For Peer Review

Medication adherence in Palestinian Arabs with

schizophrenia

Journal: Journal of Clinical Pharmacy and Therapeutics

Manuscript ID: JCPT-2011-1338

Manuscript Type: Original Article

Date Submitted by the

Author: 14-Apr-2011

Complete List of Authors: Sweileh, Waleed Ihbesheh, MAnal Jarar, Ikhlas sawalha, ansam; an-najah national university, pharamcy Abu-Taha, Adham zyoud, Sa'ed Morisky, Donald

Keywords: Schizophrenia, Ethnic Differences, Clinical Pharmacy

Journal of Clinical Pharmacy and Therapeutics

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Medication adherence in Palestinian Arabs with schizophrenia

Authors

1. Waleed M. Sweileh, Associate Professor of Clinical Pharmacology, Department of

Pharmacology and Toxicology, School of Pharmacy, An-Najah National University,

Nablus, Palestine.

2. Manal S. Ihbesheh, MS. Biochemistry, School of Pharmacy, Department of

Biochemistry, An-Najah National University, Nablus, Palestine.

3. Ikhlas S. Jarar, MS. Pharmacology, Department of Pharmacology and Toxicology,

School of Pharmacy, An-Najah National University, Nablus, Palestine.

4. Ansam F. Sawalha, Associate Professor of Clinical Toxicology, Department of

Pharmacology and Toxicology, School of Pharmacy, An-Najah National University,

Nablus, Palestine.

5. Adham S. Abu Taha, Assistant Professor of Clinical Pharmacology, Department of

Pharmacology and Toxicology, School of Pharmacy, An-Najah National University,

Nablus, Palestine.

6. Sa’ed H. Zyoud, MS Clinical Pharmacy, WHO Collaborating Centre for Drug

Information, National Poison Centre, Universiti Sains Malaysia (USM), 11800 Penang,

Malaysia.

7. Donald E. Morisky, Sc.D., M.S.P.H., Sc.M. Professor and Program Director, Doctoral

Training in the Social and Behavioral Determinants of Infectious and Chronic Disease

Prevention Department of Community Health Sciences UCLA School of Public Health,

650 Charles E. Young Drive South, Los Angeles, CA 90095-1772, USA

Corresponding author

Waleed M. Sweileh,

Associate Professor, Clinical Pharmacology,

Department of Pharmacology and Toxicology,

School of Pharmacy,

An-Najah National University,

P.O. Box: 7,

Nablus, Palestine

Short running title: Medication adherence and treatment satisfaction

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Medication adherence in Palestinian Arabs with schizophrenia

Abstract

Background and Objective: Arab world have complex societal and unique cultural beliefs about

mental illness. No studies have been carried out to assess medication adherence, treatment

satisfaction and clinical symptoms among schizophrenic patients in the Arab world. Therefore, the

objectives of this study were to assess medication adherence and to investigate relationships of

medication adherence with treatment satisfaction and clinical symptoms in a sample of Palestinian

Arab patients with schizophrenia.

Methodology: Medication adherence was measured using the 8-item Morisky Medication

Adherence Scale (MMAS) while treatment satisfaction was measured using the Treatment

Satisfaction Questionnaire for Medication (TSQM 1.4). Psychiatric symptoms were measured

using the expanded Brief Psychiatric Rating Scale (BPRS-E). Data were entered and analyzed

using SPSS 16 for windows.

Results: A convenience sample of 131 schizophrenic patients was studied. Based on MMAS, 44

patients (33.6%) had a low rate, 58 (44.3%) had a medium rate & 29 (22.1%) had a high rate of

adherence. The means of satisfaction with regard to effectiveness, side effects, convenience and

global satisfaction were 72.6 ± 20.5, 67.9 ± 31.47, 63.2 ± 14.3 & 63.1 ± 18.8 respectively. There

was a significant difference in the means of effectiveness (P<0.01), convenience (P<0.01), global

satisfaction (P<0.01), but not side effects domains (P=0.1) among patients with different levels of

adherence. Furthermore, there was a significant difference in the mean of positive symptom score

(P<0.01) but negative symptom score (P=0.4) among patients with different levels of adherence.

