Abstract
The misuse of prescription opioids is a widespread issue that has a considerable effect on the United States healthcare sector. House Bill 167, introduced in Ohio, has the potential to address the opioid crisis in the state by restricting the prescription of opioids by care providers. The bill has brought forward by a complex environment, including patients’ and providers’ attitudes to opioids, increased health care costs, and related legislative action on national and state levels.
The bill will have significant consequences for both care providers and consumers, such as improved patient safety, increased cost of care, and limited access to effective pain management. Compared to similar legislation in Canada, the bill has several weaknesses that could impair its effectiveness. The present paper analyses the bill, its context, and potential effects while also proposing amendments that would make the law more effective in addressing the problem of prescription opioid misuse.
Introduction
Healthcare in the United States is greatly influenced by the legislative environment of the country. Prevalent healthcare issues, such as access to care, prescription medications, and the cost of services, are often affected by bills on the state and national levels. The present paper will explore and discuss the bill to restrict the prescription of opioid medicines in Ohio, reflecting on the bill’s environment, passage, and consequences.
Bill Number and Title
The number of the bill to be addressed in the paper is HB 167. It is a house bill with a short title “Address Opioid Prescribing and Addiction Treatment”. An extended title of the bill is “To amend sections 4723.52, 4730.56, 4731.83, and 5119.363, to amend, to adopt a new section number as indicated in parentheses, section 3715.08 (3719.064), and to enact sections 3719.063 and 4729.283 of the Revised Code regarding naltrexone and medication-assisted treatment” (“House Bill 167,” 2018, para. 1). The bill serves to improve the mechanisms of opioid prescription and addiction treatment in the state of Ohio to reduce the incidence of overdose deaths and other adverse effects of opioid prescriptions.
Legislative Issue
The bill addresses the legislative issue of opioid prescribing and addiction treatment in the United States. Opioids are often prescribed to people with chronic pain, as well as other conditions that require superior pain management approaches. The prevalence of opioid use in the country is rather high, which influences the incidence of medication addiction and overdose. Therefore, the bill aims to restrict the use of opioids by patients to reduce the adverse effects of opioid medications.
Effect on Advanced Practice Nursing
The bill will have a significant impact on advanced practice nursing, as it will regulate the prescription of opioid medicines to patients. Hudspeth (2016) states that nurse practitioners are required to follow state and national guidelines when prescribing medications. Moreover, nurses also have a responsibility to ensure that the treatment is safe and effective. Therefore, the legislation will affect the treatment options available to advanced practice nurses and their decision-making with regards to treatment.
Sociocultural Environment
The socio-cultural environment of the bill includes people’s lifestyles and attitudes towards medications. In today’s world, many people rely on medications to live a fulfilling life, especially if the condition affects their daily functioning. Pain can have a critical effect on the quality of life of an individual, especially in the case of chronic or long-term pain that cannot be managed with over-the-counter medications. For instance, Schaller, Dejonghe, Haastert, and Froboese (2015) found that chronic low-back pain is associated with depression, anxiety, stress, and reduced mobility, and thus impairs the respondents’ quality of life.
This means that pain prevents people from living an active, healthy lifestyle, which is among the key determinants of happiness in the contemporary sociocultural environment. Therefore, pain management is necessary for people to remain physically active and have a high quality of life. While the bill seeks to regulate the prescription of opioids, it could also assist patients and care providers in adopting new options for pain management.
Ethical Environment
The ethical environment of the bill is comprised of the notions of quality of life, patient safety, and treatment efficacy. On the one hand, nurses and physicians alike have a professional responsibility to treat patients. When a condition cannot be treated or when treatment is a long-term process, care providers should focus on enhancing patients’ quality of life by managing the symptoms, including pain (Rothstein, 2017). Opioids are an effective means of controlling and relieving pain, and thus opioid prescriptions help to fulfill care providers’ responsibility to prescribe adequate pain management medications.
