Assessing the impact of a regulatory intervention in Pakistan

T I Bhutta1, C Balchin

  • 1Department of Paediatrics, King Edward Medical College, Lahore, Pakistan.

Insights

Deregistering paediatric antimotility drugs in Pakistan reduced their availability but did not eliminate their use. Blackmarketing and substitution with adult formulations highlight the need for further interventions.

Area of Science:

  • Pharmacology
  • Public Health
  • Pediatrics

Background:

  • In 1990, Pakistan deregistered paediatric formulations of antimotility drugs.
  • Preliminary data suggested a decrease in paralytic ileus in children with acute diarrhoea post-deregistration.

Purpose of the Study:

  • To assess the effectiveness of the regulatory intervention (deregistration) of paediatric antimotility drugs.
  • To identify any ongoing issues or alternative therapies used after deregistration.

Main Methods:

  • A small-scale survey was conducted in 1993 across Pakistan.
  • The survey assessed the availability of deregistered products and identified substitution patterns.

Main Results:

  • Deregistered paediatric antimotility drugs were largely withdrawn from retail outlets.
  • Blackmarketing of a specific paediatric antimotility drug was observed in one city.
  • Irrational therapies, including the misuse of adult formulations, were substituted for deregistered paediatric drugs nationwide.

Conclusions:

  • Deregistration alone is insufficient to halt the use of antimotility drugs in children.
  • Regulatory interventions must be complemented by efforts to modify patient attitudes and physician prescribing habits.
  • Addressing the misuse of paediatric antimotility drugs requires a multi-faceted approach beyond simple product withdrawal.

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