iii

ABSTRACT

PATTERN OF MEDICATION AND KNOWLEDGE ABOUT DRUGS

USED DURING PREGNANCY IN NORTH DENPASAR II PUBLIC

HEALTH CENTER BALI

Introduction: Pregnancy is a special condition that needs more attention

regarding the health. Nutrition and health of the mother can directly affect the baby

which caused many unwanted outcomes. Even if drugs can cause unwanted effects,

the need of drugs for several cases such as hypertension, asthma, epilepsy, infection,

etc., are needed. Drugs i.e. vitamin and mineral is also needed since a pregnant

women require it more than normal people. This research aims to study about the

pattern of drug use in pregnant women in Bali especially in North Denpasar.

Methods: This research is a descriptive study, cross sectional survey design.

Questionnaire had been given to 96 respondents at private midwife practice in North

Denpasar II Public Health Center, Bali coverage area on August – October 2014.

Results: There were 93.7% pregnant women who used drugs. Total of 216

drugs prescribed with average of 2.24 prescriptions per women. Majority of it was

iron supplement which is 26.1%. The drugs were prescribed most on first trimester

with 47.7%. The drugs category was 97.7% belong to category A drugs and 2.3%

was category B drugs. The knowledge of respondent was majority moderate (59,

4%) and there were only 12,5% % with good knowledge.

Conclusion: Research revealed that the majority of drugs taken were iron

and the most prescribed drugs were on first trimester. Almost half of the respondent

has moderate knowledge but only few have good knowledge, more education about

drugs and pregnancy was encouraged to the midwife and public health center.

Keyword: pregnancy, pharmacoepidemiology, drugs, pattern, knowledge

iv

ABSTRAK

GAMBARAN PENGOBATAN DAN PENGETAHUAN MENGENAI

PENGGUNAAN OBAT SELAMA KEHAMILAN DI PUSKESMAS

DENPASAR UTARA II BALI

Latar Belakang: Kehamilan adalah kondisi istimewa dimana perhatian

mengenai kesehatan lebih dibutuhkan. Nutrisi dan kesehatan ibu dapat

mempengaruhi bayi secara langsung dan dapat menyebabkan hasil yang tidak

diinginkan. Meskipun obat dapat menyebabkan efek yang tidak diinginkan, obat

untuk beberapa kasus seperti hipertensi, asma, epilepsi, infeksi, dll tetap diperlukan.

Obat seperti vitamin dan mineral juga dibutuhkan karena ibu hamil

membutuhkannya lebih banyak daripada orang normal. Penelitian ini bertujuan

untuk mengetahui pola penggunaan obat pada ibu hamil di Bali khususnya

Denpasar Utara.

Metode: Penelitian ini merupakan penelitian deskriptif, cross-sectional

dengan bentuk survey. Kuesioner diberikan kepada 96 responden pada bidan

praktik swasta di daerah cakupan Puskesmas Denpasar Utara II pada bulan Agustus

– Oktober 2014.

Hasil: Terdapat 93,7% ibu hamil yang menggunakan obat dengan jumlah

resep 216 obat dengan rata-rata 2,24 resep per ibu hamil. Mayoritas obat adalah

suplemen besi yaitu 26.1%. obat diresepkan paling banyak pada trimester satu

sebesar 47,7%. Sebanyak 97,7% obat merupakan kategori A dan 2,3% kategori B.

pengetahuan responden mayoritas sedang (59, 4%) dan hanya terdapat 12,5% yang

mempunyai pengetahuan baik.

Simpulan: Penelitian menunjukkan bahwa mayoritas obat yang diberikan

merupakan suplemen besi dan obat paling banyak diberikan pada trimester pertama.

Hampir setengah dari responden mempunyai pengetahuan cukup tetapi sedikit yang

mempunyai pengetahuan baik. Penyuluhan mengenai obat dan kehamilan

disarankan pada bidan dan puskesmas.

Kata Kunci: kehamilan, farmakoepidemiologi, obat, gambaran, pengetahuan

v

LIST OF CONTENT

INSIDE COVER .................................................................................................... i

APPROVAL SHEET ............................................................................................ ii

ABSTRACT ......................................................................................................... iii

ABSTRAK ........................................................................................................... iv

LIST OF CONTENT ............................................................................................ v

LIST OF TABLE ............................................................................................... viii