Conclusions: Medication non-adherence was common among Palestinian Arab patients and was

associated with low treatment satisfaction scores and poor positive symptom scores.

Key words: Schizophrenia, medication adherence, treatment satisfaction

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Introduction

Schizophrenia is a chronic psychiatric disorder that impairs the quality of

patients’ life (Palmer et al., 2002; Pinikahana et al., 2002; Sharma and Antonova

2003). Antipsychotic drug therapy has been reported to successfully minimize the

frequency of acute schizophrenic episodes and hospitalization and that adherence is

a necessary element to achieve such success (Awad and Voruganti 2004; Campbell

et al., 1999). Furthermore, adherence has been reported to lead to considerable cost

savings for the health system (Damen et al., 2008). However, non-adherence to

antipsychotic medications is common and is considered as an integral barrier to the

successful treatment of schizophrenia (Byrne et al., 2008; Dolder et al., 2002; Kim

et al., 2006).

Several factors can contribute to medication non adherence in patients with

schizophrenia (Misdrahi et al., 2002; Svestka and Bitter 2007; Lowry 1998). Such

factors include race, culture and religion. For example, a review article about

psychotropic medications found that rates of non-adherence were higher among

Latinos than Euro-Americans and clinical and research interventions to improve

adherence should be culturally appropriate and incorporate identified factors

(Lanouette et al., 2009). Another study examined how religious beliefs and practices

can affect medication and illness representations in chronic schizophrenia. The

authors concluded that religion and spirituality contribute to shaping representations

of disease and attitudes toward medical treatment in patients with schizophrenia and

that this dimension should be on the agenda of psychiatrists working with patients

with schizophrenia (Borras et al., 2007). In the Arab world, families of patients with

schizophrenia suffer from stigmatization (Kadri et al., 2004). Actually, the common

belief in the Arab society is that mental illnesses have a devilish and sinful

component. Unfortunately, Pubmed search showed no studies about medication

adherence and treatment satisfaction among schizophrenic Arab patients. Therefore,

the objectives of this study were to assess medication adherence and to investigate

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relationships of medication adherence with treatment satisfaction and clinical

symptoms in a sample of Palestinian Arab patients with schizophrenia.

Methodology

Study Design and Patient selection:

This cross sectional study was conducted between July 2010 and September

2010 at Al-Makhfya psychiatric Health Center in Nablus, Palestine. Approval to

perform the study was obtained from the Palestinian ministry of health and

Institutional Review Board at An-Najah National University. Patients who met the

following criteria were invited to participate in this study: 1) their age was between

20 and 65 years, 2) they were diagnosed with schizophrenia as defined by DSM-IV

and confirmed in their medical files and 3) they had not been suffering from an

acute attack of illness during the past year. A convenience sample of 150 patients

met the inclusion criteria during the study period.

Assessment and measures

The instrument used in this study consisted of four parts: part one collected

socio-demographic and medication data obtained directly from the patient and his

medical files; part two was medication adherence test, part three was the treatment

satisfaction test and the final part was the psychiatric assessment.

Medication adherence was tested using Arabic version of the validated eight-

item Morisky Medication Adherence Scale (MMAS) (Morisky et al., 2008; Morisky

et al., 1986). English version of the MMAS was translated into Arabic and was

approved by professor Morisky through e-mail communication. The translation

process was carried out according to the following procedure: 1) A forward

translation of the original questionnaire was carried out from English to Arabic

language by two qualified independent, native linguistic expert translators (2) A

back translation from Arabic language to English was carried out by two different

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translators. (3) The back translated questionnaire was tested and approved by the

developer through e-mail. The Arabic version of MMAS is an 8-item questionnaire

with 7 yes/no questions while the last question was a 5-point Likert scale. Based on

the scoring system of MMAS, adherence was rated as follows: high adherence (=

8), medium adherence (6 - <8) and low adherence (< 6).

