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Managing of acute pediatric cough in Africa: prescription of cough suppressants and associated complications

Managing of acute pediatric cough in Africa: prescription of cough suppressants and associated complications

Benoît Mbiya- Mukinayi1,2,&, Denis Mbuyi-Kalambayi1,2, Steve Kasongo-Tshiala2, Valery Daubie3


1Pediatrics Department, Faculty of Medicine, University of Mbujimayi, 06201 Mbujimayi, Democratic Republic of Congo, 2Pediatrics Department, Clinique pédiatrique de Mbujimayi-Mbujimayi paediatric clinic, 06201 Mbujimayi, Democratic Republic of Congo, 3Clinical Chemistry Department-Hereditary Red Blood Cell Disorders, Laboratoire Hospitalier Universitaire de Bruxelles-Universitaire Laboratorium Brussel, Université Libre de Bruxelles, 1070 Brussels, Belgium



&Corresponding author
Benoît Mbiya-Mukinayi, Pediatrics Department, Faculty of Medicine, University of Mbujimayi, 06201 Mbujimayi, Democratic Republic of Congo




Introduction: the use of antitussives is a crucial issue in pediatrics and can lead to respiratory complications that can affect the prognosis. The objective of this study is to determine the frequency of respiratory complications associated with the use of antitussives in pediatrics in a remote city in the Democratic Republic of Congo.


Methods: this is a cross-sectional retrospective study conducted between January 1, 2017, and December 2022. Patients under 12 years of age with an acute cough were eligible. The parameters studied were treatment with cough suppressants and associated respiratory complications.


Results: a total of 218 children suffered from an acute cough. The average age was 11 months 10, and the sex ratio (H/F) was 126/92. In 30% of cases, children were treated with cough suppressants for an average of 7 days before admission. Respiratory complications were observed in 11% (23/218) of cases. For most of these complications, 61% (14 of 23), had received antitussive treatment before hospitalization. Respiratory complications were associated with cough medications (p-value = 0.0012, relative risk (RR) = 3.66, IC90 [1.696; 7,873]). Acute respiratory distress was reported in 87% (20/23) of cases and was associated with the use of cough suppressants (p-value = 0.0065, RR: 3.060, IC90: [1.433; 6,485]).


Conclusion: the use of antitussives in pediatrics poses a risk of acute respiratory distress in a remote city that does not have sufficient human and material resources for management.



Introduction    Down

Coughing is defined as a sudden, audible expulsion of air from the lungs. It is a reflex that helps to externalize bronchial, tracheal, and laryngeal secretions or to react to any irritation of the respiratory tract. Its role is beneficial for the protection of the respiratory tract [1]. However, an acute cough causes anxiety in 90% of parents. They fear that they will miss a serious illness and that their child will be painful or even choking [2].

Acute upper respiratory tract infections are very common in children, especially during the dry tropical season. These conditions are often accompanied by an acute cough, which often resolves itself after a few weeks [3,4]. Despite its banality, the child´s acute cough remains an issue of great concern to parents. This is almost everywhere a major reason for medical consultation. It can affect the quality of life, cause anxiety, and affect the sleep of parents and children, resulting in iterative consultations. This is a real public health issue [5]. An acute cough is defined as one that lasts less than three weeks. It is subacute (three to eight weeks) and chronic when it lasts more than eight weeks.

In pediatrics, acute cough is most often secondary to high respiratory infections of viral origin and improves spontaneously within 3 weeks. Acute coughing is a common symptom in infants that should be respected. The treatment of cough in pediatrics is primarily that of its cause. Cough medications should not be prescribed in pediatrics [1]. Over-the-counter cough and cold medications are widely used [6,7] and are widely advertised and sold in pharmacies and stores around the world [6]. However, their use has been associated with high toxicity and death [8,9]. Therefore, these drugs are contraindicated in pediatrics [1,8]. Since 2017, the Food and Drug Administration (FDA) has recommended that over-the-counter cough and cold products be prohibited for use in children under 6 years of age [7,10]. Despite these recommendations, these drugs continue to be sold and widely used, especially in sub-Saharan African countries where many of these counterfeit medicines are also found. Most recently, the World Health Organization (WHO) issued a medical product alert" concerning four cough and cold syrups suspected of being linked to "kidney damage" in children and responsible for 66 deaths in The Gambia [11].

We did not find data in the literature on the use of cough suppressants in children in the Democratic Republic of Congo (DRC). This study investigates respiratory complications related to the prescription of cough suppressants in children under 12 years of age in Mbujimayi, DRC. The purpose of this article is to provide clinicians with information on the best practices required in conventional recommendations for managing acute coughs in children.



Methods Up    Down

Study design: this is a cross-sectional retrospective study conducted from January 1, 2017, to December 2022, examining the medical records of pediatric patients consulted during the study period.

