Journal : JMMR (Jurnal Medicoeticolegal dan Manajemen Rumah Sakit), 9 (2): 100-109, August 2020

Website : http://journal.umy.ac.id/index.php/mrs
DOI : https://doi.org/10.18196/jmmr.92120

Medication Adherence of Tamoxifen to Breast Cancer Patients

and the Affecting’s Factors in Indonesia
Via Dolorosa Halilintar1,2, Mardiati Nadjib3, Lucia Rizka Andalusia4
Correspondence Author : vidho.rivera54@gmail.com
1Faculty of Pharmacy, Universitas Indonesia, Pondok Cina, Beji District, Depok City, West Java, 16424, Indonesia
2School of Medicine and Health Sciences, Atma Jaya Catholic University of Indonesia, Pluit, Penjaringan, North Jakarta,
14440, Indonesia
3Faculty of Public Health, Universitas Indonesia, Pondok Cina, Beji District, Depok City, West Java 16424, Indonesia
4Dharmais Cancer Hospital, Kota Bambu, Palmerah, West Jakarta, 11420, Indonesia

INDEXING A B S T R AC T
Keywords: Several previous studies show that adherence to hormonal therapy increase survival
Breast cancer; rate in Breast Cancer (BC) with ER+ or PR+. Tamoxifen is one of oral chemotherapy
Medication which is the most used hormonal therapy in breast cancer treatment regimens. The
Adherence; focus of the study was to determine the level of adherence and factors influencing the
Tamoxifen adherence of the treatment of BC patients undergoing hormonal therapy with
Tamoxifen in patients at Dharmais Cancer Hospital in year 2018. The study is an
observational study with a cross-sectional design. The study was followed by 109
respondents. Medication adherence levels assessed via questionnaire modified
MARS-5. Sociodemographic and clinical characteristic obtained from interviews using
structured questionnaires. Medication adherence’s level of Tamoxifen was 90.9%
with the proportion of adhere patients was 75.2% (82 of 109 patients). Multivariate
analysis showed that the age of respondents, level of education, level of knowledge is
the most influential factor and determine the level of treatment adherence. Education
level is the variable that has the greatest effect on medication adherence.Through this
study, it is recommended to pay more attention to patients with specific
characteristics such as patients with low education and or low income.

Kata Kunci: Beberapa studi menunjukkan bahwa kepatuhan pengobatan dengan terapi hormonal
Kanker Payudara; meningkatkan survival rate pada pasien Kanker Payudara (KPD) dengan ER+ atau PR+.
Kepatuhan Tamoxifen (TMX) adalah salah jenis kemoterapi oral yang paling banyak digunakan
Pengobatan; sebagai terapi hormonal dalam rejimen pengobatan kanker payudara. Tujuan
Tamoxifen; penelitian ini adalah untuk mengetahui tingkat kepatuhan pasien KPD yang menjalani
terapi hormonal dengan TMX di RS Kanker Dharmais Jakarta pada tahun 2018.
Penelitian ini merupakan studi observasional dengan desain penelitian potong-lintang
(cross sectional). Studi penelitian ini diikuti oleh 109 orang responden. Tingkat
Kepatuhan dinilai dengan kuesioner MARS-5 yang telah dimodifikasi. Profil
sosiodemografi dan klinis responden diperoleh melalui wawancara menggunakan
kuesioner terstruktur. Tingkat kepatuhan pengobatan KPD dengan TMX adalah sebesar
90,9% dengan proporsi pasien yang patuh adalah sebesar 75,2% (82 dari 109 pasien).
Hasil analisis multivariat menunjukkan bahwa umur pasien, tingkat pendidikan dan
tingkat pengetahuan merupakan faktor yang paling berpengaruh dan menentukan
tingkat kepatuhan pengobatan. Tingkat pendidikan merupakan variabel dengan
pengaruh paling besar terhadap kepatuhan pengobatan. Melalui studi ini
direkomendasikan untuk memberi perhatian lebih untuk memberikan perhatian lebih
pada pasien dengan karakteristik spesifik seperti pasien dengan tingkat pendidikan dan
pendapatan rendah.
© 2020 JMMR. All rights reserved
Article History: Received 2020-06-18; Revised 2020-07-15; Accepted 2020-08-13

