The opioid epidemic has caused devastation in both the state of New Jersey and the nation, highlighting the need to make opioid prescribing practices safer. Preventing unnecessary initiation of opioids and ensuring opioid therapy is discontinued when appropriate are necessary parts of combating the opioid epidemic. To give prescribers a framework to provide the safest and most effective care, in February 2021 the New Jersey State Board of Medical Examiners unanimously approved proposed updates to opioid-prescribing regulations in the state. The updated prescribing regulations in New Jersey ensure patients who receive an opioid prescription for chronic pain have the assurance of a treatment plan, an assessment of risks, and monitoring for benefits and harms of therapy. This approach preserves access to care for patients in need while minimizing risks of abuse, diversion, and addiction. New regulations define treatment plans and require specific documentation for health care providers (HCPs) treating patients with chronic pain, giving HCPs tools to prescribe safely. The success of the regulatory updates can be measured by decreases in new cases of opioid-use disorder (OUD) and overdose deaths throughout New Jersey. New Jersey's updated regulations can serve as a model with nationwide applicability.
How can opioids be regulated to ensure access for the people who need them while minimizing potential dependency and related misuse and abuse? Clinicians, health care institutions, and government agencies have wrestled with this question since the existence of the opioid crisis in the United States became evident. Balancing the risks and benefits surrounding opioid treatment is one of the greatest challenges faced by the medical community as opioids are known to be effective for relieving intense, acute pain,1 but can be highly addictive, especially for those who receive long-term prescriptions2 and/or have behavioral health conditions.3
With the passage of time and development of a deeper understanding of the associated complexities since initial rules and regulations for opioid prescribing were written, this is a critical time to revisit and update existing regulations, as prescribers, patients, regulators, and lawmakers now have years of firsthand experience with the merits and limitations of those laws and regulations.
New Jersey recently updated its opioid prescribing regulations to harness the experiential knowledge gained from existing regulations and translate it into practice by giving prescribers a framework to offer the safest and most effective care as it relates to opioid therapy. These updated regulations have a greater focus on preventing opioid treatment-related complications that arise from prescription use while affirming access for patients who benefit from opioid therapy. The updated regulations use a “shift left” approach to decrease the risk of adverse outcomes by intervening with preventative tactics at the earliest possible juncture, ie, before a patient's first opioid prescription.
The regulatory update process in New Jersey took over 2 years to complete. While developing the updated regulations represents an important first step in the process, the development of methods to track their impact remains a critical second step, and this article proposes potential methods and data sources that could be used to measure the effectiveness of the regulatory update. The updated regulations may serve as a guide to other jurisdictions that wish to pursue prevention-focused updates to make their opioid prescribing regulations safer and more beneficial for patients. However, it is important to note the updated regulations focus on preventing harm arising from legally prescribed opioids but do not directly address the use of illicitly sourced opioids, as that is beyond the scope of these prescriber and patient-focused regulations.