LIST OF FIGURE ................................................................................................ ix

LIST OF ABBREVIATION ................................................................................. x

LIST OF ATTACHMENT ................................................................................... xi

CHAPTER I INTRODUCTION

1.1 Background ............................................................................................... 1

1.2 Statement of the Problem .......................................................................... 4

1.3 Purposes .................................................................................................... 4

1.3.1 General Purpose ............................................................................ 4

1.3.2 Specific Purposes .......................................................................... 4

1.4 Benefit ....................................................................................................... 4

1.4.1 Benefit for Science ........................................................................ 4

1.4.2 Benefit for Health and Community ............................................... 5

CHAPTER II LITERATURE REVIEW

2.1 Pregnancy .................................................................................................. 6

2.1.1 Gestational age .............................................................................. 6

2.1.2 Fetus development ........................................................................ 6

2.1.3 Maternal Physiology ..................................................................... 8

vi

2.2 Uses of Drugs during Pregnancy ............................................................ 10

2.2.1 Epidemiology .............................................................................. 10

2.2.2 Common Drugs Used .................................................................. 11

2.2.3 Drugs classification ..................................................................... 13

2.3 Teratogen................................................................................................. 13

2.3.1 Dose and timing of exposure ...................................................... 14

2.3.2 Known effect of drugs uses during pregnancy ........................... 15

2.4 Conceptual Framework ........................................................................... 16

CHAPTER III RESEARCH METHOD

3.1 Study Design, Time, and Location of Study ........................................... 17

3.2 Population and Sample ............................................................................ 17

3.2.1 Population variability .................................................................. 17

3.2.2 Sample criteria ............................................................................ 17

3.2.3 Number of sample ....................................................................... 18

3.3 Research Variable ................................................................................... 18

3.4 Operational Definition of Variables ........................................................ 19

3.5 Research Instrument ................................................................................ 20

3.6 Study Protocol ......................................................................................... 21

3.7 Data Analysis .......................................................................................... 22

3.7.1 Univariate Analysis ..................................................................... 22

CHAPTER IV RESULT AND DISCUSSION

4.1 Characteristic of Respondent ................................................................. 23

4.2 Pattern of Drugs Used ............................................................................ 24

4.3 Knowledge of Respondent ..................................................................... 31

vii

CHAPTER V CONCLUSSION AND RECOMMENDATION

5.1 Conclusion ............................................................................................. 35

5.2 Recommendation ................................................................................... 35

REFERENCES .................................................................................................... 36

ATTACHMENT ................................................................................................. 40

viii

LIST OF TABLE

Table 4.1 Socio Demographic Characteristic of Respondent ............................. 23

Table 4.2 Proportion of Drugs Type Consumed by Respondent ........................ 24

Table 4.3 Cross-tabulation of Drugs Type and Gravid ....................................... 25

Table 4.4 Cross-tabulation of Total Drugs Type and Last Formal Education .... 25

Table 4.5 Proportion of Drug Type Prescribed Based on Time of Consumption25

Table 4.6 Category of Drugs Consumed By Pregnant Women .......................... 30

Table 4.7 Respondent’s Level of Knowledge ..................................................... 31

Table 4.8 Proportion of True and False Statement in Each Level of knowledge 32

ix

LIST OF FIGURE

Figure 2.1 Classification of drugs by US FDA ................................................... 13

Figure 2.2 Conceptual Framework of the Study ................................................. 16

x

LIST OF ABBREVIATION

CDC : Center of Disease Control and Prevention

ORS : oral rehydration salt

SVR : Systemic vascular resistence

US FDA : United States of Food and Drugs Association

WHO : World Health Organization

xi

LIST OF ATTACHMENT

Attachment I Inform Consent.............................................................................. 40

Attachment II Questionnaire ............................................................................... 41

Attachment III Ethical Clearance ........................................................................ 44

Attachment IV Ijin Rekomendasi Badan Kesatuan Bangsa dan Politik ............. 45

Attachment V Ijin Penelitian Dinas Kesehatan ................................................... 46

Attachment VI Surat Perintah Tugas Puskesmas II Denpasar Utara .................. 47

Attachment VII Curriculum Vitae ...................................................................... 48

1

CHAPTER I

INTRODUCTION

1.1. Background

Pregnancy is a special condition that needs more attention regarding the

health. Nutrition and health of the mother can directly affect the baby which

caused many unwanted outcomes. The use of drugs during pregnancy needs a

special attention because the health and life of both the mother and the child is at

stake. An irresponsible use of drugs and inadequate intake of nutrition can cause

not only structural but also functional malformation. Congenital anomalies were

happened 3 – 4% of all pregnancies (Food and Drugs Administration, 2005)

(Malm, 2005). The cause of congenital anomaly generally couldn’t be assigned

for 50% of the cases. However, some of risk factors already assigned including

socioeconomic factor, genetic factor, infection, maternal nutrition status, and

environmental factor. One of the environmental factors is drugs exposure which

estimated for causing birth defect as big as 10% (Black & Hill, 2003).