On the other hand, care providers are also responsible for ensuring and promoting patient safety. Opioid misuse is connected with a variety of patient safety threats, including overdose and addiction. Keyes, Cerdá, Brady, Havens, and Galea (2014) state that the number of deaths from unintentional overdose of opioids has increased dramatically since the 1990s: “Unintentional overdose deaths from opioid pain relievers have quadrupled since 1999 and by 2007 outnumbered those involving heroin and cocaine combined” (p. 52).
Therefore, while opioids are useful and help improve patients’ quality of life, there are also significant risks associated with prescribing these medications. The two sides of the issue present a moral dilemma for care providers and legislators, thus shaping the ethical environment of the proposed bill.
Economic Environment
The misuse of opioids has a significant impact on the United States economy. Lipman and Webster (2015) state that abuse of opioids contributes to the country’s healthcare expenditures, as the annual health care costs of opioid abusers are over eight times higher than for people who only take opioids as directed. The authors report that “in 2007, prescription opioid abuse cost $55.7 billion, which included $25 billion in health care costs, $25.6 billion in workplace costs, and $5.1 billion in criminal justice costs” (Lipman & Webster, 2015, p. 893). Therefore, regulating the prescription of opioids would help to alleviate the burden of opioid misuse on the economy.
Another factor constituting the economic environment of the bill is that people of low socioeconomic status are at a higher risk of opioid misuse. According to a study by Keyes et al. (2014), economically disadvantaged populations have a much higher incidence of overdosing on prescription opioids. This increases the health gap between people of different socioeconomic status. Also, the higher prevalence of opioid misuse in disadvantaged populations enhances the economic burden of the problem, as people with low income are more likely to rely on government-sponsored health insurance schemes.
Political and Legislative Environment
The problem of opioid use in the United States has received national attention and is often referred to as the opioid crisis. Multiple states have been trying to improve drug prescription monitoring programs in response to the issue (Barlas, 2017). The 21st Century Cures Act passed towards the end of 2016, provided $1 billion in grants to help states regulate opioid use and misuse. Similar legislation called the enate’s Opioid Crisis Response Act of 2018 (OCRA) funded federal agencies to run programs for opioid misuse prevention, treatment, and recovery (Sotomayor, 2018).
The act also includes directions to reduce the number of opioid pills sold to patients and prioritize research and development of effective, non-addictive pain management medications (Sotomayor, 2018). Overall, the political and legislative environment of the bill involves actions from state and federal authorities aimed at combatting opioid misuse and addiction to prescription opioids.
Passage of the Bill
Sponsors
The primary sponsor of HB 167 is Representative Jay Edwards in Ohio House District 94, who introduced the legislation in 2017 and defended it during Committee hearings. He is supported by Representative Larry Householder in Ohio House District 72. None of the Ohio legislators opposed the bill, and it received a favorable passage in the House with 16 positive votes and no negative votes (“House Bill 167,” 2018). The bill was discussed in three separate House Committee hearings, on May 17, 2017, June 20, 2018, and June 27, 2018. No opponents of the bill presented during the Committee hearings.
Stakeholders
The principal stakeholders of the bill are patients and care providers, and their interests are usually represented by professional associations. For example, the Ohio Academy of Family Physicians (OAFP, 2017) outlined some of the care providers’ concerns with the new piece of legislation in a letter to Ohio Representatives and Senators. The organization stated that House Bill 167 is deeply flawed, as it singles out primary care physicians, does not address barriers to office-based opioid treatment, and proposes mandatory continuing medical education.
Also, the OAFP (2017) presented some of the patients’ concerns, arguing that recommending treatments that are not covered by insurance (e.g., physical therapy, massage, and non-narcotic medications) will increase out-of-pocket health care expenditures and that many people will not be able to afford them. The letter sent by the organization to Ohio Representatives and Senators served to inform them of the gaps in the bill and to affect future legislative action.
