Drug related problems (DRPs) are events or circumstances involving drug therapy that actually or potentially interfere with desired health outcomes [1
]. Examples of DRPs are contra-indications, interactions, adverse drug reactions (ADR) and inefficacy of treatment. Causes for these problems can be prescription errors, non-compliance with treatment and the specific effects of drugs in patients. Factors that increase the risk of DRPs are polypharmacy, co-morbidity, aging, non-adherence and lack of coordination between different treating physicians.
An increased number of prescribed drugs (polypharmacy) strongly increase the risk of DRP. Runciman found a correlation between increases in medication use and rates of adverse drug reactions associated with hospitalization [2
]. Another recent review of studies of the effect of polypharmacy on the health state of elderly people has shown that multiple drug use is a strong predictor of hospitalisations, nursing home placement, death, hypoglycaemia, fractures, impaired mobility, pneumonia and malnutrition [3
]. Furthermore, Leendert et al suggest that elderly people have a higher risk of hospitalisation caused by DRP, especially if they use have 4 or more co-morbidity [4
Elderly people >75 year seem at higher risk for hospitalisation caused by DRP [2
]. A study conducted in the Netherlands examined the occurrence of hospitalisations that were related to medication. This study showed 12.793 acute hospital admissions per year of which 714 admissions were medication related and 332 of these admissions were preventable. They calculated that 19.000 hospital admissions per year were related to medication and were preventable [4
]. Specific risk factors were the number of prescribing physicians [5
] and the number of diagnoses [6
], the number and combination of several (inappropriate) drugs [6
] and the use of inappropriate drugs [8
Non-adherence is another risk factor for the occurrence of DRP. Assuming that drugs have been prescribed correctly, non-compliance may substantially affect the efficacy of treatment or even enhance the risk of side effects [12
]. In the Dutch population 50% of the patients were shown to discontinue the use of chronic medication within one year after initiation. Discontinuation of chronic medication depended on the type of chronic medication and occurred frequently among patients who were using antihypertensive medication, cholesterol lowering drugs, anti-osteoporoses drugs, anti-rheumatic medications and antidepressants [15
Hospitalisation can also be the cause of DRP. Hospitalisation and subsequent discharge are associated with discontinuity of care [16
]. At the point of discharge the use of certain drugs may have been discontinued and the doses of others changed while new medication may have been added. In the Netherlands, pharmacists use a computerized system to detect drug problems among their patients. This system fails to detect all drug problems and does not provide information on problems with medication use, which elderly patients may experience. In the present study, pharmacists will perform a medication review on elderly patients discharged from the hospital. This medication review is a structured, critical examination of patient's medicines with the objective of reaching an agreement with the patient about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste [17
A systematic review conducted by Royal et al. concluded that there was evidence showing that pharmacist-initiated interventions including a medication review component are effective in reducing hospital admissions by 36%. Several studies have shown that cognitive behaviour treatment can be useful in improving medication adherence among patients [18
]. Patients may benefit of changes in attitude to medication, resulting in increased compliance with drug use.
The present randomized controlled study aims to improve pharmacotherapy by means of combining two effective strategies including medication review and cognitive behaviour treatment. To our knowledge, the effect of combining both methods to minimize drug related problems and improve compliance among elderly patients discharged from the hospital has not been studied previously.
Theoretical framework the cognitive behavioural approach
Studies have shown that a change in patients attitude to medications may enhance adherence to medications [16
]. Behavioural interventions may increase this effect [16
]. A behavioural model of medication adherence is shown in figure . This model is based on the Theory of Planned Behaviour and provides insight into the factors that may determine adherence behaviour [18
]. Patients gain 'treatment experience' once they are exposed to a medical regimen. To enable patients to adequately make informed choices about their behaviour and to motivate themselves to execute the behaviour correctly and at the right time, patients must possess a basic level of understanding about their illness. Health care professionals must communicate this information in understandable and concrete language, tailored to the needs of each specific patient [19
]. The most important concept used in the adherence model is the intention of the patient to adhere to the medical recommendations. The Theory of Planned Behaviour states that the intention to adhere is determined by the subjective norm, the attitude and the perceived behavioural control [18
]. The subjective norm is what a person thinks other people believe (s) he should do (e.g. physicians or partners) and the motivation to comply with these normative references. The subjective norm of a patient can be changed through either changing the patients perception of the norm, or through changing the patients motivation to comply with this norm.
