Bibliography
- Lazarou J, Pomeranz B, Corey P. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-5
- Kohn L, Corrigan J, Donaldson M. To err is human: building a safer health system. National Academy Press, Washington DC; 2000
- Davies E, Green C, Taylor S, Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One 2009;4(2):e4439
- Thomsen LA, Winterstein AG, Sondergaard B, Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Ann Pharmacother 2007;41(9):1411-26
- Karch AM. The gray areas of black box warnings. Am J Nurs 2006;106(6):77-8
- US Food and Drug Administration. Specific requirements on content and format of labeling for human prescription drug and biological products described in Sec. 21CFR20157: US government printing office via GPO access, 2010
- Cook D, Gurugubelli R, Bero L. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings. Drug Saf 2009;32(11):1057-66
- Lasser KE, Allen PD, Woolhandler SJ, Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287(17):2215-20
- US Food and Drug Administration. Adverse event reporting system. 2009. Available from: http://www.fda.gov/ Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm [Cited 03/October/2011]
- US Food and Drug Administration. AERS reporting by healthcare providers and consumers by year. 2011. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatory Information/Surveillance/AdverseDrugEffects/ucm070456.htm [Cited 02/January/2013]
- O'Connor N. FDA boxed warnings: how to prescribe drugs safely. Am Fam Physician 2010;81(3):298-303
- Katz LYMD, Kozyrskyj ALP, Prior HJM, Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults. CMAJ 2008;178(8):1005-11
- Kurian BT, Ray WA, Arbogast PG, Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Arch Pediatr Adolesc Med 2007;161(7):690-6
- Nagar S, Mehta S, Bhatara V, Aparasu R. Health care consequences of black-box warnings for antidepressants in the United States and Canada. Res Social Adm Pharm 2010;6(1):78-84
- Dorsey E, Rabbani A, Gallagher SA, Impact of FDA black box advisory on antipsychotic medication use. Arch Intern Med 2010;170(1):96
- Olfson M, Marcus SC, Druss BG. Effects of food and drug administration warnings on antidepressant use in a national sample. Arch Gen Psychiatry 2008;65(1):94-101
- Dusetzina SB, Higashi AS, Dorsey E, Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care 2012;50(6):466
- Becker N. Epidemiology of multiple myeloma. Multiple Myeloma 2011;183:25-35
- Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011. CA Cancer J Clin 2011;61(4):212-36
- Poulos AR, Gertz MA, Pankratz VS, Post-White J. Pain, mood disturbance, and quality of life in patients with multiple myeloma. Oncol Nurs Forum 2001;28(7):1163-71
- Campbell DT, Stanley JC, Gage NL. Experimental and quasi-experimental designs for research. Houghton Mifflin, Boston; 1963
- National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology; multiple myeloma; 2012
- US Food and Drug Administration. FDA approved drug products. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu [Cited 03/October/2011]
- PDR Network. Physicians Desk Reference. 20th to 63rd edition. Medical Economics Co, Montvale, NJ; 1966-2009
- US Food and Drug Administration. What is a serious adverse event? 2012. Available from: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm [Cited 2012 11/May/2012
- David MF, June SA, William D. Empirical Bayesian data mining for discovering patterns in post-marketing drug safety. Proceedings of the ninth ACM SIGKDD international conference on Knowledge discovery and data mining ACM; Washington, DC; 2003
- Robinson S, Pool R, Giffin RB. Emerging safety science: workshop summary. The National Academies, White Oak, MD; 2008
- Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001;10(6):483-6
- Ricci J, Coulen C, Berger J, Prescriber compliance with black box warnings in older adult patients. Am J Manag Care 2009;15(11):e103-e08
- Horlen C, Malone R, Bryant B, Frequency of inappropriate metformin prescriptions. JAMA 2002;287(19):2504-5
- Lasser KE, Seger DL, Yu DT, Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med 2006;166(3):338-44
- Marcus SC, Olfson M, Pincus HA, Therapeutic drug monitoring of mood stabilizers in medicaid patients with bipolar disorder. Am J Psychiatry 1999;156(7):1014-18
- Nebeker J, Barach P, Samore MH. Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting. Ann Intern Med 2004;140(10):795-801
- Olson M. Managing delegation in the FDA: reducing delay in the new-drug review. J Health Polit Policy Law 2004;29(3):397-430
- Center NVI. Investigative report on the vaccine adverse event reporting system. 512 Maple Ave. W. # 206. National Vaccine Information Center, Vienna, VA
- US Food and Drug Administration. Prescribing information: Melphalan. In: editor. Services UDoHaH. Silver Spring, MD; 2011. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf
- Platt R, Carnahan RM, Brown JS, The US food and drug administration's mini-sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012;21:1-8
- Platt R, Wilson M, Chan KA, The new sentinel network–improving the evidence of medical-product safety. N Engl J Med 2009;361(7):645-7
- Behrman RE, Benner JS, Brown JS, Developing the sentinel system–a national resource for evidence development. N Engl J Med 2011;364(6):498-9
- US Food and Drug Administration. FDA Adverse Event Reporting System (FAERS). 2012. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatory Information/Surveillance/AdverseDrugEffects/default.htm [Cited 2012 02/February/2013]