Assessment of drug use among pregnant women in Addis Ababa, Ethiopia

pharmacoepidemiology and drug safety 2009; 18: 462–468.interscience.wiley.com) DOI: 10.1002/pds.1732
Published online 30 March 2009 in Wiley InterScience (www
ORIGINAL REPORT

Assessment of drug use among pregnant women in Addis Ababa,Ethiopiay,z

Binyam Kebede MSc1, Teferi Gedif PhD1* and Ashebir Getachew MD2

1Department of Pharmaceutics, School of Pharmacy, Addis Ababa University, Ethiopia2Department of Gynecology & Obstetrics, Medical Faculty, Addis Ababa University, Ethiopia

SUMMARY

Purpose To assess the drug use among antenatal care (ANC) attendant pregnant women in Addis Ababa.Methods Institution-based cross sectional study was conducted reviewing the antenatal care follow up cards and interviewing pregnantwomen using semi-structured questionnaire.Results A total of 1268 women were included in the study; of which 71.3% of them were prescribed at least one drug during pregnancy.Twelve point four per cent of the pregnant women who reported illness in the 2 weeks prior to the date of the interview, self-medicatedthemselves with either over the counter or prescription drugs or traditional herbs. The majority of the drugs prescribed were iron and vitaminsfollowed by anti-infectives. Nearly 4% of the pregnant women were prescribed with drugs from category D or X of the US-FDA riskclassification.Conclusion A considerable proportion of pregnant women were exposed to drugs, including those with potential harm to the fetus.Furthermore, pregnant women self-medicated themselves with modern medications or traditional herbs. Health care providers should thusweigh the therapeutic benefits of the drug to the mother against its potential risk to the developing fetus before prescribing. In addition it isessential to routinely inquire about the woman’s self-medication practice and provide the appropriate advice to the pregnant women.Copyright # 2009 John Wiley & Sons, Ltd.

key words—pregnancy; prescription; over the counter; herbal drugs; drug use; FDA risk classification

Received 26 October 2008; Accepted 30 January 2009

INTRODUCTION

The use of medications during pregnancy has been anissue of concern since the discovery of birth defectsresulting from thalidomide use in early pregnancyduring the 1960s.1,2 It has been estimated that up to10% of congenital anomalies may be caused byenvironmental exposure i.e., exposures to medications,alcohol, or other exogenous factors that have adverseeffects on the developing embryo or fetus.3 Hence it isnecessary to avoid all potentially adverse exposures.

*Correspondence to: Dr T. Gedif, School of Pharmacy, Addis AbabaUniversity, King George VI Street, Addis Ababa, P.O. Box-1176, Ethiopia.E-mails: [email protected]; [email protected]; [email protected] institutions at which the research was conducted: Two Govern-mental Referral Hospitals, Two Private MCH Hospitals, and Six HealthCenters.zNo conflict of interest was delared.

Copyright # 2009 John Wiley & Sons, Ltd.

However, it is not possible to avoid taking medicationsduring pregnancy because a pregnant may experienceshort-term and long-term health conditions that mustbe managed and discontinuing treatments can haveprofound long-term implications for the health ofthe mother and her baby. Hypertension and epilepsy areexamples of serious maternal conditions that if leftuntreated pose real hazards for the well being of themother and the fetus.4

Studies on side effects of drugs have traditionallyfocused on the potential teratogenic effects. Howeverdrugs and other chemicals may also influence fetal wellbeing at other times. For example, the use ofangiotensin converting enzymes (ACE) inhibitorsmay cause prolonged fetal hypotension, renal tubulardysplasia, growth retardation, and death when used inthe second and third trimesters of pregnancy.5

Furthermore, toxic manifestation of intrauterine

assessment of drug use among pregnant women 463

exposure to drugs (e.g., diethylstilboestrol) may not bedetected clinically until several years after birth. Thepotential long-term consequences of intrauterineexposure to drugs emphasize the importance ofstudying drug exposure during pregnancy.6

In the developing world, poor health seekingbehavior of patients, delayed initiation of ANC, lowlevel of educational status of mothers, lack of up to dateinformation for health care providers, poor access tohealth facilities, and loose control over prescriptionand non-prescription drugs could aggravate irrationaluse of drugs during pregnancy.This study is conducted to assess drug use among

