Controlled Substances

Issues of Concern

Controlled substances are an important asset in the toolkit of a healthcare provider in any practice setting, primarily because these medications act quickly and potently. Schedule II opioids (oxycodone, hydrocodone, morphine, hydromorphone, fentanyl, etc.) are among the top drugs administered in the clinical setting as well as misused outside of the medical purview. Because of this, opioids contribute a significant portion to drug overdose, the top cause of unintentional death in the United States.[7][8]

Common misused controlled substance practices include obtaining medications from multiple sources. To obtain multiple prescriptions for controlled medications, patients visit different healthcare providers.[3] These controlled medications are often used for self-medication or diversion.

Diversion refers to the illegal distribution of regulated medications to other sources which have not prescribed these drugs. Diversion, or the redirection of legally prescribed controlled medications for unlawful use, is an ongoing regulatory battle undertaken by the United States Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other federal organizations.[9]

However, a lack of guidelines can lead to serious adverse events, including patient harm and exposure to bacteria and infections, while also causing risks to the provider.[2]

Due to the uptick in drug overdoses and addiction, many states have also implemented drug monitoring programs. These programs enable a more effective and efficient way to track prescription drugs and prevent drug abuse. In 2012, New York State created a monitoring system known as the Internet System for Tracking Over-Prescribing (I-STOP), which requires physicians and pharmacists to consult a prescription monitoring program before prescribing scheduled controlled substances.[10] The I-STOP program resulted in a significant decrease in the number of prescribed opioids in New York, creating a sense of a reduction in opioid overprescribing and drug abuse. Such monitoring systems can prevent widespread prescriptions of controlled substances from healthcare workers to constant consumers.

With the help of the DEA, numerous registries are available to help prescribers properly monitor patterns among their patients before dispensing the scheduled substance.[11]

The increase in controlled substance abuse can correlate to a lack of proper education, socioeconomic disparities, provider education, and varying laws that have created significant challenges in regulating controlled medications. However, adequate training and education can tremendously help resolve this issue.[3]

Clinical Significance

The propensity of an individual to misuse a controlled substance is multifactorial, taking into account life experiences (notably stressors), especially in childhood, in conjunction with the specific neurobiology of the individual. 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.[1] These factors can combine to create a compelling and perpetual motivation, which can only be sated with progressively increasing quantities of the implicated substance.

This concept brings up the principle of supply and demand, and demand is high for controlled substances, whether legal or otherwise. The two ways supply is available are straightforward; unregulated (i.e., drug cartels) vs. regulated (pharmaceutical companies). Both create significant burdens for federal organizations such as the FDA and DEA in limiting ease of access to the general public.[9] 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. They are 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.

To prescribe a scheduled medication, certain rules must be followed at the clinician level. These rules are most strict with Schedule II drugs and are monitored at the state and federal levels through various means, such as prescription drug monitoring programs.[8] Schedule I 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.) in several states, but not at the federal level.[3][5][12][13][14] Substance III drugs are agents deemed approved for medical application and are usually allowed up to five refills within six months of the written prescription, obtaining a maximum supply of medication for 30 days. Despite these regulations, the 30-day supply may vary based on state regulations and the patient's condition.[5][12]

There are a few scheduled drugs with an exception to the 30-day rule. The 30-day exception applies to Schedule III, IV, and V drugs. A healthcare provider may prescribe a patient up to a three-month supply of Schedule II to V medications for certain approved medical conditions and a six-month supply of Schedule III medications.[9] However, approval of such prescriptions requires specific codes:

• Code A is related to patients with panic disorders
• Code B is for patients with minimal brain dysfunction
• Code C is for chronic debilitating neurologic conditions
• Code D is for the relief of pain in chronic and incurable patients
• Code E is related to patients with narcolepsy
• Code F is related to patients with a hormone or gonadotropin deficiency and those with metastatic breast cancer

Healthcare providers authorized to prescribe controlled substances must have a DEA number and include it with prescriptions for scheduled medications. The DEA registration number is a computer-generated sequence that allows other healthcare providers, such as pharmacists, to verify the validity of the prescription to prevent fraudulent dispensing of controlled medications.[15] Healthcare providers must be familiar with the different codes and regulations on a federal and state level to avoid drug overprescribing and diversion.

Although triplicate prescriptions were previously the only means to prescribe schedule II drugs, the 2010 Controlled Substances Act introduced a revised rule called the "Electronic Prescriptions for Controlled Substances" (EPCS) which provides the prescriber with the option to send any scheduled medication (except Schedule I) prescription digitally.[16] Before electronic prescriptions can be sent by a prescriber or institution, specific infrastructure, audits, and approvals are required according to the Interim Final Rule of the DEA. Schedule II, III, and IV drug prescriptions cannot be refilled.[1][9] However, these regulations may vary based on different states. For example, New York and South Carolina have state regulations requiring Schedule II, III, and IV drug prescriptions to be issued in a 30-day supply without any refills. 

Due to these different state regulations, if a scheduled drug prescription from an out-of-state healthcare provider were dispensed by law, the prescription would fall under the rules and regulations of the dispensing state.[6]

Nursing, Allied Health, and Interprofessional Team Interventions

With the introduction and integration of EPCS and PDMP, prescribing and monitoring controlled substances has become much more efficient. While overprescribing controlled substances may have decreased, it is still prevalent among healthcare providers, and working as an interprofessional team can help further reduce overprescription.[17] It is also necessary for physicians, advanced practitioners, and pharmacists to properly utilize these tools to deter abuse and diversion while simultaneously delivering quality patient-centered care.[11]