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Barriers to Medication Use: Myths, Money, & Management

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April 30, 2007
Barriers to medication use: Myths, money, and
management
By CHRISTOPHER W. SHEA, MA, CRAT, CAC-AD
An introduction from Addiction Professional's Editor This is the third in a series of six articles designed to provide you with
the latest inform ation on the use of medications in alcohol dependence treatm ent. Medications (pharmacotherapy) used as
adjuncts to counseling techniques and biopsychosocial, educational, and spiritual therapies are an increasingly important
part of a comprehensive treatment approach for alcohol dependence.
Expanding knowledge of how medications may interact with and complem ent counseling techniques will help the addiction
counseling community optimally coordinate care of patients with other treatment providers. Thus, the article series
Pharm acotherapy: Integrating New Tools Into Practice will not only provide the latest efficacy and safety data on these
medications, it will also explore how we can b uild b etter relationships among addiction professionals and m edication
prescribers. The series will also examine the current barriers to medication use in treatment while offering potential
solutions.
The series began in the January/Feb ruary 2007 issue with an article by Carlo C. DiClem ente, PhD, who discussed recovery
from alcohol dependence as a process of change and examined how medications might facilitate that process. The series
continued with an article in the March/April 2007 issue by Carlton K. Erickson, PhD, who look ed at what some of the most
important study results from recent years have told us ab out the approved medications for alcohol dependence treatment.
In this third article, Christopher W. Shea, MA, CRAT, CAC-AD, examines how clinical professionals can help overcom e a
variety of biases and other b arriers against greater use of medications in the treatment of alcohol dependence.
In my years of chemical dependence counseling and teaching at the collegiate level, I have encountered many people who
have not only heard myths about chem ical dependency and counseling, but who als o believe these myths without ques tion.
Blind belief of myths, propagated by both clinicians and patients, can create barriers that prevent comprehensive and
effective treatment of alcohol dependence. In som e cas es , the beliefs of clinicians may be better term ed “m is conceptions
or “misperceptions.”
For exam ple, for many years I have taught an “Introduction to Pharm acology” course to chemical dependence counseling
students, many of whom have lamented having to learn about medications and neurobiology when their goal was simply to
counsel addicts and alcoholics. Thes e s tudents understand and believe that addiction is a dis eas e, yet they experience a
dis connect when they fail to consider m edications as a form of treatment. This article will explore some of the com m on
myths or mis conceptions surrounding medication use for the treatm ent of alcohol dependence, and will provide s olutions
bas ed on research and practical experience to overcome these barriers to pharm acologic therapy.
Treatment provider barriers to medication use
Addiction counselors tend to be more familiar with behavioral couns eling approaches to alcohol dependence treatment
than with pharmacologic treatments and, therefore, are less likely to recom mend m edications . 1 For example, about 40 to
54% of counselors in one study reported that they did not know m uch about the efficacy of oral naltrexone. 1 Perhaps this
lack of understanding about medications contributes to a concern among counselors that medications will negate and
replace their role in the recovery proces s . However, medication efficacy has virtually always been studied in com bination
with ps ychosocial therapy and thus is defined by its role as a com ponent part of treatment. The fact that alcohol
dependence is a diseas e with s everal contributing factors manifes ting in both physical and behavioral s ymptom s demands
a comprehensive approach to treatm ent, since exclusion or elevation of one as pect of the dis eas e fails to help distressed
patients fully. 2
Christopher W. Shea
This is an important point for consideration among clinicians who believe the us e of medication is inconsistent with the
philosophy of total abstinence, or who view the us e of medication as a crutch that takes away from the “neces sary” pain a
pers on needs to feel in early recovery. I do not presume to change another's program m atic philos ophical opinions, yet isn't
a “crutch” a tool? The crutch, in and of itself, does not heal or negate need for treatm ent. The use of medication to curb
physical symptoms, such as cravings, serves only to allow the patient the mental capacity to learn from his or her past and
thus develop new, rational thought proces s es , which can be fostered through cognitive-behavioral therapy or other forms of
counseling. Counselors need not fear medication interfering with the im portance of their role in the therapeutic process.