ANC attendant pregnant women in Addis Ababa anddescribe the pregnancy risk level of medicationsprescribed or administered on self-selection basisduring pregnancy according to the US-FDA pregnancyrisk classification of drugs.7

METHODS

Institution-based cross sectional study was conductedby reviewing the ANC follow up cards and adminis-tering a semi-structured questionnaire to 1268 ANCattendant women in Addis Ababa from June to August,2007. Information about each pregnant woman and herself-medication practice in 2 weeks recall period wasrecorded.The study participants were pregnant women, at any

gestational age, who were already enrolled in theroutine ANC program and had more than one ANCvisits before the interview date and those who gavetheir consent to participate in the study.Health institutions in Addis Ababa were stratified on

the basis of their level (referral and regional hospitalsand health centers), ownership (governmental andprivately owned) and the availability of well-estab-lished ANC services. One specialized teachinghospital, one governmental maternity hospital, twoprivately owned MCH hospitals, and six health centerswere selected using simple random sampling tech-nique.Data entry and cleaning was done using Epi-Info

Version 6.0 and analysis was done using SPSS version11.0 statistical software. Drugs were classified intotherapeutic classes according to the AnatomicalTherapeutic Chemical Classification System of theWHO.8

Drugs with a potential for fetal harm duringpregnancy was evaluated based on the US-FDApregnancy risk classification system.7 FDA riskclassification (A, B, C, D, or X) was assigned toindividual drugs using Physicians’ Desk Reference and


Briggs’ ‘‘Drugs in Pregnancy and Lactation: AReference Guide to Fetal and Neonatal Risk’’.9,10

RESULTS

From a total of 1268 pregnant women interviewed,1114 (87.9%) of the respondents were in the age groupof 20–34 years with the mean age of 26.0 years. Fourhundred sixty four (36.6%) of the respondents hadcompleted secondary school, 229 (18.1%) had highereducation, 309 (24.3%) attended primary school, and179 (14.1%) were illiterates.The majority 1190 (93.8%) of the respondents were

married and 649 (51.1%) were housewives. Sevenhundred eight (55.8%) pregnant women had 2–4pregnancies and 484 (38.2%) were primi-gravida and233 (18.4%) had given to 2–4 births.Out of the 1268 current pregnancies, 64 (5.1%) were

teenage pregnancies and 1105 (87.7%) were on theirthird trimesters on the day of the interview. Half of thepregnant women had their first ANC visits between 13and 24 weeks of their pregnancy; while 291 (22.9%)had their initial ANC visits before the 13th week and335 (26.4%) started their ANC visits after the 24thweek of their pregnancy. Eight hundred eleven (64.0%)of the respondents had at least four antenatal visits and457 (36.0%) had less than four visits up until the date ofthe interview.

Drugs used during pregnancy

A total of 904 (71.3%) pregnant women used at leastone drug during their pregnancy (excluding vaccina-tion). Four hundred thirty three (34.1%) of the pregnantwomen had received iron with folic acid or vitaminonly. Excluding only iron or vitamins users, a total of471 (37.2%) pregnant women received at least onedrug during their current pregnancy.The number of women for whom drugs were

prescribed increased from 379 (29.9%) in the firsttrimester to 893 (70.4%) and 892 (70.3%) in the secondand third trimesters, respectively.A total of 1643 drugs were prescribed to the pregnant

women. Anti-anemic preparations were the mostfrequently prescribed class of drugs (46.8%) duringall the trimesters followed by systemic antibacterials(15%), analgesics (6.3%), and antacids (4.3%)(Table 1).

