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  • News & Press: FDA

    Restricted Use of Tramadol and Tramadol-containing Products

    Tuesday, 27 November 2018   (0 Comments)
    Posted by: Paul Owusu Donkor
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    Restricted Use of Tramadol and Tramadol-containing Products

     

    The Minister for Health, Hon. Kwaku Agyeman-Manu has issued an Executive Instrument E. I. 168 to provide instructions for the control of the importation, manufacture and sale of tramadol and tramadol-containing products. The Executive Instrument was gazetted on the 26th of September, 2018.

    Executive Instrument 168 directs that a person shall not manufacture, import or offer for sale Tramadol or a Tramadol-containing product with a dosage form and strength above that which is registered by the Food and Drugs Authority (FDA). This however, does NOT apply to: tramadol tablets, capsules and injectables with 50 mg and 100 mg and 50 mg/ml to 2 ml dosage and strength; fixed-dose combination products containing 37.5 mg or 50 mg of tramadol; 325 mg or 500 mg of paracetamol.

    Earlier this year, the Food and Drugs Authority convened an emergency meeting of the Ministry of Health Standing Technical Advisory Committee on Safety of Medicines where issues relating to the abuse and misuse of Tramadol were discussed. The measures proposed for addressing the menace were submitted to the Minister for Health, who expressed satisfaction with the work done by the committee, and further found their recommendations acceptable.

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    Currently, all dosage forms and strengths of registered Tramadol and Tramadol-containing products are NOT to be prescribed and dispensed at health facilities below the level of District hospitals. The Ministry of Health is confident that the control of the importation, manufacture and sale of Tramadol and Tramadol-containing products will not affect health outcomes adversely in the Republic of Ghana since the alternative ingredients and strengths listed in the Standard Treatment Guidelines (7th Edition) exhibit similar activities compared with the controlled ingredient, while having a lower potential for addiction.