The nationwide opioid epidemic
The devastation brought about by the opioid epidemic is likely unparalleled by any modern public health crisis, with the notable exception of the COVID-19 pandemic. A pre-pandemic review article described the opioid epidemic as the “most profound public health crisis our nation has faced,”4 with 564,000 people dying in the United States between 1999 and 2020 from overdoses involving any opioid.5 Opioid-involved overdose deaths have increased more than 8 times since 1999.5 Deaths from synthetic opioids, which now consist primarily of illicitly manufactured fentanyl, rose over 1000% between 2013 and 2019.6
New Jersey's opioid epidemic in a national context
The opioid epidemic has left no state or other jurisdiction untouched, with the peak number of opioid prescriptions in the United States — 255,207,954, or 81.3 per 100 people — recorded in 2012.7 The highest reported dispensing rate was in Alabama that year, with 143.8 opioid prescriptions per 100 people.7 The lowest reported dispensing rate in 2012 was 40.3 opioid prescriptions per 100 people in the District of Columbia, while New Jersey reported 60.1 prescriptions per 100 people that year.7
Nearly a decade later in 2020, there were 31.8 opioid prescriptions per 100 people in New Jersey, compared with the national average of 43.3 per 100 people.8 The number of opioid prescriptions per 100 people in New Jersey was 74.8 in 2015 but fell to 34.8 by 2019 before reaching 31.8 in 2020.8–13 See Figure 1 for an overview of the data from 2015 to 2019.9–13
Between the height of opioid prescriptions in 2012 and the reductions reported by 2020, numerous legislative and regulatory efforts were taken at state and federal levels to regulate the prescription of opioids.14,15
In New Jersey, a law enacted in 2017 requires prescribers in most cases to limit prescriptions to the lowest effective dose of an immediate-release formulation when issuing an initial prescription to patients suffering from acute pain for any opioid or schedule II controlled dangerous substance.16 Prescribers must also assess patient history, including any history of substance use disorder, and develop a treatment plan. In the case of treating patients with chronic pain lasting more than 3 months, prescribers must discuss the risk of opioids, enter into a pain management agreement with the patient and “reassess treatment goals and make a reasonable periodic effort to taper or stop the prescribing,” every 3 months.16
While the proportion of Medicaid beneficiaries in New Jersey who received prescriptions for opioids decreased from 23% to 13% between 2015 and 2019, the overdose risk more than tripled between 2015 and 2019, with an increase in fentanyl penetration from 2% to 80%.17 There were 2914 confirmed drug overdose deaths in New Jersey in 2019, with 2248 attributed to fentanyl and 1076 attributed to heroin.18 As fentanyl-related deaths began to rise nationally in 2013, the number of illicit fentanyl-containing drug products seized by law enforce-ment rose by 426% between 2013 and 2014 while fentanyl prescribing rates remained stable. 19 The US Centers for Disease Control and Prevention (CDC) suggests that illicitly manufactured fentanyl “is driving the increase” in fentanyl deaths, as the US Drug Enforcement Agency “has not reported a sharp increase in pharmaceutical fentanyl being diverted from legitimate medical use to illegal uses.”19
Methods: Updating Existing Regulations Surrounding Opioid Prescriptions in New Jersey
While earlier opioid prescribing regulations attempted to address the increasing incidence of opioid addiction and death by strictly limiting prescriptions, this approach garnered criticism for its limits on physician prescribing and did not have the full intended effect on outcomes. For example, the 2017 law in New Jersey limited prescriptions in some circumstances,16 yet the overdose risk rose between 2015 and 2019,17 even as the number of prescriptions fell.7–13 These challenges made it clear that more nuanced approaches would be needed to address the problem at its root through prevention-focused strategies. A “shift left” strategy was designed to implement solutions at the earliest possible juncture to minimize the risk of harm which progressively increases with time. The New Jersey State Board of Medical Examiners (The NJ Board) sought to use the “shift left” strategy to prevent new cases of opioid misuse, addiction, overdose, and death by enhancing existing opioid regulations to make prescription strategies safer at the provider level.
This approach is informed by the fact that the risk of long-term opioid use increases with the duration of the first episode of opioid use.2 The long-term use rate was 6% for people who had at least 1 day of opioid treatment but was 13.5% when the first episode of opioid use was 8 days or more, and 29.9% when the first episode of use was 31 days or more.2
In developing the prevention-focused regulatory approach in New Jersey, it also became clear that requiring prescribers to assess a patient's mental/behavioral health would be a critical piece of determining if a patient either has or is at risk for opioid use disorder (OUD).
The coexistence of substance use disorders and mental health disorders are known to be a co-occurring disorder, with serious mental illness reported in 26.9% of adults with OUD and past-year mental illness reported in 64.3% of adults with OUD in the 2015–2017 National Survey on Drug Use and Health.3 Furthermore, 80% of adults with OUD have had adverse childhood experiences, which increased risk for mood or anxiety disorders among this group.20 People with OUD are more likely to have higher rates of psychiatric disorders, have a prescription history of more opioids, receive a larger supply of opioids, and have prescriptions filled at more pharmacies, than people without OUD.21
Due to the high OUD risk in people with mental and/or behavioral health conditions,3,20,21 the elevated potential for long-term opioid use with longer episodes of first use,2 and the difficulty in treating OUD,22 the updated regulations require health care providers to conduct screenings for mental and behavioral health conditions and use this information to develop treatment plans that lower the patient's risk of developing OUD.
