Root causes of opioid use disorder It appears likely that there are several root causes of the current opioid epidemic (Blumenthal & Seervai, 2017). Prescribers At the root of the opioid epidemic is the pain epidemic. It has been acknowledged that during the mid-1990s, to treat pain better, physicians overprescribed opioid medications in the absence of adequate attention to negative consequences. This may have responded to several experts at the time contending that pain was being undertreated in routine medical practice manufacturers and marketers. Investigations have established that drug makers may have partially fueled the epidemic by their efforts to enhance the sales of their opioid medications (Blumenthal & Seervai, 2017). In a current example, federal prosecutors have leveled racketeering charges against several executives of INSYS Therapeutics, alleging that they were part of a scheme involving aggressive sales of fentanyl. More specifically, the indictment suggests that prescribers offered bribes and kickbacks in exchange for higher prescribing rates for their product SUBSYS, a spray form of fentanyl (Thomas, 2016). Health insurance Although receiving less attention in the media, recent (Blumenthal & Seervai, 2017). Pharmaceutical companies Many have implicated the sales practices of opioid examinations have suggested that in some cases, insurance practices provide easy access to opioid medications while restricting access to less addictive but more expensive pain
medication. In addition, in some cases, access to addiction treatment may also be curtailed (Blumenthal & Seervai, 2017). Socioeconomics An association can be established between opioid misuse/abuse and unemployment, lack of health insurance, and poverty among adults. Unfortunately, it is difficult to confirm that financial disadvantage is a cause. Rather, this condition could result from the epidemic (Blumenthal & Seervai, 2017). Nonetheless, it remains probable that feelings of hopelessness and social trauma are at least somewhat to blame. Further, the geographic distribution of the opioid problem is revealing. Racial and ethnic minorities in cities have historically had high addiction rates. Some of the highest addiction rates in the United States occur where social dislocation is found, including densely populated urban regions and Appalachia. Since the 1970s, rural communities have suffered from employment declines. As a result of higher unemployment rates, financial problems, and limited upward mobility, the stage was set for increases in substance use and abuse (Blumenthal & Seervai, 2017). The drive for opioids combined with poverty often results in criminal activity. In 2012, a total of 259 million opioid prescriptions were written. This is adequate to provide each American adult with a medication bottle. It is estimated that of each five new heroin users, four got their start with painkillers. A 2014 survey of people suffering from opioid addiction showed that 94% of respondents chose to use heroin because of the costs; prescription opioids are more expensive and difficult to obtain (ASAM, 2017).
CONTROLLED SUBSTANCE ACT (CSA)
The Comprehensive Drug Abuse Prevention and Control Act of 1970, or the Controlled Substance Act (CSA), regulates pharmaceutical and illicit controlled substances in the United States (DEA, 2010b). The CSA requires registration, outlines specific rules about dispensing pharmaceutical controlled substances, and determines the legality of these substances (DEA, 2018a). The U.S. Drug Enforcement Agency (DEA) was formed in 1973 to enforce the CSA. For pharmaceutical controlled substances, the DEA is responsible for preventing the diversion and abuse of controlled drug substances. The agency also ensures that an adequate and uninterrupted supply of pharmaceutical controlled substances is available to meet legitimate medical, scientific, and research needs. Along with state and other federal agencies, the DEA regulates the
registration of manufacturers, distributors, and dispensers of controlled pharmaceutical substances and the import and export of these substances. The DEA prosecutes anyone who violates this law (DEA, 2020a).
Evidence-Based Practice: The U.S. federal agencies involved in scheduling controlled substances include the Drug Enforcement Agency (DEA), the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS).
CONTROLLED SUBSTANCE SCHEDULES
● Its history and current pattern of abuse. ● The scope, duration, and significance of abuse. ● What, if any, risk there is to public health. ● Its psychic or physiological dependence liability. ● Whether the substance is an immediate precursor of a substance already on the controlled substance list. (DEA, 2018b) The DEA ultimately decides whether to initiate rulemaking proceedings to reschedule a controlled substance. However, there are circumstances where the DEA is not required to follow these procedures. First, suppose a substance is an immediate precursor of a substance already on the list. In that case, the attorney general may place the immediate precursor in the same or any other schedule with a higher designation. Additionally, the DEA may, without regard to standard procedures, assign a drug or substance temporary Schedule I status if it has determined an imminent hazard to public safety. When issuing an order for provisional Schedule I status, the attorney general is only required to consider the history and pattern of abuse; the scope, duration, and significance of abuse; the risk to public safety; actual abuse; a diversion from legitimate channels; and clandestine importation, manufacture, or distribution. The DEA must issue a notice in the Federal
The CSA categorizes medications into five schedules based on medical benefits, relative abuse potential, and the likelihood of causing dependence when abused (DEA, 2018b). The U.S. attorney general may add, remove, or change the controlled substance schedule of a given compound. In addition, by the authority of the U.S. attorney general, the DEA may add or transfer substances between programs by rule (i.e., it does not require a change in statute). Other substances deemed to have the potential for abuse may be removed from the plan if they do not meet the requirements for inclusion in any schedule (DEA, 2020b). Before adding, removing, or changing the controlled substance schedule of a drug or substance, the attorney general must request a medical and scientific evaluation and recommendation from the secretary of the HHS. The FDA, which reports to the secretary of the HHS, usually performs this evaluation. These recommendations are considered binding, and the DEA must follow them. The following factors are considered when deciding how to schedule a pharmaceutical product or substance: ● Its actual or relative potential for abuse. ● Scientific evidence of its pharmaceutical effect, if known. ● The state of current scientific knowledge regarding the drug or other substance.
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Book Code: DFL3024
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