Under the Controlled Substances Act, opioids are defined as “any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.”4 Opioids include prescription medications that can be naturally derived from the poppy plant or synthetically produced (e.g., oxycodone, hydrocodone, fentanyl, morphine),5 as well as illegal drugs (e.g., heroin, illegally produced fentanyl).6 Many prescription opioids are Schedule II drugs under the Controlled Substance Act as they have a high potential for abuse.7
Opioid overdose deaths in the United States demonstrate three distinct waves.8 The first wave began in the 1990s and can be attributed to the overprescribing of prescription opioids.9 In 2010, the second wave began, with increased overdose deaths due to heroin.10 Synthetic opioids, particularly illicitly manufactured fentanyl, characterize the third wave, which began in 2013.11 From 1999-2017, almost 400,000 people died from an overdose involving any opioid, including prescription and illicit opioids.12
Though suburban and rural white Americans have been featured most prominently in news stories,13 American Indian and Alaskan Natives (AI/AN) have also experienced a steady increase in opioid overdose deaths.14 AI/AN overdose death rates from prescription and illicit opioids are higher than those for other racial and ethnic groups,15 which may be due to historical trauma as well as the lack of access to prevention, treatment and other resources.16 Further, there may be substantial racial mis-classification that affects this data, leading to an under-reporting for AI/AN overdose rates.17
Recently released preliminary data indicate that drug overdose deaths may have decreased by approximately five percent in 2018,18 the first such drop in nearly three decades.19 While this decrease is modest, it may mark the beginning of the end to one of the worst public health epidemics to face the nation. Legal actions taken at all levels of government may have helped to achieve this potential turning point in the crisis, particularly those that targeted inappropriate prescribing and use of prescription opioids, as the number of deaths caused by prescription opioids decreased the most.20 In addition, legal actions related to increased access to the overdose-reversing drug naloxone may have contributed to the reduction in opioid overdose deaths.21 This article provides an overview of select federal, state, and tribal legal actions to reduce inappropriate prescribing of opioids and increase access to naloxone.
Emergency Declaration
One major strategy utilized by various levels of government was framing the opioid crisis as a public health emergency, thereby mobilizing resources and avoiding certain legal obstacles to response efforts.22 At the federal level, President Trump directed then Acting Health and Human Services Secretary Eric Hargan to declare the opioid crisis a national public health emergency on October 26, 2017.23 This allowed the federal government to waive certain requirements for Medicaid coverage, provide best prescribing practices and training to providers, and expedite National Institutes of Health research funding for treatment for opioid use disorder and overdoses.24 The federal public health emergency declaration regarding the opioid crisis has been repeatedly renewed, with the most recent renewal on July 17, 2019.25
Eight states also declared emergencies due to the opioid crisis in order to overcome statutory and regulatory barriers and create a coordinated response to reduce the number of overdoses: Alaska, Arizona, Florida, Maryland, Massachusetts, Pennsylvania, South Carolina and Virginia.26 Massachusetts was the first state to issue such a declaration on March 27, 2014 in response to the significant number of opioid overdose deaths and opioid addiction across the state.27 Pennsylvania was the last state to issue a declaration thus far, on January 10, 2018.28 The eight state declarations vary in their terms, but include provisions related to increased distribution of naloxone, mandating prescribing restrictions, improving cross-agency data sharing and coordination, and strengthening access to medication-assisted treatment.29
Several tribal nations have also declared an emergency due to the opioid crisis. The Mashpee Wampanoag Tribal Council declared a state of emergency in 2016 after 11 tribal members died from overdoses in just over one year.30 Other tribes that have declared an emergency include Red Lake Nation, White Earth Nation, and the Bad River Band of Lake Superior Chippewa.31 These tribal declarations were issued to stem the alarming tide of overdose deaths in tribal communities.32
Prescribing Limitations for Opioids
In March 2016, the CDC issued a voluntary guideline (the CDC Guideline) that provides recommendations for primary care clinicians who prescribe opioid pain medication for treating chronic pain (pain lasting longer than three months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care.33 The three main focus areas in the guideline include: (1) determining when to initiate or continue opioids for chronic pain; (2) opioid selection, dosage, duration, follow-up, and discontinuation; and (3) assessing risk and addressing harms of opioid use.34 The CDC Guideline was associated with an accelerated decrease in certain opioid prescribing practices, including the overall rate of opioid prescribing, the rate of high-dosage opioid prescriptions, and the percentage of patients with overlapping benzodiazepine and opioid prescriptions.35 There is concern, however, that some providers have been misapplying the CDC Guideline to the detriment of patients; therefore, the CDC is evaluating the impact of the CDC Guideline on patients and may issue updated recommendations in the future.36