Additionally, it was important that updated regulations require prescribers to determine if a patient was previously issued a prescription for, used, or received an opioid drug and that prescribers make “meaningful and significant” attempts to get a patient's medical history. This can prevent patients discharged for improper opioid use by a previous provider from obtaining an opioid prescription from a new provider unaware of the patient's history with opioids.
It was also critical to require providers to create a detailed treatment plan with concrete goals if opioids are prescribed. The establishment of firm treatment goals prior to starting opioid therapy may provide the basis for the greatest opportunity. This requirement was informed by the CDC's 2016 guidance to primary care physicians to “establish treatment goals with all patients, including realistic goals for pain and function” and “consider how opioid therapy will be discontinued if benefits do not outweigh risks” before starting opioid therapy for chronic pain in a patient.23 The CDC guidance states opioid therapy should only be continued if “there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.”23
The CDC in late 2022—several months after the NJ Board approved New Jersey's updated regulations—issued updated guidelines on opioid prescribing that are consistent with the spirit of New Jersey's updated regulations. For example, the CDC's 2022 guidelines focus on assessing risk and addressing potential harms of opioid use, and now include recommendations prescribing opioids for acute pain.24
Furthermore, the American Society of Interventional Pain Physicians (ASIPP) 2017 Guidelines on prescribing opioids for chronic non-cancer pain state that “chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.”25
Within the treatment plans, it is critical to objectively define treatment goals, as pain is a subjective experience and successful pain management can be a “moving target” from a patient's perspective, especially when opioid use can induce hyperalgesia26 and impair decision-making skills.27, 28 Example endpoints of a treatment plan could be increased activity level, better daily functioning, reduced pain, or requiring less medication for the condition.
Once the general framework was finalized into an early draft of the proposed regulations, which amends New Jersey Administrative Code (NJAC) 13:35-7.6, the draft was submitted to the NJ Board for review. The NJ Board unanimously approved the draft regulations in February 2021. The draft regulations were then sent to a regulatory analyst who ensured that they were consistent with existing laws and regulations in New Jersey. The draft regulations were then reviewed by the Office of the New Jersey Attorney General's Consumer Affairs Regulations Division and sent to the New Jersey Office of the Governor before a 60-day public comment period. Once the public comment period ended, no changes to the draft regulations were necessary. The final version of the regulations was then reviewed and unanimously received approval for publication by the NJ Board on July 13, 2022. The regulations were published and took effect on January 17, 2023.
