Medication Adherence Among Psychotic Patients Before Admission to Inpatient Treatment

Promoting insight seems to be the most important lesson from our study, given that patients who gained insight had a much more favorable course in terms of hospitalization during the next year. Psychoeducation seems to hold some promise (45), yet effect sizes in terms of improvement in insight or adherence are mostly modest (8,46). Beyond this we are convinced that improvement in insight and further adherence is not only a matter of distinct treatment techniques but also a matter of convincing patients that the therapeutic efforts are aimed at achieving the very best outcomes for them, which requires a broad array of interventions and attitudes. Clearly there is much more research to be done, and further improvement in quality of treatment facilities is warranted.

Nonadherence has not only therapeutic implications but also important economic ones. Considering together both patients with poor adherence and patients who were adherent but whose dosage was too low, 71 percent had no adequate therapy before admission. There is much room for improvement given that patients who are receiving a sufficient dosage of antipsychotics have only about a fifth the risk of relapse of patients who are not taking antipsychotics (47). Weiden and Olfson (48) estimated that the costs of hospitalization due to nonadherence amounted to $800 million in the United States in 1993 dollars. Improving adherence is thus not only a therapeutic challenge but also a rewarding goal for both therapeutic and economic reasons.

Agreement Between Patients With Schizophrenia and Providers on Factors of Antipsychotic Medication Adherence

We found substantial disagreement between patients and their providers with regard to their explanatory models for schizophrenia and limited provider understanding of the barriers, facilitators, and motivators affecting individual patients' medication adherence decisions. Our results highlight the need for tools to improve mental health providers' understanding of their patients' perspectives on schizophrenia and antipsychotic medication treatment. To that end, we will use the findings from this study to develop and evaluate a patient-centered intervention to enhance antipsychotic medication adherence.

Managing Compliance

by Richard Balon, M.D.

May 2002, Vol. XIX, Issue 5

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Compliance with treatment, or treatment adherence, is a very important clinical issue. In prescribing medication, compliance usually means "the extent to which the patient takes the medication as prescribed" (Fawcett, 1995). Many mental disorders require more than just a brief medication intervention. For some patients, several months or years of medication or even lifelong medication is necessary. For instance, the recommended treatment time for the first episode of depression is six to 12 months, but almost half of patients stop taking their antidepressant within three months for various reasons (Lin et al., 1995). Noncompliance can have serious consequences, such as relapse or recurrence of the illness. Therefore, enhancing medication compliance (or preventing noncompliance) is an important treatment goal for patients and clinicians. The first step in this process is the recognition and prevention of factors that could lead to noncompliance.

Factors Affecting Compliance

Factors that may affect patients' compliance with medication can be summarized along five dimensions (Fawcett, 1995):

• patient characteristics (e.g., attitudes toward illness and medication, socioeconomic considerations, social supervision);
• the treatment setting (e.g., primary care versus specialty office and inpatient versus outpatient);
• medication characteristics (e.g., side effects, individual sensitivity to side effects, simple versus complicated medication regime);
• clinical features of the disorder (e.g., chronicity, exaggerated feelings of guilt in depression, suspiciousness in schizophrenia, substance abuse and comorbid anxiety); and
• clinician expertise (e.g., knowledge of pharmacology, empathy, instilling hope, successful integration of pharmacology and psychotherapy).

Salzman (1995) emphasized that noncompliance may be an especially serious issue in the elderly, where its prevalence may be as high as 75%. He identified three common forms of treatment nonadherence in the elderly: overuse and abuse, forgetting, and alteration of schedules and doses. Overuse of prescribed drugs could lead to emergence of or increase in side effects.

Treatment Adherence

Strategies to improve treatment adherence include: 1) recognition of factors leading to noncompliance; 2) establishment of a strong alliance with the patient (Frank et al., 1995); 3) patient education about the illness and the importance of maintenance treatment; 4) patient education about the medication, drug interactions, pharmacokinetics and side effects; 5) simplification of medication regime(s); 6) providing medication compliance assistance, such as pillboxes; 7) considering over-the-counter medications as a possible source of noncompliance with prescribed medication (Salzman, 1995); and 8) emphasizing the doctor/patient relationship (Salzman, 1995).

During the initial visit, the physician should: define illness from the patient's point of view; define target symptoms and severity; convey sympathy, support and understanding of the patient's experience; provide rationale for use of medication (mention beneficial effects, disclose side effects); elicit patient resistance to medication; explain the importance of taking the prescribed dose; convey hope and optimism; establish a therapeutic alliance; and discuss alternative treatments (Fawcett, 1995).

However, follow-up visits are also very important for enhancing and monitoring compliance. During these visits, response should be assessed and possible side effects evaluated and managed.