Treatment satisfaction was tested using the Arabic version of Treatment

Satisfaction Questionnaire for Medication (TSQM 1.4) which the researchers

obtained from Quintiles Strategic Research Services. The TSQM 1.4 is a 14-item

psychometrically robust and validated instrument consisting of four scales (Bharmal

et al., 2009). The four scales of the TSQM 1.4 include the effectiveness scale

(questions 1 to 3), the side effects scale (questions 4 to 8), the convenience scale

(questions 9 to 11) and the global satisfaction scale (questions 12 to 14). The TSQM

1.4 domain scores were calculated as recommended by the instrument’s authors,

which is described in detail elsewhere (Atkinson et al., 2005; Atkinson et al., 2004).

The TSQM 1.4 domain scores range from 0 to 100 with higher scores representing

higher satisfaction on that domain.

Psychiatric symptoms, positive and negative schizophrenic symptoms were

evaluated by a psychiatrist and well trained psychologists using the expanded Brief

Psychiatric Rating Scale (BPRS-E) (Lukoff et al., 1986; Overall and Gorham 1962;

Overall and Gorham 1988; Ventura et al., 1993) at the same visit. The BPRS–E

consists of 24 items measuring psychiatric symptoms. Each item in BPRS-E is rated

from 0 – 7 based on the severity of the symptom where the highest score indicate

the highest severity. BPRS-E measures four different dimensions: manic

excitement/ disorganization, positive symptoms, negative symptoms, and

depression/ anxiety (Ruggeri et al., 2005). Positive symptom score (PSS) was based

on the sum of scores of the followings: grandiosity, suspiciousness, hallucinations,

unusual thought content and conceptual disorganization. Negative symptom score

(NSS) was based on the sum of scores of the following symptoms: disorientation,

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blunted affect, emotional withdrawal, motor retardation, and mannerism and

posturing.

Data analysis

Continuous variables like the Morisky score, satisfaction domain scores,

BPRS, PSS and NSS were expressed as mean ± SD. Correlation between

continuous variables was carried out using Pearson correlation test. Difference in

means among groups was carried out using one-way ANOVA test with the Tukey

post-hoc test. All statistical analyses were conducted using Statistical Package for

Social Sciences (SPSS; version 16.0) for Windows. The conventional 5 percent

significance level was used throughout the study.

Results

1. Demographic and clinical characteristics

One hundred and fifty patients out of 267 registered schizophrenic patients met

the inclusion criteria. One hundred and thirty one (131) patients agreed to

participate giving a response rate of 87.3%. Of the 131 patients, 40 (30.5%) were

female and 91 (69.5%) were male. The mean age of the patients was 42.9 ± 10.3

years (range = 20 – 65 years). The mean duration of illness was 16.23 ± 9.59 years.

Eighteen patients (13.7%) had other non-psychiatric diseases mainly diabetes

mellitus (10 patients; 7.6%). Smoker schizophrenic patients represented 55% (72

patients) of the sample. None of the patients were reported to have any type of drug

abuse. Details regarding demographic and clinical characteristics of the studied

patients are shown in Table 1.

2. Assessment of adherence, treatment satisfaction and psychiatric symptoms

Based on MMAS, 44 (33.6%) of patients had a low adherence, 58 (44.3%) had a

medium adherence & 29 (22.1%) had a high medication adherence. The average

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adherence score (6.1 ± 1.7) for the patients generally indicates medium rate of

adherence. There was a significant positive correlation between age and adherence

(P = 0.028; r = 0.19). However, no such correlation was observed with the duration

of illness (P = 0.13). Furthermore, no significant difference in the means of

adherence was found between male and female (P = 0.76). Patients having other

chronic diseases have significantly higher adherence score compared to those who

do not, but the significance was at the borderline (P = 0.049).

