REFERENCES
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- Budnitz DA, Pollock DA, Weidenback, KN, National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006;296:1858.
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- Gandhi TK, Weingart SN, Borus J, Adverse drug events in ambulatory care. New Engl J Med. 348;16:1556–1564.
- Gurwitz JH, Field TS, Avorn J, Incidence and preventability of adverse drug events in nursing homes Am J Med. 2000;109:87.
- Gurwitz JH, Field TS, Avorn J, The incidence of adverse drug events in two large academic long-term care facilities. Am J Med. 2005;118:253.
- Institute of Medicine of the National Academies. Preventing Medication Errors. Washington, DC: National Academies Press; 2007:120.
- Institute of Medicine of the National Academies. Preventing Medication Errors. Washington, DC: National Academies Press; 2007:124.
- Institute of Medicine of the National Academies. Preventing Medication Errors. Washington, DC: National Academies Press; 2007:4. The IOM defines ADE as any injury due to medication. Examples include a wrong dosage leading to injury (e.g., rash, confusion, or loss of function) or an allergic reaction occurring in a patient not known to be allergic to a given medication.
- Institute of Medicine of the National Academies. Preventing Medication Errors. Washington, DC: National Academies Press; 2007:132.
- Bailey JE, Campagna E, Dart RC. The underrecognized toll of prescription opioid abuse on young children. Ann Emerg Med. 2009;53:419–424.
- Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network, 2006: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2008. DAWN Series D -30, DHHS Publication No. (SMA) 08-4339.
- Substance Abuse and Mental Health Services Administration, Office of Applied Studies. The NSDUH Report: Trends in Nonmedical Use of Prescription Pain Relievers: 2002 to 2007. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2009:143.
- Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Drug Abuse Warning Network, 2006: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: Substance Abuse and Mental Health Services Administration.
- Budnitz DS. Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Anesthetic and Life Support Drugs Advisory Committee and Nonprescription Drugs Advisory Committee. June 29. Guest Speaker Budnitz, Slide 10. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm171562.htm.
- Substance Abuse and Mental Health Services Administration, Office of Applied Studies. Department of Health and Human Services. Drug Abuse Warning Network (DAWN), 2006: National Estimates of Drug-Related Emergency Department Visits. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2006:10–11.
- Institute of Medicine of the National Academies. Preventing Medication Errors, Washington, DC: National Academies Press; 2007:4.
- Off-label use involves using a medication for a condition that was not evaluated during clinical trials and for which use information has not been provided in product labels.
- Institute of Medicine of the National Academies. Preventing Medication Errors, Washington, DC: National Academies Press; 2007:37.
- Bates DW, Boyle DL, Vander Vliet MB, Relationship between medication errors and adverse drug events. J Gen Intern Med. 1995;10:100–205.
- Woolf SH, Kuzel AJ, Dovey SM, Phillips RL. A string of mistakes: the importance of cascade analysis in describing, counting, and preventing medical errors. Ann Fam Med. 2004;2:317–326. See also Larson EB, Necomer LN, Brennan RA, et al. First Do No Harm—To Err is Human. Eff Clin Pract. 2000 Nov–Dec; 3(6):294–304.
- A 2002 survey of Americans found that one-third of respondents took more than the recommended dose of an OTC product and 91% of these respondents did so because they thought it would improve the medication's efficacy. See Harris Interactive, Inc. Attitudes and Beliefs About the Use of Over-the-Counter Medicines: A Dose of Reality; 2002:27. Available at: http://www.bemedwise.org/survey/final_survey.pdf.
- Budnitz D. APAP Advisory Committee Meeting June 29, Guest Speakers, Slide #27. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm171562.htm.
- Kimberlin CL, Winterstein AG. Expert and Consumer Evaluation of Consumer Medication Information—2008. Final Report to the U.S. Department of Health and Human Services and the Food and Drug Administration, November 4, 2008. Availabe at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ReportsBudgets/ucm163777.htm.
- Davis TC, Wolf MS, Bass PF, Literacy and misunderstanding prescription drug labels, Ann Intern Med. 2006;145:887.
- Institute of Medicine of the National Academies. Preventing Medication Errors. Washington, DC: National Academies Press; 2007, see especially 74–88.
- Bronstein AC, et al. 2007 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 25th Annual Report. Alexandria, VA: American Association of Poison; 2007:938.
- Schillie SF, Shehab N, Thomas KE, Budnitz DS. Medication overdoses leading to emergency department visits among children. Am J Prevent Med. 2009;37:181.
- Schaefer, MK, Shehab, N, Cohen, AL, Budnitz, DS. Adverse events from cough and cold medications in children. Pediatrics. 2008;121:785.
- Schillie, SF, Shehab, N, Thomas, KE, Budnitz, DS. Medication overdoses leading to emergency department visits among children. Am J Prevent Med. 2009;37:181.
- National Hospital Ambulatory Medical Care Survey 2000–2006. Available at: http://www.cdc.gov/nchs/ahcd/ahcd_questionnaires.htm.
- See, for example, discussion of Risk Evaluation and Mitigation Strategies (REMS) in the section on FDA efforts to manage risk.
- FDA. Managing the Risks from Medical Product Use. Report to the FDA Commissioner from the Task Force on Risk Management. 1999. Available at: http://www.fda.gov/Safety/SafetyofSpecificProducts/ucm180325.htm.
- FDA had long considered the drug label to be its primary means to communicate with health practitioners, but the Internet has enabled FDA to provide safety communications that target all audiences. FDA posts a variety of safety information on its Web site including Public Health Advisories, Early Communications about ongoing safety reviews, Information for Healthcare Professionals (HCP), press releases, and media briefing, among others advertising and promotion; and postmarketing surveillance for unexpected side effects.
- See FDA's Web page at: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm.
- See discussion of the Food and Drug Administration Amendments (FDAAA) Act of 2007.
- Institute of Medicine of the National Academies. The Future of Drug Safety, Promoting and Protecting the Health of the Public. Washington, DC: National Academy of Sciences; 2007.
- See FDA's safety-related reports on the FDA Web page at: http://www.fda.gov/Safety/.
- Public Law 110-85, September 27, 2007. http://prsinfo.clinicaltrials.gov/fdaaa.html.
- FDA launched the Sentinel Initiative in 2008, in part, to address the requirements of Section 905 of FDAAA. http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.
- See Phillips DP, Christenfeld H, Glynn LM. Increase in US medication-error deaths between 1983 and 1993. Lancet. 1998;351:643–644.
- Institute of Medicine. Crossing the Quality Chasm, A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001:48–51.
- See Haynes AB, Weiser TG, Berry WR, A surgical safety checklist to reduce morbidity and mortality in a global population. New Engl J Med. 2009;360:493.
- Bates DW, Gawande AA. Improving safety with information technology. New Engl J Med. 2003;348:2526.
- Among many presenters, Dr. Theo Raynor, PhD, MRPharmS, University of Leeds, UK, described European practices regarding consumer medication information. Standardized patient leaflets that are user-tested are provided with all medications. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/ucm150189.htm.
- See International Academy of Cosmetic Dermatology. Fire in the Operating Room. Available at: http://www.iacdworld.org/legal/fire.htm ; and ECRI Institute, http://www.ecri.org/Products/Pages/Surgical_Fires.aspx.