Improving Access to Medication Assisted Treatment for Persons with Opioid Use Disorder

The U.S. Opioid Epidemic began in the 1990s and has worsened with an increased number of opioid related deaths. To fight the widespread opioid crisis, MAT is considered a first-line treatment for patients with OUD, improving mortality rates by 60%, yet only 30% of patients with OUD receive treatment (Suen et al., 2022). Analyzing the literature on the impact stigma places on accessibility of medication assisted treatment for people with opioid use disorder (OUD) and the negative impacts leading to lack of access. Naltrexone, methadone, and buprenorphine are the three FDA-approved medications considered as first-line treatment for opioid use disorder. The goal of medication assisted treatment (MAT) therapy is to manage withdrawal symptoms, reduce relapses and decrease fatal overdoses. Studies were reviewed to determine factors that influence accessibility to MAT therapy and the impact on lack of access. Method: Literature was reviewed from 2009-2022 using the following databases: CINAHL,; Medline, PubMed, ScienceDirect, and Google Scholar. Results: Research demonstrates that MAT therapy is effective but factors such as stigma and the COVID-19 pandemic prevent utilization. Conclusion: Steps have been implemented to reduce stigmatization and increase the number of MAT-certified clinicians. Curriculum integration and telehealth increase access to MAT-certified clinicians in clinical settings, and continuing harm; reduction techniques will reduce fatal overdoses and improve patient outcomes.

IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER Improving Access to Medication Assisted Treatment for Persons with Opioid Use Disorder Ellen M. Kahn, Alisia Motuapuaka, Chau Quach, Louisa Tali School of Nursing and Health Sciences, Westminster College 1 IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER Acknowledgement As a group, we would like to express our immense gratitude and appreciation to our advisor Dr. Sue Jones for her endless encouragement, guidance, and never-ending sarcasm during this project. We would not have made it through without her! We would also like to express appreciation and thanks to Dr. Julie Balk, Dr. April Greener, Dr. Ronda Lucey and Dean Sheryl Steadman who all serve as an inspiration and reminder of what exceptional mentors are. 2 IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 3 Abstract Objective: The U.S. Opioid Epidemic began in the 1990s and has worsened with an increased number of opioid related deaths. To fight the widespread opioid crisis, MAT is considered a first-line treatment for patients with OUD, improving mortality rates by 60%, yet only 30% of patients with OUD receive treatment (Suen et al., 2022). Analyzing the literature on the impact stigma places on accessibility of medication assisted treatment for people with opioid use disorder (OUD) and the negative impacts leading to lack of access. Naltrexone, methadone, and buprenorphine are the three FDA-approved medications considered as first-line treatment for opioid use disorder. The goal of medication assisted treatment (MAT) therapy is to manage withdrawal symptoms, reduce relapses and decrease fatal overdoses. Studies were reviewed to determine factors that influence accessibility to MAT therapy and the impact on lack of access. Method: Literature was reviewed from 2009-2022 using the following databases: CINAHL, Medline, PubMed, ScienceDirect, and Google Scholar. Results: Research demonstrates that MAT therapy is effective but factors such as stigma and the COVID-19 pandemic prevent utilization. Conclusion: Steps have been implemented to reduce stigmatization and increase the number of MAT-certified clinicians. Curriculum integration and telehealth increase access to MAT-certified clinicians in clinical settings, and continuing harm reduction techniques will reduce fatal overdoses and improve patient outcomes. Keywords: opioid crisis, covid-19, opioid use disorder, medication for opioid use disorder, medication assisted treatment, stigma, racial disparities, vulnerable populations, health curriculum, telehealth, improving access IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 4 Table of Contents Abstract ............................................................................................................................................ 3 Background ...................................................................................................................................... 5 Specific Details of MOUDs......................................................................................................... 9 Review of Literature....................................................................................................................... 16 Structural Stigmatization ........................................................................................................... 16 Social Stigmatization ................................................................................................................. 19 Internalized Stigma .................................................................................................................... 20 Discussion ...................................................................................................................................... 21 Rural Communities .................................................................................................................... 21 Adolescent Community ............................................................................................................. 23 Individuals with Chronic Pain ................................................................................................... 23 Racial Disparities....................................................................................................................... 24 COVID-19 Pandemic Impact on Opioid Epidemic ................................................................... 24 Recommendations .......................................................................................................................... 26 Continuation of Harm Reduction .............................................................................................. 26 Curriculum Integration .............................................................................................................. 29 Continue and Expand Telehealth ............................................................................................... 30 Summary ........................................................................................................................................ 31 References ...................................................................................................................................... 