Improving Medication Concordance in Mental Health- A Review of the Literature Where a man is against his will, that to him is a prison. Epictetus Abstract There has been much discussion on why concordance with antipsychotic medication and treatment appears to differ from other fields of medicine. Does the literature support this contention? This review aims to seek out best practice and apply the principle of informed choice in assessing concordance and using appropriate interventions to educate individuals with psychosis.
Contents Abstract Introduction Compliance or concordance? Client centered therapy Administration of medicines and patient capacity Competent or non-competent? Schizophrenia in comparison with asthma and epilepsy Negotiating medication Antipsychotics- Hobson’s choice? Education – the patient’s view
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Psychosocial treatment interventions Compliance therapy Conclusion and Recommendations References Introduction The aim of this literature review is to identify if possible, what simple, easily introduced refinement may be useful on an acute mental health ward, with the aim of better understanding the factors affecting concordance with both medication and treatment provisions. The review of the evidence was necessarily broad, for two reasons. Firstly, the premise that concordance is poorer with mentally ill patients (Hughes, et al. 997, Marland and Cash, 2005), compared with those suffering from physical illnesses (although acknowledging the considerable over-lap). This premise has been personally encountered whilst on practice placements. Secondly, whether any advantage might be gained from other areas of practice and applied to the chosen patient group. The literature search strategy was carried out by initially accessing the “Pub med” and “Ovid” databases, using the terms “concordance”, “compliance” and “adherence”. Attention was focused on research papers that dealt with both physical and mental conditions.
Priority was given to any evaluation of techniques potentially useful in improving concordance, and research papers frequently referred to by other authors, or otherwise indicated as seminal. The review was limited to studies carried out in the UK, Ireland, and the USA. It was of course, necessary to limit the final discussion to a representative number, which aim to reflect some changing views, with emphasis on recent research. Gray, et al. (2002) note that non-compliance with antipsychotic medication is a major preventable cause of relapse in psychotic patients.
The causes of non-compliance are seldom immediately clear, and the literature suggests a large number of factors interplay, and individual reasons for stopping medication can be arbitrary. Evidence-based medication management aimed at enhancing treatment concordance should include a collaborative, educational approach to working with patients, tailoring medication regimes to the patient. Gray, et al. advocate using therapeutic techniques such as compliance therapy, discussed in this review, in order to empower individuals, and preserve their right to choice. Compliance or concordance?
Repper and Perkins (1998) highlighted the importance of terminology in mental health, and suggest that the use of words like compliance infer patients should be passive recipients of health-care, and should obey professionals. It has recently been proposed that “concordance” should replace the words “compliance” and “adherence”. Concordance emphasizes patient rights, and the importance of two-way decision making. More controversially, it also suggests patients have the right to make choices such as stopping medication, even if clinicians do not agree with the decision.
This principle conflicts with traditional psychiatric practice, and potentially with the provision of treatment under the Mental Health Act 1983. Since this review reflects the source literature, the three terms are retained, and may be read as synonyms, unless the context dictates otherwise. Client centered therapy Rogers (1975) Client centered therapy, described five factors affecting health behaviour; severity, susceptibility, response, self-efficacy and fear. Focusing on the latter two factors, self-efficacy has been defined as a person’s belief in his ability to accomplish a given task (Bandura, 1977, quoted by Hughes, 2004).
How a person thinks an illness will affect him is determined by previous knowledge or experience, as well as fear, or threat appraisal. Belief that a change would improve coping strategies, and the person is empowered to undertake such a change, can improve considerably the ability of the patient to be more independent, and concordant with medication strategies. Administration of medicines and patient capacity The law imposes a duty of care on those that administer medication to others (Griffith, et al. 2003). Administration of medication is not without its complications.
Minor prescribing errors, adverse drug reactions, interactions with food, or herbal products, overdoses (intentional or otherwise), and even possible genetic problems or death. These potential problems are reflected in the strict legal framework that regulates the prescribing and distribution of medication. There is however, still widespread concern in the UK over the administration of non-prescribed medicine and the practice of covert administration in the non-compliant (Wright, 2002). The law is clear that covert administration is only justifiable in cases of incapacity.
