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As all events are monitored, the technique can pick up trends in events that might not be considered to be related to the drug by doctors seeing individual patients.
Additional information, such as use during pregnancy, can be monitored, and data on the use of certain drugs during the first trimester of pregnancy have been published.7 A disadvantage of the method is that it relies on general practitioners returning completed green forms.
Subjects: Event data were obtained for a total of 43 363 patients.
A higher proportion of women than men were prescribed antihistamines, and younger people were more likely to receive the drugs than elderly people.
Figure 1 shows the most frequently reported events for loratadine in the first month of treatment and corresponding values for the other antihistamines.
Prescription-event monitoring is a form of pharmacovigilance, an exercise which has its legal basis in European Union directives 65/65 and 75/319 and in regulation 2309/93.
The method of study (records only research) also complies with the guidelines on the practice of ethics committees in medical research involving human subjects issued by the Royal College of Physicians of London in August 1996.
The data collection periods for the four drugs were May to August 1989 for cetirizine and loratadine, May 1989 to September 1990 for acrivastine, and March to August 1997 for fexofenadine.