INTRODUCTION
The prevalence of breast cancer (BC) is one of the highest among other types of cancer,
which is as much as 23% of the total types of cancer. According to WHO data in 2008, there
were about 1.38 million cases of BC, of which 209,000 were new cases in Asia, mainly in
Southeast Asia (Wigertz et al., 2012). The National Cancer registration data at the
| 101 | Via Dolorosa Halilintar1, Mardiati Nadjib2, Lucia Rizka Andalusia3 – Medication Adherence of …

"Dharmais" Cancer Hospital in Jakarta stated that in 2007 there was an increase of 437 new
cases of BC compared to 279 new cases in 2004. This increase in prevalence was also directly
related to the death rate. As of 2008, 458 people had died due to BC in Dharmais Cancer
Hospital (Data and Information Centre Ministry of Health Indonesia, 2015)
Tamoxifen (TMX) is an essential hormonal therapy that was used as a treatment
modality for BC, and through several studies, it was said to reduce mortality in BC patients
by 31% in early-stage patients estrogen-receptor-positive (ER +) (Wigertz et al., 2012). TMX
(dose of 20 mg per day) is prescribed in the BC treatment regimen for therapy for at least five
years to increase patient survival rates (Gotay & Dunn, 2011)
Some studies mention problems related to medication adherence to treatment
regimens with Hormonal Therapy. Only about 75% of women with breast cancer with ER +
(positive estrogen receptors) or PR + (positive progesterone receptors) receive hormone
therapy with Tamoxifen being obedient in carrying out their treatment (Gotay & Dunn,
2011; Moon & Moss-morris, 2017; Van Herk-Sukel et al., 2010). The long duration of
therapy is aimed at reducing the risk of future cancer re-emergence (relapse). Another study
stated that one in three women with breast cancer who had undergone TMX therapy stopped
taking therapy before the recommended end time of 5 years of therapy (Breast Cancer
Research Foundation, 2015). BC patients with ER + who undergo TMX treatment for five
years will reduce the recurrence rate by 46%, and the death rate will decrease by 26%
(Grunfeld et al., 2005).
Study conducted by Barron et al (2007) of Trinity College Dublin states that 22% of
women stop taking Tamoxifen in 1 year and 28% in 2 years. After 3.5 years of use, about
35% have stopped using Tamoxifen without using other therapies as a substitute. Younger
women (35 to 45 years) or older women (over 75 years) are more likely to stop using
tamoxifen
In Taiwan, Hsieh et al (2015) found that the level of adherence to BC treatment with
TMX was around 77.3%. Meanwhile, found that women with BC in Singapore who had
hormonal therapy with TMX had a 31.6% compliance rate only. Peng et al (2016) in China
found that only 53.4% of geriatric patients underwent hormonal therapy with TMX8. Study
in Indonesia by Budiman et al (2013) at M. Jamil Padang Hospital Padang found that 9 out
of 61 BC patient respondents (14.8%) who had hormonal therapy with TMX were not
compliant in carrying out their treatment.
This study aims to analyze the medication adherence of undergoing treatment with
TMX and the factors that influence the compliance of the treatment regimen with TMX.

RESEARCH METHOD
This study used a cross-sectional study design, conducted at the Dharmais Cancer
Hospital in Jakarta, from December 2017 to February 2018. Inclusion criteria consisted of
female patients with breast cancer, aged 18-60 years, and undergoing treatment with TMX for
at least six months. The number of respondents who met the inclusion criteria was 109
women. BC patients become respondents after expressing their consent by filling and signing
on the informed consent form. Interview using a questionnaire. Patients were interviewed
while waiting to take drugs at a hospital pharmacy.
JMMR (Jurnal Medicoeticolegal dan Manajemen Rumah Sakit), 9 (2), 100-109 | 102 |

