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  • Subject area(s): Marketing
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  • Published on: 14th September 2019
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Since the 1990s, there has been a noticeable increase in the prescription and sales of opioid medications. There has also been a surge in the number of opioid overdoses and accidental deaths, seen in the emergency departments worldwide. Additionally, there is a substantial amount of societal cost that accompany prescription opioid abuse and dependence.  \"Local, state, and federal agencies have implemented several policies to address this epidemic, including drug take-back programs, prescriber education, pain clinic laws, and prescription drug monitoring programs (PDMP)\" (Griggs, 2015). Maryland H.B.1432 Health Care Providers - Prescription Opioids - Limits on Prescribing (The Prescriber Limits Act of 2017) was introduced into the Maryland General Assembly 2017, by the Chair, Health, and Government Operations Committee, et al. This bill \"...requires a health care provider, on treatment for pain and based on the clinical judgment of the provider, to prescribe the lowest effective dose of an opioid and a quantity that is no greater than that needed for the expected duration of pain\" (General Assembly, 2017).  

Maryland H.B.1432 The Prescriber Limits Act of 2017

Opioid abuse and overdose from prescription drugs have been of developing public health concern in the United States. \"According to the Centers for Disease Control and Prevention (CDC), deaths from unintentional drug overdoses in the United States have been rising and are the second-leading cause of accidental death\"(Okie, 2010). \"Visits to emergency departments for opioid abuse more than doubled between 2004 and 2008, and admissions to substance-abuse treatment programs increased by 400% between 1998 and 2008, with prescription painkillers being the second most prevalent type of abused drug after marijuana\" (Okie,2010). \"In terms of abuse and mortality, opioids account for the greatest proportion of the prescription drug abuse problem\" (Volkow, 2014).  \"These escalations parallel an increase in the medical use of opioids and by efforts to encourage clinicians to become more proactive in identifying and treating chronic pain\" (Okie, 2010). Despite the increasing rates, many factors are at play when it comes to dealing with opioid abuse, misuse and dependence. These factors include, \"providers\' inappropriate prescribing or inadequate counseling and monitoring, patients\' misuse or abuse of drugs, sharing of pain pills with relatives or friends, \'doctor shopping\' to obtain multiple prescriptions, and diversion of opioids leading to illicit sales and abuse\" (Okie, 2010). With Maryland H. B. 1432, the expectation is that the appropriate health occupations board \"...must work to educate practitioners to ensure that Maryland residents are aware of the risks associated with opioid drugs\" (General Assembly, 2017). The effect this bill will have on the advanced practice nurse, is that the advanced practice nurse will be expected to abide by the rules and regulations set forth by the state board and legislation on the guidelines of prescribing opioid medications. Any advance practice nurse found in violation will be subject to disciplinary action. While there are many factors that play a role in opioid abuse and addiction, there are ways in which health care providers can help to counteract this upsurge. This bill would help initiate a series of events to help with controlling the opioid outbreak.

Sociocultural Environment

To understand why an individual may want to abuse opioids, one must first understand the influencing factors that lead to such a dependence. According to the Substance Abuse and Mental Health Services Administration, risk factors can derive from a \"biological, psychological, family, community, or cultural level\" (Risk and Protective Factors, 2015). They can include, \"providers\' inappropriate prescribing or inadequate counseling and monitoring, patients\' misuse or abuse of drugs, sharing of pain pills with relatives or friends, \'doctor shopping\' to obtain multiple prescriptions, and diversion of opioids leading to illicit sales and abuse\" (Okie, 2010). \"The number of prescriptions for opioids have escalated from around 76 million in 1991 to nearly 207 million in 2013\" (Volkow, 2014). While there are many reasons why patients abuse prescription drugs, the increase in number of prescriptions, written by providers, has had a seemingly huge impact at the rate at which opioids are being abused. Vulnerable populations include, patients who receive high dose opioids, multiple prescriptions from different providers, Medicaid patients, patients that live in rural areas, those with a history of substance abuse, chronic pain, and mental health disorders (Westgate, 2016). By enacting Maryland H.B.1432, the advanced practice nurse would be better equipped with helping to curb the number of opioid prescriptions, thus helping to reduce the incidences of misuse and dependence.

