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Sample records for french pharmacovigilance database

  1. Was the thrombotic risk of rofecoxib predictable from the French Pharmacovigilance Database before 30 September 2004?

    PubMed

    Sommet, A; Grolleau, S; Bagheri, H; Lapeyre-Mestre, M; Montastruc, J L

    2008-08-01

    Rofecoxib was withdrawn from the market on 30 September 2004 following the results of a randomized controlled trial. Following this sudden decision, several controversies occurred in the literature to determine whether this adverse drug reaction (ADR) could have been detected earlier. The aim of this study was to investigate whether this kind of signal could have been seen using the French Pharmacovigilance Database before this date of rofecoxib withdrawal. Using cases registered in the French Pharmacovigilance Database from May 2000 to December 2006, we applied the case-noncase method to "serious" thrombotic ADRs reported with oral formulations of rofecoxib or celecoxib in patients older than 15 years. Cases were all notifications of thrombotic ADRs [World Health Organization Adverse Reaction Terminology (WHO-ART) codes 1300] occurred under coxib (rofecoxib, celecoxib) and noncases all other reports registered in the database (whatever the drug). We calculated a cumulative odds ratio (OR) from 20 May 2000 to 31 December 2006, with a special interest for the period before the 30 September 2004. Among the 50,087 "serious" ADRs registered in the database during this period, 1,127 were thrombotic ones. Rofecoxib exposure was significantly associated with high values of odds ratio (OR) [4.2 (95% CI 1.97-8.61)] for thrombotic ADRs as early as the end of 2001. The values of ADR reporting ORs remained high (3.0-3.5) until 2006. For celecoxib, a significant trend occurred only from September 2004. Despite the compulsory limits of the case/noncase methodology, this study found an association between rofecoxib exposure and the occurrence of "serious" thrombotic ADRs as early as the end of the first year of rofecoxib marketing in France. The association between celecoxib and the occurrence of such ADRs appears less clear. Our work also shows the potential use of careful analysis of pharmacovigilance databases (investigating, for example, cumulative values of risk) in the

  2. Serotonin Syndrome: Analysis of Cases Registered in the French Pharmacovigilance Database.

    PubMed

    Abadie, Delphine; Rousseau, Vanessa; Logerot, Sophie; Cottin, Judith; Montastruc, Jean-Louis; Montastruc, François

    2015-08-01

    More information would be required for a better understanding of the actual circumstances of serotonin syndrome (SS) occurrence in routine clinical practice. The objective of the study was to analyze characteristics of SS French pharmacovigilance reports, especially involved drugs and nature of drug-drug interactions (DDIs). We performed a retrospective analysis of SS registered in the French pharmacovigilance database between January 1, 1985 and May 27, 2013. Only cases whose clinical symptoms fulfilled Sternbach, Radomski, or Hunter SS diagnostic criteria were retained for the analysis. Most of the 125 (84.0%) analyzed cases were associated with a recent change in a serotonergic drug (introduction, increasing the dose or overdose). Antidepressants were the most often involved serotonergic drugs, mostly serotonin reuptake inhibitors (SRIs, 42.1%) and to a lesser extent serotonin-noradrenalin reuptake inhibitors (9.1%, mainly venlafaxine), tricyclic antidepressants (8.6%, mainly clomipramine), and some monoamine oxidase inhibitors (6.2%, mainly moclobemide). Nonpsychotropic medications were also involved, generally opioids (14.8%, mainly tramadol). Most of the cases (59.2%) resulted from pharmacodynamic DDIs, most often involving SRIs + opioids (mostly paroxetine + tramadol). However, SS also occurred with a single serotonergic drug in a significant number of cases (40.8%), most often SRIs (mainly fluoxetine) or venlafaxine at usual doses. Lastly, a major pharmacokinetic DDI could have played a role in 1/5 (20.8%) of cases. This is the first study about SS based on a large pharmacovigilance database and published in English. Our results reveal not only the frequent involvement of antidepressants and tramadol, the importance of DDIs (both pharmacodynamic and pharmacokinetic), but also the significant risk of SS even with a single serotonergic drug used at normal dose.

  3. [Drugs and retinal disorders: A case/non-case study in the French pharmacovigilance database].

    PubMed

    Bourgeois, Nicolas; Chavant, François; Lafay-Chebassier, Claire; Leveziel, Nicolas; Pérault-Pochat, Marie-Christine

    2016-09-01

    Retina is the part of the eye suffering most damage from pharmaceutical molecules. Drug-induced retinopathies have been described but data are scarce and sometimes conflicting especially concerning its potential seriousness. The aim of this study was to investigate potential associations between drugs and retinal disorders using the French Pharmacovigilance data. We used the case/non-case method in the French PharmacoVigilance Database (FPVD) to identify drugs able to induce retinopathies. Cases were reports of retinal disorders in the FPVD between January 2008 and December 2012. Non-cases were all other reports during the same period. To assess the association between retinopathy and drug intake, we calculated the odds-ratio (OR) [with their 95% confidence intervals] for all drugs associated with at least 3 cases of retinopathy. Among the 123 687 adverse drug reactions recorded during the studied period, we identified 164 cases of retinal disorders. Significant associations were found for 11 drugs. The main therapeutic classes were antirhumatismals (hydroxychloroquine, chloroquine and etanercept: 18 cases), anti-infective (ribavirine, PEG-interferon-alfa-2a and cefuroxime: 16 cases) and antineoplastic drugs (imatinib and letrozole: 8 cases. Three other drugs were also found: raloxifene (5 cases), erythropoietin beta (4 cases) and ranibizumab (3 cases). Taking into account the limits of the methodology, our study confirmed the association between retinopathy and some expected drugs such as aminoquinolines, interferons, imatinib or ranibizumab. Other drugs like erythropoietin beta, cefuroxime, letrozole and etanercept were significantly associated with retinal disorders although this was not or poorly described in the literature. Thus, further prospective studies are necessary to confirm such associations.

  4. Drug-induced panic attacks: Analysis of cases registered in the French pharmacovigilance database.

    PubMed

    Abadie, Delphine; Essilini, Anaïs; Fulda, Virginie; Gouraud, Aurore; Yéléhé-Okouma, Mélissa; Micallef, Joëlle; Montastruc, François; Montastruc, Jean Louis

    2017-07-01

    The potential role of drugs in the onset of panic attacks (PAs) is poorly understood. The objective of our study was to characterize drug-induced PAs. We performed an analysis of PAs registered in the French pharmacovigilance database between 01/01/1985 and 05/11/2014. Among the 163 recorded cases, 136 (83.4%) were directly related to drugs, mainly antidepressants (11.3%, mainly serotonin reuptake inhibitors), mefloquine (7.2%), isotretinoin (5.2%), rimonabant (3.6%) and corticosteroids (4.7%). PAs are labelled in the Summary of Product Characteristics (SmPC) for a minority (8.6%) of these drugs. In 31.4% of these cases, withdrawal of the suspected drug was performed more than a week after the onset of PAs. PAs could also be secondary to another adverse drug reaction (ADR; n = 14, 8.6%), mainly an allergy to antineoplastic or immunomodulating agents. In 13 cases (8.0%), PAs occurred during a drug-withdrawal syndrome, mainly after benzodiazepines or opioids. Most cases (73%) involved patients without any previous psychiatric disorder. This is the first pharmacoepidemiological study about iatrogenic PAs. Beside antidepressants, the most often encountered drugs are not indicated for psychiatric diseases. This study also reveals that iatrogenic PAs mostly occur in patients without any psychiatric medical history and that PAs can be triggered by another ADR. Lastly, the many cases with delayed management underline the need to raise awareness of this relatively unknown ADR among physicians, especially since PAs are generally not labelled in SmPCs of the suspected drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database.

    PubMed

    Colin, Olivier; Favrelière, Sylvie; Quillet, Alexandre; Neau, Jean-Philippe; Houeto, Jean-Luc; Lafay-Chebassier, Claire; Pérault-Pochat, Marie-Christine

    2017-04-01

    Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period. To assess the association between PML and drug intake, we calculated an adverse drug report odds ratio (ROR) with its 95% confidence interval. We have studied the delay of onset of PML for each drug concerned. Among the 101 cases of PML, 39 drugs were mentioned as suspect. The main therapeutic classes suspected with significant ROR were antineoplastic agents (n = 85), immunosuppressants (n = 67), and corticosteroids. A latent interval from the time of drug initiation to the development of PML is established: the median time to onset was 365 days (123-1095 days). The onset of PML is highly variable and differs among drug classes [from 1 to 96 months (IQR: 39.0-126)]. An association between PML and some immunosuppressant drugs was found as expected, but also with antineoplastic agents and glucocorticoids. An important delay of PML onset after stopping treatment is suspected and should alert prescribers. Prescribers but also patients should be informed about the potential associations with all these drugs. Monitoring could be necessary for many drugs to early detect PML.

  6. Drug-induced Depression: a Case/Non Case Study in the French Pharmacovigilance Database.

    PubMed

    Lafay-Chebassier, Claire; Chavant, François; Favrelière, Sylvie; Pizzoglio, Véronique; Pérault-Pochat, Marie-Christine

    2015-01-01

    Depression is a complex disorder with heterogeneous clinical anomalies whose neurobiological understanding still remains unclear. Medications have been implicated as potential causes of depression but for many of them, data are controversial. The present study aims to investigate association bet ween drugs and reports of depression. We used the case/non case method in the French pharmacovigilance database (FPVD) to identify drugs associated with depression. Cases were reports of depression in the FPVD between January 2007 and December 2011. Non cases were all other reports during the same period. Data were expressed as reporting odds ratio (ROR) with their 95% confidence interval. Of the 114,692 reports recorded in the FPVD during the studied period, we identified 474 cases of depression. For the majority of the patients, they were considered as "non serious" (56%) and evolution was favorable (64%). Significant RORs were found for antiepileptics (topiramate, levetiracetam), anti-infective and especially anti-retroviral drugs (efavirenz, emtricitabine, tenofovir, etravirine, raltegravir), interferons and other agents including isotretinoin, methylphenidate, sodium oxybate, varenicline, montelukast, flunarizine, adalimumab, anastrozole. Taking into account the limits of the methodology, the present study described associations with mainly expected drugs belonging to various therapeutic classes but it also found a signal with some anti-retrovirals. On the contrary, we did not find some assumed associations like cardiovascular medications, antimalarial. For most of the drugs, one or more mechanisms were found to explain these depressogenic effects on the basis of animal and human literature. Even if such associations need to be confirmed by further prospective studies, cautions are necessary for many drugs to early detect depressive symptoms.

  7. French pharmacovigilance: Missions, organization and perspectives.

    PubMed

    Vial, Thierry

    2016-04-01

    Pharmacovigilance aims to identify unknown adverse drug reactions once clinical development is complete, in order to promote improved use of drugs, and thus a reduction in risk for every exposed patient. We describe in this article the missions of French pharmacovigilance system, including French drug agency, Regional Centers of Pharmacovigilance, health professionals, pharmaceutical companies, patients and their associations. We also develop the French pharmacovigilance organization, its perspectives and challenges, both in French and European levels.

  8. [Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015].

    PubMed

    Moulis, Florence; Rousseau, Vanessa; Abadie, Delphine; Masmoudi, Kamel; Micallef, Joëlle; Vigier, Caroline; Pierre, Sabrina; Dautriche, Anne; Montastruc, François; Montastruc, Jean-Louis

    2017-06-29

    Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011. We described all serious adverse drug reactions (SADRs) reported with tramadol in adults in the French National PharmacoVigilance Database from August 1st, 2011 to December 31st, 2015. We identified 1512 SADRs during the study period. The most frequently reported SADRs were neurological (29.4%, including troubles of consciousness [13.2%] and seizures [6.7%]), psychiatric (22.8%, including confusions [14.6%] and hallucinations [7.3%]) and gastrointestinal (17.0%, mostly nausea and vomiting [9.6%]). Unexpected SADRs were also reported: hyponatremia, cholestatic hepatitis, serotonin syndrome. This study demonstrates new unexpected hepatic and metabolic SADRs. Tramadol alone can induce serotonin syndrome in overdose situations. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  9. Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

    PubMed Central

    2011-01-01

    Background Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs. Methods Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: edema, heart failure, myocardial infarction and hepatitis corresponding to specific WHO-ART terms. Results Among a total of 99,284 adult patients in the FPVD, 2295 reports concerned type 2 diabetic patients (2.3% of the whole database), with 161 (7%) exposed to TZDs. The frequency of edema and cardiac failure was significantly higher with TZDs than in other patients (18% and 7.4% versus 0.8% and 0.1% respectively, p < 0.001) whereas the frequency of hepatitis was similar (5.9% versus 4%, NS). A multiple logistic regression model taking into account potential confounding factors (age, gender, drug exposure and co-morbidities) found that TZD exposure remained associated with heart failure and edema, but not with hepatitis or myocardial infarction. Conclusions Thiazolidinediones exposure is associated with an increased risk of edema and heart failure in patients with type 2 diabetes even when recommendations for use are respected. In contrast, the risk of hepatic reactions and myocardial infarction with this class of drugs seems to be similar to other hypoglycemic agents. PMID:21609444

  10. Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database.

    PubMed

    de Boissieu, Paul; Kanagaratnam, Lukshe; Abou Taam, Malak; Roux, Marie-Paule; Dramé, Moustapha; Trenque, Thierry

    2014-09-01

    The purpose of this study was to identify a notoriety bias in a database of spontaneous reports and its consequences on the calculation of the reporting odds ratio (ROR). We used the case/noncase methodology to calculate the ROR for bisphosphonates and osteonecrosis of the jaw (ONJ) in the French national pharmacovigilance database (from 1985 to 2013). To evaluate notoriety bias, drug-related risk factors for ONJ [as specified in the summary of product characteristics (SPC) of bisphosphonates] were systematically scanned for notifications of reports of ONJ occurring under bisphosphonate therapy. When a risk factor was present, the ONJ was considered as not due to bisphosphonates, and a second ROR was calculated under the hypothesis of maximum bias. In total, 148 cases of ONJ were reported (143 with bisphosphonates and five without). The raw ROR was 3448 (95% confidence interval 1413-8417). After analysis of the reports, only 86 had no mention of a risk factor for ONJ. The ROR under the maximum bias hypothesis was 87 (95% confidence interval 63-121). Among ONJ where chemotherapy was being administered simultaneously to bisphosphonates, 27 reports did not consider the chemotherapy to be implicated, despite seven of these occurring in cases where ONJ was mentioned in the summary of product characteristics. The existence of a notoriety bias has an impact on measures of disproportionality. The detection of pharmacovigilance signals might be delayed. It is advisable to list all drugs being taken when an adverse drug reaction occurs, and not only those known to be associated with the observed reaction. Copyright © 2014 John Wiley & Sons, Ltd.

  11. Drug interactions between antihypertensive drugs and non-steroidal anti-inflammatory agents: a descriptive study using the French Pharmacovigilance database.

    PubMed

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-04-01

    Drug-drug interactions (DDIs) between antihypertensive drugs and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to adverse drug reactions (ADRs). Guidelines are available to help prescribers deal with these drug associations, but their implementation is not well evaluated. The aims of this study were to assess the prevalence of NSAIDs exposure in patients treated with antihypertensive drugs, using the French Pharmacovigilance database, and explore the ADRs related to DDIs between antihypertensive drugs and NSAIDs. Over the 11, 442 notifications of ADRs recorded in this database in patients treated with oral antihypertensive drugs between 2008 and 2010, 517 (4.5 and 95% CI: 4.1-4.9) also included exposure to NSAIDs. These subjects were more frequently women, took more drugs in general, and were younger and less frequently treated with antiplatelet drugs. In 24.2% of them (125 patients), a DDI between NSAIDs and antihypertensive drugs was potentially the cause of the reported ADR. Acute renal failure caused by DDIs between NSAIDs and angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or diuretics was the most frequently reported ADR (20.7%). Finally, in the French Pharmacovigilance database, around one-fourth of associations NSAIDs  +  antihypertensive drugs are associated with a 'serious' ADR (mainly acute renal failure), suggesting that this well-known DDI is not enough taken into account by prescribers.

  12. Ulceration of the oral mucosa following direct contact with ferrous sulfate in elderly patients: a case report and a review of the French National Pharmacovigilance Database.

    PubMed

    Liabeuf, Sophie; Gras, Valérie; Moragny, Julien; Laroche, Marie-Laure; Andrejak, Michel

    2014-01-01

    To report a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients. The first case report concerns the occurrence of widespread oral ulceration in an 87-year-old woman with Alzheimer's disease. The ulceration extended from the side of the tongue to the floor of the mouth. No clear explanation was found and various local treatments were ineffective. Once it was realized that the ferrous sulfate tablets (given as an iron supplement) were crushed prior to administration (due to the patient's deglutition disorder), withdrawal of this treatment led to rapid resolution of the ulceration. Nine other cases of oral ulcerations associated with ferrous sulfate were identified in the French National Pharmacovigilance Database. All but one of the patients were over 80 years of age and the youngest patient (a 54-year-old) had dysphagia associated with facial paralysis. Only two other reports of oral ulceration due to ferrous sulfate have been published to date. Mucosal toxicity of ferrous sulfate (which is probably related to oxidative stress) has previously been reported for the hypopharynx, the esophageal lumen, and (after inhalation of a tablet) the tracheobronchial tree. The mucosal toxicity of ferrous sulfate must be taken into account when deglutition disorders are present (as in elderly patients) and appropriate pharmaceutical formulations (such as syrups) should be administered to at-risk patients. The use of iron salts other than ferrous sulfate could be considered.

  13. Frequency and Nature of Adverse Drug Reactions Due to Non-Prescription Drugs in Children: A Retrospective Analysis from the French Pharmacovigilance Database.

    PubMed

    Durrieu, Geneviève; Maupiler, Mathieu; Rousseau, Vanessa; Chebane, Leila; Montastruc, François; Bondon-Guitton, Emmanuelle; Montastruc, Jean-Louis

    2017-08-01

    Studies that evaluate the safety of non-prescription drugs in children remain scarce. The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrénées PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test. We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 ± 5.3 vs. 8.4 ± 5.7 years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with prescription drugs (21.0%) than with non-prescription drugs (14.2%, p = 0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-prescription than with prescription drugs (p = 0.0006 and p < 0.0001, respectively). The frequency of "serious" ADRs was higher with prescription drugs than with non-prescription drugs (40.9 vs. 34.2%, p = 0.007). The non-prescription drugs most frequently implicated with serious ADRs were ibuprofen (n = 37; 4.2%), tuberculosis vaccine (n = 23; 2.6%), aspirin (n = 20, 2.3%), and paracetamol (n = 17; 1.9%). ADRs from prescription drugs involved asparaginase (n = 27; 3.1%), immunoglobulins (n = 25; 2.9%), and amoxicillin (n = 23; 2.4%). Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen.

  14. Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database

    PubMed Central

    Chavant, Francois; Favrelière, Sylvie; Lafay-Chebassier, Claire; Plazanet, Caroline; Pérault-Pochat, Marie-Christine

    2011-01-01

    AIMS To investigate putative associations of reports of memory disorders and suspected drugs. METHODS We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval. RESULTS Among the 188 284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4–93). The maximal number of cases occurred between 40–49 and 50–59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin. CONCLUSIONS Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature. Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations. PMID:21557759

  15. More on the "Triple Whammy": antihypertensive drugs, non-steroidal anti-inflammatory agents and acute kidney injury - a case/non-case study in the French pharmacovigilance database.

    PubMed

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-08-01

    It has been suggested that the risk of acute kidney injury (AKI) increases with the number of drugs associated between non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin converting enzyme inhibitors (ACEis) [or angiotensin receptor blockers (ARBs)] and diuretics. We aimed to investigate whether the number of drugs associated between NSAIDs, ACEis, ARBs and diuretics was associated to disproportionate reporting of AKI in the French Pharmacovigilance Database. In reports of Adverse Drug Reactions (ADRs) recorded between 01 January 2008 and 31 December 2010, we selected patients whose medications included at least one oral antihypertensive drug. We used a case/non-case methodology. Cases were AKI and non-cases were all the remaining reports. Among the 11,442 ADR reports in patients under antihypertensive drug recorded in the French Pharmacovigilance Database, 837 ADRs were AKI (7.3%, 95% CI 6.8-7.8). AKI and the number of drugs associated were disproportionately reported (one drug alone: adjusted ROR 2.19, 95% CI: 1.65-2.89, two drugs: adjusted ROR 5.27, 95% CI: 4.00-6.94, three and more: adjusted ROR 16.46, 95% CI: 11.38-23.80). There was no significant association between NSAIDs' half-lives and reporting of AKI (adjusted ROR=0.54, 95% CI: 0.25-1.15). Given the widespread use of these hazardous drugs in general population, caution is needed when they are associated.

  16. Safety profile of etifoxine: A French pharmacovigilance survey.

    PubMed

    Cottin, Judith; Gouraud, Aurore; Jean-Pastor, Marie-Josèphe; Dautriche, Anne Disson-; Boulay, Charlène; Geniaux, Hélène; Auffret, Marine; Bernard, Nathalie; Descotes, Jacques; Vial, Thierry

    2016-04-01

    Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADRs) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine-related ADR by reviewing Individual Case Safety Reports (ICSRs) recorded in France especially unexpected ADRs. Etifoxine-related ICSRs were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADRs (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS in 5, erythema multiforme in 10 and Stevens-Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness-like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADRs included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy-proven microscopic colitis of which one recurred after etifoxine re-administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADRs, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC) was based on these findings.

  17. Atropinic burden of prescriptions forms in patients with Alzheimer disease: a cross-sectional study in a French PharmacoVigilance Database.

    PubMed

    Montastruc, François; Rouanet, Sarah; Gardette, Virginie; Rousseau, Vanessa; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-07-01

    Atropinic drugs in patients with Alzheimer disease (AD) can decrease the effects of anticholinesterase drugs and/or induce adverse drug reactions (ADRs). Several atropinic risk scales defining an atropinic burden of drugs were proposed but were little used in AD patients. All ADRs' notifications of AD patients registered in the Midi-Pyrénées PharmacoVigilance Database between 1999 and 2013 were analyzed using Anticholinergic Drug Scale (ADS) and Anticholinergic Duran's list. The primary objective was to quantify atropinic burden in AD patients and the secondary one to investigate associated factors. Among the 475 notifications, at least one atropinic drug was found in 282 notifications (59.4%) according to ADS and 214 (45.1%) according to Duran. Mean number of atropinics per notifications was 0.9 ± 0.9 (ADS) and 0.7 ± 0.9 (Duran). Mean atropinic burden per notifications was 1.2 ± 1.5 (ADS) and 0.9 ± 1.3 (Duran). Atropinic burden ≥ 3 was found in 87 notifications (18.2%) according to ADS and 50 (10.5%) according to Duran. There was no association between atropinic burden and age of patients. The number of drugs is associated to a high atropinic burden. The present work found an association between an atropinic drug and an anticholinesterase agent in around 1 out of 2 AD patients and a clinically significant atropinic burden (≥ 3) in around 1 to 2 AD patients out of 10. The benefit harm balance of atropinic drugs must be discussed before each prescription in AD patients.

  18. Causality assessment in pharmacovigilance: The French method and its successive updates.

    PubMed

    Miremont-Salamé, Ghada; Théophile, Hélène; Haramburu, Françoise; Bégaud, Bernard

    2016-04-01

    The methods for causality assessment of adverse drug reactions were developed in the 1970s and 1980s, alongside the development of pharmacovigilance. The French method is one of the earlier of these, following on from the pioneering works by Irey and Karch and Lasagna. Initially published in 1978, it was updated in 1985, and again in 2011. The main alterations to the original method are presented in tables annexed to this paper. The successive versions improved the presentation, provided more formalised definitions of the criteria for assessing causality, while at the same time ensuring the method remained easy to use. Causality assessment enables the causal link between a drug and the occurrence of an adverse reaction to be formalised and explained. It contributes to diagnosis, and to determining the action to be taken in case of an adverse drug reaction. It can contribute to the quality and the relevance of the data stored in pharmacovigilance databases.

  19. Validation and Reproducibility of the Updated French Causality Assessment Method: an Evaluation by Pharmacovigilance Centres & Pharmaceutical Companies.

    PubMed

    Théophile, Hélène; Dutertre, Jean-Paul; Gérardin, Marie; Valnet-Rabier, Marie-Blanche; Bidault, Irène; Guy, Claire; Haramburu, Françoise; Hillaire-Buys, Dominique; Méglio, Carmine; Arimone, Yannick

    2015-01-01

    Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use. A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method. To test the inter- and intra-rater reproducibility, two seniors and two juniors from a PhVC and a pharmaceutical company assessed the pairs twice with the updated method. A weighted kappa coefficient was used to measure the agreement of the two causality assessment methods with the consensual expert judgement (validity) as well as the agreement of the updated causality assessment over time (intra-rater reproducibility) and between evaluators (inter-rater reproducibility). Agreement between the current method and consensual expert judgement was fair for the PhVC team (weighted kappa [Kw] 0.33) and moderate for the pharmaceutical company team (Kw 0.41). For the updated method, agreement was better for both the PhVC (Kw 0.58) and the pharmaceutical company (Kw 0.52) teams. The inter- and intra-rater reproducibility of the updated method based on the intrinsic imputability was satisfactory overall (Kw 0.30-0.91). Discrepancies between evaluations from PhVC and pharmaceutical companies were observed with the updated method. The updated method performed better than the current one for drug causality assessment, suggesting that it should be used in routine pharmacovigilance. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  20. Adverse reactions to radiopharmaceuticals in France: analysis of the national pharmacovigilance database.

    PubMed

    Laroche, Marie-Laure; Quelven, Isabelle; Mazère, Joachim; Merle, Louis

    2015-01-01

    Radiopharmaceuticals are regarded as safe by the nuclear medicine community, but up to now, no survey has been conducted with from the perspective of pharmacovigilance. To describe the adverse reactions to radiopharmaceuticals (ARRPs) reported to the French Pharmacovigilance Database (FPVD). We selected and described all reports encompassing at least one radiopharmaceutical in the FPVD. The annual incidence of reported ARRPs used in diagnosis was also estimated. From 1989 to 2013, 304 reports of ARRPs were identified (43.0% serious, 12 deaths) in 54.6% women and 45.4% men; the median age was 58 years. Five therapeutic radiopharmaceuticals ((131)I-sodium iodide, (131)I-lipiodol, (89)Sr-chloride, (153)Sm-lexidronam, and (90)Y-ibritumomab-tiuxetan) were involved in 48 reports (97 adverse reactions: 86.6% serious, 9 deaths). Pulmonary disorders represented 44.3% of ARRPs used for therapy, mainly related to (131)I-lipiodol. There were 34 diagnostic radiopharmaceuticals involved in 256 reports (451 adverse reactions: 38.1% serious, 3 deaths); 8 diagnostic products ((99m)Tc-oxidronate, (18)F-fluorodeoxyglucose, (99m)Tc-tin pyrophosphate, (99m)Tc-tetrofosmin, (99m)Tc-dimercaptosuccinic acid, (201)Tl-chloride, (99m)Tc-sestamibi, and (111)In-pentetate) accounted for two-thirds of ARRPs. The most frequent adverse reactions were skin (34.4%), general (18.2%), nervous (9.0%), and gastrointestinal disorders (7.0%). There were 25 cases of altered images and 10 medication errors. The annual incidence of reported adverse reactions ranged from 1.2 × 10(-5) to 3.4 × 10(-5) diagnostic administrations. Reported ARRPs occurred rarely and were more serious in the therapeutic than in the diagnostic field. The notification of ARRPs was able to provide new guidance for safe use, as was the case for (131)I-lipiodol. Therefore, it is important to report ARRPs to a pharmacovigilance system. © The Author(s) 2014.

  1. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    PubMed

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  2. Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

    PubMed

    Kunac, Desireé L; Tatley, Michael V

    2011-01-01

    Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and

  3. Adverse drug reaction monitoring and the Internet: evaluation of the use of the Internet by French Pharmacovigilance Centres and a non-exhaustive survey of websites of interest for collecting information about adverse drug reaction.

    PubMed

    Morel, P; Vandel, B

    1999-01-01

    The Internet, indisputably the most important source of information obtainable in real time, was long essentially the domain of researchers in the USA, but has now become more accessible to French Pharmacovigilance Centres (CRPV) and pharmaceutical companies. A questionnaire was sent to every CRPV to determine how the Internet was perceived in terms of pharmacovigilance activities and existing Websites of particular value to CRPVs were investigated. Analysis of the questionnaires revealed that 66.7 per cent of CRPVs are connected to the Internet but do not use it fully; 94 per cent of connected CRPVs use it essentially for access to a bibliographic database such as Medline (88 per cent), and none subscribes to discussion lists concerning alert messages on problems related to drugs and therapeutics. Non-connected CRPVs do not intend to use the Internet because of financial considerations, lack of time or the assumption that it is not beneficial in everyday situations. Apparently, many French CRPVs are not sufficiently aware of the importance of the Internet for professional purposes. A non-exhaustive list of sites on the Internet providing information likely to be of use to Pharmacovigilance Centres in their everyday activities is included. The Internet offers far greater possibilities than research for bibliographic references on Medline and could improve the manner in which pharmacovigilance is practised.

  4. COX-2 inhibitors and arterial hypertension: an analysis of spontaneous case reports in the Pharmacovigilance database.

    PubMed

    Durrieu, G; Olivier, P; Montastruc, J L

    2005-09-01

    To evaluate the main characteristics of case reports of arterial hypertension (AH) related to COX-2 inhibitor (coxib) use in real-life practice. This study was based on spontaneous reports of adverse drug reactions (ADRs) submitted to the French Pharmacovigilance system. Associations between AH and the different groups of those using non-steroidal anti-inflammatory drugs (NSAIDs: rofecoxib, celecoxib and non-selective NSAIDs) were compared using calculation of the odds ratio (OR) with 95% confidence intervals (CIs). In France, between 1 April 2000 and 30 November 2003, 34 AH cases related to coxibs were reported. Case reports include predominantly patients older than 65 years, with a previous story of essential AH. Most AH (60%) occurred during the first 15 days of treatment. The AH was reported significantly more frequently for rofecoxib than celecoxib. The OR for development of AH with rofecoxib versus celecoxib was 3.3 (1.6-6.9). The AH was also reported more frequently with coxib (2.8%) than with non-selective NSAID (0.5%) use, OR = 5.9 (3.8-9.0). This study shows that coxibs are associated with a risk of AH in real-life practice. More spontaneous reports of AH to the French Pharmacovigilance system concern rofecoxib than celecoxib (and coxibs than non-selective NSAIDs). This ADR is of special epidemiological importance due to both the risks of AH and the large use of coxibs.

  5. [The congress of the French Society of Pharmacology and Therapeutics celebrate in Nancy, 20 April 2016, 40 years of French Regional Pharmacovigilance Centres!].

    PubMed

    Jonville-Béra, Annie-Pierre; Mallaret, Michel; Sgro, Catherine

    2016-09-01

    In 1976, the Regional Pharmacovigilance Centres were created in France to collect and analyze adverse drug reactions. Even if they have, to date, managed and transmitted more than 583,000 adverse drug reactions to the French and international health authorities, the missions of these university hospital structures supervised by clinical pharmacologists are not limited to this activity. They also provide a consulting and diagnostic aid for drug diseases. Their other main mission is information about drugs and their proper use for health professionals and patients on any matter relating to medicines. These queries are used to adjust and focus the training of health professionals in prevention of drug risks and improvement of drug use. Beside signal detection and identification of alerts, the 31 Regional Pharmacovigilance Centres collaborate with the French Drug Agency (Agence nationale de sécurité du medicament et des produits de santé [ANSM]) by achieving expertise on drugs and participation in various working groups and committees. Finally, Regional Pharmacovigilance Centres participate in scientific advancement through research and publication activities.

  6. Methylprednisolone liver toxicity: A new case and a French regional pharmacovigilance survey.

    PubMed

    Dumortier, Jérôme; Cottin, Judith; Lavie, Caroline; Guillaud, Olivier; Hervieu, Valérie; Chambon-Augoyard, Christine; Scoazec, Jean-Yves; Vukusic, Sandra; Vial, Thierry

    2017-09-01

    Reported hepatotoxicity induced by corticosteroids is very rare, and the diagnosis is highly challenging in the context of auto-immune disease. We report here a case of high-dose methylprednisolone (MP)-induced acute hepatitis confirmed by liver histology in a patient with multiple sclerosis (MS) and a case series (n=4) notified to the French Pharmacovigilance center of Lyon. In all 5 cases, other common causes of hepatitis were excluded. The causal relationship with MP pulse therapy was supported by the fact that MP was the only culprit drug. In addition, 3 of these 5 patients underwent unintended single or multiple positive MP rechallenge. Our 5 patients scored a RUCAM score from 6 (probable) to 10 (highly probable). MP-induced liver injury is probably very rare, since only less than 30 cases have been reported in the literature. Nevertheless, our cases strongly illustrates that many cases could have been unrecognized; final diagnosis in 3 of 5 of our patients was made after the second or third episode of acute hepatitis. In conclusion, these cases we report here strongly illustrates that high-dose MP-induced liver injury can occur in patients treated for MS or auto-immune disorder. Unintended re-challenge can confirm the diagnosis and can help to distinguish it from autoimmune hepatitis. Performing liver function tests routinely both before and after MP administration would be beneficial, as the timely recognition of this complication and early drug withdrawal may prevent progression of severe necrosis hepatic injury. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  7. Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda project.

    PubMed

    Bousquet, P-J; Demoly, P; Romano, A; Aberer, W; Bircher, A; Blanca, M; Brockow, K; Pichler, W; Torres, M J; Terreehorst, I; Arnoux, B; Atanaskovic-Markovic, M; Barbaud, A; Bijl, A; Bonadonna, P; Burney, P G; Caimmi, S; Canonica, G W; Cernadas, J; Dahlen, B; Daures, J-P; Fernandez, J; Gomes, E; Gueant, J-L; Kowalski, M L; Kvedariene, V; Mertes, P-M; Martins, P; Nizankowska-Mogilnicka, E; Papadopoulos, N; Ponvert, C; Pirmohamed, M; Ring, J; Salapatas, M; Sanz, M L; Szczeklik, A; Van Ganse, E; De Weck, A L; Zuberbier, T; Merk, H F; Sachs, B; Sidoroff, A

    2009-02-01

    Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.

  8. Interstitial lung disease induced by fluoxetine: Systematic review of literature and analysis of Vigiaccess, Eudravigilance and a national pharmacovigilance database.

    PubMed

    Deidda, Arianna; Pisanu, Claudia; Micheletto, Laura; Bocchetta, Alberto; Zompo, Maria Del; Stochino, Maria Erminia

    2017-04-11

    We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016). In the Italian Pharmacovigilance database (updated to August 2016), we found only one case of Interstitial Lung Disease, codified as "pulmonary disease". Our investigation shows that fluoxetine might be considered as a possible cause of Interstitial Lung Disease. In particular, although here we do not discuss the assessment of benefits and harms of fluoxetine, since this antidepressant is widely used, our review suggests that fluoxetine-induced Interstitial Lung Disease should be considered in patients with dyspnea, associated or not with dry cough, who are treated with this drug. An early withdrawn of fluoxetine could be useful to obtain a complete remission of this adverse drug reaction and special attention should be particularly devoted to long-term therapy, and to female and elderly patients. Although the spontaneous reporting system is affected by important limitations, drug post- marketing surveillance represents an important tool to evaluate the real world effectiveness and safety of drugs.

  9. Lexique 2: a new French lexical database.

    PubMed

    New, Boris; Pallier, Christophe; Brysbaert, Marc; Ferrand, Ludovic

    2004-08-01

    In this article, we present a new lexical database for French: Lexique. In addition to classical word information such as gender, number, and grammatical category, Lexique includes a series of interesting new characteristics. First, word frequencies are based on two cues: a contemporary corpus of texts and the number of Web pages containing the word. Second, the database is split into a graphemic table with all the relevant frequencies, a table structured around lemmas (particularly interesting for the study of the inflectional family), and a table about surface frequency cues. Third, Lexique is distributed under a GNU-like license, allowing people to contribute to it. Finally, a metasearch engine, Open Lexique, has been developed so that new databases can be added very easily to the existing ones. Lexique can either be downloaded or interrogated freely from http://www.lexique.org.

  10. Hepatotoxicity related to agomelatine and other new antidepressants: a case/noncase approach with information from the Portuguese, French, Spanish, and Italian pharmacovigilance systems.

    PubMed

    Montastruc, François; Scotto, Stefania; Vaz, Ines Ribeiro; Guerra, Leonor Nogueira; Escudero, Antonio; Sáinz, María; Falomir, Teresa; Bagheri, Haleh; Herdeiro, Maria Teresa; Venegoni, Mauro; Montastruc, Jean Louis; Carvajal, Alfonso

    2014-06-01

    Antidepressants have been associated with a low incidence of idiosyncratic hepatic injury. Some of them, nefazodone or amineptine, were observed to induce severe hepatic injury and withdrawn from the market. Recently, some cases of this severe condition have been reported in association with agomelatine use. Therefore, the objective of this study is to learn the risk of hepatic damage with agomelatine as compared with other new antidepressants. We took data from the Spanish, French, Italian, and Portuguese pharmacovigilance system databases. A case/noncase approach to assess the strength of the association between whichever antidepressant and hepatotoxicity was performed; cases were defined as reports of hepatotoxicity; noncases were reports of all reactions other than hepatotoxicity. Exposure was the recording of a new antidepressant in a report, whether or not it was suspected of causing the reaction. During the period surveyed, 3300 cases of hepatotoxicity were collected for the antidepressants assessed. They represent 10.3% of all cases collected for these drugs; the corresponding figure for all drugs was 6.0%. Meanwhile, 63 cases of hepatotoxicity associated with agomelatine were collected since its introduction until the end of the period studied; they account for a percentage of 14.6. Agomelatine was statistically associated with hepatotoxicity in Spain [reporting odds ratio (ROR), 4.9 (95% confidence interval [CI], 2.4-9.7)], France (ROR, 2.4 [95% CI, 1.5-3.7]), and Italy (ROR, 5.1 [95% CI, 1.7-14.0]). Current results support the idea of agomelatine to be related to a higher hepatotoxicity risk. Physicians should consider early discontinuation if the condition is suspected; health authorities should promptly explore the best regulatory actions to be taken.

  11. Demyelinating disease in patients treated with TNF antagonists in rheumatology: data from BIOBADASER, a pharmacovigilance database, and a systematic review.

    PubMed

    Cruz Fernández-Espartero, María; Pérez-Zafrilla, Beatriz; Naranjo, Antonio; Esteban, Carmen; Ortiz, Ana M; Gómez-Reino, Juan J; Carmona, Loreto

    2011-12-01

    To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95% CI). In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF-antagonists in BIOBADASER was 0.65 per 1000 patient-years (95% CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95% CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA (n = 19) and in the literature (n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries. Copyright © 2011. Published by Elsevier Inc.

  12. Demyelinating disease in patients treated with TNF antagonists in rheumatology: data from BIOBADASER, a pharmacovigilance database, and a systematic review.

    PubMed

    Fernández-Espartero, María Cruz; Pérez-Zafrilla, Beatriz; Naranjo, Antonio; Esteban, Carmen; Ortiz, Ana M; Gómez-Reino, Juan J; Carmona, Loreto

    2011-02-01

    To estimate the rate of demyelinating diseases in patients with rheumatic diseases treated with tumor necrosis factor (TNF) antagonists and to describe the cases reported to 3 different pharmacovigilance sources. All confirmed cases of demyelinating disease, optic neuritis, and multiple sclerosis (MS) in patients with rheumatic diseases treated with TNF-antagonists were reviewed from 3 different sources: (1) the Spanish Registry of biological therapies in rheumatic diseases (BIOBADASER); (2) the Spanish Pharmacovigilance Database of Adverse Drug Reactions (FEDRA); and (3) a systematic review (PubMed, EMBASE, and the Cochrane Library). In BIOBADASER, the incidence rate per 1000 patients was estimated with a 95% confidence interval (95%CI). In 21,425 patient-years in BIOBADASER, there were 9 patients with confirmed demyelinating disease, 4 with optic neuritis, and 1 with MS. In addition, 22 patients presented polyneuropathies, paresthesias, dysesthesias, facial palsy, or vocal cord paralysis without confirmed demyelination. The incidence rate of demyelinating disease in patients with rheumatic diseases exposed to TNF antagonists in BIOBADASER was 0.65 per 1000 patient-years (95%CI: 0.39-1.1). The incidence of MS in BIOBADASER was 0.05 (95%CI: 0.01-0.33), while the incidence in the general Spanish population was 0.02 to 0.04 cases per 1000. Compared with BIOBADASER, cases in FEDRA (n = 19) and in the literature (n = 48) tend to be younger, have shorter exposure to TNF-antagonists, and recover after discontinuation of the drug. It is not clear whether TNF antagonists increase the incidence of demyelinating diseases in patients with rheumatic diseases. Differences between cases depending on the pharmacovigilance source could be explained by selective reporting bias outside registries. Copyright © 2011 Elsevier Inc. All rights reserved.

  13. Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol)

    PubMed Central

    Tavassoli, Neda; Lapeyre-Mestre, Maryse; Sommet, Agnès; Montastruc, Jean-Louis

    2009-01-01

    AIMS Three ‘weak’ opioid analgesics in association with paracetamol are marketed in France as step 2 analgesics: dextropropoxyphene, tramadol and codeine. These combinations are involved in several adverse drug reactions (ADRs), but no data are available about their comparative reporting rate. The aim was to compare the reporting rate of ADRs between tramadol/paracetamol (TRM+P), codeine/paracetamol (COD+P) and dextropropoxyphene/paracetamol (DXP+P). METHODS All spontaneous reports submitted to the French Pharmacovigilance Database from 1 January 1987 to 31 December 2006 suspected to be induced by one of the three step 2 analgesic combinations (DXP+P, TRM+P, COD+P) were extracted. Their consumption for the same period was obtained from the French Drug Agency. The number of ADRs, serious ADRs and different organ classes of ADRs were compared according to their consumption. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each variable using DXP+P as reference. RESULTS The reporting rate of ADRs was calculated as 24.9/100 000 person-years for DXP+P, 44.5/100 000 person-years for TRM+P and 12.5/100 000 person-years for COD+P. The reporting rate (OR 0.56, 95% CI 0.50, 0.63) and ‘seriousness»’ (OR 0.65, 95% CI 0.53, 0.80) of ADRs were significantly higher with TRM+P than with DXP+P. However, hepatobiliary ADRs were significantly more frequent with the DXP+P combination (OR 2.62, 95% CI 1.59, 4.37). In contrast, the reporting rate (OR 1.99, 95% CI 1.82, 2.18) and ‘seriousness’ (OR 2.64, 95% CI 2.24, 3.11) of ADRs were significantly higher with DXP+P than with COD+P. CONCLUSIONS Among the three step 2 analgesic combinations, reporting rate and ‘seriousness’ of ADRs are the highest with TRM+P and the lowest with COD+P. Our study suggests that the safety profile of DXP+P is worst than that of COD+P. PMID:19740400

  14. Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada

    PubMed Central

    Reilly, Brian M.; Chen, Winston Yuchen; Abagyan, Ruben

    2015-01-01

    This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD) concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR). A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94–3.98; P<0.0001) and CVARD (ROR = 3.67; CI95% = 1.92–7.00; P = 0.001) databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer’s disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration. PMID:26642212

  15. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    PubMed

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.

  16. Multinomial modeling and an evaluation of common data-mining algorithms for identifying signals of disproportionate reporting in pharmacovigilance databases.

    PubMed

    Johnson, Kjell; Guo, Cen; Gosink, Mark; Wang, Vicky; Hauben, Manfred

    2012-12-01

    A principal objective of pharmacovigilance is to detect adverse drug reactions that are unknown or novel in terms of their clinical severity or frequency. One method is through inspection of spontaneous reporting system databases, which consist of millions of reports of patients experiencing adverse effects while taking one or more drugs. For such large databases, there is an increasing need for quantitative and automated screening tools to assist drug safety professionals in identifying drug-event combinations (DECs) worthy of further investigation. Existing algorithms can effectively identify problematic DECs when the frequencies are high. However these algorithms perform differently for low-frequency DECs. In this work, we provide a method based on the multinomial distribution that identifies signals of disproportionate reporting, especially for low-frequency combinations. In addition, we comprehensively compare the performance of commonly used algorithms with the new approach. Simulation results demonstrate the advantages of the proposed method, and analysis of the Adverse Event Reporting System data shows that the proposed method can help detect interesting signals. Furthermore, we suggest that these methods be used to identify DECs that occur significantly less frequently than expected, thus identifying potential alternative indications for these drugs. We provide an empirical example that demonstrates the importance of exploring underexpected DECs. Code to implement the proposed method is available in R on request from the corresponding authors. kjell@arboranalytics.com or Mark.M.Gosink@Pfizer.com Supplementary data are available at Bioinformatics online.

  17. Informatics applied to pharmacovigilance: Future perspectives

    PubMed Central

    Menniti, Michele; Menniti, Annamaria; Patanè, Marinella; Esposito, Stefania; Giofrè, Chiara; Aiello, Rossana; Russo, Emilio

    2013-01-01

    Spontaneous adverse drugs reaction (ADRs) reporting represents a precious resource for control and information about the drug's safety and pharmacovigilance. The current reporting system is mainly based on handwritten forms and later manually loaded into a national electronic database by few local pharmacovigilance centers. This reporting system is complicated for both reporters and pharmacovigilance centers which often avoid reporting ADRs for several reasons such as the lack of data on the report. The reporting system might be implemented by improving online platform for ADRs upload; this could allow inspecting all ADRs loaded. Currently, the database is only accessible by the Italian Medicine Agency (AIFA) and local pharmacovigilance centers; neither reporters nor other healthcare professionals can access the database. Finally, it would be right to implement pharmacovigilance centers with specific professional figures qualified in the pharmacovigilance to support both citizens and reporters on various aspects of ADRs reporting. PMID:24347981

  18. Importance of cytochrome P450 (CYP450) in adverse drug reactions due to drug-drug interactions: a PharmacoVigilance study in France.

    PubMed

    Danton, Anne Charlotte; Montastruc, François; Sommet, Agnès; Durrieu, Geneviève; Bagheri, Haleh; Bondon-Guitton, Emmanuelle; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2013-04-01

    Our aim was to characterize Adverse Drug Reactions (ADRs) related to drug-drug interactions (DDIs) related to involvement of cytochrome P450 (CYP450) isoenzymes in a pharmacovigilance database. ADRs recorded by Midi-Pyrénées PharmacoVigilance center (France) between 1 January and 31 August 2008 were extracted from the French PharmacoVigilance Database (FPVD). Among the 1,205 reported ADRs, 16 (1.3 %), can be explained by involvement of CYP450 isoenzymes (including 4 "serious"). All interactions involved CYP inhibitors, mainly for CYP3A4/5. The percentage of ADRs reported in the pharmacovigilance database and related to CYP450-induced DDIs appears to be relatively low (~ 1-2 %).

  19. Cyberpharmacovigilance: What is the usefulness of the social networks in pharmacovigilance?

    PubMed

    Bagheri, Haleh; Lacroix, Isabelle; Guitton, Emmanuelle; Damase-Michel, Christine; Montastruc, Jean-Louis

    2016-04-01

    Internet is changing the way people learn about health and illness. Health websites are among the most popular resources on the web. The sharing of patient experiences on a website could be an interesting source of information about adverse drug reactions (ADRs) or could generate "signals". Three examples of the use of patient forums in pharmacovigilance are discussed: (1) analysis of perceptions of risk by patients before and after withdrawal of benfluorex, and then following media coverage; (2) comparison of oral antineoplasic-induced ADRs collected on patient websites with those registered in the French pharmacovigilance database; (3) analysis of data found in the social media about drugs and pregnancy.

  20. [Pharmacovigilance update].

    PubMed

    Livio, F; Buclin, T; Biollaz, J

    2008-01-16

    The observations of pharmacovigilance reported during 2007 reflect an increasing attention towards drug-induced augmentation of the incidence of common disorders. New substances are thus to be added to the list of risk factors susceptible to favour cardiovascular events (tegaserod, rosiglitazone, erythropoïetin, aprotinine) or psychiatric disorders (dopaminergic agonists, rimonabant). The evaluation of the security profile of new medicines remains challenging. Besides biological investigations of questionable relevance and clinical trial of inconstant efficiency towards safety outcomes, the role of pharmacovigilance notifications by practitioners remains of paramount importance.

  1. Use of Epinephrine in Patients with Drug-Induced Anaphylaxis: An Analysis of the Beijing Pharmacovigilance Database.

    PubMed

    Wang, Tiansheng; Ma, Xiang; Xing, Yan; Sun, Shusen; Zhang, Hua; Stürmer, Til; Wang, Bin; Li, Xiaotong; Tang, Huilin; Jiao, Ligong; Zhai, Suodi

    2017-01-01

    Few studies assessing the use of epinephrine in drug-induced anaphylaxis (DIA) in the hospital setting are available. We utilized the Beijing Pharmacovigilance Database (BPD) to evaluate the appropriateness of epinephrine for DIA management. DIA cases collected in the BPD from January 2004 to December 2014 were adjudicated and analyzed for demographics, causative drugs, clinical signs, outcomes, initial treatment, route, dosing, and cardiovascular adverse events (CAE) of epinephrine. DIA was primarily caused by antibiotics (38.4%), radiocontrast agents (11.9%), traditional Chinese medicine injections (10.9%), and chemotherapeutic drugs (10.3%). Only 708 (59.5%) patients received epinephrine treatment. Patients who received epinephrine were more likely to experience wheezing (p < 0.001) and respiratory arrest (p < 0.001). Among 518 patients with a complete record of the epinephrine administration route, the percentage of patients receiving it by intramuscular (IM) injection, subcutaneous (SC) injection, intravenous (IV) bolus injection, or IV continuous infusion was 16.9, 31.5, 43.5, and 8.1%, respectively. Among the 427 patients with a record of both the administration route and the dosing, an overdose was more likely with IV bolus (94.1%) in contrast to IM injection (56.6%; p < 0.001) or SC injection (43.7%; p < 0.001). Among the patients analyzed for CAE (n = 349), 17 patients accounted for 19 CAE, and 13 (76.5%) of these patients were overdosed with epinephrine. Underuse, inappropriate IV bolus use, and overdosing were the 3 major problems with epinephrine use in DIA in China. Educational training for health care professionals on the appropriate use of epinephrine in managing anaphylactic reactions is suggested. © 2017 The Author(s) Published by S. Karger AG, Basel.

  2. Alopecia induced by tumour necrosis factor-alpha antagonists: description of 52 cases and disproportionality analysis in a nationwide pharmacovigilance database.

    PubMed

    Béné, Johana; Moulis, Guillaume; Auffret, Marine; Lefevre, Guillaume; Coquerelle, Pascal; Coupe, Patrick; Péré, Patrice; Gautier, Sophie

    2014-08-01

    The aim of this research was to describe the cases of TNF-α antagonist-related alopecia reported in the French Pharmacovigilance Database (FPVD) and to investigate the association between exposure to TNF-α antagonists and occurrence of alopecia. All spontaneous reports of TNF-α antagonist-related alopecia recorded in the FPVD between January 2000 and April 2012 were colligated and described. We conducted disproportionality analyses (case/non-case method) to assess the link between the occurrence of alopecia and exposure to TNF-α antagonists. Cases were all reports of alopecia and non-cases were all other reports recorded during the study period. Exposure to TNF-α antagonists was sought in cases and in non-cases. Reporting odds ratios (RORs) were calculated to assess the association. Docetaxel was used as positive control and acetaminophen as negative control. We performed sensitivity analyses excluding cases of androgenic alopecia and those occurring in psoriatic patients. Among 282 590 spontaneous reports of adverse drug reactions (ADRs) collated in the FPVD, 1068 cases (alopecia reports) were identified. Of these cases, 52 (4.9%) occurred during exposure to TNF-α antagonists (18 involved infliximab, 17 adalimumab, 15 etanercept and 2 certolizumab). Exposure to TNF-α antagonists was more frequent among alopecia reports than among other ADR reports for all TNF-α antagonists pooled (ROR 3.0, 95% CI 2.3, 4.0) as well as for each antagonist separately, with similar values. Sensitivity analyses yielded similar results. The RORs were 29.9 (95% CI 25.3, 35.5) with docetaxel and 0.3 (95% CI 0.2, 0.4) with acetaminophen. The present study confirms a strong link between TNF-α antagonist exposure (class effect) and the occurrence of alopecia. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Can drugs induce or aggravate sleep apneas? A case-noncase study in VigiBase(®) , the WHO pharmacovigilance database.

    PubMed

    Linselle, Mélanie; Sommet, Agnès; Bondon-Guitton, Emmanuelle; Moulis, Florence; Durrieu, Geneviève; Benevent, Justine; Rousseau, Vanessa; Chebane, Leila; Bagheri, Haleh; Montastruc, François; Montastruc, Jean-Louis

    2017-06-01

    The potential favorizing role of drugs in sleep apnea syndrome (SAS) is unknown. This study investigates drugs associated with SAS in a pharmacovigilance database. SAS recorded as adverse drug reactions (ADRs) in VigiBase(®) , the WHO pharmacovigilance database (more than 11 million reports), from 1978 to 2015 was selected. The risk of SAS reports was estimated using the case-noncase method, with cases being SAS and noncases all other recorded ADRs. During this 37-year period, 3325 ADRs including the word SAS were registered (0.05% of the database). Mean age was 51.2 ± 16.9 years with 52% men. ADRs were 'serious' in around 82% of cases. The case-noncase study found an association between SAS and exposition with sodium oxybate, rofecoxib, quetiapine, and clozapine for individual drugs and coxibs, antipsychotics, benzodiazepines, and opium alkaloids for drug classes. The potential role of other drugs is discussed. This study suggests that SAS can be associated with some drugs (mainly psychotropics) that are able to reveal or aggravate such a disease. Physicians should take into account the role of drugs in the etiological appraisal and management of SAS. © 2016 Société Française de Pharmacologie et de Thérapeutique.

  4. [Drug in pregnancy: studies in the French database EFEMERIS].

    PubMed

    Damase-Michel, Christine; Lacroix, Isabelle; Hurault-Delarue, Caroline; Beau, Anna-Belle; Montastruc, Jean-Louis

    2014-01-01

    The present article describes the first French database of drugs prescribed and dispensed during pregnancy and the outcome of these pregnancies, named EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques). At the present time, EFEMERIS contains anonymous data concerning around 78,000 pregnant women who gave birth to a baby between 1 July 2004 to 31 December 2012 in Haute-Garonne (South West France) and who are registered in the French health insurance service. Data sources include 1- the French health insurance database (drugs prescribed during pregnancy), 2- the mother and child protection centre database (newborn health) 3- the antenatal diagnostic centre database (medical pregnancy interruptions) and 4- medical data from the hospital (PMSI). EFEMERIS provides exact data on period of exposure to drugs, pregnancy terminations, and follow up of the babies 9 months and 2 years after birth. It is incremented each year with around 10 000 new pregnancies. Analysis of data until December 2011 shows a prevalence rate of congenital anomalies of 2.4%. Pregnant women were prescribed around 10 different reimbursed drugs during their pregnancy, the potential risk of a lot of these medications having not been evaluated during pregnancy. EFEMERIS can be used to monitor the prescription of reimbursed drugs to French pregnant women as well as to identify adverse pregnancy outcomes such as congenital malformation or effects on psychomotor development of the child. Examples of some studies already performed are given. © 2014 Société Française de Pharmacologie et de Thérapeutique.