Patient-centered barriers
Many beliefs and “myths” held by patients are, in fact, patients' perceived realities bas ed on their pas t experiences.
Understanding this concept becom es vital to ass is ting our patients in moving beyond their current perceptions and
challenging them to new outlooks. Patient concerns or misconceptions that challenge the us e of medications in treatment
include concerns regarding medications ' efficacy, addictive properties, and neces s ary duration of us e. Thus, one of the
counselor's roles is that of educator to allay patient concerns.
There is ample evidence supporting the efficacy of medications approved for alcohol dependence treatment, and none of
these medications exhibits addictive characteris tics . Patients who believe medications are helping with their sobriety are
more likely to remain adherent to treatment.3 It is therefore important for clinicians to be able to educate patients about how
medications work so that patients can better understand their potential efficacy as well as non-addictive characteris tics.
The question about duration of use cannot be definitively answered. Studies have rarely examined medication use beyond
one year, but it is logical to think that treatment providers and patients can jointly determ ine the point in recovery at which
patients no longer need medications.
It is a common misconception that Alcoholics Anonymous (AA) dis courages medication us e as part of treatment. It has
been shown that patients involved in 12-Step therapy, and som e counselors who espous e this form of therapy, may be less
likely to view medications as acceptable forms of treatment.1,4 It is vital that counselors dis cus s with patients who attend
AA—especially those who may be experiencing peer press ure to avoid m edication us e—that AA advises its mem bers
against discouraging fellow members from taking medication.5
At the other end of the spectrum , som e patients might mis takenly believe that medication can be used as a substitute for
counseling. This is potentially very harmful to recovery becaus e thought proces s es and behaviors that drive dependent
individuals to alcohol will not neces sarily change as a res ult of medication us e. Counselors must em phasize to patients
the importance of the therapeutic process involving counseling.
Another barrier to medication us e is financial. Addiction treatment services as a whole are often not properly reimbursed,6
and medication cost is cited as a reason by both patients and clinicians for inadequate medication us e.7,8 When
recom mending medications as part of treatm ent, couns elors should consider whether medications are attainable and
affordable to patients . They should work with pres cribers to ensure that patients have adequate access to medications . In
some cases, when patients cannot afford medications, com pas s ionate use programs may provide them at dis counted
rates or free of charge. Overcom ing financial barriers and helping s ecure funding for medications and services will require
cooperation among treatment providers, policy makers , and the governm ent.9 Counselors als o m ay play an im portant role
in spearheading such initiatives.
Medication management
Adherence to treatment cons titutes one of the largest barriers to optimal use of medications, but counselors can us e the
therapeutic process to enhance adherence. Com m unicating with and educating patients are vital. First, counselors can
explain the rationale for medications and how they can support patients' goal of sobriety. This can create pos itive
reinforcement and reduce patient anxiety about relapse.10 Patients who unders tand m edication is helping them and not
“cheating” their recovery may be more likely to rem ain faithful to treatment.3,11,12 Establis hing a good relationship with
patients and creating a treatm ent environm ent in which patients are comfortable can also improve adherence.11
Certain aspects of medication us e can inherently interfere with medication adherence. For exam ple, side effects may
reduce adherence.3,12 While couns elors may not directly manage adverse events from medications, they can help set and
manage patients' expectations about side effects before they actually occur. Again, counselors must know and
communicate specific information about the most com mon side effects of medications (or how long they may last) to help
prepare patients. Becaus e advers e effects from the approved m edications are us ually mild, patients' concerns might be
allayed by knowledgeable counselors . Motivational enhancement can support patients when m edications are not achieving
their desired effect.
