ORIGINAL ARTICLE. AP J Psychological Medicine Vol. 15 (1) January-June 2014

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1 81 ORIGINAL ARTICLE A study of non-compliance with pharmacotherapy in psychiatric patients Sadia Sultan, 1 MD, Sadanand S Chary, 2 MD, Sharband R,, Vemula,3, MD 1 Assistant professor of Psychiatry, 2 Assistant professor of Psychiatry, 3 Professor of Psychiatry and Head, Department of Psychiatry, SVS Medical College and Hospital, Mahabubnagar, Andhra Pradesh, India ABSTRACT Background: Non-compliance to treatment, especially medication is an important area of concern in psychiatry as it contributes to relapse and re-hospitalization of the patients. One of the ways to improve drug compliance is to know crucial factors responsible for poor drug compliance so that proper management strategies may be planned to improve patients drug compliance Aims: To find out the reasons for drug non-compliance and its association with socio demographic variables and psychiatric diagnosis. Methods: The study was conducted on patients attending psychiatry outpatient department for duration of seven months to evaluate the reasons for treatment non-compliance, using a questionnaire designed for the purpose. Results: In our study, it was observed that 63.75% of subjects were compliant and 36.25% were non-compliant. A significant association was found between non-compliance and age group more than 46 years, female gender, low socio economic class, low education rate. Non-compliance was highest among patients with schizophrenia (45.16%) and the main reason for drug non-compliance identified in the present study was a lack of knowledge about the nature of illness. Conclusion: The result of the study concludes that the major reason for non-compliance was lack of knowledge about the illness reflecting the importance of psycho education. Key message: Lack of knowledge about the nature of illness was the main reason for non-compliance. Key words: Psychiatric disorders; Non-compliance; Pharmacotherapy Date of first submission 5/3/14 Date of initial decision: 22/3/14 Date of acceptance:11/6/14 INTRODUCTION Ensuring patients adherence to treatment and to clinical appointment schedules is a major challenge in psychiatry as well as in general medicine. [1,2] Compliance broadly means the extent to which a person s behaviour in terms of taking medications, following diets and executing life style changes, visiting for follow-up etc., coincides with medical and health advice. [3] Compliance to medication usually means the extent to which the patient takes the medication as prescribed. Jim Rosack, [4] explained the phenomenon of adherence to medication in terms of refill rate. Refill rate is the proportion of days of proper adherence to prescribed medication by the patient calculated in relation to the total days of advice. Patients who had only 50 percent of their Address for correspondence: Dr Sadia Sultan. H-No: /A/28/1, LIC Colony, Sayeedabad, Hyderabad Telangana, India Phone: drsaddy2003@yahoo.com How to cite this article: Sultan S, Chary SS, Vemula SR. A study of non-compliance with pharmacotherapy in psychiatric patients. AP J Psychol Med 2014; 15(1):81-5. expected refill rate were termed non adherent. Those who filled prescriptions between 50 percent and 80 percent of the expected refill rate were termed partially adherent. Those who filled prescription between 80 percent and 110 percent were termed as adherents and those who filled their prescriptions at more than 110 percent of the expected rate were termed excess fillers. Non-compliance is closely linked to relapse, rehospitalisation and poor outcome among patients with a major mental illness. [5,29-31] Fenton, [1] found that treatment noncompliance may be associated with demographic, clinical, environmental factors, effects of medication and the clinician-patient relationship. Other studies have found an association between appointment non-compliance and young age, male gender, poverty, distance to the clinic, frequency of appointments, substance abuse and inexperienced or impersonal clinicians. [6-8] Avasthi et al, [9] found that 93 % of those not fully adhering to the treatment attributed their failure to the ill effects of medicines. Patients with schizophrenia are particularly vulnerable to relapse following medication noncompliance..[10-12] Therefore, improving medication compliance in persons with mentally ill holds the potential for reducing morbidity and suffering of patients and their families, in addition to decreasing the cost of re