The average scores of satisfaction with regard to effectiveness, side effects,

convenience & global satisfaction were 72.6 ±20.5; 67.9 ± 31.5; 63.2 ± 14.3; & 63.1

± 18.8 respectively. The mean BPRS score of the patients was 68.4 ± 24.5 with 14.4

± 6.7 & 13.7 ± 6.1 means for PSS and NSS respectively. Analysis of satisfaction and

psychiatric scores based on adherence levels (low, medium and high) is shown in

table 2. There was a significant difference in means of effectiveness (P <0.01, F =

8), convenience (P < 0.01; F = 12.5) and global satisfaction domain (P< 0.01, F = 9)

but not in side effects domain (P = 0.1; F = 2) among the three levels of adherence.

Patients in the high adherence category had the highest satisfaction score compared

to those in low and medium adherence categories. Results of post hoc analysis are

also shown in Table 2.

Significant difference was found in the means of BPRS (P < 0.01; F = 4.9),

PSS (P < 0.01, F = 5.7) but not in NSS (P = 0.3; F = 1) among the three levels of

adherence. Patients in the high adherence category had the greatest improvement in

psychiatric symptoms and positive symptoms but not in negative symptoms. Post

hoc analysis of psychiatric symptoms versus adherence levels is shown in table 2.

Discussion

This study is the first of its type in Palestine and Arab world to assess medication

adherence among patients with schizophrenia and the first study that used an Arabic

version for MMAS. Results of our study showed that the majority of schizophrenic

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Palestinian Arab patients were non-adherent and that younger patients had

significantly lower adherence scores than elderly ones. Our findings regarding

impact of age on medication adherence is in agreement with finding reported by

other researchers (Hui et al., 2006; Sajatovic et al., 2007). However, other

researchers reported equal non adherence among middle aged and elderly patients

(Jeste et al., 1999a). Several studies have shown that up to 80% of all schizophrenic

patients discontinue antipsychotic medications and that non-adherence rates ranging

from 20% to 89%, with an average rate of approximately 50%, have been reported

(Fenton et al., 1997; Lacro et al., 2002; Young et al., 1986). In a study of

schizophrenia psychopathology carried out in Kuwait, the authors concluded that

the persistence of psychotic symptoms despite freely available antipsychotic

treatment call for attention to the need for continued interaction with family

members in order to address the impact of symptoms (Zahid and Ohaeri, 2010).

There is a wide range of reported rates of adherence among schizophrenic patients.

Differences in methodology used to assess adherence as well as social and cultural

differences among different countries might be responsible for different results

obtained regarding rate of adherence (Breen et al., 2007). A study carried out in

Malaysia among people with different religious background has concluded that lay

beliefs about schizophrenia may serve different functions for different ethno-

cultural groups, which have an influence on help-seeking behaviour (Swami et al.,

2008). Similar results were obtained by Sheikh and Furnham (Sheikh and Furnham,

2000). Psychiatrists and health professionals tend to underestimate the importance

of this issue possibly due to the low rates of religious affiliation of psychiatrists, or a

lack of knowledge of religions (Shafranske 1996; Neeleman and King 1993; Lukoff

et al; 1995).

Although patient’s satisfaction with treatment regimen is crucial for

medication adherence (Atkinson et al., 2004; Taira et al., 2006), few studies had

examined the relationship between adherence, treatment satisfaction and therapeutic

outcome in patients with schizophrenia (Freudenreich et al., 2004; Fujikawa et al.,

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2008; Watanabe et al., 2004). Our findings endorse previous reports that treatment

satisfaction is positively associated with antipsychotic medication adherence and

improved clinical outcomes (Gharabawi et al., 2006; Hofer et al., 2004; Masand and

