Kigen Gabriel, Busakhala Naftali, Ogaro Francis, Chesire Emily, Saat Nathan, Too Robert, Nyandiko Winstone
Department of Pharmacology and Toxicology, Moi University School of Medicine, Eldoret, Kenya.
Department of Paediatrics, Moi Teaching and Referral Hospital, Eldoret, Kenya.
PLoS One. 2015 Nov 5;10(11):e0142092. doi: 10.1371/journal.pone.0142092. eCollection 2015.
Cough syrups are widely used in the developing world, but safety of their use in infants and children less than two years has not been well documented. Some syrups contain multiple combinations of such drugs as promethazine, diphenhydramine and ephedrine; which are individually now contraindicated in children less than two years. Despite this, the syrups are available as over the counter drugs and may be dispensed to mothers who are unaware of the potentially hazardous effects to their infants. A descriptive cross-sectional study was used to investigate suitability of cough syrups sold within Eldoret municipality for use in children less than two years of age based on their formulations and available literature.
Two semi-structured questionnaires were administered to pharmacy attendants and mothers attending sick child clinic at a referral hospital to establish whether cough syrups containing more than one active ingredient of compounds, now contraindicated in children are administered to infants, and awareness of potential serious adverse effects. Data from labeled contents of cough syrups from retail pharmacies was recorded and corroborated with information from literature to determine those deemed to contain the ingredients. The second questionnaire was administered to mothers with children less than two years to ascertain whether they had used the identified syrups. A total of 260 mothers and 55 pharmacy attendants were interviewed.
There was widespread use of the syrups in children, including infants, with 192 (74%) of the respondents having used identified syrups and over 90% of these on children less than 2 years including those less than three months.146 (76%) mothers had administered the syrup at double the recommended dose.
The regulatory authorities should make concerted efforts to discourage use of cough syrups containing ingredients that pose adverse events to infants, including campaigns to educate pharmacy workers and mothers.
止咳糖浆在发展中国家广泛使用，但在两岁以下婴幼儿中的使用安全性尚未得到充分记录。一些糖浆含有异丙嗪、苯海拉明和麻黄碱等多种药物组合；目前这些药物单独使用时对两岁以下儿童是禁忌的。尽管如此，这些糖浆作为非处方药出售，可能会分发给那些未意识到其对婴儿潜在危害的母亲。一项描述性横断面研究基于其配方和现有文献，调查了在埃尔多雷特市销售的止咳糖浆对两岁以下儿童的适用性。
向一家转诊医院的药剂师和儿科门诊的母亲发放两份半结构化问卷，以确定是否向婴儿施用了含有目前儿童禁忌的多种活性成分化合物的止咳糖浆，以及对潜在严重不良反应的认知情况。记录零售药店止咳糖浆标签内容的数据，并与文献信息进行核对，以确定那些被认为含有这些成分的糖浆。向有两岁以下儿童的母亲发放第二份问卷，以确定她们是否使用过已识别的糖浆。总共采访了260名母亲和55名药剂师。
止咳糖浆在儿童包括婴儿中广泛使用，192名（74%）受访者使用过已识别的糖浆，其中超过90%用于两岁以下儿童，包括三个月以下的婴儿。146名（76%）母亲以推荐剂量的两倍施用了糖浆。
监管当局应齐心协力，劝阻使用含有对婴儿有不良事件成分的止咳糖浆，包括开展教育药剂师和母亲的活动。
