The impact of a pharmacist assisted clinic upon medication adherence and quality of life in mental health patients

INTRODUCTION

Patients with psychiatric illness often have difficulty following a medication regimen. Rates of adherence among patients with schizophrenia are between 50–60 percent; and among those with bipolar affective disorder, the rates are as low as 35 percent.¹

Some common barriers to adherence are under the patient's control, so attention to them through education is an important step towards improvement. Complex medication regimens, side effects of medications and lack of consideration of the patient's lifestyle or cost of medication are further contributors to nonadherence.² Psychiatric patients who are nonadherent or excess fillers of prescriptions are 70 percent more likely to be hospitalized for medical reasons than patients who adhered to their drug schedule.³ Partially adherent patients are 30 percent more likely to have a medical hospitalization.³ A disturbing consequence of nonadherence among mental health patients is the potential for dangerous behavior especially during periods of mental health decompensation.⁴

Early recognition and management of side effects from psychotropic medications can improve medication adherence. Extrapyramidal symptoms, anticholinergic side effects and sexual dysfunction are a few examples of side effects that may decrease adherence. Atypical antipsychotics can cause an increase in body weight of 8 – 29 percent leading to obesity, which is a precursor to other chronic disease states.⁵⁶ Pharmacists are in an ideal position to recognize these side effects, offer education, motivation and follow-up to increase adherence, decrease emergency room (ER) and hospital visits and increase quality of life. Direct counseling and education by pharmacists has been shown to improve adherence rates and patient outcomes.⁷ Interventions that successfully improve adherence involve education about the illness and treatments, adherence aids and more frequent visits.⁸⁹ It has been reported that the factor influencing adherence to treatment the most is the relationship between subject and health care provider.¹⁰ The primary objective of this pilot was to determine if a pharmacist assisted psychiatric clinic would improve adherence to medications and quality of life over 6 months.

METHODS

The clinic was housed within the hospital-owned outpatient psychiatric clinic. Patients could be self-referred via posters in the waiting room or referred by their mental health provider via paper referral notices kept in their offices or electronic notification. The researchers then contacted the referred patients for participation. There were 3 psychiatrists and 1 psychiatric nurse practitioner in the clinic during the study. Inclusion criteria were: 1) age greater than 18 years; 2) confirmed Axis I diagnosis; 3) receiving at least one scheduled medication for mental illness; and 4) commitment to the study for the next 6 months. Exclusion criteria included patients with dementia and those who do not manage their own medications.

Primary study endpoints were the change from baseline in Medication Adherence Rating Scale (MARS), Brief Evaluation of Medication Influences and Beliefs (BEMIB), World Health Organization Quality of Life - BREF (WHOQOL-BREF) scales as well as all cause hospitalizations and emergency room visits. Secondary endpoints included 1) decreased body mass index (BMI) and weight and 2) maintenance of blood glucose, cholesterol and blood pressure at goal. Point of care testing was accomplished using Cholestech LDX. Patients were required to attend 3 clinic visits (baseline, 3 and 6 months). Medication histories and metabolic parameters were obtained at each visit. Patient's records within the local health system were reviewed for emergency room visits and hospitalizations. Data was not collected as to whether the ER visit led to a hospitalization.

Patients were educated by one of two pharmacists working in the study. Both pharmacists were faculty members at the local school of pharmacy. Medication schedules and pillboxes were supplied to improve adherence. After each visit, the pharmacist documented the encounter, provided suggestions to the subject, and submitted a report to all health care providers.

All statistical analyses were performed using PASW v18 (SPSS Inc. Chicago, IL). A p value < 0.05 was considered statistically significant. Change from baseline to study endpoint in medication adherence, quality of life, and metabolic and physiologic parameters were measured using paired t-tests, Wilcoxon Sign Rank test, or McNemar's test depending on the measurement. Pharmacist interventions were documented and analyzed qualitatively. Subject's emergency room visits and readmission rates to the hospital for any reason, mental health or medical, were compared pre- and post-participation in the study.

RESULTS

Of the 47 patients referred by physicians as potential patients for the study, 27 (57%) gave informed consent to participate in the study. Of the 27 enrolled, 7 patients (26%) dropped out before study completion. Demographic data for all enrolled patients as well as those patients who dropped out are contained in Table 1 and 2 respectively. Baseline and study completion physiologic parameters are contained in Table 3. Sample sizes may vary based on availability of data for certain patients. Of the 7 patients who dropped out, 1 left the study due to incarceration and 6 were lost to follow-up. None of the 7 patients who dropped out had data obtained beyond baseline data.

Table 1: Demographic Data –All Subjects

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Table 2: Demographic Data –Subjects who Dropped Out

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Table 3: Baseline and Study Completion Physiologic Parameters

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PRIMARY STUDY ENDPOINTS

Results can be found in Table 4. In sum, for those completing the study, the total MARS score at baseline and study end were 7.90 and 8.65, respectively (p=0.23). At baseline, 17 of the 27 patients (63%) were considered non-adherent to their medication regimens as measured by the BEMIB. For the 20 patients who completed the study, 10 (50%) were nonadherent at baseline and 9 (45%) were nonadherent at six months (p=1.00). At study completion, the WHOQOL-BREF showed statistically significant changes in both the physical capacity (p = 0.049) and the psychological (p < 0.001) domains.

Table 4: Primary Endpoint

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In the 6 months before the study began, the patients combined for a total of 20 ER visits and 10 hospitalizations for any medical or psychiatric reason. One individual accounted for 6 of these ER visits and 2 hospitalizations. During the study period, there were a total of 9 ER visits and 3 hospitalizations. In the 6 months post study, there were a total of 13 ER visits and 4 hospitalizations also for any reason; one individual accounted for 10 of the ER visits and half (2) of the hospitalizations.