Medication dosing is another concern, because it has been demonstrated that as the frequency and complexity of
medication regimens increas e, medication adherence decreas es .10 In contrast, there is evidence that long-acting agents
requiring less frequent dosing can improve treatm ent adherence.13 Couns elors s hould cons ider dos ing regim ens when
recom mending different medication options , especially if adherence poses a concern. Counselors als o can provide advice
about sim ple reminders to help patients better remember to take medications. For example, taking m edications can be
correlated with certain cues or daily routines , such as eating and brus hing teeth.10
Certain couns eling techniques are also designed to improve medication adherence. Medical management and BRENDA
are brief form s of therapy that prom ote abs tinence and adherence to medication schedules.14,15 These techniques have
manuals that clinicians can follow and eas ily learn (s ee the additional reading list for more detailed inform ation on thes e
techniques ). Medical management was used in the Com bining Medications and Behavioral Interventions for Alcoholis m
(COMBINE) study, which examined the efficacy of acampros ate and naltrexone in com bination with behavioral interventions
and found improvement in drinking outcom es am ong all groups that received medical m anagem ent, even those receiving
placebo.16 Treatment adherence was also high in all groups.
The framework for BRENDA is based in the biopsychos ocial model of addiction and cons is ts of six stages : the clinician's
(1) biops ychosocial evaluation of the patient; (2) report of that assess m ent back to the patient; (3) empathy for the patient's
situation; (4) needs identification by both patient and clinician; (5) direct advice to the patient on how to meet those needs ;
and (6) assessment of the patient's reaction to that advice as well as any necess ary adjus tments to the treatm ent plan.15
BRENDA has been effectively us ed in a trial of extended-release injectable naltrexone.17 And in a trial of oral naltrexone,
BRENDA improved treatment completion rates and medication adherence com pared with standard individual therapy.18
Other couns eling techniques specifically crafted to im prove medication adherence exist. For example, a form of compliance
therapy based on motivational interviewing and cognitive-behavioral principles was found to im prove medication adherence
in a trial of acamprosate.19
Conclusion
There are many barriers to medication use for alcohol dependence treatment—more than can be fully covered here. But
through several techniques, addiction counselors can effectively provide s olutions to those obstacles . Improved education,
knowledge, and communication among counselors and patients regarding m edication us e are vital to increase acceptance
of medications and ens ure their proper us e. Perhaps mos t important, treatment providers and patients alike must
understand that medications can be a tool that allows patients the ability to more fully participate in counseling treatment,
which is needed for long-term recovery.
Christopher W. Shea, MA, CRAT, CAC-AD, is Clinical Director at Father Martin's Ashley in Havre de Grace, Maryland.
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Article
Full-text available
Context Alcohol dependence is a common disorder associated with significant morbidity and mortality. Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence. However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and utility of oral naltrexone have been limited.Objective To determine efficacy and tolerability of a long-acting intramuscular formulation of naltrexone for treatment of alcohol-dependent patients.Design, Setting, and Participants A 6-month, randomized, double-blind, placebo-controlled trial conducted between February 2002 and September 2003 at 24 US public hospitals, private and Veterans Administration clinics, and tertiary care medical centers. Of the 899 individuals screened, 627 who were diagnosed as being actively drinking alcohol-dependent adults were randomized to receive treatment and 624 received at least 1 injection.Intervention An intramuscular injection of 380 mg of long-acting naltrexone (n = 205) or 190 mg of long-acting naltrexone (n = 210) or a matching volume of placebo (n = 209) each administered monthly and combined with 12 sessions of low-intensity psychosocial intervention.Main Outcome Measure The event rate of heavy drinking days in the intent-to-treat population.Results Compared with placebo, 380 mg of long-acting naltrexone resulted in a 25% decrease in the event rate of heavy drinking days (P = .03) and 190 mg of naltrexone resulted in a 17% decrease (P = .07). Sex and pretreatment abstinence each showed significant interaction with the medication group on treatment outcome, with men and those with lead-in abstinence both exhibiting greater treatment effects. Discontinuation due to adverse events occurred in 14.1% in the 380-mg and 6.7% in the 190-mg group and 6.7% in the placebo group. Overall, rate and time to treatment discontinuation were similar among treatment groups.Conclusions Long-acting naltrexone was well tolerated and resulted in reductions in heavy drinking among treatment-seeking alcohol-dependent patients during 6 months of therapy. These data indicate that long-acting naltrexone can be of benefit in the treatment of alcohol dependence. Figures in this Article Alcohol dependence is a major public health problem, which worldwide is the fourth leading cause of disability.1 Alcohol dependence is present in approximately 4% of the US adult population,2 