Erratum: Economic and technological drivers of generic sterile injectable drug shortages (Clinical Pharmacology and Therapeutics (2013) 93 (103-111) DOI: 10.1038/clpt.2012.220);Economic and technological drivers of generic sterile injectable drug shortages

Clinical Pharmacology and Therapeutics

Volumn 93, Issue 2, 2013, Pages 170-176

  Woodcock, J ^a   Wosinska, M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLEOMYCIN; CYTARABINE; GENERIC DRUG;

ARTICLE; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SHORTAGE; ECONOMIC EVALUATION; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HEALTH CARE COST; HEALTH CARE MANAGEMENT; HEALTH CARE PERSONNEL; HEALTH CARE SYSTEM; INJECTION; INVESTMENT; MICROBIAL CONTAMINATION; PRIORITY JOURNAL; PROCESS CONTROL; TABLET; TOTAL QUALITY MANAGEMENT;

EID: 84872682197     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.51     Document Type: Erratum

References (16)

1. Jensen, V. & Rappaport, B.A. The reality of drug shortages-the case of the injectable agent propofol. N. Engl. J. Med. 363, 806-807 (2010).
2. FDA letter to Hon. Elijah Cummings, Committee on Oversight and Government Reform, 23 July 2012, http://democrats.oversight.house.gov/images/stories/2012- 5778.Cummings.drug%20shortages.response.fnal.pdf.
3. US Department of Health and Human Services. 2011 ASPE Issue Brief: Economic Analysis of the Causes of Drug Shortages http://aspe.hhs.gov/sp/ reports/2011/DrugShortages/ib.shtml.
4. Friedman, R. Aseptic processing contamination case studies and the pharmaceutical quality system. PDA J. Pharm. Sci. Technol. Vol. 59, No. 2, March-April 2005.
5. Bureau of Labor Statistics. Current Employment Survey, http://www.bls.gov/ces, extracted July 2012.
6. Indystar.com. Eli Lilly will shed 170 jobs in manufacturing, quality control http://www.indystar.com/article/20100713/BUSINESS03/7130359/Eli-Lilly- will-shed-170-jobs-manufacturing-quality-control.
7. Thomas, P. Derek Lowe: where are pharma's jobs going?: insights on the 2012 job market from an industry insider http://www.pharmamanufacturing. com/articles/2012/036.html.
8. Thomas, K. (2012). Lapses at big drug factories add to shortages and danger. New York Times, 17 October 2012.
9. Yurukoglu, A. (2012). Medicare reimbursements and shortages of sterile injectable pharmaceuticals. National Bureau of Economic Research Working Paper No. 17987.
10. Conti, R.M. (2011). An economic assessment of the causes and policy implications of current specialty drug shortages. Testimony in front of the Senate Finance Committee, "Drug Shortages: What Causes Them and What Can We Do About Them?" 7 December 2011.
11. Jacobson, M., Alpert, A. & Duarte F. Prescription Drug Shortages: Reconsidering the Role of Medicare Payment Policies. Health Afairs blog May 2012. http://healthafairs.org/blog/2012/05/29/prescription-drug-shortages- reconsidering-the-role-of-medicare-payment-policies/.
12. US Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice. http://www.fda.gov/downloads/Drugs/./Guidances/ucm070342.pdf.
13. Allen L.V., Jr, Popovich, N.G. & Ansel, H.C. Section VII: sterile dosage forms and delivery systems. In: Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems 9th edn. (Lippincott, Williams & Wilkins, Baltimore, MD, 2010).
14. Fox, E. (2011). Drug shortage update current status & signifcant trends. University of Utah Drug Information Service http://www.fda.gov/ downloads/Drugs/NewsEvents/UCM274565.pdf.
15. US Food and Drug Administration. A Review of FDA's Approach to Medical Product Shortages, October 2011 http://www.fda.gov/downloads/AboutFDA/ ReportsManualsForms/Reports/UCM277755.pdf.
16. Kweder & Dill. Clin. Pharmacol. Ther. (2013) (in press).