Incapacity occurs where the patient is unable to comprehend and retain information material to the decision, or the patient is unable to weigh up the information as part of the process of an informed decision (Nys, et al. 2004). In the case of covert administration to an adult there would be a need to demonstrate that the patient is incapable. The nurse should be able to justify the techniques of administration were in the patients best interests, and the crushing of tablets, for example, was safe. In practice this should be a multi-disciplinary team decision.
The covert administration of medication observed on placement was one reason I have chosen to explore the literature, and examine any methods used that may be applied to adults who are non-concordant with anti-psychotic medication. Competent or non-competent? Levenson (2003), interviewed patients with Parkinson’s disease, and their views are quoted here for two reasons. Firstly health care professionals may tend to view patients with Parkinson’s disease in a similar manner to those with a mental illness, i. e. not competent to self-administer medication.
Secondly the benefits of helping patients maximize control over their own medication are so apparent, and might well be applied to patients with other illnesses. The issue of balancing the benefits of medication against very significant unwanted effects was a major concern to interviewees. The patients had in common an understanding of the symptoms of the disease, and how their medication, particularly the timing, affected their symptoms. It was clear in one case; the doctor really listened to the needs of the patient, adjusting dosages and times accordingly.
Another patient was able to use a dosset box with electronic timer as a memory aid. Some patients experienced difficulties retaining control of their medication when admitted to hospital. They found the timing of the drug rounds did not suit them. This undermined their efforts to comply with the medication. This aspect of medication administration appears to lend weight to the instrumental passivity hypothesis (Baltes and Skinner 1983, quoted in Faulkner, 2002) The argument is that hospitals and nursing homes reinforce dependent behaviour by supporting and encouraging them.
The primary ethical strategy Faulkner advocates is for staff to focus on reinforcing independent behaviour. Forms of self-medication come into this category. Melanie Baker (2003) described a scenario involving a 47 year old man suffering from bipolar affective disorder. His case typifies the interplay between physical and psychiatric health, and the patient poorly concordant with medication. Among his numerous significant medical conditions were angina, and a myocardial infarction.
He also had diabetes mellitus and developed diabetic neuropathy, which was treated with carbamazepine. His mental state was coincidentally improved with the introduction of carbamazepine, but after 18 months of stability, he took an overdose, resulting in the prescription withdrawn. Prior to the 18 month period ; stability, the patient had a long history of decline. Psychotropic medication and his unstable angina may relate to poor adherence with cardiac medications. He was more amenable to cardiac treatment when mentally well.
The consultant and Multi-disciplinary team felt that when he was mentally stable, his physical health improved in parallel, possibly due to improved compliance with both medication and lifestyle advice. He appeared to view psychiatric care as stigmatizing, contributing to poor compliance. Treatment for diabetic neuropathy was perceived as less stigmatizing. The importance of tailoring medication to each individual is highlighted in this case, as the accidental overdose of Carbamazepine led to a serious long-term deterioration.
Schizophrenia in comparison with asthma and epilepsy Marland and Cash (2005) have found that the belief that non-compliance is a direct result of disease processes in schizophrenia dominates the clinical perception of non-compliance for these patients. One explanation given, was likened to a negative feedback, where a patient who stays off medication, perhaps out of a delusional feeling (“my doctor is poisoning me”), for a time feels well, which may have the effect of strengthening the delusion.
They also demonstrated that although patient attitudes to medication change over time, the process of change is rarely well documented on an individual basis. The study objective was to compare the medicine taking decisions in people with schizophrenia to those of people with asthma and epilepsy, also both enduring, episodic illnesses. They concluded that for people taking antipsychotics, relapse was socially disadvantaging and unwelcome, particularly if it resulted in readmission to hospital.
They confirm that the association between stopping medication and hospital readmission is learned eventually by many people on anti-psychotics. Interestingly people from all three diagnostic groups seemed prepared to experiment with timing and amounts of medication when well presumably as the fear of illness subsides. Patients for whom the consequences of altering medicine regimes were delayed or relatively mild were more likely to experiment than those who experimented with medication leading to rapid or severe symptoms.
Hence there was a learned ability to balance symptoms and medication side effects to achieve an optimum quality of life, whilst living with a fear of relapse. Fear of dependence was also a strong motivator for some, and exceptionally leads to complete cessation of medicine taking for long periods, even leading to frequent or severe symptoms. They conclude by confirming interventions useful in promoting therapeutic interactions with medicine in physical illness should also be appropriate in schizophrenia.