  5. From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources.

    PubMed

    Trifirò, Gianluca; Sultana, Janet; Bate, Andrew

    2017-08-24

    In the last decade 'big data' has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processes and clinical practice by different healthcare professionals: from doctors recording their patients' medical history, drug prescriptions or medical claims to pharmacists registering dispensed prescriptions. For a long time, this data accumulated without its value being fully recognized and leveraged. Today big data has an important place in healthcare, including in pharmacovigilance. The expanding role of big data in pharmacovigilance includes signal detection, substantiation and validation of drug or vaccine safety signals, and increasingly new sources of information such as social media are also being considered. The aim of the present paper is to discuss the uses of big data for drug safety post-marketing assessment.

  6. Application of Pharmacovigilance Methods in Occupational Health Surveillance: Comparison of Seven Disproportionality Metrics

    PubMed Central

    Bicout, Dominique Joseph; de Gaudemaris, Regis

    2012-01-01

    Objectives The French National Occupational Diseases Surveillance and Prevention Network (RNV3P) is a French network of occupational disease specialists, which collects, in standardised coded reports, all cases where a physician of any specialty, referred a patient to a university occupational disease centre, to establish the relation between the disease observed and occupational exposures, independently of statutory considerations related to compensation. The objective is to compare the relevance of disproportionality measures, widely used in pharmacovigilance, for the detection of potentially new disease × exposure associations in RNV3P database (by analogy with the detection of potentially new health event × drug associations in the spontaneous reporting databases from pharmacovigilance). Methods 2001-2009 data from RNV3P are used (81,132 observations leading to 11,627 disease × exposure associations). The structure of RNV3P database is compared with the ones of pharmacovigilance databases. Seven disproportionality metrics are tested and their results, notably in terms of ranking the disease × exposure associations, are compared. Results RNV3P and pharmacovigilance databases showed similar structure. Frequentist methods (proportional reporting ratio [PRR], reporting odds ratio [ROR]) and a Bayesian one (known as BCPNN for "Bayesian Confidence Propagation Neural Network") show a rather similar behaviour on our data, conversely to other methods (as Poisson). Finally the PRR method was chosen, because more complex methods did not show a greater value with the RNV3P data. Accordingly, a procedure for detecting signals with PRR method, automatic triage for exclusion of associations already known, and then investigating these signals is suggested. Conclusion This procedure may be seen as a first step of hypothesis generation before launching epidemiological and/or experimental studies. PMID:22993712

  7. Tumor necrosis factor inhibitors added to nonbiological immunosuppressants vs. nonbiological immunosuppressants alone: a different signal of cancer risk according to the condition. A disproportionality analysis in a nationwide pharmacovigilance database.

    PubMed

    Saliba, Layla; Moulis, Guillaume; Abou Taam, Malak; Rousseau, Vanessa; Chebane, Leila; Petitpain, Nadine; Baldin, Bernadette; Pugnet, Grégory; Montastruc, Jean-Louis; Bagheri, Haleh

    2016-04-01

    We aimed at detecting a signal of an increased risk of cancer in patients treated with TNF inhibitor (TNFi) and nonbiological immunosuppressant (NBIS), compared with NBIS alone for autoimmune diseases. Secondly, we aimed at comparing this risk between the different TNFis. We conducted a disproportionality analysis (case/noncase study) from the French National PharmacoVigilance Database. We selected all the reports of serious adverse drug reactions from 2000 to 2010 in patients treated with NBIS for labeled indications of TNFi. Cases were all the reports of cancer that occurred after a minimal 3-month exposure to NBIS. Noncases were all the other reports. We searched for exposure to TNFi and calculated reporting odds ratios (RORs), stratified by condition and type of cancer and adjusted by age, gender, history of cancer, type of NBIS and year of reporting. Of the 1918 reports included in the study population, 217 were cases (135 solid and 82 blood cancers). A safety signal was found in rheumatoid arthritis (RA) (ROR: 5.43, 95% CI[3.52-8.38]) particularly for nonmelanoma skin cancer (NMSC) (20.17[2.49-163.36]), and in psoriasis/psoriatic arthritis (3.45[1.09-10.92]). No signal was found in inflammatory bowel diseases (IBD) and ankylosing spondylitis, whatever the type of cancer. There was no difference between TNFis. This study puts the argument of an increased risk of cancer (particularly NMSC) in patients with rheumatoid arthritis exposed to TNFi and NBIS compared with NBIS alone, but not in IBD and ankylosing spondylitis patients. No signal was detected for melanoma potentially related to the lack of power. The signal seems similar whatever the TNFi.

  8. Hearing impairment associated with oral terbinafine use: a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™.

    PubMed

    Scholl, Joep H G; van Puijenbroek, Eugene P

    2012-08-01

    The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR) reporting and from Vigibase™, the ADR database of the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre. The objective of the current study was to identify whether the observed association between oral terbinafine use and hearing impairment, based on cases received by Lareb, constitutes a safety signal. Cases of hearing impairment in oral terbinafine users are described. In a case/non-case analysis, the strength of the association in Vigibase™ and the Lareb database was determined (date of analysis August 2011) by calculating the reporting odds ratios (RORs), adjusted for possible confounding by age, sex and ototoxic concomitant medication. For the purpose of this study, RORs were calculated for deafness, hypoacusis and the combination of both, defined as hearing impairment. In the Lareb database, six reports concerning individuals aged 31-82 years, who developed hearing impairment after starting oral terbinafine, were present. The use of oral terbinafine was disproportionally associated with hypoacusis in both the Lareb database (adjusted ROR 3.9; 95% CI 1.7, 9.0) and in Vigibase™ (adjusted ROR 1.7; 95% CI 1.0, 2.8). Deafness was not disproportionally present in either of the databases. Based on the described cases and the statistical analyses from both databases, a causal relationship between the use of oral terbinafine and hearing impairment is possible. The mechanism by which terbinafine could cause hearing impairment has not been elucidated yet. The pharmacological action of terbinafine is based on the inhibition of squalene epoxidase, an enzyme present in both fungal and human cells. This inhibition might result in a decrease in

  9. Comparison of two drug safety signals in a pharmacovigilance data mining framework.

    PubMed

    Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

    2016-04-01

    Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database.

  10. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER) Database and Association Analysis

    PubMed Central

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed. Methods and Findings We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA). We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  11. Medication errors: pharmacovigilance centres in detection and prevention

    PubMed Central

    Bencheikh, Rachida Soulaymani; Benabdallah, Ghita

    2009-01-01

    Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. As part of this project, a questionnaire on detecting medication errors was circulated to pharmacovigilance centres and poison control centres around the world, in order to assess their ability to detect and analyse medication errors. The results showed that through their databases pharmacovigilance centres can detect, identify, analyse, and classify medication errors and carry out root cause analysis, which is an important tool in preventing medication errors. The duties of pharmacovigilance centres in preventing medication errors include informing health-care professionals about the importance of reporting such errors and creating a culture of patient safety. Pharmacovigilance centres aim to prevent medication errors in collaboration with poison control centres. Such collaboration allows improved detection and improved preventive strategies. In addition, collaboration with regulatory authorities is important in finalizing decisions. Collaboration between pharmacovigilance centres and poison control centres should be strengthened and bridges need to be built linking pharmacovigilance centres, poison control centres, and organizations dedicated to patient safety, in order to avoid duplication of workload. PMID:19594539

  12. Medication errors: pharmacovigilance centres in detection and prevention.

    PubMed

    Bencheikh, Rachida Soulaymani; Benabdallah, Ghita

    2009-06-01

    1. Detecting medication errors needs collaboration between various organizations, such as patient safety institutions, pharmacovigilance centres, and poison control centres. In order to evaluate the input of pharmacovigilance centres and poison control centres in detecting and evaluating medication errors a pilot project was initiated by the World Alliance for Patient Safety in collaboration with the Uppsala Monitoring Centre; the Moroccan pharmacovigilance centre acted as project coordinator. As part of this project, a questionnaire on detecting medication errors was circulated to pharmacovigilance centres and poison control centres around the world, in order to assess their ability to detect and analyse medication errors. 2. The results showed that through their databases pharmacovigilance centres can detect, identify, analyse, and classify medication errors and carry out root cause analysis, which is an important tool in preventing medication errors. 3. The duties of pharmacovigilance centres in preventing medication errors include informing health-care professionals about the importance of reporting such errors and creating a culture of patient safety. Pharmacovigilance centres aim to prevent medication errors in collaboration with poison control centres. Such collaboration allows improved detection and improved preventive strategies. In addition, collaboration with regulatory authorities is important in finalizing decisions. 4. Collaboration between pharmacovigilance centres and poison control centres should be strengthened and bridges need to be built linking pharmacovigilance centres, poison control centres, and organizations dedicated to patient safety, in order to avoid duplication of workload.

  13. Forensic pharmacovigilance: Newer dimension of pharmacovigilance.

    PubMed

    Sewal, Rakesh K; Saini, Vikas K; Medhi, Bikash

    2015-08-01

    Drug safety for the patients is of paramount importance for a medical professional. Pharmacovigilance attempts to ensure the safety of patients by keeping a close vigil on the pattern of adverse events secondary to drug use. Number of medicolegal cases is at rise since last few years. Forensic sciences and pharmacovigilance need to work hand in hand to unlock the mystery of many criminal and civil proceedings. Pharmacovigilance offers its wide scope in forensic sciences by putting forward its expertise on adverse profile of drugs which may be instrumental in solving the cases and bringing the justice forth. It may range from as simple affairs as defining the adverse drug reaction on one hand to putting expert advice in critical criminal cases on the other one. Pharmacovigilance experts have to abide by the ethics of the practice while executing their duties as expert else it may tarnish the justice and loosen its dependability. As a budding discipline of science, it is confronted with several hurdles and challenges which include reluctance of medical professionals for being involved in court proceedings, extrapolations of facts and data and variations in law across the globe etc. These challenges and hurdles call the medical fraternity come forward to work towards the momentous application of pharmacovigilance in the forensic sciences. Evidence based practice e.g. testing the biological samples for the presence of drugs may prove to be pivotal in the success of this collaboration of sciences.

  14. The role of data mining in pharmacovigilance.

    PubMed

    Hauben, Manfred; Madigan, David; Gerrits, Charles M; Walsh, Louisa; Van Puijenbroek, Eugene P

    2005-09-01

    A principle concern of pharmacovigilance is the timely detection of adverse drug reactions that are novel by virtue of their clinical nature, severity and/or frequency. The cornerstone of this process is the scientific acumen of the pharmacovigilance domain expert. There is understandably an interest in developing database screening tools to assist human reviewers in identifying associations worthy of further investigation (i.e., signals) embedded within a database consisting largely of background 'noise' containing reports of no substantial public health significance. Data mining algorithms are, therefore, being developed, tested and/or used by health authorities, pharmaceutical companies and academic researchers. After a focused review of postapproval drug safety signal detection, the authors explain how the currently used algorithms work and address key questions related to their validation, comparative performance, deployment in naturalistic pharmacovigilance settings, limitations and potential for misuse. Suggestions for further research and development are offered.

  15. Assessing the impact of drug safety signals from the WHO database presented in 'SIGNAL': results from a questionnaire of National pharmacovigilance Centres.

    PubMed

    Ståhl, Malin; Edwards, I Ralph; Bowring, Geoffrey; Kiuru, Anne; Lindquist, Marie

    2003-01-01

    A major task for the Uppsala Monitoring Centre (UMC) is to detect early signals of suspected adverse drug reactions (ADRs) in the WHO Database. The database currently contains over 2.8 million spontaneously reported ADR case reports continuously collected by National Pharmacovigilance Centres in countries participating in the WHO Programme for International Drug Monitoring. The database is scanned every quarter and drug-ADR combinations are filtered out using different selection criteria intended to catch potential international drug safety signals at an early stage. Summary case data are reviewed by experts on the UMC's review panel and the signals are presented to the Programme members in the restricted circulation document entitled 'SIGNAL'. The aim of the study was to investigate: (i). how the signals presented in 'SIGNAL' are used; (ii). if they reach the right target group; (iii). if they are of interest and relevance to the recipients; (iv). if they are timely and; (v). if they make any difference. We were also interested in knowing the view of member countries regarding the definition of what a signal is. A questionnaire was sent out to 71 countries participating in the WHO Programme. The recipients were asked to state what actions were taken for 26 different signal headings included in three issues of 'SIGNAL' sent out during 2001 and to rate how useful they considered these topics to be. Responses were received from 45 countries (63%). The Centres' average ratings of relevance, importance and usefulness on a scale 1-10 of the selected 26 signals were all above the expected average rating 5.5. The content of 'SIGNAL' in general was seen as always or often useful in 63.5% of the respondents. In 2001, 17 countries took actions on at least one signal. Actions were rarely taken without considering the signal from the UMC. All responding centres agreed on the WHO definition of a signal, but there were differences in the interpretation of what constitutes a

  16. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France.

    PubMed

    Olivier, Pascale; Montastruc, Jean-Louis

    2006-11-01

    Because of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France. Data coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case-control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR. A total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type-B ('unexpected') reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case-control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision. This study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco-epidemiological population-based database could represent a helpful tool to both generate and test safety hypotheses.

  17. Prevalence of immune-related systemic adverse events in patients treated with anti-Programmed cell Death 1/anti-Programmed cell Death-Ligand 1 agents: A single-centre pharmacovigilance database analysis.

    PubMed

    Le Burel, Sébastien; Champiat, Stéphane; Mateus, Christine; Marabelle, Aurélien; Michot, Jean-Marie; Robert, Caroline; Belkhir, Rakiba; Soria, Jean-Charles; Laghouati, Salim; Voisin, Anne-Laure; Fain, Olivier; Mékinian, Arsène; Coutte, Laetitia; Szwebel, Tali-Anne; Dunogeant, Laetitia; Lioger, Bertrand; Luxembourger, Cécile; Mariette, Xavier; Lambotte, Olivier

    2017-09-01

    The growing use of immune checkpoint inhibitors (ICIs) is associated with the occurrence of immune-related adverse events (irAEs). Few data are published on systemic, immunohaematological and rheumatic irAEs. In a pharmacovigilance database analysis, we screened for these irAEs and calculated their prevalence. Participants were recruited via Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie (REISAMIC)(1) a French registry of grade ≥2 irAEs occurring in ICI-treated patients. The pathologies of interest were systemic autoimmune and inflammatory diseases, rheumatic diseases and immune cytopenia. Out of 908 patients treated with anti-Programmed cell Death 1 (PD1)/anti-Programmed cell Death-Ligand 1 (PD-L1) agents (together with an anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) agent in 40 cases) between December 2012 and December 2016 at a single centre, 21 patients experienced systemic irAEs. The types and the prevalence of irAEs were as follows: immune thrombocytopenia (0.2%), Sjögren syndrome (0.3%), rheumatoid arthritis (0.2%), polymyalgia rheumatica (0.2%), psoriatic arthritis (0.2%), seronegative polyarthritis (0.7%) and sarcoidosis (0.2%). Patients with Sjögren syndrome or seronegative polyarthritis were more likely to have received combination therapy with ipilimumab (2.5% for both). We described these 21 cases, together with nine additional cases from five other centres. Most irAE were moderately severe (grade 2, 63%). The median time to onset was 57°days (interquartile range (IQR) 24-117). The ICI was withdrawn in 12 cases, 25 patients (83%) received corticosteroids, and five patients (17%) received immunosuppressant/immunomodulatory agents. The irAEs resolved fully or partially in 28 cases (93%). Although systemic, immunohaematological and rheumatic diseases are rarely associated with ICI use, the prevalence is higher when two ICIs are combined. Corticosteroids are often effective and may enable

  18. [Pharmacovigilance of major parmaceutical innovation].

    PubMed

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.

  19. Safety profile of the fluoroquinolones: analysis of adverse drug reactions in relation to prescription data using four regional pharmacovigilance databases in Italy.

    PubMed

    Lapi, Francesco; Tuccori, Marco; Motola, Domenico; Pugi, Alessandra; Vietri, Michele; Montanaro, Nicola; Vaccheri, Alberto; Leoni, Olivia; Cocci, Alfredo; Leone, Roberto; Conforti, Anita; Moretti, Ugo; Sessa, Emiliano; Mazzaglia, Giampiero; Mugelli, Alessandro; Mazzei, Teresita; Vannacci, Alfredo

    2010-09-01

    Fluoroquinolones are widely used both in primary care and in hospital settings. Since the last comparison performed in Italy on the safety profiles of different fluoroquinolones, a new molecule, prulifloxacin, has been introduced into the market and several warnings concerning this class of drugs have been released. The aim of this study was to reassess the safety profiles of fluoroquinolones using the database of the Italian Interregional Group of Pharmacovigilance (IGP) and the administrative data of fluoroquinolone prescriptions. All adverse drug reactions (ADRs) reported in four Italian regions (Lombardy, Veneto, Emilia Romagna and Tuscany) were retrieved from the IGP database. Consumption data (defined daily dose [DDD]/1000 inhabitants/day) were used as denominators. Both single reports and all ADRs (classified by System Organ Classes and MedDRA Preferred Term [PT]) due to fluoroquinolones were considered as numerators of each analysis, comparing two periods (2005 vs 2006). All fluoroquinolones with at least ten reports per year were included in the analysis. On the basis of 272 reports (532 single ADRs or PTs), patients did not show any statistically significant differences between 2005 and 2006 in terms of sex, age and number of concurrent medications. After adjustment for drug consumption, moxifloxacin showed the highest reporting rate (84.6 reports/DDD/1000 inhabitants/day; 15.4 serious reports/DDD/1000 inhabitants/day) followed by prulifloxacin (72.2; 22.2 serious) and levofloxacin (55.3; 30.6 serious) in 2005. An increment of ADR/report rates was observed over the 2 years for all fluoroquinolones except prulifloxacin, which had the lowest ADR reporting rate in 2006 (25.0; 12.5 serious). In 2006, the rate of serious ADRs associated with prulifloxacin was lower than with ciprofloxacin, while in 2005 serious events were almost equal for both compounds (55.6 vs 47.6 serious ADRs/DDD/1000 inhabitants/day). Ciprofloxacin showed the highest proportion of

  20. Contribution of Latin America to pharmacovigilance.

    PubMed

    González, Juan Camilo; Arango, Victoria E; Einarson, Thomas R

    2006-01-01

    Pharmacovigilance activities have been ongoing for 4 decades. However, little is known (especially outside of the area) about the contribution of Latin America to this field. To review and quantify the published literature on pharmacovigilance in Latin American countries. We searched electronic databases including MEDLINE (1966-2004), EMBASE (1980-2004), International Pharmaceutical Abstracts (1970-2004), Toxline (1992-2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-2004), Sistema de Información Esencial en Terapéutica y Salud (1980-2004), and the Pan American Health Organization Web site (1970-2004) for articles on pharmacovigilance or adverse drug reactions in any of the 19 major Latin American countries. Papers were retrieved and categorized according to content and country of origin by 2 independent reviewers. There were 195 usable articles from 13 countries. Fifty-one of the papers retrieved dealt with pharmacovigilance centers (15 national centers, 10 hospitals, 26 other), 55 covered pharmacovigilance itself (21 theoretical papers, 9 with description of models, 25 educational papers), and 89 were pharmacoepidemiologic studies of adverse drug reactions (69 case reports, 13 observational cohorts, 2 cohort studies, 1 randomized clinical trial, 4 clinical papers on adverse reaction management). Studies have increased exponentially since 1980. Five countries (Argentina, Brazil, Chile, Costa Rica, Venezuela) published reports from national centers. No studies were found from 6 countries: Dominican Republic, El Salvador, Honduras, Nicaragua, Paraguay, or Uruguay. Most studied categories were antiinfectives and drugs affecting the central nervous system, cardiovascular system, and musculoskeletal system. Contributions of Latin American countries to the field of pharmacovigilence have been remarkable, considering the constraints on these countries. A need exists for an increased number of formal pharmacovigilance studies and research

  1. Etonogestrel implant migration to the vasculature, chest wall, and distant body sites: cases from a pharmacovigilance database.

    PubMed

    Kang, Sarah; Niak, Ali; Gada, Neha; Brinker, Allen; Jones, S Christopher

    2017-09-01

    To describe clinical outcomes of etonogestrel implant patients with migration to the vasculature, chest wall and other distant body sites spontaneously reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a standardized Medical Dictionary for Regulatory Activities (MedDRA) query in the FAERS database (through November 15, 2015), with reports coded with one or more MedDRA preferred terms that indicate complications with device placement or migration of the device from the original site of insertion to the vasculature, chest wall and other distant body sites. We excluded any cases previously described in the medical literature. We identified 38 cases of pronounced etonogestrel implant migration. Migration locations included the lung/pulmonary artery (n=9), chest wall (n=1), vasculature at locations other than the lung/pulmonary artery (n=14) and extravascular migrations (n=14) to other body sites (e.g., the axilla and clavicle/neck line/shoulder). The majority of cases were asymptomatic and detected when the patient desired implant removal; however, seven cases reported symptoms such as pain, discomfort and dyspnea in association with implant migration. Three cases also describe pulmonary fibrosis and skin reactions as a result of implant migration to the vasculature, chest wall and other distant body sites. Sixteen cases reported surgical removal in an operating room setting. Our FAERS case series demonstrates etonogestrel implant migration to the vasculature, chest wall and other body sites distant from the site of original insertion. As noted by the sponsor in current prescribing information, a key determinant in the risk for etonogestrel contraceptive implant migration appears to be improper insertion technique. Although migration of etonogestrel implants to the vasculature is rare, awareness of migration and education on proper insertion technique may reduce the risk. Published by Elsevier Inc.

  2. The reorganisation of European pharmacovigilance. Part 2. From spontaneous reports to agency reviews and decisions.

    PubMed

    2015-02-01

    Despite the fact that adverse effects are vastly under-reported, spontaneous reporting remains the foundation of pharmacovigilance. A small series of properly documented cases, when very specific, can suffice to constitute a signal. In France, reporting adverse effects to Regional Pharmacovigilance Centres (CRPVs) permits high-quality analysis of pharmacovigilance signals, so that they can be brought to the attention of the national agency responsible for making decisions about drugs, the French Health Products Agency (ANSM). The ANSM can use this information to protect patients by implementing the measures within its power or by initiating a European referral. When a decision taken at the national level concerns a drug marketed in several Member States of the European Union, a "harmonisation" procedure results in a decision taken at community level, applicable in all Member States. This means that a safety issue raised by a single Member State sometimes leads to a decision that protects the population of the entire European Union. But it also means that other European decisions can compel national agencies to allow back onto the market a drug that they sought to withdraw in order to protect their citizens. Negotiations with other Member States, the European Medicines Agency (EMA) and the European Commission must be supported by robust data: this is yet another reason for each country to have its own effective national pharmacovigilance database, the contents of which should be publicly accessible. This is unfortunately not yet the case in France in 2014. It also provides another good reason for healthcare professionals and patients to report adverse effects, so that the details can be recorded in national and European databases.

  3. Pharmacovigilance in Asia

    PubMed Central

    Biswas, Pipasha

    2013-01-01

    An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change. PMID:24347987

  4. Pharmacovigilance in Asia.

    PubMed

    Biswas, Pipasha

    2013-12-01

    An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change.

  5. Pharmacovigilance and Biomedical Informatics: A Model for Future Development.

    PubMed

    Beninger, Paul; Ibara, Michael A

    2016-12-01

    The discipline of pharmacovigilance is rooted in the aftermath of the thalidomide tragedy of 1961. It has evolved as a result of collaborative efforts by many individuals and organizations, including physicians, patients, Health Authorities, universities, industry, the World Health Organization, the Council for International Organizations of Medical Sciences, and the International Conference on Harmonisation. Biomedical informatics is rooted in technologically based methodologies and has evolved at the speed of computer technology. The purpose of this review is to bring a novel lens to pharmacovigilance, looking at the evolution and development of the field of pharmacovigilance from the perspective of biomedical informatics, with the explicit goal of providing a foundation for discussion of the future direction of pharmacovigilance as a discipline. For this review, we searched [publication trend for the log10 value of the numbers of publications identified in PubMed] using the key words [informatics (INF), pharmacovigilance (PV), phar-macovigilance þ informatics (PV þ INF)], for [study types] articles published between [1994-2015]. We manually searched the reference lists of identified articles for additional information. Biomedical informatics has made significant contributions to the infrastructural development of pharmacovigilance. However, there has not otherwise been a systematic assessment of the role of biomedical informatics in enhancing the field of pharmacovigilance, and there has been little cross-discipline scholarship. Rapidly developing innovations in biomedical informatics pose a challenge to pharmacovigilance in finding ways to include new sources of safety information, including social media, massively linked databases, and mobile and wearable wellness applications and sensors. With biomedical informatics as a lens, it is evident that certain aspects of pharmacovigilance are evolving more slowly. However, the high levels of mutual interest in

  6. Application of data mining techniques in pharmacovigilance.

    PubMed

    Wilson, Andrew M; Thabane, Lehana; Holbrook, Anne

    2004-02-01

    To discuss the potential use of data mining and knowledge discovery in databases for detection of adverse drug events (ADE) in pharmacovigilance. A literature search was conducted to identify articles, which contained details of data mining, signal generation or knowledge discovery in relation to adverse drug reactions or pharmacovigilance in medical databases. ADEs are common and result in significant mortality, and despite existing systems drugs have been withdrawn due to ADEs many years after licensing. Knowledge discovery in databases (KDD) is a technique which may be used to detect potential ADEs more efficiently. KDD involves the selection of data variables and databases, data preprocessing, data mining and data interpretation and utilization. Data mining encompasses a number of statistical techniques including cluster analysis, link analysis, deviation detection and disproportionality assessment which can be utilized to determine the presence of and to assess the strength of ADE signals. Currently the only data mining methods to be used in pharmacovigilance are those of disproportionality, such as the Proportional Reporting Ratio and Information Component, which have been used to analyse the UK Yellow Card Scheme spontaneous reporting database and the WHO Uppsala Monitoring Centre database. The association of pericarditis with practolol but not with other beta-blockers, the association of captopril and other angiotensin-converting enzymes with cough, and the association of terfenadine with heart rate and rhythm disorders could be identified by mining the WHO database. In view of the importance of ADEs and the development of massive data storage systems and powerful computer systems, the use of data mining techniques in knowledge discovery in medical databases is likely to be of increasing importance in the process of pharmacovigilance as they are likely to be able to detect signals earlier than using current methods.

  7. [The Portuguese Pharmacovigilance System].

    PubMed

    Herdeiro, Maria Teresa; Ferreira, Mónica; Ribeiro-Vaz, Inês; Junqueira Polónia, Jorge; Costa-Pereira, Altamiro

    2012-01-01

    In Portugal, the National Pharmacovigilance System (NPS) was created in 1992, completing during this year 20 years of existence. Having been established in a centralized manner, it soon became aware that its geographic decentralization would bring advantages in terms of proximity of the System to health professionals as well as the involvement of the universities. The NPS currently has four regional pharmacovigilance centres, which cover the entire mainland, which became centers of scientific vocation, carrying out pharmacoepidemiological studies in the area of drug safety. Also, they are the guarantee of proper collection, processing and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well as the continuing disclosure of the System among health professionals and promotion of spontaneous reporting. Over these 20 years, the NPS has been adapting to the EU requirements in the area of pharmacovigilance, and is currently a mature and well implemented system, with the objectives of the evaluation of the safety profile of marketed drugs and triggering of actions to reduce the risk of these drugs. From the second half of 2012, new adaptation will be run with the implementation of recent European legislation on Pharmacovigilance, published in December 2010. Among other changes, there is the possibility for consumers to report their suspicious of ADR directly to the NPS (exclusive, so far, to health professionals). This work aims to be a reflection about the evolution of the National Pharmacovigilance System and its growing importance in the protection of public health.

  8. Nationwide incidence of motor neuron disease using the French health insurance information system database.

    PubMed

    Kab, Sofiane; Moisan, Frédéric; Preux, Pierre-Marie; Marin, Benoît; Elbaz, Alexis

    2017-08-01

    There are no estimates of the nationwide incidence of motor neuron disease (MND) in France. We used the French health insurance information system to identify incident MND cases (2012-2014), and compared incidence figures to those from three external sources. We identified incident MND cases (2012-2014) based on three data sources (riluzole claims, hospitalisation records, long-term chronic disease benefits), and computed MND incidence by age, gender, and geographic region. We used French mortality statistics, Limousin ALS registry data, and previous European studies based on administrative databases to perform external comparisons. We identified 6553 MND incident cases. After standardisation to the United States 2010 population, the age/gender-standardised incidence was 2.72/100,000 person-years (males, 3.37; females, 2.17; male:female ratio = 1.53, 95% CI1.46-1.61). There was no major spatial difference in MND distribution. Our data were in agreement with the French death database (standardised mortality ratio = 1.01, 95% CI = 0.96-1.06) and Limousin ALS registry (standardised incidence ratio = 0.92, 95% CI = 0.72-1.15). Incidence estimates were in the same range as those from previous studies. We report French nationwide incidence estimates of MND. Administrative databases including hospital discharge data and riluzole claims offer an interesting approach to identify large population-based samples of patients with MND for epidemiologic studies and surveillance.

  9. Insurance statements from French anaesthesiologists and intensivists: A database analysis.

    PubMed

    Boutonnet, Mathieu; Trouiller, Pierre; Lopard, Eric; Amalberti, René; Houselstein, Thierry; Pasquier, Pierre; Auroy, Yves; De Saint-Maurice, Guillaume

    2016-10-01

    From its origins, anaesthesia is a leading medical specialty for improving patient safety. However, perioperative adverse events remain frequent and may be preventable in 50% of cases. We conducted a collaborative retrospective study analysis of the insurance-database of the MACSF-Sou Medical insurance company to assess the perioperative risk. Retrospective study, including all the statements declared by anaesthesiologists to the MACSF-Sou Medical insurance company. A description of risk in perioperative medicine was performed by the assessment of these statements by three experts member of the SFAR. All the statements concerning regional anaesthesia and dental injuries were excluded. Eight hundred and seventy statements were analyzed. The patients involved were predominantly women (sex-ratio: 0.86), with a mean age of 56 years (±18). Three hundred and fifteen cardiac arrests, 157 severe systemic complications, 340 moderate complications and 106 conflicts were analyzed. Most of the events were revealed postoperatively (79.3%) and almost half of them after the discharge of the postanesthetic care unit. The medical consequences were considered as serious. Death followed 35.9% of the events declared. Relative or true hypovolaemia and stroke were responsible for a large part of postoperative mortality and morbidity. Collaborating with insurance companies allows a relevant approach of the perioperative risk. The study highlighted the importance of the delayed complications and is a plea for a more intense implication of anaesthesia in the postoperative care with the aim of improving patient safety. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  10. Online database for mosquito (Diptera, Culicidae) occurrence records in French Guiana

    PubMed Central

    Talaga, Stanislas; Murienne, Jérôme; Dejean, Alain; Leroy, Céline

    2015-01-01

    Abstract A database providing information on mosquito specimens (Arthropoda: Diptera: Culicidae) collected in French Guiana is presented. Field collections were initiated in 2013 under the auspices of the CEnter for the study of Biodiversity in Amazonia (CEBA: http://www.labexceba.fr/en/). This study is part of an ongoing process aiming to understand the distribution of mosquitoes, including vector species, across French Guiana. Occurrences are recorded after each collecting trip in a database managed by the laboratory Evolution et Diversité Biologique (EDB), Toulouse, France. The dataset is updated monthly and is available online. Voucher specimens and their associated DNA are stored at the laboratory Ecologie des Forêts de Guyane (Ecofog), Kourou, French Guiana. The latest version of the dataset is accessible through EDB’s Integrated Publication Toolkit at http://130.120.204.55:8080/ipt/resource.do?r=mosquitoes_of_french_guiana or through the Global Biodiversity Information Facility data portal at http://www.gbif.org/dataset/5a8aa2ad-261c-4f61-a98e-26dd752fe1c5 It can also be viewed through the Guyanensis platform at http://guyanensis.ups-tlse.fr PMID:26692809

  11. Online database for mosquito (Diptera, Culicidae) occurrence records in French Guiana.

    PubMed

    Talaga, Stanislas; Murienne, Jérôme; Dejean, Alain; Leroy, Céline

    2015-01-01

    A database providing information on mosquito specimens (Arthropoda: Diptera: Culicidae) collected in French Guiana is presented. Field collections were initiated in 2013 under the auspices of the CEnter for the study of Biodiversity in Amazonia (CEBA: http://www.labexceba.fr/en/). This study is part of an ongoing process aiming to understand the distribution of mosquitoes, including vector species, across French Guiana. Occurrences are recorded after each collecting trip in a database managed by the laboratory Evolution et Diversité Biologique (EDB), Toulouse, France. The dataset is updated monthly and is available online. Voucher specimens and their associated DNA are stored at the laboratory Ecologie des Forêts de Guyane (Ecofog), Kourou, French Guiana. The latest version of the dataset is accessible through EDB's Integrated Publication Toolkit at http://130.120.204.55:8080/ipt/resource.do?r=mosquitoes_of_french_guiana or through the Global Biodiversity Information Facility data portal at http://www.gbif.org/dataset/5a8aa2ad-261c-4f61-a98e-26dd752fe1c5 It can also be viewed through the Guyanensis platform at http://guyanensis.ups-tlse.fr.

  12. Application of the British Food Standards Agency nutrient profiling system in a French food composition database.

    PubMed

    Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Méjean, Caroline; Fezeu, Léopold; Hercberg, Serge

    2014-11-28

    Nutrient profiling systems are powerful tools for public health initiatives, as they aim at categorising foods according to their nutritional quality. The British Food Standards Agency (FSA) nutrient profiling system (FSA score) has been validated in a British food database, but the application of the model in other contexts has not yet been evaluated. The objective of the present study was to assess the application of the British FSA score in a French food composition database. Foods from the French NutriNet-Santé study food composition table were categorised according to their FSA score using the Office of Communication (OfCom) cut-off value ('healthier' ≤ 4 for foods and ≤ 1 for beverages; 'less healthy' >4 for foods and >1 for beverages) and distribution cut-offs (quintiles for foods, quartiles for beverages). Foods were also categorised according to the food groups used for the French Programme National Nutrition Santé (PNNS) recommendations. Foods were weighted according to their relative consumption in a sample drawn from the NutriNet-Santé study (n 4225), representative of the French population. Classification of foods according to the OfCom cut-offs was consistent with food groups described in the PNNS: 97·8 % of fruit and vegetables, 90·4 % of cereals and potatoes and only 3·8 % of sugary snacks were considered as 'healthier'. Moreover, variability in the FSA score allowed for a discrimination between subcategories in the same food group, confirming the possibility of using the FSA score as a multiple category system, for example as a basis for front-of-pack nutrition labelling. Application of the FSA score in the French context would adequately complement current public health recommendations.

  13. [New methods for studying drug associated risk: experience of the Toulouse Regional Pharmacovigilance Center].

    PubMed

    Montastruc, Jean-Louis; Bagheri, Haleh; Lacroix, Isabelle; Olivier, Pascale; Durrieu, Genevieve; Damase-Michel, Christine; Lapeyre-Mestre, Maryse

    2005-03-01

    This review examines the methods used to study adverse drug reactions (ADRs) and to quantify drug risk in pharmacovigilance. Beside analysis of spontaneous reports (the basic and universal alert method in pharmacovigilance), epidemiological methods can also be used. Classical methods are based on intensive recording, case-control or cohort studies, and clinical trials. Other more recent methods have been applied to pharmacovigilance. Using recent personal data, the authors present and discuss these new methods. Case/non-case studies quantify drug risk based on a pharmacovigilance database, and are used as signals in pharmacovigilance. Analysis of laboratory data can also be used to evaluate biological ADRs such as elevated liver enzyme and creatine phosphokinase levels. Cross-linkage studies can be used to minimize the consequences of under-notification in pharmacovigilance. Finally, ADR perception analysis is a useful method to evaluate the perceived social and medical importance of drug risks in different populations (public, pharmacists, general practitioners, medical specialists).

  14. Adverse drug reactions associated with off-label use of ketorolac, with particular focus on elderly patients. An analysis of the Italian pharmacovigilance database and a population based study.

    PubMed

    Viola, E; Trifirò, G; Ingrasciotta, Y; Sottosanti, L; Tari, M; Giorgianni, F; Moretti, U; Leone, R

    2016-12-01

    This study aims to evaluate the frequency of off-label use of ketorolac in Italy and the related suspected adverse drug reactions (ADRs) reported. All the suspected cases associated with ketorolac recorded in the Italian Pharmacovigilance database were retrieved. Case evaluations were carried out in order to identify the off-label use of ketorolac. Moreover, an analysis of the inappropriate use of ketorolac was conducted using the 'Arianna' database of Caserta local health unit. Up to December 2014, 822 reports of suspected ADRs related to ketorolac were retrieved in the database. The use of ketorolac was classified as off-label for 553 reports and on-label for 269. Among the off-label cases, 58.6% were serious compared to 39.0% of on-label cases. Gastrointestinal events were more frequently reported with off-label use. The analysis of Arianna database showed that 37,729 out of 61,910 patients, were treated off-label. The off-label use of ketorolac is widespread in Italy. This use increases the risk of serious ADR, especially in in case of prolonged duration of treatment and in elderly patients. The Italian Medicine Agency has decided to accurately monitor the appropriate use of the drug in Italy and, if necessary, take measures in order to minimize the risks.

  15. Strengthening pharmacovigilance in South Africa.

    PubMed

    Mehta, U; Dheda, M; Steel, G; Blockman, M; Ntilivamunda, A; Maartens, G; Pillay, Y; Cohen, K

    2014-02-01

    This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA.

  16. Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

    PubMed

    Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

    2016-10-01

    The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

  17. Are we pharmacovigilant enough in ophthalmic practice?

    PubMed

    Dubey, Ashok; Handu, Shailendra S

    2013-05-01

    No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR) database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI) to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

  18. [Pharmacovigilance of vaccines].

    PubMed

    Autret-Leca, E; Bensouda-Grimaldi, L; Jonville-Béra, A P; Beau-Salinas, F

    2006-02-01

    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.

  19. European pharmacovigilance: increasingly outsourced to drug companies.

    PubMed

    2014-12-01

    New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator (benfluorex) disaster. The European Commission's original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations. Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers. The role of the new European Pharmacovigilance Risk Assessment Committee (PRAC) has been strengthened. Patients in every Member State have the right to report adverse drug effects directly to health authorities. EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved. However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest. Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies. Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are based on data preanalysed by the drug companies. In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments. In 2012, following France's Mediator disaster, several modest

  20. Treatment performances of French constructed wetlands: results from a database collected over the last 30 years.

    PubMed

    Morvannou, A; Forquet, N; Michel, S; Troesch, S; Molle, P

    2015-01-01

    Approximately 3,500 constructed wetlands (CWs) provide raw wastewater treatment in France for small communities (<5,000 people equivalent). Built during the past 30 years, most consist of two vertical flow constructed wetlands (VFCWs) in series (stages). Many configurations exist, with systems associated with horizontal flow filters or waste stabilization ponds, vertical flow with recirculation, partially saturated systems, etc. A database analyzed 10 years earlier on the classical French system summarized the global performances data. This paper provides a similar analysis of performance data from 415 full-scale two-stage VFCWs from an improved database expanded by monitoring data available from Irstea and the French technical department. Trends presented in the first study are confirmed, exhibiting high chemical oxygen demand (COD), total suspended solids (TSS) and total Kjeldahl nitrogen (TKN) removal rates (87%, 93% and 84%, respectively). Typical concentrations at the second-stage outlet are 74 mgCOD L(-1), 17 mgTSS L(-1) and 11 mgTKN L(-1). Pollutant removal performances are summarized in relation to the loads applied at the first treatment stage. While COD and TSS removal rates remain stable over the range of applied loads, the spreading of TKN removal rates increases as applied loads increase.

  1. French database of children and adolescents with Prader-Willi syndrome

    PubMed Central

    Molinas, Catherine; Cazals, Laurent; Diene, Gwenaelle; Glattard, Melanie; Arnaud, Catherine; Tauber, Maithe

    2008-01-01

    Background Prader-Willi syndrome (PWS) is a rare multisystem genetic disease leading to severe complications mainly related to obesity. We strongly lack information on the natural history of this complex disease and on what factors are involved in its evolution and its outcome. One of the objectives of the French reference centre for Prader-Willi syndrome set-up in 2004 was to set-up a database in order to make the inventory of Prader-Willi syndrome cases and initiate a national cohort study in the area covered by the centre. Description the database includes medical data of children and adolescents with Prader-Willi syndrome, details about their management, socio-demographic data on their families, psychological data and quality of life of the parents. The tools and organisation used to ensure data collection and data quality in respect of good clinical practice procedures are discussed, and main characteristics of our Prader-Willi population at inclusion are presented. Conclusion this database covering all the aspects of PWS clinical, psychological and social profiles, including familial psychological and quality of life will be a powerful tool for retrospective studies concerning this complex and multi factorial disease and could be a basis for the design of future prospective multicentric studies. The complete database and the Stata.do files are available to any researcher wishing to use them for non-commercial purposes and can be provided upon request to the corresponding author. PMID:18831731

  2. Pharmacovigilance is... Vigilance.

    PubMed

    Edwards, I Ralph; Bencheikh, Rachida Soulayamani

    2016-04-01

    The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and they often focus on improving individual patient care, rather than the more traditional concentration on broad public health. The same stakeholders are also drawing attention to other iatrogenic outcomes that should be recognised, evaluated and their outcomes compared and contrasted with medication, such as harm from medical devices. The vigilance methods used for medication are very much applicable to all these new fields, though more and different expertise will be needed to evaluate outcomes.

  3. Development of pharmacovigilance system in Ukraine: first results.

    PubMed

    Stefanov, O; Sharayeva, M; Jajtchenja, V

    2004-03-01

    The article is devoted to the establishment and development of the National Pharmacovigilance system in Ukraine. A drug safety centre of Ukraine started to form a pharmacovigilance system in 1996. It has been operating on a regular basis since 2000 and now provides the regulatory services that include data collection and analysis, database management, education, international contacts, and the publication and dissemination of information. Our ultimate goal is to foster a rational and safe drug use and to improve the quality of pharmacotherapy in Ukraine.

  4. Obstacles to transparency over pharmacovigilance data within the EMA.

    PubMed

    2015-11-01

    In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held by the European Pharmacovigilance Risk Assessment Committee (PRAC), in order to defend their drug. They also provide for the possibility of holding non-public hearings to discuss public data. There is a great risk that the drug industry might use these provisions to influence the debate. The strings attached to the access that the EMA proposes to grant researchers to data contained in the centralised European pharmacovigilance database would allow the EMA to censor the publication of their findings. The EMA seems to regard pharmacovigilance data as commercially confidential information. Responding to these consultations provided an opportunity to remind the EMA that data about adverse effects are a public good, in the common interest, and that it is unacceptable to keep this information confidential.

  5. Prognosis and management of myocardial infarction: Comparisons between the French FAST-MI 2010 registry and the French public health database.

    PubMed

    Massoullié, Grégoire; Wintzer-Wehekind, Jérome; Chenaf, Chouki; Mulliez, Aurélien; Pereira, Bruno; Authier, Nicolas; Eschalier, Alain; Clerfond, Guillaume; Souteyrand, Géraud; Tabassome, Simon; Danchin, Nicolas; Citron, Bernard; Lusson, Jean-René; Puymirat, Étienne; Motreff, Pascal; Eschalier, Romain

    2016-05-01

    Multicentre registries of myocardial infarction management show a steady improvement in prognosis and greater access to myocardial revascularization in a more timely manner. While French registries are the standard references, the question arises: are data stemming solely from the activity of French cardiac intensive care units (ICUs) a true reflection of the entire French population with ST-segment elevation myocardial infarction (STEMI)? To compare data on patients hospitalized for STEMI from two French registries: the French registry of acute ST-elevation or non-ST-elevation myocardial infarction (FAST-MI) and the Échantillon généraliste des bénéficiaires (EGB) database. We compared patients treated for STEMI listed in the FAST-MI 2010 registry (n=1716) with those listed in the EGB database, which comprises a sample of 1/97th of the French population, also from 2010 (n=403). Compared with the FAST-MI 2010 registry, the EGB database population were older (67.2±15.3 vs 63.3±14.5 years; P<0.001), had a higher percentage of women (36.0% vs 24.7%; P<0.001), were less likely to undergo emergency coronary angiography (75.2% vs 96.3%; P<0.001) and were less often treated in university hospitals (27.1% vs 37.0%; P=0.001). There were no significant differences between the two registries in terms of cardiovascular risk factors, comorbidities and drug treatment at admission. Thirty-day mortality was higher in the EGB database (10.2% vs 4.4%; P<0.001). Registries such as FAST-MI are indispensable, not only for assessing epidemiological changes over time, but also for evaluating the prognostic effect of modern STEMI management. Meanwhile, exploitation of data from general databases, such as EGB, provides additional relevant information, as they include a broader population not routinely admitted to cardiac ICUs. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  6. An occurence records database of French Guiana harvestmen (Arachnida, Opiliones)

    PubMed Central

    Solbès, Pierre; Grosso, Bernadette

    2014-01-01

    Abstract This dataset provides information on specimens of harvestmen (Arthropoda, Arachnida, Opiliones) collected in French Guiana. Field collections have been initiated in 2012 within the framework of the CEnter for the Study of Biodiversity in Amazonia (CEBA: www.labex-ceba.fr/en/). This dataset is a work in progress.  Occurrences are recorded in an online database stored at the EDB laboratory after each collecting trip and the dataset is updated on a monthly basis. Voucher specimens and associated DNA are also stored at the EDB laboratory until deposition in natural history Museums. The latest version of the dataset is publicly and freely accessible through our Integrated Publication Toolkit at http://130.120.204.55:8080/ipt/resource.do?r=harvestmen_of_french_guiana or through the Global Biodiversity Information Facility data portal at http://www.gbif.org/dataset/3c9e2297-bf20-4827-928e-7c7eefd9432c. PMID:25589875

  7. MANULEX: a grade-level lexical database from French elementary school readers.

    PubMed

    Lété, Bernard; Sprenger-Charolles, Liliane; Colé, Pascale

    2004-02-01

    This article presents MANULEX, a Web-accessible database that provides grade-level word frequency lists of nonlemmatized and lemmatized words (48,886 and 23,812 entries, respectively) computed from the 1.9 million words taken from 54 French elementary school readers. Word frequencies are provided for four levels: first grade (G1), second grade (G2), third to fifth grades (G3-5), and all grades (G1-5). The frequencies were computed following the methods described by Carroll, Davies, and Richman (1971) and Zeno, Ivenz, Millard, and Duvvuri (1995), with four statistics at each level (F, overall word frequency; D, index of dispersion across the selected readers; U, estimated frequency per million words; and SFI, standard frequency index). The database also provides the number of letters in the word and syntactic category information. MANULEX is intended to be a useful tool for studying language development through the selection of stimuli based on precise frequency norms. Researchers in artificial intelligence can also use it as a source of information on natural language processing to simulate written language acquisition in children. Finally, it may serve an educational purpose by providing basic vocabulary lists.

  8. Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study.

    PubMed

    Schutte, Tim; Tichelaar, Jelle; Reumerman, Michael O; van Eekeren, Rike; Rolfes, Leàn; van Puijenbroek, Eugène P; Richir, Milan C; van Agtmael, Michiel A

    2017-05-01

    Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme. In this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized feedback letter to the reporter, as well as a summary for the European Medicines Agency (EMA) and World Health Organization (WHO) pharmacovigilance databases. This student assessment was then verified and evaluated by staff from The Netherlands Pharmacovigilance Centre Lareb (Lareb), using an e-questionnaire. Student attitudes, intentions, skills, and knowledge of ADR reporting were evaluated using the e-questionnaire, before and after participation in the programme. From May 2014 to January 2015, a total of 43 students assessed 100 different ADR reports selected by Lareb staff (n = 3). Student assessments were rated as useful (93%), scientifically substantiated (90%), accurate (92%), and complete (92%), and, on average, did not cost Lareb staff extra time. Medical students were positive about ADR reporting, and their awareness of ADR reporting increased significantly following participation in the programme (p < 0.05). After participation in the programme, the students intended to report serious ADRs in their future practice, and their knowledge of pharmacovigilance and ADR reporting showed they had a high overall level of pharmacological understanding. The student-run pharmacovigilance programme is a win-win venture. It offers students a valuable 'pharmacovigilance experience', creates awareness in future doctors, and has the potential to increase pharmacovigilance

  9. Pharmacovigilance of herbal medicines.

    PubMed

    Gromek, Kamila; Drumond, Nélio; Simas, Paula

    2015-01-01

    The importance of herbal remedies in pharmacovigilance systems is becoming one of the primary tasks, due to the constantly ascending potential of herbal products and herbal medicines worldwide. Nowadays, the drug development is focused on finding new active compounds or combinations, but costs are simultaneously growing, which makes herbal medicines an attractive, harmless and cheaper alternative to synthetic drugs.Like all drugs, herbal are not free of risk and many studies suggest for potential adverse reactions and interactions. Available statistics show that some herbal products, used in traditional medication for generations, may possess carcinogenic, hepatotoxic, cardiotoxic and other severe actions. Evaluation of the safety should include at least in vitro and in vivo genotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for >3 months or intermittently for >6 months), reproductive and developmental toxicity studies in some cases and examination of the effects on drug-metabolizing enzymes. Drug safety of herbal medicines should be developed, focusing on specific groups of patients.

  10. Haemoptysis in adults: a 5-year study using the French nationwide hospital administrative database.

    PubMed

    Abdulmalak, Caroline; Cottenet, Jonathan; Beltramo, Guillaume; Georges, Marjolaine; Camus, Philippe; Bonniaud, Philippe; Quantin, Catherine

    2015-08-01

    Haemoptysis is a serious symptom with various aetiologies. Our aim was to define the aetiologies, outcomes and associations with lung cancer in the entire population of a high-income country.This retrospective multicentre study was based on the French nationwide hospital medical information database collected over 5 years (2008-2012). We analysed haemoptysis incidence, aetiologies, geographical and seasonal distribution and mortality. We studied recurrence, association with lung cancer and mortality in a 3-year follow-up analysis.Each year, ~15 000 adult patients (mean age 62 years, male/female ratio 2/1) were admitted for haemoptysis or had haemoptysis as a complication of their hospital stay, representing 0.2% of all hospitalised patients. Haemoptysis was cryptogenic in 50% of cases. The main aetiologies were respiratory infections (22%), lung cancer (17.4%), bronchiectasis (6.8%), pulmonary oedema (4.2%), anticoagulants (3.5%), tuberculosis (2.7%), pulmonary embolism (2.6%) and aspergillosis (1.1%). Among incident cases, the 3-year recurrence rate was 16.3%. Of the initial cryptogenic haemoptysis patients, 4% were diagnosed with lung cancer within 3 years. Mortality rates during the first stay and at 1 and 3 years were 9.2%, 21.6% and 27%, respectively.This is the first epidemiological study analysing haemoptysis and its outcomes in an entire population. Haemoptysis is a life-threatening symptom unveiling potentially life-threatening underlying conditions. Copyright ©ERS 2015.

  11. Advancing the science of pharmacovigilance.

    PubMed

    Honig, P K

    2013-06-01

    The importance of detecting postmarketing safety signals earlier and with a high degree of fidelity is increasingly important and of great interest to industry, regulators, and the public. This issue of Clinical Pharmacology & Therapeutics contains two companion articles that represent exciting new advances in the field of pharmacovigilance and postmarketing safety signal detection. Given that drug safety evaluation and pharmacovigilance science are core competencies in the discipline of clinical pharmacology, these articles should be of interest to clinical pharmacologists as well as drug safety professionals.

  12. Pharmacogenovigilance: a pharmacogenomics pharmacovigilance program.

    PubMed

    Awada, Zeinab; Zgheib, Nathalie Khoueiry

    2014-04-01

    In this report, we review the importance of pharmacovigilance in detecting postmarketing adverse drug events and the potential for developing pharmacogenovigilance programs by integrating pharmacogenomics with pharmacovigilance. We propose to start developing such a program in primary healthcare systems that use basic features of electronic medical records and have access to large numbers of patients commonly prescribed drugs. Such programs, if carefully designed, may grow over time and hopefully enhance the collection and interpretation of useful data for the clinical applications of pharmacogenomics testing.

  13. [Pharmacovigilance center --internal medicine interactions: A useful diagnostic tool].

    PubMed

    Rochoy, M; Gautier, S; Bordet, R; Caron, J; Launay, D; Hachulla, E; Hatron, P-Y; Lambert, M

    2015-08-01

    Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect. This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression. We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]). In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value. Copyright © 2015 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  14. The importance of drug-drug interactions as a cause of adverse drug reactions: a pharmacovigilance study of serotoninergic reuptake inhibitors in France.

    PubMed

    Montastruc, Francois; Sommet, Agnès; Bondon-Guitton, Emmanuelle; Durrieu, Geneviève; Bui, Eric; Bagheri, Haleh; Lapeyre-Mestre, Maryse; Schmitt, Laurent; Montastruc, Jean-Louis

    2012-05-01

    To quantify the importance of drug-drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors in a pharmacovigilance database. All spontaneous reports of ADRs registered in 2008 by the Midi-Pyrénées PharmacoVigilance Centre that contained mention of one of the serotoninergic reuptake inhibitor (SRI) antidepressants marketed in France were reviewed. DDIs were identified according to the French National Drug Formulary (Vidal) and the interaction supplement of the French independent drug bulletin La Revue Prescrire. ADRs explained by DDIs were characterised. Among the 2,101 spontaneous reports recorded, 177 involved at least one SRI antidepressant. Among the 156 ADRs with at least one theoretical DDI, 41% (95% confidence interval 34-49%) could be explained by a DDI. The most frequent antidepressant involved in DDIs was escitalopram, followed by fluoxetine and citalopram. Among the 65 ADRs related to DDIs, 37 (52.9%) were "serious", mainly bleedings, confusion and falls, hyponatremia and serotoninergic syndromes. The most frequent drug interactions occurred with psychotropics (antipsychotics, benzodiazepines, among others), followed by antithrombotic agents (antagonists of vitamin K, antiplatelets), diuretics and angiotensin II antagonists. The group with ADRs related to DDIs was older than the group with ADRs not related to DDIs. ADRs were threefold more "serious" in the case of DDIs. Around 40% of ADRs reported with SRIs were related to DDIs. Most of these occurred after association with psychotropics, antithrombotics, or diuretics, especially in the elderly.

  15. [Technical improvement of cohort constitution in administrative health databases: Providing a tool for integration and standardization of data applicable in the French National Health Insurance Database (SNIIRAM)].

    PubMed

    Ferdynus, C; Huiart, L

    2016-09-01

    Administrative health databases such as the French National Heath Insurance Database - SNIIRAM - are a major tool to answer numerous public health research questions. However the use of such data requires complex and time-consuming data management. Our objective was to develop and make available a tool to optimize cohort constitution within administrative health databases. We developed a process to extract, transform and load (ETL) data from various heterogeneous sources in a standardized data warehouse. This data warehouse is architected as a star schema corresponding to an i2b2 star schema model. We then evaluated the performance of this ETL using data from a pharmacoepidemiology research project conducted in the SNIIRAM database. The ETL we developed comprises a set of functionalities for creating SAS scripts. Data can be integrated into a standardized data warehouse. As part of the performance assessment of this ETL, we achieved integration of a dataset from the SNIIRAM comprising more than 900 million lines in less than three hours using a desktop computer. This enables patient selection from the standardized data warehouse within seconds of the request. The ETL described in this paper provides a tool which is effective and compatible with all administrative health databases, without requiring complex database servers. This tool should simplify cohort constitution in health databases; the standardization of warehouse data facilitates collaborative work between research teams. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  16. Safety aspects of antiepileptic drugs--focus on pharmacovigilance.