Research data were obtained from direct interviews with structured questionnaires
and medical records. Medication adherence was obtained with a modified MARS-5
questionnaire. Demographic, clinical, and social characteristics were collected from the
questionnaire. Medical record data are used to collect other clinical information such as
comorbidity and cancer stage.
This study examined 12 variables affecting the level of adherence, categorized into
patient factors (age, marital status, income, level of education, also knowledge about disease
and treatment), clinical factors (cancer stage, comorbidity, the severity of side effects, use
other drugs (besides TMX), and duration of therapy. Non-patient factors consist of
availability of drugs and ownership of health insurance.
Cancer stage classification in this study is based on the results of anatomic pathology
examination as stated in the medical records. The income level is divided into two categories:
high and low. Low income if the respondent has an income below 3,500,000 IDR / month.
Comorbidity status is classified based on the presence or absence of comorbidities other than
BC. The patient's level of education in this study was divided into three levels: primary if
passed elementary school or equivalent, middle- if high school, and high, if at least partially
completed diploma education. The severity of the side effects of the treatment felt by the
patient is categorized as "None" if the patient does not feel any disturbing side effects; "Mild,"
if there are side effects of treatment but do not interfere with the activity and mobility of the
patient. "Medium" if the side effects of treatment interfere with activity but do not inhibit
patient mobility.
The use of other drugs involves taking drugs that are not included in the breast
cancer treatment regimen by a doctor. Respondents stated whether they had received
information or education from doctors, nurses, or other health professionals about breast
cancer and their treatment regimens. Patients did not get TMX on schedule because of a
vacancy in the hospital stock (availability of drugs). The duration of therapy is measured by
how long the respondent has used TMX as hormonal therapy. Socio-demographic data such
as age, marital status, employment, income, education level, type of health insurance, and
knowledge about illness and care, were obtained from a research questionnaire.
Patient clinical data in the form of comorbidity and stage of cancer were collected
from medical records, while the severity of side effects of treatment was asked through a
questionnaire.
The medication adherence questionnaire, which modified MARS-5, consisted of 5
questions: 2 questions with a Likert scale and three questions with the Guttman scale.
Validity and reliability tests were carried out on the questionnaire before being used on
research subjects. The reliability test (Cronbach Alfa) for questions number 1 and 2 was
0.913. This result is acceptable because it is greater than the standard Cronbach Alfa value of
0.6. The validity test results are known to each question is 0.840. This is greater than the "r"
value calculated from the "r" table, which is 0.541. For questions number 3-5, tests are
performed to obtain a Coefficient of Reproducibility (CR) score and a Coefficient of
Scalability (CS) score. From the results of each test, it is known that the value of CR = 0.82
and CS = 0.64. This value meets the requirements above 0.6. A score of 14-16 is categorized
as adhere, while a score of ≤ 13 is categorized as non-adhere. This categorization is based on
| 103 | Via Dolorosa Halilintar1, Mardiati Nadjib2, Lucia Rizka Andalusia3 – Medication Adherence of …

the assumption that on a score of 14-16 patients have done more than 80-85% of their
treatment.
Before being used, the methods and protocols used in this study were approved by
the Medical Research Ethics Committee of the Dharmais Cancer Hospital Jakarta on
October 23, 2017, with ethical clearance number: 088 / KEPK / X / 2017.
Univariate analysis was used to describe the characteristics of respondents. Bivariate
analysis using chi-square (χ2) and Fisher Exact test. This analysis is used to determine the
relationship between patient and non-patient factors with treatment compliance. Analysis of
multivariate using Backward LR logistic regression. Variables that have p-values <0.25 in the
bivariate analysis were included in the multivariate analysis.

