Cheever, Laura W MD, ScM*; Kresina, Thomas F PhD†; Cajina, Adan MS*; Lubran, Robert MS, MPA†
From the *HIV/AIDS Bureau, Health Resources and Services Administration, Rockville, MD; and †Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, Rockville, MD.
The authors have no funding or conflicts of interest to disclose.
Correspondence to: Laura W. Cheever, MD, ScM, Deputy Associate Administrator & Chief Medical Officer, HIV/AIDS Bureau, Health Resources and Services Administration, US Department of Health and Human Services, 5600 Fishers Lane, Suite 7-05, Rockville, MD 20857 (e-mail: email@example.com).
IMPROVING HEALTH OUTCOMES OF HIV-INFECTED INJECTION DRUG USERS: MEDICATION-ASSISTED TREATMENT FOR OPIOID DEPENDENCE AND PRESCRIPTION OPIOID ABUSE
Medication-assisted treatment (MAT) is the use of medication such as methadone or buprenorphine in combination with counseling and behavioral therapies to provide a whole-patient approach to the treatment of opioid dependence. MAT is an important component of the comprehensive treatment program addressing both opioid dependence from heroin/prescription opioid abuse and HIV treatment and prevention.
Heroin use and abuse produces a lifestyle that can impede access to medical care and antiretroviral use as well as antiretroviral medication adherence and thereby reduce therapeutic success for individual patients infected with HIV.1 A lack of therapeutic success in the treatment of HIV infection may result in significant morbidity including the development of HIV drug resistance and increased mortality. Heroin use and needle- and syringe-sharing continue to be a significant driver of the US HIV epidemic.2 Among those at risk for HIV and for many HIV-infected patients, the use and abuse of heroin can promote HIV risk-related behaviors, which result in HIV acquisition and transmission to others. For these patients, MAT has been shown to be effective in addressing both the prevention and treatment of HIV among those with heroin use and abuse.3
Another medical challenge for HIV-infected patients with substance use disorders or in recovery with a history of substance use disorders is the medical management of acute or chronic pain. HIV disease is associated with acute and chronic pain syndromes and many patients require and seek prescription opioids to relieve pain. Abuse and dependence of prescription opioids, however, is now a major health problem4 and presents an avenue to recidivism of heroin use with its risk of HIV transmission. For these patients, healthcare providers need to have a keen awareness of the potential danger of prescription drug abuse.5 The use of MAT, especially buprenorphine in an office-based setting, has been shown to be effective in the treatment of prescription drug abuse.4,6-8
Identification and treatment of drug dependence as a disease and provision of appropriate treatment services is an essential part of the clinical care of HIV-infected patients. Evidenced-based treatment of substance use disorders in the form of MAT is important in improving health outcomes of HIV-infected individuals who use and abuse heroin and prescription opioids. Research studies show that when treating substance use disorders, a combination of medication and behavioral therapies is most successful.9 MAT is clinically driven with a focus on individualized patient-centered care and is thereby a potentially important adjunct in HIV primary care.
THE FEDERAL ROLE IN DEVELOPING NEW MODELS OF CARE AND TREATMENT FOR OPIOID-DEPENDENT, HIV-INFECTED PATIENTS
For many years, the Health Services and Resources Administration's (HRSA) HIV/AIDS Bureau (HAB) sought to improve services for HIV-infected substance abusers seeking care in Ryan White-funded programs. It has remained a HAB priority for several reasons. First, despite the prevalence of heroin use, there are limited medically supervised opioid dependence treatment services available from federally regulated Opioid Treatment Programs (OTPs).10 Studies have shown that opioid treatment coverage for injection drug users ranged from 1% to 39% with a median of only 9% in 96 metropolitan areas of the United States.11 From a yearly national survey of OTPs in the United States, 272,351 patients received methadone treatment from OTPs in 48 states and territories on March 31, 2008.12 Second, as previously stated, injection drug use remains a significant driver in the US epidemic, associated with 12.9% of new cases in 2008 overall and 23.6% of cases in women and adolescents.13 Thus, decreasing drug use among HIV-infected patients is a critical part of HIV prevention in the healthcare setting and is recommended in the 2003 federal guidelines, “Incorporating HIV Prevention into the Medical Care of Persons Living With HIV.”14 Third, there are significant HIV treatment health disparities related to active injection drug use, including decreased access to care, decreased retention in care, decreased prescription and use of antiretroviral therapy, decreased adherence to therapy as well as increased mortality. Taken together, these points show that substance abuse treatment for opioid dependence is an important medical care intervention for injection drug users yet remains a significant unmet need in many communities. This unmet need has been shown in Ryan White-sponsored needs assessments.15 The Ryan White program is uniquely situated to address these patient and public health needs through the interdisciplinary care team supported by the program. It is an ideal setting to provide integrated primary care and substance abuse treatment services.