Results: Updates to Existing Regulations in New Jersey
The NJ Board's updated regulations add to existing requirements for physical examination and assessment of psychological function; obtaining, reviewing, and creating medical records; implementing and assessing treatment plans; and continued opioid access. The aim of the updated regulations is “to ensure that practitioners have a clear understanding of the patient's history from the outset, assess a patient's predilection for addiction and develop treatment objectives accordingly, and continually evaluate whether opioid therapy is providing clinically meaningful improvement in pain and function.”29 The updates are summarized in Table 1.29, 30
Evaluation of physical and psychological function
The updated regulations, which amend NJAC 13:35-7.6, now specify that the “required evaluation of underlying or coexisting diseases or conditions” prior to prescribing opioids includes “physical and psychological diseases or conditions, including anxiety and depression,” per the CDC recommendations to screen for psychological co-morbidities.29 This updates the previous regulatory language, which required prescribers to perform an “assessment of physical and psychological function, and an evaluation of underlying or coexisting diseases or conditions” but did not specifically mention anxiety and depression.30
Obtaining, reviewing, and preparing medical records related to opioid treatment
Under previous regulations with the NJ Board, the medical records requirement was limited to a patient's medical history, examination findings, prescription monitoring program data, as well as the complete name, dosage strength, and instructions for frequency of use for the prescription.30
The updated regulations require prescribers to prepare a medical record that includes the “efforts made to obtain the patient's record” in addition to the patient's medical history, findings upon examination, relevant prescription monitoring program data, treatment plan, as well as medications prescribed, dispensed, or administered.29
Prescribers are required under the updated regulations to “make a reasonable effort” to obtain and review a patient's medical record.29 Additionally, the prescriber must determine if the patient was previously issued a prescription for, used, or was administered, a drug or its pharmaceutical equivalent by reviewing the patient's medical record if available, reviewing the patient's prescription monitoring information, or consulting with the patient.29
The previous regulatory language stated treatment plans for patients receiving opioids should identify “the objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and any further diagnostic evaluations or other treatments planned, with particular attention focused on determining the cause of the patient's pain.”30
The updated regulations now define a “treatment plan” as a “memorialization of the objectives by which treatment success is to be evaluated, including, when treating the patient for pain, the specific objectives for pain relief and improved physical and psychological function and any further diagnostic evaluations or other treatments planned, with particular focus on determining the cause of the patient's pain, and when treating chronic pain, the terms of the pain management agreement.”29
Under the updated regulations, prescribers are required to discuss a treatment plan and objectives to be accomplished with a patient before an initial prescription of opioids for acute pain.29 Previous regulations required prescribers to discuss the reasons for the prescription, risks, and alternative treatments with a patient before prescribing opioids for acute pain, but discussion of a treatment plan was not required.29
Regarding issuances of a subsequent prescription for an opioid drug for acute pain, the updated regulations require prescribers to consider the treatment plan and ensure that the additional supply of the prescribed opioid is consistent with the treatment plan.29 This adds to the previous regulations, which required the prescriber to consult with the patient and determine the additional supply is “necessary and appropriate to the patient's treatment needs and does not present an undue risk of abuse, addiction, or diversion” but did not include consideration of the treatment plan.29,30
The updated regulations also add to the requirement for “documenting the practitioner's and patient's understanding of the pain management plan” before initiating an ongoing course of treatment for chronic pain.29,30 Under the updated regulations, the prescriber's and patient's understanding of the plan must be documented and take into account “the patient's history since being initiated on opioids, current progress toward objectives in the treatment plan, and modified treatment objectives, as appropriate, and in accordance with the standard of care.”29
The updated regulations now require prescribers to have discussions with the patient about the course of treatment and progress toward treatment plan objectives when a patient is continuously prescribed opioids for chronic pain.29 Additionally, prescribers are required to discontinue opioid therapy, “through tapering, if necessary” in “accordance with the standard of care, if there is insufficient clinically meaningful improvement in pain and function.”29 The prescriber must also continue to assess if the benefits of opioid treatment outweigh the risks.
Continued opioid access
The updated regulations also require prescribers to “evaluate the benefits and harms of opioid therapy when treating a patient for pain and determine that clinically meaningful improvement in pain and function outweigh the risks to patient safety” when authorizing multiple prescriptions that allow a patient to receive up to a 90-day supply of a Schedule II controlled dangerous substance.29
For patients who are continuously prescribed a 35-day supply, the prescriber is now required to discuss and document an exit strategy “consistent with the standard of care for the discontinuation of opioids in the event they are not providing clinically meaningful improvement in pain or function and modify the treatment plan, accordingly.”29
The updated regulations continue to affirm opioid access to patients who benefit from the treatment, with the regulations regarding prescribing controlled dangerous substances for acute and chronic pain not applying to patients who are in active treatment for cancer, receiving hospice care from a licensed hospice, receiving palliative care, or are residents of a long-term care facility.29,30 Those regulations also do not apply to medications prescribed to treat substance abuse or opioid dependence.29,30
Conclusions and Future Directions
Communicating the updated regulations to prescribers, patients, and the public will be an essential element of a successful implementation strategy that improves patient safety. The update to the NJ Board's regulations offers an opportunity to refresh and renew strategies for communication and education.
