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Geropharmacology

ABSTRACT

Opioid use disorder is a public health epidemic. There is increasing attention being given to opioid abuse and over- dose in the United States. The overall use of illicit substances by older adults is on the rise and in part can be attributed to the aging of Baby Boomers. Further- more, much attention is being given to prescription opioid drug overdose, but it is important to note that heroin-relat- ed deaths have also increased sharply. Heroin use is part of a larger substance abuse problem, with more than nine in 10 individuals who use heroin also using at least one other drug (e.g., cocaine, pre- scription opioid medication). The current article highlights treatment approaches, namely buprenorphine, buprenorphine/ naloxone, and naltrexone; insurance considerations; and resources to aid in understanding and managing this pub- lic health crisis. [Journal of Gerontological Nursing, 42(4), 10-15.]

A.T. is 67-year-old man who has a history of illicit drug abuse (e.g., heroin, cocaine) and has been on methadone maintenance

of 100 mg per day. He presented to the emergency department (ED) with diaphoresis and chest pains. An electrocardiogram (EKG) was or- dered, and it was noted that he had a prolonged QT of approximately 550 to 600 ms and went into ventricular fibrillation. He was rushed to the cardiac intensive care unit (CICU). He is now approximately 3 days out of the CICU and stabilized, and the medical team wants to know what should be done to address his opioid drug abuse history in context of his cardiac conditions. The patient is alert and extremely concerned about experiencing acute opioid drug withdrawal. His con- comitant medications are: warfarin

Managing Opioid Abuse in Older Adults Clinical Considerations and Challenges David Loreck, MD; Nicole J. Brandt, PharmD, MBA, CGP, BCPP, FASCP; and Bethany DiPaula, PharmD, BCPP

ABOUT THE AUTHORS Dr. Loreck is Director, Baltimore VA Medical Center/Extended Care/

Neuropsychiatry Consult Service, and Assistant Professor, Department of Psychiatry, University of Maryland Medical School; Dr. Brandt is Professor, Geriatric Pharma- cotherapy, Pharmacy Practice and Science, and Dr. DiPaula is Associate Professor, University of Maryland School of Pharmacy, Baltimore, Maryland. Dr. Brandt is also Director, Clinical and Educational Programs of Peter Lamy Center for Drug Therapy and Aging, Baltimore, and Dr. DiPaula is also Director of Pharmacy, Springfield Hos- pital Center, Sykesville, Maryland.

The authors have disclosed no potential conflicts of interest, financial or otherwise. Address correspondence to Nicole J. Brandt, PharmD, MBA, CGP, BCPP, FASCP,

Professor, Geriatric Pharmacotherapy, Pharmacy Practice and Science, University of Maryland School of Pharmacy, and Director, Clinical and Educational Programs of Peter Lamy Center for Drug Therapy and Aging, 20 North Pine Street N529, Baltimore, MD 21201; e-mail: [email protected].

doi:10.3928/00989134-20160314-04

5 mg daily for history of deep vein thrombosis, clonidine 0.1 mg every 12 hours, lisinopril 30 mg daily, tramadol 50 mg every 6 hours, and diphenhydramine 50 mg as needed for sleep. The medical team did not want to prescribe methadone but was concerned about the timing of initiation and effectiveness of the alternative approaches, namely buprenorphine/naloxone.

BACKGROUND Opioid use disorder is a public

health epidemic. There is increas- ing attention being given to opioid drug abuse and overdose in the United States (U.S. Department of Health and Human Services, 2015). The overall use of illicit substances by older adults is on the rise and in part can be attributed to the aging of Baby Boomers (National Institute on Drug Abuse [NIDA], 2015). It is estimated that every day, 44 indi- viduals in the United States die from prescription opioid drug overdose and many more individuals become addicted (NIDA, 2015).

Furthermore, much attention is being given to prescription opioid drug overdose, but it is important to note that heroin-related deaths have also increased sharply since 2010, with a 39% increase between 2012 and 2013 (Centers for Disease Control and Prevention [CDC], 2015). Of note, heroin use is part of a larger substance abuse problem, with more than nine in 10 indi- viduals who use heroin also using at least one other drug (e.g., cocaine, prescription opioid drugs) (CDC, 2015). These statistics are staggering and cases such as A.T.’s are on the

rise. The current article highlights treatment approaches, insurance considerations, and resources to aid in understanding and managing this public health crisis. The article also builds on a prior article published in the December 2015 issue of the Journal of Gerontological Nursing, which discussed a case addressing heroin addiction (Malliarakis, 2015).