Economic Environment

Opioid abuse has become a great burden on the economy. Billions of dollars are spent annually on opioid addiction. \"Total US societal costs of prescription opioid abuse were estimated at $55.7 billion in 2007\" (Birnbaum, 2011). Associated costs include health care, criminal and lost workplace productivity. Of the estimated $55.7 billion dollars spent on opioid abuse in 2007, an estimated $25 billion was spent on health care costs including, research, excess medical/drug costs and treatment for substance abuse and prevention (Birnbaum, 2011). Criminal related costs accounted for $5.1 billion and was used towards law enforcement, court systems, correctional facilities and incarceration of those committing violent crimes attributed to drug abuse (Birnbaum, 2011). Lost workplace productivity totaled an estimated $25.6 billion and was largely attributed to lost monies from premature demise and reduced compensation/lost employment (Birnbaum, 2011).

The effects of opioid abuse and dependence has had a lasting impression on the economy\'s financial state. Although further research is needed to assess other areas of costs attributed to opioid abuse, much evidence has proven the misuse of opioids affects other members of society and not just individuals with the addiction (Birnbaum, 2011).

Ethical Environment

 â€œThe US Food and Drug Administration (FDA) has been criticized for its Risk Evaluation and Mitigation Strategy (REMS) program, which some believe creates burdensome barriers for appropriate opioid prescription” (Atkinson, 2014). From an ethical standpoint, in order to reduce opioid dependence, abuse and overdose, while continuing to appropriately manage those patients with chronic pain, the key is risk mitigation (Atkinson, 2014). There is much to be considered regarding the ethics surrounding opioid and the extent to which they are prescribed. \"In the 1980s, the American pain medicine landscape was characterized by opiophobia, the fear to prescribe opioids. Around the turn of the millennium, however, we witnessed a fairly rapid shift to opiophilia, or the \'overpre-scribing\' of opioids\" (Atkinson, 2014). Due to the under treatment of pain by providers, The Joint Commission on Accreditation of Health Care Organizations felt it was necessary to include pain as a fifth vital sign. It was because of this addition, opioid prescriptions soared to new heights with a simultaneous increase in accidental overdoses (Atkinson, 2014). Difficulties in opioid management arise when providers have to differentiate between the \"abusers\" and those looking for genuine relief from their chronic pain. Ultimately, it becomes a battle between life, death and addiction. \"Just as the risk of opioid treatment was underestimated previously, today we see adverse outcomes or addiction being used to illegitimately deny access to large groups of patients who struggle daily with chronic pain\" (Atkinson, 2014).

Political and Legislative Environment

Health care providers are at the forefront of patient care and can help lead the fight against opioid addiction. \"Local, state, and federal agencies have implemented several policies to address this epidemic, including drug take-back programs, prescriber education, pain clinic laws, and prescription drug monitoring programs (PDMP)\" (Griggs, 2015). Most notably are the PDMPs, which have garnered immense popularity among policy makers. PDMPs are able to provide health care providers with a list of scheduled medications histories, in order to identify at risk patients (Griggs, 2015). Laws mandating the use of PDMPs by providers has since been passed in 22 states, as of October 2014 (Griggs, 2015). \"PDMPs identify \'doctor shopping\' through unsolicited reports sent from government agencies to clinicians, surveillance of aberrant prescribing behavior to identify irresponsible prescribing and by clinician review of patient reports before prescribing\" (Griggs, 2015). Additionally, \"the PDMP relies on Drug Enforcement Administration (DEA) numbers to identify prescribers. In the case of residents and moonlighting clinicians, many hospitals use hospital-based DEA numbers and the database reports the hospital name instead of the specific prescriber\" (Griggs, 2015).

Since the implementation of PDMPs, evidence from research for both Florida and Virginia have shown a decline in the number of opioid overdoses and patients seeking prescriptions from multiple providers. It is still unclear whether the decrease of these incidences is a direct result of the PDMP, but evidence suggests there is a strong correlation (Griggs, 2015). Additionally, \"Patients determined to deceive the system may do so by crossing state borders in states without effective data sharing or reporting false personal information when registering with hospitals and clinics\" (Griggs, 2015). Despite evidence being favorable for PDMPs, \"the cost of implementation has been a significant barrier to expansion and implementation. The Congressional Research Service reported in July 2012 that startup costs range from $450,000 to more than $1.5 million, with annual operating costs from $125,000 to nearly $1.0 million\" (Gugelmann, 2012).  Although efforts geared toward the adoption of PDMPs across the nation and consistent use among providers continues, \"there is no evidence at this time that adopting their use will guarantee long-term compliance by practitioners. It is conceivable that providers may fear the inappropriate restriction of legitimate prescribing at the hands of regulators and law enforcement officials\" (Guegelmann, 2012).