    PubMed

    Landmark, Cecilie Johannessen; Johannessen, Svein I

    2012-01-01

    Most patients with epilepsy are dependent on a life-long pharmacological treatment with antiepileptic drugs (AEDs). AEDs include a wide range of substances that possess large pharmacological variability and are often susceptible to drug interactions and adverse drug reactions (ADRs). AEDs are increasingly used in other neurological and psychiatric disorders, and new patient groups are exposed to these drugs. The aim of the present review is to focus upon how pharmacovigilance contributes to improved safety of AEDs. The present article is a review based on searches in Pubmed on articles from the last 15 years. Strengths and challenges regarding these aspects will be highlighted and discussed. The concept of pharmacovigilance includes various methods of monitoring of large patient populations with registries and databases of surveillance of ADRs and risk of suicide and sudden unexpected death, drug utilization and prescription patterns, pregnancy and birth registries and therapeutic drug monitoring (TDM) databases for studies on pharmacological variability of AEDs in large sample sizes. Challenges for existing reporting systems and databases include differences in outcome measures and thus international comparison. Continuous focus on safety aspects of AEDs and the importance of the implementation of pharmacovigilance contribute to further optimized therapy on a large scale and for the individual patient. Copyright © 2011 John Wiley & Sons, Ltd.

  17. Costs of dengue in three French territories of the Americas: an analysis of the hospital medical information system (PMSI) database.

    PubMed

    Uhart, M; Blein, C; L'Azou, M; Thomas, L; Durand, L

    2016-05-01

    Dengue is a major emerging public health concern in tropical and subtropical countries. Severe dengue can lead to hospitalisation and death. This study was performed to assess the economic burden of hospitalisations for dengue from 2007 to 2011 in three French territories of the Americas where dengue is endemic (French Guiana, Martinique and Guadeloupe). Data on dengue-associated hospitalisations were extracted from the French national hospital administrative database, Programme de Médicalisation des Systèmes d'Information (PMSI). The numbers of stays and the corresponding number of hospitalised patients were determined using disease-specific ICD-10 codes. Associated hospital costs were estimated from the payer perspective, using French official tariffs. Overall, 4183 patients (mean age 32 years; 51 % male) were hospitalised for dengue, corresponding to 4574 hospital stays. In nearly all hospital stays (98 %; 4471), the illness was medically managed and the mean length of stay was 4.3 days. The mean cost per stay was €2522, corresponding to a total hospital cost of €11.5 million over the 5 years assessed. The majority of hospitalisations (80 % of patients) and associated costs (75 % of total hospital costs) were incurred during two epidemics. Severe dengue is associated with significant hospital costs that escalate during outbreaks.

  18. French Medical-Administrative Database for Epidemiology and Safety in Ophthalmology (EPISAFE): The EPISAFE Collaboration Program in Cataract Surgery.

    PubMed

    Daien, Vincent; Korobelnik, Jean-Francois; Delcourt, Cécile; Cougnard-Gregoire, Audrey; Delyfer, Marie Noelle; Bron, Alain M; Carrière, Isabelle; Villain, Max; Daures, Jean Pierre; Lacombe, Sandy; Mariet, Anne Sophie; Quantin, Catherine; Creuzot-Garcher, Catherine

    2017-01-01

    Medical-administrative databases are an important source of big data to assess the epidemiology of diseases and interventions, compare drugs, and investigate rare adverse events. We describe the French national health insurance system databases and the Epidemiology and Safety (EPISAFE) collaboration program in ophthalmology and illustrate the paper with recent studies that used the databases to investigate cataract surgery. The Système national d'information inter-régime de l'assurance maladie (SNIIR-AM) is one of the largest databases of medical and administrative data for a general population, covering nearly 65 million people. The SNIIR-AM database links data for all outpatient-reimbursed health expenditures, hospitalization in all 1,546 French private or public healthcare facilities, and date of death. The use of this database provides information at the scale of the entire country, allowing measurement of the impact of changes in practices and new guidelines. Between 2009 and 2012, a total of 2,717,203 eyes in 1,817,865 patients underwent cataract surgery in France, and the incidence of cataract surgery increased from 9.86 to 11.08/1,000 person-years. The 4-year cumulative risk of retinal detachment was 0.99%, and patients <60 years of age were at higher risk of retinal detachment. The incidence of pseudophakic cystoid macular edema was 0.95%. From 2005 to 2014, from data including more than 6 million procedures, the incidence of endophthalmitis after cataract surgery decreased from 0.15 to 0.05%. The EPISAFE collaboration program encompasses the key issues facing ophthalmology, including public health and public policy concerning disease incidence and prevalence, safety and adverse event monitoring, and clinical guidelines. © 2017 S. Karger AG, Basel.

  19. [Case study of Chinese medicine after listing of pharmacovigilance].

    PubMed

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous increasement of adverse Chinese drug reaction reporting, especially Chinese traditional medicine injection, it becomes the key part of the post-marketing evaluation. The issue based on this research background becomes the hot research direction. But the truth is that the history of Chinese medicine and western medicine is different and the theory is not a system either, here different means between pharmacovigilance of Chinese medicine and western medicine, there are still many gaps. This becomes a barrier for Chinese medicine entering the international market. This article summarizes try to order the SFDA's adverse reaction reporting database of traditional Chinese medicine, and using three kinds of data mining methods used by WHO, the U. S. Food and Drug Administration, to establish suitable system for Chinese market after the evaluation of pharmacovigilance.

  20. UMD-MLH1/MSH2/MSH6 databases: description and analysis of genetic variations in French Lynch syndrome families

    PubMed Central

    Grandval, Philippe; Fabre, Aurélie J.; Gaildrat, Pascaline; Baert-Desurmont, Stéphanie; Buisine, Marie-Pierre; Ferrari, Anthony; Wang, Qing; Béroud, Christophe; Olschwang, Sylviane

    2013-01-01

    Lynch syndrome is an autosomal dominant disease caused by germ line heterozygous mutations mainly involving the MSH2, MLH1 and MSH6 genes that belong to the DNA MisMatch Repair (MMR) genes family. The French network counting the 16 licensed laboratories involved in Lynch syndrome genetic testing developed three locus-specific databases with the UMD® software (www.umd.be/MLH1/, www.umd.be/MSH2/ and www.umd.be/MSH6/) that presently contain a total of 7047 sequence variations including 707 distinct variations of a priori unknown functional significance (VUS) that were identified through complete mutation screening or targeted predictive testing. Mutation carriers are at high risk for developing early-onset colorectal and endometrial adenocarcinomas. Consensus clinical guidelines have been proposed, allowing the efficient detection of curable lesions. The major challenge of genetic testing is to reliably classify the genomic variations in those patients who seek genetic counseling. Combining the interactive tools of the software, the relevant published data and mainly original information produced by the French MisMatch Repair network, the UMD-MLH1/MSH2/MSH6 databases provide interpretation data for the 707 VUS that were classified according to the IARC 5-Class system. These public databases are regularly updated to improve the classification of all registered VUS, exploring their role in cancer pre-disposition based on structural and functional approaches. PMID:23729658

  1. Pharmacovigilance Discussion Forum--The European Generic Medicines Association's 8th Annual Meeting (January 21, 2015--London, UK).

    PubMed

    Lam, S

    2015-01-01

    The practice and science of pharmacovigilance first emerged following the disaster caused by thalidomide in 1961, which led to the initiation of systemic international efforts to address drug safety issues spearheaded by the WHO. Systems were developed in member states of the WHO to analyze cases of adverse drug reactions (ADRs) and collate these data into a central database to aid national drug regulatory authorities in improving safety profiles of medicines. Pharmacovigilance is a key public health function for monitoring all medicinal products to assess their quality, efficacy and safety before and following authorization. These medicines are continually assessed to detect any aspect that could compromise their safety, and ensure that the necessary measures are taken. In July 2012, new legislation for pharmacovigilance in the E.U. came into effect as a result of the changes set out in the Directive 2010/84/EU and the European Commission (EC) implementing Regulation (EU) No 520/2012 to reduce the increasing number of ADRs. The latest developments in pharmacovigilance in Europe, including news on E.U. pharmacovigilance legislation, were discussed at the 8th European Generic Medicines Association (EGA) Pharmacovigilance Discussion Forum. The meeting facilitated constructive dialogue between regulators and industry on a range of topics including how to simplify pharmacovigilance activities and improve the processes of risk management plans, periodic safety update reports, signal detection, joint studies and inspections.

  2. Pharmacovigilance: scope for a dermatologist.

    PubMed

    Prakash, Bhanu; Singh, Gurcharan

    2011-01-01

    Pharmacovigilance is defined as the science of detection, assessment, and prevention of adverse drug reactions in humans. Under-reporting of drug reactions is the major problem and has various reasons. The WHO has initiated the program of reporting all adverse drug reactions now co-ordinated by the Uppsala Monitoring Centre in Uppsala, Sweden, with oversight by an international board. This article presents in brief the relevance, functioning, importance, and the procedure of reporting adverse drug reactions. Dermatologists have the greatest opportunity in reporting various reactions that can happen as they come across majority of these drug reactions, prescribed by all sectors of the health system.

  3. Good pharmacovigilance practices: technology enabled.

    PubMed

    Nelson, Robert C; Palsulich, Bruce; Gogolak, Victor

    2002-01-01

    The assessment of spontaneous reports is most effective it is conducted within a defined and rigorous process. The framework for good pharmacovigilance process (GPVP) is proposed as a subset of good postmarketing surveillance process (GPMSP), a functional structure for both a public health and corporate risk management strategy. GPVP has good practices that implement each step within a defined process. These practices are designed to efficiently and effectively detect and alert the drug safety professional to new and potentially important information on drug-associated adverse reactions. These practices are enabled by applied technology designed specifically for the review and assessment of spontaneous reports. Specific practices include rules-based triage, active query prompts for severe organ insults, contextual single case evaluation, statistical proportionality and correlational checks, case-series analyses, and templates for signal work-up and interpretation. These practices and the overall GPVP are supported by state-of-the-art web-based systems with powerful analytical engines, workflow and audit trials to allow validated systems support for valid drug safety signalling efforts. It is also important to understand that a process has a defined set of steps and any one cannot stand independently. Specifically, advanced use of technical alerting methods in isolation can mislead and allow one to misunderstand priorities and relative value. In the end, pharmacovigilance is a clinical art and a component process to the science of pharmacoepidemiology and risk management.

  4. Pharmacovigilance in Space: Stability Payload Compliance Procedures

    NASA Technical Reports Server (NTRS)

    Daniels, Vernie R.; Putcha, Lakshmi

    2007-01-01

    Pharmacovigilance is the science of, and activities relating to the detection, assessment, understanding, and prevention of drug-related problems. Over the lase decade, pharmacovigilance activities have contributed to the development of numerous technological and conventional advances focused on medication safety and regulatory intervention. The topics discussed include: 1) Proactive Pharmacovigilance; 2) A New Frontier; 3) Research Activities; 4) Project Purpose; 5) Methods; 6) Flight Stability Kit Components; 7) Experimental Conditions; 8) Research Project Logistics; 9) Research Plan; 10) Pharmaceutical Stability Research Project Pharmacovigilance Aspects; 11) Security / Control; 12) Packaging/Containment Actions; 13) Shelf-Life Assessments; 14) Stability Assessment Parameters; 15) Chemical Content Analysis; 16) Preliminary Results; 17) Temperature/Humidity; 18) Changes in PHysical and Chemical Assessment Parameters; 19) Observations; and 20) Conclusions.

  5. Pharmacovigilance teaching in UK undergraduate pharmacy programmes.

    PubMed

    Smith, Melvyn P; Webley, Sherael D

    2013-03-01

    Pharmacists in the UK are able to report spontaneous adverse drug reactions (ADRs) to the Medicines and Healthcare Products Regulatory Authority. The level of reporting by UK pharmacists remains low. This could be explained by poor knowledge of ADR reporting. The primary objective of this study was to investigate the level of pharmacovigilance education provided to pharmacy students on undergraduate pharmacy programmes in the UK. A cross-sectional survey was used to obtain data relating to the teaching of pharmacovigilance within schools of pharmacy. The survey was designed to reveal whether core elements pertinent to pharmacovigilance and specifically to spontaneous reporting were taught and to what extent. All of the respondents taught pharmacovigilance within an assessed compulsory module. A small number (23%) did not include pharmacovigilance law within their syllabus. In 54%, the amount of time devoted to teaching pharmacy students about their role in pharmacovigilance was less than 4 h in the 4-year course; only one respondent spent approximately 20 h, the remaining respondents (38%) spent between 4 and 8 h. The amount of time dedicated to the teaching of pharmacovigilance on pharmacy undergraduate degree programmes is low. Considering the importance of spontaneous reporting in drug safety and the shift in the role of the pharmacists, more time may need to be devoted to pharmacovigilance on pharmacy undergraduate courses. By doing so, new pharmacists would be more informed of the important role they play in drug safety and thereby potentially help enhance the level of ADR reporting. Copyright © 2012 John Wiley & Sons, Ltd.

  6. Perspectives on the use of data mining in pharmaco-vigilance.

    PubMed

    Almenoff, June; Tonning, Joseph M; Gould, A Lawrence; Szarfman, Ana; Hauben, Manfred; Ouellet-Hellstrom, Rita; Ball, Robert; Hornbuckle, Ken; Walsh, Louisa; Yee, Chuen; Sacks, Susan T; Yuen, Nancy; Patadia, Vaishali; Blum, Michael; Johnston, Mike; Gerrits, Charles; Seifert, Harry; Lacroix, Karol

    2005-01-01

    In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine pharmaco-vigilance. In 2003, a group of statisticians, pharmaco-epidemiologists and pharmaco-vigilance professionals from the pharmaceutical industry and the US FDA formed the Pharmaceutical Research and Manufacturers of America-FDA Collaborative Working Group on Safety Evaluation Tools to review best practices for the use of these methods.In this paper, we provide an overview of: (i) the statistical and operational attributes of several currently used methods and their strengths and limitations; (ii) information about the characteristics of various postmarketing safety databases with which these tools can be deployed; (iii) analytical considerations for using safety data-mining methods and interpreting the results; and (iv) points to consider in integration of safety data mining with traditional pharmaco-vigilance methods. Perspectives from both the FDA and the industry are provided. Data mining is a potentially useful adjunct to traditional pharmaco-vigilance methods. The results of data mining should be viewed as hypothesis generating and should be evaluated in the context of other relevant data. The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues.

  7. Pharmacovigilance and the italian medicines agency.

    PubMed

    Pimpinella, Giuseppe; Tartaglia, Loriana

    2013-12-01

    The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of research areas and for the approval of the projects submitted by the regions. In April 2012, the AIFA started a program of visits at the regional pharmacovigilance centers (RPCs), aimed at monitoring their performances, evaluating the quality of the activities in order to understand the main differences and discrepancies and with a view to start a program of harmonization of the procedures in place. The outcome of the visits program highlighted major differences among the quality management systems of the various centers; hence, AIFA has decided to launch an initiative to promote in the next months the harmonization of procedures. The synergy among AIFA, regional structures, RPCs, and local structure responsible for pharmacovigilance is needed in order to establish a robust pharmacovigilance system working in full compliance with the provisions of the new EU legislation.

  8. Pharmacovigilance and the Italian Medicines Agency

    PubMed Central

    Pimpinella, Giuseppe; Tartaglia, Loriana

    2013-01-01

    The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of research areas and for the approval of the projects submitted by the regions. In April 2012, the AIFA started a program of visits at the regional pharmacovigilance centers (RPCs), aimed at monitoring their performances, evaluating the quality of the activities in order to understand the main differences and discrepancies and with a view to start a program of harmonization of the procedures in place. The outcome of the visits program highlighted major differences among the quality management systems of the various centers; hence, AIFA has decided to launch an initiative to promote in the next months the harmonization of procedures. The synergy among AIFA, regional structures, RPCs, and local structure responsible for pharmacovigilance is needed in order to establish a robust pharmacovigilance system working in full compliance with the provisions of the new EU legislation. PMID:24347980

  9. Identifying multiple myeloma patients using data from the French health insurance databases

    PubMed Central

    Palmaro, Aurore; Gauthier, Martin; Conte, Cécile; Grosclaude, Pascale; Despas, Fabien; Lapeyre-Mestre, Maryse

    2017-01-01

    Abstract This study aimed to assess the performance of several algorithms based on hospital diagnoses and the long-term diseases scheme to identify multiple myeloma patients. Potential multiple myeloma patients in 2010 to 2013 were identified using the presence of hospital records with at least 1 main diagnosis code for multiple myeloma (ICD-10 “C90”). Alternative algorithms also considered related and associated diagnoses, combination with long-term conditions, or at least 2 diagnoses. Incident patients were those with no previous “C90” codes in the past 24 or 12 months. The sensitivity, specificity, and positive and negative predictive values (PPVs and NPVs) were computed, using a French cancer registry for the corresponding area and period as the criterion standard. Long-term conditions data extracted concerned 11,559 patients (21,846 for hospital data). The registry contained 125 cases of multiple myeloma. Sensitivity was 70% when using only main hospital diagnoses (specificity 100%, PPV 79%), 76% when also considering related diagnoses (specificity 100%, PPV 74%), and 90% with associated diagnoses included (100% specificity, 64% PPV). In relation with their good performance, selected algorithms can be used to study the benefit and risk of drugs in treated multiple myeloma patients. PMID:28328805

  10. [French brain tumor database: general results on 40,000 cases, main current applications and future prospects].

    PubMed

    Zouaoui, S; Rigau, V; Mathieu-Daudé, H; Darlix, A; Bessaoud, F; Fabbro-Peray, P; Bauchet, F; Kerr, C; Fabbro, M; Figarella-Branger, D; Taillandier, L; Duffau, H; Trétarre, B; Bauchet, L

    2012-02-01

    This work aimed at prospectively record all primary central nervous system tumor (PCNST) cases in France, for which histological diagnosis was available. The objectives were to (i) create a national database and network to perform epidemiological studies, (ii) implement clinical and basic research protocols, and (iii) harmonize the health care of patients affected by PCNST. The methodology is based on a multidisciplinary national network already established by the French Brain Tumor DataBase (FBTDB) (Recensement national histologique des tumeurs primitives du système nerveux central [RnhTPSNC]), and the active participation of the Scientific Societies involved in neuro-oncology in France. From 2004 to 2009, 43,929 cases of newly diagnosed and histologically confirmed PCNST have been recorded. Histological diagnoses included gliomas (42,4%), all other neuroepithelial tumors (4,4%), tumors of the meninges (32,3%), nerve sheath tumors (9,2%), lymphomas (3,4%) and others (8,3%). Cryopreservation was reported for 9603 PCNST specimens. Tumor resections were performed in 78% cases, while biopsies accounted for 22%. Median age at diagnosis, sex, percentage of resections and number of cryopreserved tumors were detailed for each histology, according to the WHO classification. Many current applications and perspectives for the FBTDB are illustrated in the discussion. To our knowledge, this work is the first database in Europe, dedicated to PCNST, including clinical, surgical and histological data (with also cryopreservation of the specimens), and which may have major epidemiological, clinical and research implications. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  11. The use of a medico economic database as a part of French apheresis registry.

    PubMed

    Kanouni, T; Aubas, P; Heshmati, F

    2017-02-01

    An apheresis registry is a part of each learned apheresis society. The interest in this is obvious, in terms of knowledge of the practice of apheresis, adverse events, and technical issues. However, because of the weight of data entry it could never be exhaustive and some data will be missing. While continuing our registry efforts and our efforts to match with other existing registries, we decided to extend the data collection to a medico-economic database that is available in France, the Programme de Médicalisation du Système d'Information (PMSI) that has covered reimbursement information for each public or private hospital since 2007. It contains almost all apheresis procedures in all apheresis fields, demographic patient data, and primary and related diagnoses, among other data. Although this data does not include technical apheresis issues or other complications of the procedures, its interest is great and it is complementary to the registry. From 2003-2014, we have recorded 250,585 apheresis procedures, for 48,428 patients. We showed that the data are reliable and exhaustive. The information shows a perfect real life practice in apheresis, regarding indications, the rhythm and the duration of apheresis treatment. This prospective data collection is sustainable and allows us to assess the impact of healthcare guidelines. Our objective is to extend the data collection and match it to other existing databases; this will allow us to conduct, for example, a cohort study specifically for ECP.

  12. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    NASA Astrophysics Data System (ADS)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  13. 3D pharmacophoric similarity improves multi adverse drug event identification in pharmacovigilance.

    PubMed

    Vilar, Santiago; Tatonetti, Nicholas P; Hripcsak, George

    2015-03-06

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  14. Choice of ICD-10 codes for the identification of acute coronary syndrome in the French hospitalization database.

    PubMed

    Bezin, Julien; Girodet, Pierre-Olivier; Rambelomanana, Sahondra; Touya, Maëlys; Ferreira, Paul; Gilleron, Véronique; Robinson, Philip; Moore, Nicholas; Pariente, Antoine

    2015-12-01

    The objective of this study was to evaluate the performance of the ICD-10 (International Classification of Diseases and Related Health Problems, 10(th) Edition) coding in the French hospitalization database (PMSI) to identify acute coronary syndrome (ACS) occurrence. Eligible hospitalizations were those that occurred at the Bordeaux teaching hospitals between 1 January 2011 and 31 December 2011 and had one of the ICD-10 codes related to ischaemic heart diseases (I20 to I25, excluding I23 and I25.2). Among these, 100 hospitalizations were randomly selected; for each case, the ACS diagnosis was confirmed/excluded after medical file examination by an independent events validation committee and the performance of codes, and combinations of codes, to identify ACS was evaluated by calculating the positive predictive value (PPV). Of the individual codes, I20.0, I21 and I24 had the highest PPV; 100.0% for I24 (95%CI [15.8-100.0]); 90.0% for I21 (95%CI [76.3-97.2]); and 66.7% for I20.0 (95%CI [38.4-88.2]). The combination of I20.0 or I24 codes was able to identify 12 of the 56 validated ACS cases with a PPV of 70.6% (95%CI [44.0-89.7]), the combination of I21 or I24 identified 38 cases with a PPV of 90.5% (95%CI [77.4-97.3]), the combination of I20.0 or I21 identified 46 cases with a PPV of 83.6% (95%CI [71.2-92.2]), and the combination of I20.0, I21 or I24 identified 48 cases with a PPV of 84.2% (95%CI [72.1-92.5]). The combination of I20.0, I21 or I24 codes had the best performance to identify occurrence of ACS in the French hospitalization database.

  15. The EU-ADR Web Platform: delivering advanced pharmacovigilance tools.

    PubMed

    Oliveira, José Luis; Lopes, Pedro; Nunes, Tiago; Campos, David; Boyer, Scott; Ahlberg, Ernst; van Mulligen, Erik M; Kors, Jan A; Singh, Bharat; Furlong, Laura I; Sanz, Ferran; Bauer-Mehren, Anna; Carrascosa, Maria C; Mestres, Jordi; Avillach, Paul; Diallo, Gayo; Díaz Acedo, Carlos; van der Lei, Johan

    2013-05-01

    Pharmacovigilance methods have advanced greatly during the last decades, making post-market drug assessment an essential drug evaluation component. These methods mainly rely on the use of spontaneous reporting systems and health information databases to collect expertise from huge amounts of real-world reports. The EU-ADR Web Platform was built to further facilitate accessing, monitoring and exploring these data, enabling an in-depth analysis of adverse drug reactions risks. The EU-ADR Web Platform exploits the wealth of data collected within a large-scale European initiative, the EU-ADR project. Millions of electronic health records, provided by national health agencies, are mined for specific drug events, which are correlated with literature, protein and pathway data, resulting in a rich drug-event dataset. Next, advanced distributed computing methods are tailored to coordinate the execution of data-mining and statistical analysis tasks. This permits obtaining a ranked drug-event list, removing spurious entries and highlighting relationships with high risk potential. The EU-ADR Web Platform is an open workspace for the integrated analysis of pharmacovigilance datasets. Using this software, researchers can access a variety of tools provided by distinct partners in a single centralized environment. Besides performing standalone drug-event assessments, they can also control the pipeline for an improved batch analysis of custom datasets. Drug-event pairs can be substantiated and statistically analysed within the platform's innovative working environment. A pioneering workspace that helps in explaining the biological path of adverse drug reactions was developed within the EU-ADR project consortium. This tool, targeted at the pharmacovigilance community, is available online at https://bioinformatics.ua.pt/euadr/. Copyright © 2012 John Wiley & Sons, Ltd.

  16. Gathering and Exploring Scientific Knowledge in Pharmacovigilance

    PubMed Central

    Lopes, Pedro; Nunes, Tiago; Campos, David; Furlong, Laura Ines; Bauer-Mehren, Anna; Sanz, Ferran; Carrascosa, Maria Carmen; Mestres, Jordi; Kors, Jan; Singh, Bharat; van Mulligen, Erik; Van der Lei, Johan; Diallo, Gayo; Avillach, Paul; Ahlberg, Ernst; Boyer, Scott; Diaz, Carlos; Oliveira, José Luís

    2013-01-01

    Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborative and integrative approaches boost current drug research and development processes. Hence, new strategies are required to connect researchers, datasets, biomedical knowledge and analysis algorithms, allowing them to fully exploit the true value behind state-of-the-art pharmacovigilance efforts. This manuscript introduces a new platform directed towards pharmacovigilance knowledge providers. This system, based on a service-oriented architecture, adopts a plugin-based approach to solve fundamental pharmacovigilance software challenges. With the wealth of collected clinical and pharmaceutical data, it is now possible to connect knowledge providers’ analysis and exploration algorithms with real data. As a result, new strategies allow a faster identification of high-risk interactions between marketed drugs and adverse events, and enable the automated uncovering of scientific evidence behind them. With this architecture, the pharmacovigilance field has a new platform to coordinate large-scale drug evaluation efforts in a unique ecosystem, publicly available at http://bioinformatics.ua.pt/euadr/. PMID:24349421

  17. Pharmacovigilance in pharmaceutical companies: An overview.

    PubMed

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-12-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

  18. EU's new pharmacovigilance legislation: considerations for biosimilars.

    PubMed

    Calvo, Begoña; Zuñiga, Leyre

    2014-01-01

    Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.

  19. Gathering and exploring scientific knowledge in pharmacovigilance.

    PubMed

    Lopes, Pedro; Nunes, Tiago; Campos, David; Furlong, Laura Ines; Bauer-Mehren, Anna; Sanz, Ferran; Carrascosa, Maria Carmen; Mestres, Jordi; Kors, Jan; Singh, Bharat; van Mulligen, Erik; Van der Lei, Johan; Diallo, Gayo; Avillach, Paul; Ahlberg, Ernst; Boyer, Scott; Diaz, Carlos; Oliveira, José Luís

    2013-01-01

    Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborative and integrative approaches boost current drug research and development processes. Hence, new strategies are required to connect researchers, datasets, biomedical knowledge and analysis algorithms, allowing them to fully exploit the true value behind state-of-the-art pharmacovigilance efforts. This manuscript introduces a new platform directed towards pharmacovigilance knowledge providers. This system, based on a service-oriented architecture, adopts a plugin-based approach to solve fundamental pharmacovigilance software challenges. With the wealth of collected clinical and pharmaceutical data, it is now possible to connect knowledge providers' analysis and exploration algorithms with real data. As a result, new strategies allow a faster identification of high-risk interactions between marketed drugs and adverse events, and enable the automated uncovering of scientific evidence behind them. With this architecture, the pharmacovigilance field has a new platform to coordinate large-scale drug evaluation efforts in a unique ecosystem, publicly available at http://bioinformatics.ua.pt/euadr/.

  20. Accident study of torrential protective structures based on the French RTM database

    NASA Astrophysics Data System (ADS)

    Boncompain, Ingrid; Quefféléan, Yann; Carladous, Simon

    2017-04-01

    Torrential protective structures such as dikes, sediment traps, and check dams aim to reduce damage on elements at risk. They are built given a reference scenario. Nevertheless, this scenario can be exceeded or structures can fail because of their design or their ageing. We later talk about "accidents". The 1996 Aras disaster near Biescas (Spain) showed that consequences can be significant: 35 of 40 check dams were destroyed which involved 87 fatalities in a campsite. The accident probability and its consequences must be taken into account to analyze risk. Databases are useful tools to extract needed information. In France, the Restoration of Mountainous Areas department (RTM) has been public funded to develop a database, specific to mountainous areas (the Alps and the Pyrenees). Almost 12 500 check dams, 80 sediment traps and 600 dikes were registered in public forests in 2011. These samples were assumed significant for check dams and sediment traps but not for dikes because the most part was missing. In parallel, more than 31 000 torrential events were registered. Given these elements, an accident study was developed. We first extracted 1 925 events with accidents on protective structures: 39 % occurred during the 19th century and 53 % have occurred since 1900. Sediment traps were involved in 37 events, check dams in 336, and dikes in 1488. Then, a detailed analysis was specifically carried out for check dams. Event phenomena were extracted: torrential flood, liquid flood, snow avalanche, rock fall, and landslide. Accident typology was also specified: scouring, breaking of several check dams, total or partial destruction of one structure, overflowing. Causes of accidents on check dams were first analyzed. Torrential floods were responsible of 85 % of events (284 of 336) even if other phenomena must be also taken into account. Almost 45 % of events (152 of 336) involved total destruction of one or several check dams. Taking into account events for the last 150

  1. HIV-associated Isospora belli infection: incidence and risk factors in the French Hospital Database on HIV.

    PubMed

    Guiguet, M; Furco, A; Tattevin, P; Costagliola, D; Molina, J-M

    2007-03-01

    To determine the incidence of Isospora belli infection in HIV-infected patients in France, and to study risk factors. The French Hospital Database on HIV (FHDH) is a prospective cohort study that collects demographic, clinical and therapeutic data on patients managed in 62 hospitals. We reviewed all cases of I. belli infection recorded between 1992 and 2003. We compared the incidence in 1992-1994 [before the use of dual therapy and combination antiretroviral therapy (cART)] and in 1997-2003 (when use of cART was widespread), after stratification for CD4 cell count (< 50, 50-99, 100-199 and > 200 cells/microL). A total of 164 patients had I. belli infection either at enrollment (n=71) or during follow up (n=93). During the study period, I. belli infection tended to occur less frequently during follow up, and to be diagnosed mainly at database enrollment. The incidence of I. belli infection during follow up fell by 79% [relative hazard (RH) 0.21; 95% confidence interval (CI) 0.13-0.33] in the cART period compared with the pre-cART period; no such change was noted among patients with CD4 cell counts below 50 cells/microL. In multivariable analysis, the risk of I. belli infection was significantly higher among patients from sub-Saharan Africa (RH 4.3; 95% CI 2.6-7.3). After adjustment for CD4 cell count, patients receiving cotrimoxazole prophylaxis were found to be at a lower risk of I. belli infection (RH 0.3; 95% CI 0.2-0.6). In France, I. belli infection among HIV-infected patients is now mainly seen in patients from sub-Saharan Africa, who present at an advanced stage.

  2. French brain tumor database: 5-year histological results on 25 756 cases.

    PubMed

    Rigau, Valérie; Zouaoui, Sonia; Mathieu-Daudé, Hélène; Darlix, Amélie; Maran, Aurélie; Trétarre, Brigitte; Bessaoud, Faiza; Bauchet, Fabienne; Attaoua, Redha; Fabbro-Peray, Pascale; Fabbro, Michel; Kerr, Christine; Taillandier, Luc; Duffau, Hugues; Figarella-Branger, Dominique; Costes, Valérie; Bauchet, Luc

    2011-11-01

    This work aimed to prospectively record all primary central nervous system tumor (PCNST) cases in France, for which histological diagnosis is available. The objectives were to (i) create a national registry and a network to perform epidemiological studies; (ii) implement clinical and basic research protocols; and (iii) harmonize the health care of patients affected by PCNST. For 5 years, 25 756 cases of newly diagnosed and histologically confirmed PCNST have been recorded. Histological diagnoses included glioma (48.9%), all other neuroepithelial tumors (5%), meningioma (28.8%), nerve sheath tumors (8.4%), lymphoma (3.2%) and others (5.7%). Cryopreservation was reported for 6018 PCNST specimens. Tumor resections (R) were performed in 78% cases, while biopsies accounted for 22%. Median age (MA), sex, percentage R and number of cryopreserved tumors were detailed for each histology; for example, out of 6053 glioblastomas (MA 63 years, male 59.4%, R 62%, 1611 were cryopreserved), and out of 37 atypical teratoid/rhabdoid tumors (MA 2 years, male 56.8%, R 94%, 17 were cryopreserved). This database or databank dedicated to PCNST cases contains detailed data on clinical, histological and other characteristics, such as the inclusion of data on cryopreserved specimens that are not available in other European registries. Therefore, this is a valuable resource that can be used for planning future epidemiological and clinical research.

  3. Pharmacovigilance Programme of India: Recent developments and future perspectives

    PubMed Central

    Kalaiselvan, Vivekanandan; Thota, Prasad; Singh, Gyanendra Nath

    2016-01-01

    Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions. PMID:28066097

  4. Training in Post-authorization Pharmacovigilance

    PubMed Central

    Ahuja, Vivek; Sharma, Varun

    2010-01-01

    Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices. PMID:21829787

  5. Training in Post-authorization Pharmacovigilance.

    PubMed

    Ahuja, Vivek; Sharma, Varun

    2010-04-01

    Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.

  6. Exploitation of semantic methods to cluster pharmacovigilance terms

    PubMed Central

    2014-01-01

    Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs. This activity is usually performed within dedicated databases (national, European, international...), in which the ADRs declared for patients are usually coded with a specific controlled terminology MedDRA (Medical Dictionary for Drug Regulatory Activities). Traditionally, the detection of adverse drug reactions is performed with data mining algorithms, while more recently the groupings of close ADR terms are also being exploited. The Standardized MedDRA Queries (SMQs) have become a standard in pharmacovigilance. They are created manually by international boards of experts with the objective to group together the MedDRA terms related to a given safety topic. Within the MedDRA version 13, 84 SMQs exist, although several important safety topics are not yet covered. The objective of our work is to propose an automatic method for assisting the creation of SMQs using the clustering of semantically close MedDRA terms. The experimented method relies on semantic approaches: semantic distance and similarity algorithms, terminology structuring methods and term clustering. The obtained results indicate that the proposed unsupervised methods appear to be complementary for this task, they can generate subsets of the existing SMQs and make this process systematic and less time consuming. PMID:24739596

  7. Considerations on causality in pharmacovigilance.

    PubMed

    Edwards, I Ralph

    2012-01-01

    Causality has been a topic of debate by philosophers, scientists, lawyers and for centuries. It is essential to define as precisely as possible all steps in the logical chain of events, since each may strengthen or confound an argument. Almost always there are issues of missing and conflicting data that need to be addressed specifically. In pharmacovigilance, as in many other situations, there is not just one possible causation for an effect but several. Each must be evaluated in the given context for probability. There is also likely to be a causal chain of events to the adverse effect under consideration, and each must be considered. In an individual patient diagnosis the components of patient history, clinical findings and various laboratory test findings are combined to point to the probability of the patho-physiological diagnosis, which in turn is related to possible causes with a strength determined by the constellation of findings. The established Bradford-Hill criteria are valuable in considering all the possible causal factors. Pharmacoepidemiology allows for population incidences of causes for particular effects and therefore provides an a priori probability listing for competing possible causes, or at least of one possible cause against the background of all others in a control group. Since adverse effects of medicines are generally rare, it is not possible to exclude drug causation in an individual by reliance on epidemiological evidence alone, only to argue that the incidence is below a level determined by statistical power, of the study or studies combined. Other areas of society are concerned with the process of causal inference, and this is especially true in legal cases in which judgements are made on possible personal injury by drugs.

  8. Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.

    PubMed

    Laroche, Marie-Laure; Batz, Arnaud; Géniaux, Hélène; Féchant, Corinne; Merle, Louis; Maison, Patrick

    2016-04-01

    The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.

  9. Role of Pharmacovigilance on Vaccines Control*

    PubMed Central

    Kuçuku, Merita

    2012-01-01

    The pharmacovigilance of vaccines is defined as the science and activities relating to the detection, assessment, understanding, prevention and communication of adverse events of immunization, or any other vaccine, or issues related with immunization. The strengthening of pharmacovigilance is very important in every country because it helps professional health care workers to avoid the problems with immunization, protect the health of people from adverse events during immunization. The success of the immunization system is reducing morbidity and mortality related to the vaccine. The vaccines are biological products used to prevent infectious diseases, but sometimes the vaccines can cause some AEFI (Adverse Events Following Immunization). The detection of adverse events following correct immunization is one very important step for prevention of problems in the immunization system. The vaccines are injected into an infant body on the day of their birth and the safety of these products is vital. In Albania, the Pharmacovigilance department is established as the structure of the National Center of Drug Control. The strengthening of pharmacovigilance in Albania and other countries is necessary, because this will help to identify the risk and the risk factors, and to avoid or minimize the harms. PMID:25648188

  10. Pharmacoepidemiology and its input to pharmacovigilance.

    PubMed

    Faillie, Jean-Luc; Montastruc, François; Montastruc, Jean-Louis; Pariente, Antoine

    2016-04-01

    The aim of this article is to discuss the contribution of pharmacoepidemiology to pharmacovigilance in the context of drug safety monitoring. Because this contribution requires a comparison of the approaches and a presentation of their respective merits, we have tried to show that this comparison did not necessarily mean opposing these methods, which would not serve any useful purpose. We wanted to underline the fact that the notion of contribution of one to the other implied a complementarity that we propose to demonstrate. Pharmacovigilance is essentially based on the study of spontaneous reports and the clinical and pharmaceutical analysis of the implication of given drugs in adverse drug reactions. It yields performances that are unequalled to this day when safety warning signs relate to rare adverse events or to drugs that are rarely used, or when the drug-related event has specificities that are not found for other aetiologies. Pharmacoepidemiology for its part, through its population-related studies and the possible use of a comparison group, enables a quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect, and therefore difficult to identify from spontaneous reporting. All in all, this is the major contribution of pharmacoepidemiology to pharmacovigilance, where it can be said that it complements pharmacovigilance in drug safety monitoring but in no way could replace it.

  11. Past, present, and future of pharmacovigilance in Korea

    PubMed Central

    Kang, Dong Yoon; Ahn, Kyung-Min; Kang, Hye-Ryun

    2017-01-01

    As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for International Drug Monitoring in 1992, and the activities of Pharmacovigilance Research Network, Korean Society for Pharmacoepidemiology and Risk Management, and Regional Pharmacovigilance Center (RPVC) have contributed to the remarkable progress in the pharmacovigilance area and global status. RPVCs have played pivotal roles in establishment of pharmacovigilance system in Korea by monitoring voluntary ADR reports. RPVCs started with 3 hospitals in 2006 and have now expanded to 27 hospitals nationwide. The Korea Institute of Drug Safety & Risk Management was established in 2012 and in charge of operating the decentralized national pharmacovigilance system. The voluntary report of ADR, which is the basis of current pharmacovigilance system, has various limitations and an active surveillance system can be the overarching alternative. This change in pharmacovigilance paradigm is a global trend and Korea has excellent infrastructure such as broad distribution of electronic medical recording systems and a nationwide single healthcare insurance. As a result, the pharmacovigilance in Korea is now expected to progress to a new active surveillance system from traditional spontaneous reporting system. PMID:28765823

  12. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.

    PubMed

    Borg, John-Joseph; Aislaitner, George; Pirozynski, Michal; Mifsud, Stephen

    2011-03-01

    medicines through risk management and structured data collection in the form of Post-Authorization Safety Studies (PASS), together with rationalized single-case and periodic reporting of suspected adverse drug reactions (ADRs); (vi) involvement of stakeholders in pharmacovigilance through direct patient reporting of suspected ADRs and inclusion of patients and healthcare professionals in decision making; and (vii) simplification of the current community pharmacovigilance procedures with consequent efficiency gains for both the pharmaceutical industry and medicines regulators. For the first time, companies can be made legally liable to carry out PASS and Post-Authorization Efficacy Studies. The amendments to the Regulation and to the Directive will strengthen the European network on pharmacovigilance. A Pharmacovigilance Risk Assessment Committee (PRAC) based at the EMA will be set up, which will be responsible for all matters related to pharmacovigilance at an EU level. Three European databases will be strengthened (EudraVigilance, EudraPharm and the European Pharmacovigilance issues Tracking Tool) as well as the setting up of an EU safety portal to better inform the public on all safety issues being discussed at an EU level. Public hearings at the PRAC will improve transparency in the decision-making process, whilst details and results of all PASS agreed to by the PRAC will also be made publically available.

  13. A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

    PubMed

    Tanti, Amy; Micallef, Benjamin; Serracino-Inglott, Anthony; Borg, John-Joseph

    2017-01-01

    Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems. Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.

  14. Pharmacovigilance in clinical dentistry: overlooked or axiomatic?

    PubMed

    Carnelio, Sunitha; Khan, Sohil Ahmed; Rodrigues, Gabriel

    2011-01-01

    Developments in dental pharmacotherapeutics require dentists to constantly update their knowledge of new drugs, drug safety, and therapeutic trends. Recent incidents of bisphosphonateassociated poor healing, spontaneous intraoral ulceration, and bone necrosis in the oral and maxillofacial region stress the need for vigilant spontaneous reporting of adverse events. This article discusses the rationale for pharmacovigilance in dental practice using specific methods and reviews the pros and cons of adverse drug reporting among dental practitioners.

  15. Pharmacovigilance of herbal products in India.

    PubMed

    Wal, P; Wal, A; Gupta, S; Sharma, G; Rai, Ak

    2011-07-01

    Herbal formulations being widely accepted therapeutic agents as antidiabetics, antiarthritics, hepatoprotectives, cough remedies, memory enhancers, and adaptogens. The commonest myth regarding herbal medicines is that these medicines are completely safe, and can therefore be safely consumed by the patient on his/her own, without a physician's prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side-effects, or unwanted after-effects. There is an increasing awareness at several levels of the need to develop pharmacovigilance practices for herbal medicines. The current model of pharmacovigilance and its associated tools have been developed in relation to synthetic drugs, and applying these methods to monitoring the safety of herbal medicines presents unique challenges in addition to those described for conventional medicines. Several problems relate to the ways in which herbal medicines are named, perceived, sourced, and utilized. This may be because of differences in the use of nonorthodox drugs (e.g., herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs. The purpose of pharmacovigilance is to detect, assess, and understand, and to prevent the adverse effects or any other possible drug-related problems, related to herbal, traditional, and complementary medicines.

  16. DNA Barcoding and Pharmacovigilance of Herbal Medicines.

    PubMed

    de Boer, Hugo J; Ichim, Mihael C; Newmaster, Steven G

    2015-07-01

    Pharmacovigilance of herbal medicines relies on the product label information regarding the ingredients and the adherence to good manufacturing practices along the commercialisation chain. Several studies have shown that substitution of plant species occurs in herbal medicines, and this in turn poses a challenge to herbal pharmacovigilance as adverse reactions might be due to adulterated or added ingredients. Authentication of constituents in herbal medicines using analytical chemistry methods can help detect contaminants and toxins, but are often limited or incapable of detecting the source of the contamination. Recent developments in molecular plant identification using DNA sequence data enable accurate identification of plant species from herbal medicines using defined DNA markers. Identification of multiple constituent species from compound herbal medicines using amplicon metabarcoding enables verification of labelled ingredients and detection of substituted, adulterated and added species. DNA barcoding is proving to be a powerful method to assess species composition in herbal medicines and has the potential to be used as a standard method in herbal pharmacovigilance research of adverse reactions to specific products.

  17. Pharmacovigilance and the cardiovascular system: two sides to every story.

    PubMed

    Keller, Guillermo Alberto; Di Girolamo, Guillermo; Alvarez, Paulino Antonio

    2011-09-01

    The objective of the present study was to quantify the reported cardiovascular adverse reactions and adverse reactions to cardiovascular drugs to help to design and implement monitoring and prevention strategies. The pharmacovigilance unit (PU) is a peripheral effector of National Pharmacovigilance Center and receives adverse drug reactions notifications from 10 teaching hospitals. Data on adverse reactions beginning in 2004 and notified to the PU were extracted from the database. Cardiovascular adverse drug reactions and adverse reactions to cardiovascular drugs were identified using Medical Dictionary for Regulatory Activities (MedDRA), and the Anatomical Therapeutic Chemical (ATC) Classification System respectively. The reports of adverse reactions were classified according to their seriousness. From 2004 to 2010, 2516 notifications were received (2383 adverse reactions, 106 lack of efficacy, 26 quality failures). These notifications included 151 cardiovascular adverse reactions and 594 adverse reactions caused by cardiovascular drugs. In the first group, of the 151 cardiovascular adverse reactions through MedDRA SOC classification caused by all ATC group classes, 118 (78.2%) were caused by non cardiovascular drugs. Among them antimicrobials (27,2%) and neurologic drugs (21,2%) were the most frequent. 22 (14.6%) adverse reactions were serious. Long QT syndrome, peripheral edema, hypotension, tachycardia, and bradycardia, were the most frequent. In the second group, of the 594 reports identifying adverse reactions involving all MedDRA SOCs but caused only by cardiovascular drugs, 559 reports (94.1%) were non cardiovascular adverse reactions. Enalapril and furosemide accounted for 65.2% there were 33 (5.6%) serious adverse reactions. The most frequent adverse reactions were hyponatremia, impaired renal function, hypokalemia, metabolic alkalosis, asymptomatic elevation of liver enzymes, hyperkalemia, hyperglycemia, edema, and cough. Non-cardiovascular adverse

  18. Does language matter? A case study of epidemiological and public health journals, databases and professional education in French, German and Italian.

    PubMed

    Baussano, Iacopo; Brzoska, Patrick; Fedeli, Ugo; Larouche, Claudia; Razum, Oliver; Fung, Isaac C-H

    2008-09-30

    Epidemiology and public health are usually context-specific. Journals published in different languages and countries play a role both as sources of data and as channels through which evidence is incorporated into local public health practice. Databases in these languages facilitate access to relevant journals, and professional education in these languages facilitates the growth of native expertise in epidemiology and public health. However, as English has become the lingua franca of scientific communication in the era of globalisation, many journals published in non-English languages face the difficult dilemma of either switching to English and competing internationally, or sticking to the native tongue and having a restricted circulation among a local readership. This paper discusses the historical development of epidemiology and the current scene of epidemiological and public health journals, databases and professional education in three Western European languages: French, German and Italian, and examines the dynamics and struggles they have today.

  19. Does language matter? A case study of epidemiological and public health journals, databases and professional education in French, German and Italian

    PubMed Central

    Baussano, Iacopo; Brzoska, Patrick; Fedeli, Ugo; Larouche, Claudia; Razum, Oliver; Fung, Isaac C-H

    2008-01-01

    Epidemiology and public health are usually context-specific. Journals published in different languages and countries play a role both as sources of data and as channels through which evidence is incorporated into local public health practice. Databases in these languages facilitate access to relevant journals, and professional education in these languages facilitates the growth of native expertise in epidemiology and public health. However, as English has become the lingua franca of scientific communication in the era of globalisation, many journals published in non-English languages face the difficult dilemma of either switching to English and competing internationally, or sticking to the native tongue and having a restricted circulation among a local readership. This paper discusses the historical development of epidemiology and the current scene of epidemiological and public health journals, databases and professional education in three Western European languages: French, German and Italian, and examines the dynamics and struggles they have today. PMID:18826570

  20. Pharmacovigilance on sexual enhancing herbal supplements.

    PubMed

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

    2016-01-01

    The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the

  1. [Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

    Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).

  2. Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis

    PubMed Central

    Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

    2012-01-01

    Background: Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results: Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested). Conclusions: Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region. PMID:23826016

  3. Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.

    PubMed

    Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

    2012-09-01

    Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested). Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

  4. Overview of Pharmacovigilance System in Vietnam: Lessons Learned in a Resource-Restricted Country.

    PubMed

    Nguyen, Khac-Dung; Nguyen, Phuong-Thuy; Nguyen, Hoang-Anh; Roussin, Anne; Montastruc, Jean-Louis; Bagheri, Haleh; Olsson, Sten

    2017-10-03

    Drug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of drugs in each nation is needed to identify and manage the exact drug-related problems faced by patients in these countries. Vietnam launched its university-based National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in 2009, a significant step towards catching up with international trends. Although the center is still in its infancy and has limited resources, it has attained some achievements and largely met the minimum World Health Organization requirements for a functional pharmacovigilance center. The number of reports has increased rapidly, with some important signals generated from the national database leading to regulatory actions at a national level. In addition, this system can help detect drug-quality problems that are less common in developed countries. The success of the quantity and quality of reporting, risk assessment, and communication is still limited compared with more developed systems. A number of opportunities remain to enhance the system, particularly in risk communication and evaluation of the impact of pharmacovigilance, and to apply reporting outcomes to reduce drug-related risks throughout the country. More internal and external support is needed to develop a stronger and more comprehensive pharmacovigilance system.

  5. Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data.

    PubMed

    Solomon, C; Gröner, A; Ye, J; Pendrak, I

    2015-04-01

    Fibrinogen concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of fibrinogen concentrate were distributed over the pharmacovigilance period, corresponding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that fibrinogen concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, fibrinogen concentrate showed a promising safety profile.

  6. Naming times and standardized norms for the Italian PD/DPSS set of 266 pictures: direct comparisons with American, English, French, and Spanish published databases.

    PubMed

    Dell'Acqua, R; Lotto, L; Job, R

    2000-11-01

    The present study provides Italian normative measures for 266 line drawings belonging to the new set of pictures developed by Lotto, Dell'Acqua, and Job (in press). The pictures have been standardized on the following measures: number of letters, number of syllables, name frequency, within-category typically, familiarity, age of acquisition, name agreement, and naming time. In addition to providing the measures, the present study focuses on indirect and direct comparisons (i.e., correlations) of the present norms with databases provided by comparable studies in Italian (in which normative data were collected with Snodgrass & Vanderwart's set of pictures; Nisi, Longoni, & Snodgrass, 2000), in British English (Barry, Morrison, & Ellis, 1997), in American English (Snodgrass & Vanderwart, 1980; Snodgrass & Yuditsky, 1996), in French (Alario & Ferrand, 1999), and in Spanish (Sanfeliu & Fernandez, 1996).

  7. Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project.

    PubMed

    Patadia, Vaishali K; Coloma, Preciosa; Schuemie, Martijn J; Herings, Ron; Gini, Rosa; Mazzaglia, Giampiero; Picelli, Gino; Fornari, Carla; Pedersen, Lars; van der Lei, Johan; Sturkenboom, Miriam; Trifirò, Gianluca

    2015-01-01

    A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR system was found to be dependent on frequency of the event and utilization of drugs in the general population. The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice.

  8. [Pharmacovigilance in child and adolescent psychiatry].

    PubMed

    Egberts, Karin; Karwautz, Andreas; Plener, Paul L; Mehler-Wex, Claudia; Kölch, Michael; Dang, Su-Yin; Taurines, Regina; Romanos, Marcel; Gerlach, Manfred

    2015-01-01

    Rational pharmacotherapy is a challenging task in child and adolescent psychiatry. Increasing prescription numbers contrast with the uncertainties of safety and efficacy issues. The lack of clinical (authorization) trials often implies a non- age-specific use of drugs. However, young patients show particular metabolic conditions and a higher vulnerability for adverse drug reactions. Thus it seems mandatory to create age-specific pharmacological data about efficacy and safety of psychotropic drug use in minors. Legislation authorities became aware of this situation and introduced European and national scientific pharmacovigilance regulations and programmes accordingly in order to continuously evaluate the benefit-risk-ratio, detect, collect, minimize, and prevent adverse effects of drugs by appropriate measures, e.g., therapeutic drug monitoring. In this paper the principles and needs of pharmacovigilance in child and adolescent psychiatry are discussed. Furthermore a large multicenter clinical trial («TDM-VIGIL»), funded by the German Federal Institute for Drugs and Medical Devices, is presented, which appeals to collect epidemiological prescription and safety data of psychotropic drugs in children and adolescents using an internet-based data infrastructure (patient registry).

  9. Causality Assessment in Pharmacovigilance: Still a Challenge.

    PubMed

    Ralph Edwards, I

    2017-02-28

    Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle the many issues involved in, for example, medication error and the many other factors that lead to bad outcomes from therapy, including failure to recognise known risk factors. The aim of pharmacovigilance is not only a bureaucratic exercise in public health norms, but is mainly concerned with small minorities of statistical outliers-and even individuals-whose experiences from harms may together form messages about causation that will prevent further at-risk patients from exposure, or at least assist with earlier recognition of drug-related harm and better management of such harm. This requires more time, more data, more analysis and more patient and clinical involvement in reporting useful clinical detail. The paradigm shift back towards gathering more case data relating to possible causation can be selective and would not be just retrogressive, nor necessarily too costly. Greater transparency of hypotheses and availability of anonymised case data will enrol more expertise into evaluations and hypothesis testing, and the provision of more complete and useful information should reduce clinical burdens from bad patient outcomes as well as their overall costs to society.

  10. [The opening of the French national health database: Opportunities and difficulties. The experience of the Gazel and Constances cohorts].

    PubMed

    Goldberg, M; Carton, M; Gourmelen, J; Genreau, M; Montourcy, M; Le Got, S; Zins, M

    2016-09-01

    In France, the national health database (SNIIRAM) is an administrative health database that collects data on hospitalizations and healthcare consumption for more than 60 million people. Although it does not record behavioral and environmental data, these data have a major interest for epidemiology, surveillance and public health. One of the most interesting uses of SNIIRAM is its linkage with surveys collecting data directly from persons. Access to the SNIIRAM data is currently relatively limited, but in the near future changes in regulations will largely facilitate open access. However, it is a huge and complex database and there are some important methodological and technical difficulties for using it due to its volume and architecture. We are developing tools for facilitating the linkage of the Gazel and Constances cohorts to the SNIIRAM: interactive documentation on the SNIIRAM database, software for the verification of the completeness and validity of the data received from the SNIIRAM, methods for constructing indicators from the raw data in order to flag the presence of certain events (specific diagnosis, procedure, drug…), standard queries for producing a set of variables on a specific area (drugs, diagnoses during a hospital stay…). Moreover, the REDSIAM network recently set up aims to develop, evaluate and make available algorithms to identify pathologies in SNIIRAM. In order to fully benefit from the exceptional potential of the SNIIRAM database, it is essential to develop tools to facilitate its use. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  11. [Health status of populations living in French overseas territories in 2012, compared with metropolitan France: An analysis of the national health insurance database].

    PubMed

    Filipovic-Pierucci, A; Rigault, A; Fagot-Campagna, A; Tuppin, P

    2016-06-01

    This study uses healthcare consumption to compare the health status of beneficiaries of the French national health insurance general scheme between individuals living in French overseas territories (FOT) and those living in metropolitan France. Data were extracted from the French national health insurance database (Sniiram) for 2012, using algorithms, 56 groups of diseases and 27 groups of hospital activity were isolated. Standardized morbidity ratio for age and sex (SMR) were used to compare FOT to mainland France. Compared with mainland France, people living in the four FOT had high SMR for diabetes care (Guadeloupe 1.9; Martinique 1.7; Guyane 1.9; La Réunion 2.3), dialysis (2.7; 2.4; 3.8; 4.4), stroke (1.2; 1.1; 2.0; 1.5), and hospitalization for infectious diseases (1.9; 2.5; 2.4; 1.4) and obstetrics (1.4; 1.2; 1.9; 1.2). Care for inflammatory bowel disease or cancer were less frequent except for prostate in Martinique and Guadeloupe (2.3). People living in Martinique, Guadeloupe and la Reunion had more frequently care for psychotic disorders (2.0; 1.7; 1.2), dementia (1.1; 1.3; 11), epileptic seizures (1.4; 1.4; 16) and hospitalizations for burns (2.6; 1.7; 2.9). In la Reunion, people had more frequently coronary syndrome (1.3), cardiac heart failure (1.6), chronic respiratory diseases except cystic fibrosis (1.5), drug addiction (1.4) and hospitalizations for cardiovascular catheterization (1.4) and toxicology, poisoning, alcohol (1.7). Other differences were observed by gender: HIV infection, peripheral arterial disease, some chronic inflammatory disease (lupus) were more frequent in women living in Martinique or Guadeloupe, compared to women from mainland France and psychotic disorders for men. From la Reunion, men had more frequently liver and pancreatic diseases and hospitalisation for toxicology, poisoning, alcohol than men from mainland France. This study highlights the utility of administrative database to compare and follow population health status

  12. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    PubMed

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  13. How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

    PubMed

    Alla, François; Rosilio, Myriam; Funck-Brentano, Christian; Barthélémy, Philippe; Brisset, Sophie; Cellier, Dominic; Chassany, Olivier; Demarez, Jean-Paul; Diebolt, Vincent; Francillon, Alain; Gambotti, Laetitia; Hannachi, Hakima; Lechat, Philippe; Lemaire, François; Lièvre, Michel; Misse, Christophe; Nguon, Marina; Pariente, Antoine; Rosenheim, Michel; Weisslinger-Darmon, Nadine

    2013-01-01

    The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.

