The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique
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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.
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Can J Clin Pharmacol · Jan 2001
Improving prescribing in the elderly: a study in the long term care setting.
To determine the prevalence and predictors of potentially inappropriate prescribing of medications in the long term care setting, and to determine the effectiveness of follow-up pharmacist letters to the prescribing physicians in improving prescribing. ⋯ Potentially inappropriate prescribing in the long term care setting is common and can be improved by the provision of a follow-up letter suggesting safer alternatives.
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Can J Clin Pharmacol · Jan 2001
Case ReportsMetformin-associated lactic acidosis in a low risk patient.
Metformin is an oral hypoglycemic agent belonging to the class of biguanides that are commonly used in the treatment of type II diabetes mellitus. Lactic acidosis is a rare but severe adverse reaction that occurs primarily in patients with contraindications such as renal failure. ⋯ The present case report shows that metformin-associated lactic acidosis can occur in patients without pre-existing renal insufficiency. Metformin should be temporarily stopped when acute renal failure occurs or is anticipated.
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Can J Clin Pharmacol · Jan 2000
ReviewCritical appraisal of drug therapy for nausea and vomiting of pregnancy: II. Efficacy and safety of diclectin (doxylamine-B6).
Nausea and vomiting of pregnancy is the most common condition in pregnancy and affects up to 80% of all pregnant women. There are a large number of pharmacological agents that are effective for the treatment of nausea and vomiting associated with conditions such as motion sickness and gastrointestinal conditions; however, their use in pregnancy is limited by the lack of sufficient data on their potential teratogenic effects. The efficacy of the delayed-release combination of doxylamine and pyridoxine (Bendectin, Diclectin) has been shown in several randomized, controlled trials. The present review aims to refute the unsubstantiated beliefs that Diclectin is unsafe when used in the treatment of nausea and vomiting of pregnancy.
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Can J Clin Pharmacol · Jan 2000
Antidote availability in Quebec hospital pharmacies: impact of N-acetylcysteine and naloxone consumption.
To study the availability of 13 specific antidotes in hospitals and correlate the availability of those antidotes to the number of poisonings seen in hospitals using N-acetylcysteine and naloxone consumption as a surrogate. ⋯ Larger hospitals are more likely to have adequate stocks of antidotes. Adequate stocking of antidotes is significantly correlated with the amount of N-acetyl- cysteine and naloxone consumed. This suggests that hospitals more likely to see serious acetaminophen and opiate poisonings are more likely to maintain adequate stocks of antidotes.