Progression of the Bill and Difficulties Encountered

Maryland H.B.1432 Health Care Providers - Prescription Opioids - Limits on Prescribing (The Prescriber Limits Act of 2017) was introduced and read for the first time on February 10, 2017. This emergency bill was submitted by the Chair, Health and Government Operations Committee (By- Request- Departmental- Health and Mental Hygiene). Sponsors include Chair, Health and Government Operations Committee (By Request – Departmental - Health and Mental Hygiene) and Delegates Bromwell, Kipke, Hayes, Reznik, Wilkins, Morhaim, Platt, Malone, Pena-Melnyk, B. Wilson, Folden, Pendergrass, Angel, Barron, Cullison, Hill, Kelly, Krebs, Metzgar, Miele, Morales, Morgan, Rosenberg, Saab, Sample-Hughes, Szeliga, West, and K. Young.

One stakeholder are the consumers of the drug. This bill will set boundaries for those that suffer from addiction, but may limit treatment for those patients that may have conditions that warrant an increased amount of pain management. “Third party payers continue to deny or severely limit adjunctive non-medication options such as physical therapy, acupuncture, chiropractic care, exercise programs” (Atkinson, 2014). This can foster a sense of hopelessness due to limited resources. Legislators must take this bill into careful consideration not to reduce quality of care that patients can receive due to limitations of the insurance companies.

The government is a second stakeholder who has made note of how much opioid abuse is placing a financial strain on the economy. The opioid epidemic has led to much conversation amongst government officials on ways to combat the ongoing crisis. Maryland H.B.1432 will help to ensure health occupation boards are providing education and training to providers on opioid prescription writing, as well as hold providers accountable if not adhering to evidence-based clinical guidelines for writing such prescriptions. These new prescriber limitations will, hopefully, help halt the rising number of overdoses and accidental deaths. Additionally, these new limitations will curb the burden of costs placed on insurance companies, the health care system, and law enforcement as a result of opioid misuse and dependence.

A third stakeholder is health care professionals. As advanced practice nurses, the expectation is that we perform research and remain current with evidence-based guidelines, especially when dealing with controlled substances. Additionally, as part of the American Academy of Nurse Practitioners (AANP) and American Nurses Credentialing Center (ANCC) license renewal process, advanced practice nurses are expected to complete at least twenty-five continuing education units in advanced pharmacology. This requirement is so that advanced practice nurses are kept knowledgeable about the dangers of prescription drugs, drug-drug interactions, and knowing which drug is best for each patient. There is no one size fit all when prescribing a controlled substance for pain. Many patients have other health conditions, such as cancer, that could either potentiate or eliminate the effect of an opioid medication. Advance practice nurses must do their due diligence and ensure the right medication, at the right dose, for the right patient.

One final, yet notable stakeholder that will be affected by this bill are drug companies. Drug companies make a substantial amount of money off opioid sales. If less opioids are being prescribed, then that’s less money drug companies will make. Consequently, opioid prescriptions may become more expensive or harder to obtain. Thus, leaving those individuals who are in medical need for opioids, at a disadvantage. Or at the very least, the future costs for opioid medications could fall back on insurance companies to cover, which in turn places a burden on tax payers, state insurance and private insurance payers.

This bill was first introduced and read in the House on February 10, 2017. It was deemed favorable with amendments on March 31, 2017 and passed second reading. Third reading in the House was passed on April 4, 2017. The bill was then introduced in the Senate on April 5, 2017. The Senate ruled in favor and referred to finance at that time. On April 6, 2017, it was reassigned to Education, Health and Environmental Affairs and on April 7, 2017 a favorable report was given. Favorable report adopted, second and third reading passed in Senate on April 10, 2017. Maryland H.B.1432 Health Care Providers - Prescription Opioids - Limits on Prescribing (The Prescriber Limits Act of 2017) was approved by the governor on May 25, 2017.