  14. Mining pharmacovigilance data using Bayesian logistic regression with James-Stein type shrinkage estimation.

    PubMed

    An, Lihua; Fung, Karen Y; Krewski, Daniel

    2010-09-01

    Spontaneous adverse event reporting systems are widely used to identify adverse reactions to drugs following their introduction into the marketplace. In this article, a James-Stein type shrinkage estimation strategy was developed in a Bayesian logistic regression model to analyze pharmacovigilance data. This method is effective in detecting signals as it combines information and borrows strength across medically related adverse events. Computer simulation demonstrated that the shrinkage estimator is uniformly better than the maximum likelihood estimator in terms of mean squared error. This method was used to investigate the possible association of a series of diabetic drugs and the risk of cardiovascular events using data from the Canada Vigilance Online Database.

  15. European Union pharmacovigilance capabilities: potential for the new legislation

    PubMed Central

    Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

    2015-01-01

    European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed. PMID:26301067

  16. European Union pharmacovigilance capabilities: potential for the new legislation.

    PubMed

    Borg, John Joseph; Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

    2015-08-01

    European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

  17. [Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal].

    PubMed

    Portela, Maria Conceição; Sinogas, Carlos; Almeida, Fernando Albuquerque; Baptista-Leite, Ricardo; Castro-Caldas, Alexandre

    2017-03-31

    Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations. A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted. Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals. Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile. The existing pharmacovigilance's regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed.

  18. Statistical methods for active pharmacovigilance, with applications to diabetes drugs.

    PubMed

    Zhuo, Lan; Farrell, Patrick J; McNair, Doug; Krewski, Daniel

    2014-01-01

    Pharmacovigilance aims to identify adverse drug reactions using postmarket surveillance data under real-world conditions of use. Unlike passive pharmacovigilance, which is based on largely voluntary (and hence incomplete) spontaneous reports of adverse drug reactions with limited information on patient characteristics, active pharmacovigilance is based on electronic health records containing detailed information about patient populations, thereby allowing consideration of modifying factors such as polypharmacy and comorbidity, as well as sociodemographic characteristics. With the present shift toward active pharmacovigilance, statistical methods capable of addressing the complexities of such data are needed. We describe four such methods here, and demonstrate their application in the analysis of a large retrospective cohort of diabetics taking anti-hyperglycemic medications that may increase the risk of adverse cardiovascular events.

  19. The impact of pharmacovigilance on drug portfolio management.

    PubMed

    Bucurescu, S

    2014-01-01

    This review examines the influence of pharmacovigilance on drug portfolio. As a result of pharmacovigilance studies, actions are taken by national drug administrations and/or the World Health Organization (WHO) that have a strong impact on drug portfolio management: drug withdrawal from medical practice, discovery of new therapeutic indications, discovery of drug interactions, preference for specific pharmaceutical formulations, discovery of contraindications and change of drug prescription status.

  20. State of knowledge of Cameroonian drug prescribers on pharmacovigilance

    PubMed Central

    Nde, Francis; Fah, Aimé Bernard Djitafo; Simo, Francis Ampère; Wouessidjewe, Denis

    2015-01-01

    Introduction The present study conducted in Cameroon from June 2013 to February 2014 aimed to estimating the level of pharmacovigilance knowledge and practice of health professionals in Cameroon. Methods We conducted a descriptive cross-sectional survey on 149 health professionals in Cameroon from June to September 2013. Data were analyzed using software IBM SPSS 20.0. We calculated proportions and odd ratio, and confident interval of their values, keeping a threshold of p of 0.05 to determine the level of significance. Results Ninety percent (90%) of declaration of side effects were made to the medical representatives and 4% to the National Pharmacovigilance Centre. Fifty four percent (54%) of physicians were not aware of the existence of a National Pharmacovigilance system. Ten (10%) of prescribers had never heard of pharmacovigilance, however respondents answered unanimously that they need training on pharmacovigilance. A wrong definition was given by most of the nurses and dentists (61,1% and 58,3% respectively) as compared to physicians and pharmacists (respectively 15.2% and 26,5%). Given the results of this study, the establishment of a National Pharmacovigilance system based on a solid legal foundation is necessary in Cameroon. This implementation must go through the involvement of all stakeholders and their awareness raising on the importance of this activity and its positive impact on the health of populations. Conclusion Pharmacovigilance is a public health problem in Cameroon, with due to lack of good knowledge and practice of prescribers, precisely physicians, pharmacists, nurses, and dentists who are not always aware of an existing pharmacovigilance system in Cameroon. PMID:26090028

  1. State of knowledge of Cameroonian drug prescribers on pharmacovigilance.

    PubMed

    Nde, Francis; Fah, Aimé Bernard Djitafo; Simo, Francis Ampère; Wouessidjewe, Denis

    2015-01-01

    The present study conducted in Cameroon from June 2013 to February 2014 aimed to estimating the level of pharmacovigilance knowledge and practice of health professionals in Cameroon. We conducted a descriptive cross-sectional survey on 149 health professionals in Cameroon from June to September 2013. Data were analyzed using software IBM SPSS 20.0. We calculated proportions and odd ratio, and confident interval of their values, keeping a threshold of p of 0.05 to determine the level of significance. Ninety percent (90%) of declaration of side effects were made to the medical representatives and 4% to the National Pharmacovigilance Centre. Fifty four percent (54%) of physicians were not aware of the existence of a National Pharmacovigilance system. Ten (10%) of prescribers had never heard of pharmacovigilance, however respondents answered unanimously that they need training on pharmacovigilance. A wrong definition was given by most of the nurses and dentists (61,1% and 58,3% respectively) as compared to physicians and pharmacists (respectively 15.2% and 26,5%). Given the results of this study, the establishment of a National Pharmacovigilance system based on a solid legal foundation is necessary in Cameroon. This implementation must go through the involvement of all stakeholders and their awareness raising on the importance of this activity and its positive impact on the health of populations. Pharmacovigilance is a public health problem in Cameroon, with due to lack of good knowledge and practice of prescribers, precisely physicians, pharmacists, nurses, and dentists who are not always aware of an existing pharmacovigilance system in Cameroon.

  2. Identifying multiple myeloma patients using data from the French health insurance databases: Validation using a cancer registry.

    PubMed

    Palmaro, Aurore; Gauthier, Martin; Conte, Cécile; Grosclaude, Pascale; Despas, Fabien; Lapeyre-Mestre, Maryse

    2017-03-01

    This study aimed to assess the performance of several algorithms based on hospital diagnoses and the long-term diseases scheme to identify multiple myeloma patients.Potential multiple myeloma patients in 2010 to 2013 were identified using the presence of hospital records with at least 1 main diagnosis code for multiple myeloma (ICD-10 "C90"). Alternative algorithms also considered related and associated diagnoses, combination with long-term conditions, or at least 2 diagnoses. Incident patients were those with no previous "C90" codes in the past 24 or 12 months. The sensitivity, specificity, and positive and negative predictive values (PPVs and NPVs) were computed, using a French cancer registry for the corresponding area and period as the criterion standard.Long-term conditions data extracted concerned 11,559 patients (21,846 for hospital data). The registry contained 125 cases of multiple myeloma. Sensitivity was 70% when using only main hospital diagnoses (specificity 100%, PPV 79%), 76% when also considering related diagnoses (specificity 100%, PPV 74%), and 90% with associated diagnoses included (100% specificity, 64% PPV).In relation with their good performance, selected algorithms can be used to study the benefit and risk of drugs in treated multiple myeloma patients.

  3. Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

    PubMed Central

    Chaudhary, Anand; Singh, Neetu; Kumar, Neeraj

    2010-01-01

    Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some medical professionals, scientists and members of the public reported adverse reactions after taking Ayurvedic formulations. The World Health Organisation therefore persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines. After a year of due diligence, the pharmacovigilance program was launched nationally on 29 September 2008. Since that time, Ayurveda, Siddha and Unani medicines have been monitored according to the provisions of a protocol prepared by the National Pharmacovigilance Resource Centre, IPGTRA, Jamnagar, and approved by Department of AYUSH. The program was reviewed, first, on 21st January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU), and again, on 15 Feburary, 2010, when an evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. Recent developments include the constitution of pharmacovigilance centers at all Ayurveda Teaching institutes and research centers. PMID:21731371

  4. Pharmacovigilance in China: current situation, successes and challenges.

    PubMed

    Zhang, Li; Wong, Lisa Y L; He, Ying; Wong, Ian C K

    2014-10-01

    With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.

  5. Harnessing Scientific Literature Reports for Pharmacovigilance

    PubMed Central

    Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

    2017-01-01

    Summary Objectives We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers’ capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. Methods A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. Results All usability test participants cited the tool’s ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool’s automated literature search relative to a manual ‘all fields’ PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Conclusions Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction. PMID:28326432

  6. Cervical cancer screening and subsequent procedures in women under the age of 25 years between 2007 and 2013 in France: a nationwide French healthcare database study.

    PubMed

    Maura, Géric; Chaignot, Christophe; Weill, Alain; Alla, François; Heard, Isabelle

    2017-05-10

    Cervical cancer screening in young women may lead to the detection of lesions with a high potential for spontaneous regression and no benefit of surgery. French guidelines recommend initiating cervical cancer screening by the Pap test from the age of 25 years. To date, no French nationwide study has assessed cervical cancer screening in young women and the related subsequent work-up and surgical procedures among screen-positive women. Using data from the French national healthcare databases (around 50 million beneficiaries), annual and 3-year Pap test screening rates were calculated among women aged 15-24 years between 2007 and 2013. Cervical excisional procedures were assessed during the 15-month period following a first Pap test in women aged 20-24 years in 2007 and 2012. About 10% of the almost six million women aged 15-65 years with at least one annual Pap test were under the age of 25, mainly women aged 20-24 years, in whom the 3-year screening coverage was 35.5% in 2013. In screened women aged 20-24 years, human papillomavirus testing rates increased markedly over the study period (+105%) and surgical management became less conservative with an increased rate of both conization (+16.5%) and other excisional treatments (+74.5%). Nevertheless, because of the overall decrease in screening coverage, the absolute yearly number of women who underwent conization decreased from 1974 to 1766 between 2007 and 2012. Higher adherence to guidelines is needed to reduce the burden of surgical treatment that is potentially associated with adverse obstetric outcomes among women under the age of 25 years.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/.

  7. [French hospital discharge database: data production, validity, and origins of errors in the field of severe maternal morbidity].

    PubMed

    Chantry, A A; Deneux-Tharaux, C; Bal, G; Zeitlin, J; Quantin, C; Bouvier-Colle, M-H

    2012-06-01

    The organization of obstetric care in France brings all women in contact with the hospital system. Thus, hospital discharge data from the Program of Medicalization of the Information System (PMSI) constitute a potentially valuable source of information, particularly regarding rare events such as severe maternal morbidity. These data cover a large population but their quality has not been assessed in that field. Our objectives were to study the processes of production and the validity of PMSI data related to severe maternal morbidity. The study was conducted in four French tertiary teaching hospitals (Caen, Cochin [AP-HP, Paris], Grenoble and Lille). First, the organization of each step of the medical information process -production, formatting, verification and processing- was detailed in each center with a standardized form. Second, the validation study was based on the comparison of data related to severe maternal morbid events in the PMSI from these centers for 2006 and 2007, with the content of medical records which constituted the gold standard. Indicators of sensitivities and positive predictive values of PMSI were calculated. The processes of PMSI data production showed major differences between the four centers. In hospital discharge data, diagnoses (eclampsia and pulmonary embolism) had a high proportion of false-positives (68%). Inversely, procedures (four procedures for management of severe haemorrhage) had less than 1% of false-positives, but a low sensitivity with 37% false-negatives which could be corrected in 95%. Regarding intensive care provision, all indicators of hospital data quality were very high. In addition, the validity of hospital data in centers 1 and 2 was higher for all events. The heterogeneity of the process of PMSI data production is associated with a variable quality of these data. Intensive care provision can be used in the PMSI, as well as procedures after correction. For diagnoses, the quality of the PMSI data is better in

  8. A qualitative approach to signal mining in pharmacovigilance using formal concept analysis.

    PubMed

    Lillo-Le Louët, Agnès; Toussaint, Yannick; Villerd, Jean

    2010-01-01

    "Pharmacovigilance is the process and science of monitoring the safety of medicines, consisting in (i) collecting and managing data on the safety of medicines (ii) looking at the data to detect 'signals' (any new or changing safety issue)" [1]. Pharmacovigilance is mainly based on spontaneous reports: when suspecting an adverse drug reaction, health care practitioners send a report to a spontaneous reporting system (SRS). This produces huge databases containing numerous reports and their manual exploration is both cost and time prohibitive. Existing techniques that automatically extract relevant signals rely on statistics or Bayesian models but do not provide information to the experts about possible biases lying in the data, nor about the specificity of a signal to a particular patient profile. Our extraction method combines numerical methods from the state of the art with a qualitative approach that helps interpretation. We build a synthetic representation of the database that is used to (i) identify unexpected patterns and biases (ii) extract potentially relevant signals w.r.t. patient profiles (iii) provide traceability facilities between extracted signals and raw data.

  9. The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist.

    PubMed

    Moore, Nicholas

    2013-05-01

    Over the years since 1961 and the identification of thalidomide as the common link in thousands of birth defects, daily pharmacovigilance activities and signal generation have evolved from the analysis of individual case reports and imputology, to case series and underreporting, to spontaneous report databases and disproportionality analyses, to data mining in population databases. Regulatory requirements have also changed from purely passive monitoring and reacting to alerts to a proactive approach that includes risk management plans and risk minimization, and from reporting only by healthcare professionals to patient reporting and exploration of social media. The emphasis only on risk assessment is changing towards assessment of the risk/benefit ratio and the exploration of real-life efficacy studies to complement the measure of real-life risk. The interactions between industry and regulators have been amplified and strengthened. However, most adverse reactions, including severe ones, are related to well-known and often pharmacological effects of the older drugs, possibly with genetic predispositions. Prevention is the next frontier for pharmacovigilance, beyond simply generating alerts, and it involves not only the removal of drugs from the market, but also promotion of proper drug prescribing by better trained physicians and the proper use of drugs by better informed patients.

  10. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-22

    ... Animal and Plant Health Inspection Service Draft Guidelines on Pharmacovigilance of Veterinary Medicinal... on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal...

  11. Management and cost analysis of cancer patients treated with G-CSF: a cohort study based on the French national healthcare insurance database.

    PubMed

    Tilleul, Patrick; Jacot, William; Emery, Corinne; Lafuma, Antoine; Gourmelen, Julie

    2017-09-04

    To describe the management and costs associated with G-CSF therapy in cancer patients in France. This study analyzed a representative random population sample from the French national healthcare insurance database, focusing on 1,612 patients with hematological or solid malignancies who were reimbursed in 2013 or 2014 for at least one G-CSF treatment dispensed in a retail pharmacy. Patient characteristics and treatment costs were analyzed according to the type of cancer. Then the costs and characteristics of patients associated with the use of different G-CSF products were analyzed in the sub-set of breast cancer patients. The most frequent malignancies in the database population were breast cancer (23.3%), hematological malignancies (22.2%), and lung cancer (12.4%). The reimbursed G-CSF was pegfilgrastim in 34.1% of cases, lenograstim in 26.7%, and filgrastim in 17.9%. More than one G-CSF product was reimbursed to 21.3% of patients. The total annual reimbursed health expenses per patient, according to the type of G-CSF, were €27,001, €24,511, and €20,802 for patients treated with filgrastim, lenograstim, and pegfilgrastim, respectively. Ambulatory care accounted for, respectively, 35%, 38%, and 41% of those costs. In patients with breast cancer, ambulatory care cost was €7,915 with filgrastim, €7,750 with lenograstim, and €6,989 with pegfilgrastim, and the respective cost of G-CSF was €1,733, €1,559, and €3,668. All available G-CSF products have been shown to be effective in cancer patients, and both daily G-CSFs and pegylated G-CSF are recommended in international guidelines. Nevertheless, this analysis of G-CSF reimbursement indicates that the choice of product can markedly affect the total cost of ambulatory care.

  12. Collaboration in pharmacovigilance: lamotrigine and fatal severe cutaneous adverse reactions - a review of spontaneous reports.

    PubMed

    Brickel, Neil; Shaikh, Haris; Kirkham, Andrew; Davies, Greg; Chalker, Michelle; Yoshida, Pascal

    2017-01-01

    Pharmacovigilance presents many challenges, particularly when managing unpredictable, rare conditions, eg, severe cutaneous adverse reactions (SCARs). Such rare events are often only detected from spontaneous reports, which present their own limitations, particularly during a prolonged global launch schedule. GlaxoSmithKline's routine pharmacovigilance includes regular reviews of global adverse event (AE) reports and aggregate data from a central safety database. Lamotrigine is one of the several antiepileptic drugs associated with SCARs. After identification of increased rates of fatal SCAR cases with lamotrigine in Japan between September and December 2014, this analysis investigated the global incidence of fatal SCARs with lamotrigine and explored whether known risk factors may have contributed to these cases. Global fatal SCAR cases reported with lamotrigine administration from launch until January 2015 were reviewed for evidence of temporal association with dosing and the presence of risk factors, including comorbidities, concomitant medications, and noncompliance with the prescribing information (PI). Worldwide, the estimated cumulative exposure to lamotrigine was >8.4 million patient-years. Globally, there were 54,513 AE reports for lamotrigine, of which 3,454 (6.3%) concerned SCARs. Of these, 122 (3.5%) had a fatal outcome (attributable and nonattributable to lamotrigine), equating to 0.01 fatal SCARs per 1,000 patient-years. In Japan (estimated cumulative exposure 141,000 patient-years), 17 fatal SCARs were reported (attributable and nonattributable), equating to 0.12 per 1,000 patient-years. Seventy-one percent of fatal SCAR cases in Japan showed evidence of noncompliance with the recommended dosing regimen; in 65% of the cases, a delay in discontinuation of lamotrigine after early signs of hypersensitivity was reported. Despite a number of limitations inherent in comparing spontaneous report data, this analysis highlights the need for adherence to the

  13. Pharmacovigilance in oncology: evaluation of current practice and future perspectives.

    PubMed

    Baldo, Paolo; De Paoli, Paolo

    2014-10-01

    Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.

  14. What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?

    PubMed

    Price, John

    2016-12-01

    The pharmacovigilance of drugs for orphan diseases presents problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the pharmacovigilance of orphan drugs. The possibility of mining "big data" to detect suspected adverse reactions is being explored in pharmacovigilance generally but may have limited application to orphan drugs. Sources of big data such as social media may be infrequently used as communication channels by patients with rare disease or their caregivers or by health care providers; any adverse reactions identified are likely to reflect what is already known about the safety of the drug from the network of support that grows up around these patients. Opportunities related to potential future big data sources are discussed.

  15. [Ceará State Pharmacovigilance System: a year of experience].

    PubMed

    Coêlho, H L; Arrais, P S; Gomes, A P

    1999-01-01

    This paper summarizes the first year of activity of the Ceará State Pharmacovigilance System (SIFACE) as a strategy to discuss practical and methodological problems related to developing pharmacovigilance in Brazil. Siface is being structured by the Group for the Prevention of Improper Use of Pharmaceuticals (GPUIM), based on hospital pharmacies. A total of 63 reports (119 suspected adverse drug reactions, or ADRs) were processed, the majority among women (55.7%) and children (34.4%). Antibiotics were the drug group most frequently involved, and the most common reactions were dermatological. In 20% of the cases, patients had been re-exposed to drugs previously reported as producing adverse reactions, thus highlighting the importance of pharmacovigilance to prevent ADRs.

  16. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives

    PubMed Central

    Lu, Zhengwu

    2009-01-01

    Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance. PMID:21701609

  17. New approaches to drug safety: a pharmacovigilance tool kit.

    PubMed

    Wise, Lesley; Parkinson, John; Raine, June; Breckenridge, Alasdair

    2009-10-01

    The importance of pharmacovigilance - the ongoing assessment of the safety of a marketed medicine - has been increasingly appreciated in recent years, owing in part to high-profile safety issues with widely used drugs. In response, strategies to improve the collection, integration and analysis of data related to post-marketing drug safety are being initiated or enhanced. In this article, we summarize the key tools that are available for pharmacovigilance, discuss which might be the most appropriate to use in different situations and consider the future directions of the field.

  18. Use of Fibrates Monotherapy in People with Diabetes and High Cardiovascular Risk in Primary Care: A French Nationwide Cohort Study Based on National Administrative Databases

    PubMed Central

    Roussel, Ronan; Chaignot, Christophe; Weill, Alain; Travert, Florence; Hansel, Boris; Marre, Michel; Ricordeau, Philippe; Alla, François; Allemand, Hubert

    2015-01-01

    Background and Aim According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk. Design Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health insurance systems (07/01/08-12/31/09) with a follow-up of up to 30 months. Methods Lipid-lowering drug-naive diabetic patients initiating fibrate or statin monotherapy were identified. Patients at high cardiovascular risk were then selected: patients with a diagnosis of diabetes and hypertension, and >50 (men) or 60 (women), but with no history of cardiovascular events. The composite endpoint comprised myocardial infarction, stroke, amputation, or death. Results Of the 31,652 patients enrolled, 4,058 (12.8%) received a fibrate. Age- and gender-adjusted annual event rates were 2.42% (fibrates) and 2.21% (statins). The proportionality assumption required for the Cox model was not met for the fibrate/statin variable. A multivariate model including all predictors was therefore calculated by dividing data into two time periods, allowing Hazard Ratios to be calculated before (HR<540) and after 540 days (HR>540) of follow-up. Multivariate analyses showed that fibrates were associated with an increased risk for the endpoint after 540 days: HR<540 = 0.95 (95% CI: 0.78–1.16) and HR>540 = 1.73 (1.28–2.32). Conclusion Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy. PMID:26398765

  19. 21st century pharmacovigilance: efforts, roles, and responsibilities.

    PubMed

    Pitts, Peter J; Louet, Hervé Le; Moride, Yola; Conti, Rena M

    2016-11-01

    In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Teaching French.

    ERIC Educational Resources Information Center

    Marty, Fernand

    This comprehensive analysis of French teaching methodology reveals basic problems underlying the current philosophy of language learning, while presenting new ideas based on extensive research. Two books, "Active French; Dialogues" and "Active French: Foundations Course" (Books 1 and 2), which stress well specified learning objectives, were…

  1. Role of Pharmacovigilance in India: An overview

    PubMed Central

    Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

    2015-01-01

    Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

  2. Role of Pharmacovigilance in India: An overview.

    PubMed

    Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

    2015-01-01

    Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

  3. Opportunities for Collaboration at the Interface of Pharmacovigilance and Manufacturing.

    PubMed

    Beninger, Paul

    2017-03-30

    A case can be made that much common ground exists between pharmacovigilance and pharmaceutical manufacturing. Of the 8 major US statutes that shaped the pharmaceutical industry since early in the 20th Century, 7 followed fatally catastrophic events related to the use of a manufactured product, and 1 followed the discovery of a counterfeit product. To facilitate an understanding of the interplay between pharmacovigilance and manufacturing, it is convenient to divide manufacturing into 3 categories: (1) upstream sourcing of materials: pharmacovigilance plays an important role when adverse event clusters are seen during routine vigilance detection processes and the suspicion turns to possibly contaminated source material, (2) the manufacturing process itself: pharmacovigilance may be called on to conduct a health hazard evaluation if a manufacturing deviation is detected after product release (the assessment can inform the depth of a recall), and (3) downstream distribution and product use: there is only light regulation of the interval between product distribution after manufacturing release and just before administration to patients, a time during which product may be subject to an out-of-specification determination for environmental controls or subject to malfeasant activities, such as counterfeit substitution or product diversion. Recently introduced statutory remedies, including the FDA Safety and Innovation Act and the Drug Supply Chain Security Act in the United States and the Falsified Medicines Directive (directive 2011/62/EC) in the European Union, can provide capabilities to support pharmacovigilance signal management activities that have the potential to reduce the risk to patients of experiencing adverse events caused by counterfeit, diverted, or tampered product.

  4. Pharmacovigilance of herbal medicines in Africa: Questionnaire study.

    PubMed

    Skalli, Souad; Bencheikh, Rachida Soulaymani

    2015-08-02

    In order to describe and evaluate Herbal Medicine (HM) pharmacovigilance in African countries who are members of the WHO International Programme for Drug Monitoring a survey questionnaire was sent to the national centres and national drug regulatory agencies of these countries. Data collection was carried out from October 1st to 31st December, 2014. Among the total of 39 African countries, 34 (87.2%) answered the questionnaire and 25 (64.1%) accepted to share their data in this publication. Spontaneous adverse reaction reporting for HM is voluntary in 7 (43.7%) countries. HM pharmacovigilance programmes covered suspected adverse HM reactions in 14 (87.5%) countries; HM information in 7 (43.7%) countries; HM dependence or abuse in 6 (37.5%) countries; medication errors in 5 (31.2%) countries; falsification and adulteration in 2 (each 12.5%) countries and HM-drug interactions in 1 (6.3%) country. Groups in countries encouraged to submit herbal reports were pharmacists and physicians (both n=15); nurses (n=13); herbal therapists (n=12); patients (n=11) and local manufacturers (n=8). The number of herbal reports received by most countries was very low or even insignificant. VigiFlow is used by 10 countries. Information from pharmacovigilance activities is disseminated using many means. Only five countries have regulatory status and quality control of their HM products. The participants identified a need for HM regulation, technical and training assistance, and funding as being major challenges to HM pharmacovigilance in countries. Particular attention to the development of pharmacovigilance of HM is required in Africa.

  5. Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance

    PubMed Central

    Hauben, Manfred; Hung, Eric Y.

    2016-01-01

    Introduction: There is an interest in methodologies to expeditiously detect credible signals of drug-induced pancreatitis. An example is the reported signal of pancreatitis with rasburicase emerging from a study [the ‘index publication’ (IP)] combining quantitative signal detection findings from a spontaneous reporting system (SRS) and electronic health records (EHRs). The signal was reportedly supported by a clinical review with a case series manuscript in progress. The reported signal is noteworthy, being initially classified as a false-positive finding for the chosen reference standard, but reclassified as a ‘clinically supported’ signal. Objective: This paper has dual objectives: to revisit the signal of rasburicase and acute pancreatitis and extend the original analysis via reexamination of its findings, in light of more contemporary data; and to motivate discussions on key issues in signal detection and evaluation, including recent findings from a major international pharmacovigilance research initiative. Methodology: We used the same methodology as the IP, including the same disproportionality analysis software/dataset for calculating observed to expected reporting frequencies (O/Es), Medical Dictionary for Regulatory Activities Preferred Term, and O/E metric/threshold combination defining a signal of disproportionate reporting. Baseline analysis results prompted supplementary analyses using alternative analytical choices. We performed a comprehensive literature search to identify additional published case reports of rasburicase and pancreatitis. Results: We could not replicate positive findings (e.g. a signal or statistic of disproportionate reporting) from the SRS data using the same algorithm, software, dataset and vendor specified in the IP. The reporting association was statistically highlighted in default and supplemental analysis when more sensitive forms of disproportionality analysis were used. Two of three reports in the FAERS database were

  6. Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance.

    PubMed

    Hauben, Manfred; Hung, Eric Y

    2016-06-01

    There is an interest in methodologies to expeditiously detect credible signals of drug-induced pancreatitis. An example is the reported signal of pancreatitis with rasburicase emerging from a study [the 'index publication' (IP)] combining quantitative signal detection findings from a spontaneous reporting system (SRS) and electronic health records (EHRs). The signal was reportedly supported by a clinical review with a case series manuscript in progress. The reported signal is noteworthy, being initially classified as a false-positive finding for the chosen reference standard, but reclassified as a 'clinically supported' signal. This paper has dual objectives: to revisit the signal of rasburicase and acute pancreatitis and extend the original analysis via reexamination of its findings, in light of more contemporary data; and to motivate discussions on key issues in signal detection and evaluation, including recent findings from a major international pharmacovigilance research initiative. We used the same methodology as the IP, including the same disproportionality analysis software/dataset for calculating observed to expected reporting frequencies (O/Es), Medical Dictionary for Regulatory Activities Preferred Term, and O/E metric/threshold combination defining a signal of disproportionate reporting. Baseline analysis results prompted supplementary analyses using alternative analytical choices. We performed a comprehensive literature search to identify additional published case reports of rasburicase and pancreatitis. We could not replicate positive findings (e.g. a signal or statistic of disproportionate reporting) from the SRS data using the same algorithm, software, dataset and vendor specified in the IP. The reporting association was statistically highlighted in default and supplemental analysis when more sensitive forms of disproportionality analysis were used. Two of three reports in the FAERS database were assessed as likely duplicate reports. We did not

  7. Outcomes in patients after myocardial infarction similar to those of the PEGASUS-TIMI 54 trial: A cohort study in the French national claims database.

    PubMed

    Blin, Patrick; Dureau-Pournin, Caroline; Lassalle, Régis; Jové, Jérémy; Thomas-Delecourt, Florence; Droz-Perroteau, Cécile; Danchin, Nicolas; Moore, Nicholas

    2017-09-01

    The present study aims to describe real-life outcomes in stable patients after-myocardial infarction (MI) similar to those in the PEGASUS-TIMI 54 trial (PEGASUS), which found long-term benefits of ticagrelor in patients with a history of MI. One-year event-free post-MI patients were identified in the French claims database representative 1/97 sample (2005-2010) and followed for up to 3 years. A PEGASUS-like (PL) population included patients with age ≥ 65 years, or age ≥ 50 and diabetes, renal dysfunction or prior MI, without stroke, end-stage renal failure or oral anticoagulation. Outcomes were: a composite of all-cause death or hospital admission for MI or stroke; individual events; major bleeding. There were 1585 post-MI patients totalling 3926 person-years including 865 PL patients (2114 PY); 68% were male; mean age was 66 (standard deviation 15) in post-MI, 74 (10) in PL. Outcomes per 100 person-years [95% confidence interval] were, respectively, in post-MI and PL 6.3 [5.6-7.1] and 7.8 [6.7-8.9] for the composite outcome; 5.1 [4.4-5.8] and 6.5 [5.5-7.6] for death; 1.0 [0.7-1.3] and 1.0 [0.6-1.4] for MI; 0.6 [0.4-0.9] and 0.9 [0.5-1.2] for stroke; 1.3 [0.9-1.6] and 1.4 [0.9-1.9] for major bleeding. Event rates were stable over the 3 study years. Placebo patients in the PEGASUS-TIMI54 Study were younger, more often male and had lower event rates, especially for all-cause death and major bleeding. Patients selected using the criteria described in PEGASUS were older with more comorbidities, resulting in higher all-cause death and bleeding rates, but similar MI recurrence rates. © 2017 The British Pharmacological Society.

  8. Comparative analysis of adverse drug reactions to tetracyclines: results of a French national survey and review of the literature.

    PubMed

    Lebrun-Vignes, B; Kreft-Jais, C; Castot, A; Chosidow, O

    2012-06-01

    The question of quantitative and qualitative differences between adverse drug reactions (ADRs) to tetracyclines was raised many years ago, especially for minocycline and doxycycline. To assess and compare ADRs related to tetracyclines according to sales figures in France through a national survey. ADR data were collected from the French Pharmacovigilance Database (FPD), marketing authorization holders (MAH) and the literature. Sales analyses were based on MAH data provided annually to the French Drugs Agency. Among the tetracyclines available in France, doxycycline and minocycline are the most frequently used. However, their sales decreased between 1995 and 2007, more sharply for minocycline than doxycycline. According to the FPD, based on MAH data and published reports, minocycline-associated ADRs were more serious and were reported more frequently than for the other tetracyclines. Minocycline and doxycycline ADR patterns differed: gastrointestinal disorders (especially oesophageal lesions) predominated with doxycycline, while intracranial hypertension and hepatic disorders were primarily reported with minocycline. Autoimmune disorders, drug reaction with eosinophilia and systemic symptoms (DRESS) and other hypersensitivity reactions were also more frequent with minocycline. ADRs reported with lymecycline and metacycline were essentially cutaneous and gastrointestinal disorders. In the absence of markedly better efficacy against the various indications for tetracyclines, the minocycline benefit/risk ratio was clearly lower than that of doxycycline, and possibly those of lymecycline and metacycline. In light of these findings, minocycline should no longer be considered first-line therapy for inflammatory skin disorders, especially acne. © 2012 The Authors. BJD © 2012 British Association of Dermatologists.

  9. Utilizing Social Media Data for Pharmacovigilance: A Review

    PubMed Central

    Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O’Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

    2015-01-01

    Objective Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. Methods We identified studies, describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to utilize ADR information posted by users on any publicly available social media platform. We categorized the studies into various dimensions such as primary ADR detection approach, size of data, source(s), availability, evaluation criteria, and so on. Results Twenty-two studies met our inclusion criteria, with fifteen (68.2%) published within the last two years. The survey revealed a clear trend towards the usage of annotated data with eleven of the fifteen (73.3%) studies published in the last two years relying on expert annotations. However, publicly available annotated data is still scarce, and we found only six (27.3%) studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been

  10. Analysis of Patient Narratives in Disease Blogs on the Internet: An Exploratory Study of Social Pharmacovigilance

    PubMed Central

    Aoki, Kotonari; Tomizawa, Shiho; Sone, Masayoshi; Tanaka, Riwa; Kuriki, Hiroshi; Takahashi, Yoichiro

    2017-01-01

    Background Although several reports have suggested that patient-generated data from Internet sources could be used to improve drug safety and pharmacovigilance, few studies have identified such data sources in Japan. We introduce a unique Japanese data source: tōbyōki, which translates literally as “an account of a struggle with disease.” Objective The objective of this study was to evaluate the basic characteristics of the TOBYO database, a collection of tōbyōki blogs on the Internet, and discuss potential applications for pharmacovigilance. Methods We analyzed the overall gender and age distribution of the patient-generated TOBYO database and compared this with other external databases generated by health care professionals. For detailed analysis, we prepared separate datasets for blogs written by patients with depression and blogs written by patients with rheumatoid arthritis (RA), because these conditions were expected to entail subjective patient symptoms such as discomfort, insomnia, and pain. Frequently appearing medical terms were counted, and their variations were compared with those in an external adverse drug reaction (ADR) reporting database. Frequently appearing words regarding patients with depression and patients with RA were visualized using word clouds and word cooccurrence networks. Results As of June 4, 2016, the TOBYO database comprised 54,010 blogs representing 1405 disorders. Overall, more entries were written by female bloggers (68.8%) than by male bloggers (30.8%). The most frequently observed disorders were breast cancer (4983 blogs), depression (3556), infertility (2430), RA (1118), and panic disorder (1090). Comparison of medical terms observed in tōbyōki blogs with those in an external ADR reporting database showed that subjective and symptomatic events and general terms tended to be frequently observed in tōbyōki blogs (eg, anxiety, headache, and pain), whereas events using more technical medical terms (eg, syndrome and

  11. Indian College of Physicians (ICP) Position Statement on Pharmacovigilance.

    PubMed

    Dhamija, Puneet; Kalra, Sanjay; Sharma, Pramod Kumar; Kalaiselvan, V; Muruganathan, A; Balhara, Yatan Pal Singh; Badani, Rajesh; Bantwal, Ganapathi; Das, A K; Dhorepatil, Bharati; Ghosh, Sujoy; Jeloka, Tarun; Khandelwal, Deepak; Nadkar, Milind Y; Patnaik, Kuppili Pooja; Saboo, Banshi; Sahay, Manisha; Sahay, Rakesh; Tiwaskar, Mangesh; Unnikrishnan, A G

    2017-03-01

    Pharmacovigilance is the art and science of detection, understanding and prevention of adverse drug reactions and not merely a critical analysis of prescriptions and errors. This field starts with reporting by clinicians of a suspected adverse drug reaction (ADR) to the pharmacologist followed by joint causality analysis and ends at the application of new information by a clinician for benefit of patients. There are a number of ways, which can be utilised for reporting adverse effects using pen and paper format to software applications for smart phones. Varied types of activities spreading from systematic reviews to the mechanistic evaluation of ADR can be performed under the umbrella of pharmacovigilance. It is of utmost importance for clinicians to understand how to identify, communicate and understand adverse effects of drugs with an aim to prevent harm to patients. © Journal of the Association of Physicians of India 2011.

  12. [Pharmacovigilance: a case of phantom ships and Russian roulette].

    PubMed

    Stricker, B H Ch

    2002-07-06

    The medical literature is full of associations between drugs and adverse events which have not been proven by epidemiological studies, such as the 30-year-old discussion on levodopa use and the development of melanoma. The organisation of drug safety (pharmacovigilance) by marketing authorisation holders and regulatory authorities relies heavily on voluntary reporting schemes, despite the fact that such schemes suffer from substantial underreporting. Nevertheless, even though marketing authorisation holders are legally responsible for the product, regulatory authorities scarcely oblige them to perform hypothesis-testing epidemiological studies. In view of the importance of drug safety for healthcare and the need for checks and balances, pharmacovigilance should be coordinated by an organisation which is independent from the pharmaceutical industry and regulatory authorities, such as the Dutch Healthcare Inspectorate.

  13. Pharmacovigilance in Clinical Trials: Current Practice and Challenges.

    PubMed

    Cheaib, N

    2016-01-01

    In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing local pharmacovigilance guideline, in sync with global practice cannot be overemphasized.

  14. Hypoglycemia hospitalization frequency in patients with type 2 diabetes mellitus: a comparison of dipeptidyl peptidase 4 inhibitors and insulin secretagogues using the French health insurance database.

    PubMed

    Detournay, Bruno; Halimi, Serge; Robert, Julien; Deschaseaux, Céline; Dejager, Sylvie

    2015-01-01

    We aimed to compare the frequency of severe hypoglycemia leading to hospitalization (HH) and emergency visits (EV) for any cause in patients with type 2 diabetes mellitus exposed to dipeptidyl peptidase 4 (DPP4) inhibitors (DPP4-i) versus those exposed to insulin secretagogues (IS; sulfonylureas or glinides). Data were extracted from the EGB (Echantillon Généraliste des Bénéficiaires) database, comprising a representative sample of ~1% of patients registered in the French National Health Insurance System (~600,000 patients). Type 2 diabetes mellitus patients exposed to regimens containing either a DPP4-i (excluding treatment with IS, insulin, or glucagon-like peptide 1 analog) or IS (excluding treatment with insulin and any incretin therapy) between 2009 and 2012 were selected. HH and EV during the exposure periods were identified in both cohorts. A similar analysis was conducted considering vildagliptin alone versus IS. Comparative analyses adjusting for covariates within the model (subjects matched for key characteristics) and using multinomial regression models were performed. Overall, 7,152 patients exposed to any DPP4-i and 1,440 patients exposed to vildagliptin were compared to 10,019 patients exposed to IS. Eight patients (0.11%) from the DPP4-i cohort and none from the vildagliptin cohort (0.0%) were hospitalized for hypoglycemia versus 130 patients (1.30%) from the IS cohort (138 hospitalizations) (P=0.02 and P<0.0001, respectively). Crude rates of HH/1,000 patient-years were 1.4 (95% CI: 0.7; 2.4) in the DPP4-i cohort, 0.0 in the vildagliptin cohort (95% CI: 0.0; 4.0), versus 5.6 (95% CI, 4.7; 6.6) in the IS cohort (P<0.0001). After adjustments, rates per 1,000 patient-years of HH were 1.4 (95% CI: 0.7; 2.4) with DPP4-i versus 7.5 (95% CI: 6.0; 9.2) with IS (P<0.0001), and 0.0 (95% CI: 0.0; 4.0) with vildagliptin versus 13.6 (95% CI: 10.4; 17.5) with IS (P<0.0001). Adjusted EV rates were also significantly lower with all DPP4-i or with vildagliptin

  15. Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

    PubMed Central

    Soussi Tanani, Driss; Tebaa, Amina; Benkirane, Raja; Bennani, Kenza; Iraqi, Ghali; Soulaymani, Abdelmajid; Soulaymani Bencheikh, Rachida

    2014-01-01

    The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010–October 2012; period 2: October 2012–December 2013). The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P < 10−3). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (P = 10−4), and 40.9% of cases in the first period were serious against 15.8% in second period (P = 0.003). Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs. PMID:25013729

  16. Patterns of methylphenidate use and assessment of its abuse and diversion in two French administrative areas using a proxy of deviant behaviour determined from a reimbursement database: main trends from 2005 to 2008.

    PubMed

    Frauger, Elisabeth; Pauly, Vanessa; Natali, François; Pradel, Vincent; Reggio, Patrick; Coudert, Hervé; Thirion, Xavier; Micallef, Joëlle

    2011-05-01

    Methylphenidate is a psychostimulant drug indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Its abuse and diversion have been previously described in specific populations, such as students; however, few studies investigating abuse and diversion among the overall population are available. The aim of this study was to describe patterns of methylphenidate use and to explore the magnitude of its abuse and diversion in two French administrative areas using data from a reimbursement database. A proxy of 'deviant behaviour' was used for the abuse and diversion of methylphenidate, defined using the following parameters: total number of defined daily doses (DDDs) of methylphenidate dispensed; number of different pharmacies seen for dispensing of methylphenidate; number of prescribers consulted for a prescription of methylphenidate; and number of dispensings of methylphenidate. Data from the reimbursement database were analysed by clustering methods. These data were assessed from 2005 to 2008. The French General Health Insurance System (GHIS) database was used to obtain data on methylphenidate use in two French administrative areas. Individuals affiliated to the GHIS who had a prescription for methylphenidate reimbursed between 1 January and 31 March of 4 selected years (2005, 2006, 2007 and 2008) were included. After the first dispensing of methylphenidate for these individuals, all their dispensings (including methylphenidate and other psychoactive drugs) were monitored over a 9-month period. Following a descriptive analysis, a clustering method was used to identify different subgroups of subjects according to the methylphenidate consumer profile characteristics. With regard to the number of patients who had a dispensing for methylphenidate during the first quarter of the year, an 84% increase was observed between 2005 (n = 640) and 2008 (n = 1175). The clustering method identified two subgroups. One of them was characterized by a

  17. Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

    PubMed

    Bate, Andrew; Beckmann, Jürgen; Dodoo, Alexander; Härmark, Linda; Hartigan-Go, Kenneth; Hegerius, Anna; Lindquist, Marie; van Puijenbroek, Eugène; Tuccori, Marco; Hagemann, Ulrich

    2017-03-01

    The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.

  18. The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process.

    PubMed

    Bousquet, Cedric; Dahamna, Badisse; Guillemin-Lanne, Sylvie; Darmoni, Stefan J; Faviez, Carole; Huot, Charles; Katsahian, Sandrine; Leroux, Vincent; Pereira, Suzanne; Richard, Christophe; Schück, Stéphane; Souvignet, Julien; Lillo-Le Louët, Agnès; Texier, Nathalie

    2017-09-21

    Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules

  19. Pharmacovigilance amongst patent medicine vendors (PMVs) in Ekiti state, Nigeria.

    PubMed

    Awodele, Olufunsho; Adeniran, Adeyinka; Awodele, Deborah F

    2012-01-01

    With the current population of Nigeria and the limited number of trained health care providers, PMVs are inevitable and highly needed especially in the rural areas for the supply of drugs in treating minor illnesses. Thus, pharmacovigilance (PVG) activity in Nigeria cannot exclude the roles of PMVs; therefore, this study was aimed to determine the knowledge of PMVs on PVG and adverse drug reaction reporting system. The study was a descriptive cross-sectional survey of the knowledge of Pharmacovigilance and adverse drug reaction reporting system of 96 PMVs in Ekiti state, Nigeria before the National Pharmacovigilance training in February, 2011 and after the training. The data obtained before the training showed that more than 87% of the respondents had at least secondary level of education. About half of the respondents (58.5%) knew the correct meaning of PVG and 56.6% knew how to report ADRs. But only about one third of them (35.8%) knew where to obtain ADR forms. Very few respondents 3 (5.7%) had received report/complaints of ADR from patients in the last 1 month while just 2 (3.8%) of them reported. The most commonly mentioned factors/reasons for poor reporting of ADRs/compliance with PVG guideline by the respondents were fears of indictment (61.3%), poor public knowledge (88.7%), and poor training on PMVs (92.5%). However, the results after the training showed a statistically significant (p ≤ 0.005) improvement in the proportion of respondents who were aware of PVG (from 55.8% to 89.1%), those who knew the meaning of PVG (from 49.0% to 61.7%), where to obtain ADR form (28.3% to 92.1%) and those who knew how to report ADRs (44.2% to 88.0%). PMVs are ready to practice PVG if they are properly trained. Training has been revealed to play a significant role in the knowledge of the concept of PVG amongst PMVs. It is therefore recommended that National Pharmacovigilance Centre should continue to organize periodic trainings for PMVs especially those with poor

  20. Pharmacovigilance in Russia: current state of affairs, challenges, and prospects.

    PubMed

    Gildeeva, Geliya; Belostotsky, Andrey

    2017-06-25

    This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.

  1. The Mini Mental State Examination at the Time of Alzheimer's Disease and Related Disorders Diagnosis, According to Age, Education, Gender and Place of Residence: A Cross-Sectional Study among the French National Alzheimer Database

    PubMed Central

    Pradier, Christian; Sakarovitch, Charlotte; Le Duff, Franck; Layese, Richard; Metelkina, Asya; Anthony, Sabine; Tifratene, Karim; Robert, Philippe

    2014-01-01

    The aim of this study was firstly to describe the MMSE (Mini-Mental State Examination) score upon initial diagnosis of Alzheimer's disease and related disorders among the French population, according to age. Secondly, education, gender and place of residence were studied as factors potentially associated with delayed Alzheimer's disease diagnosis. Design we conducted a cross sectional analysis of the French National Alzheimer database (BNA). Data from 2008 to 2012 were extracted. Patients were selected at the moment of their first diagnosis of AD (n = 39,451). Results The MMSE score at initial diagnosis dropped significantly with increasing age. The test score increased with the degree of educational background regardless of age. Gender and place of residence were significantly related to the MMSE score, women and persons living in medical institutions having lower MMSE scores under the age of 90 years and at all educational levels. Conclusions Health care professionals should be aware of these risk factors in order to maximize chances of earliest possible diagnosis of Alzheimer's disease and related disorders. PMID:25093735

  2. Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation.

    PubMed

    Leporini, Christian; Marrazzo, Giuseppina; Mumoli, Laura; Esposito, Stefania; Gallelli, Luca; Mangano, Giovanna; Brancati, Giacomino; De Francesco, Emanuela Adele; Russo, Emilio; De Sarro, Giovambattista

    2017-05-01

    The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.

  3. Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems

    PubMed Central

    Schjøtt, Jan; Bergman, Jenny

    2014-01-01

    Background RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and clinical pharmacologists provide feedback to health care professionals in spontaneous drug-related questions and adverse drug-reaction (ADR) reports published in a question–answer pair (QAP) database (the RELIS database) and the Norwegian ADR database, respectively. Objective To describe the potential of RELIS’s dual service to improve detection and communication of drug-safety problems. Materials and methods We searched the RELIS database for QAPs about ADRs with use of the Norwegian ADR database as a reference. We also searched the Norwegian ADR database for reports that used the RELIS database as a reference. Both searches were limited to the years 2003–2012. We then selected the example of pregabalin and drug abuse after the marketing of Lyrica in Norway in September 2004 to illustrate RELIS’s potential to detect new drug-safety information through a limited number of QAPs and ADR reports. Results A total of 5,427 (26%) of 21,071 QAPs in the RELIS database concerned ADRs. QAPs from this database were used as references in 791 (4%) of a total of 22,090 reports in the Norwegian ADR database. The Norwegian ADR database was used as a reference in 363 (7%) of 5,427 QAPs that concerned ADRs. Between September 2004 and September 2008, RELIS received eleven questions and 13 ADR reports about suspicion of Lyrica (pregabalin) and different aspects of abuse. Conclusion RELIS processes data through two databases that facilitate communication about ADRs. Our service also has the potential to detect new drug-safety problems with a limited number of questions and ADR reports. PMID:25061339

  4. [Importance of pharmacovigilance in current medical practice].

    PubMed

    Ponte, Marcelo L; Ragusa, Martín; Armenteros, Christian; Wachs, Adolfo

    2013-01-01

    Adverse drug reactions (ADRs) are cause of significant morbi-mortality They are between the fourth and sixth cause of mortality in developed countries and cause nearly 12% of hospitalizations. The objective of this publication was to analyze the incidence of ADRs in a tertiary care hospital in Buenos Aires City. The hospital phamacovigilance database for the period June 2008- February 2012, was analyzed. The Naranjo score was applied to assess drug causality. We consider serious an ADRs when it potentially compromised life, induced hospitalization or prolonged it, caused discapacity, teratogenesis or death. In this period, a total of 2420 ADRs were detected: 469 (19.38%; CI 95%: 17.80 - 20.95) were serious, mainly because they induced hospitalization (n = 287). There were 14 ADRs- related deaths. Cardiovascular and neuropsychiatric drugs, antibiotics and corticoids were those most frequently related to toxicity. Endocrine-metabolic disorders, hepatotoxicity, nephrotoxicity and pharmacodermy were the most frequently involved. Among the ADR most frequently associated to hospitalization were Immunosuppressant-associated severe infections and upper gastrointestinal bleeding related to oral anticoagulants and non steroids anti-inflammatory drugs. The ADRs incidence in hospitalized patients and ADRs related hospital admissions were considered relatively high. Drugs involved were similar to those reported in the international bibliography except for the higher incidence of immunosuppressants related admissions here observed.

  5. Issues with regulatory pharmacovigilance in East European countries: the industry perspective.

    PubMed

    Hanzl-Dujmović, Ivana; Sulić-Milisić, Zrinka; Staresinić-Sernhorst, Ivana

    2007-02-05

    The new European Union pharmaceutical legislation emphasizes the importance of ensuring the continued safety of medicinal products in use with the main purpose to protect the public health. To fulfil this task the Member States are obliged to establish pharmacovigilance systems, which could be continually adapted to take account of scientific and technical progress. The non-EU East European countries are oriented towards the same goal on their way to the community. They are changing their legal frameworks for pharmacovigilance to harmonize it with the European requirements. As the EU accession country, Croatia is also in a phase of harmonization of the national legislation on medicines with the latest European requirements. It has established the pharmacovigilance system in which the Croatian Agency for Medicines and Medical Devices has very important role, and it involves all stakeholders-pharmaceutical industry, Healthcare Professionals and patient organizations. Belupo Inc. is faced with changes in the field of pharmacovigilance on all its markets: in Croatia, in EU as well as in the East European countries outside the EU, which are traditionally Belupo's target markets. The structure and functioning of the pharmacovigilance system in Croatia and other non-EU East European countries based on Belupo's experience gathered through the activities of its Pharmacovigilance Department and activities of its Qualified Persons for Pharmacovigilance (QP) are presented.

  6. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria.

    PubMed

    Awodele, Olufunsho; Akinyede, Akinwumi; Adeyemi, Oladunni Adejoke; Awodele, Deborah Funmilola

    2011-01-01

    Appropriate practice of pharmacovigilance in Nigeria will require total involvement of the private medical practitioners considering their number and closeness to the community. Thus, the understanding and attitude of Doctors practicing in the private sectors, towards Pharmacovigilance, was investigated. A consecutive sampling was used to distribute two hundred and seventy questionnaires to consenting doctors in the private hospitals of the Lagos West Senatorial District. The response rate was 93% and the results showed that majority of the respondents, 208 (82.9%), have heard about pharmacovigilance and a large percentage (79.3%) defined pharmacovigilance correctly. However, most of the respondents, 141 (56.2%), did not know how to report ADRs and where to obtain the ADR forms (71.7%). Only 14 (5.6%) of the respondents reported ADRs in the last one month. However, the majority of the respondents (89.6%) were willing to practice pharmacovigilance if they are trained. There were significant associations (p < 0.05) between previous areas of practice of the respondents; the respondents' academic qualifications; years of experience and reporting of ADRs. The NPC has already been organizing series' of trainings for doctors on pharmacovigilance, however, more periodic trainings should be organized for doctors especially those practicing in private hospitals. The curriculum of medical schools should be reviewed for its pharmacovigilance content.

  7. [Evolution of the number and type of penile prostheses implanted in France for erectile dysfunction: Analysis of French national coding database (2006-2013)].

    PubMed

    Lipsker, A; Saljoghi, R; Lecuelle, D; Caillet, K; Alezra, E; Le Roux, F; Demailly, M; Saint, F

    2016-09-01

    Patients who are not responding to injectable and/or vacuum oral pharmacological treatments can receive a penile prosthesis. Three types of penile prostheses are used in France: rigid, semi-rigid and inflatable prostheses 3-piece or 2-piece. We have assessed the National surgical insertion practices between 2006 and 2013 (number of prostheses insertions, types, procedure locations, number of surgeons and distribution [public or private sectors]). Data analysis from the French Technical Agency of Information on Hospitals (ATIH) (2006-2013) using the common classification of medical acts (CCAM) and after code extractions related to this surgery (JHLA002, JHLA003, JHLA004). Between 2006 and 2013, the number of penile implants in France doubled (307 to 633), inflatable penile prostheses with an extracavernous component remained the most frequently used (87 %) (228 to 552) (+142 %). The use of semi-rigid prostheses declined by 26.7 %. The distribution between the private and public sector was close to 1 in 2013. More than half of French penile prostheses were implanted in three regions (Île-de-France, Languedoc-Roussillon, Rhône-Alpes). Nearly 62 % of surgeons implanted only one or two three-compartment prostheses in 2013. The number of penile prostheses in France doubled between 2006 and 2013. Three regions were particularly active as far as this surgery is concerned (Île-de-France, Languedoc-Roussillon, Rhône-Alpes). They were boosted by 5 surgeons with more than 20 prostheses surgeries a year. 4. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  8. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia

    PubMed Central

    Aljadhey, Hisham; Mahmoud, Mansour A.; Alshammari, Thamir M.; Al-Dhaeefi, Mohammed; Louet, Hervé Le; Perez-Gutthann, Susana; Pitts, Peter J.

    2015-01-01

    Objectives: To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. Methods: This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice. Result: Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training. Conclusion: The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance. PMID:26318468

  9. Pharmacovigilance in veterinary medicine in Chile: a pilot study.

    PubMed

    Iragüen, D; Urcelay, S; San Martín, B

    2011-04-01

    Iragüen, D., Urcelay, S., San Martín, B. Pharmacovigilance in veterinary medicine in Chile: a pilot study. J. vet. Pharmacol. Therap.34, 108-115. In Chile, there is no present government policy to survey and analyse adverse drug reactions (ADRs) in the field of veterinary medicine. The intent of this study is to assess, for the first time, ADR frequency in treated animals. To this purpose, a 6-month period pilot study based on WHO recommendations was conducted to monitor ADRs in cats and dogs for frequently used drugs and common labelled signs. Of a total of 149 detected ADRs, 29 (6 in cats and 23 in dogs) were notified by means of ADR report forms, while the rest was identified after reviewing patient clinical records, thus evidencing strong under-reporting problems. More than 70% of ADRs were related to antimicrobials, vaccines and tranquilizers. In dogs, there was a significant effect on ADRs' presentation when acepromazine, amoxicillin, carprofen, ivermectin, sextuple vaccine (polyvalent vaccine that confers immunity against canine distemper virus, canine parvovirus, Leptospira canicola, L. icterohemmoragiae, canine adenovirus type 2 and canine parainfluenza virus) and phytomenadione (subcutaneous injection) were administered. In the case of cats, a significant influence on ADRs was detected when acepromazine, amoxicillin or vitamin K was administered. Present results suggest the need for a pharmacovigilance programme in veterinary medicine for timely ADR-presenting drug detection and drug safety improvement.