Setting: this study was conducted in Mbujimayi, which is the capital of the Eastern Kasai province in the DRC (Figure 1) [12]. It is the third-largest city in terms of population. The population of Mbujimayi in 2023 is estimated at 2,900,000 (Mbujimayi World Population Review 2023), covering an area of 135.12 km2 and corresponding to a population density of 12,450 inhabitants/km2. The study was conducted at the Mbujimayi Paediatric Clinic, one of the largest paediatric facilities in the province of Kasai-Oriental in the DRC. This clinic is a private vertical philanthropic program integrated into the primary health care system in the Democratic Republic of Congo. Currently, this clinic includes a pediatric ward with a capacity of 30 constantly occupied beds, a neonatal ward, a maternity ward, and a semi-automated laboratory. However, it is important to note that the city of Mbujimayi also has two large old hospitals (the Bonzola General Reference Hospital and the Dipumba General Reference Hospital) and two other new state hospitals are under construction. Both hospitals are owned by the Bakwanga Mining Company (MIBA), the first industrial diamond production company in the DRC. More than 15 years ago, this company faced very serious financial problems for its recovery. Thus, the social aspects of society, whose hospitals have been abandoned, are in poor condition and need to be rehabilitated. This has a significant impact on the quality of patient care, including pediatric patients. The city of Mbujimayi has a shortage of medical specialists. This is especially true in the field of pediatrics where there are only three pediatricians for the whole city.

Participants: patients under 12 years of age diagnosed with an acute cough were eligible for this study. Chronic cough patients were excluded from our study. We also excluded all TB, asthma, and immunocompromised patients (HIV infection).

Variables: socio-demographic parameters included age and sex. Clinical parameters were the reason for consultation, pulsed oxygen saturation (SpO2), and the history of respiratory disease. Complications following the use of antitussives (obstructive rhinitis, worsening cough, fever, respiratory distress). The therapeutic parameters are the notion of taking over-the-counter nasal, cough suppressant, or vasoconstrictors, the name of the cough suppressant used before admission. Preclinical parameters: chest X-ray. Acute cough has been defined as a cough lasting less than two weeks. Chronic cough was more than two weeks.

Data sources/measurement: the data was collected from medical records. These data were subsequently transcribed into a common database (Excel file). We used the convenience sampling technique.

Bias: confounding bias is possible given that respiratory tract infections are common in children and can be complicated by treatment other than cough suppressants.

Study size: this was an exhaustive random sample. It was calculated as 225 patients, with a significance level of 0.05 and a power of 95%, expected mean was estimated at 1.7 [13]. However, we have limited ourselves to 218 patients, based on the total number of patients with the characteristics studied.

Statistical analysis: statistical analyses were conducted using Prism 8.0.1. (GraphPad Software Inc, San Diego, California). The percentage, arithmetic mean and median of patient epidemiology data were calculated. Then we did a Fisher Exact analysis on the contingency table Antitussive versus complications. We also tested each of the identified complications. P < 0.05 was considered statistically significant.

Ethical approval: the study protocol was reviewed and approved by the Ethics Committee of the Faculty of Medicine of the University of Mbujimayi (Ref. 0012/VD-RSCU/Fac-Méd/UM/DMT/2023) This is a retrospective study based on data acquisition from the medical records of the targeted individuals or a data registry at the time of submission. There was no direct interaction between the researcher and the staff whose files were being studied. The study was carried out following the principles of the Helsinki II Declaration. The data collected were used only for research purposes. The anonymity of medical records was respected, and no personal data was recorded.



Results Up    Down

This study was conducted on 218 children diagnosed with an acute cough for 6 years (January 1, 2017, to December 2022). The average age of patients was 11 months 10, the sex ratio (H/F) was 126/92 and the average length of cough before admission was 8 days 8. Cough was the main complaint in 56% of cases and 30% of children received cough medication for an average of 7 days before hospital admission. Other epidemiological data are described in Table 1.

Results from this study showed 11% (23/218) of respiratory complications in children with acute cough. For most children with these complications, 61% (14 of 23), had received a cough suppressant before hospital admission. Statistical analyses show that the onset of respiratory complications was related to the use of cough suppressants (p-value = 0.0012, relative risk (RR) = 3.66, IC90 [1.696; 7.873]). Respiratory complications included aggravation of cough in 100% (23/23) of cases and respiratory distress in 87% (20/23). However, the only respiratory distress was associated with a cough suppressant (p-value = 0.0065, RR: 3.060, IC90: [1.433; 6.485]). Other complications were not associated with the use of cough suppressants (Table 2).