A different position on the issue was expressed by the Ohio Pharmacists Association. Antonio Ciaccia, the Director of Government & Public Affairs at the Ohio Pharmacists Association, presented at the second Committee Hearing on June 20, 2018. In their statement, Ciaccia (2018) states that the legislation is fair to patients, as it provides them with opportunities to receive Vivitrol, which is long-lasting injectable naltrexone, in place of opioids. Ciaccia (2018) also commented that the legislation would be useful in addressing the opioid crisis and assisting people who are at risk of opioid misuse, thus benefiting many patients. The statement was recorded as part of the Committee Hearing and will be used as evidence during the future stages of the bill’s passage.
Timeline
The bill was successfully passed out of the House Health Committee, and the amended version of the bill (substitute) was referred to the House on July 2, 2018. Next, the bill will likely be scheduled for a Second Hearing in the House, where a vote will take place, and any amendments to the bill will also be reviewed. The Third Hearing will only follow if the bill passes the Second Hearing and is scheduled. If the bill passes the Hird Hearing, it will be referred to the Senate, and the process will be repeated. After that, conference action will be taken to vote on the bill, and an affirmative vote would mean that the bill is sent to the Governor, where it can either be signed into law or vetoed.
The complex legislative process that takes place in the United States makes it rather difficult to predict timelines accurately. In an optimistic scenario, the bill passes every stage of the process successfully within 1-2 months and is signed into action by Governor by the end of 2019. However, if there are any further amendments to the bill or if the Governor vetoes the bill and the Chambers will act to override the veto, each step of the process might take up to 3 or 4 months. In this scenario, the bill will be signed into action no earlier than 2021. Thus, the timeline to achieve the goals is December 2019 in the optimistic scenario and March-April 2021 in the pessimistic scenario.
Consequences for Providers
Short-Term Consequences
After the bill is signed into action, it will have several negative implications for providers. Firstly, it will prohibit primary care physicians and general dentists from prescribing opioids for over three days (Molnar, 2017). Physicians and dentists who have completed training in opioid addiction and fit several other conditions will be able to prescribe opioids for a period of up to seven days. Secondly, in the treatment of chronic pain, physicians will no longer be able to exceed the dosage of 50 MED. Thirdly, physicians will be required to offer naltrexone before prescribing opioids to patients (Molnar, 2017).
Therefore, the bill will restrict the prescription of opioids by primary care physicians, although the State Medical Board will be able to impose restrictions on prescriptions of opioids by other medical professionals.
Long-Term Consequences
In the long term, the bill will reduce the prescriptions of opioids to patients and will increase naltrexone prescriptions. As a result, the bill will promote patient safety and reduce the health care costs associated with opioid misuse. Another positive outcome of the bill for providers is that it will most likely stimulate researchers to develop new drugs that are comparable to opioids in their pain management properties but are not addictive. It is also possible that the bill will have some negative consequences, including the increased demand for services. For example, patients who used to receive prescriptions for longer periods will now have to come in for additional appointments to prolong their prescriptions.
Consequences for Consumers
Short-Term Consequences
The first consequence of the bill for consumers will be the limited access to prescription opioids. This will likely harm people who rely on opioids for pain management, as they will need to come in for additional appointments to receive their medication. Another probable negative consequence is the increase in out-of-pocket costs, as physicians will be required to recommend other treatments instead of prescribing opioids (OAFP, 2017). The positive short-term consequences will include increased decision-making autonomy and improved access to naltrexone, as the bill ensures a stable supply of naltrexone as part of its key provisions.
Long-Term Consequences
The primary long-term consequence of the bill for consumers has increased patient safety. The patients’ likeliness of developing an addiction to opioids or overdosing on the medicine will reduce dramatically as a result of the bill. Moreover, patients who are addicted to opioids will receive better access to addiction treatment programs, which will improve their quality of life and health. One negative long-term consequence of the bill is that the alternative treatment methods will not be as effective in pain management as opioids, and thus patients might experience an exacerbation of symptoms over time.
