drug labeling

Summary

Summary: Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.

Top Publications

  1. ncbi FDA-approved drug labeling for the study of drug-induced liver injury
    Minjun Chen
    Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    Drug Discov Today 16:697-703. 2011
  2. ncbi Literacy and misunderstanding prescription drug labels
    Terry C Davis
    Department of Medicine Pediatrics, Louisiana State University Health Science Center, Shreveport, Louisiana 71104, USA
    Ann Intern Med 145:887-94. 2006
  3. pmc Mining FDA drug labels using an unsupervised learning technique--topic modeling
    Halil Bisgin
    Department of Information Science, University of Arkansas at Little Rock, 2801 S, University Ave, Little Rock, AR 72204 1099, USA
    BMC Bioinformatics 12:S11. 2011
  4. pmc Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use
    Michael S Wolf
    Health Literacy and Learning Program, Feinberg School of Medicine at Northwestern University, Chicago, IL 60611, USA
    Med Care 49:96-100. 2011
  5. ncbi Timing of new black box warnings and withdrawals for prescription medications
    Karen E Lasser
    Department of Medicine, Cambridge Hospital, Cambridge, MA 02139, USA
    JAMA 287:2215-20. 2002
  6. pmc Improving patient understanding of prescription drug label instructions
    Terry C Davis
    Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, LA, USA
    J Gen Intern Med 24:57-62. 2009
  7. ncbi Black box warning for topical calcineurin inhibitors and the death of common sense
    Alan B Fleischer
    Department of Dermatology, Wake Forest University School of Medicine, Winston Salem, NC, USA
    Dermatol Online J 12:2. 2006
  8. pmc A safety assessment of topical calcineurin inhibitors in the treatment of atopic dermatitis
    Mark Lebwohl
    Department of Dermatology, The Mount Sinai School of Medicine, New York, NY, USA
    MedGenMed 8:8. 2006
  9. ncbi A review of patient-reported outcome labels in the United States: 2006 to 2010
    Ari Gnanasakthy
    Novartis Pharmaceuticals Corporation, East Hannover, NJ 07936, USA
    Value Health 15:437-42. 2012
  10. pmc Predictors of medication self-management skill in a low-literacy population
    Sunil Kripalani
    Division of General Medicine, Emory University School of Medicine, Atlanta, GA 30303, USA
    J Gen Intern Med 21:852-6. 2006

