The Hainan Medical Products Administration (HMPA) has released a set of guidelines that took effect immediately, providing measures for the management of patients accessing imported drugs through the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone. The guidelines focus on managing patients who travel to Hainan to purchase products not yet available in mainland China and take supplies of these products home (“takeaways”).
Licensed Drug Scope
Patients discharged from medical institutions in the pilot zone can take with them licensed medicines for personal use, including a reasonable amount of oral, external, and subcutaneous injection drugs. External medicines are suitable for eye, nose, ear, and skin use. Subcutaneous injection drugs are only applicable when medical institutions have fully assessed that the risk of use is controllable, used for chronic disease treatment, and completed by patients themselves.
Main Body Responsibilities
The Lecheng Medical Products Bureau is responsible for the filing, daily inspection, and management of the takeaway drugs, guided by the provincial medical products administration and health commission. Medical institutions, as the main bodies responsible for the drugs taken away for use outside of hospitals, must establish management systems and ensure healthcare quality and patient medication safety. Prescribing physicians in medical institutions should monitor the rational use of drugs by patients. If they find abnormal phenomena such as patients significantly shortening the medication cycle without reasonable cause, they should stop prescribing and report to the Lecheng Medical Products Administration through the medical institution.
Prescription Timeframe
The volume of takeaway drugs should comply with medical institution prescription management rules. In principle, the maximum should be four weeks, but it can be extended to 12 weeks for chronic disease patients with stable conditions and mild adverse drug reactions. For long-term prescriptions lasting over four weeks, physicians should strictly evaluate, strengthen patient training, and record in the medical record, with the patient confirming by signing or other means. Medical institutions should enhance the management of patients who have taken away prescription drugs and subcutaneous injections for more than seven days, and may require patients to upload photos or videos for each use if necessary.-Fineline Info & Tech
