Biomedical subjects

L Bensouda-Grimaldi

Publications and source records attributed to L Bensouda-Grimaldi.

4 recordsLinked to original sources

PubMed2005

[Pharmacovigilance of vaccines].

Safety of vaccines must be excellent to make vaccine's strategy acceptable, since it usually has a deferred individual benefit but immediate adverse drug reactions (ADRs). Pharmacovigilance of vaccines after their marketing is crucial because, prior to its availability on the market, the size of clinical trials is insufficient to identify rare or deferred adverse effects. The Pharmacovigilance is based on "spontaneous reporting" of ADRs to the Pharmacovigilance Regional Centre (PVRC) which establishes a relationship between each drug taken by the patient and the ADRs occurrence (imputability). This method is crucial to generate alerts, but under-estimates the real frequency of ADRs (1 to 10% of severe ADRs are reported). Thus pharmacoepidemiology studies are necessary to confirm the alerts identified by spontaneous reporting. ADRs can be specific, related to the antigen of an attenuated alive virus vaccine (lymphocyte meningitis after anti-mumps vaccine) or non-specific, related to a component different from the antigen (aluminium hydroxide involved in the "macrophagic myofasciitis", allergic reactions to neomycin, latex, egg or gelatine). Importance of Pharmacovigilance of vaccines is illustrated. Data, especially case-control studies, about the relationship between multiple sclerosis and hepatitis B vaccine are summarised. Data about the relationship between Crohn's disease or autism and MMR vaccine are analysed. As vaccines are used in healthy people, their safety must be excellent to be accepted. To monitor them after their marketing is the unique way to detect rare ADRs. This surveillance is made through reporting of ADRs to the PVRC. However, an active and intensive surveillance of ADRs as the one set up from the marketing of Prevenar should be systematic.

Adverse Drug Reaction Reporting Systems↗

PubMed2005

[Prescriptions and children].

Because of a lack in drug evaluation in children, they receive many off license drugs prescription, which means drugs prescribed in an indication, dosage, formulation or age different from the license terms. However, drug evaluation is crucial in paediatrics population because of pharmacokinetics and pharmacodynamics modifications throughout organism development, which make usually wrong any extrapolation to children of data obtained in adults. Drug safety is generally better in infants except in newborns who are at a particularly high drug-related risk because of high frequency of off license drug use, many drugs association and drugs metabolism immaturity. The lack of evaluation in children, the fact that children are the unique target population of some drugs or the maturation phenomena explain some adverse effects more specific in children. The more the children are young, the more they are exposed to medication or drug utilization errors. Physician must take what the SPC, as found in the Vidal dictionary, mentions about children into account while prescribing. Drugs with a paediatric license must be preferred overall, however it should be kept in mind that a paediatric license means only that the drug is active in the indication of the license but it doesn't position it regarding other therapeutic alternatives. Off labeling prescription should be based on a supposed benefit, which had to be justified if a severe side effect occurred.

Child↗

PubMed2005

[Insertion problems, removal problems, and contraception failures with Implanon].

OBJECTIVE: Analysis of the results of a national pharmacovigilance study on Implanon, a contraceptive implant containing 68 mg of etonogestrel. PATIENTS AND METHODS: This survey concerns cases of pregnancies (contraception failures), of migrations and of insertion or removal problems with Implanon reported to French Regional Drug Pharmacovigilance Centres and to Organon SA between May 2001 and September 2002. RESULTS: In France, 39 unintended pregnancies were reported over 17 months. The pregnancies were in 77% of cases (N = 30) due to an insertion technique error (implant not found when pregnancy has been diagnosed). For 3 patients (7,6%), pregnancy was due to a failure of etonogestrel contraceptive effect, explained twice by its association with an enzymatic inductor drug. For 4 patients (10%), pregnancy was due to an untimely insertion (insertion after day 5 of menstrual cycle or woman already pregnant). For two patients, no information was available. The incidence of reported pregnancies in France is estimated at 0.359 / 10(3) implants [0.246-0.482], in accordance with a typical Pearl Index of 0.06 [0.04-0.08]. Twenty-eight suspected migrations (N = 11), problems or failures in removal of the implant (N = 11) and insertion difficulties (N = 6) were notified, corresponding to an incidence of 0.257/10(3) implants [0.162-0.363]. DISCUSSION AND CONCLUSION: Occurrence of pregnancy is possible with Implanon, due to errors in the insertion technique (device not really inserted) or to a non-respect of the SPC recommendations (drug-drug interaction or untimely insertion). Insertion problems can lead to localisation problems (implant not visible by X-ray) then needing further tests and even harmful practice (removal under general anaesthesia). That is why a real and strict training is highly recommended to physicians.