33 IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 5 Improving Access to Medication Assisted Treatment for Persons with Opioid Use Disorder According to Substance Abuse and Mental Health Services Administration (SAMHSA), (2022), medication-assisted treatment (MAT) is the holistic approach to treating substance use disorders and addiction. SAMHSA defines substance use disorder as the physical or physiological reliance on substances found in prescription and/or illicit drugs. Addiction is the effect on a person’s brain and behavior that leads to the inability to control the use of legal or illegal drugs or medicine (SAMHSA, 2022). A holistic approach to managing persons with opioid use disorder considers the intellectual, spiritual, physical, and emotional areas in conjunction with the disease process. MAT has been found to be most effective when combining medications with counseling and therapy that is tailored to the person. This includes avoiding a ‘one size fits all’ approach and assessing each person’s personal background, substance abuse history and treatment needs (Individualized Treatment Plans for Substance Abuse | MATClinics, n.d.). Keeping with a flexible treatment plan allows adjustment as the person moves through different phases and needs of their treatment. Research has shown that the intent behind MAT therapy is to treat substance use disorders, decrease withdrawal symptoms, sustain recovery, and reduce and prevent opioid overdose deaths. This paper addresses the barriers that limit access to MAT therapy amongst the worsening opioid epidemic. Throughout this paper, the term clinicians include physicians, nurse practitioners, and physician assistants who provide care for a patient with no planned endpoint. MAT continues to be underutilized due to lack of MAT certified clinicians and increased stigma of people with opioid use disorders (Robinson & Adinoff, 2018). Background The U.S. Opioid Epidemic began in the 1990s and has worsened with an increased number of opioid related deaths. Davis et al., (2020) reported that approximately 650,000 opioid IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 6 prescriptions are dispensed in the United States daily. In 2010, 48 million ambulatory surgical procedures were reported, 1.6 million of those patients started on long-term opioid therapy, and 160,000 of them developed an opioid use disorder (OUD). Deaths due to opioids have increased sixfold since 1999 (Garett & Young, 2022), with nearly 92,000 people dying from a druginvolved overdose from illicit drugs and prescription opioids in 2020 (Abuse, 2022). The first phase of prescription opioid misuse happened when oxycodone was first introduced in 1996. During this time, the role of pharmaceutical companies spreading misinformation about how addictive opioids were led to a rise in opioid prescriptions. Clinicians were overprescribing, then evidence of the harmful and addictive qualities of oxycodone was unveiled, leading to a sudden but temporary decrease in prescriptions (Garett & Young, 2022). Opioid overprescribing from clinicians has been cited multiple times as the major contributor to the opioid epidemic (Singh & Pushkin, 2019). To fight the widespread opioid crisis, MAT is considered a first-line treatment for patients with OUD, improving mortality rates by 60%, yet only 30% of patients with OUD receive treatment (Suen et al., 2022). To improve access to medications for opioid use disorder (MOUD), the Drug Addiction Treatment Act 2000 came out allowing physicians to prescribe buprenorphine in an office-based setting. The requirement was to have a special waiver allowing treatment to a maximum of 30 patients within the first year and then a maximum of 100 patients in subsequent years. To increase the maximum number of patients to be treated, the Comprehensive Addiction and Recovery Act (CARA) of 2016, allowed providers to increase the number of patients they can treat to 275. The waiver was expanded to include nurse practitioners (NPs) and physician assistants (PAs) without the oversight of physicians (Mackey et al., 2019). Since 2000 regulations have been established to increase access to treatment for OUD along with IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 7 current research and recommendation from SAMSHA and the CDC that supports MAT therapy. Mackey et al., (2019) indicates that even with these recommendations, 39% of people diagnosed with OUD participated in MAT, reflecting a small 3% increase between 2016 and 2018. This information spotlights how significantly underutilized MAT therapy is compared to the nearly 30% increase of drug overdose deaths from 2019 to 2020 (CDC, 2022). Three primary FDA approved medications are used in MAT; naltrexone, methadone, and buprenorphine and each drug are classified by the degree it blocks the mu-opioid receptor. A full opioid agonist drug completely binds to the mu-opioid receptor resulting in a full opioid effect. A partial agonist drug also binds to the mu-opioid receptor but has a partial response with a less active response. An antagonist drug does not bind to the mu-opioid receptor but rather blocks the receptor site therefore blocking any activation of that receptor. Figure 1 Opioid receptor activity. Heroin (red line) activates opioid receptors fully and quickly. Methadone (blue) is also a full agonist, but activation is slower and longer lasting. Buprenorphine (green) activates the receptors partially, with a similar time course to methadone. Naltrexone (purple) is an opioid receptor antagonist and therefore prevents receptor activation. Sources: Cruciani & Knotkova, 2013; Goodman et al., 2006 IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 8 Figure 2 Treatment for Substance Use Disorder, Opioid Use Disorder through medication assisted treatment (methadone, Suboxone, Vivitrol) and counseling. (2022, August 30). Retrieved November 16, 2022 from https://communitymedicalservices.org/treatment-programs/ Buprenorphine and methadone bind to the mu-opioid receptors in the brain. Because of this, the Drug Enforcement Administration (DEA) classifies them as prescription opioids, but when activated will result in much milder effects compared to other opioids (2022). Mild effects include euphoria, respiratory depression, nausea, and analgesia (inability to feel pain). Both drugs can cause physical symptoms of tolerance and dependence such as reduced responsiveness to the drug, leading to increased doses (Morgan & Christie, 2011). Opioid effects can be determined by the following factors: the strength the drug binds to receptors (receptor affinity), the rate or speed that the drug leaves the receptor site (dissociation) and the maximal possible effect that can be produced by the drug (Pathan & Williams, 2012). All three drugs are divided into 3 types based on strength and effect. A full agonist drug, such as Methadone, binds tightly to the opioid receptors and produces a maximal effect. A partial agonist IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 9 drug, such as buprenorphine, binds to opioid receptors but to a much lesser degree than full agonists. Both produce a similar response to the intended drug or chemical. Naltrexone is not considered an opioid because it blocks the mu-opioid receptor rather than activates, stopping the receptor from producing any kind of effect (Pathan & Williams, 2012). Specific Details of MOUDs Diving deeper into each drug, methadone is the most familiar and oldest of the three drugs. Methadone is classified as Schedule II, categorizing it as a drug with high potential for abuse possibly leading to dependence (Drug Scheduling, n.d.). Dr. Ruth Potes from The Curbsiders Addiction Medicine Podcast, reports methadone was discovered during WWII in Germany for pain management before being discovered as an effective use for OUD in New York City during the 1960s. Since methadone is a full agonist drug it binds completely to the mu-opioid receptor and produces a full opioid effect. Even though it occupies these receptors it does it much slower than other opioids. Because of this it does not produce the euphoria that a person with opioid use disorder experienced with illicit drugs. Side effects of methadone being a full agonist include constipation, abnormal heart rhythms, problems with liver function and decreased respiratory rate. These side effects have the potential to occur later during treatment and persist longer after the drug has reached its maximum