THE FRENCH PHARMACOVIGILANCE DATABASE SYS TEM - SOME EXAMPLES

The French drug surveillance (pharmacovigilance) system is based on a network of 31 regional centres which receive adverse drug reaction (AD R) reports from health professionals and are drug information centers. Cases are entered into a common database, with causality scores. This database contains large amounts of data, which may be used for pharma co-epidemiological studies. As an example, all cases in which an antih ypertensive drug, suspect or not, was cited were identified. ACE-inhib itor cough was also explored. Results: Since 1985, > 70 000 case repor ts have been entered into the database. 63 per cent were reported by s pecialists, 20 per cent by GPs. 54 per cent came from University Hospi tals, 21 per cent from private practice. The most numerous age group w as 60 to 69. The overall sex ratio (F/M) was 1.28, the female preponde rance being most marked at < 39 and > 70 years of age. 43 per cent too k only one drug, 20 per cent two drugs, 13.4 percent three, and 24 per cent > three drugs. The most frequently reported effects concerned th e skin and appendages (15 per cent), general status and central nervou s system (9.5 per cent each), platelets, liver, and GI systems (6 per cent each). Outcome was favourable in 74 per cent. Dechallenge was pos itive in 71 per cent, rechallence in 6 per cent. 3.4 per cent of the p atients died; in 2.2 per cent death was related to a reaction. Causali ty assessment indicated close temporal relationship (C2 or C3) in 69 p er cent of cases; in 51 per cent of cases, no other obvious cause was found. 66 per cent of the reactions were labelled when reported. The d atabase could also be used to explore drug utilisation: as an example, we studied the age and sex distribution of reports containing antihyp ertensive drugs, irrespective of their possible causal role in the rea ction. Antihypertensives were mentioned in 14 per cent of the reports. The age distribution was skewed towards greater age, with a maximum o f 70 years. F/M was 1.57, with more M use < 20 and 30-59, whereas F we re more common between 20-29 and 60 years. beta-blockers were more oft en associated with patients under 70, whereas above 70 diuretics and c entrally acting antihypertensive drugs were more often reported. This could be related to greater use or worse tolerance of these drugs. As an example of the exploration of a specific drug-reaction relationship , we explored the relationship between the use of ACE inhibitors (ACEI ) and cough. ACE inhibitors were present in 6 per cent of cases, but i n 75 per cent of reports of cough. F/M was 1.29 (NS) for all reports c oncerning ACEI, 1.28 for cough unrelated to ACEI, 2.1 for cough with A CEI (P < 0.05). Cough was present in 12 per cent of all reports concer ning ACEI. There was no clear difference between ACEI for cough or sex ratio; women cough more with ACEI. This does not seem related to grea ter ACEI use by women or to greater sensitivity of women to cough. The reason for this sex difference remains to be explained. There are lar ge amounts of essentially underutilized data in drug surveillance data bases. How they can or should be used remains to be validated.