DRUG ADDICTION TREATMENT AND INTEGRATED MEDICAL CARE FOR HIV INFECTION
Relatively few medical treatment options have emerged despite the overwhelming evidence that addiction is a brain disease,16 data that show a high prevalence of opioid abuse and dependence in the United States (estimated to be 35.7% of all illicit drug use in the United States in 200817), and the direct relationship between addiction and HIV transmission. For decades, methadone treatment has been the primary and, until recently, one of the only medical treatments for opiate addiction available in the United States.18 In the brain, opioid use and abuse releases an excess of dopamine; users develop a requirement to have a drug continuously occupy the opioid receptor in the brain to avoid withdrawal symptoms. Methadone is an opioid agonist that can treat opioid abuse and dependence by occupying the opioid receptor in the brain thereby blocking the highs associated with illicit opiate use and reducing the cravings for opioids. Methadone is dispensed in the United States at OTPs that are regulated by both federal (the Substance Abuse and Mental Health Services Administration [SAMHSA]; www.dpt.samhsa.gov) and state governments.
There are approximately 1200 OTPs nationwide with a concentration of programs in the eastern United States. There is a large treatment gap in the United States, where approximately 90% of those needing help for drug or alcohol abuse/dependence do not receive treatment. The National Epidemiologic Survey on Alcohol and Related Conditions reports 6.1% of US residents who met the criteria for substance abuse reported that they had sought treatment or help, whereas 30.7% of those meeting the more strict criteria for substance dependence reported seeking treatment.19 The presence of large numbers of individuals needing treatment but not receiving drug treatment services in the United States has placed increased responsibility on Ryan White HIV/AIDS Program providers. These front-line healthcare providers must address both substance abuse and HIV concerns to retain people in care over time. That said, programs that integrate medical care and drug treatment have shown great promise in promoting adherence to HIV treatment regimens and improving health and substance use-related outcomes.3,20 Conversely, isolating opioid treatment programs from HIV treatment programs increases the opportunities for miscommunication among healthcare providers, resulting in patient-provider confusion and conflict, adverse drug-drug interactions, and decreased therapeutic success for both diseases. Limiting injection drug user access to opioid treatment programs is also a missed opportunity to reduce HIV transmission because research has shown that treating addiction to drugs can reduce the risk for HIV transmission.21 The HIV prevention can result from a direct reduction in drug-related injection behavior or as a result of the provision of ancillary services. For example, in the United States, OTPs are required by federal law to provide HIV prevention counseling to patients receiving methadone treatment.
The path to the groundbreaking approval of buprenorphine was paved by the Drug Addiction Treatment Act of 2000 (DATA 2000),22 which allows physicians, in an office-based setting, who meet certain requirements to treat opiate addiction with Food and Drug Administration-approved Schedule III drugs under the United Nations Convention on Psychotropic Substances. Through DATA 2000, treatment for opioid abuse and dependence can be provided by primary care physicians with 8 hours of specialty training, thereby allowing a less stigmatizing treatment environment and an opportunity for those in need of treatment to have greater access. This landmark legislation has the potential to greatly expand MAT in the United States. Furthermore, by promoting substance abuse treatment in a primary care and outpatient setting, the legislation further destigmatizes substance abuse treatment by taking MAT outside of traditional OTP treatment settings and establishing models of integrated substance abuse treatment in primary care settings.
SAMHSA is charged with implementing DATA 2000, including the required physician certification process. In October 2002, the Food and Drug Administration approved two sublingual formulations of the Schedule III opioid partial agonist medication buprenorphine for the office-based treatment of opioid dependence. With these two approvals, HIV primary care physicians had the tools they needed to begin MAT in their practices as allowed for in DATA 2000.
Since 2003, over 22,000 physicians in the United States have been trained in detoxification and long-term treatment with buprenorphine with approximately 16,000 physicians certified by SAMHSA. Since its approval in 2002, over one million patients have used buprenorphine in the treatment of opioid dependence. Physician and patient surveys conducted for SAMHSA in the initial years after the introduction of buprenorphine treatment for opioid dependence suggest that patients were not being shifted from methadone treatment to receive buprenorphine. The new buprenorphine-treated patients had, in general, little addiction treatment experience, with 31% of patients indicating they were new to substance abuse treatment; 60% new to MAT; and 60% dependent on nonheroin opioids. Only 9% transitioned from methadone treatment.18 The high percent of individuals dependent on nonheroin opioids receiving buprenorphine treatment in primary care reflects the increasing burden of prescription opioid abuse in the United States and the improved access to care for these users afforded by an integrated model in primary care. Thus, introducing office-based treatment of opioid dependence to this population through new treatment models can and should address the full spectrum of opioid dependence.
These models of care and federal initiative are important because buprenorphine has fewer adverse events associated with its use in patients and fewer drug-drug interactions among patients with HIV disease that require treatment with antiretroviral therapy.3,18 Therefore, it may be preferable to use buprenorphine rather than methadone treatment for patients with HIV disease and opioid dependence. Because buprenorphine is available by prescription, HIV treatment providers and primary care providers could offer both medication treatment for opioid dependence and concurrent treatment of HIV disease. HIV clinical providers interested in obtaining a waiver to prescribe buprenorphine are directed to SAMHSA's web site for detailed information (http://buprenorphine.samhsa.gov/howto.html).