RESULT AND DISCUSSION

Table 1. shows the average age of patients 45.73 years. The average income of patients
is Rp 4,325,688 with a high proportion of income (above Rp3,500,000 / month) 74.3%. The
group of patients with secondary education is greatest (57.8%). The largest proportion of
respondents with stage 2 BC (38.5%). Respondents with mild side effects were highest
among patients without side effects and moderate (53.2% vs. 37.6% vs. 9.2%). As many as
55% of respondents did not use medication other than TMX in the treatment regimen.
Based on the presence of comorbidities, there were more patients without
comorbidities than those who had comorbidities (58.7% vs. 41.3%). Respondents with a
high level of knowledge were 58.7% compared to 41.3%. About 56% come from patients
who have received information and education about care. Drug supply vacancies at hospital
pharmacies that cause patients not to receive TMX occurred in 11.3% of respondents.
Table 2. shows that respondents with a characteristic age of patients between 41-59 years,
high level of education, receiving information and education about treatment, having health
insurance, and a high level of patient knowledge have a significant relationship with TMX
treatment adherence in BC patients.

Table1. Clinical and Sociodemographic Characteristic (n=109)

Variable (s) Descriptive Proportion of total (%)
Marital Status Unmarried 9,2
Married 91,8
Age (s) 20 - 40 22,9
41 - 59 74,3
> 59 2,8
Stage of Cancer 1 22,0
2 38,5
3 36,7
4 2,8
Income High 75,2
Low 24,8
Comorbidities Yes 41,3
No 58,7
Educational Level Basic 8,3
Intermediate 57,8
Higher 33,9
Side Effect (s) None 37,6
JMMR (Jurnal Medicoeticolegal dan Manajemen Rumah Sakit), 9 (2), 100-109 | 104 |

Variable (s) Descriptive Proportion of total (%)

Mild 53,2
Medium 9,2
Another Medication None 45
Some 55
Provision of Information and Education None 44,0
Some 56,0
Incidence of Void Medication Never 88,1
Ever 11,9
Knowledge Low 41,3
High 58,7
Duration of Therapy (in years) 0-1 30,3
>1 29,4
>2 22,0
>3 18,3
Adherence No 24,8
Yes 75,2

Table 3. shows the result of a multivariate final modeling analysis, shows that the
respondent's age, level of education, and patient knowledge significantly influence treatment
compliance. The education level factor has the most significant impact on the level of
adherence. Adjuvant therapy with hormonal therapy in BC patients aims to increase disease-
free survival (remission), reduce the risk of relapse, and reduce the risk of death.

Table 2. Relationship between Respondent Characteristics and Medication Adherence

Variable (s) Description Proportion (% of total) Sig.*
Non-Adhere Adhere
Marital Status Unmarried 2 ( 20 ) 8 ( 80 ) 1.000
Married 25 ( 26,3 ) 74 ( 73,7 )
Age (s) 20 - 40 9 (16) 16 ( 64 ) 0,050
41 - 59 16 ( 19,8 ) 65 ( 80,2 )
> 59 2 ( 66,7 ) 1 ( 33,3 )
Stage of Cancer 1 4 ( 16,7 ) 14 ( 83,3 ) 0,295
2 11 ( 26,2 ) 31 ( 73,8 )
3 10 ( 25 ) 30 ( 75 )
4 2 ( 66,7 ) 1 ( 33,3 )
Income High 10 ( 12,3 ) 71 ( 87,7 ) 0,001
Low 17 ( 60,7 ) 11 ( 39,3 )
Comorbidities Yes 14 ( 28,9 ) 50 ( 71,1 ) 0,542
No 13 ( 21,9 ) 32 ( 78,1 )
Educational Level Basic 9 ( 100 ) 0 (0) 0,00 1
Intermediate 18 (26,4) 45 (74,6)
| 105 | Via Dolorosa Halilintar1, Mardiati Nadjib2, Lucia Rizka Andalusia3 – Medication Adherence of …

Higher 0 (0) 37 ( 100 )