States have also issued prescribing restrictions, guidelines, and requirements.37 Massachusetts was the first state to limit the duration of initial opioid prescriptions in 2016, setting a seven-day supply limit for initial opioid prescriptions.38 Other states enacted legislation limiting opioid prescriptions in 2016 and 2017; by October 2018, 33 states had passed legislation that includes some form of limitation, guidance, or requirement regarding opioid prescribing.39 These state laws vary widely in their characteristics, with most limiting initial opioid prescriptions to a certain number of days (usually seven but ranging from three to 21).40 Most of the states focus on general opioid prescribing limitations and set exceptions for chronic pain treatment, similar to the CDC Guideline.41 Eight states -- Alaska, Connecticut, Indiana, Louisiana, Massachusetts, Nebraska, Pennsylvania, and West Virginia -- also set limits on any opioid prescriptions for minors.42
Another way states are restricting opioid prescriptions is by limiting dosage, as there is evidence that monitoring total daily dosage for patients in addition to monitoring duration of initial therapy may reduce misuse of prescription opioids.43 These laws establish morphine equivalent daily dose (MEDD) or milligrams morphine equivalent (MME) thresholds. MEDD or MME allows for comparisons across different types of opioid formulations and strengths.44 The first such policy was implemented in Washington state in 2007; by 2017, 22 states had enacted MEDD policies, with progressively lower MEDD thresholds.45
Tribal nations have also implemented opioid prescribing and dispensing restrictions. For example, the Confederated Salish and Kootenai Tribes of the Flathead Nation voted to adopt a controlled substance utilization and dispensing limitation policy to provide guidance to tribal health pharmacy staff, clinicians, nurses, administrators, and recipients regarding quantity limits and acceptable parameters for the utilization of certain controlled substances.46 The tribal nation adopted the CDC Guideline regarding treatment for acute pain; under the policy, tribal health pharmacists are required to contact prescribing physicians for medical documentation for patients who receive prescriptions over the limits recommended in the CDC Guideline.47 In addition, the tribal policy outlines expansion of pain management resources, including access to pain specialists and non-pharmacological options.48
Prescription Drug Monitoring Programs
Prescription drug monitoring programs or PDMPs are electronic databases that track controlled substance prescriptions in a given state in order to capture prescription drug usage by patients to assist prescribers with identifying unsafe use or misuse of prescription opioids without hindering the practice of medicine.49 While 49 states, the District of Columbia, and Guam have legislation authorizing the creation and operation of a state PDMP and all are now operational,50 the laws vary tremendously51 with respect to the drugs monitored, who has access to the data, and which agency administers the program.52
In states with mandatory PDMPs, prescribers are required to query the PDMP prior to initially prescribing or dispensing a controlled substance to a patient.53 Failure to do so can result in disciplinary action by an appropriate state licensing board, generally the medical board or the board of pharmacy. While previous studies found limited or no impact from PDMPs in relation to prescription drug misuse,54 such studies did not differentiate between voluntary and mandatory PDMPs.55 A recent study found that laws that mandate that prescribers query PDMPs increased PDMP utilization rates; moreover, such PDMPs were significantly associated with a reduction in prescription drug abuse.56
The Indian Health Service (IHS) has also started a drug monitoring program that mandates participation with state PDMPs for both prescribers and dispensers.57 Under this policy, the IHS Area Director ensures that a memorandum of understanding is signed with the state PDMP that establishes the requirements for data disclosure to the PDMP.58 Prescribers must register with the state PDMP and request a report as a normal process for accepting a new patient.59 Prescribers must review PDMP data when opioid prescriptions for acute pain exceed seven days, when progressing from acute to chronic pain therapy, and periodically during opioid therapy for chronic pain.60 Pharmacists must access PDMP data prior to processing an outside prescription for a controlled substance and every three months prior to reissuing or refilling a chronic controlled substances prescription.61
Electronic Prescribing of Controlled Substances
In 2010, the U.S. Drug Enforcement Administration (DEA) issued regulations permitting the electronic prescribing of controlled substances (EPCS) in order to address issues of diversion.62 The DEA believed that EPCS would prevent diversion from stealing prescription pads and writing false prescriptions; altering a legitimate prescription to obtain a higher dosage; and altering a prescription record at the pharmacy to conceal diversion.63