The approach to communication and education should be multi-pronged and focus on using the updated regulations to improve appropriate opioid use; reduce misuse, abuse, OUD, and opioid diversion; and reduce opioid overdoses and deaths. Some of the most successful tactics to address these issues were identified in a meta-analysis, which found the “most promising strategies to improve appropriate opioid use” included educational strategies developed for health care providers and clinical strategies designed for patients, people who use opioids, and health care providers.31
The most successful strategies for reducing opioid misuse, misuse, abuse, OUD, and opioid diversion include educational efforts directed toward patients, people who use opioids, and health care providers; clinical strategies designed for patients, people who use opioids, and health care providers; prescription monitoring programs; collaborations; public health; and opioid substitution.31 The “most promising strategies” to reduce opioid overdoses and deaths include naloxone distribtuion and education aimed at patients and people who use opioids.31
Communicating the updated regulations to prescribers in a simplified, yet nuanced fashion will be particularly critical, as prescribers are ultimately the individuals responsible for understanding and applying the updated regulations in practice. Prescribers who do not comply with the updated regulations may be subject to disciplinary action by the NJ Board.
Potential strategies to educate patients and the public include communicating the most impactful updates to regulations—such as the mental health screening component and expanded use of treatment plans—through simple and accessible graphics and videos designed for social media and online consumption. In addition, it would be worthwhile to develop print and digital materials such as brochures, posters, and pamphlets that explain what the updated regulations mean for patients and prescribers. These materials could be displayed and distributed in public places, government agencies, hospitals, clinics, and offices of health care providers. Newspaper, television, and radio campaigns could also help the message reach a wide audience.
Partnerships at state and local levels with key stakeholders—such as local, county, and state health departments; the New Jersey Office of the Attorney General's Division of Consumer Affairs; community action groups; health care institutions and providers; and other entities—will be crucial to successful development, deployment, and implementation of educational and communication materials.
While it can be difficult to fund large communication campaigns and educational offerings, the opioid settlement money awarded to counties and states could be a potential source of funding for communications and educational outreach. New Jersey will receive $641 million from settlements with Johnson & Johnson, McKesson, Cardinal Health, and Amerisource Bergen, which will be paid through 2038 and fund state and local programs “focused on treatment, prevention, and other strategies to combat the opioid epidemic in the state.”32
This opioid settlement money available to the state and counties would be well spent on communications highlighting the updated regulations and educational programs for the public and health care providers, as the impact of the updated regulations will be directly related to their implementation and use.
Tracking the impact of updated regulations
While updating the regulations is an important first step, implementing a system to report and evaluate their impact represents a critical second step that is under development. At a minimum, the impact of the regulations can be retrospectively tracked through county-level data on opioid-related harms and public records. However, there are multiple potential sources that could be used to track the impact of the updated regulations from the date of their effect. One major source of data is all-payer claims databases, which include “medical claims, pharmacy claims, dental claims, and eligibility and provider files collected from private and public payers.”33
This data is reported to states by insurers and includes information on private insurances, data from “most or all” insurance companies operating in each state, and information on patients across care sites, which are distinct advantages of all-payer claims databases, as many data sets do not include this information.33
Another potential method for tracking the impact of updated regulations is through the state's prescription monitoring database, which already tracks the number of opioid prescriptions in the state. The updated regulations do not impact the state's prescription monitoring database or requirements surrounding it, but the updated regulations are expected to affect the number of opioid prescriptions in the state, with this impact showing up in the state's prescription monitoring database.