Adult↗

PubMed2005

[Isotretinoin: compliance with recommendations in childbearing women].

INTRODUCTION: The aim of this survey is to ascertain if the incidence of isotretinoin exposed pregnancies was reduced by the late recommendations of prescription and issue (AMM modification on 06/08/2001 and 25/09/2001). METHODS: All isotretinoin exposed pregnancies registered by the French Regional Drug Monitoring Centres, the Information Centre for Teratogenic Agents and Roche (Roaccutane), Pierre Fabre (Curacné Gé) and Expanscience (Procuta Gé) laboratories, from January 1st, 1999 to December 31st, 2002, were analysed. Enforcement of the strengthening of isotretinoin prescription recommendations was analysed on a sample of 68 prescriptions from 45 pharmacies throughout France. RESULTS: In 4 years, 103 isotretinoin exposed pregnancies (Roaccutane 97 p. 100, Curacné(R) Gé 3 p. 100) during teratogenic risk period, were registered. Pregnancy started less than one month after isotretinoin stopping (37 p. 100), during the treatment (43 p. 100), or was in progress when the treatment was initiated (20 p. 100). The reason of the 22 lacking contraception was known 12 times, i.e. an absence of prescription (6 times), a refusal to take a prescribed contraception (3 times) and a self-medication (3 times). Among the 71 pregnancies whose contraceptive status is known, 48 p. 100 could had been avoided if recommendations had been followed (pregnancies due to a premature stopping or an absence of contraception). The issue of pregnancies is a voluntary termination in 60 cases (87 p. 100). Malformations frequency is 25 p. 100. Incidence of isotretinoin exposed pregnancies remained stable, 0.26/1000 treated women (vs 0.34 after 2001's AMM modifications). Of 68 prescriptions studied, 23 (24 p. 100) carried all the legal warnings, which is close to the previous survey's results. Contraception was in accordance with the recommendations in 78 p. 100 of cases and women learned and applied information given in 38 p. 100 of cases. At last, only 6 patients (9 p. 100) have both a correctly written prescription, a contraception and a time between the pregnancy test date and prescription and issue dates, in accordance with the licence and have had a correct information and understood it. Regarding the previous survey, pregnancy test before treatment was more often prescribed (96 p. 100 vs 88 p. 100). On the other hand, less women knew the necessity to keep on taking contraception one month after isotretinoin stopping (82 p. 100 vs 93 p. 100). CONCLUSION: Despite 3 successive isotretinoin prescription and issue recommendations strengthening in childbearing women, pregnancies can't be totally avoided. Bad compliance concerns the prescription and/or an incomplete or not understood information by the patient who does not scrupulously apply the care and contraception agreement. However, this study does not allow to assess the proportion of issued prescriptions despite their non-accordance with the licence criteria. The National Commission of Pharmacovigilance did not like to limit isotretinoin prescription to dermatologists only. It estimates that the administrative authority must intensify information by dermatologists, general practitioners and pharmacists, about measures to take to avoid an exposure to isotretinoin during pregnancy.

Abnormalities, Drug-Induced↗