effect (Coffa & Snyder, 2019). Current regulatory processes limit methadone to be prescribed for patients with OUD, who are being treated in a hospital or a federally certified clinic with increased physician oversight. Without being federally certified with physician oversight, primary care clinics cannot prescribe methadone. People with OUD referred to methadone clinics require a strict protocol of appearing every day to receive their daily dose of methadone. Patients are then closely observed IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 10 by clinicians and undergo frequent urinalysis testing, especially when it is the first-time initiating methadone (Velander, 2018). Most clinics and treatment programs for methadone are in lower socioeconomic areas with high rates of unemployment, homelessness, food insecurity, and lack of transportation (Hooker et al., 2022). Clinics in these areas typically require security due to high theft rates. Clinics being located sparsely result in longer transportation time and cost for the patients (Khazaee-Pool et al., 2018). One of the most appealing traits of methadone, however, is the increased bioavailability and half-life of medication. Bioavailability is the proportion of a medication or substance that enters circulation to produce an effect after ingestion. Half-life refers to the amount of time it takes for medication or substance to be metabolized or passed through the body. When methadone is ingested, the body sees 85% of it and with the half-life of methadone being 8-59 hours, we see less intense withdrawal symptoms and less euphoric effects as other opioids (Patel et al., 2021 & Potee et al., 2022). Although a great option, hesitancy surrounds the time it takes to initiate methadone and find an appropriate maintenance dose. Maintenance doses are usually in the higher ranges, around 80-100 mg/daily, initiating methadone in an outpatient setting; providers have reported feeling uncomfortable dispensing the high maintenance dose needed for their patients (Coffa & Snyder, 2019). In a study by Patel et al., (2021) high doses of methadone were found to be effective for patients who are addicted to heroin, with an 80% success rate. Success rate was determined by patients reaching the following goals of social reintegration, increased job productivity and job re-employment. Methadone has been found effective for use in pregnancy, with improved maternal and neonatal outcomes. Individuals are also able to start treatment as early as 18 years old (Toce et al., 2018). Methadone’s biggest barrier continues to be the IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 11 requirement of daily visits to the clinic, especially for those trying to balance work, life, childcare and other needs, but it still proves to be an effective and successful option for many populations. Buprenorphine was developed in the 1970’s as a safer opioid alternative for the treatment of pain in comparison to oxycodone and morphine. Buprenorphine comes in two different forms. The first is buprenorphine as a partial opioid agonist, meaning it activates the mu-opioid receptors but to a much lesser degree than a full agonist such as methadone. The second form, buprenorphine/naloxone adds naloxone as a safety guard against fatal overdose (Pharmacological Treatment | Medication Assisted Recovery, n.d.). Both forms became a better alternative to methadone due to its fewer regulations and “inherent abuse deterrence” properties (Velander, 2018). Buprenorphine is a schedule III drug classifying it as a drug with moderate to low potential for physical and psychological dependence (Drug Scheduling, n.d.). As a long-acting, high-affinity partial agonist, it binds at the mu-opioid receptor and will displace or block any other opioids from binding to that receptor site if taken with other opioids. These properties also allow buprenorphine to block or replace the binding of any other opioid to the mu-opioid receptors as well. Buprenorphine can cause mild euphoria, mild respiratory depression, slow gut motility, lower blood pressure and mild decreased alertness but is significantly weaker than full agonist drugs such as methadone (Griffin, 2017; Kumar et al., 2022). In addition, it produces analgesic effects similar to full opioids but these effects plateau regardless of dosage amount of buprenorphine or the presence of other opioids also known as a ceiling effect. Buprenorphine was then petitioned for an exception to the Narcotic Addict Treatment Act 1974, asking for permission to use buprenorphine for the treatment of opioid use disorder IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 12 (Velander, 2018). As of this date, buprenorphine is only available from clinics that were part of an opioid treatment program and federally regulated and certified to dispense FDA-approved MAT medications (SAMHSA, 2022). Clinicians outside of opioid treatment programs are unable to prescribe buprenorphine, limiting the availability of the medication to community residents with OUD. In the year 2000 the Drug Addiction Treatment Act was enacted, authorizing qualified physicians to obtain a separate waiver for the treatment of opioid dependence with buprenorphine in clinical settings resulting in broader access to MAT (SAMHSA, 2022). When taken as prescribed, buprenorphine has shown to decrease the use of illicit-opioid drugs and reduce the risk of fatal overdose, adverse events and relapse outcomes when compared to detoxification alone (Fishbain, 2021; Y.-I. Hser et al., 2016). Buprenorphine also helps provide moderate pain relief without the risk of opioid dependence or fatal overdose and helps diminish symptoms of opioid withdrawals and cravings (SAMHSA, 2022; Andraka-Christou & Capone, 2018). Initiating buprenorphine can be tricky and delicate because waiting until withdrawal symptoms appear is crucial to initiating MAT, as too soon after taking buprenorphine can precipitate withdrawal symptoms (Srivastava et al., 2020). Although withdrawal is not fatal, it can be extremely uncomfortable and difficult for patients who experience it and can last 4-20 days depending on the type of opioid used. Symptoms of withdrawal are assessed using a short opioid withdrawal scale to determine buprenorphine treatment (“Clinical Guidelines for Withdrawal Management and Treatment of Drug Dependence in Closed Settings,” 2009). Although this subtle nuance can cause fear and distress for the patient as well as the provider, with its safer side effect profile than methadone, buprenorphine has proven to be a safe effective substitute therapy for addiction (Kumar et al., 2022). IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 13 Naltrexone, as an oral tablet, was approved for use in alcohol and opioid use disorders in 1984 and 1994 respectively. The oral tablet revealed cases of non-compliance and poor adherence since the patient had to remember to take it daily. To address these issues, the FDA approved the extended-release naltrexone (XR-NLT) injection in 2006 (Sudakin, 2016). Currently the oral tablet naltrexone is reserved only for alcohol addiction and the XR-NLT injectable is only approved for OUD (Sudakin, 2016). XR-NLT is prescribed, dispensed, and administered in primary care settings monthly via an intramuscular gluteal injection (AndrakaChristou & Capone, 2018). Naltrexone attaches to the mu-opioid receptors and completely blocks the effects of opioids. Since it is not an opioid, there are no euphoric and sedative effects commonly found with use of opioids. However, naltrexone does require the patient to completely withdraw from any recreational opioid use causing the patient to fear the