US-FDA pregnancy risk classification of drugs

As shown in Table 2, 662 (52.2%) of the pregnantwomen received a drug from category A; 345 (27.2%)

Pharmacoepidemiology and Drug Safety, 2009; 18: 462–468DOI: 10.1002/pds

Table 1. Commonly prescribed class of drugs according to gestational agein Addis Ababa, August 2007

Therapeutic class Trimester Alltrimesters

%

First Second Third

Anti-anaemic preparations 118 370 281 769 46.8Antibacterial drugs 42 108 97 247 15.0Analgesics 11 38 54 103 6.3Antacids and ulcer healing drugs 17 26 28 71 4.3Vitamins 16 17 22 55 3.3Antiemetics 30 8 6 44 2.7Antihistamins 23 7 9 39 2.4Gynaecological anti-infectives 3 13 13 29 1.8Sex hormones 22 6 0 28 1.7Drugs used in Diabetes 9 9 7 25 1.5Anthelmintics 2 7 16 25 1.5Anti-inflammatory, antirheumatics 3 11 10 24 1.5Psycholeptics 15 6 2 23 1.4Anti-virals for systemic use 6 5 9 20 1.2Anti hypertensives 2 6 3 11 0.7Antifungal for dermatological use 4 3 4 11 0.7Anti-asthmatics 3 6 2 11 0.7Others� 23 37 48 108 6.6Total 349 683 611 1643 100.0

�Others include: antiprotozoals, antidiarrhoeals, antiepileptics, antispasmo-dics, diuretics, and immunoglobulins.

Table 3. Drugs prescribed during pregnancy according to US-FDA riskcategory and gestational age (n¼ 1643, No. of drugs) in Addis Ababa,August, 2007

US-FDArisk category

Trimester

First n (%) Secondn (%)

Thirdn (%)

All trimestersn (%)

A 138 (8.4) 395 (24.1) 312 (19.0) 845 (51.5)B 105 (6.3) 188 (11.4) 193 (11.8) 486 (29.6)C 79 (4.8) 83 (5.1) 87 (5.3) 249 (15.2)D 25 (1.6) 14 (0.9) 16 (0.9) 55 (3.3)X 2 (0.1) 0 (0.0) 0 (0.0) 2 (0.1)

464 b. kebede ET AL.

from category B; 186 (14.7%) from category C; 46(3.6%) from category D, and 2 (0.2%) women receiveda drug from category X of the US-FDA riskclassification system. Frequently prescribed categoryA drugs were iron, vitamins, thyroxin, and nystatinvaginal tabs; while the category B drugs prescribedwere amoxicillin, paracetamol, metoclopramide, andinsulin; the category C drugs prescribed werealuminum hydroxide, chlorpromazine, promethazine,and mebendazole; the category D drugs used werehydroxyprogesteron, acetyl salicylic acid, phenobar-bitone, and propylthiouracil (PTU); and the category Xdrugs used were warfarin and oestradiol valerate.Excluding female reproductive hormones, 22 (1.7%)pregnant women received a category D drug and onewoman received a category X drug. The proportion ofwomen receiving drugs with potential for fetal harm

Table 2. Pregnant women exposed to drugs according to US-FDA riskcategory and gestational age (n¼ 1268) in Addis Ababa, August 2007

US-FDArisk category

Trimester

First n (%) Second n (%) Third n (%) All trimesters�

A 134 (10.6) 381 (30.0) 298 (23.5) 662 (52.2)B 92 (7.3) 152 (11.9) 163 (12.9) 345 (27.2)C 65 (5.1) 76 (6.0) 79 (6.2) 186 (14.7)D 24 (1.9) 13 (1.0) 15 (1.2) 46 (3.6)X 2 (0.2) 0 (0.0) 0 (0.0) 2 (0.2)�A pregnant woman could be exposed to more than one drug/classes odrugs.


f

was higher in the first trimester compared to the secondand third trimesters.Only 17 (1.3%) pregnant women received a drug

from category A other than iron and vitamins; while267 (21.1%) pregnant women received a combinationof two or more drugs from category A, B, C, or D.Three hundred forty nine (21.2%) drugs were

prescribed during the first trimester, 680 (41.4%)during the second trimester, and 608 (37.0%) duringtheir third trimester of pregnancy (Table 3).

