In the late 1990s, the American Pain Society advocated assessing pain more frequently⁵ and the Veteran’s Administration subsequently initiated the “Pain as the 5th Vital Sign” initiative.⁶ Concurrently, relatively poorly designed studies of patients who received opioid medications to manage pain showed little risk of addiction.^7,8 As a result of the increased emphasis on pain management, many pain experts used these and other similar studies to justify escalation of opioid medications for the management of chronic pain.⁹

In spite of the liberalization of opioid use for chronic pain management, it is estimated that over 100 million people in the United States suffer from chronic pain and often turn to their primary care physician for treatment.¹⁰ However, morbidity and mortality from opioid-related overdose has grown with the increase in opioid prescriptions. In 2015, 12.5 million people in the United States misused opioid medications¹ and 33,000 died from complications associated with opioid overdose.² In fact, at the time of this publication, opioid overdose is now the leading cause of accidental death in the United States²

Roughly 50% of the deaths were attributed to overdose of prescription medications. However the 2009 National Survey on Drug Use and Health (NSDUH) reported that one-third of individuals older than 12 years who misused any drug started by abusing prescription medications.¹¹ In essence, prescription medications have been implicated as a “gateway” drug for those who abuse other controlled substances that often result in significant morbidity and mortality.²

Federal and state laws and regulations govern the prescribing and distribution of opioids and other medications used in pain management. The language contained in legislation written to govern opioid distribution tends to be general rather than specific. The regulatory agency assigned to enforce these laws is tasked with interpreting broad language in these laws.

The Centers for Disease Control (CDC)³ and Federation of State Medical Boards (FSMB)⁴ released updated opioid medication guidelines to reduce the risk of harm to patients who may benefit from opioids medications to help manage chronic pain. These guidelines also outline recommendations for optimal physician and patient opioid pain agreements. Adherence to these recommendations will help prescribers practice within the standard of care when prescribing opioids and other scheduled medications. Well-written opioid agreements can also be used to document that the patient has been educated regarding the risks and benefits of chronic opioid therapy as well as certain provider expectations such as appropriate use of opioids, refills, and monitoring when opioid medications are prescribed for chronic pain.

The principal federal law that governs the prescribing of controlled substances is the Controlled Substance Act (CSA), a subset of the Comprehensive Drug Abuse Prevention and Control Act of 1970.^12,13 The CSA stipulates that licensed medical practitioners can prescribe controlled substances for legitimate medical purposes in accordance with accepted standard medical practice. The CSA also assigned controlled substances to five classifications, with differing penalties for unlawful uses, based on the potential for misuse. Schedule I substances have an extremely high potential for abuse, are deemed to have no medicinal benefit, and cannot be prescribed. Drugs in this class include the opioid heroin and nonopioid drugs such as marijuana, gamma-hydroxybutyric acid (GHB), and lysergic acid diethylamide (LSD). Schedule II drugs also have an extremely high potential for abuse yet are deemed to have medicinal benefit in limited circumstances. Such substances include the opioids fentanyl, codeine, hydromorphone, meperidine, methadone, morphine, and oxycodone. When the CSA was developed, schedule III drugs were believed to have less abuse potential than schedule II drugs, and include opioids such as dihydrocodeine, or codeine, in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen. Schedule IV drugs are those that have less abuse potential than schedule III drugs and include the weak opioid pentazocine and benzodiazepine drugs such as clonazepam, diazepam, and alprazolam. Schedule V drugs are those with lowest abuse potential among the controlled substances within the CSA and include compounds with limited quantities of opioids such as codeine or opium used in preparations for cough or diarrhea, respectively.