severe withdrawal episodes they must endure before initiating this treatment (Naltrexone, 2022). Buprenorphine and methadone do not require the patient to go through complete withdrawal before starting. Two situations arise with the use of naltrexone. Several hurdles present for physicians in terms of initiating the use of XRNLT for OUD. Some major obstacles revolve around the prescription requirements, such as limited access to medically supervised opioid detoxification. There is also a lack of education causing physicians and patients to have disinterest or fear on naltrexone (Andraka-Christou & Capone, 2018). Physicians have noted challenges in prescribing XR-NLT for the treatment of OUD in primary care settings. Although special training is not required to prescribe, dispense, and administer naltrexone, it requires prior authorizations through insurance for use. Insurance has proven to be difficult in regard to naltrexone due to its limited coverage. The cost of the medication is exorbitant and insurance companies typically do not cover the price or the required IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 14 medically supervised detoxification. Both these factors reflect how insurance coverage impacts healthcare access (Alanis-Hirsch et al., 2016). These challenges do not diminish the most prominent positive factor of XR-NLT – as of January 2020, naltrexone was removed from the list of controlled substances and has low risk of diversion (2020 - Removal of 6[Beta]-Naltrexol From Control, n.d.). The U.S. Department of Health and Human Services defines diversion as “the illegal distribution or abuse of prescription drugs for their use for purposes not intended by the prescriber” (2022). Another plus is that providers do not have a limit to how many patients they can treat with this drug, compared to methadone and buprenorphine (Andraka-Christou & Capone, 2018). One of the most appealing benefits of naltrexone is when a drug is discontinued there will be no withdrawal as it does not possess an addictive property. Conversely individuals are required to completely abstain from any opioid use for 7-10 days as well as go through complete withdrawal before induction of naltrexone (Suen et al., 2022). Because of this unique requirement many patients relapse before beginning naltrexone but patients who are successful with the withdrawal period and started on naltrexone describe it as “not a drug” and report they did not feel they were “trading in one thing for another” (Gauthier et al., 2021). Naltrexone’s ability to be prescribed, dispensed, and administered in primary care settings along with not requiring affiliation with substance abuse treatment programs contribute to patients feeling less stigmatized seeking treatment (Andraka-Christou & Capone, 2018). The more a person takes opioids, the more they become dependent on this substance, and if they abruptly stop using, they will experience withdrawal symptoms (Sturgeon et al., 2020). Opioid withdrawal is a clinical syndrome where patients experience significant discomfort, compulsive drug-seeking behavior, and intercept involvement in inappropriate treatment for IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 15 patients with OUD and chronic non-cancer pain. Although not fatal, symptoms include hypertension, tachycardia, dilated pupils, lacrimation, rhinorrhea, yawning, insomnia, nausea, vomiting, and diarrhea (Srivastava et al., 2020). A common thread through research of MAT is the avoidance of going through withdrawal. Management of withdrawal symptoms is a crucial step in successful transition and avoiding relapse in MAT (Srivastava et al., 2020). Although approved for the treatment of OUD, the dosing of MOUDs has risks. Solutions to these risks such as standardizing care to manage opioid withdrawal, can help increase access to treatment and decrease hesitancy in patients and providers, thus increasing demand and utilization of MOUDs. Providers admitted difficulty initiating conversations with patients on MAT therapy about tapering. Some providers experience hesitancy to tapering due to limited institutional support. Physicians are more comfortable writing for opioids but not writing to taper down due to the high risk of termination of care (Davis et al., 2020). Tapering is not suitable for all patients and providers feel inadequately prepared to initiate tapers effectively (Sturgeon et al., 2020). Due to treatment being so individualized and lack of high-quality studies on tapering. Tapering practice is based on experience rather than evidence or protocol (Davis et al., 2020). Mackey et al., 2019 identified a higher rate of concern among physicians about attracting “drug users” to their practice if offering MAT therapy. Other providers view the initiation of MAT therapy as a negative effect to their provider-patient rapport and contributes to clinician burden and burnout with their peers (Sturgeon et al., 2020). Burnout and clinician burden relates to lack of certified clinicians. If only one certified is present, that clinician unintentionally is taking all the patients with opioid use disorder. IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 16 Review of Literature Stigmatization Against Individuals with Opioid Use Disorder When it comes to treatment, the intent behind medications to treat OUD is to decrease withdrawal symptoms, reduce cravings, and decrease the amount of opioid use that can lead to a fatal overdose. One of the major reported barriers for patients seeking treatment is the stigmatization surrounding opioid use. In The Impact of Stigma on People with Opioid Use Disorder, Opioid Treatment and Policy, divides stigma into three types of interaction: structural, social, and internalized (Cheetham et al., 2022). Structural Stigmatization The first type of stigma described in Cheetham et al. (2022) is institutional stigma, also known as structural or macro-level stigmatization. Structural stigma addresses the rules, policies, and practices that decrease the available resources for specific populations. Unfortunately, healthcare systems have been a significant contributor to institutional stigma. From the growing need for providers in family medicine and in specialties, we also see a lack of funding and support from the government. Extensive institutional barriers surrounding the regulations and certification for prescribing buprenorphine will be discussed in the following section. SAMHSA (2021) allows two pathways to become MAT certified. Clinicians may file an alternative notice of intent (NOI) that allows eligible clinicians to treat up to 30 patients at any one time without required training requirements. This exemption only applies to Schedule III-V drugs and clinicians, under this exemption, cannot qualify for a higher patient limit. Depending on the state law, clinicians may be required to have supervision from an MD. The second pathway was updated in 2020, requiring MDs to obtain eight hours of training, while nurse practitioners and physician assistants are required 24 hours of mandatory training. This allows IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 17 treating up to 100 patients within their first year and then 275 patients in subsequent years. All waivered clinicians are mandated by the DEA, who keep record of all controlled substances dispensed. Contradicting opinions on requirements have been reported with new clinicians feeling overwhelmed and more experienced clinicians finding the required training hours an arbitrary amount. Currently no literature has been found confirming why it is required to have specifically eight hours of didactic training, which may