disorders.
Figure 1. Trends for Most Commonly Dispensed Controlled Substances in US Commercially- Insured Adults (January 2004 to June 2019)*
Figure 1. Trends for Most Commonly Dispensed Controlled Substances in US Commercially-Insured Adults (January 2004 to June 2019)
*Based on de-idenIfied longitudinal claims data on beneficiaries of a large US employer-sponsored commercial health insurance provider and covers approximately 9 million individuals ages 19 to 64 years in any given month across all 50 states. *Based on de-identified longitudinal claims data on beneficiaries of a large US employer-sponsored commercial health insurance provider and covers approximately 9 million individuals ages 19 to 64 years in any given month across all 50 states.
3
Powered by FlippingBook