is common among primary care patients,3- 4 and may contribute to more than 100 000 preventable deaths per year.5 Addiction counseling, behavioral treatments, and self-help groups (eg, Alcoholics Anonymous) are the primary interventions used to treat alcohol dependence in the United States. Although these treatments are often effective, a substantial number of patients fail to complete them or relapse.6 Similar to diabetes, hypertension, and asthma, alcohol dependence is increasingly recognized as a chronic disease in which genetic vulnerability and social and environmental factors are involved in the etiology and course of the disease.7 As with other chronic diseases, long-term comprehensive management strategies are necessary to achieve and sustain the benefits of alcohol dependence treatment. Pharmacotherapy represents an emerging treatment option that could be used by primary care practitioners and addiction specialists.8 In 1994, naltrexone was approved by the US Food and Drug Administration to treat alcohol dependence after the medication was shown to reduce drinking frequency and the likelihood of relapse to heavy drinking.9- 10 Naltrexone, an opioid antagonist, is thought to reduce the reinforcing subjective or behavioral response to alcohol.11- 12 In about 3200 alcohol-dependent patients in at least 19 published controlled studies, oral naltrexone, compared with placebo, has shown efficacy in the treatment of alcohol dependence although some studies have reported no or minimal effectiveness.13- 18 Despite substantial evidence of efficacy, clinical use of naltrexone has been limited, in part because of the heterogeneity in treatment response.19 One documented reason for the heterogeneity of response across naltrexone trials has been poor adherence to the daily medication regimen.20- 23 Adherence to a daily oral medication regimen is a general problem in medicine.7 Additional challenges to adherence in the context of substance abuse include variable patient motivation toward treatment; impaired cognitive function, particularly executive function; and denial.24 As a prototypical addictive disorder, alcohol dependence is thought to involve dysfunction of the brain’s reward system with attendant impaired control over drives and motivation.25 Moreover, treatment may directly conflict with the behaviors and rewards associated with the abused substance.26 Since the 1970s, several efforts have been made to develop a parenteral extended-release naltrexone,27- 29 and 1 formulation has reported an effect on abstinence.29 Recently, a new polylactide-co-glycolide (PLG)–based, long-acting naltrexone formulation that releases naltrexone for 1 month following a single injection was developed.30 We conducted a 6-month, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 dosing levels of this long-acting injectable formulation of naltrexone in combination with a low-intensity psychosocial intervention for treatment of alcohol dependence.
Article
Background: Medications (such as naltrexone and acamprosate) as well as behavioral therapies have been previously reported to be effective in the reduction of alcohol intake and to prevent relapse drinking. However, the efficacy of using several medications alone or together in combination with behavioral therapies has not been widely investigated. The purpose of this study was to evaluate the feasibility of this combined therapy approach to apply it to a larger scale multisite clinical trial. Outcome focused on recruitment, retention, adherence to study parameters and medication, physical complaints, and physiologic toxicity.
Article
In December 1994, naltrexone, marketed under the brand name Revia, became the first adjunctive medication in almost 50 years approved by the FDA for treatment of alcoholism. Despite the evidence of its efficacy in randomized clinical trials, the use of naltrexone is not widespread. OBJECTIVE: To identify possible barriers to the use of naltrexone and other new medications in the treatment of alcoholism. METHODS: Focus groups were conducted in Washington, DC. The first comprised physicians who treat substance abuse, recruited nationally through a professional association and physician consultant referrals. The second comprised individuals who had been treated for alcoholism in the past three years and were in recovery, recruited locally through a newspaper advertisement. The physician group was taped and transcribed; the patient group was not taped in order to protect confidentiality. RESULTS: Public and provider lack of information were identified as key reasons why naltrexone has not been used more widely. Patients also pointed out medication side effects, the philosophy of Alcoholics Anonymous (AA), the high price of naltrexone, and stigma as barriers. In addition, physicians noted lack of evidence of efficacy in practice, difficulty measuring efficacy in practice, lack of physician time for patient management, patient reluctance to take medication, uncertainty in identifying appropriate patients for naltrexone, and lack of knowledge of and attitudes toward the use of medications among counselors as barriers. The findings will be used to inform the design of a national survey of providers. CONCLUSIONS: The findings suggest that physicians will not adopt innovations based solely on the clinical literature. While millions of dollars have been invested in the development of new alcoholism medications, licensing medications may not result in significant changes in treatment without educational and marketing efforts to promote the medications through the diverse members of the alcoholism treatment community.
