Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 6 de 6
Filter
Add more filters










Database
Publication year range
1.
Eur J Clin Pharmacol ; 73(8): 1009-1018, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28391408

ABSTRACT

PURPOSE: Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports. METHODS: A retrospective study was conducted on patient reports between July 2011 and July 2015. Informativeness of 16 key elements of information (including drug start and end date, duration of treatment, time to onset and duration of the ADR, outcome, medical history and concomitant medication) was assessed in initial reports before and after review by a pharmacovigilance assessor. RESULTS: Overall, 240 reports concerning 522 ADR and involving 278 drugs were reported over this 4-year period. Mean number of available key elements of information in initial reports was increased from 11/16 to 15/16 after review of reports by the PVC. Time to onset and duration of the ADR were respectively available in only 51 and 58% of the reports before review compared to 83 and 90% after review. Medical history and concomitant medication were missing in 75% of the initial reports compared to less than 30% of the reports after review. Contacting the reporter enabled an increase of informativeness of most elements of information for more than 90% of the reports. CONCLUSION: Patient reports often need to be completed on key elements of information that are required to assess reports. Both upstream education of patients and downstream intervention of a pharmacovigilance assessor to complete missing information could help to enhance the informativeness of such reports.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Self Report/standards , Adult , Aged , Female , France/epidemiology , Humans , Male , Middle Aged , Pharmacovigilance
2.
Ann Dermatol Venereol ; 142(1): 37-40, 2015 Jan.
Article in French | MEDLINE | ID: mdl-25600793

ABSTRACT

BACKGROUND: When fixed drug eruption occurs following use of cyclophosphamide and mesna, it is difficult to establish which drug is responsible. We report a new case of patch tests that resulted in withdrawal of mesna and enabled continued treatment with cyclophophamide. PATIENTS AND METHODS: A 57-year-old female patient with multiple sclerosis presented increasingly severe cutaneous lesions after successive courses of cyclophosphamide. Twenty-four hours after her latest treatment, she presented at the ER with a worse eruption than those to date and including facial lesions. The clinical diagnosis was a fixed drug eruption, and patch tests for mesna one month later were positive. CONCLUSION: Fixed drug eruption always occurs after recurrent treatment and the investigation must be precise. Patch tests may be used to determine which drug could be responsible. The most conclusive test comprises withdrawal of the incriminated drug with no further signs of drug eruption on resumption of the other medication.


Subject(s)
Antirheumatic Agents/therapeutic use , Cyclophosphamide/therapeutic use , Drug Eruptions/etiology , Mesna/adverse effects , Patch Tests , Protective Agents/adverse effects , Drug Therapy, Combination , Female , Humans , Middle Aged
3.
Rev Med Interne ; 34(9): 515-21, 2013 Sep.
Article in French | MEDLINE | ID: mdl-23523077

ABSTRACT

PURPOSE: Recent data show that the quality of anticoagulation evaluated in patients receiving vitamin K antagonists (VKA) is not optimal in France. The aim of this retrospective study was to estimate the performances of six French anticoagulant clinics that manage VKA treatments over a 3-year period, from 2009 to 2011. METHODS: All clinics used the same rule based software. We determined the time spent in the therapeutic range (TTR), a surrogate end-point of quality of treatment with VKA. RESULTS: The overall duration of follow-up was 2755 patient-years concerning 2385 patients. The time spent in the therapeutic range 2 to 3 assigned for 89% of the patients, was 73%. On the other hand the time spent in the therapeutic range for the other two INR ranges (2.5-3.5 and 3-4.5) concerning 11% of patients with prosthetic heart valve was lower (63.7% and 68.8% respectively) with an imbalance in favour of the time below the range. In this study, warfarin (Coumadine(®)) and fluindione (Previscan(®)) allowed an equivalent quality of anticoagulation. The 1728 patients of age ranged from 60 to 100 years spent more time in TTR than the 651 younger patients. The percentage of time spent with an INR greater than 5 was extremely reduced which is a guarantee of safety. CONCLUSION: These results prove that anticoagulant clinics in France have the same good performances as their counterparts abroad. It can be assumed that a high TTR contributes to a low incidence of both bleedings and thrombosis.


