Assessing the impact of a regulatory intervention in Pakistan.

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of the regulatory intervention conclusively proved that while the deregistered products had been successfully withdrawn from the overwhelming majority of retail outlets, blackmarketing of a paediatric antimotility drug was taking place in one city.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.