Narasimhan 2006). Other researchers also had similar conclusions. A study by

Maneesakorn and colleagues indicated that antipsychotic medication adherence has

positive impact on psychiatric symptoms and satisfaction with medication

(Maneesakorn et al., 2007; Mohamed et al., 2009). On the other hand, medication

non-adherence had negative impact on treatment response, highlighting the

importance of adherence to achieve satisfactory treatment outcome (Lindenmayer et

al., 2009). A study by Liu-Seifert et al 2005 has found that discontinuing of

treatment may lead to exacerbation of psychiatric symptoms and undermining

therapeutic progress (Liu-Seifert et al., 2005). In these studies, poor response to

treatment and worsening of underlying psychiatric symptoms, and to a lesser extent,

intolerability to medication were the primary contributors to treatment being

discontinued.

The conclusions of our study can be summarized as follows: First, the

majority of the patients had low to medium rate of adherence. Second, treatment

satisfaction and psychiatric symptoms are better in patients with higher adherence

rate. Our study has few limitations. First, sample size used in the study might be

relatively small to draw conclusions for assessing adherence, satisfaction and

psychiatric symptoms. Furthermore, the convenience sampling might create a bias

problem in assessing adherence and satisfaction. Second, instruments that we used

to assess adherence, satisfaction and BPRS might not be the gold standard for this

purpose. A third potential limitation of our study is that the patients who participated

in the study were homogenous in that all of them had governmental insurance and

tends to use similar medications and treated by the same psychiatric team. Non-

adherence among schizophrenic patients might be inherent in the context of the

disease itself. Despite these limitations, results of this study were useful in

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understanding adherence, satisfaction and psychiatric symptoms among Arab

culture in which publication in this field is scarce.

Acknowledgement: The authors would like to acknowledge and thank the

Palestinian ministry of health and the team at the Al-Makhfya psychiatric center/

Nablus/ Palestine.

Funding: None

Conflict of Interest: None

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Table 1 Baseline demographic and clinical data

Variable Mean ± SD or

frequency (%)

Age (years) 42.9 ± 10.3

Gender (male) 91 (69.5)

Presence of other chronic diseases

Yes

18 (13.7)

Duration of illness (years) 16.2 ± 9.6

Smokers 72 (55)

Morisky score

Low adherence

Moderate adherence

High adherence

6.1 ± 1.7

44 (33.6)

58 (44.3)

29 (22.1)

TSQM scales :

- Effectiveness

- Side effect

- Convenience

- Global satisfaction

72.6 ± 20.5

67.9 ± 31.5

63.2 ± 14.3

63.1 ± 18.8

BPRS score

- Positive symptom score

- Negative symptom score

68.4 ± 24.5

14.4 ± 6.7

13.7 ± 6.1

Abbreviation: SD: standard deviation; TSQM: Treatment satisfaction

Questionnaire for medication; BPRS: Brief Psychiatric Rating Scale.

Table 2 Treatment satisfaction and psychiatric symptoms stratified by level of adherence.

Adherence level

Variable Low

adherence

(a)

Medium

adherence

(b)

High

adherence

(c)

P value

Post hoc analysis;

significant pairs

Effectiveness

65.9±20 71.5±20 84.7±15.7 < 0.01 a – c; b - c

Side Effects

61.2 ±27.4 67.8±33.7 76.1±31.3 0.1 none

Convenience

55.7±12.2 64.8±13.4 70.2±13.5 <0.01 a – b; a - c

Global Satisfaction

56.5±18.9 61.9±18.6 75.5±13.8 <0.01 a – c; b - c

BPRS

76±22.4 67.8±23.3 58±26.5 <0.01 a – c

PSS

16.9±7.1 14.1±6 11.6±6 <0.01 a - c

NSS

14.4±4.9 13.9±6.5 12.3± 6.8 0.4 none

Abbreviation: BPRS: Brief Psychiatric Rating Scale; PSS: Positive Symptom Score; NSS: Negative

Symptom Score

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