Drug utilization pattern during pregnancy in Nekemte referral hospital: a cross sectional study

INTRODUCTION

Medication use during pregnancy has been an issue of concern since the discovery of birth defects resulting from thalidomide use in early pregnancy during the 1960s. Diseases occurring during pregnancy are more dangerous because of the difficulties in their treatment strategy. These days, pregnancy care is one of the great challenges in health care systems since drug therapy protocols may affect the life of the mother and her baby too.¹ Pregnancy management using medications has a teratogen effects and the potential for foetal harm. This has increased the burden of risk assessment for health care providers.^2,3

Administration of a drug to the pregnant women presents unique problem for the physician. Not only must maternal pharmacologic mechanisms be taken in to consideration while using drugs but also the foetus must always be kept in mind that drugs administered during pregnancy can affect the foetus. Nevertheless studies conducted in the past few years indicate that drug consumption during pregnancy is increasing due to several reasons.⁴ Most people in the developing world are unaware of their drug and chemical exposure. Many are uninformed about the potential harmful effect of drug on the foetus even if there are some concerned groups. In the modern society, many individuals are overly concerned with their own comfort and seek pharmacological solution to the many systems that may affect pregnant women. Absence of enough information about safety of many medications when they are taken by pregnant women is the first factor for hazardous effects which has been evidenced by the thalidomide crisis that has occurred so far.²

Being a pregnant is a special physiological condition where there must be a precaution in administration of drugs to avoid teratogenic effect and undesired effect on the mother.⁵ Rational drug use in pregnancy requires the balancing of benefits and potential risks associated with the use of the drug. The benefits of rational drug use during pregnancy are not only restricted to the recovery of maternal health, but are also helpful in the development of the foetus appropriate treatment of conditions like diabetes mellitus and infectious disease of genital organs, embryopathies and preterm births.^5,6 Per-conception folic-acid supplements can prevent most neural tube defects and other congenital abnormalities of the cardiovascular system, urinary tract and limb deficiencies.^7-10 Moreover, folic- acid supplementations in pregnancy complications like placental abruption and preeclampsia.⁴

Iron and vitamin supplementation are the most frequently used drugs followed by analgesics, colytic agents and drugs for chronic conditions and common pregnancy symptoms.¹¹ Of all the medications, about (70%) folate, (38%) iron and (27%) multivitamins are the drugs taken by pregnant women along with herbal drugs like, ginger (20%) and raspberry leaf (9%).¹² A similar trend for use of herbal drugs like cannabis ginger and raspberry leaf during pregnancy is also reported.^12,13 Data on herbal drug use by pregnant women and factor like prior use of herbs, high knowledge about herbal drugs and age between 26 and 35 years, showed associations.¹⁶ Usually, herbal preparations are classified as dietary supplements and are not regulated like conventional drugs.¹⁷

There are reports of use of potentially harm full drugs 1.5% to 4.8% during pregnancy from developed and under developed countries of the world.^3,18-20 In a retrospective register-based cohort study, it was found that 20.4% women purchase at least one drug classified as clearly harmful.²¹ Many women can be exposed to drugs (mainly non steroidal anti inflammatory drugs) that can leads to some risk during pregnancy.²² A vast majority of these prescribed drugs during pregnancy, belonged to over the counter (OTC) medications (Ibuprofen) that are contraindicated in pregnancy. This is used at unexpectedly at high rates during pregnancy. These uses of common OTC drugs during pregnancy can lead to risks that ranges from a small to extremely high risk to both mother and the fetus.²³

Only a few studies have instigated the pattern of drug use particularly focusing on the drug safety of the pregnant females in the study area in Ethiopia.²⁴ There is no enough information on drug use pattern, which has importance in determining drug utilization during pregnancy and sensitize policy makers to know the magnitude of teratogenicity in the study area so far. Hence, this study underscores on the need to understand drug utilization patterns for pregnant women and investigate safety of drugs taken by the target population through the identification of the type of drugs prescribed and the pattern of drug prescription to pregnant females in Nekemte referral hospital.

METHODS

Study design and population

A cross-sectional study was conducted by using health records book of inpatient and outpatient departments in Nekemte referral hospital in West Oromia, Ethiopia from March 2013 to April 2013 to assess drug utilization pattern among pregnant women. Pregnant women who visited Nekemte referral hospital in past one year (2012-2013 G.C) were the target population. The number of study population was 100 individuals who were purposely (pregnant woman only) selected to represent the study population. Data were collected from their records of drug administered for pregnant women study population using a designed data collection sheet that included the class of pregnancy, types of drugs, roots of administration, dosage forms and sociodemographic information.

Data analysis

The collected data were checked manually for completeness, recorded in excel and analyzed using table and graphs for nonparametric analysis. SPSS version 16 was used for one way ANOVA and p<0.05 was considered significant.

RESULTS

A total of 100 pregnant women who were admitted to Nekemte referral hospital were considered for this study. The registration book in each ward and outpatient department was used to sample the number of pregnant women who visited the hospital. Gynecology (GYN) (32), antenatal care (ANC) (45) and Obstetric surgery (OBS) (23) women were identified. The highest number of women visited the ANC ward. Of 100 gravid who attended the hospital 96 of them had records that showed prescription for medication of which 44, 22 and 30 were from ANC, OBS and GYN respectively as given in Table 1. Out of 96 pregnant women who received at least a prescription for medication during their visit, 32 (33.3%) were in the first trimester, 30 (31.3%) were in the second trimester and 34 (35.4%) were in the third trimester as seen in Table 1.

