Bhutta T I, Balchin C
Department of Paediatrics, King Edward Medical College, Lahore, Pakistan.
Soc Sci Med. 1996 Apr;42(8):1195-202. doi: 10.1016/0277-9536(95)00392-4.
In 1990 paediatric formulations of antimotility drugs were deregistered in Pakistan. Although preliminary research data suggests the incidence of paralytic ileus in children suffering from acute diarrhoea has fallen, cases continue to be recorded. A small-scale survey conducted in 1993 to assess the effectiveness of the regulatory intervention conclusively proved that while the deregistered products had been successfully withdrawn from the overwhelming majority of retail outlets, blackmarketing of a paediatric antimotility drug was taking place in one city. The results also indicated that throughout the country the deregistered formulations were being substituted by other irrational therapies, including the misuse of adult formulations. As a regulatory intervention, therefore, deregistration needs to be accompanied by efforts to change patient attitudes and physician prescribing habits.
1990年，巴基斯坦取消了抗动力药物的儿科制剂注册。尽管初步研究数据表明，急性腹泻患儿中麻痹性肠梗阻的发病率有所下降，但仍有病例记录在案。1993年进行的一项小规模调查，旨在评估监管干预措施的有效性，最终证明，虽然已注销的产品已成功从绝大多数零售网点撤出，但在一个城市中仍存在儿科抗动力药物的黑市交易。结果还表明，在全国范围内，已注销的制剂正被其他不合理的疗法所取代，包括滥用成人制剂。因此，作为一项监管干预措施，取消注册需要同时努力改变患者的态度和医生的处方习惯。