Detail Information

Publications215 found, 100 shown here

  1. ncbi FDA-approved drug labeling for the study of drug-induced liver injury
    Minjun Chen
    Division of Systems Biology, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
    Drug Discov Today 16:697-703. 2011
    ..We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide ..
  2. ncbi Literacy and misunderstanding prescription drug labels
    Terry C Davis
    Department of Medicine Pediatrics, Louisiana State University Health Science Center, Shreveport, Louisiana 71104, USA
    Ann Intern Med 145:887-94. 2006
    ..Health literacy has increasingly been viewed as a patient safety issue and may contribute to medication errors...
  3. pmc Mining FDA drug labels using an unsupervised learning technique--topic modeling
    Halil Bisgin
    Department of Information Science, University of Arkansas at Little Rock, 2801 S, University Ave, Little Rock, AR 72204 1099, USA
    BMC Bioinformatics 12:S11. 2011
    ..Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive...
  4. pmc Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use
    Michael S Wolf
    Health Literacy and Learning Program, Feinberg School of Medicine at Northwestern University, Chicago, IL 60611, USA
    Med Care 49:96-100. 2011
    ..To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared with typical instructions...
  5. ncbi Timing of new black box warnings and withdrawals for prescription medications
    Karen E Lasser
    Department of Medicine, Cambridge Hospital, Cambridge, MA 02139, USA
    JAMA 287:2215-20. 2002
    ..Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs...
  6. pmc Improving patient understanding of prescription drug label instructions
    Terry C Davis
    Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, LA, USA
    J Gen Intern Med 24:57-62. 2009
    ..Patient misunderstanding of instructions on prescription drug labels is common and a likely cause of medication error and less effective treatment...
  7. ncbi Black box warning for topical calcineurin inhibitors and the death of common sense
    Alan B Fleischer
    Department of Dermatology, Wake Forest University School of Medicine, Winston Salem, NC, USA
    Dermatol Online J 12:2. 2006
    ..This commentary is designed to provide a clinical viewpoint regarding the Food and Drug Administration (FDA) and its recent decision to imposed a "black box warning" on the topical calcineurin inhibitors, pimecrolimus and tacrolimus...
  8. pmc A safety assessment of topical calcineurin inhibitors in the treatment of atopic dermatitis
    Mark Lebwohl
    Department of Dermatology, The Mount Sinai School of Medicine, New York, NY, USA
    MedGenMed 8:8. 2006
    ..Overall, TCIs have been shown to be an effective and valuable treatment option for AD...
  9. ncbi A review of patient-reported outcome labels in the United States: 2006 to 2010
    Ari Gnanasakthy
    Novartis Pharmaceuticals Corporation, East Hannover, NJ 07936, USA
    Value Health 15:437-42. 2012
    ....
  10. pmc Predictors of medication self-management skill in a low-literacy population
    Sunil Kripalani
    Division of General Medicine, Emory University School of Medicine, Atlanta, GA 30303, USA
    J Gen Intern Med 21:852-6. 2006
    ..Patients' ability to manage medications is critical to chronic disease control. Also known as medication management capacity (MMC), it includes the ability to correctly identify medications and describe how they should be taken...
  11. ncbi Pediatric drug labeling: improving the safety and efficacy of pediatric therapies
    Rosemary Roberts
    Office of Counter Terrorism and Pediatric Drug Development, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20855, USA
    JAMA 290:905-11. 2003
    ..In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA), which encouraged pediatric drug development by providing an incentive in the form of additional marketing exclusivity...
  12. ncbi Safety information in drug labeling: a comparison of the USA, the UK, and Japan
    Rumiko Shimazawa
    Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
    Pharmacoepidemiol Drug Saf 22:306-18. 2013
    ..Despite globalization of drug approvals, there is a disparity in drug safety regulations among the USA, Europe, and Japan. We sought to determine differences in safety information on drug labels among the three regions...
  13. pmc Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization
    Robert J Berlin
    University of Minnesota, Minneapolis, USA
    Am J Public Health 99:1693-8. 2009
    ....
  14. ncbi Developing consumer-centered, nonprescription drug labeling a study in acetaminophen
    Jennifer P King
    Health Literacy and Learning Program, Division of General Internal Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Chicago, IL 60611, USA
    Am J Prev Med 40:593-8. 2011
    ..Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage...
  15. ncbi Fake antimalarials in Southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials
    A M Dondorp
    Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
    Trop Med Int Health 9:1241-6. 2004
    ..To assess the prevalence of counterfeit antimalarial drugs in Southeast (SE) Asia...
  16. ncbi Improving drug labeling and counseling for limited English proficient adults
    Stacy Cooper Bailey
    Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, Chicago, IL 60611, USA
    J Health Care Poor Underserved 22:1131-43. 2011
    ..Enhanced, language concordant prescription labeling and counseling is needed to promote safe use of prescription medications among limited English proficient patients...
  17. ncbi The variability and quality of medication container labels
    William H Shrank
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120, USA
    Arch Intern Med 167:1760-5. 2007
    ..Medication errors occur frequently, and poor medication labeling is cited as a potential cause. We assessed the format, content, and variability of prescription drug container labels dispensed in the community...
  18. pmc Accuracy of computer-generated, spanish-language medicine labels
    Iman Sharif
    Division of Social Pediatrics, Montefiore Medical Center, Bronx, New York, USA
    Pediatrics 125:960-5. 2010
    ..We evaluated the accuracy of translated, Spanish-language medicine labels among pharmacies in a borough with a large Spanish-speaking population...
  19. pmc Misunderstanding and potential unintended misuse of acetaminophen among adolescents and young adults
    Laura P Shone
    Department of Pediatrics, University of Rochester Medical Center, Rochester, New York 14642, USA
    J Health Commun 16:256-67. 2011
    ..Better labeling, public health programs, and educational efforts could facilitate safer use of acetaminophen...
  20. ncbi What's in a label? An exploratory study of patient-centered drug instructions
    Laura J Sahm
    School of Pharmacy, Pharmaceutical Care Research Group, University College Cork, Cavanagh Pharmacy Building, College Rd, Cork, Ireland
    Eur J Clin Pharmacol 68:777-82. 2012
    ..To assess the efficacy of patient-centered label (PCL) instructions on the knowledge and comprehension of prescription drug use compared to standard instructions...
