Safety Profile of Drug Use During Pregnancy at Peripheral Health
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Drugs - Real World Outcomes (2018) 5:193–206 https://doi.org/10.1007/s40801-018-0141-1 ORIGINAL RESEARCH ARTICLE Safety Profle of Drug Use During Pregnancy at Peripheral Health Centres in Burkina Faso: A Prospective Observational Cohort Study Toussaint Rouamba1,2 · Innocent Valea2 · Joel D. Bognini2 · Herve Kpoda3 · Petra F. Mens4 · Melba F. Gomes5 · Halidou Tinto2 · Fati Kirakoya‑Samadoulougou1 Published online: 28 August 2018 © The Author(s) 2018 Abstract Purpose Safety data of many drugs used during pregnancy remain scarce. This is especially true in developing countries characterised by the absence of a robust pharmacovigilance system, high prevalence of diferent tropical diseases afecting patients and potential for drug-drug interactions. This study aimed to assess the safety profle of drugs used in women at high risk of malaria during pregnancy and delivery in Burkina Faso’s health facilities. It also aimed to assess factors associated with the use of potentially risky drugs over the entire course of pregnancy. Methods We enrolled pregnant women from their frst antenatal care visit and followed them up until delivery, and col- lected data on drug use. Based on United States Food and Drug Administration (FDA) or Australian Therapeutic Goods Administration (TGA) drug risk classifcation, drugs were classifed into three groups: ‘probably safe’, ‘potentially risky’ or ‘unclassifed’. A modifed classifcation was built to take into account national malaria policy treatment guidelines and World Health Organization Malaria Treatment Guidelines recommending malaria chemoprophylaxis during pregnancy. Results Out of 2371 pregnant women enrolled, 56.7% used at least one medication during the entire course of the pregnancy (excluding sulphadoxine-pyrimethamine and iron-folic acid). A total of 101 diferent types of medications were used by study participants and 36.6, 49.5 and 13.9% were, respectively, classifed as ‘probably safe’, ‘potentially risky’ and ‘unclassifed’. Antimalarials and antibiotics were the most frequently used drugs. Around 39% of women used a least one medication clas- sifed as potentially risky. However, this proportion dropped to 26% with the modifed classifcation. Living in urban areas and attending the frst antenatal care within their frst trimester of pregnancy (longer health surveillance) were associated with using ‘potentially risky’ medications. Conclusion This study provides rare and valuable information on the current use of drugs among pregnant women in Burkina Faso. Many pregnant women used medications classifed as potentially risky. Our fndings suggest the need for rational drug prescription and community education to reduce hazardous drug exposure during pregnancy. * Toussaint Rouamba Key Points [email protected] 1 Centre de Recherche en Epidémiologie, Biostatistique et To our knowledge, this study provides the frst analysis Recherche Clinique, Ecole de Santé Publique, Université on the current use of drugs in pregnant women in Bur- libre de Bruxelles, Brussels, Belgium kina Faso. 2 Centre National de la Recherche Scientifque et de la Technologie, Institut de Recherche en Science de la About half of medications used to manage illness during Santé, Unité de Recherche Clinique de Nanoro, Nanoro, pregnancy were classifed as potentially risky. Burkina Faso Nearly one-seventh of medications lacked a safety clas- 3 Centre Muraz, Département de Recherche Clinique, sifcation (US-FDA and AU-TGA drug classifcation) Bobo‑Dioulasso, Burkina Faso and more than one-quarter of women used medications 4 Department of Medical Microbiology, Academic Medical classifed as potentially risky to use during pregnancy. Centre, Amsterdam, The Netherlands 5 World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland Vol.:(0123456789) 194 T. Rouamba et al. 1 Introduction were the most common drugs used in pregnancy. A study conducted in Mozambique reported that antibiotic agents Through government and international eforts to improve (41%) and antimalarial drugs (24%) were the most maternal and child health in high mortality countries, commonly used drugs [21]. Another study in Tanzania there have been massive eforts to improve care during reported that analgesics were the most commonly used pregnancy, increase the number of antenatal consulta- drugs (24%), followed by antibiotics (17%) and antima- tions (ANC), deploy essential medicines in health facili- larials (15%) [22]. ties, and improve skilled attendance at birth [1, 2]. These We are unaware of any study carried out in Burkina eforts have increased patient access to medicines of dif- Faso to assess the profle and the magnitude of medications ferent therapeutic classes, especially for tropical