The official letter 15113/QLD-ĐK Limit the use and update codeine pharmacological information

The official letter 15113/QLD-ĐK Limit the use and update codeine pharmacological information

To:
– Provincial/municipal Health Services;
– Hospitals, institutes with beds;
– Applicants, manufacturers have drugs marketing in Vietnam.

Codeine is an opioid central analgesic used in the case of moderate pain. Codeine is also used in combination with other medications to reduce cough.
Recently, after reports of dangerous side effects, even fatal, especially in children using codeine for pain after tonsillectomy and/or V.A Surgical procedures to evacuate, U.S Food and Drug Administration (U.S. FDA), European Medicines Agency (EMA) has conducted research and revaluation of drug safety. Drug Administration of Vietnam has the official letter No. 12886/QLD-TT dated 08.08.2013 sent to the provincial/municipal Health Services, hospitals to provide drug information and the recommendations of the Drug Administration of other countries, and suggests health care centers to enhance monitoring, detection and management of cases of adverse reactions occurred during the use of drugs containing codeine.

After the official letter No. 12886/QLD-TT dated 08.08.2013 mentioned above, based on the conclusions of The advisory Board of the issuance of medicine registration numbers – Ministry of Health and recommendations of EMA, U.S. FDA to drugs containing codeine; to ensure objective the use of drug reasonable, safe and effective, the Drug Administration of Vietnam request:

1. For provincial/municipal Health Services, hospitals, institutes with beds belong to Ministry of Health.
1.1. Continue to implement the requirements stated in the official letter No. 12886/QLD-TT dated 08.08.2013 by The Drug Administration of Vietnam.
1.2. Update recommendations related to drugs containing codeine to health care centers, the pharmaceutical companies on the local:

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– Codeine should not be used at all in children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea, as these patients are more susceptible to respiratory problems.
– Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
– Codeine should be used at the lowest dose that effectively and in the shortest time.
– Codeine-containing medicines should not be recommended for children have problems related to respiratory that can cause symptoms of severe morphine poisoning.
– Breastfeeding women should not use drugs because drugs can be excreted in breast milk.

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2. For applicants and manufacturers:
2.1. For codeine-containing drugs have been licensed for marketing:
2.2.1. Within 3 months from the date of signing of this official letter. Request applicants, manufacturers to implement update, supplement in Labels, Package insert and/or Patient information leaflet with the contents follows:
a. Section Contraindication:
– Children under 18 years old who undergo surgery for the removal of the tonsils or adenoids.
b. Section Special warning and precautions for use:
– Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
– Codeine should be used at the lowest dose that effectively and in the shortest time
– Codeine-containing medicines should not be recommended for children have problems related to respiratory (E.g.: shortness of breath or wheezing when sleeping…)
– Caution when using codeine for children under 12 years (due to research information about the influence of these drugs to ones is limited).
– Caution when using medicines for breastfeeding women (drug may be excreted in breast milk)
2.1.2. Updated form:
– Companies update and supplement the information specified in paragraph 2 of item 3 of Section II Annex II – Circular 22/2009/TT-BYT Circular dated 24/11/2009 of the Ministry of Health, Guiding medicine registration and is responsible for updating the content as required in this official letter.
– Case when updating the above content lead to major variations specified in Section I of Annex II – Circular 22/2009/TT-BYT, the applicants must submit major variations registration dossiers in accordance with existing regulations.
2.2. For drug registration dossiers with codeine-containing active ingredients pending approval at Drug Administration of Vietnam:
Drug Administration only considers grant registration numbers after applicants submitted documentation updates, additional content of section Contraindication, Special warning and precautions for use, as mentioned at point 2.1.1 of this official letter into the relevant parts of dossier and satisfactory evaluation.
Drug Administration of Vietnam notifies agencies to know and implement.

The official letter 15113/QLD-ĐK Limit the use and update codeine pharmacological information