Medications can divide down into two sub-categories: non-controlled and controlled. Most prescriptions for infections or chronic conditions are non-controlled. For example, blood pressure and cholesterol medications, diabetes medications (including insulin), asthma inhalers, and antimicrobials are all non-controlled medications. Both types require prescriptions from a provider. However, controlled substances require special prescription paper (triplicate) or specific protocols if prescribed through other means such as telephone, fax, or digital, and refills are not available under certain circumstances.
Controlled substances are medications or illicit drugs which are primarily active in the central nervous system and have the potential to cause a relative physical and mental dependence leading up to addiction. Further, these substances can have significant deleterious health consequences at high doses. Controlled medications have explicit restrictions on how they can be filled and refilled. The Controlled Substances Act of 1970 established five separate 'Schedules' delineating abuse potential, with Schedule 1 having the highest potential for abuse and each schedule after that with progressively less abuse potential.
Any individual or entity involved in the dissemination of controlled substances, from manufacturer to pharmacy, requires registration with the Drug Enforcement Agency (DEA), which is the primary organization responsible for regulating these substances at the federal level.
Controlled substances are an important asset in the toolkit of a healthcare provider in any practice setting, chiefly because these medications act quickly and potently. Schedule 2 opioids (oxycodone, hydrocodone, morphine, hydromorphone, fentanyl, etc.) are among the top drugs administered in the clinical setting as well as misused outside of medical purview. Because of this, opioids contribute a significant portion to drug overdose being the top cause of unintentional death in the United States.
Diversion, or the redirection of legally prescribed controlled medications for illegal use, is an ongoing regulatory battle undertaken by the United States Food and Drug Administration (USFDA), Drug Enforcement Agency (DEA), and other federal organizations.
An individual’s propensity to misuse a controlled substance is multifactorial, taking into life experiences (notably stressors), especially in childhood, in conjunction with the individual’s specific neurobiology. It is well known that the dopamine reward system is implicated in addiction. However, specific gene sequences and transcription factors are also involved in addiction phenotypes. These factors can combine to create a very powerful and perpetual motivation, the likes of which can only be sated with progressively increasing quantities of the implicated substance. This concept brings up the principle of supply and demand and with regards to controlled substances, whether legal or otherwise, demand is high. The two means through which supply is available are straightforward; unregulated (i.e., drug cartels) vs. regulated (pharmaceutical companies). Both create significant burdens to federal organizations such as the USA's FDA and DEA in limiting ease of access to the general public. Besides conditions such as acute traumatic injuries or cancer-related pain, indications for the short or long-term use of opioid medications are not explicitly defined and somewhat subjective from provider-to-provider. Moreover, a patient’s pain tolerance and personal opinion of appropriate opioid usage can turn a short-term course into a longer, and possibly chronic course of treatment.
At the clinician level, to prescribe a scheduled medication, certain rules have to be followed. These rules are most strict with Schedule 2 drugs and monitored at the state and federal level through various means, such as prescription drug monitoring programs (PDMP). Schedule 1 drugs are agents deemed to have no approved medical application and are considered illicit drugs; the only exception (as of the publication of this article) is marijuana, which has approval for limited medical use (i.e., palliative, pain, psychiatric, seizure, etc.) at the state level for multiple states, but not at the federal level. Although triplicate prescriptions were previously the only means to prescribe schedule 2 drugs since the Controlled Substances Act, in 2010 the DEA introduced a revised rule called the “Electronic Prescriptions for Controlled Substances” (EPCS) which provides the prescriber the option to send any scheduled medication (except schedule 1) prescription digitally. Before electronic prescriptions can be sent by a prescriber or institution, specific infrastructure, audits, and approvals are required according to the DEA’s Interim Final Rule. Only schedule 2 drug prescriptions cannot have any refills.
With the introduction and integration of EPCS and PDMP, prescribing and monitoring controlled substances has become much more efficient. It is necessary for physicians, advanced practitioners, and pharmacists to properly utilize these tools to deter abuse and diversion while simultaneously delivering quality patient-centered care.
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