Self-medication during pregnancy

Among 419 (33.0%) pregnant women who reportedillnesses in the 2 weeks preceding the interview date,158 (37.7%) took drugs either on self-selection basis orprescribed by health professionals. The rest (62.3%)pregnant women with reported illness did not take anyaction against their illness. Fear of unwanted effects ofdrugs on the fetus, perceptions that the illnesses wereminor and preference to wait until the next ANCappointment date were the major reasons for not takingaction by 76 (29.1%), 106 (40.6%), and 79 (30.3%) ofthe pregnant women, respectively.Fifty-two (12.4%) of the pregnant women self-

medicated themselves, of whom 28 (53.8%) did sousing traditional herbs. Next to herbal drugs, para-cetamol, and antacids were the commonly used drugsfor self-medication by the pregnant women. Table 4describes the potential risk of the drugs used for self-medication during pregnancy according to the US-FDA risk classification system.

DISCUSSION

Despite concerns regarding the potential prenataleffects of any drug taken by a woman duringpregnancy, several studies have demonstrated thatwomen commonly use medications over the course ofgestation.11,12 In the present study, the prevalence of


Table 4. Drugs and traditional herbs used for self-medication according toFDA risk Classification by pregnant women (n¼ 52), Addis Ababa, August2007

Drug name US-FDArisk

category

No. of pregnantwomenexposed�

Percentage(%)

Paracetamol B 10 19.2ASA C/D 1 1.9Antacids C 3 5.7Metronidazole B 1 1.9Ciprofloxacin C 1 1.9Chlorpromazine C 1 1.9Promethazine injection C 1 1.91% Hydrocortisone ointment C 1 1.9Herbal drugs:Allium sativum(Garlic) Cx 6 11.5Ocimum lamiifolium Ux 4 7.7Lepidium sativum Ujj 3 5.7Cucrbita pepo(Pumpkin) Ux 2 3.8Linum usitatissimum Ux 2 3.8Echinops kebericho Mesfin Ujj 1 1.9Glinus lotoides Ux 1 1.9Ruta chalepensis Ujj 1 1.9Zingeber officinale(Ginger) Cx 1 1.9Othersy 7 13.5

U: risk not determined by FDA.�More than one drug could be used by a pregnant woman.yOthers include: lemon, papaya, pineapple, and other unknown mixtures ofherbs.xDrugs grouped as ‘potentially harmful’.jjDrugs grouped as ‘clearly harmful’.


drugs prescribed and the self-medication practice ofpregnant women were evaluated after the initialprenatal care visit to allow a justified assessment ofdrug use after a recognized pregnancy.Published studies on the use of drugs during

pregnancy differ widely regarding methods employed.There are also variations in the variables used, size, anddemographic characteristics of the study population.Besides, it is apparent from previous reports on drugutilization during pregnancy that use of drugs variesbetween countries, making comparison betweenstudies and interpretation of results difficult. Forexample, a WHO sponsored study carried out between1988 and 1990 in 22 countries reported that there was amarked variation in drug taking habits in countriesparticipated in the study. For example, former GDR,Czechoslovakia, and Yugoslavia appeared to have hadrelatively the lowest prescribing habits with 61, 64, and73% of the pregnant women, respectively, receivingdrugs during the antenatal period; while Finland,Ghana, India, Ireland, Malta, Panama, and Sri Lankahad antenatal prescription rates greater than 95%.These differences reflect the broad spectrum ofmedicalcare, public health problems, and cultural differencesbetween countries.13


The present study revealed that 71.3% of thepregnant women received at least one drug duringpregnancy and 3.8% of the pregnant women wereprescribed drugs with evidence of fetal risk but forwhich benefit may outweigh risks (Category D) ordrugs with proven fetal risks (Category X).Our result on the use of drugs during pregnancy was;

however, comparable to studies done in South Africaand Italy.14,15 A slightly lower prevalence of drug usewas reported in a study done at Glasgow, where 34.8%of the pregnant women took a total of 153 differentdrugs excluding vitamins and iron.16

The mean number of drugs prescribed duringpregnancy was also consistent with other reports thatindicated mean number of drug use in pregnancy to befrom 1 to 3 medications per woman.6,15,17

The present study also revealed that the proportion ofwomen who were prescribed at least one drug duringpregnancy increased with trimester. This couldpossibly be explained by the fact that, the majorityof the pregnant women in our study started theirantenatal follow-up late in the second and thirdtrimester of pregnancy and prescribers might also bemore reluctant to prescribe drugs during the firsttrimester of pregnancy than other trimesters. Thisincreasing trend in drug use with trimester was alsoreported in studies done in the Netherlands andItaly.15,18

