Dataset Information

Introduction and geographic availability of new antibiotics approved between 1999 and 2014.

ABSTRACT: BACKGROUND:Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014. MATERIAL AND METHOD:We identified antibiotics, considered new chemical entities (NCEs) for systemic use approved globally between 1999 and 2014, from national medicine agencies' lists of approved drugs, and data from the WHO Collaborating Center for Drug Statistics. Geographic availability was mapped using sales data from IQVIA, and analyzed with regards to class, indication, safety, and origin. RESULTS:Of the 25 identified NCEs, only 12 had registered sales in more than 10 countries. NCEs with the widest geographic availability had registered sales in more than 70 countries within a ten-year timeframe and 30 countries within a three-year timeframe, spreading across five different geographic regions and three country income classes. Half (52%) of the NCEs had an indication for infections caused by antibiotic- resistant bacteria, little diversity was seen regarding target pathogen and indication. Antibiotics originated from and/or marketed by companies from the US or Europe had greater geographic availability compared to Japanese antibiotics, which seldom reached outside of Asia. For 20 NCEs developers chose to fully or partially sublicense marketing rights to a number of companies of different sizes. CONCLUSION:Our findings show great variation in geographic availability of antibiotics, indicating that availability in multiple regions and country income classes is possible, but rarely seen within a few years of market authorization. Sublicensing agreements between multiple companies was common practice. Moreover, differences were seen between countries regarding benefit/risk evaluations and company behavior. These findings could be a potential source of uncertainties, and create barriers to assure that working antibiotics are developed and made available according to public health needs.

SUBMITTER: Kallberg C

PROVIDER: S-EPMC6191083 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Introduction and geographic availability of new antibiotics approved between 1999 and 2014.

Kållberg Cecilia C Årdal Christine C Salvesen Blix Hege H Klein Eili E M Martinez Elena E Lindbæk Morten M Outterson Kevin K Røttingen John-Arne JA Laxminarayan Ramanan R

PloS one 20181016 10

<h4>Background</h4>Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014.<h4>Material and method</h4>We id ...[more]

PMID: 30325963

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Project description:IntroductionWe examined trends in seven mutually exclusive tobacco product use patterns (T-PUPs) in nationally representative samples of U.S. youth over time and age.MethodsWe used time varying effect modeling on National Youth Tobacco Surveys, 1999-2014 (N = 38662, 9-17 years, M = 15.02). Regression coefficients were estimated as a non-parametric function of time. T-PUPs were cigarette only, non-cigarette combustible only, noncombustible only, non-cigarette combustible and noncombustible dual, cigarette and noncombustible dual, cigarette and non-cigarette combustible dual, and POLY (i.e. cigarettes, non-cigarette combustibles, and noncombustibles) use.ResultsAmong youth tobacco users, cigarette only use was the predominant T-PUP from 1999 to 2010. After 2010 and 2013, non-cigarette combustible only (AOR 1.38, CI = 1.02-1.87) and noncombustible only (AOR 1.57, CI = 1.00-2.45) use became more prevalent than cigarette only use. In 2011, dual and POLY T-PUPs were on the rise although not significantly different from cigarette only use. Cigarette only use was the predominant T-PUP among 11- to 17-year-old tobacco users. Non-cigarette combustible only (AOR 0.14, CI = 0.10-0.19), noncombustible only (AOR 0.01, CI = 0.008-0.02), non-cigarette combustible and noncombustible (AOR 0.01, CI = 0.01-0.03), cigarette and noncombustible (AOR 0.02, CI = 0.01-0.04), cigarette and non-cigarette combustible (AOR 0.32, CI = 0.24-0.43), and POLY (AOR 0.02, CI = 0.01-0.04) use were less prevalent than cigarette only use at age 17.ConclusionsNon-cigarette, dual, and POLY T-PUPs are rising among youth tobacco users. Screening for all tobacco use and delivering treatment during pediatrician visits should be standard clinical practice.ImplicationsTracking trends in tobacco product use patterns (T-PUPs) over time and age is necessary to achieve Healthy People 2020 goal of reducing tobacco use among youth. Trends over time show a rise of non-cigarette T-PUPs especially noncombustible products but cigarette only use remains the most prevalent among 11- to 17-year-old tobacco users. The recent extension of FDA's regulatory jurisdiction over all tobacco products (e.g. e-cigarettes, hookah) is a step toward comprehensive tobacco control especially among youth. Public health practitioners should extend prevention and cessation efforts among youth to T-PUPs beyond exclusive cigarette smoking.

Dataset Information

Introduction and geographic availability of new antibiotics approved between 1999 and 2014.

Publications

Introduction and geographic availability of new antibiotics approved between 1999 and 2014.

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