Other sources of data include the New Jersey Department of Health, which offers a website with an overdose dashboard that “uses interactive data visualizations to display opioid and other drug-related overdose indicators for public health practitioners, researchers, policymakers, and the public.”34 The dashboard includes information on the prescription monitoring program, naloxone, drug-related hospital visits, drug-related deaths, treatment statistics, viral hepatitis, and neonatal abstinence syndrome. The data used comes from multiple sources, including the New Jersey Department of Health, the New Jersey Office of the Attorney General and its Division of Consumer Affairs, as well as other law enforcement agencies.
Each partner that collects data has a unique piece of the puzzle to help best understand the impacts of these regulations. Furthermore, each partner may have distinct abilities to obtain certain information from prescribers, health care institutions, health insurers, government agencies, or other sources. These partnerships and resulting data will be instrumental in measuring and evaluating the success of the updated regulations.
A potential quantitative measure of a successful implementation of the updated regulations would be a decrease of at least 10% in opioid-related deaths and new diagnoses of OUD stemming from legitimate medical prescribing. Another potential quantitative measure would be a decline in opioid prescriptions as measured by the state's PMP.
Challenges encountered with previous opioid regulations and guidelines
Planning to measure the impact of the updated regulations is particularly important, as it can be difficult to assess the true effectiveness of previous opioid regulations and guidelines, especially because fentanyl penetration and overdose deaths continued to rise as prescriptions fell. There are conflicting reports on the effectiveness of previous regulations and guidelines, although some of these differences may be due to the population studied, the specific regulation or guideline that was implemented and studied, the outcome(s) measured, the timing of the study, and other factors. For example, 1 study of 26 states that enacted prescription opioid prescribing and/or dispending laws in 2016 and 2017 suggested opioid prescribing laws were not associated with a short-term decline in prescription opioid distribution.35 However, a larger analysis of 38 states and the District of Columbia from 2006 to 2013 “revealed that combined implementation of mandated provider review of state-run prescription drug monitoring program data and pain clinic laws” reduced opioid amounts prescribed by 8% and prescription opioid overdose death rates by 12%.36 One study that assessed outcomes of New Jersey's 2017 5-day prescribing limit and electronic medical record alert showed they were “associated with an approximately 22% greater decrease in opioid dose per new prescription” in New Jersey. 37
Regulations and guidelines—at both the state and national levels—run the risk of garnering criticism from providers and health care professional associations for being restrictive, limiting potential access for those who benefit from therapy, potentially causing more illicit medication use in those who benefit from medically prescribed opioid therapy, and limiting physician autonomy. Specifically in New Jersey, the biggest criticism was related to the 5-day limit for the initial prescription of opioids. There were no public comments submitted for the 2022 regulation updates, suggesting that there was little concern regarding adverse effects of the regulation updates.
Due to these challenges, the updated regulations aim to make opioid prescription practices safer and more effective. The updated regulations affirm legitimate medical use in patients who benefit from the therapy while requiring prescribers to evaluate a patient's condition, history, and risk factors to develop a treatment plan with specific goals and benchmarks to assess the impact of opioid therapy.
Implications as a nationwide model
The NJ Board's updated regulations will serve as a resource and model for other states. The lessons of New Jersey's experience can be readily applied to other states, as it shows that it is not necessary to “reinvent the wheel” when developing a prevention-focused regulatory strategy. In the case of New Jersey, regulators were able to build off strong pre-existing regulations to develop updated regulations that continue to focus on safety by promoting preventative tactics while reaffirming access to legitimate opioid use in patients who benefit from the treatment.
While the laws and regulations regarding opioids throughout the 50 states and territories vary, New Jersey's model of updated regulations provides a cost-effective approach that allows for wide-reaching change. Regulators and public health officials should carefully review the existing laws and regulations in their jurisdictions to evaluate their current effectiveness and determine what prevention-focused updates could be made. For example, if a state's existing regulations do not require a mental health assessment or a treatment plan for an initial opioid prescription, it would be worthwhile to investigate adding these requirements to current regulations.
The process and entities involved in updating regulations varies by state, but a simplified overview guide based on the steps taken in New Jersey was designed to serve as a general guide to those who are interested in pursuing a regulatory update in their state. The overview is provided in the Appendix.