  10. [Use abusive of benzydamine in Brazil: an overview in pharmacovigilance].

    PubMed

    Mota, Daniel Marques; Costa, Alessandra Alves da; Teixeira, Christiane Dos Santos; Bastos, Augusto Amorim; Dias, Murilo Freitas

    2010-05-01

    The abusive drug use has been object of increasing concern in public health and is commonly issued in the Brazilian press. Amongst medicines, those that are abuse substances and cause physical and/or psychic dependence, barbiturates, benzodiazepines, opioid analgesics and amphetamines are included. Analgesics, antipyretics and non-steroidal anti-inflammatory drugs, even not making part of this list, are generally associated with recreational use or non therapeutical purpose. The objective of this essay is to present information on the abusive use of benzydamine in Brazil. The present study is an exploratory essay in which different methodological strategies adopted in the regulatory practice of pharmacovigilance have been used. The abusive use of this drug was evidenced in scientific literature, press releases and on the internet. Considering the facility of purchasing drugs under medical prescription, among other factors, it must be demanded ways to assess the marketing and use of medicines, and assure its safe and rational use, including the strengthening of pharmacovigilance in Brazil.

  11. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

    PubMed

    Tsintis, Panos; La Mache, Edith

    2004-01-01

    In this article we review the current initiatives by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) on pharmacovigilance planning that are due for general release during 2004. These initiatives could form the basis for applying concepts of risk management to medicines throughout their life cycle, from preclinical and clinical development to marketed use. The CIOMS VI Working Group (with 28 senior scientists worldwide from drug regulatory authorities and pharmaceutical companies) is currently developing scientific guidance that relates to clinical trials for medicines during development. It recommends a developmental pharmacovigilance concept - a 'living' concept that would start early in drug development supporting the science and ethics of research leading up to licensing (marketing authorisation) and continuing to post-authorisation (postmarketing) pharmacovigilance. This approach is seen as complementary to current ICH initiatives called 'Pharmacovigilance Planning'. ICH will introduce two concepts in pharmacovigilance management of medicinal products: the 'Pharmacovigilance Specification' and the 'Pharmacovigilance Plan'. The 'Pharmacovigilance Specification' will summarise important knowns and unknowns about the medicine. It will include safety risks identified at the licensing stage, potential risks and any key missing information. These elements will be essential to the formulation of pharmacovigilance plans. Dialogue and common understanding between regulators and the pharmaceutical industry will be a key factor for developing pharmacovigilance plans during the life cycle of medicines. Appropriate interaction with health professionals and patients should also be planned for the future as regulatory systems become more transparent. Where no significant issues are apparent at the licensing (marketing authorisation) stage, routine pharmacovigilance practices will be followed

  12. Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

    PubMed

    Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

    2013-12-01

    Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

  13. Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis

    PubMed Central

    Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

    2013-01-01

    Introduction: Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. Materials and Methods: We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. Results: A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar®), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups “41-65” (39.07%) and “over 65” (27.9%) were the most affected. Conclusions: Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed. PMID:24347984

  14. Healthcare professionals’ awareness and knowledge of adverse drug reactions and pharmacovigilance

    PubMed Central

    Almandil, Noor B.

    2016-01-01

    Objectives To document the knowledge of, attitudes toward, and practices of adverse drug reaction (ADR) reporting and pharmacovigilance systems among healthcare professionals. Methods This descriptive cross-sectional study was conducted using a questionnaire. This study took place at King Fahd Hospital of the University (KFHU), Khobar, Kingdom of Saudi Arabia, between April 2015 and April 2016. Healthcare professionals, including physicians, pharmacists, pharmacy technicians, and nurses, were considered eligible and invited to take part in the study. A link to the online questionnaire was sent to each participant via E-mail, and a hard copy was circulated at the hospital after the objectives of the study were explained. The questionnaire comprised items regarding knowledge/awareness of pharmacovigilance and ADRs, perception/attitude towards pharmacovigilance and ADR reporting, and practices of ADR reporting. Descriptive statistics were used to analyze the data. Results A total of 400 questionnaires were distributed to the healthcare professionals and 331 participants responded, providing a response rate of 82.75%. The healthcare professionals comprised 161 physicians, 39 pharmacists, 21 pharmacist technicians, and 110 nurses. Most of the participants were female (n=198) and Saudi (61.9%). Most healthcare professionals (62.5%) were unaware of the term pharmacovigilance; the pharmacists and pharmacist technicians had the highest rate of pharmacovigilance awareness (60.5% of the pharmacists and 40% of pharmacist technicians). Conclusion There is a lack of awareness and knowledge of pharmacovigilance and ADR reporting among healthcare professionals working at KFHU. PMID:27874152

  15. Data mining in pharmacovigilance: the need for a balanced perspective.

    PubMed

    Hauben, Manfred; Patadia, Vaishali; Gerrits, Charles; Walsh, Louisa; Reich, Lester

    2005-01-01

    Data mining is receiving considerable attention as a tool for pharmacovigilance and is generating many perspectives on its uses. This paper presents four concepts that have appeared in various professional venues and represent potential sources of misunderstanding and/or entail extended discussions: (i) data mining algorithms are unvalidated; (ii) data mining algorithms allow data miners to objectively screen spontaneous report data; (iii) mathematically more complex Bayesian algorithms are superior to frequentist algorithms; and (iv) data mining algorithms are not just for hypothesis generation. Key points for a balanced perspective are that: (i) validation exercises have been done but lack a gold standard for comparison and are complicated by numerous nuances and pitfalls in the deployment of data mining algorithms. Their performance is likely to be highly situation dependent; (ii) the subjective nature of data mining is often underappreciated; (iii) simpler data mining models can be supplemented with 'clinical shrinkage', preserving sensitivity; and (iv) applications of data mining beyond hypothesis generation are risky, given the limitations of the data. These extended applications tend to 'creep', not pounce, into the public domain, leading to potential overconfidence in their results. Most importantly, in the enthusiasm generated by the promise of data mining tools, users must keep in mind the limitations of the data and the importance of clinical judgment and context, regardless of statistical arithmetic. In conclusion, we agree that contemporary data mining algorithms are promising additions to the pharmacovigilance toolkit, but the level of verification required should be commensurate with the nature and extent of the claimed applications.

  16. The periodic safety update report as a pharmacovigilance tool.

    PubMed

    Klepper, Michael J

    2004-01-01

    The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool. Numerous steps are involved in the PSUR process including: intake of adverse drug reaction information, case processing, data retrieval, data analysis, and medical review and risk assessment. These processes are heavily reliant on the availability of adequate resources. An overarching principle throughout the PSUR process is the need for a proactive approach in order to identify the critical steps in the process and to have a clear understanding of the consequences of any critical 'mis-step'. With this information comes appropriate planning, building quality into each step of the PSUR process and monitoring performance will maximise the likelihood of generating a quality report. Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health. A pragmatic approach that will avoid or minimise these pitfalls includes the following: adequate resource planning, training, development of 'scripts' designed to maximise the capture of key information for medically important reactions, standardised and harmonised Medical Dictionary for Regulatory Activities (MedDRA) coding procedures, pre-specified search criteria for data retrieval, ongoing medical review, and metrics to evaluate

  17. Association Between Psychotropic and Cardiovascular Iatrogenic Alerts and Risk of Hospitalizations in Elderly People Treated for Dementia: A Self-Controlled Case Series Study Based on the Matching of 2 French Health Insurance Databases.

    PubMed

    Zerah, Lorene; Boddaert, Jacques; Leperre-Desplanques, Armelle; Bonnet-Zamponi, Dominique; Verny, Marc; Deligne, Jean; Boelle, Pierre-Yves

    2017-06-01

    Elderly people are at risk of repeated hospitalizations, some of which may be drug related and preventable. In 2011, a group of French healthcare experts selected 5 iatrogenic alerts (IAs), based on criteria identified in a literature search and from their professional experience, to assess the appropriateness of medication in elderly patients. Our objective was to examine the association between hospitalizations and IAs in elderly patients treated for Alzheimer disease who are particularly sensitive to adverse drug events. A 2-year (January 1, 2011, to December 31, 2012) longitudinal national database study, with a study design similar to self-controlled case series, was performed to analyze data on drug prescriptions and hospitalization. IAs were defined as (1) long half-life benzodiazepine; (2) antipsychotic drugs in patients with Alzheimer disease; (3) co-prescription of 3 or more psychotropic drugs; (4) co-prescription of 2 or more diuretics; and (5) co-prescription of 4 or more antihypertensive drugs. Data were obtained by matching of 2 French National Health Insurance Databases. France. All affiliates, aged ≥75 years, receiving treatment for Alzheimer disease, alive on January 1, 2011 were included. We calculated the relative increase in the number of hospitalizations in patients with IAs. The analysis was performed over four 6-month periods. A total of 10,754 patients were included. During the periods with IAs, hospitalization rates increased by 0.36/year compared with 0.23/year in the periods without for the same patient, and the number of hospitalizations doubled [proportional fold change = 1.9, 95% confidence interval (1.8, 2.1)]. We estimated that 22% [95% confidence interval (20%, 23%)] of all hospitalizations were associated with IAs, 80% of which were due to psychotropic IAs. The IAs could be used as a simple and clinically relevant tool by prescribing physicians to assess the appropriateness of the prescription in elderly patients treated for

  18. Affective norms for French words (FAN).

    PubMed

    Monnier, Catherine; Syssau, Arielle

    2014-12-01

    The present study provides affective norms for a large corpus of French words (N = 1,031) that were rated on emotional valence and emotional arousal by 469 French young adults. Ratings were made using the Self-Assessment Manikin (Lang, 1980). By combining evaluations of valence and arousal, and including ratings provided by male and female young adults, this database complements and extends existing French-language databases. The response reliability for the two affective dimensions was good, and the consistency between the present and previous ratings was high. We found a strong quadratic relationship between the valence and arousal ratings. Perceptions of the affective content of a word were partly linked to sex. This new affective database (FAN) will enable French-speaking researchers to select suitable materials for studies of how the character of affective words influences their cognitive processing. FAN is available as an online supplement downloadable with this article.

  19. Health Professionals' Knowledge, Attitudes and Practices about Pharmacovigilance in India: A Systematic Review and Meta-Analysis

    PubMed Central

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Jamshed, Shazia Qasim; Shehab, Abdulla

    2016-01-01

    Background Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals. Methods A systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis. Results A total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4–66.9; p<0.001) of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI), and 31.9% (95% CI 16.3–47.4; p<0.001) thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4–40.9; p<0.001) of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9–81.9; p<0.001) never reported any ADR to PV centers. Conclusion There was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India. PMID:27010447

  20. Real-world costs and outcomes in metastatic renal cell carcinoma patients treated with targeted therapies: a cohort study from the French health insurance database.

    PubMed

    Maroun, Rana; Fleury, Laetitia; Nachbaur, Gaelle; Maunoury, Franck; Vanhille, Jean-Louis; Durand-Zaleski, Isabelle

    2017-10-01

    The objective of this study was to describe treatment patterns, survival, healthcare use and costs in patients with metastatic renal cell carcinoma (mRCC) in a real-world setting. We used the National Health Insurance (NHI) claims database for the Ile-de-France region to perform a retrospective cohort analysis of patients with mRCC treated by a first-line targeted therapy. Treatment naïve patients were identified combining the 10th revision of the International Classification of Diseases (ICD-10) codes (C64 & C77-C79) and a first prescription of targeted therapies. Descriptive analyses were performed on treatment patterns and patients' characteristics. Progression free survival (PFS) and overall survival (OS) were determined using Kaplan-Meier actuarial survival analysis. All healthcare resource use and costs were estimated on a per patient per month (PPPM) basis (€2016). A total of 327 treatment naïve patients with mRCC were included. Median follow-up was 13.4 months. Sunitinib accounted for 73% of first-line treatments. The most frequently observed treatment sequence for the first two lines was sunitinib-everolimus (16%; n = 137) and for the first three lines sunitinib-everolimus-axitinib (20%; n = 49). First-line PFS for sunitinib, everolimus, pazopanib, sorafenib and other was 8.7, 6.2, 10.7, 5.7 and 11.2 months, respectively. Median OS for patients treated by first-line sunitinib, everolimus, pazopanib, sorafenib and other was respectively 14.7, 8.1, 21.1, 8.9 and 14.0 months. From the NHI's perspective, the mean PPPM was €5546. The average PPPM in pre-progression was €5597 compared to €5541 beyond progression of the disease. Oral targeted therapies accounted for 53% of the total PPPM. This descriptive study showed that the economic burden of mRCC is substantial with oral targeted therapies accounting for 53% of the PPPM. OS and PFS in real life are poorer than observed in clinical trials.

  1. In-Hospital Economic Burden of Metastatic Renal Cell Carcinoma in France in the Era of Targeted Therapies: Analysis of the French National Hospital Database from 2008 to 2013

    PubMed Central

    2016-01-01

    Background & Objectives The aim of this study was to assess the economic burden of hospitalisations for metastatic renal cell carcinoma (mRCC), to describe the patterns of prescribing expensive drugs and to explore the impact of geographic and socio-demographic factors on the use of these drugs. Methods We performed a retrospective analysis from the French national hospitals database. Hospital stays for mRCC between 2008 and 2013 were identified by combining the 10th revision of the International Classification of Diseases (ICD-10) codes for renal cell carcinoma (C64) and codes for metastases (C77 to C79). Incident cases were identified out of all hospital stays and followed till December 2013. Descriptive analyses were performed with a focus on hospital stays and patient characteristics. Costs were assessed from the perspective of the French National Health Insurance and were obtained from official diagnosis-related group tariffs for public and private hospitals. Results A total of 15,752 adult patients were hospitalised for mRCC, corresponding to 102,613 hospital stays. Of those patients, 68% were men and the median age at first hospitalisation was 69 years [Min-Max: 18–102]. Over the study period, the hospital mortality rate reached 37%. The annual cost of managing mRCC at hospital varied between 28M€ in 2008 and 42M€ in 2012 and was mainly driven by inpatient costs. The mean annual per capita cost of hospital management of mRCC varied across the study period from 8,993€ (SD: €8,906) in 2008 to 10,216€ (SD: €10,527) in 2012. Analysis of the determinants of prescribing expensive drugs at hospital did not show social or territorial differences in the use of these drugs. Conclusion This study is the first to investigate the in-hospital economic burden of mRCC in France. Results showed that in-hospital costs of managing mRCC are mainly driven by expensive drugs and inpatient costs. PMID:27649305

  2. Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom

    PubMed Central

    2013-01-01

    The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting. In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use. We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way. PMID:23758677

  3. Improving pediatric drug safety: need for more efficient clinical translation of pharmacovigilance knowledge.

    PubMed

    Castro-Pastrana, Lucila I; Carleton, Bruce C

    2011-01-01

    There is an urgency to improve the evaluation of pediatric drug safety in the pre-market and post-market phases of drug evaluation. The need to improve pharmacovigilance methods concerns not only new drugs but also existing drugs that have been used for many years in an off-label manner in children. Effective methods for early detection of adverse drug reactions (ADRs) and drug safety epidemiologic studies are a pressing need in pediatrics. Moreover, the nature and severity of an ADR as well as the extent to which the suspected drug is being used, will determine how quickly the information about risk needs to be made available to users and what would be the most appropriate method of communication. Based on our experience through the Genotype-specific Approaches to Therapy in Children study, an active ADR surveillance network of pediatric hospitals across Canada, we present five strategic elements that should be included in pharmacovigilance initiatives in pediatrics: active ADR surveillance; drug or ADR targeted pharmacovigilance; trained surveillance clinicians; case-control methodology and standardized procedures for recognition; reporting and evaluating drug-induced harm. In addition, linking pharmacovigilance with pharmacogenomics to find drug safety solutions is presented as a promising strategy for knowledge generation. Finally, we discuss the importance of an efficient translation of the pharmacovigilance knowledge into clinical practice to achieve safer drug therapy in children.

  4. Pharmacy Students’ Knowledge and Perceptions About Pharmacovigilance in Malaysian Public Universities

    PubMed Central

    Elkalmi, Ramadan Mohamed; Hassali, Mohamed Azmi; Ibrahim, Mohamed Izham M.; Widodo, Riyanto T.; Efan, Qais M. A.; Hadi, Muhammad Abdul

    2011-01-01

    Objective. To assess senior pharmacy students’ knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia Methods. A cross-sectional study was conducted between December 1, 2010, and January 31, 2010, using a validated self-administered questionnaire delivered to a sample of 510 final-year (fourth-year) pharmacy students at 5 Malaysian public universities. Results. Four hundred twenty-one (84%) students responded to the survey. About 60% (n = 240) indicated that they had taken courses on the concept of pharmacovigilance during their current pharmacy curriculum. The mean score for knowledge about pharmacovigilance and ADR reporting was 6.9 ± 1.4. There was a significant difference in the mean scores for knowledge about pharmacovigilance across the 5 universities. The majority (82.3%) of respondents felt it was necessary to confirm the causal relationship between the drug and the ADR. About 57.8% (n = 241) of the respondents believed that pharmacy students are competent and capable of reporting ADRs during their clerkships. The majority (87.0%) of respondents perceived that pharmacy students should be taught how to report ADRs. Conclusion. The results of this study demonstrate that the majority of final-year pharmacy students in Malaysian public universities have insufficient knowledge about pharmacovigilance and ADR reporting. PMID:21829270

  5. Safety monitoring of herb-drug interactions: a component of pharmacovigilance.

    PubMed

    Skalli, Souad; Soulaymani Bencheikh, Rachida

    2012-10-01

    Adverse drug reactions, including those resulting from interactions between herbal medicines and conventional drugs, are a public health problem worldwide. The need for pharmacovigilance for herb-drug interactions (HDIs) is essential for the identification and assessment of risks of using herbal products (questionable safety, efficacy and quality), which are not always tested with rigor, or often not subject to approval by regulatory agencies. Spontaneous and active surveillance conducted by national pharmacovigilance centres permits a rapid detection of potentially harmful combinations of products. The incidence and prevalence of HDIs are difficult to predict because of the underreporting of adverse effects. It is important for health professionals, consumers, regulatory authorities and suppliers of herbal medicines to be aware of the possible adverse effects and drug interactions caused when herbal medicines are co-administered with conventional drugs. National pharmacovigilance centres continue to play a significant role in increasing awareness of drug safety, in this case with HDIs. The authors' objective for this paper is to provide awareness among policy makers responsible for the design of appropriate pharmacovigilance practices and therefore to highlight the importance of pharmacovigilance in the safety monitoring of HDIs.

  6. Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom.

    PubMed

    Dinnett, Eleanor M; Kean, Sharon; Tolmie, Elizabeth P; Ronald, Elizabeth S; Gaw, Allan

    2013-06-12

    The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use.We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way.

  7. Pharmacy students' knowledge and perceptions about pharmacovigilance in Malaysian public universities.

    PubMed

    Elkalmi, Ramadan Mohamed; Hassali, Mohamed Azmi; Ibrahim, Mohamed Izham M; Widodo, Riyanto T; Efan, Qais M A; Hadi, Muhammad Abdul

    2011-06-10

    To assess senior pharmacy students' knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia. A cross-sectional study was conducted between December 1, 2010, and January 31, 2010, using a validated self-administered questionnaire delivered to a sample of 510 final-year (fourth-year) pharmacy students at 5 Malaysian public universities. Four hundred twenty-one (84%) students responded to the survey. About 60% (n = 240) indicated that they had taken courses on the concept of pharmacovigilance during their current pharmacy curriculum. The mean score for knowledge about pharmacovigilance and ADR reporting was 6.9 ± 1.4. There was a significant difference in the mean scores for knowledge about pharmacovigilance across the 5 universities. The majority (82.3%) of respondents felt it was necessary to confirm the causal relationship between the drug and the ADR. About 57.8% (n = 241) of the respondents believed that pharmacy students are competent and capable of reporting ADRs during their clerkships. The majority (87.0%) of respondents perceived that pharmacy students should be taught how to report ADRs. The results of this study demonstrate that the majority of final-year pharmacy students in Malaysian public universities have insufficient knowledge about pharmacovigilance and ADR reporting.

  8. Pharmacovigilance of herb-drug interactions among preoperative patients.

    PubMed

    Gallo, Eugenia; Pugi, Alessandra; Lucenteforte, Ersilia; Maggini, Valentina; Gori, Luigi; Mugelli, Alessandro; Firenzuoli, Fabio; Vannacci, Alfredo

    2014-01-01

    The Pharmacovigilance Center of the University of Florence conducted a survey across 3 hospitals in Tuscany (Empoli, Florence, and Prato) on a sample population consisting of 478 patients admitted to the hospital for a preoperative assessment before surgical intervention. The aim of the study was to assess the concomitant use of herbal remedies (HRs) and prescribed medications and to evaluate the most important potential interactions. Almost 50% of the patients surveyed-238 of 478 (49.8 %)-used at least 1 HR. Among them, 55 (23.1%) were actually exposed to at least 1 potential interaction. In particular, 42 participants had an HR-drug interaction and 17 participants had a dietary supplement drug interaction. A large percentage of patients undergoing surgery take HRs that could potentially interact with drugs administered perioperatively. Antihypertensive, antiplatelet, anticoagulant, and central nervous system (CNS) agents were the main products involved. The use of HRs is not devoid of risks and adverse effects due to potential interactions that may be serious or even lifethreatening. HR-drug interactions should be deeply investigated, especially in high-risk patient populations. Health care professionals should pay close attention and always investigate the consumption of HRs among their patients.

  9. Pharmacovigilance on Twitter? Mining Tweets for Adverse Drug Reactions

    PubMed Central

    O’Connor, Karen; Pimpalkhute, Pranoti; Nikfarjam, Azadeh; Ginn, Rachel; Smith, Karen L; Gonzalez, Graciela

    2014-01-01

    Recent research has shown that Twitter data analytics can have broad implications on public health research. However, its value for pharmacovigilance has been scantly studied – with health related forums and community support groups preferred for the task. We present a systematic study of tweets collected for 74 drugs to assess their value as sources of potential signals for adverse drug reactions (ADRs). We created an annotated corpus of 10,822 tweets. Each tweet was annotated for the presence or absence of ADR mentions, with the span and Unified Medical Language System (UMLS) concept ID noted for each ADR present. Using Cohen’s kappa1, we calculated the inter-annotator agreement (IAA) for the binary annotations to be 0.69. To demonstrate the utility of the corpus, we attempted a lexicon-based approach for concept extraction, with promising success (54.1% precision, 62.1% recall, and 57.8% F-measure). A subset of the corpus is freely available at: http://diego.asu.edu/downloads. PMID:25954400

  10. Pharmacovigilance, risks and adverse effects of self-medication.

    PubMed

    Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle; Abadie, Delphine; Lacroix, Isabelle; Berreni, Aurélia; Pugnet, Grégory; Durrieu, Geneviève; Sailler, Laurent; Giroud, Jean-Paul; Damase-Michel, Christine; Montastruc, François

    2016-04-01

    Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified.

  11. A Multiagent System for Integrated Detection of Pharmacovigilance Signals.

    PubMed

    Koutkias, Vassilis; Jaulent, Marie-Christine

    2016-02-01

    Pharmacovigilance is the scientific discipline that copes with the continuous assessment of the safety profile of marketed drugs. This assessment relies on diverse data sources, which are routinely analysed to identify the so-called "signals", i.e. potential associations between drugs and adverse effects, that are unknown or incompletely documented. Various computational methods have been proposed to support domain experts in signal detection. However, recent comparative studies illustrated that current methods exhibit high false-positive rates, significantly variable performance across different datasets used for analysis and events of interest, but also complementarity in their outcomes. In this regard, in order to reinforce accurate and timely signal detection, we elaborated through an agent-based approach towards systematic, joint exploitation of multiple heterogeneous signal detection methods, data sources and other drug-related resources under a common, integrated framework. The approach relies on a multiagent system operating based on a collaborative agent interaction protocol, aiming to implement a comprehensive workflow that comprises of method selection and execution, as well as outcomes' aggregation, filtering, ranking and annotation. This paper presents the design of the proposed multiagent system, discusses implementation issues and demonstrates the applicability of the proposed solution in an example signal detection scenario. This work constitutes a step towards large-scale, integrated and knowledge-intensive computational signal detection.

  12. Adverse drug reactions in newborns, infants and toddlers: pediatric pharmacovigilance between present and future.

    PubMed

    Fabiano, Valentina; Mameli, Chiara; Zuccotti, Gian Vincenzo

    2012-01-01

    The detection, assessment, understanding and prevention of adverse drug reactions (ADRs) are the primary aims of pharmacovigilance activities. Pediatric patients, especially all newborns and infants, are particularly at risk for experiencing drug-related adverse events. This review briefly analyzes the physiological peculiarities of pharmacodynamic and pharmacokinetic aspects of drugs in newborns, infants and toddlers and children. It also deals with specific pediatric pharmacovigilance aspects, such as the frequent use of unlicensed and/or off-label drugs in neonatal intensive care units in European countries and in Australia. This review reports on European, American and Canadian data about the incidence and type of pediatric ADRs, particularly focusing on neonates, infants and toddlers. The awareness of pediatricians about the importance of reporting ADRs should be stimulated, new reporting systems should be encouraged and pediatric pharmacovigilance activities should be improved, first, by intensifying active post-marketing surveillance methods.

  13. Toward Enhanced Pharmacovigilance using Patient-Generated Data on the Internet

    PubMed Central

    White, Ryen W.; Harpaz, Rave; Shah, Nigam H.; DuMouchel, William; Horvitz, Eric

    2014-01-01

    The promise of augmenting pharmacovigilance with patient-generated data drawn from the Internet was called out by a scientific committee charged with conducting a review of FDA's current and planned pharmacovigilance practices. To this end, we present a study on harnessing behavioral data drawn from Internet search logs to detect adverse drug reactions (ADRs). By analyzing search queries collected from 80 million consenting users and by using a widely recognized benchmark of ADRs, we find that the performance of ADR detection via search logs is comparable and complementary to detection based on FDA's adverse event reporting system (AERS). We show that by jointly leveraging data from AERS and search logs, the accuracy of ADR detection can be improved by 19% over the use of each data source independently. The results suggest that leveraging nontraditional sources, such as online search logs, could supplement existing pharmacovigilance approaches. PMID:24713590

  14. A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals

    PubMed Central

    2010-01-01

    Background Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests. Methods The Global Fund - Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund - Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan. Results Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities. Conclusions There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The

  15. Psychotropic drug initiation during the first diagnosis and the active treatment phase of B cell non-Hodgkin's lymphoma: a cohort study of the French national health insurance database.

    PubMed

    Conte, Cécile; Rueter, Manuela; Laurent, Guy; Bourrel, Robert; Lapeyre-Mestre, Maryse; Despas, Fabien

    2016-11-01

    Patients with B cell non-Hodgkin's lymphomas (B-NHLs) are known to be at risk of developing psychological disorders. The aims of this study were to measure the incidence of psychotropic drug use during the diagnosis and the active treatment phase in comparison with controls from the general population, and to identify factors associated with this use. B-NHL patients were selected through the French national health insurance database in the Midi-Pyrénées region (southwestern France) from January 1, 2011, to April 31, 2013. Patients with a previous history of B-NHL and/or psychotropic drug treatment were excluded. Among 745 newly diagnosed B-NHL patients, psychotropic treatment was initiated in 31.5 % (95 % CI [28.1-34.9]), compared to 7.6 % (95 % CI [7.57-7.64]) in the general population during the same period. This incidence was comparable in colorectal cancer patients (33.5 %) but higher than that in patients with myocardial infarction (23.5 %) or with a first knee replacement surgery (22.4 %). Anxiolytics and hypnotics were the most frequently used drugs. Median duration of treatment was 37 days for anxiolytics and 58 days for hypnotics, with 20.8 % of patients remaining under treatment at 8 months. Factors associated with psychotropic drug initiation were young age, health care consumption in the year before diagnosis, and initial care at a university hospital. The high rate of psychotropic drug initiation reflects a high level of anxiety at the initial phase of B-NHL patients' trajectory. This pharmacoepidemiological study reveals inappropriate use in some patients, which should now be investigated in lymphoma survivorship.

  16. Pharmacovigilance in the Middle East: a survey of 13 arabic-speaking countries.

    PubMed

    Wilbur, Kerry

    2013-01-01

    The importance of countries to support their own national pharmacovigilance cannot be understated. While adverse drug reaction (ADR) data from other countries is helpful in making medication safety decisions, information may not be relevant or applicable to domestic populations. The aim of this study was to inventory national pharmacovigilance systems in place in the Middle East region. The Uppsala Monitoring Centre Assessment of Country Pharmacovigilance Situation questionnaire (February 2008) was adapted and translated into Arabic and administered to the head of the identified centres responsible for medication safety in 13 Arabic-speaking Middle Eastern countries. This survey contains domains pertaining to general programme information; overview of technology and personnel support; suspected ADR reporting and subsequent data use; and pharmacovigilance activity and advocacy. Data for 11 countries were obtained: representatives from two countries did not participate (Lebanon, Syria). Six described formal national pharmacovigilance programmes (Egypt, Iraq, Jordan, Oman, Kingdom of Saudi Arabia and the United Arab Emirates), while five (Bahrain, Kuwait, Palestine, Qatar and Yemen) reported no active programme or designated centre. The majority are government funded, but staff resources are constrained, ranging from two to ten people. Sixty-seven percent of programmes facilitated submission of spontaneous ADRs to the centre by email, but none directly through a web-based platform. All used the information for drug regulatory purposes and five reported dissemination of safety information to the public. This is the first survey to inventory the status of pharmacovigilance in the Middle East. While a number of countries participate in suspected ADR reporting activities, an estimated population of 30-50 million is without formal domestic programmes. Current emphasis of drug safety in the region is on detection and prevention of counterfeit products reaching the consumer

  17. French Teaching Aids.

    ERIC Educational Resources Information Center

    Miller, J. Dale

    Supplementary teaching materials for French language programs are presented in this text. Primarily intended for secondary school students, the study contains seven units of material. They include: (1) French gestures, (2) teaching the interrogative pronouns, (3) French cuisine, (4) recreational learning games, (5) French-English cognates, (6)…

  18. Developing a consumer reporting program in Malaysia: a novel initiative to improve pharmacovigilance.

    PubMed

    Palaian, Subish; Alshakka, Mohammed; Mohamed Izham

    2010-02-01

    The national pharmacovigilance program in Malaysia is limited to very few centers and under-reporting of adverse drug reactions (ADRs) is a major limitation. Studies from developed countries have documented the importance and usefulness of consumer reporting of ADRs. Involving consumers in ADR reporting can be very useful in improving the reporting rates in Malaysia. The present article highlights the proposed plan of initiating a consumer based pharmacovigilance program in University Wellness Center located inside the campus of the Universiti Sains Malaysia, Penang, Malaysia.

  19. Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems.

    PubMed

    Aronson, Jeffrey K

    2017-03-30

    Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa

  20. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital.

    PubMed

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2014-01-01

    With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. The 74.1% of the nurses definition of "severe adverse effect" of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance.

  1. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital

    PubMed Central

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2015-01-01

    OBJECTIVE: With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. METHODS: This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. RESULTS: The 74.1% of the nurses definition of “severe adverse effect” of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. CONCLUSION: Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance. PMID:28058321

  2. Natural Language Processing for EHR-Based Pharmacovigilance: A Structured Review.

    PubMed

    Luo, Yuan; Thompson, William K; Herr, Timothy M; Zeng, Zexian; Berendsen, Mark A; Jonnalagadda, Siddhartha R; Carson, Matthew B; Starren, Justin

    2017-06-22

    The goal of pharmacovigilance is to detect, monitor, characterize and prevent adverse drug events (ADEs) with pharmaceutical products. This article is a comprehensive structured review of recent advances in applying natural language processing (NLP) to electronic health record (EHR) narratives for pharmacovigilance. We review methods of varying complexity and problem focus, summarize the current state-of-the-art in methodology advancement, discuss limitations and point out several promising future directions. The ability to accurately capture both semantic and syntactic structures in clinical narratives becomes increasingly critical to enable efficient and accurate ADE detection. Significant progress has been made in algorithm development and resource construction since 2000. Since 2012, statistical analysis and machine learning methods have gained traction in automation of ADE mining from EHR narratives. Current state-of-the-art methods for NLP-based ADE detection from EHRs show promise regarding their integration into production pharmacovigilance systems. In addition, integrating multifaceted, heterogeneous data sources has shown promise in improving ADE detection and has become increasingly adopted. On the other hand, challenges and opportunities remain across the frontier of NLP application to EHR-based pharmacovigilance, including proper characterization of ADE context, differentiation between off- and on-label drug-use ADEs, recognition of the importance of polypharmacy-induced ADEs, better integration of heterogeneous data sources, creation of shared corpora, and organization of shared-task challenges to advance the state-of-the-art.

  3. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

    PubMed

    Edwards, Brian

    2004-01-01

    The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

  4. [Assessment of an active pharmacovigilance system carried out by a pharmacist].

    PubMed

    Sánchez, Ignacio; Amador, Cristián; Plaza, José Cristian; Correa, Gonzalo; Amador, Roberto

    2014-08-01

    Despite the importance of notifying and preventing adverse drug reactions (ADRs), they are under reported and their consequences are not adequately evaluated. To assess the impact of a pharmacovigilance system carried out by a pharmacist. In an internal medicine service, the spontaneous report of ADRs was compared blindly with an active pharmacovigilance system in which a pharmacist detected, monitored and prevented ADRs. A total of 1,196 patients was included. Of these 604 were hospitalized in intervened wards, where 50 suspected ADRs in 47 patients were reported. In non-intervened wards, only three ADRs were spontaneously reported. Therefore, the pharmacovigilance system significantly improved the detection and report of ADRs with a risk ratio of 15.4 (95% confidence intervals 4.8-49.1). Sixty six percent of ADRs were classified as severe. Antimicrobials were the main group of medications causing ADRs in 44% of reports. Forty three percent of ADRs were preventable and prolonged hospital stay by a mean of eight days. An active pharmacovigilance system carried out by pharmacists improves the detection of ADRs and promotes its prevention.

  5. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH).

    PubMed

    Bahri, Priya; Tsintis, Panos

    2005-06-01

    Marketing authorisations for medicines need to be based on the universal criteria quality, safety and efficacy, whilst taking into account local public health needs. With view to using resources efficiently and avoiding delay in access to medicines, scientific standards for investigating quality, safety and efficacy should be universal too. A major step to achieve this was taken in 1990 when the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established between authorities and industry in the European Union (EU), Japan and the United States. Since then more than 50 ICH Guidelines have been published, out of which six are specific to pharmacovigilance. They refer to management and expedited reporting of individual adverse drug reaction (ADR) cases, including electronic formats, periodic reporting of worldwide data and planning of pharmacovigilance. Their development has to be seen in the context of initiatives taken in the three ICH Regions to strengthen pharmacovigilance. Most recently this involves making use of risk management concepts, reflecting new thinking of proactivity in pharmacovigilance. Moreover, consideration is given to regional and international cooperation beyond the ICH Regions.

  6. Pharmacovigilance implemented by patients: A necessity in the 21st century.

    PubMed

    Lafond, Jean

    2016-04-01

    Pharmacovigilance should become a well-thought-out reflex for each of us, for any drugs taken on prescription or by self-medication. The issue of pharmacovigilance should naturally take its place in the dialogue between patients and health professionals, through advice given before medication is taken. Patients need to be told the importance of notifying any adverse drug reactions (ADRs). Pharmacovigilance would then become a post-hoc way of protecting patients. The importance of using pharmacovigilance should be promoted by emphasizing the fact that the life of a drug really starts after its marketing. This state of mind could be reinforced by a wider advertising campaign on the possibility of notifying the relevant authorities of any ADRs. Patient associations should encourage and help their members to do this. Notifying any ADRs should become a concern for all medical and paramedical staff: those who prescribe drugs, those who dispense them (pharmacists or pharmacy assistants), those who administer them (nurses), but also the consumers (patients) whose place is becoming more and more prominent.

  7. Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies.

    PubMed

    Rodrigues, Eliana; Barnes, Joanne

    2013-01-01

    Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance

  8. Why Study French?

    ERIC Educational Resources Information Center

    Bunge, Gerard

    This brochure for parents and prospective students of French points out career opportunities available to qualified speakers of French. Suggestions concerning student eligibility and the time requirements of language programs are also offered. (RL)

  9. Towards a French Revolution

    ERIC Educational Resources Information Center

    Breach, H. T.

    1972-01-01

    Contends that secondary school students lose their appeal for French as they advance in school. Suggests that French teachers endeavor to motivate students by focusing more attention on their students and less on their own credentials. (DS)

  10. Towards a French Revolution

    ERIC Educational Resources Information Center

    Breach, H. T.

    1972-01-01

    Contends that secondary school students lose their appeal for French as they advance in school. Suggests that French teachers endeavor to motivate students by focusing more attention on their students and less on their own credentials. (DS)

  11. Two decades of pharmacovigilance and clinical experience with highly purified rabies immunoglobulin F(ab')2 fragments.

    PubMed

    Reveneau, Elisa; Cottin, Pascale; Rasuli, Anvar

    2017-03-01

    Rabies is a worldwide zoonotic viral disease with no specific treatment once symptoms occur; manifest disease is almost always fatal. WHO recommendations for exposed individuals include immediate attention to the wound and use of rabies immunoglobulin and/or vaccine for post-exposure prophylaxis (PEP). Here, we provide an overview of the clinical experience with a highly purified preparation of F(ab')2 fragments from equine rabies immunoglobulin (F(ab')2 pERIG; Favirab(TM)) in rabies PEP. Areas covered: Our review comprises a retrospective analysis of adverse event reports in the Sanofi Pasteur global pharmacovigilance database for F(ab')2 pERIG, including adverse event reports from eight Sanofi Pasteur-sponsored clinical trials and post-market surveillance data collected between 1995 and 2014. The general safety profile of F(ab')2 pERIG is discussed, as are the occurrence of rare anaphylactic reactions, and suspected intervention failure. Expert commentary: Over 20 years of clinical development and post-licensure experience has established the safety and effectiveness of F(ab')2 pERIG (Favirab(TM)) in rabies PEP.

  12. French Computer Terminology.

    ERIC Educational Resources Information Center

    Gray, Eugene F.

    1985-01-01

    Characteristics, idiosyncrasies, borrowings, and other aspects of the French terminology for computers and computer-related matters are discussed and placed in the context of French computer use. A glossary provides French equivalent terms or translations of English computer terminology. (MSE)

  13. French Studies: A Bibliography.

    ERIC Educational Resources Information Center

    Markey, William L., Comp.

    A bibliography of materials relating to French language and area studies includes citations of bibliographies, books, articles, and general and specialized reference materials in French and English in these categories: general reference guides; guides to French studies; style manuals; research methodology and handbooks; library resources;…

  14. Spoken French: Book One.

    ERIC Educational Resources Information Center

    Denoeu, Francois; Hall, R. A., Jr.

    This textbook offers a course in French designed for those who need to make themselves understood on ordinary topics in French and cannot devote years of study to the language. It is a self-instructional course, but it is designed to be used with a native French speaker as a guide or, if no native speaker is available, with recordings that are…

  15. The Verb-Lists of Modern French.

    ERIC Educational Resources Information Center

    Reed, J.

    1988-01-01

    Reviews and compares the main published repertoires of French verbs. By combining the material from these different sources, one can construct a database of approximately 10,300 formally distinct verbs. It is suggested that analysis of such a wide corpus may reveal structures not yet acknowledged. (Author/LMO)

  16. OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

    PubMed Central

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  17. [Pharmacovigilance idea should be introduced sufficiently into the safety monitoring and evaluation process of Chinese drugs].

    PubMed

    Zhang, Li; Yang, Xiao-Hui

    2009-09-01

    Along with the general improving of public consciousness on drugs' safety and the increasing of new Chinese drugs' manufacture and application, the safety of Chinese drugs has become a more prominent concern and a focus of attention. The scientific identification, analysis and evaluation of this affairs greatly impacts the scientific decision-making for ensuring the public use of drugs in security, also influences the healthy development of Chinese medicine industry. In this paper, the different meanings of "adverse reaction" and "adverse events" of Chinese drugs were introduced from pharmacovigilance idealistic view, and the influencing factors on safety of Chinese drugs were analyzed from the perspective of pharmacovigilance. The authors proposed that "Chinese medicine safety monitoring and evaluation" is a much more practical concept in consistency with the current situation. They pointed out that introducing sufficiently the concept of pharmaco vigilance idea into the safety monitoring and evaluation process is the basis for overall evaluation and effective risk controlling of Chinese drugs.

  18. Pharmacist’s knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process

    PubMed Central

    Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

    2014-01-01

    Background Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. Objectives This study is considered the first study in the region to evaluate pharmacist’s knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. Method A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. Results The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. Conclusion The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist’s role in the reporting process, and thus to have a positive impact on the overall patient caring process. PMID:25972734

  19. Social media and pharmacovigilance: A review of the opportunities and challenges.

    PubMed

    Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

    2015-10-01

    Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. © 2015 The British Pharmacological Society.

  20. Social media and pharmacovigilance: A review of the opportunities and challenges

    PubMed Central

    Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

    2015-01-01

    Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. PMID:26147850

  1. National strategy for the integration of pharmacovigilance in the Moroccan TB Control Program

    PubMed Central

    Tanani, Driss Soussi; Serragui, Samira; Hammi, Sanae; Moussa, Latifa Ait; Soulaymani, Abdelmajid; Soulaymani, Rachida; Cherrah, Yahia

    2017-01-01

    The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). The integration of pharmacovigilance in MTCP was conducted in October 2012with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010–October2012; period 2: October 2012–December 2013). The detection of signals was based on the Information Component available inVigiMine. We used the SPSS version 10.0 and Med Calc version 7.3 for data analysis. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P< 10-3). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (P = 10-4), and40.9% of cases in the first period were serious against 15.8% in second period (P = 0.003). Nine signals were generated (hepaticenzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs. PMID:28451026

  2. [Misuse of drugs: conclusions of the pharmacovigilance workshops at La Baule, France].

    PubMed

    Fermont, I

    2002-01-01

    Drug iatrogeny is a current Public Health issue; it is often related to misuse and is therefore preventable. The congress "Les Ateliers de Pharmacovigilance de La Baule" (May 2001) bringing together pharmacovigilance staff from both the industry and Health authorities, showed that misuse concerns every step of the drug process--prescription, dispensing and administration--and all health professionals as well as the patient. New concepts have been brought to light with regard to the definition of misuse: the medical point of view should be preferred, based on the risk taken by a given patient without the expected benefit. product characteristics alone are inadequate and should be enlarged by relevent scientific data. the main goal is to improve the quality of healthcare by preventing misuse. A working group including Pharmacovigilance staff from the industry, the CRPV and the Afssaps has: to reach a consensus on definition in France and then propose it to EMEA; to analyse and propose specific prevention actions; to write a vademecum of those involved in this prevention.

  3. Off-Label Baclofen Prescribing Practices among French Alcohol Specialists: Results of a National Online Survey

    PubMed Central

    Rolland, Benjamin; Paille, François; Fleury, Benoit; Cottencin, Olivier; Benyamina, Amine; Aubin, Henri-Jean

    2014-01-01

    Objective To evaluate, among alcohol specialists belonging to the Société Française d’Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict the features of individual prescribing and monitoring practices. Methods On-line survey among 484 French alcohol specialists. Physicians were asked whether they prescribed baclofen for AUDs. If they did not, the reasons for this choice were investigated. If they did, the features of the physician’s prescribing practice were explored, including the number of patients treated, the mean and maximum doses, the monitoring precautions and the pharmacovigilance reporting. Participants were also asked about their empirical findings on HDB’s efficacy and safety. Results In total, 302 physicians (response rate of 62.4%) participated in the survey. Data from 296 participants were analysed, representing 59.4% of all active prescribing physicians belonging to the SFA. HDB use was declared by 74.6% of participants (mean dose 109.5±43.6 mg/d; maximum dose 188±93.3 mg/d). However, 79.2% of prescribers had treated less than 30 patients, and 67.8% used HDB as a second-line medication. Although HDB was perceived as more efficacious than approved drugs by 54.3% of prescribers, it was also declared less safe by 62.8%. Nonetheless, 79.7% of prescribers had never filed any pharmacovigilance report. Non-prescribers (25.6%) were primarily deterred by the current lack of scientific data and official regulation. Conclusion A majority of French alcohol specialists reported using HDB, although often on a limited number of their patients. HDB was considered efficacious but also potentially hazardous. Despite this, physicians reported minimal safety data to the health security system. While French health authorities are planning to draft a specific regulatory measure for framing off-label HDB prescribing practices

  4. Poststructuralism and the ARTFL Database: Some Theoretical Considerations.

    ERIC Educational Resources Information Center

    Wolff, Mark

    1994-01-01

    Describes textual database queries in the humanities based on poststructuralist theories and experiences with the ARTFL (American and French Research on the Treasury of the French Language) database. The use of computers for literary research and text interpretation and analysis is considered. (Contains nine references.) (LRW)

  5. Knowledge and Perception about Pharmacovigilance among Pharmacy Students of Universities in Sana’a Yemen

    PubMed Central

    Othman, Gamil Qasem; Ibrahim, Mohamed Izham Mohamed; Alshakka, Mohammed; Ansari, Mukhtar; Al-Qadasi, Farouk

    2017-01-01

    Introduction Pharmacists in community or hospital setting play a key role in reporting Adverse Drug Reaction (ADRs) during practice. Under reporting is considered as a profession malpractice worldwide. Aim To determine the level of knowledge and perception about phramacovigilance and ADRs reporting among final year pharmacy students of Universities in Sana’a Yemen. Materials and Methods A cross-sectional study design was conducted among 385 final year pharmacy students. One public and four private universities were selected randomly using a validated self-administered questionnaire. The questionnaire contained data about student demographic data, knowledge and perception about the ADRs. The data was analysed by SPSS program and Chi-square tests were used to assess the significance of association. Results The male students were more knowledgeable than female (p=0.035), as well as private university students had better ideas on how to report ADRs than public university students (p=0.009). Private university students reported that pharmacovigilance topic is well covered in their curriculum compared to public university students (p≤0.001). A significant difference was seen amongst the students of public and private universities when asked about reporting ADRs in future, former found more confident (p≤0.001). Furthermore, the private university students also had more command on the concept of post-marketing surveillance than public university students (p≤0.001). The private university students in Yemen were more known to causality assessment of ADRs as compared to the students of public universities (p≤0.001). The results of perception revealed regarding perception toward ADRs and pharmacovigilance. Female students (p≤0.018) and private universities students (p≤0.001) had positive perception than male and public university students respectively. Conclusion The findings showed poor knowledge among students in Sana’a Universities and positive perception

  6. Knowledge and Perception about Pharmacovigilance among Pharmacy Students of Universities in Sana'a Yemen.

    PubMed

    Othman, Gamil Qasem; Ibrahim, Mohamed Izham Mohamed; Alshakka, Mohammed; Ansari, Mukhtar; Al-Qadasi, Farouk; Halboup, Abdulsalam M

    2017-06-01

    Pharmacists in community or hospital setting play a key role in reporting Adverse Drug Reaction (ADRs) during practice. Under reporting is considered as a profession malpractice worldwide. To determine the level of knowledge and perception about phramacovigilance and ADRs reporting among final year pharmacy students of Universities in Sana'a Yemen. A cross-sectional study design was conducted among 385 final year pharmacy students. One public and four private universities were selected randomly using a validated self-administered questionnaire. The questionnaire contained data about student demographic data, knowledge and perception about the ADRs. The data was analysed by SPSS program and Chi-square tests were used to assess the significance of association. The male students were more knowledgeable than female (p=0.035), as well as private university students had better ideas on how to report ADRs than public university students (p=0.009). Private university students reported that pharmacovigilance topic is well covered in their curriculum compared to public university students (p≤0.001). A significant difference was seen amongst the students of public and private universities when asked about reporting ADRs in future, former found more confident (p≤0.001). Furthermore, the private university students also had more command on the concept of post-marketing surveillance than public university students (p≤0.001). The private university students in Yemen were more known to causality assessment of ADRs as compared to the students of public universities (p≤0.001). The results of perception revealed regarding perception toward ADRs and pharmacovigilance. Female students (p≤0.018) and private universities students (p≤0.001) had positive perception than male and public university students respectively. The findings showed poor knowledge among students in Sana'a Universities and positive perception towards pharmacovigilance and ADRs reporting. A poor knowledge

  7. Reevaluating the French Revolution.

    ERIC Educational Resources Information Center

    Stromberg, Roland N.

    1986-01-01

    Analyzes previous interpretations concerning the French Revolution. Discusses several weaknesses of the Marxist views in light of recent philosophical and sociological thinking about social change. (RKM)

  8. Reevaluating the French Revolution.

    ERIC Educational Resources Information Center

    Stromberg, Roland N.

    1986-01-01

    Analyzes previous interpretations concerning the French Revolution. Discusses several weaknesses of the Marxist views in light of recent philosophical and sociological thinking about social change. (RKM)

  9. FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients.

    PubMed

    Fracchiolla, Nicola S; Artuso, Silvia; Cortelezzi, Agostino; Pelizzari, Anna M; Tozzi, Paola; Bonfichi, Maurizio; Bocchio, Federica; Gargantini, Livio; De Rosa, Elisa; Vighi, Giuseppe D; Prestini, Lucia; Sammassimo, Simona; Frungillo, Niccolò; Pasquini, Maria C; Ragazzi, Alessandra; Boghi, Daniele; Pastore, Alessia; Lanzi, Eraldo; Gritti, Giuseppe; Quaresmini, Giulia; Voltolini, Simone; Gaiardoni, Roberta; Corti, Consuelo; Vilardo, Maria C; La Targia, Maria L; Berini, Giacomo; Magagnoli, Massimo; Bacci, Claudia; Consonni, Dario; Rivolta, Alma L; Muti, Giuliana

    2017-08-03

    Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project "FarmaREL" has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned. The ADRs occurring in haematological patients were collected electronically and then analysed with multiple logistic regression. Between January 2009 and December 2011, 887 reports were collected. The number of ADRs was higher in older adults (528; 59%), in male (490; 55%), and in non-Hodgkin lymphoma patients (343; 39%). Most reactions were severe (45% required or prolonged hospitalization), but in most cases, they were fully resolved at the time of reporting. According to Schumock and Thornton criteria, a percentage of ADRs as high as 7% was found to be preventable versus 2% according to reporter opinion. Patients' haematological diagnosis, not age or gender, resulted to be the variable that most influenced ADR, in particular severity and outcome. The employment of personnel specifically dedicated to pharmacovigilance is a successful strategy to improve the number and quality of ADR reports. "FarmaREL", the first programme of active pharmacovigilance in oncohaematologic patients, significantly contributed to reach the WHO "Gold Standard" for pharmacovigilance in Lombardy, Italy. Copyright © 2017 John Wiley & Sons, Ltd.

  10. The French Revolution.

    ERIC Educational Resources Information Center

    Baltimore City Public Schools, MD.

    This outline on the French Revolution is designed to illustrate how this period of French history influenced various aspects of contemporary culture. Four main sections are treated: (1) ideas that led to the Revolution, (2) the reigns of the Bourbon kings, (3) the Revolution, and (4) the rise of Napoleon as a reaction to chaos. A list of 16mm…

  11. Skiing in French.

    ERIC Educational Resources Information Center

    Moeller, Paulette

    1984-01-01

    A high school French program conducted entirely in French on local ski slopes is based on the philosophy that language is a social tool for communicative purposes and can best be learned in social interaction. The successful program uses teamwork, an open attitude toward language learning, non-stressful evaluation, and innovative techniques. (MSE)

  12. French in Quebec.

    ERIC Educational Resources Information Center

    d'Anglejan, Alison

    1979-01-01

    Discusses language legislation in Canada where French and English are both official languages, and in Quebec province where French has been declared the sole official language. Outlines the conflicts and the impact of these differing laws on Quebec, its population, and its relations with the rest of Canada. (JMF)

  13. Demythifying French Grammar.

    ERIC Educational Resources Information Center

    Bryant, William H.

    1984-01-01

    Focuses on several myths and fallacies prevalent in the field of French grammar. The importance of keeping up-to-date with language and grammatical usage is stressed, since the rules of language do change. Thus, the validity of the linguistic content of French grammar books must be questioned, so that any outmoded or invalid concepts can be…

  14. French Phonology. Programmed Introduction.

    ERIC Educational Resources Information Center

    Salazar, Robert

    This self-instructional course is designed to help students in attaining a high degree of competence in French pronunciation and a basic knowledge of how French sounds correspond to the writing system. The material is divided into ten chapters. Each chapter has three parts. Part One is the presentation of a short dialogue for memorization. It…

  15. Illustrated French Idioms.

    ERIC Educational Resources Information Center

    Ainsa, Serge M.

    Designed to promote an awareness of the everyday French language, this supplementary textbook was developed to enable students of French to use idiomatic expressions from the early learning stages to the more advanced levels. The units are arranged as follows according to the verb component of the expression: "avoir,""etre,""faire," the three…

  16. Paediatric Pharmacovigilance: Use of Pharmacovigilance Data Mining Algorithms for Signal Detection in a Safety Dataset of a Paediatric Clinical Study Conducted in Seven African Countries

    PubMed Central

    Kajungu, Dan K.; Erhart, Annette; Talisuna, Ambrose Otau; Bassat, Quique; Karema, Corine; Nabasumba, Carolyn; Nambozi, Michael; Tinto, Halidou; Kremsner, Peter; Meremikwu, Martin; D’Alessandro, Umberto; Speybroeck, Niko

    2014-01-01

    Background Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) for treatment of uncomplicated malaria in African children. Methods We used paediatric safety data from a multi-site, multi-country clinical study conducted in seven African countries (Burkina Faso, Gabon, Nigeria, Rwanda, Uganda, Zambia, and Mozambique). Each site compared three out of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) or chlorproguanil/dapsone and artesunate (CD+A). We examine two pharmacovigilance signal detection methods, namely proportional reporting ratio and Bayesian Confidence Propagation Neural Network on the clinical safety dataset. Results Among the 4,116 children (6–59 months old) enrolled and followed up for 28 days post treatment, a total of 6,238 adverse events were reported resulting into 346 drug-event combinations. Nine signals were generated both by proportional reporting ratio and Bayesian Confidence Propagation Neural Network. A review of the manufacturer package leaflets, an online Multi-Drug Symptom/Interaction Checker (DoubleCheckMD) and further by therapeutic area experts reduced the number of signals to five. The ranking of some drug-adverse reaction pairs on the basis of their signal index differed between the two methods. Conclusions Our two data mining methods were equally able to generate suspected signals using the pooled safety data from a phase IIIb/IV clinical trial. This analysis demonstrated the possibility of utilising clinical studies safety data for key

  17. Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study.