Identification of Noncompliance as a Major Medical Problem

Much of the research concerning patient compliance deals with the identification of adherence as a medical problem. This area of research aims to convince the reader that something needs to be done about the current patient noncompliance situation. As expected, much of the data behind this type of study exists in the form of factual and numerical information. The following is a list of typical compliance statistics:9

-Approximately 125,000 people with treatable ailments die each year in the USA because they do not take their medication properly.

-Fourteen to 21% of patients never fill their original prescriptions.

-Sixty percent of all patients cannot identify their own medications.

-Thirty to 50% of all patients ignore or otherwise compromise instructions concerning their medication.

-Approximately one fourth of all nursing home admissions are related to improper self-administration of medicine.

-Twelve to 20% of patients take other people's medicines.

-Hospital costs due to patient noncompliance are estimated at $8.5 billion annually.

Noncompliance is typically cited as occurring in from 50% to 75% of patients. In other words, in the United States, 50% to 70% of patients do not properly take prescribed medication. The rate of noncompliance is even higher in patients with chronic illnesses.10 This is because the drug regimens for these patients are often long-term, complex regimens that alter existing behavioral patterns. In addition, children are less likely than adults to follow a treatment plan because of their dependence on an adult caregiver.11 Clearly, the research has proven that noncompliance is a serious medical issue. It is a major medical problem that may lead to death and elevated costs, both for patients and providers.

In response to a New England Journal of Medicine article published yesterday and subsequent media coverage, Eli Lilly and Company issued the following

January 18, 2008

INDIANAPOLIS, Jan 18, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials.

The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac -- the NEJM article didn't identify a single Prozac study as unpublished -- but it also likely created a strong false impression with readers that Lilly suppresses data.

Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results -- whether favorable or unfavorable to a Lilly medicine -- in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products.

In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004.

In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice -- first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004.

The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data.

We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it -- more than once -- in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times ... if only they had called and asked.

About Prozac

PROZAC is available by prescription only.

A rash can be a sign of a serious medical condition. See your doctor immediately if you develop a rash while taking PROZAC. Also, you should not take PROZAC at the same time as or within 2 weeks if stopping a type of antidepressant medication known as an MAO inhibitor. Don't take MAO inhibitors for at least 5 weeks after stopping PROZAC.

Thioridazine should not be administered with PROZAC or within a minimum of 5 weeks after PROZAC has been discontinued.

Prozac® Weekly™, PROZAC, generic versions of PROZAC, and Sarafem® contain the same active ingredient, fluoxetine hydrochloride.

Some people experience side effects like nausea, difficulty sleeping, drowsiness, anxiety, nervousness, weakness, loss of appetite, tremors, dry mouth, sweating, decreased sex drive, impotence, or yawning. Most of these tend to go away within a few weeks of starting treatment and, in most cases, aren't serious enough to cause people to stop taking PROZAC.

You should also talk to your doctor if you are pregnant or are nursing.

In addition, you, your family and other caregivers should be aware of the following information: Depression, as a disease, can be associated with periods when the symptoms can worsen and thoughts of suicide can emerge. Patients and their families should watch for these as well as for anxiety, agitation, panic, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or over excitement and hyperactivity. Call the doctor if any of these are severe or occur suddenly. Be especially observant at the initiation of antidepressant drug therapy and when there is a change in dose.

Tell your doctor if you have ever been told you had Bipolar Disorder ("Manic Depression") or have had a "manic" or "psychotic" episode.

For more information, including full Prescribing Information, please visit www.prozac.com, or call 1-800-LillyRX.

Prozac® is a registered trademark of Eli Lilly and Company. Prozac®Weekly™ is a trademark of Eli Lilly and Company. Sarafem® is a registered trademark of Warner Chilcott, Inc.

About Cymbalta

Important Safety Information

Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder and manage diabetic peripheral neuropathic pain. Antidepressants can increase suicidal thoughts and behaviors in children, adolescents and young adults. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril® (thioridazine) or have uncontrolled glaucoma. Patients should speak with their doctor about any medical conditions they may have, including liver or kidney problems or glaucoma. Patients should tell their doctor about all of their medicines, including those for migraine to avoid a potentially life-threatening condition, and NSAIDs, aspirin or blood thinners due to an increased risk of bleeding. They also should talk to their doctor about their alcohol consumption. Patients should consult with their doctor before stopping Cymbalta or changing the dose and if they are pregnant or nursing.

Patients taking Cymbalta may experience dizziness or fainting upon standing. The most common side effects of Cymbalta include nausea, dry mouth, sleepiness and constipation. This is not a complete list of side effects.

For full Patient Information, visit www.cymbalta.com.