2 82 Sultan, et al: Non-compliance with pharmacotherapy hospitalization. [13] One of the ways to improve drug compliance is to know crucial factors responsible for poor drug compliance, so that proper management strategies may be planned to improve patients drug compliance. Keeping these points in view, our study attempted to identify factors associated with non-adherence to scheduled outpatient visits at a major psychiatric teaching hospital. Aims and objectives To study the non-compliance with pharmacotherapy in relation to the socio demographic variables. To study the non-compliance with pharmacotherapy in relation to various psychiatric diagnoses. To study the reasons for non-compliance with pharmacotherapy in patients. MATERIALS AND METHODS The study was conducted in the outpatient department of our hospital over a period of seven months i.e., from 1 st of June to 31 st of December Initially 528 patients who attended the OPD were considered. Inclusion criteria for the patients were those aged between 16 to 60 years, both males and females and accompanied with a reliable informant. Of them 48 were excluded, exclusion criteria being those needing urgent attention for physical problems and without reliable informants. Thereby our final study sample was 480 patients. After taking written informed consent, all the patients were systematically interviewed along with the attendants. The resultant data were entered into a semi structured proforma. A patient was labelled as non-compliant if he/she was non adherent as per Jim Rosack s criteria. [4] The diagnoses taken were confirmed by the consultants in accordance with International Classification of Diseases, tenth revision (ICD-10). [32] The data was analyzed employing chi-square test. Tools used Socio-demographic and clinical information about the patients and their family were entered on a semi structured proforma specifically designed for this study. Reasons for poor drug compliance were assessed using a checklist that was prepared based on the clinical experience of the investigator in dealing with psychiatric patients. Main areas covered under the checklist were lack of knowledge, financial difficulty, commuting difficulties, side effects, no improvement of symptoms and unconcerned family member. A category named others was included to cover reasons that were not specified in the check list. Patients were free to choose more than one reason in each category, if applicable. RESULTS Table No.1 shows that out of the total 528 patients initially considered for the study 48 were excluded based on the fixed exclusion criteria. The final study sample was 480(100%) of which 306 (63.75%) were compliant and 174(36.25%) were non-compliant to the medication. Table 1: The study sample Total Patients Initially Considered 528 Patients Excluded 48 (9.09%) Final Study Sample 480 Compliant 306 (63.75%) Non-Compliant 174 (36.25%) Table No.2 shows the relationship between non-compliance and socio-demographic variables. It was found that poor compliance is seen in age group of more than 46 years (61.53%), females (48.43%), unmarried (48.71%), people belonging to extended families (45.95 %), low socio economic status (52.63%), low educational qualification (50.94%) and unemployed population (38.24%). Table 2: Sociodemographic variables in relation to noncompliance Variable Compliant Non-compliant Total P value (n=306) (n=480) (n=174) Age( years) <30 87(69%) 39(30.9%) 126(100%) (68.5%) 87(31.5%) 276(100%) >46 30(38.5%) 48(61.5%) 78(100%) Sex Male 207(71.9%) 81(28.1%) 288(100%) Female 99(51.6%) 93(48.4%) 192(100%) Marital status Married 246(67.8%) 117(32.2%) 363(100%) Un-married 60(51.3%) 57(48.7%) 117(100%) Family pattern Nuclear 231(62.6%) 138(37.4%) 369(100%) Extended 60(54.1 %) 51(45.9 %) 111(100%) Income status Lower 108(47.4%) 120(52.6%) 228(100%) Middle 174(77.3%) 51(22.7%) 225(100%) Upper 24(88.9%) 3(11.1%) 27(100%) Educational qualification Illiterate 78(49.1) 81(50.9) 159(100%) Lower Primary 93(65.9%) 48(34.0%) 141(100%) Upper Primary 72(72.7%) 27(27.3%) 99(100%) Secondary and more 63(77.8%) 18(22.2%) 81(100%) Employment status Employed 174(63.0%) 102(36.9%) 276(100%) Un Employed 126(61.8%) 78(38.2%) 204(100%) 0.01; S 0.04; S 0.08; NS 0.1; NS 0.03; S 0.04; S 0.3; NS Diagnosis wise consideration as seen in Table No.3 reveals that the rate of non-compliance was highest among patients with schizophrenia (45.16%) followed by schizoaffective (40%), Bipolar affective disorder (33.33%), depression (33.33%), substance abuse(30.76%), obsessive compulsive disorder(28.57%), somatisation disorder(28.57%) and others(22.22%).