Article
The key elements for enhancing patient compliance when prescribing are selecting the fewest number of daily doses (taking patient's other medications into consideration), scheduling when doses are to be taken, and helping the patient select an appropriate reminder or "cue." Developing reminder cues, such as clock time, meal time, or bathroom ritual, requires only a few minutes of careful planning to mesh with the patient's lifestyle. If one type of cue is not successful, another or combinations of cues are tried over time. Asking patients about their cues at each visit not only helps patients develop personalized cuing systems, but also reminds them that their physician has a consistent interest in the way they take their medication. Unfortunately, no single specific strategy will enhance compliance in all patients. Physicians have the greatest influence on medication compliance when they provide specific suggestions that fit into the patient's lifestyle.
Article
Advanced controlled release (CR) dosage forms are relative newcomers to pharmaceutical markets, and few studies relate their efficacy, safety or compliance benefits to economic value. This literature review was undertaken to assess the cost effectiveness of CR dosage forms using such measures as purchase costs, total treatment costs, and economic value of improved therapeutic outcomes compared with those with non-CR dosage forms. Three therapeutic areas were examined: cardiovascular therapy, pain management and estrogen replacement therapy. In cardiovascular therapy, prescription costs of sustained re lease (SR) verapamil were significantly higher than for conventional release verapamil. However, these were more than offset by lower physician, hospital and laboratory expenditures for the SR group, in whom compliance was superior. Similarly, patients receiving SR diltiazem had better prescription refill compliance than those using a conventional formulation of the drug, as well as significantly lower aggregate healthcare costs during a 1-year study period. These lower costs with both SR verapamil and diltiazem may relate to better compliance. CR nifedipine has lower daily acquisition costs than the conventional form, simplifies the dosage regimen to once daily, extends the indications of the drug to hypertension as well as angina, and reduces vasodilatory adverse effects by reducing peak plasma drug concentrations and the postdose rate of increase in concentration. Compared with oral clonidine given twice daily, transdermal clonidine, given once weekly, had higher purchase costs, but was associated with improved compliance, reduced adverse effects (due to control of plasma concentrations), and lower nondrug health costs, such as physician, hospital and laboratory costs. Lower costs were also found for once daily oral formulations of various antihypertensives, suggesting that the economics of both types of CR dosage forms related to compliance. CR metoprolol 50 or 100mg and conventional release atenolol 50mg, each given once daily, provided effective β1-adrenoceptor blockade. The conventional formulation caused deterioration in the sense of well-being that was temporally associated with sharp peaking of its plasma concentrations. Such peaking did not occur with either dose of CR metoprolol, nor did any deterioration in the sense of well-being. Transdermal nitroglycerin (glyceryl trinitrate), compared with long-acting oral nitrates, improved quality of life (QOL) [despite a higher incidence of some adverse effects, such as headache, dizziness and skin irritation]. Furthermore, in some studies, this formulation reduced angina attacks, sublingual nitroglycerin use, and hospitalisation or emergency room use. Cost comparisons between transdermal products favoured those that have superior adhesion. In pain management, CR oral morphine and transdermal fentanyl have higher acquisition costs than short-acting tablets or injectable agents, but lower total administration costs may outweigh the higher purchase price. The long-acting products also alleviate many pain management problems, including inadequate or mistimed dosage, labour intensiveness, lack of patient acceptance, and adverse effects on QOL. Transdermal fentanyl is comparable in price to CR morphine, but is administered every 3 days versus twice daily for CR morphine. The transdermal formulation can be used by patients unable to take oral medication. Transdermal estrogen has a higher acquisition cost than oral estrogen, but is effective in lower doses. Furthermore, the transdermal formulation does not cause an increase in renin substrate or other hepatic proteins, and is not associated with adverse hepatobiliary changes, while providing physiological estrogen levels. It is applied twice weekly, reducing noncompliance due to adverse effects or forgetfulness. In conclusion, some CR dosage forms add economic value to drug products by simplifying administration regimens, with resultant enhanced compliance, and by controlling drug input, which prevents super- or subtherapeutic plasma drug concentrations. The subsequent improvements in efficacy, adverse effect profile and QOL can decrease the costs associated with diagnosing and treating toxic effects of drugs. In addition, the need for costly re-evaluation to adjust dose, change medications or escalate therapy is minimised. Thus, overall care costs, not solely drug purchase costs, should be the criteria for assessing the economic value of drug products.