    PubMed

    Poirot, Eugenie; Soble, Adam; Ntshalintshali, Nyasatu; Mwandemele, Asen; Mkhonta, Nomcebo; Malambe, Calisile; Vilakati, Sibonakaliso; Pan, Sisi; Darteh, Sarah; Maphalala, Gugu; Brown, Joelle; Hwang, Jimee; Pace, Cheryl; Stergachis, Andy; Vittinghoff, Eric; Kunene, Simon; Gosling, Roland

    2016-07-22

    Countries remain reluctant to adopt the 2012 World Health Organization recommendation for single low-dose (0.25 mg/kg) primaquine (SLD PQ) for Plasmodium falciparum transmission-blocking due to concerns over drug-related haemolysis risk, especially among glucose-6-phosphate dehydrogenase-deficient (G6PDd) people, without evidence demonstrating that it can be safely deployed in their settings. Pharmacovigilance methods provide a systematic way of collecting safety data and supporting the rollout of SLD PQ. The Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT), comprising: (1) a standardized form to support the surveillance of possible adverse events following SLD PQ treatment; (2) a patient information card to enhance awareness of known adverse drug reactions of SLD PQ use; and (3) a database compiling recorded information, was developed and piloted. Data on patient characteristics, malaria diagnosis and treatment are collected. Blood samples are taken to measure haemoglobin (Hb) and test for G6PD deficiency. Active follow-up includes a repeat Hb measurement and adverse event monitoring on or near day 7. A 13-month prospective pilot study in two hospital facilities in Swaziland alongside the introduction of SLD PQ generated preliminary evidence on the feasibility and acceptability of PROMPT. PROMPT was well received by nurses as a simple, pragmatic approach to active surveillance of SLD PQ safety data. Of the 102 patients enrolled and administered SLD PQ, none were G6PDd. 93 (91.2 %) returned on or near day 7 for follow-up. Four (4.6 %) patients had falls in Hb ≥25 % from baseline, none of whom presented with signs or symptoms of anaemia. No patient's Hb fell below 7 g/dL and none required a blood transfusion. Of the 11 (11 %) patients who reported an adverse event over the study period, three were considered serious and included two deaths and one hospitalization; none were causally related to SLD PQ. Four non-serious adverse events were

  18. Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe.

    PubMed

    Vermeer, N S; Duijnhoven, R G; Straus, S M J M; Mantel-Teeuwisse, A K; Arlett, P R; Egberts, A C G; Leufkens, H G M; De Bruin, M L

    2014-12-01

    Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which uncertainties in the safety profile are resolved through this proactive approach is unknown. We therefore examined the evolution of safety concerns in the RMP after initial approval for a selected cohort of 48 drugs, to provide insight into the knowledge gain over time. We found that 20.7% of the uncertainties existing at approval had been resolved 5 years after approval. Because new uncertainties were included in the RMP at a similar rate, the overall number of uncertainties remained approximately equal. The relatively modest accrual of knowledge, as demonstrated in this study through resolution of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning.

  19. Evolvement of French advanced practice nurses.

    PubMed

    Bonnel, Galadriel

    2014-04-01

    The purpose of this review is to chronicle the development of the advanced practice nurse (APN) in France and compare international APN indictors of quality care with French studies. A review of the literature was performed by accessing the MEDLINE, Science Direct, and Cochrane Databases for studies of quality of care by APNs during 1965-2012. The author's participation on a national task force in collaboration with the French Ministry of Health provided additional information. After applying limits of this search, 36 studies fulfilled inclusion and exclusion criteria. In both the French and international APN nursing literature, the most frequently described quality of care measures were level of patient satisfaction and other patient outcomes (clinical and laboratory measures) according to evidence-based guidelines. In three French studies (nephrology, neuro-oncology, and urology settings), nurses performed direct patient care and were legally permitted to take on some limited responsibilities usually held by French physicians, including clinical examinations, diagnosing, and prescribing. Creation of the APN role in France can respond to public health challenges including the rising incidence of chronic diseases and an impending physician shortage. Future APN research should focus on rigorous, innovative design development including collaborative care models. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

  20. Matching bacteriological and medico-administrative databases is efficient for a computer-enhanced surveillance of surgical site infections: retrospective analysis of 4,400 surgical procedures in a French university hospital.

    PubMed

    Leclère, Brice; Lasserre, Camille; Bourigault, Céline; Juvin, Marie-Emmanuelle; Chaillet, Marie-Pierre; Mauduit, Nicolas; Caillon, Jocelyne; Hanf, Matthieu; Lepelletier, Didier

    2014-11-01

    Our goal was to estimate the performance statistics of an electronic surveillance system for surgical site infections (SSIs), generally applicable in French hospitals. Three detection algorithms using 2 different data sources were tested retrospectively on 9 types of surgical procedures performed between January 2010 and December 2011 in the University Hospital of Nantes. The first algorithm was based on administrative codes, the second was based on bacteriological data, and the third used both data sources. For each algorithm, sensitivity, specificity, and positive and negative predictive values (PPV and NPV) were calculated. The reference method was the hospital's routine surveillance: a comprehensive review of the computerized medical charts of the patients who underwent one of the targeted procedures during the study period. A 3,000-bed teaching hospital in western France. We analyzed 4,400 targeted surgical procedures. Sensitivity results varied significantly between the three algorithms, from 25% (95% confidence interval, 17-33) when using only administrative codes to 87% (80%-93%) with the bacteriological data and 90% (85%-96%) with the combined algorithm. Fewer variations were observed for specificity (91%-98%), PPV (21%-25%), and NPV (98% to nearly 100%). Overall, performance statistics were higher for deep SSIs than for superficial infections. A reliable computer-enhanced SSI surveillance can easily be implemented in French hospitals using common data sources. This should allow infection control professionals to spend more time on prevention and education duties. However, a multicenter study should be conducted to assess the generalizability of this method.

  1. The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

    PubMed

    Smith, Meredith Y; Benattia, Isma

    2016-09-01

    Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

  2. Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?

    PubMed

    Sharma, Pramod Kumar; Singh, Surjit; Dhamija, Puneet

    2016-01-01

    Reporting adverse drug reactions (ADRs) associated with drug use is an important factor in patient safety. Majority of ADRs are preventable through improved prescribing and monitoring. Endocrinologists prescribe drugs with actions on almost all organs and for relatively longer durations. ADR are expected following the use of these drugs. Pharmacovigilance is the study of drug-related adverse effects aimed at protecting patients and public from drug-related harms. The concept of pharmacovigilance is relatively new in India, and this survey is an attempt to explore awareness among doctors of an establishing institution of national importance. The survey was conducted on faculty and resident doctors by administering a written structured questionnaire in a voluntary manner. The questionnaire contained questions meant to evaluate their awareness, understanding, and misconception about ADR reporting. Identity of the responder was kept confidential. A total of 106 (faculty = 56; residents = 50) participated in survey. The most common cause cited for not reporting an ADR was "do not know how to report" by 64.15%. Majority of them (64%) had no information about the Pharmacovigilance Programme of India (PvPI), and only few (8.5%) had actually reported or published an ADR. ADRs are major public health problem that needs to be addressed at all levels of health care. High index of clinical suspicion are crucial for their timely detection and management. Various educational interventions have shown to improve medical professionals' awareness, understanding about ADRs and in their reporting behavior. PvPI is an important initiative toward ensuring patient safety.

  3. French Antilles and Guiana.

    PubMed

    1989-01-01

    Attention in this discussion of French Antilles and Guiana is directed to the following: geography; the people; history; government; political conditions; the economy; and relations with the US. In 1988, the population of Martinique, the official name, numbered 351,105 with an annual growth rate in 1988 of 1.71%. The population of Guadeloupe, the official name, numbered 337,524 in January 1988 with an annual growth rate in 1987 of 1.2%. French Guiana, Guadeloupe, and Martinique, as overseas departments of France since 1946, are integral parts of the French Republic. In 1972, the metropolitan departments of France were combined into 22 regions, with an elected regional council for each region. As integral parts of the French Republic, the political systems of the 3 French Caribbean departments are essentially extensions of those of metropolitan France. Guadeloupe and Martinique owed their colonial prosperity to agriculture, primarily sugar. Martinique no longer exports sugar, but sugar still accounts for 20% of Guadeloupe's export earnings. In Martinique, sugar has been replaced as an export crop by bananas and pineapples. Bananas now account for almost 50% of Guadeloupe's total export earnings. In French Guiana, the impact of the French National Space Agency's Guiana Space Center has been great. US policy toward these overseas departments is inseparable from its overall policy of friendly relations with France.

  4. An evaluation of the knowledge and perceptions of pharmacy students on pharmacovigilance activities in Nigeria.

    PubMed

    Osemene, Kanayo P; Afolabi, Margaret O

    2017-07-12

    The use of the modified-prescription event monitoring technique has facilitated the understanding and reporting of pharmacovigilance (PV). However, in Nigeria, PV activities are largely misunderstood. Furthermore, there is a dearth of information on the knowledge and perceptions of pharmacy students on PV activities in relation to demographics. This study investigated and assessed the knowledge and perceptions of pharmacy students about pharmacovigilance as well as the demographic factors that are related to pharmacovigilance activities. A cross-sectional survey was conducted among final year pharmacy students in three universities in months of January and February, 2016 with permission from the institutions and with written consents from 342 respondents. Pre-tested questionnaire was used to elicit information on the study objectives. Data were analysed using appropriate descriptive and inferential statistical techniques. The study revealed that the mean score on knowledge of pharmacy students on pharmacovigilance activities was 4.3 ± 0.18 which was significant according to gender (P < 0.001), students' university (P < 0.001), and previous exposure to PV subjects (P < 0.001). Sixty-four percent of the students had positive perceptions about PV activities which was significant at P < 0.00 according to gender and their various universities. Less than half of the respondents 165 (48.2%) were able to correctly name the organisation that collates and document ADR reports in Nigeria. Only 21 (6.1%) of the respondents gave the correct answer to whether or not all possible ADRs of a drug can be determined during clinical trials or during pre-marketing phase of drug assessment. About 204 (59.7%) of the respondents erroneously believed that adverse reactions caused by cosmetics should not be reported. Respondents have inadequate knowledge of PV activities. Therefore, pharmacy student educators should enhance students' knowledge about PV through training, during

  5. French for Business and Journalism

    ERIC Educational Resources Information Center

    Lacombe, Anne

    1977-01-01

    A description of a university course in French whose object is to give students some facility in current French as found in newspapers, magazines, radio and films; and to introduce them to contemporary French civilization. Methods used are reading, translation, synopsis writing, correspondence and interviews. (Text is in French.) (AMH)

  6. Teaching Middle School French

    ERIC Educational Resources Information Center

    Olson, Marilyn L.

    1975-01-01

    Author described some of the techniques she used for teaching French at Roosevelt Junior High School, West Palm Beach. She also explained how these techniques helped students to maintain an early desire to learn a foreign language. (Author/RK)

  7. The French Strategic Dilemma.

    DTIC Science & Technology

    1984-03-01

    crisis . The language of French strategic doctrine is that of dissuasion (deterrence). The French talk publicly much less about warfighting (and employment...threaten vital lines of supply in a crisis situation. Nuclear forces would not *-"e necessarily be useful In deterring Soviet actions in this regard. Rather...34 in Pierre Lellouche, ed., Pacifisme et Dissuasion (Paris: Economica , 1983), pp. 253-266. C. % 6. See Pierre Lacoste, Strategie Navale (Paris: Fernand

  8. Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study.

    PubMed

    Ali, Ayad K; Heran, Balraj S; Etminan, Mahyar

    2015-07-01

    Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary to low-dose finasteride use in young men. Retrospective pharmacovigilance disproportionality analysis. United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Low-dose finasteride-related adverse event reports for men aged 18-45 years that were submitted to the FAERS between 1998 and 2013 were retrieved. Multi-item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (EBGM) and corresponding 95% confidence interval (CI) as an association metric between low-dose finasteride and the events of interest. Signals were defined as associations with thresholds of a CI lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to SD and SI were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent SD and 39 SI adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low-dose finasteride; 34 (87.2%) of the 39 men with SI also experienced SD. The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low-dose finasteride was associated with more than expected reporting of SD in young men compared with reporting of these events with all other drugs within the database (EBGM 28.0, 95% CI 26.1-30.0). Disproportional reporting in SI events was noted, although it did not reach signal threshold (EBGM 1.72; 95% CI 1.31-2.23). Among serious SD events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life-threatening. Six fatal SD

  9. Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

    PubMed

    Sorbello, Alfred; Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

    2017-03-22

    We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. All usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

  10. Therapeutic drug monitoring as a measure of proactive pharmacovigilance in child and adolescent psychiatry.

    PubMed

    Gerlach, Manfred; Egberts, Karin; Dang, Su-Yin; Plener, Paul; Taurines, Regina; Mehler-Wex, Claudia; Romanos, Marcel

    2016-11-01

    Off-label or unlicensed use of psychotropic drugs is common rather than the exception in child and adolescent psychiatry. This use exposes patients to an unknown additional risk of ineffective or even harmful treatment. In addition, treatment with psychotropic drugs during a period of life when the patient undergoes marked developmental hormonal and neurobiological changes often requires different dosing regimes in later life and may result in adverse drug reactions, which are either not seen in adults at all or not in the same frequency. Areas covered: Given these critical safety issues, efficient pharmacovigilance methods as part of routine practice are essential for the improvement of patient care. The purpose of this article is to introduce methods to increase the safety of psychotropic drug use in youngsters. In particular, therapeutic drug monitoring (TDM) as a routine measure of proactive pharmacovigilance is discussed. Expert opinion: Given the special features of psychopharmacological therapy in children and adolescents in day-to-day clinical practise, proactive surveillance by using a close standardized 'patient monitoring' and long-term follow-up with TDM is very important. This approach could minimize the risk of exposing paediatric patients to ineffective treatments of uncertain or unknown risks.

  11. Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

    PubMed Central

    Black, Corri; Tagiyeva-Milne, Nara; Helms, Peter; Moir, Dorothy

    2015-01-01

    Aims A systematic review of the literature published in English over 10 years was undertaken in order to describe the use of electronic healthcare data in the identification of potential adverse drug reactions (ADRs) in children. Methods MEDLINE and EMBASE were searched using MESH headings and text words. Titles, keywords and abstracts were checked for age <18 years, potential ADRs and electronic healthcare data. Information extracted included age, data source, pharmacovigilance method, medicines and ADRs. Studies were quality assessed. Results From 14 804 titles, 314 had a full text review and 71 were included in the final review. Fifty were published in North America, 10 in Scandinavia. Study size ranged from less than 1000 children to more than 10 million. Sixty per cent of studies used data from one source. Comparative observational studies were most commonly reported (66.2%) with 15% using passive surveillance. Electronic healthcare data set linkage and the quality of the data source were poorly reported. ADRs were classified using the International Classification of Disease (ICD10). Multi-system reactions were most commonly studied, followed by central nervous system and mental and behavioural disorders. Vaccines were most frequently prescribed followed by corticosteroids, general anaesthetics and antidepressants. Conclusions Routine electronic healthcare records were increasingly reported to be used for pharmacovigilance in children. This growing and important health protection activity could be enhanced by consistent reporting of studies to improve the identification, interpretation and generalizability of the evidence base. PMID:25819310

  12. New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS).

    PubMed

    Shin, Ju-Young; Jung, Sun-Young; Ahn, So-Hyeon; Lee, Shin Haeng; Kim, Su-Jin; Seong, Jong-Mi; Chung, Soo-Youn; Park, Byung-Joo

    2014-11-01

    Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS. In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications. Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance. The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information. Copyright © 2014 John Wiley & Sons, Ltd.

  13. Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database.

    PubMed

    Kim, JaYoung; Kim, Munsin; Ha, Ji-Hye; Jang, Junghoon; Hwang, Myungsil; Lee, Byung Koo; Chung, Myeon Woo; Yoo, Tae Moo; Kim, Myung Jung

    2011-11-01

    Data mining is critical for signal detection in pharmacovigilance systems. In this study, we compared signals between spontaneous reporting data and health insurance claims data for a socially issued drug, methylphenidate. We implemented data-mining tools for signal detection in both databases: Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Chi-squared test, and Information Component (IC), in addition to a Relative Risk (RR) tool in the claims database. The claims database generated 15, 15, 36, 1, and 1 adverse drug reactions (ADRs) by ROR, PRR, chi-square, IC, and RR, respectively. The World Health Organization (WHO) spontaneous database generated 91, 91, 137, and 96 ADRs by ROR, PRR, chi-square, and IC, respectively. We found seven potential matching associations from the claims and WHO databases, but only one of them was present in the Korean spontaneous reporting database. In Korea, spontaneous reporting is still underreported and there is a small amount of data for Koreans. Signal comparison between the claims and WHO databases can provide additional regulatory insight.

  14. Translating Word-Play: French-English, English-French.

    ERIC Educational Resources Information Center

    Gordon, W. Terrence

    1986-01-01

    The linguistic complexity of humor is illustrated with examples of word play translated from French to English and English to French. Examples from the writings of James Joyce and Marcel Proust are highlighted. (CB)

  15. Translating Word-Play: French-English, English-French.

    ERIC Educational Resources Information Center

    Gordon, W. Terrence

    1986-01-01

    The linguistic complexity of humor is illustrated with examples of word play translated from French to English and English to French. Examples from the writings of James Joyce and Marcel Proust are highlighted. (CB)

  16. Therapeutic management of inflammatory bowel disease in real-life practice in the current era of anti-TNF agents: analysis of the French administrative health databases 2009-2014.

    PubMed

    Kirchgesner, J; Lemaitre, M; Rudnichi, A; Racine, A; Zureik, M; Carbonnel, F; Dray-Spira, R

    2017-01-01

    Management of inflammatory bowel disease (IBD) has evolved in the last decade. To assess IBD therapeutic management, including treatment withdrawal and early treatment use in the current era of anti-TNF agents (anti-TNFs). All patients affiliated to the French national health insurance diagnosed with IBD were included from 2009 to 2013 and followed up until 31 December 2014. Medication uses, treatment sequences after introduction of thiopurine or anti-TNF monotherapies or both (combination therapy), surgical procedures and hospitalisations were assessed. A total of 210 001 patients were diagnosed with IBD [Crohn's disease (CD), 100 112; ulcerative colitis (UC), 109 889]. Five years after diagnosis, cumulative probabilities of anti-TNF monotherapy and combination therapy exposures were 33.8% and 18.3% in CD patients and 12.9% and 7.4% in UC patients, respectively. Among incident patients who received thiopurines or anti-TNFs, the first treatment was thiopurine in 69.1% of CD and 78.2% of UC patients. Among patients treated with anti-TNFs, 45.2% and 54.5% of CD patients and 38.2% and 39.9% of UC patients started monotherapy and combination therapy within 3 months after diagnosis, respectively; 31.3% of CD and 27.1% of UC incident patients withdrew from thiopurine or anti-TNFs for more than 3 months after their first course of treatment. Five years after diagnosis, the cumulative risks of first intestinal resection in CD patients and colectomy in UC patients were 11.9% and 5.7%, respectively. Step-up approach remains the predominant strategy, while exposure to anti-TNFs is high. Surgery rates are low. Treatment withdrawal in IBD is more common than expected. © 2016 John Wiley & Sons Ltd.

  17. Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.

    PubMed

    Hopf, Y M; Francis, J; Helms, P J; Haughney, J; Bond, C

    2016-01-01

    Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs. The objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland. A Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation. 121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree - strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach. It would

  18. French Antilles and Guiana.

    PubMed

    1983-11-01

    This discussion of French Antilles and Guiana cover the following: the people, geography, history, government, political conditions, economy, and relations with the US. In 1983 the population totaled 303,000 with an annual growth rate of 0.09%. The infant mortality rate (1981) was 12.6/1000 and life expectancy 68 years. About 98% of the people of Martinique are of Afro European or Afro European Indian descent. The remainder are the old planter families and a sizable number of metropolitan French. Most of the work force are employed in agriculture or food processing and associated industries. Most permanent residents of Guadeloupe are of mixed Afro European descent. A few thousand Metropolitan French reside there. Most French Guianese live along the coast, about 1/2 of them in the capital. Martinique is the northernmost of the Windward Islands, which are part of the Lesser Antilles chain in the Caribbean Sea southeast of Puerto Rico. Guadeloupe comprises 2 of the Leeward Islands, which are also part of the Lesser Antilles chain. French Guiana is located on the northern coast of South America, a few degrees north of the Equator. Indians were the 1st known indigenous inhabitants of French Guiana and the French Antilles. Columbus sighted Guadeloupe in 1493, Martinique in 1493 or 1502, and the Guiana coast probably during his 3rd voyage in 1498. French Guiana, Guadeloupe, and Martinique, as overseas departments of France since 1946, are integral parts of the French Republic. Their relationship to Metropolitan France is somewhat similar to that of Alaska and Hawaii to the counterminous US. Each department has a general council composed of 1 representative elected by each canton. Guadeloupe and Martinique each elect 2 senators to the French Senate and 3 deputies to the National Assembly. French Guiana elects 1 senator and 1 deputy. In each of the 3 departments exist individuals and small political parties that advocate immediate independence, but their adherents form only

  19. Advancing pharmacovigilance through academic-legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis-a Research on Adverse Drug Events and Reports (RADAR) report.

    PubMed

    Edwards, B J; Laumann, A E; Nardone, B; Miller, F H; Restaino, J; Raisch, D W; McKoy, J M; Hammel, J A; Bhatt, K; Bauer, K; Samaras, A T; Fisher, M J; Bull, C; Saddleton, E; Belknap, S M; Thomsen, H S; Kanal, E; Cowper, S E; Abu Alfa, A K; West, D P

    2014-10-01

    To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts. The Research on Adverse Drug events And Reports methodology was used for assessment-the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration. The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA. Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA. This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

  20. Comparing Written Competency in Core French and French Immersion Graduates

    ERIC Educational Resources Information Center

    Lappin-Fortin, Kerry

    2014-01-01

    Few studies have compared the written competency of French immersion students and their core French peers, and research on these learners at a postsecondary level is even scarcer. My corpus consists of writing samples from 255 students from both backgrounds beginning a university course in French language. The writing proficiency of core French…

  1. French for Marketing. Using French in Media and Communications.

    ERIC Educational Resources Information Center

    Batchelor, R. E.; Chebli-Saadi, M.

    The textbook, entirely in French, is designed to help prepare anglophone students for French language usage in the media and telecommunications. It is organized according to two major themes. The first part addresses the French of advertising; chapter topics include the actors in advertising (agencies, announcers, supports), forms of advertising,…

  2. French for Marketing. Using French in Media and Communications.

    ERIC Educational Resources Information Center

    Batchelor, R. E.; Chebli-Saadi, M.

    The textbook, entirely in French, is designed to help prepare anglophone students for French language usage in the media and telecommunications. It is organized according to two major themes. The first part addresses the French of advertising; chapter topics include the actors in advertising (agencies, announcers, supports), forms of advertising,…

  3. The French Revolution and the French Language: A Paradox?

    ERIC Educational Resources Information Center

    Djite, Paulin

    1992-01-01

    Explores the relationship between revolutionary ideals and the subsequent expansion and promotion of the French language. It is shown, through a linguistic and sociopolitical history of the French Revolution and the French language, that there is no incompatibility between the two and that the movement of Francophonie is a continuation of France's…

  4. The French Revolution and the French Language: A Paradox?

    ERIC Educational Resources Information Center

    Djite, Paulin

    1992-01-01

    Explores the relationship between revolutionary ideals and the subsequent expansion and promotion of the French language. It is shown, through a linguistic and sociopolitical history of the French Revolution and the French language, that there is no incompatibility between the two and that the movement of Francophonie is a continuation of France's…

  5. French nuclear physics accelerator opens

    NASA Astrophysics Data System (ADS)

    Dumé, Belle

    2016-12-01

    A new €140m particle accelerator for nuclear physics located at the French Large Heavy Ion National Accelerator (GANIL) in Caen was inaugurated last month in a ceremony attended by French president François Hollande.

  6. [Evaluation of the website of the Nord-Pas-de-Calais regional pharmacovigilance center].

    PubMed

    Rochoy, Michaël; Béné, Johana; Messaadi, Nassir; Auffret, Marine; Gautier, Sophie

    2016-06-01

    We posted the Nord-Pas-de-Calais regional pharmacovigilance center website and distributed a survey to its potential users between August 2014 and October 2014 (135 general practitioners, 45 pharmacists, 14 patients). Satisfaction was 7.3±1.6 out of 10 points for the visual aspect, 7.8±1.5 out of 10 points for navigation and 7.6±1.4 out of 10 points for content. The website was declared useful by 98% respondents, particularly for the reporting of adverse drugs reactions (89%).

  7. America's Tolerance for French Radicalism

    ERIC Educational Resources Information Center

    Wolin, Richard

    2008-01-01

    The publication of Francois Cusset's "French Theory" raises a series of fascinating questions concerning the trans-Atlantic transmission and circulation of ideas. Most important, it impels everyone to inquire why for a time French thought managed to flourish in American universities while French intellectuals rapidly abandoned the entire…

  8. French Polynesia. Asian Studies Module.

    ERIC Educational Resources Information Center

    Outs, JoAnn

    This curriculum outline presents the components of an introductory course to French culture which focuses on the colonization of French Polynesia. First, the general goals and student objectives for the course, which focuses on different historical periods of French Polynesia, are discussed. Next, the pre-test to determine students knowledge of…

  9. Aspects of Bordeaux French Phonology.

    ERIC Educational Resources Information Center

    Rochet, Bernard

    Among the characteristics which set Bordeaux French apart from Standard French are the rules governing the behavior of its mid-vowels. These rules are much simpler and more extensive (in that they also apply to unstressed vowels) than in Standard French. Their application is, however, systematically conditioned by the presence or absence of word…

  10. Comparative analysis of pharmacovigilance methods in the detection of adverse drug reactions using electronic medical records

    PubMed Central

    Liu, Mei; McPeek Hinz, Eugenia Renne; Matheny, Michael Edwin; Denny, Joshua C; Schildcrout, Jonathan Scott; Miller, Randolph A; Xu, Hua

    2013-01-01

    Objective Medication  safety requires that each drug be monitored throughout its market life as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient harm. Recently, electronic medical records (EMRs) have emerged as a valuable resource for pharmacovigilance. This study examines the use of retrospective medication orders and inpatient laboratory results documented in the EMR to identify ADRs. Methods Using 12 years of EMR data from Vanderbilt University Medical Center (VUMC), we designed a study to correlate abnormal laboratory results with specific drug administrations by comparing the outcomes of a drug-exposed group and a matched unexposed group. We assessed the relative merits of six pharmacovigilance measures used in spontaneous reporting systems (SRSs): proportional reporting ratio (PRR), reporting OR (ROR), Yule's Q (YULE), the χ2 test (CHI), Bayesian confidence propagation neural networks (BCPNN), and a gamma Poisson shrinker (GPS). Results We systematically evaluated the methods on two independently constructed reference standard datasets of drug–event pairs. The dataset of Yoon et al contained 470 drug–event pairs (10 drugs and 47 laboratory abnormalities). Using VUMC's EMR, we created another dataset of 378 drug–event pairs (nine drugs and 42 laboratory abnormalities). Evaluation on our reference standard showed that CHI, ROR, PRR, and YULE all had the same F score (62%). When the reference standard of Yoon et al was used, ROR had the best F score of 68%, with 77% precision and 61% recall. Conclusions Results suggest that EMR-derived laboratory measurements and medication orders can help to validate previously reported ADRs, and detect new ADRs. PMID:23161894

  11. Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform.

    PubMed

    Mosha, Dominic; Mazuguni, Festo; Mrema, Sigilbert; Abdulla, Salim; Genton, Blaise

    2014-09-15

    There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy. Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome. 1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08-0.3). Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.

  12. Spontaneous reporting of adverse drug events by Korean regional pharmacovigilance centers.

    PubMed

    Shin, Yoo Seob; Lee, Yong-Won; Choi, Young Hwa; Park, Byungjoo; Jee, Young Koo; Choi, Sung-Kyu; Kim, Eung-Gyu; Park, Jung-Won; Hong, Chein-Soo

    2009-10-01

    Patterns of prescriptions are markedly influenced by regional disease entities, medical education, culture, economic status, and available pharmaceutical companies. Features of adverse drug reactions (ADRs) may vary in different countries. In this study, we analyzed the causative drugs and clinical manifestations of spontaneously reported ADRs in Korea. Six Korean Regional Pharmacovigilance Centers collected 1418 cases of spontaneously reported adverse drug events (ADEs) by doctors, pharmacists, and nurses, and the clinical features and causative drugs were evaluated. The data were collected from general hospitals (76.5%), primary clinics, and pharmacies (23.5%). Based upon the World Health Organization (WHO)-Uppsala Monitoring Center criteria (certain-13.7%, probable-46.1%, possible-32.1%), 91.9% of the collected events were suspected to be ADRs and 15.8% of patients experienced serious ADRs. The most prevalent causative drugs were antibiotics (31.6%), followed by contrast dyes (14.0%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.1%), anti-psychotics (5.4%), anti-convulsants (5.2%), cardiovascular agents (4.8%), anti-neoplastics (4.6%), and opiates and non-opiate pain killers (3.5%). Among the antibiotics, cephalosporins (8.1%) were the most common, followed by anti-tuberculosis agents (5.7%), quinolones (4.0%), vancomycin (3.1%), and penicillin (2.8%). The most common side effect was skin manifestations, which were seen in 42% of the patients, followed by neurologic manifestations (14%), gastrointestinal involvements (12.9%), generalized reactions (9.4%), and respiratory involvements (4.5%). Antibiotics, contrast dyes, and NSAIDs were the most common causative drugs for ADRs, which reflects the prescription pattern and the prevalence of diseases in Korea. These data may be useful in establishing a Korean pharmacovigilance system. 2009 John Wiley & Sons, Ltd.

  13. Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009.

    PubMed

    Aldea, A; García Sánchez-Colomer, M; Fernández Quintana, E; García Sáiz, M

    2012-09-01

    This study was conducted to evaluate relevant new information about ADRs reported in the Spanish paediatric population over a 6-year period. Adverse drug reactions (ADRs) for individuals aged 0-17 years reported to the Spanish Pharmacovigilance System from 2004 to 2009 were analysed with respect to time, age and sex, category of ADR [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the Anatomical Therapeutic Chemical (ATC) Classification System] and type of reporter. In total, 4,279 ADR reports corresponding to 8,196 ADRs were analysed, approximately two ADRs per report. The rate of paediatric ADR reports in 2009 was 165 per million, of which nearly half (46 %) were for children (age group 2-11 years). Similar total numbers of ADRs were reported for boys and girls. The most frequent ADRs reported were from the following SOCs: general disorders and administration site conditions (34 %); skin and subcutaneous tissue disorders (15 %); nervous system disorders (14 %). Reports encompassed medicines from various ATC groups: vaccines and anti-infectives for systemic use (67 %); nervous system (9 %); respiratory system (9 %). On average, 37 % of ADRs were classified as serious. There were 33 fatal ADRs, and 35 % of the paediatric population associated with the ADR notifications required hospitalization or extended hospital stay. In Spain, ADR reporting rate in the paediatric population has increased since 2004. The proportion of suspected ADR reports related to vaccines was predominant, which highlights the important role played by nurses. ADR notification of congenital malformations in newborn infants highlights the need for joint action between the Spanish System of Pharmacovigilance of Medicines for Human Use (SEFV-H) and paediatricians, obstetricians and gynaecologists. The publication of safety reports by regulatory agencies is determinant for the increased number of ADR notifications.

  14. Syllabification and French Phonology.

    ERIC Educational Resources Information Center

    Walker, D. C.

    1973-01-01

    Much research has focused on the question of whether phonological rules can and should be stated more appropriately in terms of the syllable than other units, notable segments and various boundaries. Formulation of rules without reference to the syllable obscures the motivation and unity of alternations. French has rules for consonant deletion…

  15. Technoscientific French for Teachers.

    ERIC Educational Resources Information Center

    Muller, Brigitte D.

    A two-semester sequence of courses in French and Spanish for science and technology at Eastern Michigan University responds to alumni demands for better linguistic and cultural preparation for increasingly global business and industry. In addition, high schools teacher enrolled in the courses find they answer a need for professional upgrading of…

  16. Know Your Laws. French.

    ERIC Educational Resources Information Center

    Watson, Joan Q.; Ledun, Andree

    This French language version of "Know Your Laws" consists of 24 self-contained modules designed to acquaint the Florida adult student with laws she/he will meet in everyday life; fundamentals of local, state, and federal governments; and the criminal and juvenile justice systems. (The 130 objectives are categorized in the first three…

  17. French 3200, Course Description.

    ERIC Educational Resources Information Center

    Newfoundland and Labrador Dept. of Education, St. John's. Div. of Instruction.

    The objectives and course content for French 3200, a secondary level course intended for the second or third year of four- and six-credit language course sequences in Newfoundland high schools, are outlined. Its primary objectives relate to the skill development in the four language skill areas (listening, speaking, reading, and writing),…

  18. Old French for Undergraduates.

    ERIC Educational Resources Information Center

    Sargent, Barbara Nelson

    A list of six main benefits of the study of Old French at the undergraduate level follows a discussion of the value, function, and goals of such a program. The advantages discussed result in: (1) a first-hand acquaintance with medieval masterpieces, (2) a sense of continuity in the history of literature, (3) improved techniques in critical…

  19. French Theory's American Adventures

    ERIC Educational Resources Information Center

    Cusset, Francois

    2008-01-01

    In this article, the author discusses how it is simply too late to be still speaking about French theory and its role in the intellectual life of the United States today. It seems to many observers that the gap between real-life politics and theory's guerrillas is much too wide already, after 30 years of academic fever, for the two worlds to even…

  20. Know Your Laws. French.

    ERIC Educational Resources Information Center

    Watson, Joan Q.; Ledun, Andree

    This French language version of "Know Your Laws" consists of 24 self-contained modules designed to acquaint the Florida adult student with laws she/he will meet in everyday life; fundamentals of local, state, and federal governments; and the criminal and juvenile justice systems. (The 130 objectives are categorized in the first three…

  1. Teaching the French Revolution.

    ERIC Educational Resources Information Center

    Adams, Thomas M.

    1989-01-01

    Reports on presentations made at a symposium sponsored by the Connecticut Humanities Council. Papers dealt with teaching the French Revolution by presenting European history in new relationships with the rest of the world and by examining the Declaration of the Rights of Man as it related to the role of women. (KO)

  2. The French Revolution.

    ERIC Educational Resources Information Center

    Scrofani, E. Robert; Johnston, Anne

    This 10-day unit on the French Revolution is designed to help high school students understand the interplay of economic, social, and political forces in the process of revolutionary change, and the development of modern democratic forms of government. Critical thinking and geographic skill activities are employed throughout the unit and include…

  3. Teaching the French Revolution.

    ERIC Educational Resources Information Center

    Adams, Thomas M.

    1989-01-01

    Reports on presentations made at a symposium sponsored by the Connecticut Humanities Council. Papers dealt with teaching the French Revolution by presenting European history in new relationships with the rest of the world and by examining the Declaration of the Rights of Man as it related to the role of women. (KO)

  4. The French Revolution.

    ERIC Educational Resources Information Center

    Scrofani, E. Robert; Johnston, Anne

    This 10-day unit on the French Revolution is designed to help high school students understand the interplay of economic, social, and political forces in the process of revolutionary change, and the development of modern democratic forms of government. Critical thinking and geographic skill activities are employed throughout the unit and include…

  5. Living in Ontario French

    ERIC Educational Resources Information Center

    Nadasdi, Terry

    2005-01-01

    This article presents a variationist analysis of verbs meaning "reside" in Ontario French. Four lexical variants are examined: "demeurer," "habiter," "rester" and "vivre." Results reveal that "rester" is used most often by unrestricted speakers and least often by those whose use of French…

  6. I Can Speak French.

    ERIC Educational Resources Information Center

    New York City Board of Education, Brooklyn, NY. Div. of Curriculum and Instruction.

    The guide presents content and techniques for teaching conversational French in the elementary grades. It contains an introductory section and 20 units for classroom instruction. The introduction includes notes on the overall objectives of the course, general guidelines on classroom procedure, and specific techniques for use of the materials…

  7. I Can Speak French.

    ERIC Educational Resources Information Center

    New York City Board of Education, Brooklyn, NY. Div. of Curriculum and Instruction.

    The guide presents content and techniques for teaching conversational French in the elementary grades. It contains an introductory section and 20 units for classroom instruction. The introduction includes notes on the overall objectives of the course, general guidelines on classroom procedure, and specific techniques for use of the materials…

  8. Biofuel Database

    National Institute of Standards and Technology Data Gateway

    Biofuel Database (Web, free access)   This database brings together structural, biological, and thermodynamic data for enzymes that are either in current use or are being considered for use in the production of biofuels.

  9. The importance of monitoring adverse drug reactions in elderly patients: the results of a long-term pharmacovigilance programme.

    PubMed

    Carnovale, Carla; Gentili, Marta; Fortino, Ida; Merlino, Luca; Clementi, Emilio; Radice, Sonia; ViGer Group

    2016-01-01

    To recognise and prevent ADRs (including DDIs) in the elderly through a 4-year post-marketing active pharmacovigilance programme. The programme was designed to enhance high quality spontaneous reporting of ADRs in elderly patients by sampling the Italian population and was termed 'Pharmacovigilance in Geriatry (ViGer)'. ADRs were collected for adults aged over 65 years of age treated in nursing homes, continuing care retirement communities and territorial health services in Lombardy. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analysed with respect to time, sex, category of ADR, seriousness, suspected medicines, notoriety. We analysed all the potential DDIs. We detected 1073 cases reports corresponding to 2110 ADRs. Vaccines, antibacterials for systemic use and antineoplastic agents were the pharmacotherapeutic subgroups most frequently involved. 18% of ADRs reports were classified as serious. In 752 reports patients were described as in polytherapy; in 55 patients (7.3%) the reported ADR were probably preventable because of DDIs involvement. The ViGer project demonstrated that active pos-marketing pharmacovigilance programmes are a valid strategy to increase awareness on geriatrics pharmacology, reduce underreporting and provide important information on previous unknown ADRs and DDIs, resulting in a therapy optimisation in clinical practice in the geriatric setting.

  10. Health care professionals knowledge and perception of pharmacovigilance in a tertiary care teaching hospital in Amman, Jordan.

    PubMed

    Abu Hammour, Khawla; El-Dahiyat, Faris; Abu Farha, Rana

    2017-06-01

    Underreporting of adverse drug reactions (ADRs) by health care professionals is a common inherent health problem encountered in many countries. This could be explained by the lack of awareness and knowledge about the guidelines to follow to identify and report ADRs. Thus, this study aimed to evaluate the awareness, knowledge, and perceptions among medical doctors and nurses regarding their role as ADRs reporters in Jordan. A cross-sectional study was conducted between September 2015 to January 2016 at the Jordan University Hospital in Amman. During the study period, a total of 670 validated questionnaires were distributed to medical doctors and nurses in different departments. Most of health care professionals were not aware of the concept of pharmacovigilance. Medical doctors showed a better overall knowledge compared with nurses (P < .05). Interestingly, despite the low level of awareness, the majority of respondents believed in the necessity of reporting ADRs. Although there is a low level of awareness among health care professionals regarding pharmacovigilance, there is strong agreement among them about the necessity of reporting ADRs and attending educational sessions about pharmacovigilance which will help them to improve the quality of services they provide. © 2017 John Wiley & Sons, Ltd.

  11. Improving Detection of Arrhythmia Drug-Drug Interactions in Pharmacovigilance Data through the Implementation of Similarity-Based Modeling.

    PubMed

    Vilar, Santiago; Lorberbaum, Tal; Hripcsak, George; Tatonetti, Nicholas P

    2015-01-01

    Identification of Drug-Drug Interactions (DDIs) is a significant challenge during drug development and clinical practice. DDIs are responsible for many adverse drug effects (ADEs), decreasing patient quality of life and causing higher care expenses. DDIs are not systematically evaluated in pre-clinical or clinical trials and so the FDA U. S. Food and Drug Administration relies on post-marketing surveillance to monitor patient safety. However, existing pharmacovigilance algorithms show poor performance for detecting DDIs exhibiting prohibitively high false positive rates. Alternatively, methods based on chemical structure and pharmacological similarity have shown promise in adverse drug event detection. We hypothesize that the use of chemical biology data in a post hoc analysis of pharmacovigilance results will significantly improve the detection of dangerous interactions. Our model integrates a reference standard of DDIs known to cause arrhythmias with drug similarity data. To compare similarity between drugs we used chemical structure (both 2D and 3D molecular structure), adverse drug side effects, chemogenomic targets, drug indication classes, and known drug-drug interactions. We evaluated the method on external reference standards. Our results showed an enhancement of sensitivity, specificity and precision in different top positions with the use of similarity measures to rank the candidates extracted from pharmacovigilance data. For the top 100 DDI candidates, similarity-based modeling yielded close to twofold precision enhancement compared to the proportional reporting ratio (PRR). Moreover, the method helps in the DDI decision making through the identification of the DDI in the reference standard that generated the candidate.

  12. Resveratrol: French Paradox Revisited

    PubMed Central

    Catalgol, Betul; Batirel, Saime; Taga, Yavuz; Ozer, Nesrin Kartal

    2012-01-01

    Resveratrol is a polyphenol that plays a potentially important role in many disorders and has been studied in different diseases. The research on this chemical started through the “French paradox,” which describes improved cardiovascular outcomes despite a high-fat diet in French people. Since then, resveratrol has been broadly studied and shown to have antioxidant, anti-inflammatory, anti-proliferative, and anti-angiogenic effects, with those on oxidative stress possibly being most important and underlying some of the others, but many signaling pathways are among the molecular targets of resveratrol. In concert they may be beneficial in many disorders, particularly in diseases where oxidative stress plays an important role. The main focus of this review will be the pathways affected by resveratrol. Based on these mechanistic considerations, the involvement of resveratrol especially in cardiovascular diseases, cancer, neurodegenerative diseases, and possibly in longevity will be is addressed. PMID:22822401

  13. Database Administrator

    ERIC Educational Resources Information Center

    Moore, Pam

    2010-01-01

    The Internet and electronic commerce (e-commerce) generate lots of data. Data must be stored, organized, and managed. Database administrators, or DBAs, work with database software to find ways to do this. They identify user needs, set up computer databases, and test systems. They ensure that systems perform as they should and add people to the…

  14. FIREMON Database

    Treesearch

    John F. Caratti

    2006-01-01

    The FIREMON database software allows users to enter data, store, analyze, and summarize plot data, photos, and related documents. The FIREMON database software consists of a Java application and a Microsoft® Access database. The Java application provides the user interface with FIREMON data through data entry forms, data summary reports, and other data management tools...

  15. Database Administrator

    ERIC Educational Resources Information Center

    Moore, Pam

    2010-01-01

    The Internet and electronic commerce (e-commerce) generate lots of data. Data must be stored, organized, and managed. Database administrators, or DBAs, work with database software to find ways to do this. They identify user needs, set up computer databases, and test systems. They ensure that systems perform as they should and add people to the…

  16. A pharmacovigilance study of adults on highly active antiretroviral therapy, South Africa: 2007 – 2011

    PubMed Central

    Dube, Nomathemba Michell; Summers, Robert; Tint, Khin-San; Mayayise, Guistee

    2012-01-01

    Background Of the 1.6 million South African people infected with human immunodeficiency virus (HIV), approximately 970,000 (55%) have been initiated on HAART. Despite these numbers, very little has been published about the safety profile of antiretroviral (ARV) medicines in the country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for regimen changes; and adverse effects of ARV medicines. Methods A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. Results After HAART initiation, with an average lapse of 17.8 months (range: 0 – 83.8 months), 2,815 patients were enrolled into the study. Results show that patients were observed for 1,606.2 person-years for pharmacy visits (collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6% (1,958/2,815) of the study population. Almost all patients initiated HAART on first-line regimens (2,801/2,815). Some patients (6.7%, 190/2,815) dropped out of the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5% (22/891) of the patients who changed regimens. The primary reason for regimen changes was drug-related toxicity (76.1%, 678/891), mostly evident in patients taking first-line regimens. Adverse effects experienced by patients were polyneuropathy (24.0%, 163/678); lipodystrophy (23.9%, 162/678); neuropathy (10.6%, 72/678); and suspected lactic acidosis (3.8%, 26/678). Conclusion The majority of prescribers complied with the HAART guidelines and initiated most patients on first-line regimens. However, adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health should

  17. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil

    PubMed Central

    2013-01-01

    Background Adverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service. Methods A prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed. Results The overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had

  18. Pharmacovigilance Assessment of Immune-Mediated Reactions Reported for Checkpoint Inhibitor Cancer Immunotherapies.

    PubMed

    Ali, Ayad K; Watson, David E

    2017-09-26

    Ipilimumab, pembrolizumab, and nivolumab are checkpoint inhibitors (CPI) that activate T cell-mediated immune response. CPI can provide durable benefits to some cancer patients with melanoma, renal cell cancer, non-small cell lung cancer, and a growing list of other cancers. However, CPI treatment is also associated with adverse immune-mediated reactions (IMR) that can be life-threatening. This pharmacovigilance analysis aims to characterize IMR signals in relation to CPI treatment. Retrospective pharmacovigilance disproportionality analysis. FDA Adverse Event Reporting System (FAERS). Adverse event reports submitted to FAERS between 2011 and 2015 were analyzed. CPI were identified by generic names, and IMR were identified by MedDRA Preferred Terms. Empirical Bayes Geometric Means with corresponding 95% confidence interval (EB05-EB95) were calculated as CPI-IMR association metrics. Signals were defined as metrics with EB05≥2.0. Overall, 1,018 IMR events were submitted for CPI, corresponding to 76% for ipilimumab, 15% for nivolumab, and 9% for pembrolizumab. The period of data collection precluded data on the most recently approved CPI agents. IMR comprised of 51% colitis, 16% endocrinopathies, 12% pneumonitis, 11% hepatitis, 4% infusion-related reactions, 3% nephritis, and 3% other IMR. Colitis contributed to 63% and 41% of IMR for ipilimumab and nivolumab, respectively. Pneumonitis and hepatitis contributed to majority of IMR for pembrolizumab, for which nephritis and infusion-related reactions were not reported. Signals of IMR were detected for CPI as a class (EB05=12.4) and individual agents: ipilimumab (EB05=13.2), nivolumab (EB05=15.0), and pembrolizumab (EB05=7.3). Colitis and pneumonitis had the strongest signals for CPI (EB05=45.6 and EB05=17.6, respectively). Colitis was the strongest signal for ipilimumab (EB05=54.2), and pneumonitis was the strongest signal for nivolumab (EB05=48.0) and pembrolizumab (EB05=21.8). Cancer immunotherapy with CPI is

  19. A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.

    PubMed

    Pacurariu, Alexandra C; Coloma, Preciosa M; van Haren, Anja; Genov, Georgy; Sturkenboom, Miriam C J M; Straus, Sabine M J M

    2014-12-01

    New pharmacovigilance legislation in the European Union has underlined the importance of signal management, giving the European Medicines Agency's newly established Pharmacovigilance Risk Assessment Committee (PRAC) the mandate to oversee all aspects of the use of medicinal products including detection, assessment, minimization, and communication relating to the risk of adverse reactions. In this study, we describe the signals as brought to the PRAC during the first 18 months of its operation and the ensuing regulatory actions. Data were collected from publicly available sources, for the period July 2012-December 2013, classified according to predefined rules, and described using the appropriate descriptive statistics. Suspected adverse drug reactions were categorized into the Medical Dictionary for Regulatory Affairs and drug names were mapped to the Anatomical Therapeutic Chemical codes. During the study period, 125 signals concerning 96 medicinal products were discussed by the PRAC. The majority of signals were triggered by spontaneous reports (62%) and the median drug age (since marketing authorization) for drugs that prompted a signal was 12 years, significantly less compared with drugs that had no signal within the same period (20 years). The mean time until a decision was reached by the PRAC was 75 days (median 30 days, range 0-273) with 43% of all decisions taken during the first meeting. The decisions to start a referral and to send a direct healthcare professional communication took the least amount of time [54 days (median 27 days, range 0-186) and 51 days (median 0 days, range 0-153)]. The importance of spontaneous reporting in signal detection and monitoring of safety issues throughout the entire life cycle of a medicinal product is confirmed in this study. The amount of time a drug has been on the market is correlated with the number of signals detected. The PRAC decision-making process seems efficient particularly with respect to serious concerns

  20. French perspectives on psychiatric classification.

    PubMed

    Crocq, Marc-Antoine

    2015-03-01

    This article reviews the role of the French schools in the development of psychiatric nosology. Boissier de Sauvages published the first French treatise on medical nosology in 1763. Until the 1880s, French schools held a pre-eminent position in the development of psychiatric concepts. From the 1880s until World War I, German-speaking schools exerted the most influence, featuring the work of major figures such as Emil Kraepelin and Eugen Bleuler. French schools were probably hampered by excessive administrative and cultural centralization. Between the 1880s and the 1930s, French schools developed diagnostic categories that set them apart from international classifications. The main examples are Bouffée Délirante, and the complex set of chronic delusional psychoses (CDPs), including chronic hallucinatory psychosis. CDPs were distinguished from schizophrenia by the lack of cognitive deterioration during evolution. Modern French psychiatry is now coming into line with international classification, such as DSM-5 and the upcoming ICD-11.

  1. [French immigration policy].

    PubMed

    Weil, P

    1994-01-01

    From the late nineteenth century through 1974, France permitted immigration to furnish workers and to compensate for the low level of fertility. Intense immigration from North Africa, the economic crisis of the 1970s, and other factors led to policy changes in 1974. French immigration policy since 1974 has fluctuated between guaranteeing foreigners equal rights regardless of their religion, race, culture, or national origin, and attempting to differentiate among immigrants depending on their degree of assimilability to French culture. From 1974 to 1988, France had five different policies regarding whether to permit new immigration and what to do about illegal immigrants. In July 1984, the four major political parties unanimously supported a measure in Parliament that definitively guaranteed the stay in France of legal immigrants, whose assimilation thus assumed priority. Aid for return to the homeland was no longer to be widely offered, and immigration of unskilled workers was to be terminated except for those originating in European Community countries. Major changes of government in 1988 and 1993 affected only the modalities of applying these principles. The number of immigrants has fluctuated since 1974. Unskilled workers, the only category whose entrance was specifically controlled by the 1984 measures, have declined from 174,000 in 1970 to 25,000 in the early 1990s. The number of requests for political asylum declined from 60,000 in 1989 to 27,000 in 1993, and in 1991, 15,467 persons were granted refugee status. The number of immigrants of all types permitted to remain in France declined from 250,000 or 3000 per year in the early 1970s to around 110,000 at present. Although the decline is significant, it appears insufficient to the government in power since 1993. Although migratory flows are often explained as the product of imbalance in the labor market or in demographic growth, the French experience suggests that government policies, both in the sending and

  2. Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.

    PubMed

    Inokuma, Yasuko

    2017-06-01

    Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result. Through the amendment, regenerative medicine is defined as a new category and is covered by the Relief Service under the amended Pharmaceutical Affairs Act, called the 'Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics' (PMD Act). This amendment allows the use of Relief Service data for pharmacovigilance activities, making the Relief Service the third adverse drug reaction reporting route in addition to the existing reporting routes from marketing authorization holders and healthcare providers. For optimum incorporation and use of this Relief Service data, earlier access should be allowed even before the reports from the Pharmaceuticals and Medical Devices Agency to the Ministry of Health, Labour and Welfare are finalized, which is mandatory under the current PMD Act.

  3. Cutaneous adverse drug reactions notified by pharmacovigilance in a tertiary care hospital in north India.

    PubMed

    Mittal, Niti; Gupta, Mahesh; Singla, Mohit

    2014-12-01

    Medication-related adverse events, apart from causing significant morbidity and mortality, increase the healthcare cost burden and lead to early treatment discontinuations. Knowing the fact that cutaneous adverse drug reactions (cADRs) are most frequent, this study was conducted with an aim to describe their clinical profiles and preventive strategies. All adverse drug reaction (ADR) forms filled from January 2012 to January 2013 were scrutinised and forms with cADRs analysed and assessed for causality, preventability and severity. Of 400 ADR forms, 109 included cADRs. Sixty-eight percent patients were males and mean ± SD age was 35 ± 18 years. Rash, Steven-Johnson syndrome and toxic epidermal necrolysis were the most common presentations. Most frequent culprit drugs included antibiotics and anti-inflammatory agents. Causality was probable or possible in majority. Ninety percent cases were "not preventable". Majority of the patients had mild to moderate reactions and recovered completely after medical management. Pharmacovigilance, with special attention to monitoring and reporting of cADRs must be encouraged. As major bulk of cADRs result from physician prescribed drugs, awareness on part of the physician can help in their timely detection and management, thereby restricting the associated damage.

  4. Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

    PubMed Central

    Solomon, Cristina; Korte, Wolfgang; Fries, Dietmar; Pendrak, Inna; Joch, Christine; Gröner, Albrecht; Birschmann, Ingvild

    2016-01-01

    Background Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile. PMID:27781024

  5. Post Launch Monitoring of food products: what can be learned from pharmacovigilance.

    PubMed

    van Puijenbroek, E P; Hepburn, P A; Herd, T M; van Grootheest, A C

    2007-03-01

    Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

  6. Pharmaco-EcoMicrobiology: a newer component of medical sciences bridging pharmacovigilance, ecology, and environmental microbiology.

    PubMed

    Shahid, M; Khardori, Nancy; Tripathi, T; Bergman, Scott

    2010-01-01

    Environmental scientists are now raising great concern on the impact of drugs on the environment and microbiologists are concerned about increasing antibiotic resistance due to irrational usage. However, a focus on the impact by the use of antibiotics (irrational/prescribed) to the environment at therapeutic doses has not been instituted. Even the World Health Organization (WHO) defined "Pharmacovigilance" activities as the monitoring, detection, assessment, understanding and prevention of any adverse reactions to drugs at therapeutic concentration on animals and humans. Nevertheless, there is little attention being given to identifying the adverse effects (ADEs) of antimicrobial agents on the environment (given at therapeutic doses). This issue has been highlighted in the present commentary and a new domain, "Pharmaco-EcoMicrobiology", has been proposed which should deal with and monitor such adverse effects. The term "Pharmaco-EcoMicrobiology" has been proposed to define the interplay between antimicrobial pharmacological agents and animate microbial ecology. This new domain, "Pharmaco-EcoMicrobiology", has been derived by the aggregation of three important branches of science (pharmacology+ecology+microbiology) and would be responsible for studying the ADEs due to antimicrobial drugs excreted in environment.

  7. Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India

    PubMed Central

    Kalaivani, M; Singh, Abhishank; Kalaiselvan, V

    2015-01-01

    A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs. PMID:25523367

  8. Impact of manufacturing improvements on clinical safety of albumin: Australian pharmacovigilance data for 1988-2005.

    PubMed

    Che, Yan; Wilson, Fiona J; Bertolini, Joseph; Schiff, Peter; Maher, Darryl W

    2006-12-01

    To evaluate the impact of manufacturing improvements on the clinical safety of human albumin solutions in Australia. This retrospective study examined the incidence of spontaneously reported post-market adverse drug reactions (ADRs) in Australia associated with successive generations of albumin products manufactured by the Bioplasma Division of CSL Limited (CSL Bioplasma) over 18 years (1988-2005). Key characteristics of each product generation which could affect clinical safety, such as purity, aggregates and prekallikrein activator (PKA) levels, were also identified from CSL batch release records. A total of 3.7 million bottles of iso-oncotic and hyperoncotic albumin products were distributed in Australia over the period. Improvements to manufacturing processes resulted in products with increased albumin purity, lower levels of impurities such as aggregates and PKA, and reduced batch-to-batch variation. The total ADR incidence (number of ADRs per 100 000 bottles distributed) associated with the products currently supplied was 1.5 and 1.7 for Albumex 4 (2VI) and Albumex 20 (2VI), respectively. This was a significant reduction compared with the earlier generation products Stable Plasma Protein Solution (14.1) and 20% Normal Serum Albumin (11.5), respectively (P<0.0001). In particular, hypotensive reactions declined substantially. Post-market pharmacovigilance data collected for successive generations of human albumin products supplied in Australia over 18 years indicates that manufacturing improvements have significantly improved the clinical safety profile of this product.

