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Management of Mifepristone and Misoprostol Packaged Together for Termination of Pregnancy

After the drug was registered in 2014, the Food and Drug Administration requested the Department of Health, Ministry of Public Health, to manage and closely monitor the use of the drug for 2 years. The Department of Health thus acted as the drug manager and distributor to various hospitals by performing the following duties:

  1. Coordinate with healthcare facilities both within and outside the Ministry of Public Health to assess readiness to provide services and authorize the provision of Mifepristone and Misoprostol for pregnancy termination services.
  2. Prepare a manual for the use of Mifepristone and Misoprostol and send the manual to various healthcare facilities that provide the drug.
  3. Collect reports of Mifepristone and Misoprostol imported by the importing and distributing companies.
  4. Establish a VMI (Vendor Managed Inventory) system in collaboration with the NHSO and the Government Pharmaceutical Organization.
  5. Collect and analyze drug administration and pregnancy termination reports from various healthcare facilities.
  6. Monitor and follow up on adverse side effects from drug use.
  7. Prepare statistical reports to show progress every 3 months.

And on June 13, 2016, the resolution of the Subcommittee on the Development of the National List of Essential Medicines considered selecting Mifepristone and Misoprostol packaged together for medical termination of pregnancy with a gestational age not exceeding 24 weeks to be included in the National List of Essential Medicines, Sub-list J(1). The Sub-list J(1) must have a special project by a government agency, requiring the Department of Health to prepare a project proposal for the subcommittee. Therefore, the Department of Health must manage the use of the drug in collaboration with the National Health Security Office and the Government Pharmaceutical Organization.

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