EPCS allows the secure transmission of prescriptions for controlled substances, including opioids, from the point of prescribing to the point of dispensing (i.e., a pharmacy). Under DEA protocols, prescribers are authenticated prior to prescribing the controlled substance, with the e-prescriptions sent via specially equipped electronic health records (EHRs).64 In many states, the EHR can access PDMP data, which may prevent doctor shopping by patients.65 One study found that the overall number of opioid prescriptions decreased significantly in a New York emergency department after New York State implemented its EPCS mandate in 2016.66
EPCS is permitted in all 50 states67 and 26 states now require electronic prescribing for opioids, controlled substances, or all prescriptions.68 The SUPPORT for Patients and Communities Act, signed into law in October 2018, requires the use of electronic prescribing for all controlled substances under Medicare Part D by January 1, 2021.69
In Pennsylvania, EPCS will become mandatory for prescribers on October 24, 2019 for Schedule II-V controlled substances.70 Pennsylvania’s mandatory EPCS law was passed as lawmakers recognized “to combat the current opioid epidemic, health care clinicians need up-to-date tools and technology that support appropriate prescribing of prescription opioids. EPCS has the potential to … reduce prescription forgery, diversion, and theft in Pennsylvania.”71
Access to Naloxone
Naloxone is a prescription medication that quickly reverses an opioid overdose.72 Typically physicians and others authorized to prescribe medications may issue such prescriptions only to patients under their care (i.e., there is a physician-patient relationship); under this traditional model, providers may prescribe naloxone to their individual patients who may be at high risk of opioid overdoses but not to others who may be in need.73 In addition, dispensing of naloxone is limited to pharmacists or physicians.74 Naloxone access laws vary across jurisdictions but may allow providers to prescribe naloxone to a patient’s family members and others likely to assist in the event of an overdose (i.e., third party prescriptions).75 Prescription via standing order is another method of increasing access to naloxone, where a prescriber (e.g., state or local health officer) issues a prescription for naloxone to be provided to any individual who meets the standing order’s criteria rather than a named person.76 All 50 states and the District of Columbia have passed laws that improve access to naloxone by laypersons.77 In addition, states have passed laws that provide immunity protections for prescribers, dispensers, and administrators of naloxone to alleviate liability concerns and further improve access to naloxone.78
To facilitate naloxone deployment in tribal communities, IHS and the Bureau of Indian Affairs (BIA) entered into a memorandum of understanding in December 2015 to issue naloxone to BIA law enforcement officers.79 IHS pharmacists developed a comprehensive training program for law enforcement officers to effectively administer naloxone in response to suspected opioid overdose.80 By December 2017, IHS had trained and provided no-cost naloxone for more than 300 BIA officers and certified 47 BIA officers as naloxone trainers.81
Tribal nations are also taking steps to improve access to naloxone in their communities to reduce the number of opioid-related deaths. For example, the Paiute Indian Tribe of Utah (PITU) has an opioid overdose recognition and naloxone administration policy along with procedures for training on the use of naloxone.82 In addition to PITU Health Department staff, any PITU community member who wishes to possess a naloxone rescue kit will be trained to recognize the signs of an opioid overdose and how to administer naloxone.83
Another way jurisdictions are increasing access to naloxone is by passing overdose Good Samaritan laws that provide immunity or liability protections to individuals who report an overdose, as well as individuals experiencing an opioid-related overdose.84 Such individuals may fear arrest or criminal prosecution for possession or use of illegal drugs, providing drugs to someone who overdoses, and probation violations.85 New Mexico was the first state to pass a 911 Good Samaritan law in 2007; by 2018, 46 states and District of Columbia had passed such laws,86 as well as some Indian Tribes.87 Similar to naloxone access laws, these 911 Good Samaritan laws vary widely in terms and in the extent that they provide protection for individuals who report overdoses.88 Generally, 911 Good Samaritan laws provide immunity from arrest, charge, or prosecution for controlled substance possession, drug paraphernalia offenses, and/or being under the influence for the person requesting aid and the individual experiencing the opioid-related overdose.89 More expansive laws also provide immunity for parole or probation conditions and violations of protection from abuse or restraining orders.90
Conclusion
The opioid crisis has had a devastating impact on communities across the United States. Many legal actions implemented by the federal government, as well as state and tribal governments, have targeted prescription opioids (e.g., prescribing restrictions, PDMPs), as well as increased access to, and use of, naloxone to reverse overdoses. The nation may now be seeing results from those legal efforts, as provisional data recently released by the government indicate a slight decrease in overdoses,91 particularly from prescription opioids, the first wave of the crisis. The data are preliminary; moreover, overdose deaths from fentanyl rose in many jurisdictions.92 Thus, it is imperative that all jurisdictions continue to utilize legal actions to combat opioid addiction and overdose deaths, perhaps targeted towards heroin and fentanyl, to ensure an end to this public health crisis.