not instill confidence in providers (Bottner et al., 2021). Lai et al., (2022) study demonstrates that only 35.8% of primary care clinicians believe removing the mandatory waiver training is a positive step toward improving access. The remaining 64.2% disagree with the statement, suggesting that a lack of familiarity and education is associated with disagreement over the removal of mandatory training. The current and additional requirements and policies clinicians must fulfill create a disparity in resources for individuals struggling with opioid use disorder. Another hurdle affecting lack of access to MAT is clinicians' hesitancy to become MAT certified because of the unique and subtle nuances of it. From initiation to maintenance dosing and tapering, a lack of education has been found, preventing providers from feeling confident with MAT. Madras et al., (2020) indicates that education is a necessary tool for increasing the use of medications for opioid use disorder. In a cross-sectional study, psychiatrists are more likely to prescribe buprenorphine and have an increased acceptance of the medication after completing the necessary training and receiving continuing education (Madras et al., 2020). While increasing the number of waivered clinicians is essential, it is important to note that institutional support and peer support, or the lack thereof, will either facilitate or hinder the prescribing of buprenorphine. Clinicians have concerns with institutional support in terms of IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 18 staffing resources for MAT therapy. Practices lack the necessary staffing resources, such as oncall providers, administrative support from insurance companies, and patient set-up arrangements (Barry et al., 2009). Auty et al., (2020) suggest that clinicians may be more likely to acquire waivers if their workplace has certified MAT clinicians actively treating patients highlighting the importance of an organization’s institutional support and the influence it has on more clinicians becoming MAT certified. Haffajee et al., (2018) emphasizes that implementing mentors as ‘institutional champions’ demonstrates and encourages the facilitation of buprenorphine prescribing. Institutional support increases the availability of information and tools for this treatment. Although guidance and peer support are paramount to institutional support, continuous collateral support is just as essential and positively influences prescribers' decisions to use MAT therapy. Patients with opioid use disorders typically have mental health comorbidities. This factor alone is a hurdle since most providers are uncomfortable treating this specialized population without resources to refer them to (Barry et al., 2009). Research calls attention to the significance of having decent access to consultation services with an expert provider, as well as access to behavioral health services that include counseling (Huhn & Dunn, 2017). According to studies, clinicians in private practice are more reluctant than their colleagues in group practices to prescribe and initiate MAT therapy. The advantages of group practices are a greater number of waivered clinicians, better collaboration, and administrative support, resulting in a higher rate of MAT therapy initiation. Several clinic characteristics were identified as factors associated with a higher probability of prescribing MOUDs. The clinic characteristics include “the provision of HIV specialty care, the provision of a secure storage IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 19 facility for narcotics, the availability of an addiction specialist over the phone, and continuing medical education credit for the training (Walley et al, 2008). Social Stigmatization The second type of stigma described by Cheetham et al., (2022), is social stigma, also identified as meso-stigma that includes stereotypes resulting in discrimination and prejudice. The National Academies of Sciences, Engineering, and Medicine (2019) summarizes that social stigma from the public is rooted in misconceptions that addiction results from moral failure or a lack of self-discipline that is worthy of blame. There is an apparent willingness to socially exclude people with OUDs resulting in lower support for health-oriented policies and greater support for punitive policies. Primary care providers who believe that OUD treatment is simply substituting one drug for another influence and solidify negative public views (Adams et al., 2021). Kennedy-Hendricks et al., (2016) discovers that primary care providers believe individuals struggling with addiction to be riskier and more precarious, leading some employers to deny employment to candidates who are using MAT therapy. Mass media contributes a large part to public stigmatization. From the discourse on COVID-19, alternative treatment, and vaccine hesitancy, misinformation has flourished online. Misinformation has been shown to negatively influence people’s health literacy and affect public health negatively. A ten-year study completed revealed that 49% of news stories in those ten years mentioned stigmatizing terms such as “addict”, “substance abuse” and “opioid addict” (McGinty et al., 2019). 6,399 news stories about the opioid epidemic were analyzed between the years 2008 and 2018. All news stories were aired or published in news outlets with high circulation and high viewership. The type of stigmatizing language used contributes and reinforces the widespread stigma towards people with opioid use disorders. Werder et al., (2022) IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 20 suggests non-stigmatizing language such as “substance use disorder”, “person with substance use disorder” and “person with opioid use disorder” reduce stigma and bias and improve outcomes among people who use opioids. Whether it be news stories, billboards or articles, language communicates attitudes, ideas, and judgments. From a meso-level, addressing the language choice in visual campaigns and text-based vignettes will significantly reduce negative attitudes and stigmas against people with opioid use disorder (Aronowitz & Meisel, 2022). Internalized Stigma The third type of stigma is internalized stigma, also known as micro-stigma. This is a person’s perception, negative thoughts, and feelings toward the stigmatized group. Racism bias in medical settings is a prominent example of the effects of micro-level stigma. Studies have shown that black/African American patients have much lower odds of being referred for treatment compared to their white counterparts, as they are less likely to finish treatment (Entress, 2021). This is among the many health inequities among racial and ethnic minorities concerning MAT programs and MOUDs. From a micro-level approach, providers moving away from slang and idioms towards appropriate terms and language when referring to patients with OUD is the first step. Broyles et al., (2014) explains that using appropriate language focuses on the worth and dignity of the individual or group, therefore decreasing negative stereotypes and biases. A common theme throughout the literature is MAT therapy is replacing one opioid for another, thus having a negative effect on providers and their view of MAT therapy. According to Dickson-Gomez et al. (2022), providers who have exposure to substance use disorders tend to be more accepting of MAT therapy. Providers and people with OUDs believe MAT therapy is an acute, temporary short-term tool to be used until the individual is tapered off. Many experts IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 21 advise against opioid discontinuation and abstinence for