The most commonly prescribed class of drugs in thisstudy were anti-anemic and vitamins. The next groupof drugs commonly prescribed during the antenatalperiod include the anti-infectives followed by analge-sics. Similar findings in drug use was also reported byCGDUP study where it was found that next to vitaminsand iron, the most frequently used medications wereanti-infectives and analgesics.14 Analysis of medicalrecord and survey data of pregnant women from 2001to 2003 in San Francisco revealed that the mostcommon classes of medications prescribed wereantibiotics 62%, analgesics (18%), asthma medications(18%), and anti-emetics (17%).19

The current study also showed increasing pro-portions of antacids, analgesics, and anthelminticsprescribed with trimesters; while a higher proportion ofantihistamines, antiemetics, and sex hormones wereprescribed in the first trimester. The increased use ofgastrointestinal drugs, especially antacids, throughoutpregnancy and a higher proportion of antihistaminesuse during the first trimester had also been reportedfrom a study done in Norway.20

The US-FDA pregnancy risk classification systemwas used to evaluate the risk levels of drugs prescribed



during pregnancy. Although this system of classifi-cation does not fully answer the question of whether itis appropriate to treat or not to treat an individualpregnant woman, it is a widely recognized classifi-cation and provides guidance on risk.1,21,22

Nearly 4% of the pregnant women in this study wereprescribed a category D or X drugs, with 3.6% exposedto a category D drugs and approximately 0.2% exposedto a category X drugs. Excluding the femalereproductive hormones (progestins), 1.7% of thewomen received a category D drug and 0.1% womenreceived category X drug. A comparable result wasreported by Andrade et al. (2004)23 where 4.2% of thepregnant women received category D or X drugs afterthe initial prenatal care visit but when ovulationstimulants and other fertility drugs and contraceptivehormones were excluded, 1.9% of women received acategory D drug; and 0.1% of women receivedcategory X drug. Riley et al.,19 also reported that4% of the pregnant women were exposed to a categoryD or X medication; with 3% exposed to category Ddrug and 1% exposed to category X drug.Other studies also showed that 0.1–2% of pregnant

women received drugs from Category X for which riskto the fetus is known to outweigh any possible benefit;and an additional 2–3% received prescriptions fromCategory D drugs for which the benefit might havemade the known fetal risk acceptable.2,22–25

Drugs that were prescribed during pregnancy fromclass D or X of US-FDA risk classification systeminclude hydroxyprogesteron, acetyl salicylic acid,propylthiouracil, cotrimoxazole, enalapril, sodiumvalporate, warfarin, and oestradiol valerate. Althoughthe prenatal use of many of the category D and X drugsidentified in our study might place women or theirunborn child at unnecessary risk (e.g., use ofcotrimoxazole in the third trimester and warfarin inthe first trimester), some of these drugs (such asphenobarbital and PTU) might have been prescribedafter careful consideration that benefits outweigh therisks. The use of cotrimoxazole late in pregnancyshould be avoided as it causes fetal hyperbilirubinemia;salicylates use may result in fetal/neonatal hemor-rhage; anticonvulsants are known to cause cardiacanomalies, mental retardation, and neuronal tubedefects; exposure to warfarin might result in nasaldysplasia, middle face dysplasia, fetal hemorrhage, andCNS abnormalities; ACE inhibitors may causeoligohydraminos (deficiency on amniotic fluid);propylthiouracil causes Goiter; and the use ofhydroxyprogesteron is suggested to be associatedwith: central nervous system anomaly, cardiac defects,


cataract, ambiguous genitalia of both male and femalefetuses, and limb defects.4,10,26

Most of the drugs that belong to class D and all classX drugs were prescribed during the first trimester ofpregnancy whilst the risk of teratogenicity is higher. Adecreasing trend with trimester was observed inprescribing these categories of drugs unlike the othercategories of drugs. In addition, our finding indicatedthat about 15% of the study participants wereprescribed category C drugs, for which there is noevidence of safety during pregnancy in humans or forwhich there is evidence of fetal risk in animals orstudies in women and animals are not available. Suchdrugs are potentially harmful and should be prescribedonly if the potential benefit justifies the potential risk tothe fetus. Our finding that dipyrone (a drug banned inmany countries) is still in use in our country and isbeing prescribed during pregnancy is a concern.Dipyrone may cause maternal thrombocytopenia,leucopenia, and agranulocytosis. It is contraindicatedin the first trimester and in the last 6 weeks ofpregnancy.27–29

