An observational assessment of the safety of mass drug administration for trachoma in Ethiopian children

Abstract

Background: The International Trachoma Initiative (ITI) provides azithromycin for mass drug administration (MDA) to eliminate trachoma as a public health problem. Azithromycin is given as tablets for adults and powder for oral suspension (POS) is recommended for children aged <7 y, children <120 cm in height (regardless of age) or anyone who reports difficulty in swallowing tablets. An observational assessment of MDA for trachoma was conducted to determine the frequency with which children aged 6 mo through 14 y received the recommended dose and form of azithromycin according to current dosing guidelines and to assess risk factors for choking and adverse swallowing events (ASEs).

Methods: MDA was observed in three regions of Ethiopia and data were collected on azithromycin administration and ASEs.

Results: A total of 6477 azithromycin administrations were observed; 97.9% of children received the exact recommended dose. Of children aged 6 mo to <7 y or <120 cm in height, 99.6% received POS. One child experienced choking and 132 (2%) experienced ≥1 ASEs. Factors significantly associated with ASEs included age 6-11 mo or 1-6 y, non-calm demeanor and requiring coaxing prior to drug administration.

Conclusions: There is a high level of adherence to the revised azithromycin dosing guidelines and low incidence of choking and ASEs.

Keywords: airway obstruction; azithromycin; mass drug administration; pharmacovigilance; program evaluation; trachoma.

Figure 1.

Height- and age-based dosing for Zithromax powder for oral suspension and tablets. Recommended dose of Zithromax by height and age for mass drug administrations to prevent blinding trachoma. Infants aged <6 mo receive tetracycline eye ointment (TEO) (not included in the assessment). Children aged 6 mo through 6 y receive powder for oral suspension (POS), regardless of height, while children aged 7–14 y receive tablets, if at least 120 cm in height. Children aged ≥15 y receive tablets regardless of height (also not included in the assessment). Figure provided by the International Trachoma Initiative.

Figure 2.

Distribution of participants by age, height, receipt of azithromycin tablets or powder for oral suspension, and receipt of exact recommended dose. The figure tracks the decision points in the revised azithromycin-dosing guidelines (Figure 1) based on age (<7 or ≥7 y), height (<120 or ≥120 cm), drug form (powder for oral suspension [POS] or tablets) and whether the exact recommended dose was received (yes or no). Areas of highest concern are shown in red and areas of some concern are shown in yellow. Nine children were measured by the wrong side of the pole and we were unable to determine if the recommended dose was received. ^aUnable to determine if the recommended dose was received for one child. ^bUnable to determine if the recommended dose was received for one child. ^cUnable to determine if the recommended dose was received for one child. ^dUnable to determine if the recommended dose was received for four children. ^eUnable to determine if the recommended dose was received for two children.