people with moderate to severe OUD, or chronic exposure to opioids due to the higher likelihood of relapse, discontinuation of treatment, increase in pain, and higher mortality rate of those with OUD (Ma et al., 2019; Sturgeon et al., 2020). Despite the robust research data on medications for opioid use disorders and their pharmacotherapy efficacy, providers continue to view complete abstinence or sobriety as an accurate measurement of opioid recovery (Dickson-Gomez et al., 2022). Discussion People with opioid use disorders tend to receive substandard quality of care due to lack of access to MAT therapy and MAT providers. The lack of access has been linked to worsening health conditions, increased overdoses, increased suicides and worsening mental health (Cedarbaum & Banta-Green, 2016; US Department of Health and Human Services, 2020). Many communities are impacted to a higher degree due to marginalized factors such as race, poverty, and immigration status. The following sections are a few of those marginalized communities. Rural Communities National efforts have focused on promoting opioid treatment in primary care to expand MOUD access. Within the rural health care systems, primary care plays a central role, yet clinicians face roadblocks such as limited economies of scale, high dependency on public payers, and low patient volumes. These factors affect clinicians' decisions to work in these areas (Y. Hser & Mooney, 2021). Rural communities have been slow to implement office-based opioid treatment, with 29.8% of rural Americans living in counties without a buprenorphine provider compared to 2.2% of urban Americans (Y. Hser & Mooney, 2021). The number of opioid-related deaths in rural areas has increased rapidly in recent years compared to non-rural areas (Madras et IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 22 al., 2020). Many of these deaths in rural America are attributed in part to barriers such as stigma against MAT therapy, shortage of certified clinicians, and a weak healthcare infrastructure. A noticeable increase is present in the number of physicians with DEA waivers, however access to treatment services remain a problem for many patients in rural areas (Andrilla et al., 2020). Because treatment facilities providing MAT therapy are lacking in these areas, patients must travel farther to receive treatment. Traveling farther compounds barriers such as lack of public transportation in the community causing a patient to rely on friends or family. Factors such as these impair and influence follow-up visits and the adherence to treatment (Barriers to Medication for Opioid Use Disorder (MOUD) in Rural Areas - RHIhub Toolkit, n.d.). The shortage of psychiatrists in rural areas is another compounding factor. Approximately 50% of individuals with psychiatric disorders have met criteria for drug and alcohol abuse or dependence. According to surveys the rate of substance abuse in individuals with schizophrenia is approaching 70% and the rate of substance abuse in individuals with bipolar disorder is approaching 50-70% (George & Krystal, 2000). Individuals in MAT therapy often have significant challenges with mental health problems that are intertwined with opioid abuse. Regarding opioid fatalities, 61.5% of them are individuals diagnosed with depression, anxiety, and chronic pain (Kroenke et al., 2019). The shortage of psychiatrists creates additional difficulty for patients with comorbid substance abuse and psychiatric disorders. In rural areas, buprenorphine-waivered physicians are practicing less in private clinics and more in settings with safety networks and support. Although being a part of a group helps providers feel more confident it decreases treatment growth in an area that would benefit from expansion (Kvamme et al., 2013). A study done by Madras et al., (2020) indicates that more than half of rural counties have an insufficient number of buprenorphine providers. IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 23 Adolescent Community In 2016, 1 in 10 adolescents and young adults (age 15-24 years) were involved in opioidrelated deaths. It has been reported that 1 in 4 adolescents use some type of opioid ranging from misuse of medical prescriptions to illicit opioids such as heroin and fentanyl. “In recent estimates, 891,000 (3.6%) adolescents younger than 18 years old misuse medication prescriptions and 2.5 million (7.3%) young adults (18-25 years old) misuse opioids annually” (C. A. Robinson & Wilson, 2020). Cedarbaum & Banta-Green, (2016) conducted a study showing that younger users of injectable drugs reported being “hooked on'' prescription-type opioids prior to using heroin (62.5% vs 36.9%) as well as reported recent syringe sharing (36.7% vs 19.9%). An additional study revealed that 22% of adolescents avoided treatment for fear of others finding out and 22% avoided treatment for fear of the neighbors having negative opinions about MAT therapy (Wu, et al., 2011). Another complication with this population is that adolescents must rely on adults to initiate treatment resulting in the majority of providers refusing to start an adolescent on buprenorphine until they are arrested or there is a court order (Wu et al., 2011). Individuals with Chronic Pain With the nationwide opioid crisis, there is a lack of evidence to support long-term opioid therapy for treatment of chronic pain. Healthcare and government systems have turned their focus to effective ways to discontinue, taper, and reduce long-term opioid therapy. Pressure on clinicians to wean chronic pain patients off opioids to avoid addiction is increasing. Fear of tapering a chronic pain patient comes with a fear that the chronic pain will return, further debilitating the patient (Fishbain, 2021). Research shows that this may not be the case with the use of MAT therapy. IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 24 In research by Sturgeon et al. (2020) interventions to weaning patients off long-term opioid therapy in outpatient settings while transitioning to buprenorphine proved effective. Researchers successfully tapered 46% of the patient sample to less than 90mg morphine equivalent dosing (MED); but 18% of the sample failed the taper but were effectively transitioned to buprenorphine. Patients on higher doses of opioids failed the initial taper but successfully transitioned to buprenorphine as well. Results showed the individuals who successfully tapered to less than 90mg MED without the transition to buprenorphine, reported an increase in pain intensity. Those who failed the taper but transitioned successfully to buprenorphine showed no significant change in their pain intensity. These findings emphasize “structured outpatient tapering and a transition to buprenorphine for failed tapers can help improve treatment safety and patient outcome for patients'' (Sturgeon et al., 2020). Racial Disparities Access to MAT therapy has been found to be racially and geographically different. Analysis of nationally representative data reveals that white/Caucasian populations are more likely to receive buprenorphine than black/African American populations. Research indicates the reasoning behind this is clinics offering MAT therapy are more prevalent in high-income, lowdiversity areas (Hansen et al., 2016). Along with lack of access in low-income areas, stigma and racial bias among healthcare clinicians lead to differential patient management. This mistreatment within the healthcare system discourages minority patients from seeking treatment (FitzGerald & Hurst, 2017). COVID-19 Pandemic Impact on Opioid Epidemic The use of buprenorphine among people struggling with OUD was already limited