Analysis of variables affecting drug compliance in schizophrenia.

CONTEXT: As compliance of the patient during management of schizophrenia is crucial, the current study was conducted to find out the factors that affected compliance. AIMS: The aim of the study was to analyze the prevalence of noncompliance and to find out different factors affecting compliance in schizophrenic patients.
MATERIALS AND METHODS: Observational cross-sectional study was conducted on 100 adult schizophrenic patients. Noncompliance was assessed using the rating of medication influence (ROMI) scale. Severity of illness was measured using positive and negative syndrome scale (PANSS).
RESULTS: Prevalence of noncompliance was 37%. Using ROMI scale; positive relationship with psychiatrist, family pressure for taking medications, stigma, and substance abuse were found to be significant factors. Severity of illness was also found as determining factor.
CONCLUSION: To improve the compliance in schizophrenia patients, roles of both psychiatrists and family members are crucial.

Patients who do not follow the treatment schedule prescribed by physicians can be described as noncompliant.[1] Side effect remains an important issue and substance abuse is an important factor leading to noncompliance.[23]

If we look at the problem statement, the mean levels of compliance were 58% for antipsychotics.[4] One Indian study shows prevalence of noncompliance to be 38.7%.[5] It is estimated that the rate of noncompliance is approximately 50% during first year and 75% during second year.[6]

Reasons for noncompliance are multiple. Hence, the current study was conducted to know different factors affecting compliance in schizophrenia.

MATERIALS AND METHODS

The current study was carried out at one of the Mental Health Center in the district of Aurangabad, Maharashtra. Patient profile in the study area was mixed, covering both rural and urban populations.

This is an observational cross-sectional study. The study population comprised registered adult schizophrenic patients from outpatient and inpatient departments. Inclusion criteria was a primary axis I diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR),[7] age of 18–65 years, and 1 year or more duration of illness. Exclusion criteria was presence of medical disorder or organicity, mental retardation, unavailability of reliable relatives, and the patients who were not prescribed medicines in the past 6 months.

The study was conducted in 2009–2010. Sample size was calculated based on the prevalence of noncompliance in schizophrenic patients using sample size formula.[28] According to the formula, the sample size worked out as 81.8. It was rounded up to 100. Consent was obtained from each of the patient and family members.

With the help of predesigned proforma, preliminary data regarding socio-demographic profile were noted. The patient's history was noted and the clinical examination was carried out. The severity of illness was measured using positive and negative syndrome scale (PANSS). Reasons of noncompliance were assessed using rating of medication influence (ROMI) scale.

Statistical analysis: Risk factors affecting compliance were analyzed using the Statistical Package for Social Sciences, version 16 (SPSS V16.0). For qualitative data, Pearson's Chi-square test was applied. For quantitative data, mean, standard deviation, and standard error were calculated. Student t test was performed to assess severity of disease using PANSS score.

RESULTS

Among 100 schizophrenic cases, 37 were noncompliant. Among socio-demographic variables, gender, residential area, and substance abuse were statistically significantly associated with noncompliance.

Table 1 shows different reasons for compliance using ROMI scale. The responses to the question ‘what is your main motivation for taking the medication?’ are grouped into six questions in the ROMI scale. The responses to the question ‘what is your main motivation for not taking the medication?’ are grouped into twelve closed questions in the ROMI scale [Table 2].

Table 1

Various reasons of compliance using ROMI scale: Comparison

Table 2

Various reasons of noncompliance using ROMI scale: Comparison

After applying Student t-test, the correlation of noncompliance with severity of schizophrenia was found very highly significant [Table 3].

Table 3

Correlation of compliance with severity of disease using PANSS

DISCUSSION

The current study was conducted on 100 adult schizophrenic patients with duration of illness of more than 1 year. The noncompliance rate observed in the current study was 37%, which was consistent with other Indian studies.[59] The point of concern coming out of these observations is that this is a very high prevalence of noncompliance, which could affect the management of schizophrenia cases.

Most of the previous studies showed that substance abuse is a strong predictor of noncompliance, which is consistent with the current study.[910] Statistically significant reasons of compliance found as per ROMI scale emphasize the fact that the number of positive effects of neuroleptics are of greater significance for compliance than the unwanted effects of the medication, and positive doctor–patient relationship is essential in improving compliance.[1011]

Evaluation of reasons of noncompliance using ROMI scale highlighted five important reasons. Patients who do not comply are likely to feel that their medications do not help as opposed to patients who comply with neuroleptics and are hence more likely to report feeling better.[12] Poor relationship with psychiatrist leads to poor compliance. Poor insight was another important factor. Stigma related to schizophrenia is exponential. The presence of any of neuroleptic side effects was also a determining factor for noncompliance. The severity of illness was strongly correlated to noncompliance.

CONCLUSION

Looking at the high prevalence of noncompliance, all the related factors need to be urgently addressed. Compliance is highly influenced by benefit with medicines and positive relationship with the psychiatrists; therefore, psychiatrists should maintain a good therapeutic relationship with schizophrenic patients. Family pressure on the subjects for taking medication increases compliance, suggesting a need for psycho-education to family members. There is a need for treatment of substance abuse along with management of schizophrenia.