3 Sultan, et al: Non-compliance with pharmacotherapy 83 Table 3: Non-compliance in relation to diagnostic distribution Diagnosis Compliant Non-compliant Total P value (n=306) (n=174) Schizophrenia 102(54.83%) 84(45.16%) 186(100%) 0.06; NS Bipolar Affective Disorder 30(66.66%) 15(33.33%) 45(100%) 0.09; NS Depression 18(66.66%) 9(33.33%) 27(100%) 0.3; NS Substance Abuse 81(69.23%) 36(30.76%) 117(100%) 0.08; NS Schizoaffective 9(60%) 6(40%) 15(100%) 0.1; NS Ocd 15(71.42%) 6(28.57%) 21(100%) 0.08; NS Somatisation 30(71.42%) 12(28.57%) 42(100%) 0.1; NS Others 21(77.77%) 6(22.22%) 27(100%) 0.2; NS Total 306(63.75%) 174(31.25%) 480(100%) 0.08; NS Table 4 depicts various reasons for poor adherence to medication in non-compliant patients. More than one cause was found to be responsible for the poor compliance. The most common reason found was lack of knowledge about the need to use regular medication (n=81) followed by financial difficulty (n=66), side effects of the medication (n=24), poor improvement of the symptoms (n=15), unable to attend for follow up visits (n=9), reluctant care giver (n=6) and others (n=9). Table 4: Causes of discontinuation of medication in study sample (N=174) Cause Number Percentage Lack of Knowledge Financial Difficulty Commuting difficulties Side Effects No Improvement of Symptoms Unconcerned family member Others DISCUSSION Available literature provides a non-compliance rate of 12-60% [14, 15] in the present study non-compliance rate was 36.25%. Poor compliance was found more in the age group of more than 46 years when compared to younger (<30 yrs) and middle (31-45 yrs) age groups. The association between age and non-compliance was statistically significant (p=0.01).this may be because people with more than 46 years with psychiatric morbidity are dependent and the neglected population in our society. In contrast, earlier studies by Klinkenberg et al, [19] Carpenter et al, [20] and Nose et al, [21] have observed a relatively higher non-adherence in young population. Compliance in males (71.87%) was found to be better than females 1.56%).This difference was statistically significant (p=0.04). This was concurrent with the previous findings. [22] This might be because males receive more family and social support than females, which makes them more compliant to medication. In the study it was found that compliance was better in married population (67.76%) than unmarried population (51.28%).Though this difference was not statistically significant, our finding was similar to the previous studies that, marital status was significantly related with the compliance and married patients are more likely to be compliant. [23] This may be due to the necessary care provided by the spouse in the married population. Patients living in nuclear families are more compliant to medication when compared with the patients from joint families. This was an interesting finding we got in our study and we could not find any previous studies with similar finding. Better compliance in nuclear families might be because in these families there will be proper supervision of medication administration or watch dog effect of family member upon the patient which might partially contribute to the compliant behaviour of the patient. However the difference was not statistically significant. Non-compliance was more in low socio-economic status (52.63%) than in middle (22.66%) and upper (11.11%) socioeconomic groups. The difference was statistically significant (p=0.03). Carpenter et al, [20] Atwood and Beck, [24] and Nose et al, [21] too had similar observations in a different set up. Low socio-economic status was associated with poverty, less affording capacity and poor awareness. Hence such observation can be logically expected. Non-compliance in people with low educational qualification was high. The difference was statistically significant (p=0.04). This was similar to the early observation of Nose et al, [21] who found that education was positively associated with the compliance. Better compliance in the employed population can be because higher education obviously promotes insight to the illness and a better appreciation for the need of the treatment. This difference was not statistically significant. This was similar to the finding of Nose et al [21] who in a compilation analysis of 86 studies involving 23,796 patients of psychoses had found a positive association between unemployment and non adherence, which indicates a financially poor affordable capacity in this population. The most common psychiatric diagnosis in non-compliant patients was schizophrenia (45.16%) and non-compliance was least in somatisation disorder (28.57%). Significant association has not been found between non-compliance and any of the diagnostic sub groups. Vulnerability of the patients with schizophrenia and depressive disorders to be noncompliant was well documented by Nose et al [21] and Gilmer et al [18] Sparr et al [14] had highlighted that patients with substance abuse were significantly more likely to miss appointments. In the present study, in contrast to the observation of Sparr et al [14] higher noncompliance among substance abuse disorder was not observed. This was possibly because of taking into consideration only a singular diagnosis of substance abuse instead of taking into account all the cases of any diagnosis with substance abuse which was done in previous studies. The others group had 27 patients of which

