[Pharmacokinetics of cardiovascular drugs in the elderly]. / Pharmacocinétique des médicaments cardiovasculaires chez la personne agée.

Adverse drug effects are more frequent in elderly patients, especially with drugs that have small safety margins. This is the case of many cardiovascular drugs. Patients who are frail, owing to their age and their psychomotor, nutritional and social stratus, are particularly at risk. Two pharmacokinetic factors appear to be of major concern, namely the age-related decrease renal function and changes in drug metabolism and distribution. Renal function is probably the single factor most responsible for altered drug levels in the elderly. The normal age-related decrease in creatinine clearance can lead to the accumulation of drugs that are normally excreted by the kidneys without being inactivated Dose adjustment of such drugs is usually based on the Cockcroft-Gault formula of creatinine clearance. Changes in hepatic metabolism and drug distribution are less commonly taken into account. The avoidance of drug toxicity requires familiarity with the medications prescribed and particular vigilance for signs of adverse effects.

[Pharmacovigilance of hepatitis B vaccines]. / Pharmacovigilance des vaccins contre l'hépatite B.

Since the hepatitis B vaccine are on the market in France, until the end of 2002, 1211 observations of demyelinating disease of the central nervous system (1109 cases of which 895 multiple sclerosis) or peripheral (102 cases of which 49 Guillain Barre Syndrome), have been reported to the french network of pharmacovigilance and to the AFSSAPS. It is not possible to singularize these observations, neither from a clinical nor an epidemiological point of view. No risk factor has been detected. Only the chronology could suggest a causal relationship, the vaccine preceding the pathology in all the cases notified.

[Drug vigilance]. / Pharmacovigilance.

The goal of drug vigilance is to identify, analyse and anticipate adverse reactions resulting from the use of a drug. It is of utmost importance to ensure that a drug remains safely used, and to update its prescription when necessary. Vigilance is based on professional judgments by specialists who flag putative side effects to the network. To ascertain causality between drug use and possible side-effects, the available evidence is discussed within the vigilance network, closely involving the health professional who originally identified a possible effect, and with reference to the French drug vigilance database, as well as the existing relevant literature. The possibility of a side-effect triggers an alarm, and generates an investigation, which must often he completed by an epidemiological analysis when the risk associated with the drug is low. Drug vigilance is crucial to public health. It currently collects data both from the relevant units in pharmaceutical companies and the public drug vigilance networks.