The present study also showed that 52 (12.4%) of thepregnant women, who reported illness in the 2 weeksprior to the interview self-medicated themselves. Theextent of self-medication during pregnancy documen-ted in this study might be underestimated as thosepregnant women who did not visit health institutionsfor ANC check up were not included and the ANCcoverage in Addis Ababa was only 58%.30 Thisfinding, however, is consistent with the results reportedfrom the Pegasus study where 14.2% of the studyparticipants self-medicated.31 A little lower percentageof Pegasus medication practice was reported in a studydone at Glasgow, where among pregnant womenattending the ANC clinics of a general hospital, 8.8%took a self-administered drug, mainly analgesic.16

Another study documented a 4.1% use of herbalmedications, slightly lower compared to our findings.32

Generally, previous studies have reported herbalmedicine usage frequencies ranging from 3.6 to 42%.33

Although the study participants in this study arethose coming to modern health institutions for ANCfollow ups; more than half of those who practiced self-medication used traditional herbs. Although manypatients use herbs, it is important to recognize thatmany of these herbs are understudied, especially inpregnancy.34 There is also a threat of interactionbetween herbal drugs and other medications, poten-tially making them less active or less safe. Likewise,some concerns exist as to the safety of the herbs usedby the pregnant women. For instance, Echinops



kebericho Mesfin is known to contain sesquiterpenelactones which might exert cytotoxic effect;35 Ocimumlamiifolium is known to contain eugenol and estragolwith anticonvulsant, sedative, and antispasmodiceffects; Allium sativum (Garlic) showed uterinestimulant effect; Zingeber officinale were found tohave abortifacient, emmenagogue, and mutageniceffects;36,37 Ruta chalepensis contains furanocumarinsand is embryo toxic causing implantation failure andabortion.38,39 Lepidium sativum contains sodiumbenzylisothiocyanate which induced low fetal andplacental weights and the seeds were found to havecontraceptive effect in laboratory mice.40,41 Increasedanticoagulant effect of warfarin has been reportedduring concurrent ingestion of Cucurbita pepo.42

The evidences available to date imply that someherbal medicinal products are associated with risks. Yetonly few attempts have been made to identify the riskof specific herbs and those that have been publishedlack statistical power to produce conclusive results.43

Thus, generally the use of herbs by the pregnantwomen is of major concern. Until definitive dataemerge, the best advice is to consider all herbalproducts contraindicated during pregnancy and toinform the pregnant women accordingly.44

Although easy access and ability to self-medicatewith commonly used medications out side pregnancymay create the impression that OTC medications aresafe to use in pregnancy, the use of certain OTCmedications has the potential to cause fetal harm,particularly non-steroidal anti-inflammatory medi-cations and acetyl salicylic acid.45 Health careproviders should, therefore, be aware that pregnantwomen are in potential danger of practicing self-medication using traditional herbs, OTC, or prescrip-tion drugs and need to routinely inquire about the use ofthese drugs for self-medication and advise against theiruse during pregnancy.

KEY POINTS

� Studying the type and extent of prescription, over thecounter drugs and traditional herbs used duringpregnancy would provide a useful knowledge as tothe current practice and help in rationalizing drug use.

� Pregnant women practiced self-medication usingprescription drugs, non-prescription drugs, and poten-tially harmful traditional herbs.

� The majority of the ANC attendant pregnant womenwere prescribed drugs from category A followed bycategory B and C, although a smaller proportion ofpregnant women received category D or X medi-cations.


The Ethics Committee of the School of Pharmacy,AAU, has approved this study.

ACKNOWLEDGEMENTS

The authors thank the Graduate Program of Addis AbabaUniversity for financially sponsoring this research project.

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Assessment of drug use among pregnant women in Addis Ababa, Ethiopia

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