Abarca J, Malone DC, Armstrong EP, Grizzle AJ, Hansten PD, Van Bergen RC, Lipton RB. 2004. Concordance of severity ratings provided in four drug interaction compendia. Journal of the American Pharmacists Association 44(2):136–141.
Abarca J, Malone DC, Skrepnek GH, Rehfeld RA, Murphy JE, Grizzle AJ, Armstrong EP, Woosley RL. 2006. Community pharmacy managers’ perception of computerized drug-drug interaction alerts. Journal of the American Pharmacists Association 46(2): 148–153.
Bates DW, Evans RS, Murff H, Stetson PD, Pizziferri L, Hripcsak G. 2003. Detecting adverse events using information technology. Journal of the American Medical Informatics Association 10(2):115–128.
Bennett CL, Nebeker JR, Lyons EA, Samore MH, Feldman MD, McKoy JM, Carson KR, Belknap SM, Trifilio SM, Schumock GT, Yarnold PR, Davidson CJ, Evens AM, Kuzel TM, Parada JP, Cournoyer D, West DP, Sartor O, Tallman MS, Raisch DW. 2005. The research on adverse drug events and reports (RADAR) project. Journal of the American Medical Association 293:2131–2140.
Brewer T, Colditz GA. 1999. Postmarketing surveillance and adverse drug reactions: Current perspectives and future needs. Journal of the American Medical Association 281(9):824–829.
CDC (Centers for Disease Control and Prevention). 2005. Assessing the National Electronic Injury Surveillance System—Cooperative Adverse Drug Event Surveillance Project—Six Sites, United States, January 1–June 15, 2004. [Online]. Available: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5415a2.htm [accessed March 6, 2006].
CDISC (Clinical Data Interchange Standards Consortium). 2006. Mission Statement. [Online]. Available: http://www.cdisc.org/about/index.html [accessed March 1, 2006].
Chui MA, Rupp MT. 2000. Evaluation of online prospective DUR programs in community pharmacy practice. Journal of Managed Care Pharmacy 6:27–32.
CMS (Centers for Medicare and Medicaid Services). 2005. Draft Guidance for the Public, Industry, and CMS Staff: Factors CMS Considers in Making a Determination of Coverage with Evidence Development. [Online]. Available: http://www.cms.hhs.gov/coverage/download/guidance.pdf [accessed April 3, 2005].
Durie BG, Katz M, Crowley J. 2005. Osteonecrosis of the jaw and bisphosphonates. New England Journal of Medicine 353:99–102.
Evaluation of Drug Interactions. 2001. St. Louis, MO: First DataBank, the Hearst Corporation.
FDA (Food and Drug Administration). 2003. Drug Interactions: What You Should Know. [Online]. Available: http://www.fda.gov/cder/consumerinfo/druginteractions.htm [accessed February 14, 2006].
FDA. 2005a. FDA unveils Rx safety board, website; postmarket surveillance overhaul next. Pink Sheet 67(8):4.
FDA. 2005b. Adverse Event Reporting System (AERS). [Online]. Available: http://www.fda.gov/cder/aers [accessed February 15, 2006].
FDA. 2005c. Postmarketing Reporting of Adverse Drug Experiences. [Online]. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80 [accessed March 3, 2006].
FDA. 2005d. MedWatch. [Online]. Available: http://www.fda.gov/medwatch/ [accessed March 4, 2006].
FDA. 2005e. Office of Drug Safety Annual Report FY 2004. [Online]. Available: http://www.fda.gov/cder/Offices/ODS/AnnRep2004/default.htm [accessed March 6, 2006].
FDA. 2006. FDA News: FDA Announces New Prescription Drug Information Format to Improve Patient Safety. [Online]. Available: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01272.html [accessed February 14, 2006].
FTC (Federal Trade Commission). 2001. Hearst Corp. to Disgorge $19 Million and Divest Business to Facts and Comparisons to Settle FTC Complaint. [Online]. Available: http://www.ftc.gov/opa/2001/12/hearst.htm [accessed February 14, 2006].
