Traduction de «lariam safety monitoring program » (Anglais → Français) :

Lariam Safety Monitoring Study [ Lariam (Mefloquine) Safety Monitoring Program ]

With reference to the antimalarial drug mefloquine administered to Canadian Forces bound for Somalia in 1992-93 and the legal framework under which it was available for use and administered: (a) was mefloquine a licensed drug when it was administered to Canadian Forces, if not what was its status, and how was it legally available; (b) were the Canadian Forces participating in the Lariam (mefloquine) Safety Monitoring Study during this period; (c) was the mefloquine administered in accordance with the Lariam Safety Monitoring Study a ...[+++]nd the Food and Drug Act; (d) who was the “principal investigator” responsible for the Lariam Safety Monitoring Study in the Canadian Forces; (e) who was the Canadian Forces physician responsible to the “principal investigator” of the Lariam Safety Monitoring Study; (f) what was the role of Canadian Forces physician, Dr. Martin Tepper, in the Lariam Safety Monitoring Study; (g) who was responsible for the Lariam Safety Monitoring Study at the Department of Health's Health Protection Branch during this period; (h) what was the role and responsibility of the Health Protection Branch under the Lariam Safety Monitoring Study and the Food and Drug Act and its regulations in regard to the use of mefloquine by Canadian Forces personnel; (i) when did the Health Protection Branch become aware that mefloquine was being administered to Canadian Forces personnel bound for Somalia; (j) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act prior to the licensing of mefloquine to inform the manufacturer of its use; (k) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act to the soldiers who were administered the drug; (l) did the Canadian Forces fulfil their responsibility to the manufacturer under the Lariam Safety Monitoring Study and the Food and Drug Act prior to the licensing of mefloquine and if so how did they do ...

With reference to the side effects experienced by those taking the anti-malarial drug mefloquine (Lariam): (a) provide a detailed update on the clinical study of mefloquine (Lariam) announced by the Department of National Defence in 1997, including trial design, subject inclusion/exclusion criteria, numbers of study subjects recruited to date and participating centres; (b) have reviews been undertaken of the side effects experienced by the Australian, British and Dutch forces, if so what were the results and recommendations, and what steps have been undertaken to implement these recommendations; (c) with regard to the mefloquine (Laria ...[+++]m) used for the prophylaxis of Canadian troops deployed to Somalia, what was the nature of the Department of Health's Health Protection Branch investigations in October 1997 into the failure of the manufacturer to properly supervise and ensure compliance with the Lariam safety monitoring study and the failure of the Department of National Defence to comply with its obligations under the safety monitoring study; (d) with regard to the mefloquine (Lariam) used for the prophylaxis of Canadian troops deployed to Somalia, what was the outcome of the Department of Health's Health Protection Branch investigations in October 1997 into the failure of the manufacturer to properly supervise and ensure compliance with the Lariam safety monitoring study and the failure of the Department of National Defence to comply with its obligations under the safety monitoring study; (e) what is the date of the insert in the mefloquine (Lariam) package used in Canada today; (f) what is the date of the product monograph for mefloquine (Lariam) used in Canada today; (g) have reviews been undertaken of the insert in the mefloquine (Lariam) package and the prescribing information used in Australia, if so what were the results and recommendations of the reviews, and what steps have been taken to implement the recommendations; (h) have reviews been undertaken ...

With regard to the purchase of mefloquine from the manufacturer and the oversight of mefloquine by the Health Protection Branch as mandated by the Food and Drug Act: (a) did the Canadian Forces indicate to the manufacturer on the order form when ordering mefloquine for Somalia that it was for use under the Food and Drug Act's Lariam Safety Monitoring Study; when was the order submitted; and when was the shipment received; (b) was the Health Protection Branch informed by the manufacturer that the Canadian Forces had indicated on the order form that the mefloquine was being ordered under the authority of the Lariam Safety ...[+++] Monitoring Study and that this mefloquine was apparently purchased for the Somalia deployment; and when was the Health Protection Branch so informed; (c) did the Health Protection Branch receive from the manufacturer a request to fast track licensing approval for mefloquine (Lariam), and was licensing approval granted prior to the end of the Canadian Forces deployment in Somalia; (d) what was the date the Health Protection Branch received the final results of the Lariam Safety Monitoring Study from the manufacturer, and the date of the receipt by the Health Protection Branch of the last submission of the Safety Monitoring Study's results prior to licensing approval; (e) did the Department of National Defence prepare an advisory note acknowledging that evidence provided to the Somalia Inquiry had mislead the Inquiry as to the status of mefloquine approvals for the mefloquine used in the Somalia deployment; was the advisory note forwarded to the Minister of National Defence; and what action was taken when the Minister was so informed?

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