THE COLLABORATIVE: HEALTH SERVICES AND RESOURCES ADMINISTRATION AND SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION DEVELOP NEW MODELS OF INTEGRATED CARE
A HRSA-SAMHSA collaboration was established to improve outcomes for opiate-dependent HIV-infected patients through promotion of integrated models of HIV primary care and substance abuse treatment using MAT. HRSA/HAB began work with SAMHSA's Center for Substance Abuse Treatment in early 2002 in anticipation of the licensing of buprenorphine for substance abuse treatment. Both HRSA/HAB and SAMHSA/Center for Substance Abuse Treatment viewed the passage of DATA 2000 and the licensing of buprenorphine as an ideal opportunity to expand critically needed substance abuse treatment services to the Ryan White community of people living with HIV/AIDS. Initial discussions and financial support led to a consultation on “Buprenorphine and Primary HIV Care” convened by the Forum for Collaborative HIV Research in June 2004. The goals of the consultation were to review the current state of knowledge and gaps in knowledge; identify barriers to the integration of buprenorphine into HIV primary care at the patient, clinic, and systems level; review policy and financing issues; and recommend strategies for the integration of buprenorphine into HIV primary care with special emphasis for the Ryan White CARE act-funded programs. The meeting brought together the Ryan White/HIV treatment community with the substance abuse treatment and research communities. The consultation highlighted many critical aspects of the new endeavor, including the need to “bridge the two cultures” of substance abuse treatment and HIV primary care; the need to build capacity for both MAT and the supportive services that are critical to its success; and the reality that shifting MAT into primary care may mean a shift in funding streams to support the services.
With many of the challenges delineated, HAB developed and supported a Special Projects of National Significance (SPNS) project entitled “The Buprenorphine Initiative: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care.” The HRSA/HAB SPNS program funds or cofunds national demonstration projects for the purposes of developing, evaluating, and disseminating new service models for HIV/AIDS. Cumulative outcomes and impact of these projects have been studied and show that the national demonstration projects have developed new models for services and provided these enhanced services to a large number of clients.
This 5-year buprenorphine initiative, which began in September 2004, comprised 10 demonstration sites coordinated by a technical assistance/evaluation center (referred to as Evaluation and Technical Assistance Center) that worked collaboratively to refine planned interventions, address state-of-the-art treatment and policy issues relating to the use of buprenorphine opioid abuse treatment in HIV primary care settings, conduct local and multisite evaluations, and disseminate program findings. Many of the findings of this SPNS initiative are contained in this issue of Journal of Acquired Immune Deficiency Syndrome.
BEYOND THE COLLABORATIVE: NEXT STEPS
Through the HRSA/HAB/SPNS buprenorphine initiative, patient-centered care models sought integration of substance abuse treatment and primary care. Lessons learned from this initiative must be understood and translated more broadly to other primary care settings. Diverse healthcare delivery programs are being developed and piloted that include: integration at the clinic level, with both on-site addiction and HIV treatment specialists; integration at the physician level, with HIV primary care physicians providing buprenorphine treatment to their patients; extensive use of nurses and drug counselors as “buprenorphine coordinators”; and community outreach services.23 The implementation of these diverse practices and their incorporation of MAT can substantially impact the HIV epidemic in the United States, which continues to disproportionately impact racial and ethnic minorities as well as men who have sex with men. These models of care will provide an opportunity for the medical community to provide comprehensive medical care and manage the patients' other chronic diseases-most notably, cardiovascular disease, renal disease, diabetes, and non-AIDS-defining cancers-and enhance their quality of life though preventive lifestyle changes, including smoking cessation, weight loss, exercise programs, and diet modifications.
Many challenges anticipated in the initial “Buprenorphine in Primary HIV Care” consultation have occurred: the challenges of cultural shifts toward substance abuse and substance abuse treatment among Ryan White-funded programs; challenges in developing infrastructure to do counseling and toxicology screening in primary care settings; and tensions associated with cost shifting of substance abuse treatment from traditional payers of substance abuse to Ryan White. Challenges not anticipated included: 1) meeting training needs, not just of MD/DO, but the unanticipated training needs of other staff on the interdisciplinary team; and (2) the interdisciplinary team, while critical to the success of Ryan White program, complicated implementation of buprenorphine, because physicians assistants and nurse practitioners who function as the primary care providers of many of the patients, are prohibited by federal regulation to prescribe buprenorphine.
Looking forward, it is important to understand the lessons learned from this initiative to inform our future work of expanding substance abuse treatment into not just HIV primary care, but primary care more generally. This is critically needed if we are to expand substance abuse treatment and improve health and quality-of-life outcomes among these individuals.
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© 2011 Lippincott Williams & Wilkins, Inc.