Gottlieb S. 2005. Opening Pandora’s pillbox: Using modern information tools to improve drug safety. Health Affairs 24(4):938–948.
Goulding MR. 2004. Inappropriate medication prescribing for elderly ambulatory care patients. Archives of Internal Medicine 164:305–312.
Graham DJ, Drinkard CR, Shatin D, Tsong Y, Burgess MJ. 2001. Liver enzyme monitoring in patients treated with troglitazone. Journal of the American Medical Association 286:831–833.
Greenhill LL, Vitiello B, Abikoff H, Levine J, March JS, Riddle MA, Capasso L, Cooper TB, Davies M, Fisher P, Findling RL, Fried J, Labellarte MJ, McCracken JT, McMahon D, Robinson J, Skrobala A, Scahill L, Varipatis E, Walkup JT, Zito JM. 2003. Developing methodologies for monitoring long-term safety of psychotropic medications in children: Report on the NIMH conference, September 25, 2000. Journal of the American Academy of Child and Adolescent Psychiatry 42(6):651–655.
Griffin MR, Stein CM, Graham DJ, Daugherty JR, Arbogast PG, Ray WA. 2004. High frequency of use of rofecoxib at greater than recommended doses: Cause for concern. Pharmacoepidemiology of Drug Safety 13:339–343.
Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, Bates DW. 2003. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. Journal of the American Medical Association 289:1107–1116.
Hansten PD, Horn JR. 2001. Drug Interactions: Analysis and Management. St. Louis, MO: Facts and Comparisons.
HHS (Department of Health and Human Services) Office of Human Research Protections 2005. Request for Public Comment on OHRP’s Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others .[Online]. Available: http://www.hhs.gov/ohrp/requests/com101105.html [accessed March 7, 2006].
Hillestad R, Bigelow J, Bower A, Girosi F, Meili R, Scoville R, Taylor R. 2005. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Affairs 24:1103–1117.
Howard RL, Avery AJ, Howard PD, Partridge M. 2003. Investigation into the reasons for preventable drug related admissions to a medical admissions unit: Observational study. Quality and Safety in Health Care 12:280–285.
Hunter D. 2006. First, gather the data. New England Journal of Medicine 354(4):329–333.
Kraft WK, Waldman SA. 2001. Manufacturer’s drug interaction and postmarketing adverse event data. Drug Safety 24(9):637–643.
Kush RD. 2001. The Cost of Clinical Data Interchange in Clinical Trials. [Online]. Available: http://www.cdisc.org/pdf/Cost_of_CDI_in_CT.pdf [accessed March 1, 2006].
Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. 2002. Timing of new black box warnings and withdrawals for prescription medications. Journal of the American Medical Association 287(17):2215–2220.
Liu GG, Christensen DB. 2002. The continuing challenge of inappropriate prescribing in the elderly: An update of the evidence. Journal of the American Pharmacy Association 42:847–857.
Longo DR, Hewett JE, Bin G, Schubert S. 2005. The long road to patient safety: A status report on patient safety systems. Journal of the American Medical Association 294(22):2858–2865.
Lowe J, Krulic A. 2005. William Cutler Pickering Hale and Dorr, LLP: Antitrust and Competition Law Update. [Online]. Available: http://www.wilmerhale.com/files/Publication/bb848305-cf38-4e19-a1d1-0d16c759aa5d/Presentation/PublicationAttachment/257b97d9591c-4361-afc5-107572647477/Antitrust%20Update%2012-02-05.pdf [accessed February 20, 2006].
Malenka DJ, Kaplan AV, Sharp SM, Wennberg JE. 2005. Postmarketing surveillance of medical devices using Medicare claims. Health Affairs 24(4):928–937.
Malone DC , Hutchins DS, Haupert H, Hansten P, Duncan B, Van Bergen RC, Solomon SLLipton RB. 2005. Assessment of potential drug-drug interactions with a prescription claims database. American Journal of Health System Pharmacy 62(19):1983–1991.