Side Effect (s) None 8 ( 19,5 ) 33 ( 80,5 ) 0,381
Mild 15 ( 25,9 ) 43 ( 74,1 )
Medium 4 ( 40 ) 6 ( 60 )
Another Medication None 9 ( 18,4 ) 10 ( 81,6 ) 0,239
Some 18 ( 30 ) 42 ( 70 )
Provision of None 16 ( 42,6 ) 35 ( 57,4 ) 0,001
Information and Some 2 ( 4,2 ) 46 ( 95,8 )
Education
Incidence of Void Never 25 ( 26 ) 71 ( 74 ) 0,512
Medication Ever 2 ( 15,4 ) 11 ( 84,6 )
Knowledge Low 23 ( 51,1 ) 22 ( 48,9 ) 0,001
High 4 ( 6,2 ) 60 ( 93,8 )
Duration of Therapy 0-1 7 ( 21,2 ) 26 ( 78,8 ) 0,889
(in years) >1 8 ( 25 ) 24 ( 75 )
>2 6 ( 25 ) 18 ( 75 )
>3 6 ( 30 ) 14 ( 70 )
* Significance at confidence interval = 95% or p < 0,05

The level of adherence to respondents in this study was higher than the findings of
Hsieh et al., 2015 (77.33%), Wu and Lu, 2013 (71-75%) and Ali et al., 2017 (40.8%).
Meanwhile, the proportion of obedient respondents was lower than the research by Budiman
et. al., 2013, Which stated that the proportion of compliant BC patients was 85.2%.
Treatment adherence rates below 80% are often associated with reduced survival rates
(Grunfeld et al., 2005). Meanwhile, treatment adherence with rates between 41-72% from
some studies associated with increased mortality. These differences in results can be due to
differences in the measurement tools (questionnaires) used, and patient characteristics by a
respondent in the study (Peng M-T, Chen S-C, Shen W-C, Lin Y-C, 2016).
Table 3. The Multivariate Test Final Model
Variable (s) B pValue EXP B

Age In Years 0,09

> 59 (Ref)
> 41 - 59 2.38 0,09 3. 84
< 41 1,35 0, 07 10.89
Educational level 0, 03
Basic (Ref)
Intermediate 23.19 0,99 13.20
Higher 41.66 0,99 21.37
Knowledge 0,03 5,40
JMMR (Jurnal Medicoeticolegal dan Manajemen Rumah Sakit), 9 (2), 100-109 | 106 |

In this study, marital status had no relationship with medication adherence (95% CI:
0.529). Marital status is often associated with partner and family support is undergoing
treatment with a long duration (Jimmy & Jose, 2011; Mccowan et al., 2013) . Inclusion
criteria based on age are limited between 18-60 years to reduce the likelihood of respondent
bias because patients forget their treatment history.
This study shows that there is a relationship between the age of respondents and the
level of knowledge. MARS-5 scores in young patients and elderly patients are lower than
patients aged between 41-59 years. These results are in line with the findings of Wigertz et al.,
(2012) who show that patients who are younger (less than 40 years old) or older (70-80 years)
are less likely to be obedient in carrying out BC medication with TMX.
In young patients, non-adherence occurs because the side effects of treatment can
interfere with the patient's activity and productivity. While in elderly patients, apart from
adverse side effects, decreased memory and patient perceptions about treatment can cause
non-compliance with treatment. Study from The Arimidex (2006) states that early-stage
cancer patients are less adherent in carrying out treatment. At an early stage, signs and
symptoms of cancer do not significantly affect the patient so that the patient's awareness is
lacking in complying with treatment (Jimmy & Jose, 2011).
Income relates to an individual's ability to access health services related to medical costs
or indirect costs such as transportation costs (Grunfeld et al., 2005; Wigertz et al., 2012).
Weaver et al (2013) states that the lower a person's income, the more likely he is not to
comply with the prescribed treatment regimen. The results of this study show that there is a
relationship between income levels and medication adherence. This is likely because even
though treatment with TMX has been covered by BPJS, other costs such as transportation
costs can burden low-income individuals.
Murphy et al (2012) and Wigertz et al (2012) found that there was no relationship
between the level of education with the level of patient compliance in undergoing treatment.
This result may occur due to differences in literacy levels at the previous study location. The
level of health literacy in developed countries is higher than in developing countries.
Understanding of medication also relates to the level of adherence. Bender et al (2014)
found the fact that patients with a high level of knowledge (regarding the disease and
treatment undertaken) were more obedient in carrying out treatment . This is in line with the
results of research showing the relationship between knowledge level with medication
adherence. Knowledge of treatment regimens has an association with the level of education
and the availability of educational information about treatment. These results are also in line
with research conducted by Sinaga, Sinaga et al (2017) which shows that education level is
related to survival in patient with BC.
Co-morbid conditions also affect treatment compliance, which is associated with
additional treatment regimens and decreased patients' quality of life. Half of the patients with
comorbidity discontinue treatment before five years. This study shows no relationship
between comorbidity and medication adherence. Factors could cause this difference in
patients who have a positive perception of the condition of the disease. (Van Herk-Sukel et
al., 2010)
Gotay and Dunn (2011) mentions as many as 35% of patients stop using TMX because
of the side effects of hot flashes and 25% stop due to joint pain. The results of this study
| 107 | Via Dolorosa Halilintar1, Mardiati Nadjib2, Lucia Rizka Andalusia3 – Medication Adherence of …

