The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique
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Can J Clin Pharmacol · Jan 2002
A retrospective survey of the use of bupropion slow release by members of the Canadian Armed Forces.
Since the addition of bupropion slow release (Zyban, GlaxoSmithKline, Mississauga) to the Department of National Defence (DND) smoking cessation program (Butt Out), utilizing bupropion (Zyban) in combination with behaviour modification counselling, the Directorate of Medical policy has received several anecdotal reports from pharmacists and Canadian Forces members attributing significant side effects to the use of Zyban. As a result, the DND wished to assess the benefits versus the risks of using Zyban as part of the smoking cessation program. Subsequently, a retrospective review of the use of Zyban within the Canadian Forces over a one-year period was solicited to assess current policies. ⋯ In light of the demonstrated effectiveness of Zyban and the overwhelming health benefits associated with smoking cessation, it is recommended that the current policies of funding for the DND smoking cessation program be left in place. The impact of Zyban's side effects on job performance and medical resources should be minimized through close monitoring and Zyban prescriptions should be dispensed in two-week quantities.
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Can J Clin Pharmacol · Jan 2002
Human resources for the approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States.
The time required to approve new drugs in Canada is significantly longer than that in Sweden, the United Kingdom and the United States. The timeliness with which a regulatory agency approves drugs may be influenced by the human resources available to review applications. Therefore, the number of full-time equivalent (FTE) staff members who evaluate and approve new drug applications was sought directly from the regulatory agencies of Canada, Australia, Sweden, the United Kingdom and the United States. ⋯ After adjustment to eliminate staff members whose primary responsibility is reviewing generic applications, there were an estimated 159 FTE staff members at the TPD, 1610 at the FDA, an estimated 76 at the TGA, 60 at the MCA and 46 at the MPA. Thus, the number of personnel in Canada is two to 3.5 times that in Australia, the United Kingdom and Sweden, but less than 10% of that in the United States. Because Sweden, the United Kingdom and the United States all have significantly shorter review and approval times than Australia and Canada, the number of review staff does not appear to be a direct major determinant of the timeliness of an agency's review and approval performance.