Mangini RJ. 2001. Drug Interaction Facts. St. Louis, MO: Facts and Comparisons.
May FW, Rowett DS, Gilbert AL, McNeece JI, Hurley E. 1999. Outcomes of an educationaloutreach service for community medical practitioners: Non-steroidal anti-inflammatory drugs. Medical Journal of Australia 170:471–474.
Medicines and Healthcare Products Regulatory Agency (MHRA). 2005. What Happens to a Yellow Card. [Online]. Available: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=623 [accessed March 6, 2006].
Mitchell AA. 2003. Systematic identification of drugs that cause birth defects—A new opportunity. New England Journal of Medicine 349(26):2556–2559.
Moore LL, Minne K, Moore KB. 2001. DRUG-REAX System. [Online]. Available: http://www.micromedex.com/products/drugreax/ [accessed February 21, 2006].
NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention). 2005. NCC MERP: The First Ten Years. Defining the Problem and Developing Solutions: Executive Summary. [Online]. Available: http://www.nccmerp.org/tenYearReportExecSummary.html [accessed February 15, 2006].
Okie S. 2005. Safety in numbers—Monitoring risk in approved drugs. New England Journal of Medicine 352(12):1173–1176.
Phase IV status report: Fewer open studies, but more overdue reports. 2005. Pink Sheet 67(9):17–19.
Platt R, Ommaya A. 2005. A beneficial side effect of the Medicare drug benefit. New England Journal of Medicine 353:2742–2743.
Psaty BM, Furberg CD. 2005. COX-2 inhibitors—Lessons in drug safety. New England Journal of Medicine 352:1133–1135.
Psaty BM, Furberg CD, Ray WA, Weiss NS. 2004. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: Use of cervastatin and risk of rhabdomyolysis. Journal of the American Medical Association 292(21):2622–2631.
Ray WA. 2003. Population-based studies of adverse drug effects. New England Journal of Medicine 349(17):1628–1635.
Ray WA. 2005. Observational studies of drugs and mortality. New England Journal of Medicine 353:2319–2321.
Ray WA, Griffin MR. 1993. Evaluating drugs after their approval for clinical use. New England Journal of Medicine 329(27):2029–2032.
Ray WA, Stein CM. 2006. Reform of drug regulation—Beyond an independent drug-safety board. New England Journal of Medicine 354(2):194–201.
Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M, Chan KA, Platt R, Schech SD, Ray WA. 2000. Contraindicated use of cisapride: Impact of Food and Drug Administration regulatory action. Journal of the American Medical Association 284:3036–3039.
Spina JR, Glassman PA, Belperio P, Cader R, Asch S. 2005. Clinical relevance of automated drug alerts from the perspective of medical providers. American Journal of Medical Quality 20(1):7–14.
Stagnitti MN. 2004. Trends in outpatient prescription drug utilization and expenditures, 1997–2000. AHRQ Statistical Brief. [Online]. Available: http://www.meps.ahrq.gov/papers/st21/stat21.htm [accessed April 4, 2006].
Strom BL. 2004. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: A counter point. Journal of the American Medical Association 292(21):2643–2646.
Supermarkets, Computer Hardware and Software, Online Search Engines, and Packaged Goods Top the List of Industries Doing a Good Job for Their Consumers. 2005. Harris Interactive. [Online]. Available: http://www.harrisinteractive.com/harris_poll/index.asp?PID=562 [accessed April 4, 2006].
Trontell A. 2004. Expecting the unexpected—Drug safety, pharmacovigilance, and the prepared mind. New England Journal of Medicine 351(14):1385–1387.
Winterstein AG, Sauer BC, Hepler CD, Poole C. 2002. Preventable drug-related hospital admissions. Annals of Pharmacotherapy 36:1238–1248.
Wood AJ. 1999. The safety of new medicines: The importance of asking the right questions. Journal of the American Medical Association 281(18):1753–1754.
Woosley RL. 2000. Drug labeling revisions—Guaranteed to fail? Journal of the American Medical Association 284(23):3047–3049.