Discussion Up    Down

This study describes the complications associated with taking antitussives in pediatric acute cough patients. It involved 218 cases of acute cough in children aged 11 months to 10 months on average followed at the Mbujimayi Pediatric Clinic in the DRC. This study showed that 30% of children received cough suppressants for an average of 7 days before hospital admission. Acute cough is a common symptom in pediatrics that should be respected, and the treatment of acute cough should be that of its cause. Cough medication should not be used in pediatrics (Bourillon). For more than 10 years, the Food and Drug Administration (FDA) recommendations have warned against the use of cough and cold medications in young children [7,13]. Despite FDA recommendations, this study shows that cough suppressants continue to be administered in children in Mbujimayi, DRC. These results could be explained by a high frequency of self-medication in Africa [14], a lack of knowledge of qualified medical personnel [15,16], or by the informal drug market in sub-Saharan Africa [17]. Studies also show a scarcity of specialist doctors in African cities, particularly in remote cities [16,18], which could also explain this abuse of cough suppressants in children.

For most children with acute coughs with complications, 61% (14 of 23), had received cough medications before hospital admission. This study shows that respiratory complications, including respiratory distress, are related to taking cough medication. These results confirm what is reported in the literature. Several studies have already shown the harms of cough suppressants in pediatrics [2,6-8,10,13,19-22]. As noted above, the use of cough suppressants is already prohibited in pediatrics. Cough suppressants can, with side effects up to and including death if management is not appropriate [13]. However, other authors argue for the safety of cough suppressants in children. This is the case of Dart et al. and Green et al. who showed that the rate of adverse reactions associated with cough suppressants in children was low. Deaths are even less frequent. No deaths involved a therapeutic dose. Unsupervised accidental ingestions were the most common types of exposure and single-ingredient liquid pediatric formulations were the most frequently reported products. These features provide an opportunity for targeted prevention efforts [23].

Respiratory diseases are a common cause of death in pediatrics and cough is the main symptom of these diseases [24,25]. In the face of a cough, parents and healthcare staff should have the right information on how to manage coughs in children [26]. In the context of the city of Mbujimayi which has a shortage of specialists in pediatrics, underequipped hospitals with very limited possibilities of oxygen delivery, preventing complications related to respiratory diseases must be a priority. The context of the city of Mbujimayi is almost identical to the rest of the Congolese and African cities and therefore, The Ministry of Public Health and Children´s Respiratory Programs has a critical role to play in regulating the sale of cough suppressants and in developing training programs for medical personnel in the management of respiratory and community outreach.

Concerning the limitations, this study was conducted in a remote city in the DRC and covers a minimal sample and needs to be conducted in other cities of the country to have a complete mapping of the use of antitussives in pediatrics. Such a study could provide data to help policymakers regulate the sale of these products.



Conclusion Up    Down

This study shows that pediatric cough suppressants pose a risk of respiratory complications and confirms what is already described in the literature. It makes it possible to sensitize parents as well as health workers, to stop the use of cough medications in children.

What is known about this topic

  • Coughs are very common in pediatrics; it is generally not serious and can even be useful; coughing is a normal reflex to clear the airways;
  • Cough suppressants are not recommended for children under the age of 6: their effectiveness has not been sufficiently proven; in some cases, these medicines do more harm than good by blocking the expulsion of unwanted secretions; what's more, cough suppressants can cause dangerous side effects in babies and young children;
  • In 2013, the Federal Agency for Medicines and Health Products (FAMHP) reviewed the benefit-risk balance of cough and cold medicines; this assessment led to the recommendation that medicines containing codeine, pholcodine, dextromethorphan, and pentoxyverine, among others, should not be used in children under 6 years of age.

What this study adds

  • This study describes the complications associated with the use of cough suppressants in pediatrics in a remote area in the Democratic Republic of Congo;
  • The results show that conventional recommendations concerning the restriction of the use of cough suppressants in pediatrics are either not applied or are ignored; these data could be used to develop local recommendations for improving cough management in children.



Competing interests Up    Down

The authors declare no competing interests.



Authors' contributions Up    Down

Benoît Mbiya-Mukinayi is the main author of the study. She initiated and coordinated the study during the publication, correction, and finalization of the manuscript. She also provided important criticisms for improving the content and formed the guidance and support for publication. Denis Mbuyi-Kalambayi and Steve Kasongo-Tshiala contributed to the data collection. Analysis and interpretation of data: Valery Daubie and Benoît Mbiya-Mukinayi. All authors were involved in drafting the article or revising it critically for important intellectual content. Benoît Mbiya-Mukinayi had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All the authors have read and agreed to the final manuscript.



Acknowledgments Up    Down

The authors wish to thank all the staff (physicians and nurses) of the clinique pédiatrique de Mbujimayi.



Tables and figure Up    Down

Table 1: epidemiological data

Table 2: association between use of cough suppressants and the onset of respiratory complications

Figure 1: location of the city of Mbujimayi on the map of the Democratic Republic of Congo



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