prior to COVID-19 due to the limited availability of waived clinicians, disparities in access among IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 25 racial groups, and long waiting times for treatment. These obstacles result in buprenorphine access being based on income, education, county of residence, or race rather than equality (Wang et al., 2021). The COVID-19 pandemic brought to light the spillover effects impacting people struggling with opioid addiction. The pandemic is the perfect storm for those struggling with addiction, bringing on triggers such as depression, anxiety, job insecurity, financial stressors, and isolation. During the pandemic the message of “Stay Home & Stay Safe” swept the country to encourage individuals to limit contact. The fear of contracting COVID-19 resulted in a national decrease of 42% of emergency department visits but no change in visits concerning opioids (Alexander et al., 2020; Hartnett, 2020). A study done at the University of Vermont Medical Center (UVMMC) Emergency Department compared two time periods, pre-pandemic (February 1, 2019 - February 29, 2020) and during the pandemic (March 1, 2020 - May 31, 2020) to showcase the impacts of COVID on their Start Treatment and Recover (STAR) program. The STAR program was initiated to help individuals receive MOUDs and outpatient treatment within 72 hours of their admission to the ED. During the pandemic the monthly average number of visits to the UVMCC ED decreased considerably from 5126.9 to 3306.7 admissions yet there was no significant change to opioid use disorder and overdose visits. A slight increase from 4.3 to 4.6 was found with patients positive for opioid use disorder and a slight increase from 17.7 to 20.3 for overdose admissions. The Chittenden County Police Department records reveal that during the pandemic opioid fatalities increased by 63.4% and 80% of those fatalities attributed to opioids used in isolation (Grunvald et al., 2021). A study done in Kentucky reviewed EMS opioid overdose runs in the 52 days before and after the COVID state of emergency declaration on March 6, 2020. It showed a “17% increase in IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 26 the EMS opioid overdose runs with transportation to an emergency department” and a “50% increase in runs for suspected opioid overdoses with deaths at the scene” (Slavova et al., 2020). Overdose deaths from the opioid epidemic significantly increased in the months preceding the COVID-19 pandemic but research suggests an intense acceleration of opioid overdose deaths during the pandemic. The CDC reports over “81,000 drug overdose deaths occurred in the United States in the 12 months leading up to May 2020” being the highest number of overdose deaths in a year (Coronavirus Disease 2019, 2020). These are a few of the many studies that provide evidence that opioid overdoses increased during the COVID-19 pandemic and continue to rise. Recommendations To improve access to MAT therapy, the following recommendations should be implemented or continued if already utilized. Continuation of Harm Reduction Harm reduction is considered “an umbrella term for interventions aiming to reduce the problematic effects of behaviors” and is “most frequently associated with substance use” (Logan & Marlatt, 2010). Harm reduction supports any steps in the right direction and focuses on their individualized goals and changes. Harm reduction can be broken down into two lenses. The micro lens is what providers do in a clinic setting and the practical strategies and techniques used to reduce the consequences of drug use (ie. Naloxone access and needle exchanges). The macro lens focuses on promoting the health and dignity of people who use drugs and treating them with dignity, respect, and compassion (ie. proper access to food and housing). Harm reduction is expansive and a social movement that spans many dimensions and should be continued (Stahl et al., 2022). IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 27 Critics of harm reduction tend to view this approach as enabling and encouraging negative choices and decisions with people who use opioids (Logan & Marlatt, 2010). Abstinence may be the ultimate or ideal goal, but history has shown that substance abuse prevention programs do not work. A well-known example is DARE (Drug Abuse and Resistance Education), which used uniformed police officers to educate school-aged children about the dangers of substance use as well as ways to resist peer pressure. Research has found DARE to be largely ineffective and ironically increased the intake of substances (Lilienfeld, 2007). Abstinence based programs can be extremely challenging and it is most common for people who use opioids to relapse on these programs. Focusing solely on the addictive behavior and literal drug use blinds the clinician from the co-occurring conditions such as increased exposure to bloodborne pathogens and use of shared or unsanitary supplies. The US Department of Health (2020) reports that injection drug users are at risk for increased incidence of infectious diseases such as HIV, hepatitis C and bacteria that causes heart infections, primarily via sharing syringes and other injection equipment. These factors exacerbate an already difficult situation. Treatment strategies that embrace harm reduction rely heavily on a clinician’s acceptability of the approach as well as the clinician’s willingness to individualize a patients’ ability to change. Logan & Marlatt (2010) suggest that clinicians take on a non-judgmental, empathetic tone to build rapport and trust with people struggling with OUD. Motivational interviewing (MI) is a “client centered, evidence-based method of communication designed to address ambivalence and promote behavioral change” and emphasizes the individual's autonomy (Walker et al., 2020). Clinicians are encouraged to use MI to understand where the patient stands currently in terms of their addiction and help to set reasonable goals for change. As stated in the Hooker et al. (2022) article, reasonable goals might include defining what sobriety means to the IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 28 patient, establishing goals of MAT therapy, improving mental and physical health, increasing emotional well-being, reengaging in meaningful life goals, and reducing internalized stigma or self-shame. As important as change is, being flexible with the patient is just as crucial. Being able to accept the client’s hesitancy or resistance will aid in building that trusting relationship (Logan & Marlatt, 2010). An example of this took place at a family clinic practice in Utah. At the clinic a patient arrived for a checkup with their clinician. The patient had been on 2 months of buprenorphine/naloxone treatment for heroin use. The patient's urine test reflected the use of methamphetamine. The clinician talked openly with the patient about the methamphetamine use and asked questions revolving around triggers to use, new life challenges. Although the patient did use methamphetamine, ultimately their goal was met, and they abstained from using heroin for the last 2 months. The clinician and patient collaborated and readjusted their plan, assessed triggers, and discussed coping skills (Personal observation, 4/2/2022). Abstinence based addiction treatment was built on the foundation that any amount of drug use is unsafe. Criticism about these programs touch on the rigid principles such as those who do not maintain abstinence are dismissed from a program (When It Comes to Addiction, What Is the Best Path to Recovery - Abstinence or Harm Reduction?, n.d.). With the patient above, a traditional