Literature DB >> 21690598

Enhancing prescription drug innovation and adoption.

G Caleb Alexander1, Alec B O'Connor, Randall S Stafford.   

Abstract

The adoption and use of a new drug would ideally be guided by its innovation and cost-effectiveness. However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a marketplace in which most new drugs are little better than their older counterparts. Five proposed mechanisms are considered for promoting innovation and reducing the use of therapies ultimately found to offer poor value or have unacceptable risks. These changes range from increasing the evidence required for U.S. Food and Drug Administration approval to modifying the structure of drug reimbursement. Despite the challenges of policy implementation, the United States has a long history of successfully improving the societal value and safe use of prescription medicines.

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Year:  2011        PMID: 21690598      PMCID: PMC4049188          DOI: 10.7326/0003-4819-154-12-201106210-00012

Source DB:  PubMed          Journal:  Ann Intern Med        ISSN: 0003-4819            Impact factor:   25.391


  28 in total

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Authors:  B M Psaty; N S Weiss; C D Furberg; T D Koepsell; D S Siscovick; F R Rosendaal; N L Smith; S R Heckbert; R C Kaplan; D Lin; T R Fleming; E H Wagner
Journal:  JAMA       Date:  1999-08-25       Impact factor: 56.272

2.  A look back at 2000: overabundance and deregulation.

Authors: 
Journal:  Prescrire Int       Date:  2001-04

3.  How Medicare could use comparative effectiveness research in deciding on new coverage and reimbursement.

Authors:  Steven D Pearson; Peter B Bach
Journal:  Health Aff (Millwood)       Date:  2010-10       Impact factor: 6.301

4.  A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

Authors:  John Abraham; Courtney Davis
Journal:  Soc Sci Med       Date:  2005-03-02       Impact factor: 4.634

5.  Do higher drug costs lead to better health?

Authors:  Barbara Mintzes; Joel Lexchin
Journal:  Can J Clin Pharmacol       Date:  2005-01-07

Review 6.  Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.

Authors:  Ernst R Berndt; Adrian H B Gottschalk; Tomas J Philipson; Matthew W Strobeck
Journal:  Nat Rev Drug Discov       Date:  2005-07       Impact factor: 84.694

Review 7.  Surrogate end points in clinical trials: are we being misled?

Authors:  T R Fleming; D L DeMets
Journal:  Ann Intern Med       Date:  1996-10-01       Impact factor: 25.391

8.  Surrogate endpoints in clinical trials: cardiovascular diseases.

Authors:  J Wittes; E Lakatos; J Probstfield
Journal:  Stat Med       Date:  1989-04       Impact factor: 2.373

9.  Some factors to consider when using the results of economic evaluation studies at the population level.

Authors:  R M Leidl
Journal:  Int J Technol Assess Health Care       Date:  1994       Impact factor: 2.188

10.  Back to thiazide-diuretics for hypertension: reflections after a decade of irrational prescribing.

Authors:  Atle Fretheim
Journal:  BMC Fam Pract       Date:  2003-12-23       Impact factor: 2.497

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  9 in total

1.  Patterns and predictors of physician adoption of new cardiovascular drugs.

Authors:  Timothy S Anderson; Wei-Hsuan Lo-Ciganic; Walid F Gellad; Rouxin Zhang; Haiden A Huskamp; Niteesh K Choudhry; Chung-Chou H Chang; Seth Richards-Shubik; Hasan Guclu; Bobby Jones; Julie M Donohue
Journal:  Healthc (Amst)       Date:  2017-10-21

2.  Is treatment heterogeneity an Achilles' heel for comparative effectiveness research?

Authors:  G Caleb Alexander; Bruce L Lambert
Journal:  Pharmacotherapy       Date:  2012-07       Impact factor: 4.705

3.  Regional variation in use of a new class of antidiabetic medication among medicare beneficiaries: the case of incretin mimetics.

Authors:  Zachary A Marcum; Julia Driessen; Carolyn T Thorpe; Julie M Donohue; Walid F Gellad
Journal:  Ann Pharmacother       Date:  2014-12-16       Impact factor: 3.154

4.  Academic centers play a vital role in the study of drug safety and effectiveness.

Authors:  Jingwen Tan; G Caleb Alexander; Jodi B Segal
Journal:  Clin Ther       Date:  2013-03-22       Impact factor: 3.393

5.  National trends in oral anticoagulant use in the United States, 2007 to 2011.

Authors:  Kate Kirley; Dima M Qato; Rachel Kornfield; Randall S Stafford; G Caleb Alexander
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2012-09-04

6.  Adverse Events Associated With Radium-223 in Metastatic Prostate Cancer: Disproportionality Analysis of FDA Data Reflecting Worldwide Utilization.

Authors:  Minh-Phuong Huynh-Le; Randall C Shults; Michael J Connor; Jona A Hattangadi-Gluth
Journal:  Clin Genitourin Cancer       Date:  2019-12-05       Impact factor: 2.872

7.  Adoption of new drugs by physicians: a survival analysis.

Authors:  Francisco Javier Garjón; Ana Azparren; Iván Vergara; Borja Azaola; Jose Ramón Loayssa
Journal:  BMC Health Serv Res       Date:  2012-03-08       Impact factor: 2.655

8.  Modeling chemical interaction profiles: II. Molecular docking, spectral data-activity relationship, and structure-activity relationship models for potent and weak inhibitors of cytochrome P450 CYP3A4 isozyme.

Authors:  Yunfeng Tie; Brooks McPhail; Huixiao Hong; Bruce A Pearce; Laura K Schnackenberg; Weigong Ge; Dan A Buzatu; Jon G Wilkes; James C Fuscoe; Weida Tong; Bruce A Fowler; Richard D Beger; Eugene Demchuk
Journal:  Molecules       Date:  2012-03-15       Impact factor: 4.411

9.  Designing concept maps for a precise and objective description of pharmaceutical innovations.

Authors:  Maia Iordatii; Alain Venot; Catherine Duclos
Journal:  BMC Med Inform Decis Mak       Date:  2013-01-18       Impact factor: 2.796

  9 in total

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