They found it important to ascertain the individual’s level of understanding and insight, of the illness, medication and side effects. Negotiating medication Carder, et al. (2003) were concerned with how adults with illnesses characterized by repeated flare-ups, or instability, resulting in temporary inability to manage tasks of daily living, negotiated their medication needs. They included sufferers of multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosis, along with those with schizophrenia and bipolar disorder.
They described how these individuals with chronic illnesses made on-going negotiations with health-care practitioners, balancing health and illness with a preservation of self-identity. Many of those interviewed described on-going efforts to find the right medication or combination of medications. In addition, a third of participants described the use of alternative medications, such as vitamins, Chinese herbal tablets, and naturopathic remedies. It was found the necessity of taking daily medication did not always square with the individuals self-identity (“I am not ill”), so adaptation was stressed.
The psychotic individual can often be fixed in their thinking, however, or for some, their illness appeared to have ended. Others described an aversion to feeling dependent on drugs, or perceived themselves subject to their prescriber’s ‘experimentation’. Some researchers describe resistance to medication as an initial stage (Gray, et al. 2002), but these participants described an on-going and periodic resistance to taking medication. Some described withholding accurate accounts of their symptoms, fearing an increase in dosage or a change in medication.
One woman, at first appeared concordant, but described the emotion as one of “surrender”, a process of “going with the flow”, rather than fighting the illness and feeling resigned to whatever medication was prescribed. In the conclusion (Carder, et al. 2003), it was acknowledged medication remains the paramount way to manage chronic illness. For those who are asymptomatic while on medication, the medication is the only indicator of illness, and non- concordant individuals are sometimes led to question the need for medication, the diagnosis, or the reliability of the health-care team.
The emphasis of this study was how healthcare practitioners must guide people through negotiations, identifying different choices, how best to self-regulate, and the effect that symptoms, side effects, and medication have on the body and on self-identity. A useful exploratory study confirming the findings of Carder, et al. was carried out by Hostick and Newell, (2004). They wished to determine the reasons service users discontinue community mental health-care. Although the presenting problems of respondents could not generally be classified as serious mental illness, the findings were significant.
The study began on the premise that users would stop attending for two main reasons, either they had improved, or they were dissatisfied with the service. Few users cited improvement as the reason for non-completion. Many users expressed dissatisfaction about the lack of service flexibility, but could also be linked to practical difficulties or accessibility. The theme therefore continues for the need for a flexible, patient centered approach. Antipsychotics- Hobson’s choice? Hughes, et al. 1997) begins by describing what has become the standard medication regime for schizophrenia sufferers in the community, that is, the depot injection, administered intramuscularly on a regular basis at home, or at a community mental health centre. Depot injections are a dosage form of the anti-psychotic, allowing the drug to be released slowly into the bloodstream over a period of 1-5 weeks. For patients treated in the community, where good compliance with oral treatment cannot be guaranteed, depot anti-psychotics potentially provide a practical solution.
However while having a monthly or fortnightly injection may be for some, less problematic than following an oral medication regime, good compliance is not guaranteed. Healy (2002) noted that far from blaming the medication, there was a tendency among mental health personnel to see the compliance issue in terms of patient unreliability or lack of insight. In effect however, the depot removes control from the user, and even the administering nurses, since it is immediately obvious to service managers when someone stops receiving their depot injection.
In addition to the unwanted side effects of anti-psychotic medication, there are the potential problems of intra-muscular injections to consider, and whilst good practice should minimize these, subcutaneous fat in adults in the dorso-gluteal area (site of choice for many UK nurses) varies from 1cm to 9cm. If injected into this layer, absorption of the drug will be adversely affected, and the tissue may become irritated. This occurs in up to 15% of patients (Greenway, 2004), and the threat of injury also remains significant to the sciatic nerve, and superior gluteal artery, which lie only a few centimeters from the optimum site.