SECONDARY STUDY ENDPOINTS

Overall, there were no significant changes in the physiologic parameters and metabolic parameters measured except for total cholesterol and LDL (Table 3). Total cholesterol dropped from 185.7 ± 42 mg/dL to 173.1 ± 40.9 (p=0.04) and LDL dropped from 116.1 ± 30.1 to 95.9 ± 34.5 (p=0.04). When comparing patients' mean (± SD) weight, patients who were on atypical antipsychotics gained an average of 2.9 pounds (±6.8), while patients not on atypical antipsychotics gained 1.8 (±12.1) pounds (p=0.79). There was a non-significant increase in HDL (p=0.84).

OTHER RESULTS

At baseline, the mean (±SD) total number of medications was 6.9 (± 3.8). At study completion, this had increased to a mean of 7.8 (± 4.3) medications due to nutritional and vitamin supplementation as well as side effect management recommendations including stool softeners for constipation and dry mouth management with sour candy, increased fluid intake and artificial saliva. Other pharmacist recommendations included an increase in exercise, a change in timing of medication administration, education for a decrease in tobacco use and generic medication substitution. Qualitative analysis of pharmacists' interventions included recommendations (number of times) to: increase exercise to promote weight loss and reduce stress (12), calcium and vitamin D supplementation (12), to add or change a prescription medication based on disease states or cost (11), medication administration issues (timing/food) (10), smoking cessation education (9), addition of a multivitamin (9), and adding an over the counter product (9). Patient self-reported acceptance of these recommendations were: exercise (50%); calcium and vitamin D (83%); add or change a prescription medication based on disease state or cost (45%); medication administration issues (90%); smoking cessation (22%); multivitamin addition (77%); adding an over the counter product for disease management (77%).

Patients identified at metabolic goal are reflected in Table 5. Although not statistically significant, 2 more patients were identified as being at goal for glucose values at the 6-month visit versus baseline (p=0.63). During the study, two patients were newly identified with hyperglycemia, 12 with hypercholesterolemia and 5 with hypertension and were referred to their primary care provider by the pharmacist.

Table 5: Metabolic Parameters: Subjects at Goal

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DISCUSSION

Patients reported a small non-statistically significant increase in adherence according to MARS and BEMIB scores over 6 months. Given the small sample size, it was found to be non-significant. This is an encouraging result that should be studied again with a larger sample size. Improvements noted in both scores may reflect the benefit of pharmacist-conducted follow-up, monitoring and education.

This study suggests that pharmacists may be capable of making improvements on several domains in the WHOQOL-BREF, in particular, the physical capacity and psychological domains. This improvement could have been due to side effect management, better medication administration timing, close follow-up, attention to subject complaints and follow-through with prescribers concerning identification of hypercholesterolemia, hyperglycemia, hypertension and sleep issues.

Readmission rates for any hospitalization dropped during the study from 37% pre-study to 20% post study. Excluding one subject who accounted for 50% of hospitalizations, the readmission rate was 31% pre-study and only 11% post-study. ER visits dropped from 74% to 65%. Excluding the one subject as above, ER visits were 54% pre-study and only 16% post-study. Substantial costs were avoided, as one days stay on the behavioral health unit of the study site is ~$1200. All cause visits and admissions to the ER and hospital were included due to the study involving all medication use both medical and psychiatric.

Seventy-four percent of our patients were on atypical antipsychotics. While overall, LDL and cholesterol significantly decreased, the patients who showed the greatest improvements were still not at goal attributing to the non-significant change in number of patients defined as at goal. The reduction in absolute value may reflect the impact of recognition, referral, counseling (diet; fish oil), the identification of hypercholesterolemia and improved adherence to cholesterol lowering therapy.

Medications for mental illness cause side effects, which may lead to nonadherence. Commonly reported side effects were of dry mouth, daytime sleepiness, and weight gain. Patients accepted the majority of side effect management recommendations made by the pharmacists. Most were unable to make the lifestyle change to increase exercise or decrease tobacco use. Although patients were successful at getting back on their cholesterol medications, HDL and triglyceride values were not significantly changed possibly due to lack of exercise and the limited 6-month follow up time. Pharmacists are ideally positioned to assist in improving adherence given their accessibility and knowledge. The dropout rate and nonparticipation rate was not surprising given the inherent difficulty in mental health patients adhering to not only medications but also to appointments.

Limitations within this study included only 1 clinic referred patients although several were solicited. The investigators could only offer limited hours of availability for the clinic, which also limited many possible participants. Therefore, the resultant sample size is small to evaluate many of the intended parameters. Subject drop out rates were also higher than anticipated but not entirely unexpected in the mental health population. Patients were also reimbursed fifty dollars for their travel and time commitment.

Other limiting factors included only utilizing the data from the local hospital for admission and ER data. There is not another hospital within 45 miles but patients theoretically could have presented to other facilities. This factor could lead to an overestimation of the pharmacist's impact on ER visits and hospitalizations. The rating scales, surveys and acceptance of pharmacists' recommendations were self-reported; therefore the results may be overly subjective.

CONCLUSION

Improvements were seen in two domains of the WHOQOL-BREF – physical capacity and psychological well-being. While some improvements were seen in other scales, due to small sample sizes, these were insignificant improvements. Reductions in hospitalizations and ER visits were seen during the study and up to 6 months post study. Statistically significant improvements were seen in some of the secondary outcomes such as LDL and total cholesterol. The lack of improvement in many of the study outcomes reflects the small sample size but also the difficulty of the mental health population to adhere to treatment recommendations; but also underscores the need for continued research in this area. This pilot demonstrates the pharmacist's ability to provide comprehensive medication management services to the psychiatric outpatient.