A total of 183 drugs with an average of 1.83 drugs per individual woman were prescribed to pregnant women in the hospital. In ANC alone, on average 0.8 drugs /woman was prescribed. Among 81 drugs prescribed during ANC follow up, the majority 54 (62.8%) were prescribed in capsule form. Tablets 14 (16.4%), injection 12(13.9%) Ccx 1 (0.1%) and no prescription were made for syrup and pessary. About 58 drugs with an average of 1.8 drugs per pregnant woman were prescribed to women who attended GYN ward. About 18, 16, 18, 4 and 2 drugs in the form of injection, tablet, capsule, syrup and pessary were prescribed respectively and no prescription was made for Ccx form in this ward. On average in OBS ward, a woman received 1.9 prescription for the drug forms with the highest (54.5%) being injection form (parenteral). The majority of the prescription in GYN and ANC were capsule forms and injection forms are used mostly in OBS ward and majority of the prescription were from ANC ward with no significant difference. But significantly (p<0.05) high amount of capsule forms were prescribed in the three wards of the hospital when compared to other forms of drugs as shown in Table 2A.

The majority of prescription was made in first trimester. About 64 drugs with an average of 2.2 drugs per pregnant woman were prescribed in the first trimester. These drugs were prescribed for upper respiratory tract infection in the first, second and third trimester. An average of 1.9 drugs per pregnant woman in second trimester; and 58 drugs with an average of 1.7 drugs per pregnant woman in third trimester were prescribed. Mainly, the drugs were administered in PO rout and the least being virginal route as shown in Table 2B.

The data presented in Table 3 reveal that antibiotics for treating infections were the most frequently prescribed drug followed by iron folates iron supplement. Anti-acids, Chlorpromazine and IV fluids were still the third, fourth and fifth respectively. Potentially harmful drugs, oxytocin and paracetamol (FDA category X and B respectively) were prescribed 12 times each. The frequency of antibiotics prescription was significantly high (p<0.05) when compared to other prescriptions. Majority of the drug prescription 70 (40%) was in the 1^st and 54 (30%) for each of 2^nd and 3^rd trimester.

The socio-demographic status of the patients is depicted in Table 4. Among the 100 pregnant women visited Nekemte referral hospital during the study period, 15% were under age of 20 and 76% and 9% of them are 20-35years and >35 years old respectively with 85% married and the rest 15% single, 39% primi gravid and 61% multi gravid woman. Multigravida and married woman are the dominant group of the pregnant female attended the hospital. Most 76% of the woman were in the regular periods of high fertility rate ages. Most of them were and unemployed house wives.

The highest group are protestant and followed by ortho-dox and muslims respectively.

DISCUSSION

Women received prescription for many drugs in ANC ward in the study subjects. This probably to treat infection of upper respiratory tract infection in the first, second and third trimester which is also common in other parts of Ethiopia ²¹and those vising for health care also have increased the proportion. Most of the drugs in OBS ward were given by parenteral administration. The patients admitted to OBS ward for labour and they underwent cesarean section for delivery in which they took different IV fluids and anesthetics parentrally. The high value for the injectable prescribed in GYN ward may be due to the nature of the diagnosis observed i.e., hyper emesis gravid arum in which the patient can’t take drugs orally.²⁵

From the results of this study, diclofenac FDA category X (pregnancy contraindicated) was used in third trimester for pregnant women in labour; however, this can cause early closure and constriction of ductus arteriosus with subsequent neonatal pulmonary hypertension and transient right-sided hypertrophic cardiomyopathy.¹⁸ Therefore, it is very important to search for other alternatives that could alleviate pain during labour than using this drugs without prior risk assessment methods. Among the total drugs prescribed during ANC, on average 2.2 drug per woman was antibiotics. This prescription is against FDA (US) as the drugs can cross the placenta and their use late in pregnancy causes permanent discoloration of teeth, enamel hyperplasia and impaired fetal skeletal growth.^9,26 Folate supplementation stands second to antibiotics 44 (out of 178 drugs prescribed) which is common in pregnancy. Nearly all women are to some degree iron deficient and more than half of pregnant women in developing countries suffer from iron deficiency anemia.^10,12 Our result have shown that higher dose of histamine H₂ blocker prescribed for the patients with dyspepsia.¹⁷ Category D drugs (tetracycline, doxycycline, and others) and category C (cimetidine) drugs were prescribed to some of the patients.^27,28 These drugs should not be prescribed without assessing its risk and benefits. Their use may be acceptable if the benefit outweighs the associated risk. To minimize the risk, either safe alternatives should be used or close monitoring of the patient is required.

Most of the patients who attend Nekemte referral hospital were uneducated and unemployed. This may indicate bias by the mothers for being safe when treated in a referral hospital which may be linked to their socio-economic background. Majority of the woman who attended the hospital were multi gravida which may be due to persisted outcome of their family management burden and level of depression they might have faced during successive pregnancies.²⁹ Among the pregnant women who visited Nekemte referral hospital, 96% had a record for drug (s) with the first trimester accounting for 33.3% being the highest drug utilization recorded in the hospital. In the study FDA category X, C and D which are pregnancy contraindicated were used. Uses of these drugs, would rather impair the health of the mother and the new born, it is important to search for other alternatives that could alleviate pain during labour and treat infections during pregnancy period other than these drugs. Some drugs were prescribed against local and international guidelines for drug use to some of the patients. Such a prescription of drugs should not be underestimated because it definitely affects the life of both the mother and the foetus.

CONCLUSION

It is recommendable that there should be intensive assessment of pregnant women treatment including the US Food and Drug Administration Agency (FDA) and local operating guidelines risk category, the gestational period, and the risk-benefit balance of a drug before its prescription. The use of teratogenic drugs should be avoided during pregnancy in less severe diseases unless other alternatives are totally impossible to use.

ACKNOWLEDGEMENTS

The authors acknowledge Nekemte referral hospital and Wollega University School of pharmacy for cooperation during this study.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the institutional ethics committee

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