The famous thalidomide tragedy resulted in the births of 6000 – 8000

malformed babies worldwide. A tragic reminder that drugs cannot be taken

lightly, this number does not include the probably considerable number of

abortions and fetal deaths associated with thalidomide exposure. The first report

of a suspected association between thalidomide and severe congenital

malformations were published in 1961 by McBride. Typical malformations were

bilateral shortened or missing limbs (phocomelia or amelia), but defects in other

organ systems (gastrointestinal, cardiovascular, eye and ear anomalies) were also

common (Malm, 2005). The guidance for evaluating the risk of drug exposure in

2

human pregnancies from Food and Drug Administration (FDA) has cited that the

use of any drug at any time during pregnancy can harm the developing embryo or

fetus. Based on study by Black (2003), more than 80 percent of pregnant women

in United States take over the counter drugs (OTC) or prescription drugs during

pregnancy and at least 10 percent of birth defects are thought to result from

maternal drug exposures (Food and Drugs Administration, 2005).

The used of prescription and OTC by pregnant women are reported high in

several countries (Black & Hill, 2003) (Rohra et al., 2008) (Stephansson et al.,

2011) (Kureshee & Dhande, 2013). Study conducted on Western India revealed

that the majority uses of drugs were from Category A (71.2%) and Category B

(16.5%) were prescribed for diseases encountered during pregnancy. These are

followed by those from Category C (9.09%) and D (1.12%) drugs that are mostly

prescribed to prevent complications caused by various disease conditions.

Category X drug was prescribed (0.7%) in cases of threatened miscarriages,

missed abortions and preterm labor. From all of them, only 24.55% of the women

believed that drug use in pregnancy could be harmful to both mother and baby,

while 2.59% believed that drugs use dangerous only to the mother and 4.39%

believed that drugs use is safe throughout pregnancy (Kureshee & Dhande,

2013). Study in Brazil, revealed that medicines with evidence of fetal risk

(category D and X) were used by less than 12% of pregnant women (Bertoldi et

al., 2012). This is contrary to the result of a study conducted in France, in which

the percentage of exposure to category D drugs was very high (59%) (Lacroix et

al., 2000).

3

The teratogenic effects of the drugs depends on several factors, which are

the quantity, the absorption, the metabolism, the protein binding ability, the cell

storages, the size, and the solubility of drug on the fat which determine the ability

of the drugs to cross the placental barrier (Gondo, 2007).

Even if drugs can cause unwanted effects, the need of drugs for several

cases such as hypertension, asthma, epilepsy, infection, etc., are needed. However,

the benefits of using drugs should be bigger than the disadvantages. Not only for

chronic illness, drugs i.e. vitamin and mineral is also needed since a pregnant

women require it more than normal people. Nonetheless not few women doesn’t

aware about it and didn’t consume it due to misperception regarding the

supplement benefit. The physiology changed caused by pregnancy should also be

considered by the physician when prescribing drugs. During pregnancy,

cardiovascular, respiratory, liver, and renal functions are changing. Not only

those, but also changes in the expression and activity of transport proteins and

enzymes systems. All the changes can cause pregnancy induce pharmacokinetic,

pharmacodynamics, and efficacy changes which need special attention from the

physician (Feghali & Mattison, 2011).

Pharmacoepidemiological studies can measure the extent of prescription

and effect of drug use in pregnant women. Recently no pharmacoepidemiological

study of drugs used on pregnancy is available in Indonesia, therefore, it becomes

important to know the proportion and pattern of drug used in pregnancy, as well

as the knowledge regarding drug use in pregnancy in Indonesia, especially in Bali.

4

1.2. Statement of the Problem

1) How much the prevalence of pregnant women using drugs in North

Denpasar II Public Health Center?

2) How is the pattern of drugs use in pregnancy?

3) How well the knowledge of pregnant women about drugs used in

pregnancy?

1.3. Purposes

1.3.1. General Purpose

This research aims to study about the drug use in pregnant women in Bali

especially in North Denpasar.

1.3.2. Specific Purposes

1) To study the prevalence of drug use in pregnant women in Bali

especially North Denpasar

2) To study the pattern of drug use in pregnant women in Bali especially

North Denpasar

3) To study the knowledge of pregnant women in Bali especially North

Denpasar about drugs used in pregnancy

1.4. Benefit

1.4.1. Benefit for Science

Hopefully this study will be useful for giving scientific information

regarding drug use during pregnancy especially in Bali. It might provide basic

information for subsequent study related to our study.

5

1.4.2. Benefit for Health and Community

Since the pharmaco-epidemiology study about drugs used during

pregnancy in Indonesia especially Bali is limited, this descriptive study can

provide basic information needed to develop a preventive strategy in order to

diminish the risk of drug exposure in pregnant women.