Subject(s)
4-Hydroxycoumarins/therapeutic use , Ambulatory Care Facilities , Anticoagulants/therapeutic use , Blood Coagulation Disorders/drug therapy , Indenes/therapeutic use , Vitamin K/antagonists & inhibitors , Adolescent , Adult , Aged , Aged, 80 and over , Ambulatory Care Facilities/statistics & numerical data , Blood Coagulation Disorders/epidemiology , Child , Female , France/epidemiology , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Professional Practice , Retrospective Studies , Vitamin K/therapeutic use , Young Adult
4.
Euro Surveill ; 10(11): 222-5, 2005 Nov.
Article in English | MEDLINE | ID: mdl-16371687

ABSTRACT

In August 2004, a case of rabies was diagnosed in a puppy that had been illegally imported from Morocco to Bordeaux (France). Because a great number of people and animals were thought to have come into contact with the puppy, extensive tracing measures were implemented, and an international alert was launched to trace and treat the contacts at risk. One hundred and eighty seven people received post-exposure treatment, eight of whom also received serovaccination, and 57 animals known to have been exposed to the puppy were tested. Six months after the death of the rabid animal, none of the people treated showed any signs of rabies, nor was any secondary animal case reported. The management of this crisis highlights the importance of the role of a rapid alert system at European level. Strict application of sanitary control regulations is essential for animals introduced into EU countries, and all necessary information must be made available to EU residents travelling to rabies enzootic areas.


Subject(s)
Commerce/legislation & jurisprudence , Communicable Disease Control , Contact Tracing , Dog Diseases/transmission , Rabies/veterinary , Zoonoses , Adolescent , Adult , Aged , Aged, 80 and over , Animals , Child , Child, Preschool , Dogs , Female , France , Humans , Immunoglobulins, Intravenous/therapeutic use , Infant , Internationality , Male , Middle Aged , Rabies/prevention & control , Vaccination
5.
Euro Surveill ; 10(11): 9-10, 2005 Nov.
Article in English | MEDLINE | ID: mdl-29208098

ABSTRACT

In August 2004, a case of rabies was diagnosed in a puppy that had been illegally imported from Morocco to Bordeaux (France). Because a great number of people and animals were thought to have come into contact with the puppy, extensive tracing measures were implemented, and an international alert was launched to trace and treat the contacts at risk. One hundred and eighty seven people received post-exposure treatment, eight of whom also received serovaccination, and 57 animals known to have been exposed to the puppy were tested. Six months after the death of the rabid animal, none of the people treated showed any signs of rabies, nor was any secondary animal case reported. The management of this crisis highlights the importance of the role of a rapid alert system at European level. Strict application of sanitary control regulations is essential for animals introduced into EU countries, and all necessary information must be made available to EU residents travelling to rabies enzootic areas.

6.
Med Mal Infect ; 34(12): 551-60, 2004 Dec.
Article in French | MEDLINE | ID: mdl-15603930

ABSTRACT

Twenty people died of rabies in France between 1970 and 2003 (compared to 55,000 yearly worldwide), 80% on returning from Africa. Dogs were the contaminating animals in 90% of the cases and children were the most common victims. The last instance of rabies in a native French animal was reported in 1998. However the illegal importation of animals still poses a risk. The disease is transmitted by saliva, even before the appearance of clinical symptoms, through a bite, scratch, or licks of mucous membranes or broken skin. Person-to-person transmission has only been observed in cases of grafts (cornea). The mean incubation time of 1 to 3 months is long enough to allow passive immunization and vaccination. After its onset, the disease presents as encephalitis or a paralytic syndrome the outcome of which is always fatal. Clinical diagnosis may be difficult in the early stages of the disease. If rabies is suspected, the National Reference Centre is responsible for the sampling and proper transportation of these samples so as to ensure assessment results within 5 days. If stringent hygiene rules are complied to, there is no risk of contamination for those in close contact. Vaccination, which is performed in official rabies centers, is only performed after a diagnosis based on laboratory evidence, and solely for exposed persons or those for whom a reliable history cannot be established (children under 6 years). Prevention is based on information. People traveling abroad, particularly to Africa, are warned not to approach unknown animals (especially dogs) nor to try to import them, and are advised to comply with vaccinal recommendations for travelers, particularly for toddlers.


Subject(s)
Rabies/epidemiology , Adolescent , Africa , Aged , Animals , Case Management , Child , Child, Preschool , Dog Diseases/transmission , Dog Diseases/virology , Dogs/virology , Fatal Outcome , Female , France/epidemiology , Humans , Immunization, Passive , India , Male , Mexico , Middle Aged , Personnel, Hospital , RNA, Viral/isolation & purification , Rabies/diagnosis , Rabies/therapy , Rabies/transmission , Rabies/veterinary , Rabies/virology , Rabies Vaccines/administration & dosage , Rabies Vaccines/therapeutic use , Rabies virus/isolation & purification , Saliva/virology , Seizures/etiology , Skin/injuries , Transplantation/adverse effects , Travel , Vaccination , Wound Infection/virology
SELECTION OF CITATIONS
SEARCH DETAIL
...