TREATMENT APPROACHES Caring for older adults is increas-

ingly more challenging due to the fact that these individuals may have multiple comorbidities and be tak- ing numerous medications, as noted in A.T.’s case. These comorbidities and medications complicate the situ- ation and have implications on how to monitor, as well as manage, opi- oid drug addiction, especially when considering the limited treatment approaches currently available. One strategy for preventing and manag- ing opioid use disorder is to im- prove health care providers’ knowl- edge on appropriate prescribing of opioid medications for chronic pain management. The CDC Guideline for Prescribing Opioids for Chronic Pain is under development to assist primary care providers in delivering safer, more effective chronic pain management for patients with pain outside of active cancer treatment, palliative care, and end-of-life care. The draft of this document can be found on the CDC website (access http://www.cdc.gov/drugoverdose/ prescribing/guideline.html). Top- ics include: (a) when to initiate or continue opioid drugs for chronic pain; (b) opioid drug selection, dosage, duration, follow-up, and

discontinuation; and (c) assessing risk and addressing harms of opioid drug use, including the use of opioid medications in patients 65 and older. Educational initiatives such as this are one of many steps that can be taken in managing opioid drug ad- diction.

Access to Medication-Assisted Treatment

Methadone. Mechanism of ac- tion. Methadone is a µ-receptor agonist and a weak N-methyl- D-aspartate receptor antagonist. It is a mixture of (R)-methadone and (S)-methadone, with the (R)-methadone eight to 50 times more potent than (S)-methadone and responsible for most of its ac- tions. The challenging aspects of prescribing methadone are the com- plex and variable pharmacokinetics noted by variability in absorption, distribution, metabolism, and elimination as well as the significant legal restrictions. For instance, renal impairment as well as the existence of drugs that affect the P450-3A4 system can impact the levels of methadone (Chhabra & Bull, 2008).

Safety concerns. Methadone maintenance treatment (MMT) programs have existed for approximately 50 years and have been shown to increase the life expectancy of heroin users (Brugal et al., 2005). Some of the most significant side effects associated with methadone include respira- tory depression and cardiac rhythm disorders related to QT interval prolongation. An association has been found between methadone doses and incidence of prolonged

11JOURNAL OF GERONTOLOGICAL NURSING • VOL. 42, NO. 4, 2016

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QTc. Therefore, before initiating methadone, patients should receive an EKG, especially those with risk factors such as structural heart disease, treatment with CYP P450 inhibitors, treatment with other QT-prolonging drugs, and HIV infection. In patients with a long QTc interval and other risk factors, a reduction of dose with close clini-

cal monitoring or changing from methadone to other long half-life opiate drugs that do not affect QT would be appropriate (Fonseca et al., 2009).

Buprenorphine and Buprenorphine/Naloxone. Mecha- nism of action. A semisynthetic de- rivative of thebaine, buprenorphine hydrochloride is a partial µ-opioid receptor agonist and �-receptor antagonist with a long duration of action. There are several oral dosage forms of buprenorphine commercially available, includ-

ing buprenorphine (Subutex®) and buprenorphine/naloxone sublin- gual tablets (Suboxone®). The phar- macokinetic and pharmacodynamic profiles of buprenorphine are not well characterized (Boothby & Doering, 2007).

Safety concerns. The Drug Ad- diction Treatment Act of 2000 (DATA 2000) made it possible for physicians to treat opioid drug dependence from office-based practices with Schedule III, IV, or V opioid medications that have received U.S. Food and Drug Administration approval for that indication. Buprenorphine and buprenorphine/naloxone are the first drugs to meet the DATA 2000 criteria. To prescribe and dispense buprenorphine for the treatment of opioid drug depen- dence, health care providers must meet certain qualifications and be granted a special waiver. Bu- prenorphine is generally safer in overdose and produces less signifi-

cant withdrawal symptoms upon discontinuation than methadone. However, buprenorphine must be initiated with care. Because it is only a partial opioid agonist, it can induce withdrawal if administered too soon to opioid drug–dependent patients. To prevent producing more severe symptoms, buprenor- phine should not be started until the patient has discontinued opioid drug use long enough to experience moderate withdrawal symptoms. Buprenorphine may be safer for some patients with heart disease,

as it has not been shown to signifi- cantly prolong QTc over extended periods of time and, therefore, may not require routine EKG screen- ing upon initiation (Fareed et al., 2013). For additional guidance in the use of buprenorphine in the treatment of addiction, refer to http://buprenorphine.samhsa.gov/ Bup_Guidelines.pdf.

