Dataset Information

The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study.

ABSTRACT: OBJECTIVES:The aim was to provide figures for drug shortages in France and describe their characteristics, causes and trends between 2012 and 2018. METHODS:Data from the national reporting system from the Agency of Medicine and Health Product Safety (ANSM) was analysed. This database contains information regarding effective and predicted shortages of major therapeutic of interest drugs (ie, drugs whose shortage would be life-threatening or representing a loss of treatment opportunity for patients with a severe disease) which are mandatory reported by marketing authorisation holders to the ANSM. Data are presented as numbers or percentages of pharmaceutical products (ie, the product name and its formulation) reported on shortage between 2012 and 2018. RESULTS:There were 3530 pharmaceutical products reported on shortage during the period, including 1833 different active substances. Drugs on shortage were mostly old products (63.4%) with national marketing authorisation procedures (62.8%), as well as injectable and oral forms (47.5% and 43.3%, respectively). Anti-infectives for systemic use ranked first (18%), followed by nervous and cardiovascular system drugs and by antineoplastic and immunomodulating agents (17.4%, 12.5% and 10.4%, respectively). The number of reported shortages presented a fourfold increase between 2012 and 2018 and a sharp rise in 2017 and 2018, along with a rise in the number of active substances on shortage. The therapeutic classes concerned remained similar over time. Manufacturing and material supply issues were the main reported reasons for the shortage each year (30%) and there was an overall rise of pharmaceutical market reasons. CONCLUSION:Drug shortages were increasingly reported in France. Preventive measures should specifically target the products most on shortage, in particular old drugs, injectable, anti-infective, nervous system and cardiovascular system drugs as well as antineoplastic and immunomodulating agents.

SUBMITTER: Benhabib A

PROVIDER: S-EPMC7059530 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study.

Benhabib Amine A Ioughlissen Saïd S Ratignier-Carbonneil Christelle C Maison Patrick P

BMJ open 20200304 3

<h4>Objectives</h4>The aim was to provide figures for drug shortages in France and describe their characteristics, causes and trends between 2012 and 2018.<h4>Methods</h4>Data from the national reporting system from the Agency of Medicine and Health Product Safety (ANSM) was analysed. This database contains information regarding effective and predicted shortages of major therapeutic of interest drugs (ie, drugs whose shortage would be life-threatening or representing a loss of treatment opportun ...[more]

PMID: 32139487

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Project description:BackgroundEarly identification is critical for mitigating the impact of medicine shortages on patients. The internet, specifically social media, is an emerging source of health data.ObjectiveThis study aimed to explore whether a routine analysis of data from the Twitter social network can detect signals of a medicine shortage and serve as an early warning system and, if so, for which medicines or patient groups.MethodsMedicine shortages between January 31 and December 1, 2019, were collected from the Dutch pharmacists' society's national catalog Royal Dutch Pharmacists Association (KNMP) Farmanco. Posts on these shortages were collected by searching for the name, the active pharmaceutical ingredient, or the first word of the brand name of the medicines in shortage. Posts were then selected based on relevant keywords that potentially indicated a shortage and the percentage of shortages with at least 1 post was calculated. The first posts per shortage were analyzed for their timing (median number of days, including the IQR) versus the national catalog, also stratified by disease and medicine characteristics. The content of the first post per shortage was analyzed descriptively for its reporting stakeholder and the nature of the post.ResultsOf the 341 medicine shortages, 102 (29.9%) were mentioned on Twitter. Of these 102 shortages, 18 (5.3% of the total) were mentioned prior to or simultaneous to publication by KNMP Farmanco. Only 4 (1.2%) of these were mentioned on Twitter more than 14 days before. On average, posts were published with a median delay of 37 (IQR 7-81) days to publication by KNMP Farmanco. Shortages mentioned on Twitter affected a greater number of patients and lasted longer than those that were not mentioned. We could not conclusively relate either the presence or absence on Twitter to a disease area or route of administration of the medicine in shortage. The first posts on the 102 shortages were mainly published by patients (n=51, 50.0%) and health care professionals (n=46, 45.1%). We identified 8 categories of nature of content. Sharing personal experience (n=44, 43.1%) was the most common category.ConclusionsThe Twitter social network is not a suitable early warning system for medicine shortages. Twitter primarily echoes already-known information rather than spreads new information. However, Twitter or potentially any other social media platform provides the opportunity for future qualitative research in the increasingly important field of medicine shortages that investigates how a larger population of patients is affected by shortages.

