Literature DB >> 23488502

How the US Food and Drug Administration can solve the prescription drug shortage problem.

Stuart O Schweitzer1.   

Abstract

Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections' focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed-the most frequent cause of drug shortages.

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Year:  2013        PMID: 23488502      PMCID: PMC3698821          DOI: 10.2105/AJPH.2013.301239

Source DB:  PubMed          Journal:  Am J Public Health        ISSN: 0090-0036            Impact factor:   9.308


  7 in total

1.  The shortage of essential chemotherapy drugs in the United States.

Authors:  Mandy L Gatesman; Thomas J Smith
Journal:  N Engl J Med       Date:  2011-10-31       Impact factor: 91.245

2.  Drug shortages--a critical challenge for the generic-drug market.

Authors:  Bruce A Chabner
Journal:  N Engl J Med       Date:  2011-10-31       Impact factor: 91.245

3.  Deepening drug shortages.

Authors:  Duff Wilson
Journal:  Health Aff (Millwood)       Date:  2012-02       Impact factor: 6.301

4.  Evergreening, patent challenges, and effective market life in pharmaceuticals.

Authors:  C Scott Hemphill; Bhaven N Sampat
Journal:  J Health Econ       Date:  2012-02-09       Impact factor: 3.883

5.  The reality of drug shortages--the case of the injectable agent propofol.

Authors:  Valerie Jensen; Bob A Rappaport
Journal:  N Engl J Med       Date:  2010-06-16       Impact factor: 91.245

6.  Trying times at the FDA--the challenge of ensuring the safety of imported pharmaceuticals.

Authors:  Stuart O Schweitzer
Journal:  N Engl J Med       Date:  2008-04-24       Impact factor: 91.245

7.  Reacting to rankings: evidence from "America's Best Hospitals".

Authors:  Devin G Pope
Journal:  J Health Econ       Date:  2009-09-02       Impact factor: 3.883

  7 in total
  14 in total

1.  Association Between the Number of Suppliers for Critical Antineoplastics and Drug Shortages: Implications for Future Drug Shortages and Treatment.

Authors:  Helen M Parsons; Susanne Schmidt; Anand B Karnad; Yuanyuan Liang; Mary Jo Pugh; Erin R Fox
Journal:  J Oncol Pract       Date:  2016-02-02       Impact factor: 3.840

Review 2.  Why drug shortages are an ethical issue.

Authors:  Wendy Lipworth; Ian Kerridge
Journal:  Australas Med J       Date:  2013-11-30

3.  Drugs, money, and power: the Canadian drug shortage.

Authors:  Chris Kaposy
Journal:  J Bioeth Inq       Date:  2013-12-20       Impact factor: 1.352

4.  [Not Available].

Authors:  Isabelle Barthélémy; Jean-François Bussières
Journal:  Can J Hosp Pharm       Date:  2013-07

5.  Medicine shortages: Implications for the Australian healthcare system.

Authors:  Betty B Chaar
Journal:  Australas Med J       Date:  2014-03-31

6.  Impact of Drug Shortages on Health System Pharmacies in the Southeastern United States.

Authors:  Celeste R Caulder; Brenna Mehta; P Brandon Bookstaver; LaVetra D Sims; Bill Stevenson
Journal:  Hosp Pharm       Date:  2015-04-08

7.  Current Situation, Determinants, and Solutions to Drug Shortages in Shaanxi Province, China: A Qualitative Study.

Authors:  Caijun Yang; Lina Wu; Wenfang Cai; Wenwen Zhu; Qian Shen; Zongjie Li; Yu Fang
Journal:  PLoS One       Date:  2016-10-25       Impact factor: 3.240

Review 8.  Drug tendering: drug supply and shortage implications for the uptake of biosimilars.

Authors:  George Dranitsaris; Ira Jacobs; Carol Kirchhoff; Robert Popovian; Lesley G Shane
Journal:  Clinicoecon Outcomes Res       Date:  2017-09-29

9.  Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries.

Authors:  Tomasz Bochenek; Vafa Abilova; Ali Alkan; Bogdan Asanin; Iñigo de Miguel Beriain; Zeljka Besovic; Patricia Vella Bonanno; Anna Bucsics; Michal Davidescu; Elfi De Weerdt; Natasa Duborija-Kovacevic; Jurij Fürst; Mina Gaga; Elma Gailīte; Jolanta Gulbinovič; Emre U Gürpınar; Balázs Hankó; Vincent Hargaden; Tor A Hotvedt; Iris Hoxha; Isabelle Huys; Andras Inotai; Arianit Jakupi; Helena Jenzer; Roberta Joppi; Ott Laius; Marie-Camille Lenormand; Despina Makridaki; Admir Malaj; Kertu Margus; Vanda Marković-Peković; Nenad Miljković; João L de Miranda; Stanislav Primožič; Dragana Rajinac; David G Schwartz; Robin Šebesta; Steven Simoens; Juraj Slaby; Ljiljana Sović-Brkičić; Tomas Tesar; Leonidas Tzimis; Ewa Warmińska; Brian Godman
Journal:  Front Pharmacol       Date:  2018-01-18       Impact factor: 5.810

Review 10.  Drug Shortage: Causes, Impact, and Mitigation Strategies.

Authors:  Sundus Shukar; Fatima Zahoor; Khezar Hayat; Amna Saeed; Ali Hassan Gillani; Sumaira Omer; Shuchen Hu; Zaheer-Ud-Din Babar; Yu Fang; Caijun Yang
Journal:  Front Pharmacol       Date:  2021-07-09       Impact factor: 5.810

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