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These studies correlated prescriptions issued in general practice with events reported by the patients to their general practitioners after the drug was dispensed.By monitoring these events in a substantial population of allergy sufferers, without the restrictions imposed by clinical trials methodology, it was possible to measure differences in side effects between these drugs.
The pharmacist sends all these prescriptions to the Prescription Pricing Authority, which under conditions of full confidentiality, provides electronic copies of the exposure data to the Drug Safety Research Unit.
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 differences between the antihistamines in the incidence density of events classified as “drowsiness or sedation” are further investigated in table 2.