Article
The purpose of this study was to systematically assess the attitudes of Alcoholics Anonymous (AA) members toward the newer medications used to prevent relapse (e.g., naltrexone) and to assess their experiences with medication use, of any type, in AA. Using media solicitations and snowball sampling techniques, 277 AA members were surveyed anonymously about their attitudes toward use of medication for preventing relapse and their experiences with medication use of any type in AA. Over half the sample believed the use of relapse-preventing medication either was a good idea or might be a good idea. Only 17% believed an individual should not take it and only 12% would tell another member to stop taking it. Members attending relatively more meetings in the past 3 months had less favorable attitudes toward the medication. Almost a third (29%) reported personally experiencing some pressure to stop a medication (of any type). However, 69% of these continued taking the medication. The study did not find strong, widespread negative attitudes toward medication for preventing relapse among AA members. Nevertheless, some discouragement of medication use does occur in AA. Though most AA members apparently resist pressure to stop a medication, when medication is prescribed a need exists to integrate it within the philosophy of 12-step treatment programs.
Article
The effectiveness of naltrexone, a FDA-approved medication for alcohol dependence, can be improved if we support and help patients to consistently take their medication. We illustrate how patient noncompliance with treatment negatively affects outcome, and, we describe a new intervention to enhance medication compliance. Outcome was evaluated for 196 alcohol dependent outpatients who were treated with 50 mg/day naltrexone or placebo for 12 weeks. For patients who adhered to the prescribed treatment, relapse rates were lower with naltrexone than placebo (10% vs. 38.6%, p < 0.001). For noncompliant patients, relapse rates were high and comparable between naltrexone- and placebo-treated patients (42.9% vs. 40%). In a second study of 100 alcohol dependent outpatients, we introduced an intervention that resulted in better medication compliance rates compared to a previous naltrexone study of patients who did not receive the intervention (77.0% vs. 60.8%, p < 0.01). This provided some support for the use of an intervention that targets medication compliance when prescribing naltrexone.
Article
Naltrexone has been found to be an effective adjunct to treatment to reduce the rate of drinking among alcoholics. However, adherence to the medication has been of considerable concern; the high rates of noncompliance with the medication limits the benefits that could potentially be realized from this pharmacotherapy. Knowledge of predictors of noncompliance could result in interventions targeted at these variables. Participants were 128 alcohol-dependent patients who participated in a clinical placebo-controlled trial of naltrexone. Upon discharge from a 1- to 2-week partial hospital program, patients were randomly placed into 12 weeks of naltrexone (50 mg/day) or placebo (n = 64 per condition). Patients met with a physician and a research assistant weekly for 4 weeks then biweekly for 8 weeks. Compliance (number of days taking medication) was not predicted by demographic or pretreatment alcohol use variables. Number and severity of side effects in the first week, particularly nausea and fatigue, predicted early termination. Compliance was not predicted by commitment to abstinence or self-efficacy about abstinence, but was greater among patients who believed more strongly that the medication would help them stay sober. Compliance was not predicted by general level of urge to drink during the first week on medication but compliance was greater among those with a higher urge to drink in response to alcohol stimuli in the laboratory. Implications for approaches to increase compliance include reducing side effects and increasing patients' beliefs in the efficacy of naltrexone.