The suggestion was made by Hughes, et al. (1997) that it may not be the presence of unwanted side effects themselves, but rather how these side effects are regarded by the patient, that is in determining compliance. The physical discomfort of side effects may be less important in influencing compliance than the meaning patients attach to these side effects, for example, a movement side effect (tremor) is taken as the beginning of multiple sclerosis, or Parkinson’s disease. In this way, compliance may be improved simply by allowing patients to voice fears and concerns about side ffects. Hughes, et al. (1997) draws attention to another explanation for poor compliance in the hypo-manic or psychotic individual. Some sufferers enjoy the sense of euphoria that can characterize hypo-manic episodes. Similar problems have been experienced with patients with a history of recreational drug use. One likened his psychotic experiences to “tripping”. Education – the patient’s view Carder, et al. (2003) found that even without structured efforts on the part of clinicians to inform patients about medication, education played an important role in their decision making.
Of note in the context of this review, was the response of persons diagnosed with depression, who, in common with those suffering psychoses, are poorly motivated. They found these persons go through an extensive interpretive process that includes understanding the condition and its causes, the reality of medication side effects, and negotiating with healthcare practitioners. The view of one perplexed woman with bipolar disorder reflected the experience of many. “Some of the psychiatrists would hand you five or six different medications at once.
I mean, how do you know which one’s working, or what’s not working. It took a while before I found a psychiatrist who sat and listened… “. The suggestion is made of using motivational interviewing techniques to weigh up identified positive and negative aspects of psychotic symptoms. For this reason, some clinicians have concentrated on schizophrenics with relatively higher levels of negative symptoms. Hughes, (2004) describes how recent self-management approaches have produced better outcomes in these patient groups.
Self-management programmes aim to encourage, or coach, patients, by supporting and influencing health behaviour and increasing knowledge of specific aspects of care, for example, pain and symptom control, or medication side effects. Nurses are well placed to offer holistic support to patients becoming more independent, but issues surrounding power and control in the nurse-patient relationship must be acknowledged in this process. The health belief model has been used to help patients perceive the benefits of following the recommended treatment regimen.
Four factors identified as influencing patients were; the benefits of the treatment, susceptibility to relapse, the severity of the symptoms, and the cost in effort and pain from side effects. It was recommended health care practitioners not neglect the ‘secondary’ benefits of the medication, i. e. feeling calmer, sleeping better, easier socializing, and improved concentration, when seeking the views of patients , it was correctly predicted the secondary benefits of the medication would be valued as often as the main benefit of improving positive and negative symptoms. 5% of patient identified the main benefit, but 70% noted the secondary benefits (for example; “it allows me to make friends”) and these were found to be more strongly associated with medication compliance than the primary benefits. Zygmunt, et al. (2002) was not so favorable to the health belief model. They felt the rational assumptions and broad generalizations implicit in it were not helpful in predicting concordance. This may reflect a more recent shift towards motivational interviewing and its development into compliance therapy. Psychosocial treatment interventions
Zygmunt, et al. (2002) carried out a study of psychosocial interventions tailored for psychoses. Adherence to medication and outpatient appointments has become crucial for positive outcome during maintenance treatment. No one specific intervention demonstrated significant advantages in improving adherence; however, the small sample size may have been a factor. It was felt that both patients and their families need a more active role and greater self-responsibility. They found the greatest benefit of the six interventions studied, most evident during the first six months of treatment.
The most prominent conclusion reached however, was that psycho-education alone had no effect on patient compliance, but felt this finding did not negate the need for further education and implementation of structured treatment programmes Psycho-educational interventions focused primarily on dissemination of information about the illness, medication and treatment, group therapy was based on the evidence of peer support and shared problems. Family interventions derived from a belief in the family as a critical influence on the course of a member’s illness.
Community programs typically . involved a complex variety of supportive and rehabilitation services delivered without a choice. Cognitive treatment targets patient’s attitudes and belief toward medication. An assumption is made that adherence is a coping behaviour, heavily determined by each person’s own interpretation of his illness and medication regime. Behavioural modification techniques assumed that behaviours are acquired through learning and conditioning, and can be modified through rewards and punishment, reinforcement, and the promotion of self-management.
Behavioural strategies worthy of note include providing selected patients with detailed medication instructions, reminders, self-monitoring tools, cues and reinforcements. In another instance, the therapist used assertiveness training techniques to teach patients to negotiate with their prescribers more effectively. An important conclusion about this study was that of the many interventions in practice, most were viewed as too complex, and multifaceted, and hence difficult to identify exactly what contributed to individual successes or failures.