For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com/.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

    Prozac® (fluoxetine hydrochloride, Dista)
   Cymbalta® (duloxetine hydrochloride)

   C-LLY

Review of "Your Medicine"

“Health teachers are always searching for good manuals and resources to use to improve the educational setting. “Your Medicine” can help in two ways: It can help teach skills to students so that they can empower themselves about medicine as well as increase their knowledge about the importance of the prescription drugs benefits. Secondly, teachers have students who do not take their medicine, or these students’ parents do not adhere to their children’s medicinal needs and this results in poor school performance because of the student’s mental health. Therefore, it can inform the teacher on how to help the parent and child about medicine compliance.

Ulana Keer, B.S., M.S.A., M.A.

Review of "Your Medicine"

“Julia Kohutiak has created a series of workbooks and instructor's manuals that is a must for patients, health care providers and facilities everywhere. “Your Medicine” is an easy to read and understand guide for safe medication administration. It provides practical, basic information and answers questions that are commonly asked (or should be). The use of this manual could greatly reduce potential medication errors. It should be included in the library of anyone who is a patient, or who cares for and about a patient.”

Lynne C Pompetti, APRN-BC, MCSN, Psychiatric Clinical Nurses Specialist

Review of "Your Medicine"

by Dr James Kennedy

“Despite the availability of increasingly effective psychotropic medications, treatment noncompliance is an ongoing problem. This problem is faced continually by those trying to provide effective treatments for clients suffering from mental illnesses. Noncompliance is being addressed in many ways, including the use of long acting depot preparations; however, central to all efforts is patient education and patient empowerment. To help realize the potential in these areas, "Your Medicine" is a series of workbooks and instructor's manuals written for use in behavioral health programs. In reviewing them, I found they provide a framework to help clients be more comfortable with their medication through empowering them with skills needed to obtain critical information about their medication. Information from sources as basic as the prescription bottle itself, all the way up to those prescribing the medication. This knowledge inspires confidence about their medications and increased awareness of the importance of medicine compliance.”

Many Mental Health Consumers Need Education Concerning Their Medicines

Clinicians in our Shreveport, Louisiana outpatient mental health clinic are piloting a medication education program called "Your Medicine". The nurse and psychiatrist designing the program asked me to help edit the project, so I follow our pilot program with great interest. Medication noncompliance could be the most significant factor in relapses and hospitalizations among the chronically mentally ill.
Before beginning the education program, we give consumers a pre-test. Our social workers also lead a group discussion, asking group members to talk about problems they have had with medication compliance. Here are some interesting trends we see at the outset of treatment:

• Virtually all consumers either fail to recognize or minimize the effects of past medication noncompliance.
• Initially, few consumers can list or narrate the names of their medicines, dosing information, or what condition the medicine treats without significant errors or omissions.
• Even among consumers that take numerous medicines, many are not using pill planners or any other method to organize their medicines.
• Many consumers do not know how to recognize or interpret basic information from a prescription label, such as the number of refills remaining.
• Many consumers need a better understanding about how to have their prescriptions refilled or reissued before they run out.

After consumers complete "Your Medicine", we give a post test. This provides insight into how much help a particular consumer will need with his medicines after discharge. We communicate these needs to the consumer’s family or others providing support.
Education is probably not the silver bullet for combating medication noncompliance. Nevertheless, it is hard to envision widespread success if our consumers and their support systems lack insight into medications. Education is but one of many tools we use in medication management.

Medication Management in Hedis scores

As a consultant, I find it interesting that behavioral health shows the least HEDIS scores.

The National Committee for Quality Assurance developed HEDIS (Healthcare Effective­ness Data and Information Set) as a framework for health plans to collect, analyze and report identical performance measurements each year. The performance measures in HEDIS are related to many significant public health issues. HEDIS allows objective assessment of a health plan’s value in comparison with other health plans.

The scope of the NCQA HEDIS Compliance Audit includes the following domains:

Effectiveness of Care; Access/Availability of Care; Satisfaction with the Experience of Care; Health Plan Stability; Use of Services; Cost of Care; and Health Plan Descriptive Information.

AV health plan:

Antidepressant medication management and compliance:

Optimal practitioner contacts 14.02%

Effective acute phase treatment 60.46%

Effective continuation phase treatment 42.47%

Harvard Pilgrim Health Care – 2007 HEDIS Results
(Calendar year 2006 performance – Reported in September 2007)
Table shows percent of sample meeting HEDIS or CAHPS measurement criteria (see companion Measure Guide for details)

	HPHC, Inc. (MA, ME)	HPHC-NE (NH)	National Average
BEHAVIORAL HEALTH CARE (Adults only)
Antidepressant medication management Optimal practitioner contacts Effective acute-phase treatment Effective continuation-phase treatment	35% 66% 51%	31% 62% 48%	20% 61% 45%
Follow-up appt. after hospitalization for mental illness Within seven days of discharge Within 30 days of discharge	89% 96%	90% 97%	57% 76%
Initiation of alcohol and other drug treatment	45%	41%	43%
Engagement of alcohol and other drug	15%	15%	14%