diseases. exposure during pregnancy. Existing studies on the use of Improved access to essential drugs for the general popula- drugs during pregnancy have normally targeted a specifc tion in many Sub-Saharan Africa countries [1, 3–5] and the drug used often within a clinical trials framework [24, 25]. introduction of an efective universal healthcare coverage Therefore, there are no data available on the profles, ranges in a few countries (Botswana, Namibia, Ghana and South and magnitude of drug exposure during pregnancy. This Africa) [6] have made it clear that drug safety data are not can be of concern. Indeed, the epidemiological profle of available for many drugs that are commonly used during Burkina Faso, like that of most countries in Sub-Saharan pregnancy. Regulatory requirements for drugs to be used Africa, is dominated by parasitical (such as malaria) and during pregnancy are substantially stricter since the tha- infectious diseases, where the pattern of medicine use would lidomide disaster [7–9], but one consequence is that many be a higher elevating risk for drug-drug interactions, in the medications commonly authorised for general use have no presence of other risk factors afecting patient outcome (mal- data on efcacy or safety for pregnant women. For legal nutrition, drug resistance and low quality or fake medicines) and ethical reasons, the acquisition of safety data during [26–28]. Furthermore, in many Sub-Saharan African coun- pregnancy is normally collected during pharmacovigilance tries [29], self-medication is common, potentially exposing studies, post-registration [10, 11]. Since it takes years, or the fetus to drugs that may have negative outcomes during even decades, to acquire systematic safety data that can gestation or at birth [30, 31]. Some studies have revealed be used to extend the therapeutic indication to pregnancy, that drug prescribing errors occur signifcantly more often in drug safety during pregnancy remains generally unknown, children and pregnant women [32]. Drug prescription (with/ except for drugs used for obstetric conditions. For many without errors) and self-medication may occur before a preg- important infections, including malaria and HIV where nancy is known [33]. For this reason, we conducted a study there are few safety data in pregnancy on efective medica- to assess the therapeutic classes and risk categories of drug tions, the World Health Organization (WHO) recommends use among pregnant women at high risk of malaria (dur- treatment of pregnant women with severe malaria with ing pregnancy and delivery, especially during labour) when artemisinin parenteral drugs and uncomplicated Plasmo- they attended antenatal clinics (ANC) at peripheral health dium falciparum malaria during the frst trimester with centres, in Burkina Faso. Furthermore, after categorizing 7 days of quinine + clindamycin and artemisinin combi- the drugs according to their risk, we assessed the factors nation therapy (ACT) in the second and third trimester associated with use of potentially risky drugs during the [12]. A high prevalence of HIV with poor safety evidence entire course of pregnancy. for treatment in pregnancy is equally important in many Sub-Saharan countries; at present, transition to efavirenz is sanctioned on condition that safety surveillance is carried 2 Methods out in implementing countries [13, 14]. Several studies have monitored drug use during preg- 2.1 Study Settings nancy both in developed [15–18] and in developing coun- tries [19–23]. Most studies found that pregnant women The study was conducted in two health districts located in were prescribed and used a large number of drugs during the western region of Burkina Faso, Dafra and Do. In this pregnancy and that a number of potentially risky drugs region, malaria is the most common cause of outpatient are used, based on United States Food and Drug Admin- attendance (45.0%) in peripheral health centres, followed istration (FDA), Australian Therapeutic Goods Adminis- by acute respiratory infection (21.8%) and diarrheal diseases tration (AU-TGA) or Farmaceutiska Spesialiteter i Sver- (2.9%). In 2016, the health facilities of the region recorded ige, Europe (FASS) drug-risk classifcation systems. In 1,000,786 malaria cases in a population of 2,025,511, Sub-Saharan African countries, studies have reported that including 39,862 cases of severe malaria [34]. Dafra and drug exposure to antibiotics, analgesics and antimalarials Do are districts with mixed urban and rural health facilities. The sites are characterized by a high malaria transmission Safety Profle of Drug Use During Pregnancy at Peripheral Health Centres in Burkina Faso 195 season from June to October [35]. In 2016, there were an medical card was used to record treatment and drug expo- estimated 799,951 inhabitants in