  9. Pharmacogenetics and ethnicity: relevance for clinical implementation, clinical trials, pharmacovigilance and drug regulation in Latin America.

    PubMed

    Sosa-Macías, Martha; Teran, Enrique; Waters, William; Fors, Martha M; Altamirano, Catalina; Jung-Cook, Helgi; Galaviz-Hernández, Carlos; López-López, Marisol; Remírez, Diadelis; Moya, Graciela E; Hernández, Francisco; Fariñas, Humberto; Ramírez, Ronald; Céspedes-Garro, Carolina; Tarazona-Santos, Eduardo; LLerena, Adrián

    2016-10-28

    Congress of Pharmacogenetics and Personalized Medicine. Ethnicity, clinical implementation and regulatory environment (MESTIFAR 2016 Quito). Quito, Ecuador, 19-21 May 2016. The Ibero-American Network of Pharmacogenetics and Pharmacogenomics (RIBEF) was created in 2006 with the main aim of promoting personalized medicine and collaborative pharmacogenetics research in Spanish- and Portuguese-speaking countries in America and the Iberian Peninsula. The final goal of this initiative was the inclusion of Latin American populations that may benefit from the implementation of personalized medicine in drug therapy. Several initiatives have been promoted including the MESTIFAR project, which aimed to analyze the ethnicity, genotype and/or metabolic phenotype in Ibero-American populations. To date, 6060 healthy volunteers have been analyzed; among them, 2571 were admixed, 1824 were Caucasians, 1395 were Native Americans, 174 were Jews and 96 were Afro-descendants. Due to the large genetic variability within Latin Americans, ethnicity may be a relevant factor for the clinical implementation of personalized medicine. Moreover, the present status of clinical implementation and the future perspectives of pharmacogenetics, pharmacovigilance and clinical trials for drug regulation in Latin America compared with the EMA-Pharmacogenomics Working Party and the US FDA initiatives were analyzed.

  10. Pharmacovigilance and pharmacoepidemiology of drugs in a Mexican pediatric hospital. A proposed guide.

    PubMed

    Juárez-Olguín, Hugo; Pérez-Guillé, Gabriela; Flores-Pérez, Janett

    2007-02-01

    We describe the procedures of pharmacovigilance (PV) and pharmacoepidemiology (PE) of drugs in a pediatric hospital. These activities contribute to the detection and registration of adverse drug reactions and to determine the patterns of drug prescription among children attended at the hospital. The PV activities show that there is a relation between an increase in incidence of adverse drug reactions and the prescription of a larger number of drugs. The PE activities reveal that antibiotics are the most frequently prescribed drugs and next are drugs used for gastrointestinal diseases. Since PV and PE activities were initiated at our hospital, they have contributed to a more adequate use of drugs in children. As a conclusion of these activities, it could be that if the PE of a hospital is known, drug consumption can be optimally planned. PV and PE demonstrate that, if polytherapy is not necessary, it must be avoided. Finally, the present guide can be adopted to initiate PV and PE at a hospital.

  11. Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

    PubMed

    Kalaivani, M; Singh, Abhishank; Kalaiselvan, V

    2015-01-01

    A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

  12. Eco-pharmacovigilance of non-steroidal anti-inflammatory drugs: Necessity and opportunities.

    PubMed

    He, Bing-Shu; Wang, Jun; Liu, Juan; Hu, Xia-Min

    2017-08-01

    Eco-pharmacovigilance (EPV) is a practical and powerful approach to minimize the potential risks posed by pharmaceutical residues in environment. However, it is impracticable to practise rigorous and unitary EPV process for all the existing and new pharmaceuticals. Here, we focused on non-steroidal anti-inflammatory drugs (NSAIDs), and discussed the necessity and potential opportunities of practising EPV of NSAIDs. We found that the consumption of NSAIDs is huge and ubiquitous across the globe. NSAIDs were worldwidely reported as one of the most dominant and frequently detected groups in environmental matrices including wastewater, surface water, suspended solids, sediments, groundwater, even drinking water. Besides, there is definitive evidence for the adverse impacts of NSAID residues on scavenging birds and aquatic species. These data suggested the necessity of implementing EPV of NSAIDs. From the perspective of drug administration, we identified some things that can be done as management practice options for EPV implementation on NSAIDs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Invitation Refusals in Cameroon French and Hexagonal French

    ERIC Educational Resources Information Center

    Farenkia, Bernard Mulo

    2015-01-01

    Descriptions of regional pragmatic variation in French are lacking to date the focus has been on a limited range of speech acts, including apologies, requests, compliments and responses to compliments. The present paper, a systematic analysis of invitation refusals across regional varieties of French, is designed to add to the research on…

  14. Invitation Refusals in Cameroon French and Hexagonal French

    ERIC Educational Resources Information Center

    Farenkia, Bernard Mulo

    2015-01-01

    Descriptions of regional pragmatic variation in French are lacking to date the focus has been on a limited range of speech acts, including apologies, requests, compliments and responses to compliments. The present paper, a systematic analysis of invitation refusals across regional varieties of French, is designed to add to the research on…

  15. The French Revolution on Film: American and French Perspectives

    ERIC Educational Resources Information Center

    Harison, Casey

    2005-01-01

    It is not hard to locate negative or condescending images of the French Revolution in aspects of popular American culture, including film. Despite a handful of instances where nuanced or ambiguous "messages" may be identified, the number of American film interpretations of the French Revolution that might be judged historically…

  16. The French Revolution on Film: American and French Perspectives

    ERIC Educational Resources Information Center

    Harison, Casey

    2005-01-01

    It is not hard to locate negative or condescending images of the French Revolution in aspects of popular American culture, including film. Despite a handful of instances where nuanced or ambiguous "messages" may be identified, the number of American film interpretations of the French Revolution that might be judged historically…

  17. Aptamer Database

    PubMed Central

    Lee, Jennifer F.; Hesselberth, Jay R.; Meyers, Lauren Ancel; Ellington, Andrew D.

    2004-01-01

    The aptamer database is designed to contain comprehensive sequence information on aptamers and unnatural ribozymes that have been generated by in vitro selection methods. Such data are not normally collected in ‘natural’ sequence databases, such as GenBank. Besides serving as a storehouse of sequences that may have diagnostic or therapeutic utility, the database serves as a valuable resource for theoretical biologists who describe and explore fitness landscapes. The database is updated monthly and is publicly available at http://aptamer.icmb.utexas.edu/. PMID:14681367

  18. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    PubMed Central

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  19. Spotlight: French Polynesia.

    PubMed

    May, J F

    1988-01-01

    French Polynesia is a group of 4 archipelagos in the South Pacific with an estimated 1987 population of 176,600. Its people are mainly Tahitians, Polynesians, Chinese, Europeans, and persons of mixed heritage. More than half of the population live in the Society Islands. About half of the population is less than 20 years old and slightly more than 5% is older than 60. Due to a recent decline in fertility, the rate of natural increase is moderate--about 2.5% annually. In the early 1980s, about two thirds of women in Tahiti aged 15-49 used a modern method of contraception. It remains to be seen whether this pattern will spread to the entire area. Projections by the World Bank, assuming little decline in mortality, yield a total population of 400,000 by the year 2030. The major challenge for French Polynesia is to develop the many small islands spread across an ocean territory half the size of the contiguous 48 states of the U.S. Tourist-related activities have replaced traditional income-generating such as production of coconuts, mother-of-pearl, and vanilla. The value of exports from the area make up only 5% of the value of imports. To extract the potentially huge food and mineral resources from the ocean, enormous infusions of capital will be necessary.

  20. French intensive truck garden

    SciTech Connect

    Edwards, T D

    1983-01-01

    The French Intensive approach to truck gardening has the potential to provide substantially higher yields and lower per acre costs than do conventional farming techniques. It was the intent of this grant to show that there is the potential to accomplish the gains that the French Intensive method has to offer. It is obvious that locally grown food can greatly reduce transportation energy costs but when there is the consideration of higher efficiencies there will also be energy cost reductions due to lower fertilizer and pesticide useage. As with any farming technique, there is a substantial time interval for complete soil recovery after there have been made substantial soil modifications. There were major crop improvements even though there was such a short time since the soil had been greatly disturbed. It was also the intent of this grant to accomplish two other major objectives: first, the garden was managed under organic techniques which meant that there were no chemical fertilizers or synthetic pesticides to be used. Second, the garden was constructed so that a handicapped person in a wheelchair could manage and have a higher degree of self sufficiency with the garden. As an overall result, I would say that the garden has taken the first step of success and each year should become better.

  1. Maize databases

    USDA-ARS?s Scientific Manuscript database

    This chapter is a succinct overview of maize data held in the species-specific database MaizeGDB (the Maize Genomics and Genetics Database), and selected multi-species data repositories, such as Gramene/Ensembl Plants, Phytozome, UniProt and the National Center for Biotechnology Information (NCBI), ...

  2. Database Manager

    ERIC Educational Resources Information Center

    Martin, Andrew

    2010-01-01

    It is normal practice today for organizations to store large quantities of records of related information as computer-based files or databases. Purposeful information is retrieved by performing queries on the data sets. The purpose of DATABASE MANAGER is to communicate to students the method by which the computer performs these queries. This…

  3. Image Databases.

    ERIC Educational Resources Information Center

    Pettersson, Rune

    Different kinds of pictorial databases are described with respect to aims, user groups, search possibilities, storage, and distribution. Some specific examples are given for databases used for the following purposes: (1) labor markets for artists; (2) document management; (3) telling a story; (4) preservation (archives and museums); (5) research;…

  4. Database Manager

    ERIC Educational Resources Information Center

    Martin, Andrew

    2010-01-01

    It is normal practice today for organizations to store large quantities of records of related information as computer-based files or databases. Purposeful information is retrieved by performing queries on the data sets. The purpose of DATABASE MANAGER is to communicate to students the method by which the computer performs these queries. This…

  5. The French Revolution and "Revisionism."

    ERIC Educational Resources Information Center

    Langlois, Claude

    1990-01-01

    Outlines revisionist interpretations of the French Revolution that challenged the dominant historiographical tradition during the 1950s and 1960s. Distinguishes four central characteristics of revisionist works. Identifies a key split in current French Revolution historiography between reflection on nineteenth-century…

  6. The French Revolution and "Revisionism."

    ERIC Educational Resources Information Center

    Langlois, Claude

    1990-01-01

    Outlines revisionist interpretations of the French Revolution that challenged the dominant historiographical tradition during the 1950s and 1960s. Distinguishes four central characteristics of revisionist works. Identifies a key split in current French Revolution historiography between reflection on nineteenth-century…

  7. French in the Ivory Coast.

    ERIC Educational Resources Information Center

    Djite, Paulin G.

    1989-01-01

    Overviews the Ivory Coast's sociolinguistic situation. Standard French, restricted to the elite, is threatened by the local lingua franca. The spread and functional allocations of Dyula and Popular French support the point that the pervasive use of a language does not always lead to its adoption as a national language. (CB)

  8. French Basic Course. Area Studies.

    ERIC Educational Resources Information Center

    Defense Language Inst., Monterey, CA.

    This volume provides the prescribed cultural background that is part of the final phase of the Basic Course in French. The texts provide the basis for discussions and personal research through which students become acquainted with various aspects of the French-speaking world and learn the referential meaning of words and expressions as they are…

  9. French for Journalists: Classroom Techniques.

    ERIC Educational Resources Information Center

    Rodina, Herta

    The use of authentic materials for an advanced French course for students of journalism and communication has the drawback that authentic French sources assume a regular, informed readership sharing the same culture and history. A solution found at Ohio University is to use a publication that bridges the two cultures, such as the "Journal…

  10. Negative Association in Quebec French.

    ERIC Educational Resources Information Center

    Larrivee, Pierre

    In Quebec French, unlike standard French, sentence negation "pas" ("not") can occur in the same clause as a negative quantifier like "personne" ("nobody"), for instance. This paper proposes that "pas" in these contexts marks negative association in the same way that "ne" does in standard…

  11. Exploring French, German, and Spanish.

    ERIC Educational Resources Information Center

    Steigerwald, Jacob

    This text- and workbook serves as an introduction to French, German, and Spanish as second languages. An introductory chapter discusses the relatedness of languages and the interrelationships of the Indo-European language families. The relationships of French, German, and Spanish to English are demonstrated in cognate exercises. In the second…

  12. Diversity of Mycobacterium tuberculosis lineages in French Polynesia.

    PubMed

    Osman, Djaltou Aboubaker; Phelippeau, Michael; Drancourt, Michel; Musso, Didier

    2017-04-01

    French Polynesia is an overseas territory located in the South Pacific. The incidence of tuberculosis in French Polynesia has been stable since 2000 with an average of 20 cases/y/100,000 inhabitants. Molecular epidemiology of Mycobacterium tuberculosis in French Polynesia is unknown because M. tuberculosis isolates have not been routinely genotyped. From 2009 to 2012, 34 isolates collected from 32 French Polynesian patients were identified as M. tuberculosis by probe hybridization. These isolates were genotyped using spoligotyping and 24-loci mycobacterial interspersed repetitive units (MIRUs)-variable number of tandem repeat (VNTR). Spoligotype patterns obtained using commercial kits were compared with the online international database SITVIT. MIRU-VNTR genotyping was performed using an in-house protocol based on capillary electrophoresis sizing for 24-loci MIRU-VNTR genotyping. The results of the spoligotyping method revealed that 25 isolates grouped into six previously described spoligotypes [H1, H3, U likely (S), T1, Manu, and Beijing] and nine isolates grouped into six new spoligotypes. Comparison with the international database MIRU-VNTRplus distributed 30 isolates into five lineages (Haarlem, Latin American Mediterranean, S, X, and Beijing) and four as unassigned isolates. Genotyping identified four phylogenetic lineages belonging to the modern Euro-American subgroup, one Beijing genotype responsible for worldwide pandemics, including remote islands in the South Pacific, and one Manu genotype of the ancestral lineage of M. tuberculosis. Copyright © 2015. Published by Elsevier B.V.

  13. Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

    PubMed Central

    Varallo, Fabiana Rossi; Planeta, Cleopatra S; de Carvalho Mastroianni, Patricia

    2017-01-01

    OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1) an interactive lecture, 2) a practical class, 3) a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4) educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations) and the relevance (seriousness and expectancy) of the events. RESULTS: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001) and their knowledge of pharmacovigilance (p<0.0001). The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. CONCLUSIONS: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in hospitals. PMID

  14. The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial

    PubMed Central

    Gamble, Carrol; Wolf, Andrew; Sinha, Ian; Spowart, Catherine; Williamson, Paula

    2013-01-01

    Background Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug. Methodology/Principal Findings The Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions. Conclusions/Significance No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions. PMID:23554852

  15. Pharmacovigilance and adverse drug reaction reporting: a perspective of community pharmacists and pharmacy technicians in Sana’a, Yemen

    PubMed Central

    Al-Worafi, Yaser Mohammed; Kassab, Yaman Walid; Alseragi, Wafa Mohammed; Almutairi, Masaad Saeed; Ahmed, Ali; Ming, Long Chiau; Alkhoshaiban, Ali Saleh; Hadi, Muhammad Abdul

    2017-01-01

    Objective The aim of this study was to compare the knowledge, attitude and barriers of pharmacy technicians and pharmacists toward pharmacovigilance, adverse drug reactions (ADRs) and ADR reporting in community pharmacies in Yemen. Methods This cross-sectional survey was conducted among community pharmacists and pharmacy technicians in the capital of Yemen, Sana’a. A total of 289 community pharmacies were randomly selected. The validated and pilot-tested questionnaire consisted of six sections: demographic data, knowledge about pharmacovigilance, experience with ADR reporting, attitudes toward ADR reporting, and the facilitators to improve ADR reporting. Results A total of 428 pharmacy technicians and pharmacists were contacted and 179 went on to complete a questionnaire (response rate: 41.8%). Of the 179 respondents, 21 (11.7%) were pharmacists and 158 (88.3%) were pharmacy technicians, of which, 176 (98.3%) were male and 3 (1.7%) were female. The mean age of the respondents was 25.87±2.63 years. There was a significant difference between the pharmacists and pharmacy technicians in terms of knowledge scores (P<0.05). The mean knowledge scores for pharmacists was 3.33±2.852 compared to 0.15±0.666 for pharmacy technicians. With regard to attitudes toward ADR reporting, all pharmacists (100%) showed a positive attitude, while only 43% of pharmacy technicians showed a positive attitude. Conclusion Pharmacists have a significantly better knowledge than pharmacy technicians with regard to pharmacovigilance. More than half of pharmacy technicians showed a negative attitude toward ADR reporting. Therefore, educational interventions and training is very important for community pharmacists and pharmacy technicians in Yemen to increase their awareness and participation in ADR reporting. PMID:28924350

  16. Evaluation of 'SAEFVIC', A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia.

    PubMed

    Clothier, Hazel J; Crawford, Nigel W; Russell, Melissa; Kelly, Heath; Buttery, Jim P

    2017-06-01

    Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community). The aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia. We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination. AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population. SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly

  17. Improving Detection of Arrhythmia Drug-Drug Interactions in Pharmacovigilance Data through the Implementation of Similarity-Based Modeling

    PubMed Central

    Vilar, Santiago; Lorberbaum, Tal; Hripcsak, George; Tatonetti, Nicholas P.

    2015-01-01

    Identification of Drug-Drug Interactions (DDIs) is a significant challenge during drug development and clinical practice. DDIs are responsible for many adverse drug effects (ADEs), decreasing patient quality of life and causing higher care expenses. DDIs are not systematically evaluated in pre-clinical or clinical trials and so the FDA U. S. Food and Drug Administration relies on post-marketing surveillance to monitor patient safety. However, existing pharmacovigilance algorithms show poor performance for detecting DDIs exhibiting prohibitively high false positive rates. Alternatively, methods based on chemical structure and pharmacological similarity have shown promise in adverse drug event detection. We hypothesize that the use of chemical biology data in a post hoc analysis of pharmacovigilance results will significantly improve the detection of dangerous interactions. Our model integrates a reference standard of DDIs known to cause arrhythmias with drug similarity data. To compare similarity between drugs we used chemical structure (both 2D and 3D molecular structure), adverse drug side effects, chemogenomic targets, drug indication classes, and known drug-drug interactions. We evaluated the method on external reference standards. Our results showed an enhancement of sensitivity, specificity and precision in different top positions with the use of similarity measures to rank the candidates extracted from pharmacovigilance data. For the top 100 DDI candidates, similarity-based modeling yielded close to twofold precision enhancement compared to the proportional reporting ratio (PRR). Moreover, the method helps in the DDI decision making through the identification of the DDI in the reference standard that generated the candidate. PMID:26068584

  18. Genome databases

    SciTech Connect

    Courteau, J.

    1991-10-11

    Since the Genome Project began several years ago, a plethora of databases have been developed or are in the works. They range from the massive Genome Data Base at Johns Hopkins University, the central repository of all gene mapping information, to small databases focusing on single chromosomes or organisms. Some are publicly available, others are essentially private electronic lab notebooks. Still others limit access to a consortium of researchers working on, say, a single human chromosome. An increasing number incorporate sophisticated search and analytical software, while others operate as little more than data lists. In consultation with numerous experts in the field, a list has been compiled of some key genome-related databases. The list was not limited to map and sequence databases but also included the tools investigators use to interpret and elucidate genetic data, such as protein sequence and protein structure databases. Because a major goal of the Genome Project is to map and sequence the genomes of several experimental animals, including E. coli, yeast, fruit fly, nematode, and mouse, the available databases for those organisms are listed as well. The author also includes several databases that are still under development - including some ambitious efforts that go beyond data compilation to create what are being called electronic research communities, enabling many users, rather than just one or a few curators, to add or edit the data and tag it as raw or confirmed.

  19. Status of French reactors

    SciTech Connect

    Ballagny, A.

    1997-08-01

    The status of French reactors is reviewed. The ORPHEE and RHF reactors can not be operated with a LEU fuel which would be limited to 4.8 g U/cm{sup 3}. The OSIRIS reactor has already been converted to LEU. It will use U{sub 3}Si{sub 2} as soon as its present stock of UO{sub 2} fuel is used up, at the end of 1994. The decision to close down the SILOE reactor in the near future is not propitious for the start of a conversion process. The REX 2000 reactor, which is expected to be commissioned in 2005, will use LEU (except if the fast neutrons core option is selected). Concerning the end of the HEU fuel cycle, the best option is reprocessing followed by conversion of the reprocessed uranium to LEU.

  20. Pharmacovigilance in hospice/palliative care: net effect of gabapentin for neuropathic pain.

    PubMed

    Sanderson, Christine; Quinn, Stephen J; Agar, Meera; Chye, Richard; Clark, Katherine; Doogue, Matthew; Fazekas, Belinda; Lee, Jessica; Lovell, Melanie R; Rowett, Debra; Spruyt, Odette; Currow, David C

    2015-09-01

    Hospice/palliative care patients may differ from better studied populations, and data from other populations cannot necessarily be extrapolated into hospice/palliative care clinical practice. Pharmacovigilance studies provide opportunities to understand the harms and benefits of medications in routine practice. Gabapentin, a γ-amino butyric acid analogue antiepileptic drug, is commonly prescribed for neuropathic pain in hospice/palliative care. Most of the evidence however relates to non-malignant, chronic pain syndromes (diabetic neuropathy, postherpetic neuralgia, central pain syndromes, fibromyalgia). The aim of this study was to quantify the immediate and short-term clinical benefits and harms of gabapentin in routine hospice/palliative care practice. Multisite, prospective, consecutive cohort. 127 patients, 114 of whom had cancer, who started gabapentin for neuropathic pain as part of routine clinical care. 42 centres from seven countries. Data were collected at three time points-at baseline, at day 7 (and at any time; immediate and short-term harms) and at day 21 (clinical benefits). At day 21, the average dose of gabapentin for those still using it (n=68) was 653 mg/24 h (range 0-1800 mg) and 54 (42%) reported benefits, of whom 7 (6%) experienced complete pain resolution. Harms were reported in 39/127 (30%) patients at day 7, the most frequent of which were cognitive disturbance, somnolence, nausea and dizziness. Ten patients had their medication ceased due to harms. The presence of significant comorbidities, higher dose and increasing age increased the likelihood of harm. Overall, 42% of people experienced benefit at a level that resulted in continued use at 21 days. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  1. Pharmacovigilance in hospice/palliative care: net effect of pregabalin for neuropathic pain.

    PubMed

    Sanderson, Christine; Quinn, Stephen J; Agar, Meera; Chye, Richard; Clark, Katherine; Doogue, Matthew; Fazekas, Belinda; Lee, Jessica; Lovell, Melanie R; Rowett, Debra; Spruyt, Odette; Currow, David C

    2016-09-01

    Real-world effectiveness of many medications has been poorly researched, including in hospice/palliative care. Directly extrapolating findings from other clinical settings may not yield robust clinical advice. Pharmacovigilance studies provide an opportunity to understand better the net impact of medications. The study aimed to examine immediate and short-term benefits and harms of pregabalin in routine practice for neuropathic pain in hospice/palliative care. A consecutive cohort of 155 patients from 62 centres in 5 countries was started on pregabalin and studied prospectively. Data were collected at three time points: baseline; day 7 (immediate, short-term harms); ad hoc reports of any harms ≤21 days; and day 21 (short-term benefits). Median dose for 155 patients at day 21 was 150 mg/24 h. Benefits were reported by 61 patients (39%), of whom 11 (7%) experienced complete pain resolution. Harms were reported by 51 (35%) patients at or before 7 days, the most frequent of which were somnolence, fatigue, cognitive disturbance and dizziness. 10 patients (6%) ceased pregabalin due to harms, but 82 patients (53%) were being treated at 21 days. In regression modelling, people with worse baseline pain derived more benefit (OR=8.5 (95% CI 2.5 to 28.68). Pregabalin delivered benefit to many patients, with 4 of 10 experiencing pain reductions by 21 days. Harms, occurring in 1 in 3 patients, may be difficult to detect in clinical practice, as they mostly involve worsening of symptoms prevalent at baseline. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Pharmacovigilance in hospice/palliative care: net effect of gabapentin for neuropathic pain

    PubMed Central

    Sanderson, Christine; Quinn, Stephen J; Agar, Meera; Chye, Richard; Clark, Katherine; Doogue, Matthew; Fazekas, Belinda; Lee, Jessica; Lovell, Melanie R; Rowett, Debra; Spruyt, Odette; Currow, David C

    2015-01-01

    Objective Hospice/palliative care patients may differ from better studied populations, and data from other populations cannot necessarily be extrapolated into hospice/palliative care clinical practice. Pharmacovigilance studies provide opportunities to understand the harms and benefits of medications in routine practice. Gabapentin, a γ-amino butyric acid analogue antiepileptic drug, is commonly prescribed for neuropathic pain in hospice/palliative care. Most of the evidence however relates to non-malignant, chronic pain syndromes (diabetic neuropathy, postherpetic neuralgia, central pain syndromes, fibromyalgia). The aim of this study was to quantify the immediate and short-term clinical benefits and harms of gabapentin in routine hospice/palliative care practice. Design Multisite, prospective, consecutive cohort. Population 127 patients, 114 of whom had cancer, who started gabapentin for neuropathic pain as part of routine clinical care. Settings 42 centres from seven countries. Data were collected at three time points—at baseline, at day 7 (and at any time; immediate and short-term harms) and at day 21 (clinical benefits). Results At day 21, the average dose of gabapentin for those still using it (n=68) was 653 mg/24 h (range 0–1800 mg) and 54 (42%) reported benefits, of whom 7 (6%) experienced complete pain resolution. Harms were reported in 39/127 (30%) patients at day 7, the most frequent of which were cognitive disturbance, somnolence, nausea and dizziness. Ten patients had their medication ceased due to harms. The presence of significant comorbidities, higher dose and increasing age increased the likelihood of harm. Conclusions Overall, 42% of people experienced benefit at a level that resulted in continued use at 21 days. PMID:25324335

  3. Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study

    PubMed Central

    Ajanal, Manjunath N.; Nayak, Shradda U.; Kadam, Avinash P.; Prasad, B. S.

    2015-01-01

    Introduction: Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines. Aim: To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup. Materials and Methods: In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed. Results: In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence. Conclusion: The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines. PMID:27011712

  4. A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries.

    PubMed

    Babigumira, Joseph B; Stergachis, Andy; Choi, Hye Lyn; Dodoo, Alexander; Nwokike, Jude; Garrison, Louis P

    2014-03-01

    Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Well-functioning PV programs can improve population health by identifying and reducing medicines-related problems (MRPs). Many low- and middle-income countries lack functional PV systems, but this deficiency has not been described in terms of the potential economic value of strengthening PV systems. The assessment of economic value for PV can support rational decision making at the country level. We propose a framework for assessing the economic value of PV. We divide national PV systems into four levels: (1) no PV, (2) basic PV, (3) semi-functional PV, and (4) functional PV. These categories represent increasing levels of investment in PV capacity at the national or health facility level for all available medicines, including vaccines. The proposed framework can be used to estimate the costs of PV (including the value of investments to increase PV capacity and the costs of managing MRPs) and outcomes associated with PV (including improvements in morbidity, mortality, and quality of life as a result of the reduction in MRPs). The quantitative approach proposed for assessing costs and benefits uses a decision-analytic modeling framework that would estimate the value of the consequences of MRPs adjusted for their probability of occurrence. This allows the quantification of value using monetary outcomes (cost-benefit analysis), natural units (cost-effectiveness analysis), or mortality adjusted for quality of life or disability (cost-utility analysis). Evidence generated using this framework could assist policy makers, program managers, and donors in evaluating investments that aim to increase the capacity and efficiency of national and facility-level PV programs in low- and middle-income countries.

  5. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.

    PubMed

    Bahri, Priya

    2010-12-01

    As a contribution to the debate on how best to communicate information on the effective and safe use of medicines to patients, healthcare professionals and the general public, this article proposes to distinguish between communication and transparency purposes, and to test a strategic health communication approach. Any organization aiming to improve medicines use could adapt this approach to its remits and legal obligations. The approach includes agreeing measurable communication objectives through shared problem ownership of all concerned parties, evidence-based design and a cyclic process for planning, implementation and evaluation of communication as a public health intervention. The evidence base, which supplements risk assessment for product- and situation-specific communication on safety concerns, would be derived from research into drug utilization, medical decision making and risk perception, as well as from the participation of patients and healthcare professionals. It is crucial to address the practical questions and concerns of medicine users and to find out why unfavourable patterns of medicine use persist, in order to develop behaviour change models for overcoming these obstacles. For this purpose, appropriate models for facilitating the participation of medicine users in the risk management process will need to be explored. Such two-way communication would inform risk assessment as well as the analysis of risk minimization options, allow for agreement upon communication objectives and enable understandable, attractive communication materials to be designed. The communication programme should use mixed media and repetition of messages for long-term success. This would require cooperation within healthcare and medical information systems. An evaluation of the effectiveness of the communication should support the sustainability of the programme and provide lessons for the future. Given its mission, the pharmacovigilance community has the standing and

  6. Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study.

    PubMed

    Ajanal, Manjunath N; Nayak, Shradda U; Kadam, Avinash P; Prasad, B S

    2015-01-01

    Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines. To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup. In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed. In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence. The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines.

  7. Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India.

    PubMed

    Manohar, Hasitha Diana; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha

    2016-01-01

    The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society.

  8. Nonchemotherapy drug-induced agranulocytosis in children detected by a prospective pharmacovigilance program.

    PubMed

    Medrano-Casique, Nicolás; Tong, Hoi Y; Borobia, Alberto M; Carcas, Antonio J; Frías, Jesús; Ramírez, Elena

    A prospective evaluation of nonchemotherapy drug-induced agranulocytosis (DIA) cases, which are infrequent in the pediatric population. We characterize agranulocytosis cases and assess lab test differences between drug- and nondrug-induced agranulocytosis. Through our Prospective Pharmacovigilance Program from Laboratory Signals at Hospital we detected pediatric agranulocytosis cases from July 2007 to December 2010. This program estimates the incidence, drug causality, clinical features, outcomes of DIA pediatric cases, and assesses laboratory differences with respect to non-DIA. We detected 662 agranulocytosis in 308 pediatric patients, of which 14 were caused by nonchemotherapy drugs. The incidence rate of DIA for 10,000 pediatric patients was 3.92 (Poisson 95% confidence interval 1.09-8.77); 78.6% of DIA cases occurred in patients younger than 3 years. The final outcome was recovery without sequela in all cases. The pharmacologic group most frequently implicated was antimicrobial drugs (11 drugs), 7 of which were beta-lactams. The drugs most frequently suspected were cefotaxime and vancomycin (3 cases each). We found 3 drugs (cloperastine, codeine, and enoxaparin) not previously described to induce DIA. Automatic linear modeling (n = 56, R(2) = 45.2%) showed a significant inverse association with platelets (R(2) = 17.5%), hemoglobin, and alanine transaminase, and a direct association with red cell distribution (R(2) = 16.2%). A generalized linear model (Type III, n = 1188; DIA, n = 86; likelihood ratio chi-squared = 156.16) retained eosinophils (p <.001), platelets (p <.001), total serum proteins (p <.001), and hemoglobin (p =.039). We found a higher incidence of DIA in children than previously described. Our findings also suggest an immune-mediated destruction or myeloid toxicity, possibly facilitated by an increase in drug exposure.

  9. Non-Chemotherapy-Induced Agranulocytosis Detected by a Prospective Pharmacovigilance Program in a Tertiary Hospital.

    PubMed

    Medrano-Casique, Nicolás; Tong, Hoi Y; Borobia, Alberto M; Carcas, Antonio J; Frías, Jesús; Ramírez, Elena

    2015-12-01

    We conducted a prospective evaluation of non-chemotherapy-induced agranulocytosis (NIA) in a tertiary hospital in Spain. Through our Prospective Pharmacovigilance Program from Laboratory Signals at Hospital, we detected agranulocytosis cases over a period of 42 consecutive months. This report estimates incidence, drug causality, clinical features and outcomes of NIA cases and assesses laboratory differences with respect to non-NIA. We detected 1349 cases of agranulocytosis in 538 adult patients; of these, 43 cases in 40 patients were caused by non-chemotherapy drugs. The incidence rate for 10,000 patients during the study period was 2.75 [Poisson confidence interval (CI)-95%: 0.62-7.22]. The mean (S.D.) age was 48 (21) years. All cases were categorized as serious, because they required hospitalization (28 cases) or prolongation of hospitalization (15 cases). The outcome was recovery without sequela (39 cases), recovery with sequela (one case of toe amputation) or death (three cases, 7%). The most frequent cause of NIA was antimicrobial drugs (19 cases). The highest incidence rate per 10,000 defined daily doses was for cefepime (83.85; Poisson-CI 95%: 67-102.89). Automatic linear modelling (n = 75, R(2) = 77.9%) showed a significant inverse association with platelets, alkaline phosphatase, C-reactive protein, fibrinogen, lactate dehydrogenase; and direct association with mean corpuscular haemoglobin, and haematocrit. A generalized linear model retained platelets, total serum proteins, creatinine and haemoglobin. The findings suggest an immune-mediated destruction or myeloid toxicity, possibly facilitated by an increase in drug exposure. There might be additional contributing factors, such as nutritional deficiencies or chronic diseases, to develop NIA after exposure to a potentially causative drug. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  10. Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India

    PubMed Central

    Manohar, Hasitha Diana; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha

    2016-01-01

    Objectives: The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Materials and Methods: Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. Results: A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. Conclusions: This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society. PMID:27721535

  11. Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction

    PubMed Central

    Betancourt, Blas Y; Marrero-Miragaya, María A; Jiménez-López, Giset; Valenzuela-Silva, Carmen; García-Iglesias, Elizeth; Hernández-Bernal, Francisco; Debesa-García, Francisco; González-López, Tania; Alvarez-Falcón, Leovaldo; López-Saura, Pedro A

    2005-01-01

    Background Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice. Methods A national, prospective and spontaneous reporting-based pharmacovigilance program was conducted in Cuba. Patient demographics, suspected ADR description, elements to define causality, and outcomes were documented and analyzed. Results A total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 %) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3%) were male, 67.2% were white and mean age was 61.6 ± 13.0 years. The mean time interval between the onset of symptoms and the start of the SK infusion was 4.9 ± 3.7 h. The most frequently reported ADRs were hypotension, arrhythmias, chills, tremors, vomiting, nauseas, allergy, bleeding and fever. ADR severity was 38% mild, 38% moderate, 10% severe, and 4% very severe. Only 3 patients with hemorrhagic stroke were reported. Seventy-two patients died in-hospital mainly because of cardiac causes associated with the patient's underlying clinical condition. Mortality was 3 times more likely in patients suffering arrhythmias than in those without this event (odds ratio 3.1, 95% CI: 1.8 to 5.1). Most of the reported ADRs were classified as possibly or probably associated with the study medication. Conclusion Recombinant SK was associated with a similar post-marketing safety profile to those suggested in previous clinical trials. PMID:16262910

  12. Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol

    PubMed Central

    Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Pham, Ba; Straus, Sharon E

    2017-01-01

    analytics platform for social media and crowd-sourced data for pharmacovigilance in Canada and internationally. Registration details Our protocol was registered prospectively with the Open Science Framework (https://osf.io/kv9hu/). PMID:28104709

  13. 7 CFR 993.7 - French prunes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false French prunes. 993.7 Section 993.7 Agriculture... Order Regulating Handling Definitions § 993.7 French prunes. French prunes means: (a) Prunes produced from plums of the following varieties of plums: French (Prune d'Agen, Petite Prune d'Agen), Coates (Cox...

  14. Teaching for Content: Greek Mythology in French.

    ERIC Educational Resources Information Center

    Giauque, Gerald S.

    An intermediate-level university French course in Greek mythology was developed to (1) improve student skills in reading, writing, speaking, and comprehending French, (2) familiarize students with Greek mythology, and (3) prepare students to deal better with allusions to Greek mythology in French literature. The texts used are a French translation…

  15. Dialect Effects in Speech Perception: The Role of Vowel Duration in Parisian French and Swiss French

    ERIC Educational Resources Information Center

    Miller, Joanne L.; Mondini, Michele; Grosjean, Francois; Dommergues, Jean-Yves

    2011-01-01

    The current experiments examined how native Parisian French and native Swiss French listeners use vowel duration in perceiving the /[openo]/-/o/ contrast. In both Parisian and Swiss French /o/ is longer than /[openo]/, but the difference is relatively large in Swiss French and quite small in Parisian French. In Experiment 1 we found a parallel…

  16. Feudalism and the French Revolution.

    ERIC Educational Resources Information Center

    Kaiser, Thomas E.

    1979-01-01

    Reviews and questions the traditional established interpretation that the French Revolution was about feudalism. Concludes that revisionist historians have cast doubt upon the orthodox theory but that they have not supplied an alternative explanation. (Author/DB)

  17. Feudalism and the French Revolution.

    ERIC Educational Resources Information Center

    Kaiser, Thomas E.

    1979-01-01

    Reviews and questions the traditional established interpretation that the French Revolution was about feudalism. Concludes that revisionist historians have cast doubt upon the orthodox theory but that they have not supplied an alternative explanation. (Author/DB)

  18. Predicting growth in English and French vocabulary: The facilitating effects of morphological and cognate awareness.

    PubMed

    D'Angelo, Nadia; Hipfner-Boucher, Kathleen; Chen, Xi

    2017-07-01

    The present study investigated the contribution of morphological and cognate awareness to the development of English and French vocabulary knowledge among young minority and majority language children who were enrolled in a French immersion program. Participating children (n = 75) were assessed in English and French on measures of morphological awareness, cognate awareness, and vocabulary knowledge from Grades 1 to 3. Hierarchical linear modeling was used to investigate linear trends in English and French vocabulary growth for minority and majority language children and to identify metalinguistic contributions to Grade 1 and Grade 3 English and French vocabulary performance and rate of growth. Results demonstrated a similar pattern of prediction for both groups of children. English and French morphological awareness and French-English cognate awareness significantly predicted concurrent and longitudinal vocabulary development after controlling for nonverbal reasoning, phonological awareness, and word identification. The contributions of morphological awareness to English vocabulary and cognate awareness to French vocabulary strengthened between Grades 1 and 2. These findings highlight the emerging importance of morphological and cognate awareness in children's vocabulary development and suggest that these metalinguistic factors can serve to broaden the vocabulary repertoire of children who enter school with limited language proficiency. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  19. Experiment Databases

    NASA Astrophysics Data System (ADS)

    Vanschoren, Joaquin; Blockeel, Hendrik

    Next to running machine learning algorithms based on inductive queries, much can be learned by immediately querying the combined results of many prior studies. Indeed, all around the globe, thousands of machine learning experiments are being executed on a daily basis, generating a constant stream of empirical information on machine learning techniques. While the information contained in these experiments might have many uses beyond their original intent, results are typically described very concisely in papers and discarded afterwards. If we properly store and organize these results in central databases, they can be immediately reused for further analysis, thus boosting future research. In this chapter, we propose the use of experiment databases: databases designed to collect all the necessary details of these experiments, and to intelligently organize them in online repositories to enable fast and thorough analysis of a myriad of collected results. They constitute an additional, queriable source of empirical meta-data based on principled descriptions of algorithm executions, without reimplementing the algorithms in an inductive database. As such, they engender a very dynamic, collaborative approach to experimentation, in which experiments can be freely shared, linked together, and immediately reused by researchers all over the world. They can be set up for personal use, to share results within a lab or to create open, community-wide repositories. Here, we provide a high-level overview of their design, and use an existing experiment database to answer various interesting research questions about machine learning algorithms and to verify a number of recent studies.

  20. French perspectives on psychiatric classification

    PubMed Central

    Crocq, Marc-Antoine

    2015-01-01

    This article reviews the role of the French schools in the development of psychiatric nosology. Boissier de Sauvages published the first French treatise on medical nosology in 1763. Until the 1880s, French schools held a pre-eminent position in the development of psychiatric concepts. From the 1880s until World War I, German-speaking schools exerted the most influence, featuring the work of major figures such as Emil Kraepelin and Eugen Bleuler. French schools were probably hampered by excessive administrative and cultural centralization. Between the 1880s and the 1930s, French schools developed diagnostic categories that set them apart from international classifications. The main examples are Bouffée Délirante, and the complex set of chronic delusional psychoses (CDPs), including chronic hallucinatory psychosis. CDPs were distinguished from schizophrenia by the lack of cognitive deterioration during evolution. Modern French psychiatry is now coming into line with international classification, such as DSM-5 and the upcoming ICD-11. PMID:25987863

  1. French fireball network FRIPON

    NASA Astrophysics Data System (ADS)

    Colas, F.; Zanda, B.; Vaubaillon, J.; Bouley, S.; Marmo, C.; Audureau, Y.; Kwon, M. K.; Rault, J.-L.; Caminade, S.; Vernazza, P.; Gattacceca, J.; Birlan, M.; Maquet, L.; Egal, A.; Rotaru, M.; Birnbaum, C.; Cochard, F.; Thizy, O.

    2015-01-01

    FRIPON (Fireball Recovery and Interplanetary Observation Network) was recently founded by ANR (Agence Nationale de la Recherche), its aim being to connect meteoritical science with asteroidal and cometary sciences, in order to better understand our solar system formation and evolution. The main idea is to cover all the French territory to collect a large number of meteorites (one or two per year) with an accurate orbit determination, allowing to pinpoint possible parent bodies. 100 all-sky cameras will be installed at the end of 2015, creating a dense network with an average distance of 100 km between the stations. To maximize the accuracy of the orbit determination, we will mix our optical data with radar data from the GRAVES transmitter received by 25 stations (Rault et al., 2015). As the network installation and the creation of research teams for meteorites involves many persons, at least many more than our small team of professionals, we will develop a participative science network for amateurs called Vigie-Ciel (Zanda et al., 2015). It will be possible to simply use our data, participate in research campaigns or even add cameras to the FRIPON network.

  2. Paradoxes of French accreditation.

    PubMed

    Pomey, M-P; François, P; Contandriopoulos, A-P; Tosh, A; Bertrand, D

    2005-02-01

    The accreditation system introduced into the French healthcare system in 1996 has five particular characteristics: (1) it is mandatory for all healthcare establishments; (2) it is performed by an independent government agency; (3) surveyors have to report all instances of non-compliance with safety regulations; (4) the accreditation report is delivered to regional administrative authorities and a summary is made available to the public; and (5) regional administrative authorities can use the information contained in the accreditation report to revise hospital budgets. These give rise to a number of paradoxes: (1) the fact that accreditation is mandatory lends itself to ambiguity and likens the process to an inspection; (2) the fact that decision makers can use the information contained in the accreditation report for resource allocation can incite establishments to adopt strategic behaviours aimed merely at complying with the accreditation manual; and (3) there is a tendency for establishments to reduce quality processes to nothing more than the completion of accreditation and to focus efforts on standardizing practices and resolving safety issues to the detriment of organizational development. All accreditation systems must be aware of these paradoxes and decide on the level of government involvement and the relationship between accreditation and resource allocation. With time, accreditation in France could benefit from both a professionally driven system and from the increased amount of freedom to focus on quality improvement which is necessary for organizational development.

  3. Paradoxes of French accreditation

    PubMed Central

    Pomey, M; Francois, P; Contandriopoulos, A; Tosh, A; Bertrand, D

    2005-01-01

    

 The accreditation system introduced into the French healthcare system in 1996 has five particular characteristics: (1) it is mandatory for all healthcare establishments; (2) it is performed by an independent government agency; (3) surveyors have to report all instances of non-compliance with safety regulations; (4) the accreditation report is delivered to regional administrative authorities and a summary is made available to the public; and (5) regional administrative authorities can use the information contained in the accreditation report to revise hospital budgets. These give rise to a number of paradoxes: (1) the fact that accreditation is mandatory lends itself to ambiguity and likens the process to an inspection; (2) the fact that decision makers can use the information contained in the accreditation report for resource allocation can incite establishments to adopt strategic behaviours aimed merely at complying with the accreditation manual; and (3) there is a tendency for establishments to reduce quality processes to nothing more than the completion of accreditation and to focus efforts on standardizing practices and resolving safety issues to the detriment of organizational development. All accreditation systems must be aware of these paradoxes and decide on the level of government involvement and the relationship between accreditation and resource allocation. With time, accreditation in France could benefit from both a professionally driven system and from the increased amount of freedom to focus on quality improvement which is necessary for organizational development. PMID:15692004

  4. Solubility Database

    National Institute of Standards and Technology Data Gateway

    SRD 106 IUPAC-NIST Solubility Database (Web, free access)   These solubilities are compiled from 18 volumes (Click here for List) of the International Union for Pure and Applied Chemistry(IUPAC)-NIST Solubility Data Series. The database includes liquid-liquid, solid-liquid, and gas-liquid systems. Typical solvents and solutes include water, seawater, heavy water, inorganic compounds, and a variety of organic compounds such as hydrocarbons, halogenated hydrocarbons, alcohols, acids, esters and nitrogen compounds. There are over 67,500 solubility measurements and over 1800 references.

  5. Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements

    PubMed Central

    Maigetter, Karen; Pollock, Allyson M.; Kadam, Abhay; Ward, Kim; Weiss, Mitchell G.

    2015-01-01

    Background: Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization’s (WHO’s) minimum PV requirements for a Functional National PV System. Methods: A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results: All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion: A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in

  6. Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol.

    PubMed

    Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Pham, Ba; Straus, Sharon E

    2017-01-19

    -sourced data for pharmacovigilance in Canada and internationally. Our protocol was registered prospectively with the Open Science Framework (https://osf.io/kv9hu/). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  7. Use of a Text Message-Based Pharmacovigilance Tool in Cambodia: Pilot Study

    PubMed Central

    Baron, Sophie; Goutard, Flavie; Nguon, Kunthy

    2013-01-01

    Background There is no functional pharmacovigilance system in Cambodia to our knowledge. Mobile phone–based tools, such as short message service (SMS) text messages, are increasingly used for surveillance purposes. Objective To pilot-test the FrontlineSMS mobile phone–based tool for notification of adverse events, using Cambodia’s only International Vaccination Center at the Institut Pasteur du Cambodge as a field site. Methods People receiving vaccinations, aged over 18 years, and who owned a cell phone were recruited in the study following informed consent. The names and mobile phone numbers of the participants interviewed were entered each day into the FrontlineSMS software. Two days after being vaccinated, participants received an automatically generated SMS text message asking whether any adverse events had occurred. Their SMS reply was number-coded and exported from the software daily to an Excel spreadsheet and examined before being saved. If the participant replied with a code for a severe adverse event (8 or 9), they were automatically advised to consult the nearest doctor. Results The active surveillance study was conducted over 72 days in the spring of 2012. Patients agreed to be asked by SMS text message whether unwanted events had occurred after vaccination. Of 1331 persons aged over 18 years referred to the vaccination unit, 184 (13.8%) were asked and agreed to participate. When texted for clinical status 48 hours after vaccination, 52 (28.3%) participants did not reply, 101 (54.9%) sent an immediate SMS reply, and 31 (16.8%) sent an SMS reply after additional prompting. Of the initial 184 participants, 132 (71.7%) replied. These 132 participants received 135 vaccine doses and 109 (82.6%) reported no adverse events, whereas 23 (17.4%) reported adverse events, all benign. Conclusions Notification using an SMS-based text message system is already used in Cambodia for syndromic surveillance in health centers and reporting by health care workers

  8. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients

    PubMed Central

    Jacob, Dalia; Marrón, Belén; Ehrlich, Jay; Rutherford, Peter A

    2013-01-01

    Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients – those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease – are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler) and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions). Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance – the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs) and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of pharmacovigilance and the process of adverse event reporting, highlights the new directions that pharmacovigilance has taken, and provides insight for HCPs managing dialysis patients into the important role that they play in helping to shape

  9. Mining approximate temporal functional dependencies with pure temporal grouping in clinical databases.

    PubMed

    Combi, Carlo; Mantovani, Matteo; Sabaini, Alberto; Sala, Pietro; Amaddeo, Francesco; Moretti, Ugo; Pozzi, Giuseppe

    2015-07-01

    Functional dependencies (FDs) typically represent associations over facts stored by a database, such as "patients with the same symptom get the same therapy." In more recent years, some extensions have been introduced to represent both temporal constraints (temporal functional dependencies - TFDs), as "for any given month, patients with the same symptom must have the same therapy, but their therapy may change from one month to the next one," and approximate properties (approximate functional dependencies - AFDs), as "patients with the same symptomgenerallyhave the same therapy." An AFD holds most of the facts stored by the database, enabling some data to deviate from the defined property: the percentage of data which violate the given property is user-defined. According to this scenario, in this paper we introduce approximate temporal functional dependencies (ATFDs) and use them to mine clinical data. Specifically, we considered the need for deriving new knowledge from psychiatric and pharmacovigilance data. ATFDs may be defined and measured either on temporal granules (e.g.grouping data by day, week, month, year) or on sliding windows (e.g.a fixed-length time interval which moves over the time axis): in this regard, we propose and discuss some specific and efficient data mining techniques for ATFDs. We also developed two running prototypes and showed the feasibility of our proposal by mining two real-world clinical data sets. The clinical interest of the dependencies derived considering the psychiatry and pharmacovigilance domains confirms the soundness and the usefulness of the proposed techniques.

  10. Glaucoma database.

    PubMed

    K, Rangachari; M, Dhivya; Pj, Eswari Pandaranayaka; N, Prasanthi; P, Sundaresan; Sr, Krishnadas; S, Krishnaswamy

    2011-02-07

    Glaucoma, a complex heterogenous disease, is the leading cause for optic nerve-related blindness worldwide. Primary open angle glaucoma (POAG) is the most common subset and by the year 2020 it is estimated that approximately 60 million people will be affected. MYOC, OPTN, CYP1B1 and WDR36 are the important candidate genes. Nearly 4% of the glaucoma patients have mutation in any one of these genes. Mutation in any of these genes causes disease either directly or indirectly and the severity of the disease varies according to position of the genes. We have compiled all the related mutations and SNPs in the above genes and developed a database, to help access statistical and clinical information of particular mutation. This database is available online at http:bicmku.in:8081/glaucoma The database, constructed using SQL, contains data pertaining to the SNPs and mutation information involved in the above genes and relevant study data. The database is available for free at http:bicmku.in:8081/glaucoma.

  11. Cardiac Arrests Associated with Low Plasma and Tissue Levels of Local Anaesthetics.

    PubMed

    Alexandre, Joachim; Humbert, Xavier; Sassier, Marion; Cesbron, Alexandre; Le Naourès, Cécile; Pottier, Véronique; Puddu, Paolo-Emilio; Milliez, Paul; Coquerel, Antoine; Fedrizzi, Sophie

    2015-10-16

    Although local anaesthetics cardiac toxicity is usually the result of high local anaesthetics dose, based on a pharmacovigilance case report and an analyze of the French Pharmacovigilance Database between January 1(st), 2007 and December 31(st), 2013, we hypothesized that in some patients, the combination of medical or drug risk factors may be responsible for cardiac anaesthetics toxicity at lower plasma concentrations. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  12. Perspective view of span over French Creek and east abutment, ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    Perspective view of span over French Creek and east abutment, looking NW. - Pennsylvania Railroad, French Creek Trestle, Spanning French Creek, north of Paradise Street, Phoenixville, Chester County, PA

  13. ["Eosinophilia-myalgia" syndrome due to L-tryptophan containing products. Cooperative evaluation of French Regional Centers of Pharmacovigilance. Analysis of 24 cases].

    PubMed

    Castot, A; Bidault, I; Bournerias, I; Carlier, P; Efthymiou, M L

    1991-01-01

    By November 17, 1989, the MMWR published the 154 first reports of a syndrome consisting of myalgia and eosinophilia (EMS), occurring with the consumption of L-tryptophan containing products (L-TrpCp) and which might represent a new clinical entity. To standardize reporting over the country, the CDC of Atlanta developed the following case definition: 1) a peripheral blood total eosinophil count of more than 1 x 10(9) cells per liter 2) generalized myalgia sufficiently severe to affect a patient's ability to pursue daily activities 3) the exclusion of infections or neoplastic conditions. The FDA then, announced its intention to seek a nationwide recall of all tryptophan containing products, followed by other european countries (UK, Germany, France). In France, a first decree (January 4th 1990) completed by a decree on May 11th confirms this decision for one year. This measure did not concern the medicinal products or some dietary supplements for newborn or young children. Since December 11th, 1989, 24 cases have been reported to the Regional Adverse Drug Reaction Monitoring Centres in France. These cases share the same features as the cases notified previously in the USA: overrepresentation of females, no relationship with the time and the daily intake, clinical similarities to the Shulman syndrome, and unknown prognosis. Now, more than one year after the onset of this illness, it seems that discontinuation of the ingestion of L-TrpCp can resolve or improve the symptoms in most cases, but sometimes the syndrome can persist. The causal relationship between the ingestion of L-TrpCp and this syndrome has been established. Whatever the mechanism for the development of EMS among tryptophan users remains unclear, as well as the role of eosinophilia and the factors for fibroblast proliferation. The epidemic emergence of this syndrome in July 89 raises the possibility of the contamination of tryptophan during the manufacturing process. To confirm this hypothesis, the same unusual peak in HPLC analysis was found both in case-associated L-Trp lots and in implicated-japanese manufacturer L-Trp lots in USA. But this would not explain the previous EMS reports before this contamination. Other hypotheses consist an inabnormality of tryptophan metabolism and/or an autoimmune process.

  14. Nurses in municipal care of the elderly act as pharmacovigilant intermediaries: a qualitative study of medication management

    PubMed Central

    Johansson-Pajala, Rose-Marie; Jorsäter Blomgren, Kerstin; Bastholm-Rahmner, Pia; Fastbom, Johan; Martin, Lene

    2016-01-01

    Objective To explore registered nurses’ experience of medication management in municipal care of the elderly in Sweden, with a focus on their pharmacovigilant activities. Design A qualitative approach using focus-group discussions was chosen in order to provide in-depth information. Data were analysed by qualitative content analysis. Setting Five focus groups in five different long-term care settings in two regions in Sweden. Subject A total of 21 registered nurses (RNs), four men and 17 women, aged 27–65 years, with 4–34 years of nursing experience. Results The findings reveal that RNs in municipal long-term care settings can be regarded as “vigilant intermediaries” in the patients’ drug treatments. They continuously control the work of staff and physicians and mediate between them, and also compensate for existing shortcomings, both organizational and in the work of health care professionals. RNs depend on other health care professionals to be able to monitor drug treatments and ensure medication safety. They assume expanded responsibilities, sometimes exceeding their formal competence, and try to cover for deficiencies in competence, experience, accessibility, and responsibility-taking. Conclusion The RNs play a central but also complex role as “vigilant intermediaries” in the medication monitoring process, including the issue of responsibility. Improving RNs’ possibility to monitor their patients’ drug treatments would enable them to prevent adverse drug events in their daily practice. New strategies are justified to facilitate RNs’ pharmacovigilant activities. Key pointsThis study contributes to the understanding of registered nurses’ (RNs’) role in medication management in municipal care of the elderly (i.e. detecting, assessing, and preventing adverse drug events or any drug-related problems). RNs can be considered to be “vigilant intermediaries” in elderly patients’ drug treatments, working at a distance from staff

  15. Drinking Water Treatability Database (Database)

    EPA Science Inventory

    The drinking Water Treatability Database (TDB) will provide data taken from the literature on the control of contaminants in drinking water, and will be housed on an interactive, publicly-available USEPA web site. It can be used for identifying effective treatment processes, rec...