The CSA does not regulate medical practice, as state governments hold this authority. However, the CSA specifically stipulates that controlled substances must be made available for medical purposes. This is accomplished through a quota system that attempts to balance the medical need for these medications while discouraging overproduction, which could lead to diversion. The CSA also does not limit the dose or the length of time that patients may use controlled substances for legitimate medical purposes. In fact, specific language contained in the CSA addressed the issue of extended opioid use for the treatment of intractable pain.¹⁴

Within the United States, the Drug Enforcement Agency (DEA) has been designated by the US Department of Justice to ensure that controlled substances are prescribed, administered, and dispensed by licensed practitioners solely for legitimate medical purposes.¹⁵ Legitimate medical purpose has been further interpreted to mean that practitioners act in the “usual course of professional practice” when prescribing such medications for their patients.¹⁶ To fulfill this role, licensed clinicians who wish to prescribe controlled substances must be registered with the DEA.¹⁴ Although the DEA does not have the legal authority to regulate medical practice, it does have the authority to investigate practitioners who do not comply with laws regarding controlled substance prescribing practices. The DEA has stated that it uses court rulings and legal precedent when evaluating whether a practitioner is prescribing opioid medications in accordance with the CSA. In the Supreme Court Case Gonzales v. Oregon, the definition of legitimate medical purpose is clarified. The ruling states that the CSA “ensures patients use controlled substances under the supervision of a doctor to prevent addiction and recreational use.” Furthermore the court stated: “as a corollary, the provision also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”^16,17 The DEA has cited these statements when describing how it determines whether or not physicians are prescribing opioids for a legitimate legal purpose. The DEA has outlined common behaviors that result in the revocation of DEA registration: issuing prescriptions for controlled substances without a bona fide physician-patient relationship, issuing prescriptions in exchange for sex, issuing several prescriptions at once for a highly potent combination of controlled
substances, charging fees commensurate with drug dealing rather than providing medical services, issuing prescriptions using fraudulent names, and self-abuse by practitioners.^16,18

The DEA has also said that there are no specific parameters that would lead to the conclusion that a physician is practicing outside the norms of professional practice citing legal precedent that the evidence of reasonable guilt must be decided on a case-by-case basis.¹⁹ According to reporting data available through 2005, in any given year less than 0.01% of physicians in the United States lose their controlled substance registrations based on a DEA investigation. Additionally, most investigations of physicians suspected of substandard prescribing practices that result in the revocation of DEA registration are initiated by state medical boards.¹⁶

State governments share the responsibility of governing the prescribing and dispensing of controlled substances with the federal government. However, States also have the sole responsibility of regulating the health care practice of physicians, pharmacists, nurses, and other health care professionals. State licensing boards establish minimum standards of practice for any profession as well as for the use of controlled substances. They also have the authority to discipline practitioners who fail to adhere to these minimum standards. States have now turned to the state medical boards to assist with the control of opioid distribution by authorizing them to issue regulatory health guidelines. By allowing the State Medical Boards to shoulder this responsibility, the hope was that regulatory guidelines would be more congruent with recent scientific findings and medical interventions than laws passed by legislative bodies. This was done to promote better pain management and address provider fears of investigation and disciplinary action.²⁰ In 1998, the Federation of State Medical Boards adopted a policy template entitled Model Guideline for the Use of Controlled Substances for the Treatment of Pain (Model Policy).²¹ This template was introduced with the intention of promoting consistent policy across state medical boards with regards to pain medication regulations for clinicians. An update to the policy was introduced in 2004, and the current policy was updated in 2013.^4,22

Recent reports in the popular press regarding the opioid epidemic in the United States and the release of the CDC Guidelines for Opioid Prescribing in 2016³ have prompted several states to pass laws restricting opioid prescribing for chronic and acute pain. Many of these new laws mirror the guidelines set forth by the CDC or similar guidelines.^23,24,25 Additionally, many states now require that practitioners who prescribe schedule II substances participate in approved Continuing Medical Education (CME) courses that address the risks and benefits of opioid medication use for chronic pain treatment.²⁶

Prescription drug monitoring programs (PDMPs) have been in existence since the middle of the 20th Century, with California and Hawaii implementing PDMPs in the 1940s. Such programs collect prescription data at the state level to monitor the flow of controlled medication prescriptions. As of 2017, all 50 states, with the exception of Missouri, and the US Territory Guam have functional PDMPs.²⁷ For a PDMP to be fully functional, data on a prescribed controlled substance must be entered into the system. Most states have mandatory reporting policies, usually through data input from the pharmacist, though some states only strongly encourage pharmacies and physicians to report these data. New York enacted a law requiring that physicians supply controlled substance prescription information to the state PDMP at the time a prescription is written. Furthermore, pharmacists are also required to update the database as soon as such prescriptions are filled. Similar laws have been passed or are under consideration in other states.^28,29