abstinence-based clinic or program might have considered this patient’s use of methamphetamine as a failure and a reason to refuse further treatment putting the patient at higher risk of relapse. Medications alone, although essential for the treatment of OUD, is only one component of the treatment. Redefining treatment goals between the clinician and patients other than treatment retention and drug abstinence will aid in improving the patient as a whole person (Kroenke et al., 2019). IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 29 Curriculum Integration Innovative medical schools and states, like Massachusetts and Michigan, are taking steps to incorporate MAT therapy into the curriculum. A study done at the Wayne University School of Medicine in Detroit, requires medical students to complete the 8-hour MAT waiver training, at no cost to the student. A pre-survey and post survey was completed to assess the impact on the students’ knowledge about opioid use disorders. Of the 369 students that completed the MAT waiver training students found themselves more confident when it came to self-assessments of their knowledge, skills and career plans regarding MAT therapy as well as felt they were more familiar with buprenorphine/naloxone after the training (Lien et al., 2021). Table 1 Informative tool to describe different forms of opioid use medications from the Recovery Research Institute (2021). Retrieved November 18, 2022 from https://www.recoveryanswers.org/research-post/extended-releasemedications-opioid-use-disorder-increase-uptake-decrease-stigma/ Change in the level of policy and systems is required to ensure that people with OUD are treated with dignity and respect (Cheetham et al., 2022). One proposed idea is to encourage an IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 30 increase in training and education for MAT therapy by integrating the training into the healthcare curriculum. With buprenorphine prescriber training incorporated as part of the current mandated graduate school curriculum, similar to how medications with complicated dosing like warfarin are, students will have exposure early in their continuing education. Doing so, creates opportunities to find mentorships through services like Providers Clinical Support System and generate a more educated and knowledgeable body of clinicians (Haffajee et al., 2020). Given the subtleties of MAT therapy the hope is the increase in education and exposure will also increase the clinician's confidence when providing MAT therapy. Continue and Expand Telehealth Telehealth can have a significant impact on lowering healthcare costs, it has been estimated that by reducing 1% of emergency department visits by utilizing telehealth, $101,920,000 annually may be saved (Kichloo et al., 2020). Technology is advancing exponentially yet physician shortages increase, our population ages, and the pandemic puts an even greater burden on our healthcare system. Teleconferencing has become an increasingly popular medical tool and through this real-time communication, people with opioid use disorder have greater access to treatment (Lin et al., 2019). Prior to the COVID-19 pandemic, one of the requirements for prescribing buprenorphine fell under the Ryan Haight Act 2008 requiring an in-person screening for buprenorphine. While well intentioned, this in-person policy created a barrier to people with OUD receiving treatment in a timely manner (Langabeer et al., 2021). In the wake of the COVID-19 pandemic the Ryan Haight Act 2008 was temporarily lifted, therefore not requiring in-person screening for people with OUD. Wang et al (2021) states that this new approach for extending treatment speeds up the IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 31 treatment process and decreases wait times, deterring people with OUD from using illicit drugs as a coping mechanism. Establishing a collaborative relationship between primary care and a telehealth service provider with a well-developed technology platform will help to facilitate delivery of comprehensive MAT therapy (Y. Hser & Mooney, 2021). It is anticipated that telehealth will offer several advantages going forward, including convenience and increased access to care from a distance, especially for patients in rural areas (Kichloo et al., 2020). Once "normalcy" returns, it is uncertain whether telehealth will remain accessible. State and federal policymakers must cooperate to ensure that regulatory changes regarding telehealth remain permanent (Wang et al., 2021). Summary MAT therapy and harm reduction techniques have been found to decrease opioid overdose deaths. In Baltimore there was shown to be a significant decrease in opioid related deaths after buprenorphine became available. Between 2007 and 2009 there was a 37% decrease in opioid related deaths (Abuse, 2016). Naloxone, when given, reverses the effects of opioids therefore preventing overdose. It is considered a positive harm reduction strategy (Abuse, 2017). In 2017, after the Naloxone Access Law was enacted, a large-scale national study reflected an ongoing decrease in deaths. Recent numbers from the National Institute of Drug Abuse (2022) reflect an increase in opioid related deaths but this is not a reflection of failure of MAT therapy. It is most likely caused by the pandemic and the most recent introduction of illicit fentanyl. The United States Drug Enforcement Administration reports overdose deaths involving Fentanyl have risen 55.8% and continue to rise. An increase in access and education concerning MAT therapy is needed IMPROVING ACCESS FOR PERSONS WITH OPIOID USE DISORDER 32 more than ever now. To increase the number of MAT providers in the community, creation of holistic education and training are needed. 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Addictive Behaviors, 36(12), 1233–1239. https://doi.org/10.1016/j.addbeh.2011.07.033 APPROVAL of a thesis/project submitted by Author(s): Louisa Tali, Chau Quach, Alisia Motuapuaka, Ellen Kahn Ellen Kahn Alisia Motuapuaka Chau Quach School Department: MSN Title of Thesis: Improving Access to Medication Assisted Treatment for Persons with Opioid Use Disorder The above named master's thesis/project has been read by each member of the supervisory committee and has been found to be satisfactory regarding content, English usage, format, citations, bibliographic style, and consistency, and is ready to be deposited and displayed in the Westminster College—Institutional Repository. Chairperson, Supervisory Committee: Susanne Jones Approved On 12/13/2022 4:36:29 PM Dean, School: Sheryl Steadman Ph.D Approved On 12/14/2022 1:28:49 PM STATEMENT OF PERMISSION TO DEPOSIT & DISPLAY THESIS IN THE INSTITUTIONAL REPOSITORY Name of Author(s): Louisa Tali, Chau Quach, Alisia Motuapuaka, Ellen Kahn Ellen Kahn Alisia Motuapuaka Chau Quach School Department: MSN Title of Thesis: Improving Access to Medication Assisted Treatment for Persons with Opioid Use Disorder With permission from the author(s), the staff of the Giovale Library of Westminster College has the right to deposit and display an electronic copy of the above named thesis in its Institutional Repository for educational purposes only. I hereby give my permission to the staff of the Giovale Library of Westminster College to deposit and display as described the above named thesis. I retain ownership rights to my work, including the right to use it in future works such as articles or a book. Submitted by the Author(s) on 12/13/2022 3:59:19 PM The above duplication and deposit rights may be terminated by the author(s) at any time by notifying the Director of the Giovale Library in writing that permission is withdrawn.