Model for Medication Adherence: theory of planned behaviour.
The attitude reflects salient beliefs about the perceived outcomes of these behaviours (e.g. adherence leads to better health than non-adherence) and the evaluations of these outcomes (e.g. good health is essential for living longer). It is important for the patient to realise that the benefit of adhering to the medical regimen outweigh the costs. It is therefore important that doctors and community pharmacists explain to the patient what the benefits are of medication adherence. The patient will then be able to make his own informed choice about his medicines and outweigh the costs of this behaviour.
The last component is the perceived behavioural control (PBC). The PBC has two components: self-efficacy dealing with the perceived ease or difficulty of performing behaviour, such as feeling confident to always take medication correctly in a private setting and controllability the extent to which the behaviour is up to the person. If a person has a demanding job it is sometimes difficult to remember intake or have some privacy. To optimize someone's PBC, it is useful to separate behaviour in small and simple steps and to facilitate the behaviour where possible (for example: use dose organizers) and plan the execution of the behaviour in a setting in which the patient feels confident about correctly performing the behaviour on a daily basis.
The outcome of the attitude, subjective norm and perceived behaviour control is expressed in a behavioural intention. This intention leads to accepting or refusing adherence to the treatment as prescribed [19
Medication review is an intervention that can be used to prevent the occurrence of DRP. Medication review requires access to the patients notes, full record of prescriptions and non-drug care and results from laboratory tests etc. The medicines used by the patient will be reviewed in the context of the patients condition and the perspective of the patient. In this process the patient is involved as a full partner. This means listening to the patient's views and beliefs about their medicines, reaching an honest understanding of their medicine taking behaviour and taking full account of their preferences in any decisions about treatment. Possible detected DRPs are communicated with the prescriber, in order to find a solution for these problems. Any changes made will then be communicated with the patient.
Cognitive behaviour treatment
To increase concordance with drug use, according to our theoretical framework, we have developed a combined intervention with motivational interviewing (MI) and Problem Solving Treatment (PST). MI is used to increase patient's motivation towards concordance with medication prescription [21
]. When patients experience barriers with medication use, PST will be used in order to give patients the tools to overcome these barriers [22
Motivational interviewing is a client-oriented counselling method that is shown to be effective in improving health behaviour [21
]. Increasing the intrinsic motivation of patients can then lead to a positive behavioural change. During the counselling sessions the therapist does not take an expert role but rather a role as a partner. MI includes 5 counselling techniques aimed at helping patients resolve ambivalence about health behaviour: (1) expressing empathy; (2) developing discrepancy; (3) avoiding argument (4) rolling with resistance; and (5) supporting self-efficacy [21
]. When patients are motivated to change their health behaviour, the next step is to increase their self-management towards this behaviour by using PST.
Problem solving treatment
This intervention increases the ability of patients to solve their problems in a structured way and improve their confidence in dealing with future problems. The treatment aims to give patients the tools to overcome barriers in order to stimulate structural healthy behaviour. During the treatment session there is an active collaboration between the patient and the pharmacist, in which the patient takes an active role in the planning of his treatment [23
]. PST can be considered as a series of 7 stages [22
1. Explanation of the intervention and its rationale
2. Definition and breaking down of the problem
3. Establishing achievable goals for the problem resolution. Achieve goals are SMART goals: Specific, Measurable, Achievable, Relevant, Timed
4. Generating multiple possible solutions
5. Evaluating and choosing the solution
6. Implementing the preferred solution
7. Evaluating the outcome
Objectives of this study
The objective of this study is to investigate the effects of a multifaceted intervention, existing of medication review and a CBT intervention for medication adherence, on the occurrence of DRP in elderly patients of 60 year and older discharged from the hospital using five or more drugs. The hypothesis of this study is that this multifaceted intervention will reduce the occurrence of DRP and improve compliance. The secondary objectives are to evaluate the effect of the intervention on: attitude to drugs, incidence of Re-hospitalisations related to medicines, functional status of the patient, quality of life. Moreover, the cost-effectiveness of this intervention will be analysed.