Interventions addressing medication non-adherence specifically, were found to work better than those covering a wider range of problem areas. One recommendation noted from this study, was the monitoring of patients with a history of non-adherence involving any medication prescribed for physical, not simply psychotic illness, and the authors opted for a definition of non-adherence as a complete cessation of medication for at least one week, as opposed to dosage deviations. Compliance therapy Kemp, et al. 1996), sought to determine if compliance therapy could improve compliance with treatment and hence social adjustment, and if the effects persisted six months later. 25 patients received compliance therapy and showed significant improvement in their attitude to drug treatment in comparison to a similar control group. Individuals were assigned to the two groups on a random basis. The 4 -6 counseling sessions lasted between 10 and 60 minutes. The following issues were addressed, eliciting the patient’s stance towards treatment, exploring ambivalence to treatment, and a treatment maintenance plan.
The patient is first encouraged to review their recent past, identify likely barriers to treatment adherence, and describe any negative outcomes experienced. Secondly, the patient is encouraged to systematically choose possible alternative strategies to their antipsychotic medication. There is an emphasis on “normalizing” the experiences, for example, “in extreme situations hallucinations can occur to anyone”, and if requested, provide more information about treatment options.
Thirdly, the patient’s freedom to choose whether to maintain treatment is emphasized, and parallels drawn with conditions such as diabetes, where regular insulin injections may be required. The object is to lessen any perceived stigma. The patient is encouraged to look ahead, set goals, examine what they find personally important, and the emphasis is on how not taking medication could affect the outcome of their goals. Finally, the therapist acknowledges, and empathizes, with the costs associated with any course of action, including the desired outcome of concordance with treatment.
The control group received a similar number of timed sessions, but the sessions had no discussion of treatment, and were less structured. By rating compliance using a scale of 1 to 7, with 1 being fully compliant, and with an added interest in the medication, the authors were able to demonstrate a 23% improvement over six months. There are problems associated with measuring patient compliance, common techniques such as urine tests may overestimate compliance when drugs have a long half-life. Blood serum tests, when available, are invasive, and of limited value in assessing partial compliance.
Pill counts are widely considered a useful indicator, but potential exists for inaccuracy or deception, with no guarantee the patient ingested the tablets. A similar problem exists for electronically tagged dosset boxes. The study noted the high human and social costs of relapse, or persisting symptoms, and felt any proved means of counteracting non-compliance had important managerial implications. Kemp, et al. (1998) carried out a further investigation of the original trial, extending the number of participants, and including an 18 month follow-up.
An effort was made to measure not only compliance, but also insight, attitudes, and a functional assessment. There were comparatively few participants dropping out, 11 over 18 months, or less than 10%. Results indicated a definite advantage for those who received compliance therapy. Relatively poor results with first admission patients could have been related to acuteness of illness onset, lack of previous experience with antipsychotic effectiveness, or perhaps denial. Overall, the work supported the premise that poor compliance was associated with more severe drug side-effects. A recent study in Dublin (O Donnell, et al. 003), using the same basic techniques, failed to replicate the previous findings, and found no advantage over non-specific therapy in terms of patient adherence. Then again, in common with the earlier studies, there were fewer than 100 participants; therefore the possibility of false negatives remained. They did confirm that patient attitudes change over time, and were a useful predictor of future compliance. Despite the name, compliance therapy fits with a concordance model, involving patients in each decision making phase, with no coercion, implied or explicit, to obey professional opinion.
Conclusion and Recommendations All of the papers reviewed agreed that ignorance about medication was common. Frequently, antipsychotic treatment had not been fully explained to patients or their families, where appropriate. The individual needs to be fully informed about the effects of the prescribed medication, there is no justification for withholding knowledge about adverse effects or poor prognosis, this would be paternalistic and unethical. The aim of the treatment should be made as clear as humanly possible, and alternatives clearly presented.
Such patient empowerment enables genuine participation, reduces fear, facilitates informed consent, and gives the closest opportunity for concordance. Although by definition, the primary responsibility lies with the consultant, as part of a multi-disciplinary team, nurses on ward level, in primary care, or in the community, are well placed to facilitate evidence-based treatment regimens. The most promising recent development has been “compliance therapy”. Three of the papers discussed sought to quantify its potential. O’ Donnell et al (2003) gave a conflicting view, but most authors mention it as promising.