Naltrexone. Mechanism of action. Naltrexone is an opioid an- tagonist that is thought to decrease the euphoria associated with opioid drug use. Although naltrexone has little potential for abuse and diver- sion, its utility as monotherapy for opioid dependence is less than optimal. The limited efficacy of oral naltrexone monotherapy may be due to low rates of patient compliance and medication adher- ence. Extended-release injectable naltrexone has been demonstrated to be more efficacious than placebo in managing opioid use disorder (Krupitsky et al., 2011). Patients with opioid use disorder must be opioid-free for at least 7 days before extended-release inject- able naltrexone can be initiated to prevent the risk of precipitated withdrawal.

Safety concerns. Extended- release injectable naltrexone has less legal restrictions than bu- prenorphine or methadone. How- ever, patients generally present monthly for administration. Poten- tial adverse effects include injection site irritation, opioid withdrawal in opioid-dependent individuals, nausea, vomiting, diarrhea, head- ache, dizziness, arthralgia, anxiety, and hepatitis.

Based on Cochrane meta- analysis data, methadone produces greater treatment retention than buprenorphine in flexible dosing trials (Mattick, Breen, Kimber, & Davoli, 2014). However, metha- done and buprenorphine produced similar effects in suppressing opioid drug use as evidenced by urinalysis (Mattick et al., 2014). Naltrexone

One strategy for preventing and managing opioid

use disorder is to improve health care providers’

knowledge on appropriate prescribing of opioid

medications for chronic pain management.

may be efficacious in managing opioid use disorder and can be con- sidered an alternative to buprenor- phine or methadone for medication- assisted treatment (MAT).

Prescription Insurance Considerations

There has been an increasing amount of attention being given to access and coverage of MAT. In October 2015, President Obama issued a Memorandum to Heads of Federal Departments and Agencies to identify barriers to MAT for opioid use disorders and develop action plans to address these bar- riers. Annually, the Centers for Medicare and Medicaid Services (CMS; 2015) releases a Call Letter that describes mandates as well as initiatives regarding medica- tion use. In the 2016 Call Letter, CMS investigated the concurrent use of buprenorphine and opioid drugs in Part D. An analysis of prescription drug event data from April 1, 2014 through March 31, 2015, identified more than 24,500 Medicare Part D beneficiaries with concurrent buprenorphine buccal formulation and opioid drug use, including more than 20% with 30 or more concurrent opioid drug days (CMS, 2015). Based on these findings, CMS (2015) suggested that there are additional opportu- nities for improvements through drug use management. Additional education and resources will be provided by CMS to inform physi- cians, Medicare Advantage (MA) organizations, and Part D spon- sors about MAT coverage, includ- ing clarifying that MA plans have the same obligation to cover addic- tion treatment as is available under Original Medicare and that Part D plans must ensure access to MAT that are covered under Medicare Part D.

It is important to note that currently only buprenorphine, buprenorphine/naloxone, and

naltrexone are covered under Part D when used for MAT of opioid drug addiction. Under current cov- erage, methadone is not covered by Part D for substance abuse treat- ment because it does not meet the Part D requirement that it “may be dispensed only upon a prescrip- tion” (CMS, 2010, p. 4) because it cannot be dispensed upon a prescription at a pharmacy when used for this purpose. Further- more, Medicare Part D plans often impose varying formulary utiliza- tion management approaches (e.g., prior authorization, quantity lim- its) that may be burdensome and challenging for prescribers, as well as patients, to manage. It is critical that Medicare beneficiaries who are in need of these therapies have appropriate access to these drugs in Part D.

CLINICAL CHALLENGES There are key clinical challenges

when caring for dual diagnosed older adults with addiction and mental health issues. At least 50% of patients with severe mental illness have significant addiction issues (Regier et al., 1990). It is daunting to manage these coexist- ing conditions in younger patients, but with the aging population, it is even more overwhelming due to the progressive medical complex- ity, polypharmacy, and increasing intricacy of drug–drug interac- tions. The aggregate medical and psychiatric complexity of aging patients with chronic mental illness and addiction may be more than one medical or mental health clini- cian can manage.

