Hainan Province issued new administrative measures for use of imported drugs in urgent need in Lecheng Pilot Zone

2022-07-05

The provincial drug administration, together with the Provincial Health Commission, issued the administrative measures for the withdrawal and use of clinically urgently needed imported drugs in Hainan Boao Lecheng International Medical Tourism pilot area in order to further optimize the approval and supervision of the use of licensed drugs.

According to the administrative measures, when patients leave the hospital and medical institutions in the pilot area, (according to the actual situation) only a reasonable amount of oral, external and subcutaneous injection can be taken away from the medical institutions for self-use.

Among them, topical drugs suitable for eye, nose, ear and skin; subcutaneous injection drugs are only applicable to the situation where the medical institutions have fully assessed that the use of drugs is controllable in risk, can be used for the treatment of chronic diseases, and can be operated by themselves.

When applying for leaving the hospital with drugs, the medical institution shall submit the filing materials to Lecheng medical regulatory bureau through the licensed drug equipment traceability management platform, and generate the unique record number.

At the same time, medical institutions need to associate patients and drug information on the licensed drug equipment traceability management platform, and determine that the minimum independent package of drugs is recorded with the traceability code, so as to realize the whole process traceability.

The management measures adhere to the combination of ensuring medical safety and meeting the drug demand, focusing on the compaction of the main responsibility of medical institutions, strengthening the management of doctors' practice according to law, improving the compliance of patients, relying on information technology means and strengthening supervision and management, etc., to further strengthen the risk prevention and control, and prevent the arbitrage, sale and transfer of licensed drugs.

According to the administrative measures, taking drugs out of hospital involves many subjects, such as health, drug supervision, medical institutions, doctors and patients.

At the same time, it is seen as necessary to set up a strict punishment system for doctors who violate the regulations of special medical institutions.