It is recommended here that further application of its principles, in a local setting, be attempted. As an aid to an admitting nurse, or during a care plan review, a simple evaluation tool be devised, a questionnaire, to address past concordance issues, an area we noted was often overlooked, with the principle of future self-management the goal. If possible, such a tool could be applied on a rehabilitation ward or acute setting. Other considerations that should be studied are: ethical issues, staff education, and through multidisciplinary evaluation.
Finally, although in this review evidence has been highlighted from a patient perspective, of the considerable debilitating side effects of antipsychotic medication, it is not the aim to argue here that it has no role in helping to relieve the suffering of patients with psychotic symptoms. There does remain considerable scope for discussion of implementing informed choice for the mentally ill individual, and multidisciplinary cooperation in how to best inform them. References Baker, M. (2003) The coincidental treatment of a major mood disorder Progress in Neurology and Psychiatry, accessed from www. rogressnp. com Carder, P. C. Vuckovic, N. and Green, C. A. (2003) Negotiating Medications: Patient perceptions of long term medication use Journal of Clinical Pharmacy and Therapeutics 28, 409- 417 Faulkner, M. (2002) Instrumental passivity: A behavioural theory of dependence Nursing Older People 14(2) 20- 22 Gray, R. Wykes, T. and Gournay, K. (2002) From compliance to concordance: a review of the literature on interventions to enhance compliance with anti-psychotic medication Journal of Psychiatric and Mental Health 9, 277- 284 Greenway, K. 2004) Using the ventrogluteal site for intramuscular injections Nursing Standard 18 (25) 39- 42 Griffith, R. Griffiths, H. and Jordan, S. (2003) Administration of medicines part one: the law and nursing Nursing Standard 18 (2) 47- 53 Healy, D. (2002) Psychiatric Drugs Explained (3rd Edition) London, Churchill Livingstone Hostick, T. and Newell, R. (2004) Concordance with community health appointments: service users’ reasons for discontinuation Journal of Clinical Nursing 13 (7) 895- 910 Hughes, I. Hill, B. and Budd, R. 1997) Compliance with anti-psychotic medication: from theory to practice Journal of Mental Health 6 (5) 473- 489 Hughes, S. A. (2004) Promoting self-management and patient independence Nursing Standard 19 (10) 47- 52 Kemp, R. Hayward, P. Applewhaite, G. Everitt, B. and David, A. (1996) Compliance therapy in psychotic patients: randomized controlled trial British Medical Journal 312, 345-349 Kemp, R. Kirov, G. Everitt, B. Hayward, P. and David, A. (1998) Randomised controlled trial of compliance therapy: 18 month follow-up British Journal of Psychiatry 172, 413- 419 Levenson, R. 2003) Compliance in medicine taking- seeking the views of patients London, Department of Health, Medicines Partnership Marland, G. R. ; Cash, K. (2005) Medicine taking decisions: schizophrenia in comparison to asthma and epilepsy Journal of Psychiatric and Mental Health Nursing 12, 163- 172 Nys, H. Welie, S. Garanis-Papadatos, T. and Ploumpidis, D. (2004) Patient capacity in mental healthcare: legal overview Health Care Analysis 12 (4) 329- 337 O’Donnell, C. Donohoe, G. Sharkey, L. Owens, N. Migone, M. Harries, R. Kinsella, A. Larkin, C. and O’Callaghan, E. 2003) Compliance therapy: a randomized controlled trial in schizophrenia British Medical Journal 327, 834- 842 Repper, J. and Perkins, R. (1998) Different but normal: language, labels, and professional mental health practice Mental Health Care 2 90- 93 Rogers, R. (1975) A protection motivation theory of fear appeals and change Journal of Psychology 91, 93 Wright, D. (2002) Medication administration in nursing homes Nursing Standard 16 (42) 33- 38 Zygmunt, A. Olfson, M. Boye, R. C. and Mechanic, D. (2002) Interventions to improve medication adherence in schizophrenia American Journal of Psychiatry 159 (10) 1653- 1664