An alternative dual diagnosis model would be patients with concurrent pain and addiction problems. Opioid drug abuse and chronic pain syndromes coexist in 37% to 61% of patients seek- ing opiate drug abuse treatment (Rosenblum et al., 2003). These are some of the most challenging

patients, as many clinicians find pain management difficult if not impossible if there are active addic- tion problems. Some of the chal- lenges are the ability to differenti- ate whether pain complaints are legitimate or part of the addiction. Similarly, clinicians find effective management of addiction difficult to impossible when patients report uncontrolled pain. Dual-diagnosed patients are best managed in multidisciplinary settings where they can be assessed and managed in an integrated care model.

ACCESSIBILITY AND SHARED TREATMENT DECISIONS

A recent qualitative study identi- fied the need for better clinician– patient communication, improved patient education, and increased collaboration and partnership that empower patients with opioid use disorder to actively engage in treatment-related decision making (Yarborough et al., 2016). Often- times, patients are not aware of treatment alternatives or have the opportunity to choose medications. Discussions that take into account past experiences with opioid ago- nist medications (including non- prescribed use), examine expecta- tions regarding addiction potential and withdrawal, clarify anticipated duration of treatment, and explore the need for monitored support may improve clinician–patient relation- ships, treatment goal concordance between clinicians and patients, and treatment adherence (Yarborough et al., 2016).

CLINICAL IMPLICATIONS AND CONCLUSION

With the increasing number of older adults managing addic- tion as well as the abuse of opioid drugs, more needs to be done by all involved. The Table highlights the various stakeholders and tactics to tackle this public health crisis. It is imperative that more preventive ap-

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proaches are used, such as avoiding the high-dose opioid medications being prescribed over extended peri- ods of time to minimize misuse and diversion. Nursing is on the front lines to identify and implement many of these approaches.

REFERENCES Boothby, L.A., & Doering, P.L. (2007). Bu-

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Brugal, M.T., Domingo-Salvany, A., Puig, R., Barrio, G., García do Olalla, P., & de la Fuente, L. (2005). Evaluating the impact of methadone maintenance pro- grammes on mortality due to overdose and aids in a cohort of heroin users in Spain. Addiction, 100, 981-989.

Centers for Disease Control and Preven- tion. (2015). Today’s heroin epidemic. Retrieved from http://www.cdc.gov/ vitalsigns/heroin

Centers for Medicare and Medicaid Ser- vices. (2010). Medicare prescription drug benefit manual. Chapter 6 – Part D drugs and formulary requirements. Retrieved from https://www.cms. g o v / M e d i c a r e / P r e s c r i p t i o n - D r u g - Coverage/PrescriptionDrugCovContra/ downloads/chapter6.pdf

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capitation rates and Medicare advan- tage and Part D payment policies and final call letter. Retrieved from https:// www.cms.gov/medicare/health-plans/ medicareadvtgspecratestats/downloads/ announcement2016.pdf

Chhabra, S., & Bull, J. (2008). Metha- done. American Journal of Hos- pice & Palliative Care, 25, 146-150. doi:10.1177/1049909107312597

Fareed, A., Patil, D., Scheinberg, K., Black- inton Gale, R., Vayalapalli, S., Casarella, J., & Drexler, K. (2013). Comparison of QTc interval prolongation for patients in methadone versus buprenorphine main- tenance treatment: A 5-year follow-up. Journal of Addictive Diseases, 32, 244- 251. doi:10.1080/10550887.2013.824333

Fonseca, F., Marti-Almor, J., Pastor, A., Cladellas, M., Farré, M., de la Torre, R., & Torrens, M. (2009). Prevalence of long QTc interval in methadone main- tenance patients. Drug and Alcohol De- pendence, 99, 327-332. doi:10.1016/j. drugalcdep.2008.06.018

Krupitsky, E., Nunes, E.V., Ling, W., Illepe- ruma, A., Gastfriend, D.R., & Silverman, B.L. (2011). Injectable extended-release naltrexone for opioid dependence: A double-blind, placebo-controlled, multi- centre randomised trial. Lancet, 377, 1506- 1513. doi:10.1016/S0140-6736(11)60358-9

Malliarakis, K.D. (2015). Managing heroin addiction in an outpatient setting: A case study. Journal of Gerontological Nursing, 41(12), 10-14. doi:10.3928/00989134- 20151111-01

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