indicate that the side effects of treatment do not influence adherence. These results can be
related to the level of patient acceptance of treatment and information about possible side
effects.
Over time, disease progression increases, and new disorders arise, such as osteoporosis,
which requires separate treatment (Nguyen et al.,2014). A systematic review conducted by
Moon & Moss-morris (2017) mentions that more and more drugs are used, which decreases
medication adherence. In this study, drugs for other conditions did not affect the level of
adherence.
Information and education on treatment regimens are essential for patients to know
about and the benefits of treatment risks. Nguyen et al (2014) said that special attention was
needed in the form of educational education in patients with chronic diseases and requiring
long-term care. This is in line with the study results that patients who are exposed to
information and education tend to be more obedient in carrying out their treatment.
The availability of drugs affects the ability of patients to meet treatment needs (Breast
Cancer Research Foundation, 2015). A drug vacancy does not affect medication adherence
because patients can buy TMX at other pharmacies. Other influential factors include
ownership of health insurance. Hess et. al. (2006) mentioned that 10% of patients with
chronic illnesses who did not have health insurance were unable to meet their medication
needs. Health insurance can reduce financial restrictions in accessing health services.
The main challenge in the treatment of chronic diseases is the long duration of
treatment (Kardas et al., 2013). The recommended duration of BC with TMX is 4-5 years or
can be extended to 6-8 years, depending on the patient's prognosis. Regarding the long
duration of treatment, patients can become bored, become disobedient, or even discontinue
treatment (Mccowan et al., 2013a; Nguyen et al., 2014; Wigertz et al., 2012). In this study,
the duration of therapy did not significantly influence perhaps because the side effects were
quite mild and relatively did not reduce the quality of life.
Result of multivariate analysis shows that the education level is the variable that has the
most influence. This is different from the study conducted by Mccowan et al (2013), which
states that the duration of treatment is most influential. Meanwhile, Budiman et al (2013)
research showed that patients' perception of treatment most significantly affected the level of
medication with TMX.

CONCLUSION
The level of medication adherence and the proportion of adherent patients with
carrying out the BC treatment regimen with TMX in Dharmais Cancer Hospital Jakarta is
already quite high. Nevertheless, interventions in the form of providing information and
treatment education, treatment evaluation, and monitoring of drug availability still need to
be done. This study suggests more attention than before to patients with low levels of
education. The use of more common communication diction may be needed in providing
information to this group.
This study only measures explicitly the level of compliance of patients using TMX.
Therefore, it is recommended to conduct studies on other types of hormonal therapy in
patients with BC. This is suggested because the transition between types of drugs are quite
common.
JMMR (Jurnal Medicoeticolegal dan Manajemen Rumah Sakit), 9 (2), 100-109 | 108 |

ACKNOWLEDGMENT
Pharmacy Department and Medical Record Section Dharmais Cancer Hospital.

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