Effects on Consumers

With the passing of this bill, there is no doubt consumers will be affected in many ways. Positive ways in which this bill will affect consumers is the decrease in accidental deaths and over doses, less violent crimes committed due to opioid abuse and misuse, as well as less money spent on healthcare costs due to the excessive number of opioid prescriptions and subsequent dependence. The decrease in amount of money paid by private and government health insurance companies, alone, would offset some of the financial burden placed on the economy and its citizens.  Those patients with true chronic pain and cancer patients will suffer because of providers not prescribing an adequate amount of opioid medication for their pain. These patients may look to other recreational or illicit drugs to help with their chronic pain.

Effects on Providers

With the passing of Maryland H. B. 1432 and the hopeful implementation of PDMPs, positive effects for providers include \"...improving their opioid prescribing by decreasing prescription amounts and increasing comfort with prescribing opioids\" (Lin, 2017). Negative effects this bill will have on providers include practitioners \"limiting\" the appropriate opioid prescription to match the patient\'s pain. Providers may start to \"under-prescribe\" for fear of legal action being taken against them or the possibility of patient addiction. Additionally, there are barriers that accompany PDMPs. \"Common barriers to PDMP use included not knowing about the program, registration difficulties and data access difficulties\" (Lin, 2017). In the short term, with this bill holding health care providers to a higher ethical and legal standard, the hope is that the health care provider will act in a responsible and knowledgeable manner when prescribing opioids. Long term effects on providers may include seeing an overall decline in the number of overdoses, accidental deaths and opioid dependent patients. With the help of Maryland H. B. 1432 and the aid of PDMPs, may persuade more states and providers to implement the use of PDMPs.

Accomplishments in other States or Countries

\"The United States puts minimal constraints on aggressive marketing by pharmaceutical companies. U.S. pharmaceutical manufacturers have been highly successful at promoting prescription opioids in this lightly regulated, profit-driven health-care environment\" (Humphreys, 2017). With that said, there are a number of states who have had promising success with the use of PDMPs and other programs. For instance, \"Florida enacted pain clinic legislation in 2010 and prohibited dispensing by prescribers in 2011. It subsequently experienced a decline in rates of drug diversion and a 52% decline in its oxycodone overdose death rate\" (Paulozzi, 2014). \"Florida legislature required that pain clinics treating pain with controlled substances register with the state. In February 2010, the Drug Enforcement Administration and various Florida law enforcement agencies began to work together in Operation Pill Nation\" (Johnson, 2014).  One year later, \"...law enforcement conducted statewide raids, resulting in numerous arrests, seizures of assets, and pain clinic closures\" (Johnson, 2014). In July 2011, \"coinciding with a public health emergency declaration by the Florida Surgeon General, the state legislature prohibited physician dispensing of schedule II or III drugs from their offices and activated regional strike forces to address the emergency\" (Johnson, 2014). From then forward, \"mandatory dispenser reporting to the newly established prescription drug monitoring program began in September 2011. Finally, in 2012, the legislature expanded regulation of wholesale drug distributors and created the Statewide Task Force on Prescription Drug Abuse and Newborns\" (Johnson, 2014).

Options for Refinement

One option I recommend would be to advocate or propose for the use of PDMPs in the bill, where applicable. By mandating providers to use PDMPs, it would help to guide practitioners in addition to using evidence-based practice guidelines. This would provide a \"picture\" of the patient, and aid the practitioner with prescribing the best prescription for opioid medication. This option would also help with cutting down on the number of opioid prescriptions and hopefully decrease the chances of a patient becoming addicted.

Another option is outlining a pain management support program for those abusing opioid medications. “The treatment for most types of chronic pain with the highest evidence-basis and the lowest level of iatrogeneses – interdisciplinary pain management programs – is facing extinction in the United States” (Atkinson, 2014). Insurance companies are refusing to pay for these programs, “despite strong empirical evidence of cost-effectiveness as well as clinical efficacy” (Atkinson, 2014). If this bill could outline replacement support and options suitable to patients addicted to opioids, providers might feel more comfortable and less conflicted about how much medication to prescribe.

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