4 84 Sultan, et al: Non-compliance with pharmacotherapy 6 were noncompliant. As it was a heterogeneous group with very small number of cases of mental retardation, attention deficit hyperkinetic disorder, generalized anxiety disorder, personality disorder and organic mental disorders the related findings have limited implications. Patients and relatives in the noncompliant group were asked to explain reasons of their noncompliance. More than one factor was found responsible for the poor compliance. The main reason found was lack of knowledge about the nature of illness, treatment and follow up visits (46.55%). The cost factor as a result of noncompliance has also been highlighted by Rana et al, [3] Awad and Voruganti, [25] who observed that increased adherence to second generation antipsychotics was due to fewer side effects. Ignorance which has been observed as the most common reason for non-compliance in the present study is of paramount importance in planning of mental health services and relapse prevention programs. Over the years, advent of newer medication with lesser side effects and better tolerability did not effectively change the compliance rate in patients. Therefore it is important to educate people regarding psychiatric illnesses and make them appreciate that mental disorder is an illness of mind just as we have bodily illnesses and are fairly treatable. They need to know that often prolonged treatment is required and regular follow-up is an essential feature of patient management in psychiatry. On the whole, the present study revealed noncompliance rate of 36.25%, being positively associated with age group more than 46 years, female gender, low income status, low educational level. This finding of the present study was also in agreement with the observations of previous studies by Cruz et al, [16] Kar et al, [17] and Gilmer et al. [18] The patients with schizophrenia had a relatively higher rate of noncompliance. Lack of knowledge and financial incapacity were stated to be other important factors hindering compliance. Prevention of non-compliance will not only benefit concerned patients but also makes the service available to more number of patients. The issues like interactional components between patients and care providers, involvement of family, limitation of side effects, detecting prodromal symptoms and identification of patients at risk have been highlighted in various programmes for relapse prevention by different authors. [14,25-28] Salient findings of the study: Non-compliance was more seen in age group more than 46 years and female gender It was more associated with low socio economic status and education The disorder which was more associated with noncompliance was schizophrenia Lack of knowledge about the nature of illness was the major factor leading to non-compliance Limitations The limitation of the study is a smaller sample size and limited time frame. The checklist used in the study was not pretested and validated. The patients who were labelled noncompliant might be continuing treatment elsewhere. There was a strong chance of wrong information from patients and attenders and lastly the use of semi-structured proforma. CONCLUSIONS Thus the result of the study allows us to know that the major factor leading to non-compliance is lack of knowledge about the illness reflecting importance of psycho education. The importance of good communication between patient and doctor is increasingly acknowledged in relation to adherence. Therefore more extensive longitudinal study should be carried out focusing on doctor/patient relationship and related social, financial and clinical factors. Psychiatrists should recognize factors leading to noncompliance. They should explain the rationale for use of regular medication and impart proper psycho education to patient and attenders. A Community level mental health education and proper counselling to psychiatric patients may improve compliance. Acknowledgements: Nil REFERENCES 1. Fenton WS, Blyer CR, Heinssen RK. Determinants of medication compliance in schizophrenia: empirical and clinical findings. Schizophr Bull 1997;23: Buckalew LW, Buckalew NM. Survey of the nature and prevalence of patient s non-compliance and implications for intervention. Psychol Rep 1995[Medline];76: Rana NH, Ayub M. Non-compliance to medicine in psychiatry patients. 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