This Issue in Canada
Canada is one of a few countries that have been able to address the misuse of prescription opioids successfully. The Canadian government took three key steps to address the rising use and prescribing of opioids. Firstly, the government passed a law making overdose-reversal drug naloxone available without a prescription (Wood, 2018). This helped to reduce the number of deaths from prescription opioid overdosing, thus resolving one of the most critical issues associated with the opioid prescription. The HB 167 does not stipulate the prevention of overdosing using naloxone, and the medication is still considered a prescription drug in most states.
The second step taken by the Canadian government facilitated the patients’ use of supervised injection facilities, which also helped to reduce overdose deaths (Wood, 2018). HB 167 does not consider opioid use by drug addicts and focuses only on regulating the process of prescribing these drugs, which may impair its effectiveness in addressing the misuse of opioids. The government of Canada also issued evidence-based guidelines for the treatment of opioid addiction and enabled care providers to refer people to short-term inpatient programs instead of continued addiction treatment (Wood, 2018).
This is also a shortcoming of the HB 167, as the bill does not stipulate the use of free, short-term detoxification programs. One similarity between the approach used in Canada and HB 167 is that both aim to improve care providers’ awareness of opioid addiction treatment. This proved to be an effective way of ensuring that people with opioid addiction receive adequate treatment and reducing the incidence of overdose deaths.
Refinement or Change
To refine the bill, it is critical to address the costs of alternative treatments and the treatment of opioid addiction, as these are the two main weaknesses of the bill identified in the analysis. While restricting providers from prescribing opioids could be effective in reducing addiction and overdosing rates in the long-term, it is also critical to ensure that people have access to safe and effective alternatives.
Therefore, for patients who might receive opioids prescriptions, alternative pain management strategies should be covered by insurance or government-sponsored schemes. In treating opioid addiction, the legislators should also consider introducing some of the programs used in Canada, such as allowing the sale of naloxone without a prescription and referring patients for short-term detoxification programs without mandatory further addiction treatment. These provisions would help to decrease the number of deaths from opioids, as well as opioid addiction rates.
Conclusion
All in all, the proposed bill will have a significant impact on patient safety, cost of care, and the misuse of opioids. It could also be potentially useful in reducing deaths and hospitalizations related to prescription opioid overdosing, thus alleviating the economic burden imposed by opioid abuse on the healthcare sector. The progression of the bill appears to be smooth so far, and the bill may be signed into action before 2020. Nevertheless, legislators should also consider refining HB 167 to address the increase in out-of-pocket costs and create new options for treating patients with opioid addiction. These changes would help the bill to achieve its goals while also addressing the main concerns of patients and care providers.
References
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Ciaccia, A. (2018). Testimony for HB 167. Web.
House Bill 167. (2018). Web.
Hudspeth, R. S. (2016). Safe opioid prescribing for adults by nurse practitioners: Part 2. Implementing and managing treatment. The Journal for Nurse Practitioners, 12(4), 213-220.
Keyes, K. M., Cerdá, M., Brady, J. E., Havens, J. R., & Galea, S. (2014). Understanding the rural-urban differences in nonmedical prescription opioid use and abuse in the United States. American Journal of Public Health, 104(2), 52-59.
Lipman, A., & Webster, L. (2015). The economic impact of opioid use in the management of chronic nonmalignant pain. Journal of Managed Care & Specialty Pharmacy, 21(10), 891-899.
Molnar, E. (2017). H.B. 167 bill analysis. Web.
Ohio Academy of Family Physicians (OAFP). (2017). A letter to Ohio Representatives and Senators. Web.
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Schaller, A., Dejonghe, L., Haastert, B., & Froboese, I. (2015). Physical activity and health-related quality of life in chronic low back pain patients: A cross-sectional study. BMC Musculoskeletal Disorders, 16(1), 62-69.
Sotomayor, M. (2018). Senate passes sweeping legislation to combat opioid epidemic. NBC News. Web.
Wood, E. (2018). Strategies for reducing opioid-overdose deaths—Lessons from Canada. New England Journal of Medicine, 378(17), 1565-1567.