  16. Questions about complementary and alternative medicine to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive pilot study

    PubMed Central

    2014-01-01

    Background Provision of clinically relevant information about complementary and alternative medicine (CAM) to health care professionals is not well described. The aim of the study was to assess questions about CAM to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). Methods All question-answers pairs (QAPs) in the RELIS database indexed with alternative medicine from 2005-2010 constituted the study material. A randomly selected sample of 100 QAPs was characterized with regard to type of question (category, patient-specific or general), occupation and workplace of enquirer, the type of information search performed (simple or advanced), and if the answers contained information to provide factual or consultative replies (facts about or advice on clinical use of CAM, respectively). Proportions were compared with Fisher’s exact test with significance at the 0.05 level. Results One thousand and thirty-eight (7.7%) out of 13 482 questions involved CAM. Eighty-two out of 100 questions concerned products containing one or more herbs, vitamins and minerals as well as other substances. Thirty-eight out of 100 questions concerned the category documentation (substance identification and/or literature reports about clinical effects), 36 interactions, 16 adverse effects, 9 pregnancy and lactation, and 1 question concerned contraindications. Sixty-three questions were patient-specific and 37 general. Fifty-four questions came from physicians, 33 from pharmacists and 13 from others (including nurses, midwives, students, CAM practitioners, and the public). Pharmacists asked more frequently about interactions while physicians asked more frequently about adverse effects (p < 0.05). Seventy-six of the questions came from outside hospital, mainly general practice and community pharmacies. Fifty-nine answers were based on a simple and 41 on an advanced information search. Thirty-three factual and 38 consultative answers were provided. In 29 answers

  17. [Developing a terminology in the French language for clinical practice and research in drug safety].

    PubMed

    Roulet, Lucien; Ballereau, Françoise; Lapeyre-Mestre, Maryse; Joris-Frasseren, Muriel; Asseray, Nathalie

    2015-01-01

    While several attempts have been made to clarify the English terminology of drug-related iatrogeny, a consensus has still not been reached in the French language. We set up a multidisciplinary task force to propose a terminology that differs from the one used in pharmacovigilance and risk management. We prefer the term "adverse drug event" (ADE) over "adverse drug reaction", and recommend avoiding the term "adverse event", which is too general. We propose to classify ADEs as "direct drug effect" or "drug involvement in a multifactorial pathological condition", taking into account the close relationship commonly found between drug and non-drug etiologies of a pathology. The consistent association between the notions "error" and "preventability" is also questionable, and we suggest assessing the "ameliorability" of ADEs rather than their "preventability". "Misuse" (i.e., the non-respect by the patient of the drug label) must be distinguished from "off-label use or substance abuse". © 2014 Société Française de Pharmacologie et de Thérapeutique.

  18. Medical Histories: A Case Report of Pharmacovigilance in Supporting Dentists and Participation in a Drug-Safety Program

    PubMed Central

    Karl, Edward H.; Curro, Frederick A.

    2014-01-01

    Introduction Antibiotics are a class of medications widely used by dentists. The class of agents has a number of listed side effects. This case report details an unusual adverse effect of tetracycline-induced psychosis recognized due to the diligence of a practitioner. To our knowledge, this is the first reported case by a dentist. Case Presentation A 44-year-old patient was started on tetracycline therapy for prophylaxis before a periodontal procedure. The patient began having paranoid and psychotic experiences. The patient sought psychiatric medical care and was diagnosed with tetracycline-induced psychosis. He was treated with an antipsychotic drug, which resolved his symptoms. Conclusion Dental medical histories are a resource that is underused and can often be of value in the continual assessment of drug safety and pharmacovigilance. PMID:26146592

  19. Affective norms for 720 French words rated by children and adolescents (FANchild).

    PubMed

    Monnier, Catherine; Syssau, Arielle

    2016-12-07

    FANchild (French Affective Norms for Children) provides norms of valence and arousal for a large corpus of French words (N = 720) rated by 908 French children and adolescents (ages 7, 9, 11, and 13). The ratings were made using the Self-Assessment Manikin (Lang, 1980). Because it combines evaluations of arousal and valence and includes ratings provided by 7-, 9-, 11-, and 13-year-olds, this database complements and extends existing French-language databases. Good response reliability was observed in each of the four age groups. Despite a significant level of consensus, we found age differences in both the valence and arousal ratings: Seven- and 9-year-old children gave higher mean valence and arousal ratings than did the other age groups. Moreover, the tendency to judge words positively (i.e., positive bias) decreased with age. This age- and sex-related database will enable French-speaking researchers to study how the emotional character of words influences their cognitive processing, and how this influence evolves with age. FANchild is available at https://www.researchgate.net/profile/Catherine_Monnier/contributions .

  20. A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project

    PubMed Central

    Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M.; Corripio, Iluminada; Aguilar, Eduardo J.; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J.

    2016-01-01

    Background: The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Methods: Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. Results: The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, P<.001). Conclusions: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. PMID:26506856

  1. A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project.

    PubMed

    Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M; Corripio, Iluminada; Aguilar, Eduardo J; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J; Bernardo, Miguel

    2016-04-01

    The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, P<.001). These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. © The Author 2015. Published by Oxford University Press on behalf of CINP.

  2. The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

    PubMed

    Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

    2016-01-01

    With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy.

  3. A Film Study Option for HSC French

    ERIC Educational Resources Information Center

    Connole, Pat

    1974-01-01

    In 1974, after a trial period of two years, the study of two selected French feature films will be offered as an option to the study of prescribed texts in Higher School Certificate French in Victoria. (Author)

  4. Retraining French Language Educators in the Teaching of Commercial French.

    ERIC Educational Resources Information Center

    Marfurt, Rose Marie A.

    A retraining program for language teachers wishing to teach college-level business French is described. The course may be taught in five 5-hour weekend seminars or in a 2-week summer seminar of 12 hours per week. Since the teachers already have language skills, the course focuses on building confidence and interest in the subject matter by showing…

  5. English versus French: Language Rivalry in Tunisia.

    ERIC Educational Resources Information Center

    Battenburg, John

    1997-01-01

    Examines the competition between English and French in Tunisian educational institutions and programs. Scrutinizes two periods in postprotectorate Tunisia: the introduction of English and the spread of English. Findings indicate that the decline in French linguistic influence may be accompanied by a future decrease in French political and economic…

  6. The French Revolution: A Simulation Game

    ERIC Educational Resources Information Center

    Kiernan, James Patrick

    1978-01-01

    Describes a college-level simulation game about the French Revolution. Based on George Lefebvre's "The Coming of the French Revolution," the role-play focuses on social and economic causes of the revolution and allows students to understand citizens' grievances against the French government. (AV)

  7. The French Revolution: A Simulation Game

    ERIC Educational Resources Information Center

    Kiernan, James Patrick

    1978-01-01

    Describes a college-level simulation game about the French Revolution. Based on George Lefebvre's "The Coming of the French Revolution," the role-play focuses on social and economic causes of the revolution and allows students to understand citizens' grievances against the French government. (AV)

  8. France: Africans and the French Revolution.

    ERIC Educational Resources Information Center

    Fatunde, Tunde

    1989-01-01

    The French Revolution had profound and long-term effects for Africans, both in Africa and throughout the Western hemisphere. Revolutionary leaders not only opposed the emancipation of slaves in French territories but supported an intensified slave trade, sparking numerous rebellions. French exploitation of Africans extended well into the twentieth…

  9. A Comparative Evaluation of French Grammar Checkers.

    ERIC Educational Resources Information Center

    Burston, Jack

    1996-01-01

    Four grammar checkers, all of French Canadian origin, were evaluated: "Le Correcteur 101,""GramR,""Hugo Plus," and "French Proofing Tools." Results indicate that "Le Correcteur 101" is the best French grammar checker on the market and worth its premium cost. (two references) (CK)

  10. France: Africans and the French Revolution.

    ERIC Educational Resources Information Center

    Fatunde, Tunde

    1989-01-01

    The French Revolution had profound and long-term effects for Africans, both in Africa and throughout the Western hemisphere. Revolutionary leaders not only opposed the emancipation of slaves in French territories but supported an intensified slave trade, sparking numerous rebellions. French exploitation of Africans extended well into the twentieth…

  11. French Spelling Rectifications: A Failed Coup.

    ERIC Educational Resources Information Center

    Horan, Ron

    1992-01-01

    The proposed 1991 reforms to French spelling discussed in a previous issue of "Babel" have been abandoned. This article notes the history of other efforts to rectify French spelling and reviews the French Academy's decision-making process in the current effort. (LB)

  12. The new IAGOS Database Portal

    NASA Astrophysics Data System (ADS)

    Boulanger, Damien; Gautron, Benoit; Thouret, Valérie; Fontaine, Alain

    2016-04-01

    IAGOS (In-service Aircraft for a Global Observing System) is a European Research Infrastructure which aims at the provision of long-term, regular and spatially resolved in situ observations of the atmospheric composition. IAGOS observation systems are deployed on a fleet of commercial aircraft. The IAGOS database is an essential part of the global atmospheric monitoring network. It contains IAGOS-core data and IAGOS-CARIBIC (Civil Aircraft for the Regular Investigation of the Atmosphere Based on an Instrument Container) data. The IAGOS Database Portal (http://www.iagos.fr, damien.boulanger@obs-mip.fr) is part of the French atmospheric chemistry data center AERIS (http://www.aeris-data.fr). The new IAGOS Database Portal has been released in December 2015. The main improvement is the interoperability implementation with international portals or other databases in order to improve IAGOS data discovery. In the frame of the IGAS project (IAGOS for the Copernicus Atmospheric Service), a data network has been setup. It is composed of three data centers: the IAGOS database in Toulouse; the HALO research aircraft database at DLR (https://halo-db.pa.op.dlr.de); and the CAMS data center in Jülich (http://join.iek.fz-juelich.de). The CAMS (Copernicus Atmospheric Monitoring Service) project is a prominent user of the IGAS data network. The new portal provides improved and new services such as the download in NetCDF or NASA Ames formats, plotting tools (maps, time series, vertical profiles, etc.) and user management. Added value products are available on the portal: back trajectories, origin of air masses, co-location with satellite data, etc. The link with the CAMS data center, through JOIN (Jülich OWS Interface), allows to combine model outputs with IAGOS data for inter-comparison. Finally IAGOS metadata has been standardized (ISO 19115) and now provides complete information about data traceability and quality.

  13. Atomic Databases

    NASA Astrophysics Data System (ADS)

    Mendoza, Claudio

    2000-10-01

    Atomic and molecular data are required in a variety of fields ranging from the traditional astronomy, atmospherics and fusion research to fast growing technologies such as lasers, lighting, low-temperature plasmas, plasma assisted etching and radiotherapy. In this context, there are some research groups, both theoretical and experimental, scattered round the world that attend to most of this data demand, but the implementation of atomic databases has grown independently out of sheer necessity. In some cases the latter has been associated with the data production process or with data centers involved in data collection and evaluation; but sometimes it has been the result of individual initiatives that have been quite successful. In any case, the development and maintenance of atomic databases call for a number of skills and an entrepreneurial spirit that are not usually associated with most physics researchers. In the present report we present some of the highlights in this area in the past five years and discuss what we think are some of the main issues that have to be addressed.

  14. Cinque's Functional Verbs in French

    ERIC Educational Resources Information Center

    Rowlett, Paul

    2007-01-01

    This article focuses on the syntax of a number of subcategories of verb in French which are compatible with a following bare infinitive and which express various kinds of grammatical tense, mood, modality, aspect and voice, as well as such (more lexical?) notions as perception, causation and locomotion. The article starts by cataloguing a number…

  15. Verlan: Talking Backwards in French.

    ERIC Educational Resources Information Center

    Lefkowitz, Natalie J.

    1989-01-01

    The history of "Verlan," a form of French word play involving inversion of syllables with varying degrees of complexity, is described and its phonological and morphological patterns are outlined. Appropriate and inappropriate contexts for use of Verlan, extralinguistic functions, and the results of lexicalization of verlanized words are…

  16. Belgium--The French Community

    ERIC Educational Resources Information Center

    Sägesser, Caroline

    2017-01-01

    Since 1993, Belgium has been a federal state where education is entrusted to the Communities. There are three Communities in Belgium: Flemish, French and German-speaking. They are responsible for personal matters (mainly education, culture and social affairs). There are also three Regions in Belgium: Flanders, Wallonia and Brussels. Regions are…

  17. Some "English" Words in French.

    ERIC Educational Resources Information Center

    Thogmartin, Clyde

    1984-01-01

    Examines "pseudoborrowing" of some English words into the French vocabulary. Considered the prestige language of Western Europe, English is viewed as a social hallmark of higher education; thus, even a modest knowledge and use of English reinforces this attitude. However, also suggests a modification of this concept, noting a reciprocal prestige…

  18. An Interview with Fiona French

    ERIC Educational Resources Information Center

    Lewis, David

    2005-01-01

    In this interview Fiona French discusses her work and career with David Lewis. She describes early influences and stresses her lifelong love of colour and pattern. Amongst other themes she considers the factual basis of most of her books and her lack of interest in fantasy; her preference for clear, simple prose; her constant shifts in style and…

  19. French String Grammar. Final Report.

    ERIC Educational Resources Information Center

    New York Univ., NY. Linguistic String Project.

    This work reports on an initial study of the possibility of providing a suitable framework for the teaching of a foreign language grammar through string analysis, using French as the target language. Analysis of a string word list (word-class sequences) yields an overall view of the grammar. Details are furnished in a set of restrictions which…

  20. An Interview with Fiona French

    ERIC Educational Resources Information Center

    Lewis, David

    2005-01-01

    In this interview Fiona French discusses her work and career with David Lewis. She describes early influences and stresses her lifelong love of colour and pattern. Amongst other themes she considers the factual basis of most of her books and her lack of interest in fantasy; her preference for clear, simple prose; her constant shifts in style and…

  1. Normenbuch Franzoesisch (Norm Book French)

    ERIC Educational Resources Information Center

    Pamp, Friedhelm

    1976-01-01

    Critizes the Norm Book for French Final (Abitur) Examination 1975 for German Schools, as to its arrangement and some resulting difficulties; also for its over-emphasis on written work over speaking. Additional publications are needed to make the existing requirements more specific. (Text is in German.) (IFS/WGA)

  2. Exploiting French Songs as Genre.

    ERIC Educational Resources Information Center

    Hamblin, Vicki L.

    1993-01-01

    Describes strategy for teaching culture and conversation at the third- and fourth-year undergraduate level using authentic documents as the primary materials. The medium chosen for this course was the French chanson, but similar strategies may be applicable to any modern language using the culturally appropriate materials. (eight references) (LET)

  3. [Herman Lundborg and French eugenicists].

    PubMed

    Drouard, A

    1999-01-01

    Herman Lundborg, the director of the Institute of Racial Biology in Uppsala, corresponded with some prominent French eugenicists in the 1920s and 1930s. The historical context of this correspondence is analyzed, and the importance of the national differences as well as of the international eugenic organization's efforts are emphasized.

  4. Guide to French Noun Gender.

    ERIC Educational Resources Information Center

    Wilson, Perkins

    This guide presents a system for determining the qender of French nouns that has been tested against 12,000 pages of general reading: novels, history, social science, law, finance, and the Bible. The guide discusses the rules for determining gender and also presents various lists of the non-routine or exceptions to the rules. It is asserted that…

  5. French on the Advanced Level.

    ERIC Educational Resources Information Center

    Pawlik, Teresa Wilkinson

    1969-01-01

    Presented in this article is an outline of some of the special interest course work included in the curriculum guidelines being developed in the Atlanta Public Schools System for advanced secondary school French classes. Titles of the audiolingually-oriented courses described are--(1) "Teenagers and Teenage Life in France Today," (2)…

  6. Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France?

    PubMed

    Paludetto, Marie-Noelle; Olivier-Abbal, Pascale; Montastruc, Jean-Louis

    2012-12-01

    The objective of our study was to determine the nature of scientific evidence leading to drug withdrawal for safety reasons in France (between 2005 and 2011). Drugs (i.e., active ingredients) withdrawn were identified from the Web site of the French Health Products Agency. Additional information allowed us to classify these withdrawals according to the nature of evidence as clinical trials (CT), case reports/case series (CR/CS), case-control studies (CC), cohort, animal, or observational studies. A total of 22 active ingredients were withdrawn from the French market between 2005 and 2011. The nature and type of adverse drug reactions (ADRs) leading more frequently to drug withdrawal were cardiovascular (10-fold), neurological (5-fold), or hepatic, cutaneous, or psychiatric (3-fold each) ADRs. CR (19/22; 86.4%) and CT (13/22; 59.1%) were the most frequently involved methods. In 5 of 22 (23%) cases, CR were the sole evidence. However, 68% (15/22) of regulatory decisions were based on multiple sources of evidence: For example, data from CR + CT were used in eight cases. CC or cohort studies were used in only five cases. This study underlines that spontaneous reporting remained the most important source of drug withdrawals between 2005 and 2011. However, its relative importance decreased in comparison with that in 1997-2004. The importance of pharmacoepidemiological methods slightly increased but remained low. Finally, regulatory authorities seem to have more frequently based their safety decisions on multiple sources of evidence than before. Copyright © 2012 John Wiley & Sons, Ltd.

  7. Stackfile Database

    NASA Technical Reports Server (NTRS)

    deVarvalho, Robert; Desai, Shailen D.; Haines, Bruce J.; Kruizinga, Gerhard L.; Gilmer, Christopher

    2013-01-01

    This software provides storage retrieval and analysis functionality for managing satellite altimetry data. It improves the efficiency and analysis capabilities of existing database software with improved flexibility and documentation. It offers flexibility in the type of data that can be stored. There is efficient retrieval either across the spatial domain or the time domain. Built-in analysis tools are provided for frequently performed altimetry tasks. This software package is used for storing and manipulating satellite measurement data. It was developed with a focus on handling the requirements of repeat-track altimetry missions such as Topex and Jason. It was, however, designed to work with a wide variety of satellite measurement data [e.g., Gravity Recovery And Climate Experiment -- GRACE). The software consists of several command-line tools for importing, retrieving, and analyzing satellite measurement data.

  8. Safety of a pasteurized plasma-derived Factor VIII and von Willebrand factor concentrate: analysis of 33 years of pharmacovigilance data.

    PubMed

    Kouides, Peter; Wawra-Hehenberger, Kathrin; Sajan, Anna; Mead, Henry; Simon, Toby

    2017-10-01

    Haemate-P/Humate-P (Humate-P) is a pasteurized human plasma-derived concentrate containing both Factor VIII and von Willebrand factor for treatment of hemophilia A and von Willebrand disease (VWD). We analyzed the safety of Humate-P based on more than 33 years of postmarketing pharmacovigilance data, representing an estimated exposure of approximately 25,000 patient-years. The analysis comprises reports of potential adverse drug reactions (ADRs) from all sources, reported as part of routine pharmacovigilance at CSL Behring. ADRs considered clinically relevant or potential risks of Humate-P were identified based on defined and standardized Medical Dictionary for Regulatory Activities queries. Recognizing the limitations of spontaneous reporting, we also reviewed the literature, including clinical trials with mandatory reporting. From 1982 to 2015, a total of 670 postmarketing cases had been reported via pharmacovigilance, for an overall reporting rate of approximately one ADR per 3900 administered standard doses. Of these cases, 343 involved ADRs considered clinically relevant risks (33 thromboembolic complications, 97 inhibitor formation, 110 hypersensitivity or allergic reactions) or potential risks (103 suspected virus transmissions) for Humate-P. Most thromboembolic complications occurred in patients undergoing surgery or with other known risk factors. Inhibitor formation occurred mostly in patients with hemophilia A (24 cases were high titer). Most patients with hypersensitivity or allergic reactions had VWD. None of the reported suspected virus transmission cases were confirmed to be associated with Humate-P. Reported results of company-sponsored studies showed a low incidence of adverse events possibly or probably related to Humate-P. More than 33 years of pharmacovigilance data continue to support the safety of Humate-P. © 2017 The Authors. Transfusion published by Wiley Periodicals, Inc. on behalf of AABB.

  9. French roots of French neo-lamarckisms, 1879-1985.

    PubMed

    Loison, Laurent

    2011-01-01

    This essay attempts to describe the neo-Lamarckian atmosphere that was dominant in French biology for more than a century. Firstly, we demonstrate that there were not one but at least two French neo-Lamarckian traditions. This implies, therefore, that it is possible to propose a clear definition of a (neo)Lamarckian conception, and by using it, to distinguish these two traditions. We will see that these two conceptions were not dominant at the same time. The first French neo-Lamarckism (1879-1931) was structured by a very mechanic view of natural processes. The main representatives of this first period were scientists such as Alfred Giard (1846-1908), Gaston Bonnier (1853-1922) and Félix Le Dantec (1869-1917). The second Lamarckism - much more vitalist in its inspiration - started to develop under the supervision of people such as Albert Vandel (1894-1980) and Pierre-Paul Grassé (1895-1985). Secondly, this essay suggests that the philosophical inclinations of these neo-Lamarckisms reactivated a very ancient and strong dichotomy of French thought. One part of this dichotomy is a material, physicalist tradition, which started with René Descartes but developed extensively during the 18th and 19th centuries. The other is a spiritual and vitalist reaction to the first one, which also had a very long history, though it is most closely associated with the work of Henri Bergson. Through Claude Bernard, the first neo-Lamarckians tried to construct a mechanical and determinist form of evolutionary theory which was, in effect, a Cartesian theory. The second wave of neo-Lamarckians wanted to reconsider the autonomy and reactivity of life forms, in contrast to purely physical systems.

  10. French Alps, Mont Blanc, French/Italian Border

    NASA Image and Video Library

    1992-04-02

    In this southeast looking view, Mont Blanc, on the French/Italian border, (48.0N, 4.5E) the highest mountain peak in all of Europe, is just below and right of center (below the end of the prominent valley of the Aosta River, in the center of the photo. The rivers flow out of the Alps into Italy toward Turin. Chamonix, the famous resort town and center of Alpine mountain climbing, lies in the valley just below Mont Blanc.

  11. Venus transits - A French view

    NASA Astrophysics Data System (ADS)

    Débarbat, Suzanne

    2005-04-01

    After a careful study of Mars observations obtained by Tycho Brahé (1546-1601), Kepler (1571-1630) discovered the now-called Kepler's third law. In 1627 he published his famous Tabulae Rudolphinae, a homage to his protector Rudolph II (1552-1612), tables (Kepler 1609, 1627) from which he predicted Mercury and Venus transits over the Sun. In 1629 Kepler published his Admonitio ad Astronomos Advertisement to Astronomers (Kepler 1630), Avertissement aux Astronomes in French Au sujet de phénomènes rares et étonnants de l'an 1631: l'incursion de Vénus et de Mercure sur le Soleil. This was the beginning of the interest of French astronomers, among many others, in such transits, mostly for Venus, the subject of this paper in which dates are given in the Gregorian calendar.

  12. [The French lessons of anatomy].

    PubMed

    Bouchet, Alain

    2003-01-01

    The "Lessons of Anatomy" can be considered as a step of Medicine to Art. For several centuries the exhibition of a corpse's dissection was printed on the title-page of published works. Since the seventeenth century, the "Lessons of Anatomy" became a picture on the title-page in order to highlight the well-known names of the european anatomists. The study is limited to the French Lessons of Anatomy found in books or pictures after the invention of printing.

  13. [Twenty-five years of the French Addictovigilance Network (FAN)].

    PubMed

    Micallef, Joëlle; Mallaret, Michel

    2016-09-01

    Based on recommendations from the World Health Organization (WHO), the French addictovigilance network was set up since 1990, in order to assess and to monitor the potential for abuse and dependence of psychoactive substances. This network composed of 13 addictovigilance centers implemented in medical pharmacology departments of French university hospitals has developed specific pharmacoepidemiological tools repeated each year so as to lead us to updated pharmacological indicators related to drug abuse. As a single source may not be informative enough, the French addictovigilance network consider simultaneously a range of indicators focusing on health insurance database, health professional sentinel networks, characteristics of psychotropic consumptions and analysed them from a medical and pharmacological point of view combined to pharmacodynamic and pharmacokinetic data. The task force and the original role of this addictovigilance network is to work with reactivity to all different levels (local, regional, national) linked to all heath professionals in order to detect more quickly a potential warning signal leading to information, public health decision at a regional and/or national level and contributing also to a European and an international overview.

  14. French field experience with buprenorphine.

    PubMed

    Auriacombe, Marc; Fatséas, Mélina; Dubernet, Jacques; Daulouède, Jean-Pierre; Tignol, Jean

    2004-01-01

    In most European countries, methadone treatment is provided to only 20-30% of opiate abusers who need treatment due to regulations and concerns about safety. To address this need in France, all registered medical doctors since 1995 have been allowed to prescribe buprenorphine (BUP) without any special education or licensing. This led to treating approximately 65,000 patients per year with BUP, about ten times more than with more restrictive methadone policies. French physician compensation mechanisms, pharmacy services, and medical insurance funding all minimized barriers to BUP treatment. About 20% of all physicians in France are using BUP to treat about half of the estimated 150,000 problem heroin users. Daily supervised dosing by a pharmacist for the first six months resulted in significantly better treatment retention (80% vs 46%) and lower heroin use. Intravenous diversion of BUP may occur in up to 20% of BUP patients and has led to various infections and relatively rare overdoses in combination with sedatives. Opiate overdose deaths have declined substantially (by 79%) since BUP was introduced in 1995. Newborn opiate withdrawal in mothers treated with buprenorphine compared to methadone was reported to be less frequent, less severe, and of shorter duration. Although some of the public health benefits seen during the time of buprenorphine expansion in France might be contingent upon characteristics of the French health and social services system, the French model raises questions about the value of tight regulations on prescribing BUP imposed by many countries throughout the world.

  15. Are consumers ready to take part in the Pharmacovigilance System?--a Portuguese preliminary study concerning ADR reporting.

    PubMed

    Matos, Cristiano; van Hunsel, Florence; Joaquim, João

    2015-07-01

    New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. Consumers are more likely to do

  16. Emotional norms for 524 French personality trait words.

    PubMed

    Ric, François; Alexopoulos, Theodore; Muller, Dominique; Aubé, Benoîte

    2013-06-01

    Newly measured rating norms provide a database of emotion-related dimensions for 524 French trait words. Measures include valence, approach/avoidance tendencies associated with the trait, possessor- and other-relevance of the trait, and discrete emotions conveyed by the trait (i.e., anger, disgust, fear, happiness, and sadness). The normative data were obtained from 328 participants and were revealed to be stable across samples and gender. These data go beyond a dimensional structure and consider more fine-grained descriptions such as the categorical emotions, as well as the perspective of the evaluator conveyed by the traits. They should thus be particularly useful for researchers interested in emotion or in the emotional dimension of cognition, action, or personality. The database is available as supplementary material.

  17. French security policy: From independence to interdependence

    SciTech Connect

    Laird, R.F.

    1986-01-01

    The book features the first-time translation of some of the most significant recent papers by leading French analysts of security affairs. Beginning with a look at continuity and change in French policy since de Gaulle, this books presents the evolution of French security policy in the 1970s and 1980s. Dr. Laird pays special attention to the French nuclear modernization process and to the trend in the last two decades toward greater emphasis on security interdependence within the Western Alliance at the expense of the classic Gaullist stance of independence. He examines the major dimensions of French security policy, particularly French nuclear employment policy and doctrine, the Franco-German relationship, and France's role in Europe and in East-West relations.

  18. Overweight and obesity in French Hajj pilgrims.

    PubMed

    Gautret, Philippe; Bauge, Marie; Simon, Fabrice; Benkouiten, Samir; Valéro, René; Parola, Philippe; Brouqui, Philippe

    2013-02-01

    High prevalence of overweight (45%) and obesity (30%) were recorded in French Hajj pilgrims originating from North Africa. Females were significantly more likely to suffer from obesity compared to males. The overall prevalence of obesity among French pilgrims born in North-Africa was twice that of the overall French population. The prevalence of obesity in pilgrims aged 55-64 years and 65 years and over were respectively 38 and 25% compared to 20 and 18% in the corresponding overall French population age classes. The prevalence of diabetes in French pilgrims was five times higher compared to that of the overall French population. This situation prompts us to organize in the next future, pre-Hajj education seminars for diabetics.

  19. Appropriating Written French: Literacy Practices in a Parisian Elementary Classroom

    ERIC Educational Resources Information Center

    Rockwell, Elsie

    2012-01-01

    In this article, I examine French language instruction in an elementary classroom serving primarily children of Afro-French immigrants in Paris. I show that a prevalent French language ideology privileges written over oral expression and associates full mastery of written French with rational thought and full inclusion in the French polity. This…

  20. Appropriating Written French: Literacy Practices in a Parisian Elementary Classroom

    ERIC Educational Resources Information Center

    Rockwell, Elsie

    2012-01-01

    In this article, I examine French language instruction in an elementary classroom serving primarily children of Afro-French immigrants in Paris. I show that a prevalent French language ideology privileges written over oral expression and associates full mastery of written French with rational thought and full inclusion in the French polity. This…

  1. Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010-2013.

    PubMed

    Diomandé, Fabien V K; Yaméogo, Téné M; Vannice, Kirsten S; Preziosi, Marie-Pierre; Viviani, Simonetta; Ouandaogo, Claude-Roger; Keita, Modibo; Djingarey, Mamoudou H; Mbakuliyemo, Nehemie; Akanmori, Bartholomew Dicky; Sow, Samba O; Zuber, Patrick L F

    2015-11-15

    The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns. National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects. Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits. Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future. © 2015 World Health Organization; licensee Oxford Journals.

  2. 'The more you link, the more you risk …' - a focus group study exploring views about data linkage for pharmacovigilance.

    PubMed

    Hopf, Yvonne M; Bond, Christine; Francis, Jill; Haughney, John; Helms, Peter J

    2014-11-01

    The aim of this study was to assess opinions of frontline healthcare professionals on the linking of routinely collected national (Scottish) paediatric data for the purpose of identifying earlier signals of adverse drug reactions. Stratified purposive sampling led to profession-specific focus groups with pharmacists, nurses and medical doctors from primary and secondary care in different Scottish Health Boards. A topic guide was used to explore the proposed data linkage of routinely collected paediatric data. Discussions were audio recorded and transcribed verbatim. Transcripts were analysed using a framework approach to identify themes. Ethical approval was obtained from the North of Scotland Research Ethics Service. Six focus groups were conducted in 2011 with 22 participants. Views of the proposed data linkage were generally positive. Several issues were identified, including lack of clarity on data ownership and concerns about diversion of funding. Identified issues were at a practical rather than a strategic level. This study identified that professional stakeholder groups are likely to find linkage of paediatric patient data acceptable. Barriers identified could be addressed. Focus group participants commented on the importance of informing patients and members of the public about the benefits of linking healthcare data. These findings clarify the steps that should be taken to ensure the acceptability of data linkage for pharmacovigilance. © 2014 The British Pharmacological Society.

  3. [Dealing with adverse drug reactions in dentistry. Procedures on encountering adverse drug reactions and goal of the Swiss Pharmacovigilance system].

    PubMed

    Egger, Sabin S; Krähenbühl, Stephan; Schlienger, Raymond G

    2005-01-01

    Dentists may be confronted with adverse drug reactions (ADRs) in their dental practice, and are--like other health professionals--obliged to report certain ADRs. The aim of this article is to sensitise dentists for this topic, to show how to proceed in case of a supposed ADR, and to emphasise the importance of spontaneous reporting of ADRs. ADRs may not always be clearly distinguished from symptoms of underlying diseases, and in cases of polypharmacy multiple drugs may be responsible for the reaction. It is therefore important to get a detailed medical history, and to establish a temporal relationship between start of a therapy and appearance of the symptom. Information from the medical literature, exclusion of other possible causes, and identification of risk factors help to confirm a causal relationship between a suspected drug and an observed reaction. In Switzerland severe and unexpected ADRs have to be reported to one of the regional Pharmacovigilance centres with the yellow ADR reporting form from Swissmedic. The spontaneous reports of ADRs help to early identify new problems of a drug therapy, and permit to take measures to minimise the risk.

  4. Lessons Learned From Enhancing Vaccine Pharmacovigilance Activities During PsA-TT Introduction in African Countries, 2010–2013

    PubMed Central

    Diomandé, Fabien V. K.; Yaméogo, Téné M.; Vannice, Kirsten S.; Preziosi, Marie-Pierre; Viviani, Simonetta; Ouandaogo, Claude-Roger; Keita, Modibo; Djingarey, Mamoudou H.; Mbakuliyemo, Nehemie; Akanmori, Bartholomew Dicky; Sow, Samba O.; Zuber, Patrick L. F.

    2015-01-01

    Background. The rollout of the group A meningococcal vaccine, PsA-TT, in Africa's meningitis belt countries represented the first introduction of a vaccine specifically designed for this part of the world. During the first year alone, the number of people who received the vaccine through mass vaccination campaigns was several hundredfold higher than that of subjects who participated in the closely monitored clinical trials. Implementation of a system to identify rare but potentially serious vaccine reactions was therefore a high priority in the design and implementation of those campaigns. Methods. National authorities and their technical partners set up effective vaccine pharmacovigilance systems, including conducting active surveillance projects. Results. Implementation of national expert advisory groups to review serious adverse events following immunization in all countries and active monitoring of conditions of interest in 3 early-adopter countries did not identify particular concerns with the safety profile of PsA-TT, which had already provided tremendous public health benefits. Conclusions. Lessons learned from this experience will help to improve preparations for future vaccine introductions in resource-poor settings and capitalize on such efforts to advance vaccine safety systems in the future. PMID:26553675

  5. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    PubMed

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

  6. A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study

    PubMed Central

    Kendall, Jason; Maconochie, Ian; Wong, Ian C K; Howard, Richard

    2015-01-01

    Objectives To establish the safety of an intranasal diamorphine (IND) spray in children. Design An open-label, single-dose pharmacovigilance trial. Setting Emergency departments in eight UK hospitals. Participants Children aged 2–16 years with a fracture or other trauma. Outcome measures Adverse events (AE) specifically related to nasal irritation, respiratory and central nervous system depression. Results 226 patients received 0.1 mg/kg IND. No serious or severe AEs occurred. The incidence of treatment-emergent AEs (TEAEs) was 26.5% (95% CI 20.9% to 32.8%), 93% being mild. 89% were related to treatment, all being known effects of the drug or route of administration except for three events in two patients. 20.4% (95% CI 15.3% to 26.2%) patients reported nasal irritation, all mild except one moderate and one ‘unknown’ severity. No respiratory depression was reported. Three AEs related to reduced Glasgow Coma Score (GCS) occurred, all mild. Conclusions There were no safety concerns raised during the conduct of the study. In addition to expected side effects, IND can cause mild nasal irritation in a proportion of patients. European Union Drug Regulating Authorities Clinical Trial No 2009-014982-16. PMID:24406329

  7. Hepatotoxicity associated with agomelatine and other antidepressants: Disproportionality analysis using pooled pharmacovigilance data from the Uppsala Monitoring Centre.

    PubMed

    Gahr, Maximilian; Zeiss, René; Lang, Dirk; Connemann, Bernhard J; Schönfeldt-Lecuona, Carlos

    2015-07-01

    Since its marketing approval, the attention to the hepatic side-effect profile of the antidepressant agomelatine (AGM) has gradually increased. Several cases of severe hepatotoxic adverse drug reactions (ADR) have been reported and the European Medicines Agency has released a safety warning regarding AGM-associated hepatotoxicity. However, there are insufficient data for an adequate safety assessment of AGM-related hepatotoxicity. Therefore, we performed a quantitative signal detection analysis using pharmacovigilance data from the Uppsala Monitoring Centre from the WHO that records ADR data from worldwide sources; we calculated reporting odds ratios (ROR) as measures for disproportionality within a case/non-case approach for AGM and several other antidepressants. AGM was statistically associated with an increased risk of hepatotoxicity (ROR 6.4 [95%CI 5.7-7.2]) as well as both positive controls: amineptine (ROR 38.4 [95%CI 33.8-43.6]) and nefazodone (ROR 3.2 [95%CI 3.0-3.5]). Following amineptine, AGM was associated with the second highest ROR, followed by tianeptine (ROR 4.4 [95%CI 3.6-5.3]), mianserin (ROR 3.6 [95%CI 3.3-3.9]), and nefazodone. These results support the hypothesis that AGM is associated with relevant hepatotoxicity. However, the used data and applied method do not allow a quantitative evaluation of hepatotoxicity or assessment of substance-specific differences regarding the extent of hepatotoxicity.

  8. Text mining for pharmacovigilance: Using machine learning for drug name recognition and drug-drug interaction extraction and classification.

    PubMed

    Ben Abacha, Asma; Chowdhury, Md Faisal Mahbub; Karanasiou, Aikaterini; Mrabet, Yassine; Lavelli, Alberto; Zweigenbaum, Pierre

    2015-12-01

    Pharmacovigilance (PV) is defined by the World Health Organization as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. An essential aspect in PV is to acquire knowledge about Drug-Drug Interactions (DDIs). The shared tasks on DDI-Extraction organized in 2011 and 2013 have pointed out the importance of this issue and provided benchmarks for: Drug Name Recognition, DDI extraction and DDI classification. In this paper, we present our text mining systems for these tasks and evaluate their results on the DDI-Extraction benchmarks. Our systems rely on machine learning techniques using both feature-based and kernel-based methods. The obtained results for drug name recognition are encouraging. For DDI-Extraction, our hybrid system combining a feature-based method and a kernel-based method was ranked second in the DDI-Extraction-2011 challenge, and our two-step system for DDI detection and classification was ranked first in the DDI-Extraction-2013 task at SemEval. We discuss our methods and results and give pointers to future work.

  9. Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features

    PubMed Central

    Sarker, Abeed; O’Connor, Karen; Ginn, Rachel

    2015-01-01

    Objective Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. Methods We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs). ADRMine utilizes a variety of features, including a novel feature for modeling words’ semantic similarities. The similarities are modeled by clustering words based on unsupervised, pretrained word representation vectors (embeddings) generated from unlabeled user posts in social media using a deep learning technique. Results ADRMine outperforms several strong baseline systems in the ADR extraction task by achieving an F-measure of 0.82. Feature analysis demonstrates that the proposed word cluster features significantly improve extraction performance. Conclusion It is possible to extract complex medical concepts, with relatively high performance, from informal, user-generated content. Our approach is particularly scalable, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets. PMID:25755127

  10. [On the history of French eugenics].

    PubMed

    Drouard, A

    1998-01-01

    The French Eugenical Society was founded in 1913, but eugenics had been actively discussed already much earlier, although under varing names. The main protagonists of early French eugenics were Georges Vacher de Lapouge, who was inspired by Galton and socialism, Adolphe Pinard, who propagated the "puericulture", and Paul Robin, who represented neo-malthusianism in his country. Alexis Carrel's ideas on improving the human race became widespread especially through his book "Man, the Unknown", published simultaneously in French and English in 1935. In general, the French eugenicists were more in favour of positive eugenics than negative selection, including sterilization, but their general influence was weaker than in several other countries.

  11. Learning to Read in English and French: Emergent Readers in French Immersion

    ERIC Educational Resources Information Center

    Chung, Sheila Cira; Koh, Poh Wee; Deacon, S. Hélène; Chen, Xi

    2017-01-01

    This longitudinal study investigated the predictors of word reading in English and French for 69 children in early total French immersion from first through third grade. The influence of phonological awareness, orthographic processing, and vocabulary in English and French on the achievement and growth of word reading in the 2 languages were…

  12. Cultural Understanding: French, Level One. Selected Cultural Concepts Which May Be Developed in French Level I.

    ERIC Educational Resources Information Center

    Walpole, Earl L.

    This manual was prepared to instruct the language teacher on concepts of French culture to be taught in a beginning French class to students of any age. The cultural concepts are cross-referenced and intended to be used with five of the most widely used French texts. Certain deeper cultural concepts are meant to be used for longer unit…

  13. Evaluation of the French Immersion Weekends, French Centre, University of Calgary, 1979-80.

    ERIC Educational Resources Information Center

    Klinck, Patricia

    Four French immersion weekends for continuing education students at the University of Calgary were evaluated. Each weekend involved recreational activities for twenty students and four French-speaking monitors at one of two recreational retreats near Calgary. The purpose of the program was to promote fluency in French by encouraging its use in a…

  14. A Search Engine to Access PubMed Monolingual Subsets: Proof of Concept and Evaluation in French

    PubMed Central

    Schuers, Matthieu; Soualmia, Lina Fatima; Grosjean, Julien; Kerdelhué, Gaétan; Kergourlay, Ivan; Dahamna, Badisse; Darmoni, Stéfan Jacques

    2014-01-01

    Background PubMed contains numerous articles in languages other than English. However, existing solutions to access these articles in the language in which they were written remain unconvincing. Objective The aim of this study was to propose a practical search engine, called Multilingual PubMed, which will permit access to a PubMed subset in 1 language and to evaluate the precision and coverage for the French version (Multilingual PubMed-French). Methods To create this tool, translations of MeSH were enriched (eg, adding synonyms and translations in French) and integrated into a terminology portal. PubMed subsets in several European languages were also added to our database using a dedicated parser. The response time for the generic semantic search engine was evaluated for simple queries. BabelMeSH, Multilingual PubMed-French, and 3 different PubMed strategies were compared by searching for literature in French. Precision and coverage were measured for 20 randomly selected queries. The results were evaluated as relevant to title and abstract, the evaluator being blind to search strategy. Results More than 650,000 PubMed citations in French were integrated into the Multilingual PubMed-French information system. The response times were all below the threshold defined for usability (2 seconds). Two search strategies (Multilingual PubMed-French and 1 PubMed strategy) showed high precision (0.93 and 0.97, respectively), but coverage was 4 times higher for Multilingual PubMed-French. Conclusions It is now possible to freely access biomedical literature using a practical search tool in French. This tool will be of particular interest for health professionals and other end users who do not read or query sufficiently in English. The information system is theoretically well suited to expand the approach to other European languages, such as German, Spanish, Norwegian, and Portuguese. PMID:25448528

  15. A search engine to access PubMed monolingual subsets: proof of concept and evaluation in French.

    PubMed

    Griffon, Nicolas; Schuers, Matthieu; Soualmia, Lina Fatima; Grosjean, Julien; Kerdelhué, Gaétan; Kergourlay, Ivan; Dahamna, Badisse; Darmoni, Stéfan Jacques

    2014-12-01

    PubMed contains numerous articles in languages other than English. However, existing solutions to access these articles in the language in which they were written remain unconvincing. The aim of this study was to propose a practical search engine, called Multilingual PubMed, which will permit access to a PubMed subset in 1 language and to evaluate the precision and coverage for the French version (Multilingual PubMed-French). To create this tool, translations of MeSH were enriched (eg, adding synonyms and translations in French) and integrated into a terminology portal. PubMed subsets in several European languages were also added to our database using a dedicated parser. The response time for the generic semantic search engine was evaluated for simple queries. BabelMeSH, Multilingual PubMed-French, and 3 different PubMed strategies were compared by searching for literature in French. Precision and coverage were measured for 20 randomly selected queries. The results were evaluated as relevant to title and abstract, the evaluator being blind to search strategy. More than 650,000 PubMed citations in French were integrated into the Multilingual PubMed-French information system. The response times were all below the threshold defined for usability (2 seconds). Two search strategies (Multilingual PubMed-French and 1 PubMed strategy) showed high precision (0.93 and 0.97, respectively), but coverage was 4 times higher for Multilingual PubMed-French. It is now possible to freely access biomedical literature using a practical search tool in French. This tool will be of particular interest for health professionals and other end users who do not read or query sufficiently in English. The information system is theoretically well suited to expand the approach to other European languages, such as German, Spanish, Norwegian, and Portuguese.

  16. A unique database for gathering data from a mobile app and medical prescription software: a useful data source to collect and analyse patient-reported outcomes of depression and anxiety symptoms.

    PubMed

    Watanabe, Yoshinori; Hirano, Yoko; Asami, Yuko; Okada, Maki; Fujita, Kazuya

    2017-11-01

    A unique database named 'AN-SAPO' was developed by Iwato Corp. and Japan Brain Corp. in collaboration with the psychiatric clinics run by Himorogi Group in Japan. The AN-SAPO database includes patients' depression/anxiety score data from a mobile app named AN-SAPO and medical records from medical prescription software named 'ORCA'. On the mobile app, depression/anxiety severity can be evaluated by answering 20 brief questions and the scores are transferred to the AN-SAPO database together with the patients' medical records on ORCA. Currently, this database is used at the Himorogi Group's psychiatric clinics and has over 2000 patients' records accumulated since November 2013. Since the database covers patients' demographic data, prescribed drugs, and the efficacy and safety information, it could be a useful supporting tool for decision-making in clinical practice. We expect it to be utilised in wider areas of medical fields and for future pharmacovigilance and pharmacoepidemiological studies.

  17. Overlap in Bibliographic Databases.

    ERIC Educational Resources Information Center

    Hood, William W.; Wilson, Concepcion S.

    2003-01-01

    Examines the topic of Fuzzy Set Theory to determine the overlap of coverage in bibliographic databases. Highlights include examples of comparisons of database coverage; frequency distribution of the degree of overlap; records with maximum overlap; records unique to one database; intra-database duplicates; and overlap in the top ten databases.…

  18. Current developments in French ethnopsychoanalysis.

    PubMed

    Sturm, Gesine; Nadig, Maya; Moro, Marie Rose

    2011-07-01

    French ethnopsychoanalytic approaches to therapy with immigrants combine the psychoanalytical interest in subjectivity with a specific concern for cultural factors and with the role migration plays as a crucial life event. Recent approaches consider culture as profoundly hybrid and use the notions of ''métissage'' and ''décentrage'' as central concepts. This article presents extracts from a qualitative study of ethnopsychoanalytic therapies with immigrant families. The authors argue that the ethnopsychoanalytic approach helps to open new ways of considering cultural hybridity and create a third space where experiences ''from the margins'' may be verbalized.

  19. JICST Factual Database JICST DNA Database

    NASA Astrophysics Data System (ADS)

    Shirokizawa, Yoshiko; Abe, Atsushi

    Japan Information Center of Science and Technology (JICST) has started the on-line service of DNA database in October 1988. This database is composed of EMBL Nucleotide Sequence Library and Genetic Sequence Data Bank. The authors outline the database system, data items and search commands. Examples of retrieval session are presented.

  20. Photocopy of photograph (from Mrs. Martin, grandniece of John French, ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    Photocopy of photograph (from Mrs. Martin, grandniece of John French, Clinton, Missouri) Circa 1900, photographer unknown JOHN AND ALMIRA FRENCH IN FRONT OF WEST AND SOUTH FACADES - John French Farm, South Grand River, Deepwater, Henry County, MO

  1. Dietary Supplement Ingredient Database

    MedlinePlus

    ... and US Department of Agriculture Dietary Supplement Ingredient Database Toggle navigation Menu Home About DSID Mission Current ... values can be saved to build a small database or add to an existing database for national, ...

  2. Aerodynamic characteristics of French consonants

    NASA Astrophysics Data System (ADS)

    Demolin, Didier; Hassid, Sergio; Soquet, Alain

    2004-05-01

    This paper reports some aerodynamic measurements made on French consonants with a group of ten speakers. Speakers were recorded while saying nonsense words in phrases such as papa, dis papa encore. The nonsense words in the study combined each of the French consonants with three vowels /i, a, u/ to from two syllables words with the first syllable being the same as the second. In addition to the audio signal, recordings were made of the oral airflow, the pressure of the air in the pharynx above the vocal folds and the pressure of the air in the trachea just below the vocal folds. The pharyngeal pressure was recorded via a catheter (i.d. 5 mm) passed through the nose so that its open end could be seen in the pharynx below the uvula. The subglottal pressure was recorded via a tracheal puncture between the first and the second rings of the trachea or between the cricoid cartilage and the first tracheal ring. Results compare subglottal presssure, pharyngeal pressure, and airflow values. Comparisons are made between values obtained with male and female subjects and various types of consonants (voiced versus voiceless at the same place of articulation, stops, fricatives, and nasals).

  3. HARMONIZING HEALTH TECHNOLOGY ASSESSMENT PRACTICES IN UNIVERSITY HOSPITALS: TO WHAT EXTENT IS THE MINI-HTA MODEL SUITABLE IN THE FRENCH CONTEXT?

    PubMed

    Martelli, Nicolas; Devaux, Capucine; van den Brink, Hélène; Billaux, Mathilde; Pineau, Judith; Prognon, Patrice; Borget, Isabelle

    2017-01-01

    The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis. The aim of this study was to assess a mini-HTA model as a potential solution to harmonize HTA methodology in French UHs. A systematic review was conducted on Medline, Embase, Health Technology Assessment database, and Google Scholar to identify published articles reporting the use of mini-HTA tools and decision support-like models. A survey was also carried out in eighteen French UHs to identify in-house decision support tools. Finally, topics evaluated in the Danish mini-HTA model and in French UHs were compared using Jaccard similarity coefficients. Our findings showed differences between topics evaluated in French UHs and those assessed in decision support models from the literature. Only five topics among the thirteen most evaluated in French UHs were similar to those assessed in the Danish mini-HTA model. The organizational and ethical/social impacts were rarely explored among the surveyed models used in French UHs when introducing new medical devices. Before its widespread and harmonized use in French UHs, the mini-HTA model would first require adaptations to the French context.

  4. Malignancies and ustekinumab: an analysis of the FDA Adverse Event Reporting System and the European Union Drug Regulating Authorities Pharmacovigilance database.

    PubMed

    Florek, A G; Nardone, B; Thareja, S; Tran, G; Giles, F J; West, D P

    2017-06-24

    Ustekinumab is a fully human monoclonal antibody that targets the common p40 subunit shared by interleukins (IL)-12 and IL-23, approved in the United States and in Europe on September 2009, for treatment of moderate to severe psoriasis and on September 2016 for moderately to severely active Crohn's disease(1) . Pre-marketing studies supported an acceptable risk-to-benefit profile(2-4) . This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  5. More French, s'il vous plait!

    ERIC Educational Resources Information Center

    McGillivray, W. Russ, Ed.

    The collection of essays on French second language instruction in Canada, directed to parents, includes: "Our Brave New World" (Andrew Kniewasser); "French in Your School: Identifying and Achieving the Right Program" (Carolyn Hodych, Jos Scott); "So, You're Worried About Becoming an Immersion Parent" (Judy Gibson);…

  6. Reading Speed of Contracted French Braille

    ERIC Educational Resources Information Center

    Laroche, Louise; Boule, Jacinthe; Wittich, Walter

    2012-01-01

    This study was designed to address three hypotheses: (1) The reading speed of both readers of French braille and readers of French print will be faster in the silent condition; however, this gain in speed will be larger for print readers; (2) Individuals who acquired braille before age 10 will display faster reading speeds at lower error rates…

  7. Reading Speed of Contracted French Braille

    ERIC Educational Resources Information Center

    Laroche, Louise; Boule, Jacinthe; Wittich, Walter

    2012-01-01

    This study was designed to address three hypotheses: (1) The reading speed of both readers of French braille and readers of French print will be faster in the silent condition; however, this gain in speed will be larger for print readers; (2) Individuals who acquired braille before age 10 will display faster reading speeds at lower error rates…

  8. Le Francais Courant (Contemporary French), Part II.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    This course has been developed basically within the limits of Units 4-6 of "A-LM French: Level 1", second edition. The primary objectives are to develop French vocabulary relative to the family, home, transportation, and foods by continuing to work with short dialogues based on everyday, teenage experiences. While reviewing previously studied…

  9. Why Learn French for Business in 2001?

    ERIC Educational Resources Information Center

    Maratier-Declety, Guilhene

    This essay makes the case for why it is worth learning French for business purposes, even though it is acknowledged that English is increasingly the lingua franca of international business, science, technology, and the Internet. It is asserted that French is still the dominant language in some important markets, and being able to conduct business…

  10. French Higher Education: A Cartoon Essay

    ERIC Educational Resources Information Center

    Hall, Matthew Henry

    2012-01-01

    In this cartoon essay, the author shares his experience from a travel to Paris to see the French higher education system. From his travel, he learned that in France, "degree" inflation may be an issue, but not grade inflation. On the flight home, the author reflects how French and American academics answer one question about the state of…

  11. Act Up-Paris: French Lessons

    ERIC Educational Resources Information Center

    Nakayama, Thomas K.

    2012-01-01

    The francophone world has always been at the center of the HIV/AIDS epidemic. From the mythical (French Canadian) "patient zero," Gaetan Dugas, to Rock Hudson's flight to Paris for medical treatment and the blaming of Haiti for AIDS, as well as the close relationships between Belgian and French and their former African colonies,…

  12. Metropolitan French: Familiarization & Short-Term Training.

    ERIC Educational Resources Information Center

    Iszkowski, Marie-Charlotte

    The U.S. Department of State's Foreign Service Institute French Familiarization and Short-Term (FAST) course for personnel working and living in France consists of 10 weeks of French language instruction combined with practical and cultural information. An introductory section outlines FAST course objectives and sample teaching techniques in…

  13. The French Regions and Their Social Health

    ERIC Educational Resources Information Center

    Jany-Catrice, Florence

    2009-01-01

    In this article, a new indicator designed to capture the multidimensionality of the social health of the French regions is put to the test. Drawing on regional data for 2004, this indicator of social health (ISH) sheds new light on the social performance of the French regions. The worst performers are the highly urbanised regions, whereas others,…

  14. Left Dislocation in Near-Native French

    ERIC Educational Resources Information Center

    Donaldson, Bryan

    2011-01-01

    The present study is concerned with the upper limits of SLA--specifically, mastery of the syntax-discourse interface in successful endstate learners of second-language (L2) French (near-native speakers). Left dislocation (LD) is a syntactic means of structuring spoken French discourse by marking topic. Its use requires speakers to coordinate…

  15. French Higher Education: A Cartoon Essay

    ERIC Educational Resources Information Center

    Hall, Matthew Henry

    2012-01-01

    In this cartoon essay, the author shares his experience from a travel to Paris to see the French higher education system. From his travel, he learned that in France, "degree" inflation may be an issue, but not grade inflation. On the flight home, the author reflects how French and American academics answer one question about the state of…

  16. Les affaires "en francais" (Business "In French").

    ERIC Educational Resources Information Center

    Sanko, Helene N.

    1993-01-01

    A French brochure entitled "700 Current Words for Business" was developed to familiarize the business community with modern French business vocabulary and avoid intrusion of terminology from other languages. Some terms are neologisms. Translations from Latin, Japanese, and English illustrate the etymology and morphological patterns of…

  17. Lafayette School District: French Immersion Program

    ERIC Educational Resources Information Center

    Boudreaux, Nicole

    2007-01-01

    From 1969 to the late 1980's, most French programs in schools were based on a traditional foreign language instructional model, usually offering 30 minutes a day of French language instruction in elementary grades, increasing to 50 minutes a day in middle school. Contingent on funding and political swings over time, programs expanded from…

  18. Learning French Pronunciation: Audiocassettes or Multimedia?

    ERIC Educational Resources Information Center

    Weinberg, Alysse; Knoerr, Helene

    2003-01-01

    Describes a two phase experiment that was conducted at the university of Ottawa using audiocassettes and multimedia while teaching French, specifically French phonetics, intonation, and pronunciation, to a group of low-intermediate level language students. Looks at whether receptive and productive skills are influenced by the explicit teaching of…

  19. The French Regions and Their Social Health

    ERIC Educational Resources Information Center

    Jany-Catrice, Florence

    2009-01-01

    In this article, a new indicator designed to capture the multidimensionality of the social health of the French regions is put to the test. Drawing on regional data for 2004, this indicator of social health (ISH) sheds new light on the social performance of the French regions. The worst performers are the highly urbanised regions, whereas others,…

  20. Vowel Aperture and Syllable Segmentation in French

    ERIC Educational Resources Information Center

    Goslin, Jeremy; Frauenfelder, Ulrich H.

    2008-01-01

    The theories of Pulgram (1970) suggest that if the vowel of a French syllable is open then it will induce syllable segmentation responses that result in the syllable being closed, and vice versa. After the empirical verification that our target French-speaking population was capable of distinguishing between mid-vowel aperture, we examined the…