Project description:BackgroundThyroid function can be influenced by external stimuli such as light and temperature. However, it is currently unknown whether there is seasonal variation of thyroid function in women of reproductive age. Adequate thyroid function in reproductive-aged women is necessary for optimal fetal-maternal outcomes. Therefore, this study aims to evaluate the seasonal changes in levels of thyrotropin (TSH), free triiodothyronine (FT3), free thyroxine (FT4), and TSH index (TSHI) in women of reproductive age.MethodsA large retrospective study was conducted that included women aged 20-49 years who visited our outpatient or checkup center between 2012 and 2018. Thyroid function was measured using the automated immunochemiluminescent assay kit. Subjects with overt thyroid dysfunction, pregnancy, thyroid disease, cancer, and severe infectious or psychological disease were excluded. Seasonal differences of thyroid function were analyzed using the Kruskal-Wallis test or the analysis of means with transformed ranks. Spearman's correlation was performed to evaluate the association between thyroid function parameters and age. A subset of 181 subjects was included in the longitudinal analyses. Differences in thyroid function between summer and winter were analyzed using the Wilcoxon signed-rank test.ResultsA total of 48,990 women with a median age of 39 years were included. The prevalence of subclinical hypothyroidism was lower in summer but higher in winter (5.6% vs. 7.0%, p < 0.05). The TSH, FT3, and FT4 levels and TSHI reached a peak in winter, while they declined to trough in summer. The TSH concentrations (r = 0.044, p < 0.001) and TSHI (r = 0.025, p < 0.001) were positively correlated with age, whereas FT3 (r = -0.073, p < 0.001) and FT4 (r = -0.059, p < 0.001) were negatively correlated with age. The associations of thyroid parameters with age were similar between subjects with positive thyroid peroxidase antibody (TPOAb) and those with negative TPOAb. In the matched longitudinal analysis of 181 subjects, no differences were detected in the thyroid parameters between summer and winter.ConclusionsThis retrospective single-center study showed that thyroid hormone levels and central sensitivity to thyroid hormones are influenced by age and seasonal fluctuations among women of reproductive age, while their impact on reproductive health remains to be elucidated in future studies.

Project description:BACKGROUND:Pneumonia has a high human toll and a substantial economic burden in developed countries like Japan, where the crude mortality rate was 77.7 per 100,000 people in 2017. As this trend is going to continue with increasing number of the elderly multi-morbid population in Japan; monitoring performance over time is a social need to alleviate the disease burden. The study objective was to determine the characteristics of hospital standardized mortality ratios (HSMRs) for pneumonia in Japan from 2010 to 2018 to describe this trend. METHODS:Data of the DPC (Diagnostic Procedures Combination) database were used, which is an administrative claims and discharge summary database for acute care in-patients in Japan. HSMRs were calculated using the actual and expected numbers of in-hospital deaths, the latter of which was calculated using logistic regression model, with a number of explanatory variables, e.g., age, sex, urgency of admission, mode of transportation, patient volume per month in each hospital, A-DROP score, and Charlson comorbidity index (CCI). We constructed two HSMR models: a single-year model, which included hospitals with > 10 in-patients per month and, a 9-year model, which included those hospitals with complete 9-year data. Predictive accuracy of the logistic models was assessed using c-index (area under receiver operating curve). RESULTS:Total 230,372 patients were included for the analysis over the 9-year study period. Calculated HSMRs showed wide variation among hospitals. The proportion of hospitals with HSMR less than 100 increased from 36.4% in 2010 to 60.6% in 2018. Both models showed good predictive ability with a c-statistic of 0.762 for the 9-year model, and no less than 0.717 for the single-year model. CONCLUSION:This study denoted that HSMRs of pneumonia can be calculated using DPC data in Japan and revealed significant variations among hospitals with comparable case-mixes. Therefore, HSMR can be used as yet another measure to help improve quality of care over time if other indicators are examined in parallel and to get a clear picture of where hospitals excel and lack.

Dataset Information

The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study.

Publications

The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study.

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