As prescribers, patients, the NJ Board, the New Jersey Office of the Attorney General, and the public garner more experience and data related to New Jersey's updated regulations, they can serve as a further resource and guide to others. The strengths, challenges, and opportunities for further improvement will become evident as the updated regulations are applied and their impact is tracked in the coming months and years. Furthermore, if other states develop similar regulations, they can, in turn, serve as a resource for others, including New Jersey. Thus, the updated regulations in New Jersey may help reduce new cases of opioid addiction, overdoses, and deaths not only in the state, but throughout the entire nation.
These regulatory updates represent a critical “shift left” in addressing opioid-related harms by introducing patient-focused strategies at the prescriber level that can prevent OUD before it begins while affirming access for patients who benefit from opioid treatment.
The updated regulations aim to proactively stop opioid-related harms that arise from legitimate medical prescribing and are based on an understanding of psychosocial and biological factors that put individuals at risk for developing OUD. Rather than placing “one-size-fits-all” restrictions upon all prescribers and patients, this regulatory update requires prescribers to conduct nuanced, individualized evaluations of patients before initiating opioid therapy. This proactive, safety-focused approach benefits all patients, as it can help prescribers tailor treatment to an individual's specific pain management needs while reducing the risk of new cases of OUD arising from an opioid prescription.
Preventing new cases of OUD before they begin may reduce the need for reactive approaches to address OUD, which are known to be costly, complex, and often come too late to fully mitigate the harm done to an individual, family, community, or society. In conclusion, this “shift left” in opioid prescribing regulations may serve as a model to transform the reactive responses surrounding the opioid epidemic into proactive solutions that focus on promoting safety and preventing further devastation by tailoring opioid treatment to a given individual's profile of needs, challenges, and risks.
The authors thank their colleagues and the journal's reviewers for providing valuable feedback on the manuscript, as well as Cecilia Brown and Mark Megerian for their assistance in the process.
Appendix: UPDATING OPIOID PRESCRIPTION REGULATIONS
New Jersey's updated opioid prescription regulations can serve as a model and guide to other states. Ready to start the process? This guide outlines the steps taken in New Jersey.
UNDERSTAND CURRENT REGULATIONS IN YOUR STATE
What laws and regulations regarding opioid prescriptions are currently on the books in your state? Assess these existing laws and regulations to understand the current situation in your state and where changes may be needed.
Determine what changes can be made to implement prevention-focused regulations that continue to ensure access for those who benefit from opioid treatment. For example, New Jersey required prescribers to perform mental/behavioral health assessments and develop treatment plans.
Check in with your state's medical board and other key stakeholders to identify important contacts and resources, determine a potential timeline, and understand the logistics of the process.
Write a draft of the proposed new regulations to submit to the state medical board or equivalent authority in your state.
MEDICAL BOARD REVIEW
Allow appropriate time for your state's medical board or equivalent authority to review the draft and place it on a meeting agenda for a vote.
REVIEW BY REGULATORY ANALYST
Ensure revised regulations are compliant and consistent with existing laws by enlisting a regulatory analyst to review the draft.
REVIEW BY STATE OFFICIALS
Submit the proposed new regulations to the office of the attorney general for review before submitting it to the governor's office for review.
ALLOW TIME FOR PUBLIC COMMENT
In New Jersey, the Office of the Attorney General's Division of Consumer Affairs published a draft online of the proposed regulations with a 60-day public comment period.
RETURN TO MEDICAL BOARD FOR APPROVAL FOR PUBLICATION
Understand the timeline for state medical board review after public comment and final approval for publication.
PUBLICATION AND ENACTMENT
Keep tabs on the exact date for publication and enactment of the new regulations and be prepared to spread the word. Apply for federal opioid settlement funding dollars to support media and communication outreach for awareness about the regulations.
Other disclosures: None
Author contributions: Development and conceptualization of regulations (SM); Writing, drafting, and critically revising manuscript for key medical context and content (SM, OM); Critical technical support (OM).