Accordingly, the Ministry of Health has declared that protamine sulfate is a drug on the list of rare drugs that should be given priority in return for issuing a circulation registration certificate; however, no establishment has so far submitted an application for circulation registration of drugs containing the active ingredient protamine sulfate in Vietnam.
Recently, the Drug Administration of Vietnam has allowed many institutions to import injection drugs containing the active ingredient protamine sulfate (which has not yet obtained a circulation registration certificate) to meet the special treatment needs of institutions. medical examination and treatment. in accordance with the provisions of Article 68 of Government Decree No. 54/2017/ND-CP detailing several articles and implementing measures of the Pharmacy Law.
According to the information provided by importers, although the quantity of protamine sulphate drugs authorized for importation exactly corresponds to the quantity estimated by the medical examination and treatment establishments in need, the amount of protamine sulphate drugs imported into Vietnam is still insufficient in the near future as the demand is higher than the current estimate.
The main reason for this is that protamine sulfate is a specialty drug, used only in cardiac – thoracic surgery procedures with little demand. Therefore, manufacturers usually produce only after receiving orders from other facilities.
Meanwhile, after receiving estimates from medical examination and treatment institutions and receiving import permits from the Ministry of Health, Vietnamese importers will place orders with foreign drug suppliers.
Therefore, in the event that the medical examination and treatment institutions do not proactively and promptly place orders with drug importers and drug importers with foreign drug suppliers, it may lead to a temporary shortage of drugs when Vietnamese importers place an order but foreign drug suppliers do not have enough stock to supply the Vietnamese market as needed. It will take a few months to make new drugs.
The Ministry of Health also stated that because protamine sulfate is a rare drug, supply and demand are lower than other drugs; therefore, in recent years, the Drug Administration of Vietnam has sent dispatches to health departments, hospitals, medical institutes and importing institutions requesting to proactively contact protamine sulfate drug importing companies to pass some orders.
Last but not least, health departments, hospitals, medical institutes and importing establishments should stock the drug beyond the regular demand in case of emergency, sudden demand or drug supply problems in addition to the regular amount. These organizations should review their orders, purchases and inventory of injectable drugs containing the active ingredient protamine sulfate to avoid disruption of drug supply for hospital treatment needs.
With the current situation, the Drug Administration of Vietnam requires establishments importing protamine sulphate drugs to urgently synthesize all estimates from medical examination and treatment establishments in order to plan and sign contracts with suppliers quickly. establishments. Foreign drug manufacturers and suppliers should ensure that these establishments can be proactive in producing and supplying drugs in a timely manner to the Vietnamese market, avoiding drug shortages due to late signing of contracts.
In addition, they should work with medical institutions and infirmaries that are in desperate need of the drug to place orders for protamine sulfate drugs according to regulations and submit them to the Drug Administration of Vietnam immediately after completing the records. .
Because it is an indispensable part in the process of heart – thoracic surgery, to ensure timely and sufficient supply of drugs for use, Vietnam Drug Administration recommends that provincial and district health departments cities, hospitals, institutes and drug importers Establishments seriously apply the guidance documents of the Drug Administration of Vietnam on the procurement of protamine sulfate drugs that have been issued in the past.
Drug import establishments should report to Vietnam Pharmaceutical Administration by August 20 on the import plan of protamine sulfate in the near future and propose solutions to address it.