  21. pmc Risk of unintentional overdose with non-prescription acetaminophen products
    Michael S Wolf
    Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, 60611, USA
    J Gen Intern Med 27:1587-93. 2012
    ..There is increasing concern over the risk of consumer unintentional misuse of non-prescription (a.k.a. 'over-the-counter') medications containing acetaminophen, which could lead to acute liver failure...
  22. ncbi Current requirements and emerging trends for labelling as a tool for communicating pharmacovigilance findings
    A Leander Fontaine
    Wyeth Research, Collegeville, Pennsylvania, USA
    Drug Saf 27:579-89. 2004
    ..This technology, bar coding of medicines, and preventive evaluation of labelling and packaging for clarity, readability and potential confusion can also help reduce medication errors...
  23. ncbi Communication of medical product risk: how effective is effective enough?
    Stephen A Goldman
    Stephen A Goldman Consulting Services LLC, Morris Plains, New Jersey 07950, USA
    Drug Saf 27:519-34. 2004
    ..However, in assessing risk communication effectiveness, the particular benefit- risk relationship of any individual medical product must also be part of the evaluative process...
  24. ncbi Safety-related regulatory actions for biologicals approved in the United States and the European Union
    Thijs J Giezen
    Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, The Netherlands
    JAMA 300:1887-96. 2008
    ..Biologicals are a relatively new class of medicines that carry specific risks (eg, immunogenicity). However, limited information is available on the nature and timing of safety problems with their use that were identified after approval...
  25. pmc Low literacy impairs comprehension of prescription drug warning labels
    Terry C Davis
    Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, LA 71104, USA
    J Gen Intern Med 21:847-51. 2006
    ..Adverse events resulting from medication error are a serious concern. Patients' literacy and their ability to understand medication information are increasingly seen as a safety issue...
  26. ncbi Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001
    Catherine Acquadro
    MAPI Research Institute, Lyon, France
    Value Health 6:522-31. 2003
    ..The working group therefore became known as the PRO Harmonization Group...
  27. pmc Access to multilingual medication instructions at New York City pharmacies
    Linda Weiss
    Center for Urban Epidemiologic Studies, New York Academy of Medicine, New York, USA
    J Urban Health 84:742-54. 2007
    ..Pharmacists should post signs and make other efforts to inform patients about the language resources available to them...
  28. ncbi To err is human: patient misinterpretations of prescription drug label instructions
    Michael S Wolf
    Health Literacy and Learning Program, Institute for Healthcare Studies, Division of Internal Medicine, Northwestern University, Chicago, IL 60611, USA
    Patient Educ Couns 67:293-300. 2007
    ..To examine the nature and cause of patients' misunderstanding common dosage instructions on prescription drug container labels...
  29. ncbi Impact of medication packaging on adherence and treatment outcomes in older ambulatory patients
    Philip J Schneider
    Latiolais Leadership Program, College of Pharmacy, Ohio State University, Columbus, OH 43210, USA
    J Am Pharm Assoc (2003) 48:58-63. 2008
    ..To evaluate medication adherence and treatment outcomes in elderly outpatients using daily-dose blister packaging (Pill Calendar) compared with medications packaged in bottles of loose tablets...
  30. ncbi Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic review
    William Shrank
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA, USA
    Ann Pharmacother 41:783-801. 2007
    ..To evaluate the evidence regarding the optimal content and format of prescription labels that might improve readability, understanding, and medication use...
  31. ncbi Comparison of the packaging and labeling of Target ClearRx with conventional prescription drug packaging and labeling
    R William Soller
    Department of Clinical Pharmacy, School of Pharmacy, University of California, San Francisco 94143 0622, USA
    J Am Pharm Assoc (2003) 47:484-90. 2007
    ..To compare consumer preferences for Target pharmacy's clearrx packaging and labeling with conventional prescription drug packaging and labeling...
  32. ncbi What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling
    Mary E Willy
    Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 13:201-6. 2004
    ..The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States...
  33. ncbi Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART program
    Allen Brinker
    Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Safety, Rockville, MD 20857, USA
    Arch Dermatol 141:563-9. 2005
    ....
  34. doi Pharmaceutical promotion to physicians and First Amendment rights
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, USA
    N Engl J Med 358:1727-32. 2008
  35. ncbi Diagramming patients' views of root causes of adverse drug events in ambulatory care: an online tool for planning education and research
    Mary Brown
    University of Arizona Center for Education and Research on Therapeutics, Tucson, USA
    Patient Educ Couns 62:302-15. 2006
    ..Diagram patients' views of the causes of adverse drug events (ADEs) in ambulatory care, examine characteristics of causes reported by patients, and identify those that have been studied in the medical and social science literatures...
  36. ncbi Inside the black box: current policies and concerns with the United States Food and Drug Administration's highest drug safety warning system
    Kylene Halloran
    Greenwich Hospital, Greenwich, Connecticut, USA
    Curr Opin Anaesthesiol 23:423-7. 2010
    ..To evaluate the United States Food and Drug Administration use of the black-box warning system to promote drug safety and to examine the droperidol black-box warning as a case study...
  37. pmc Unlicensed and off label prescribing of drugs in general practice
    J McIntyre
    Academic Division of Child Health University of Nottingham, Derbyshire Children s Hospital, Uttoxeter Road, Derby DE22 3NE, UK
    Arch Dis Child 83:498-501. 2000
    ..To determine the incidence and nature of unlicensed and off label prescribing of drugs for children in general practice...
  38. ncbi The major role of clinicians in the discovery of off-label drug therapies
    Harold J Demonaco
    Massachusetts Institute of Technology Sloan School of Management, Cambridge, Massachusetts 02114, USA
    Pharmacotherapy 26:323-32. 2006
    ..S. Patent and Trademark Office...
  39. ncbi Recommendations on health-related quality of life research to support labeling and promotional claims in the United States
    D A Revicki
    MEDTAP International, Bethesda, Maryland, USA
    Qual Life Res 9:887-900. 2000
    ....
  40. ncbi The FDA announces new drug labeling for pharmacogenetic testing: is personalized medicine becoming a reality?
    Georgirene D Vladutiu
    Departments of Pediatrics, Neurology and Pathology, School of Medicine and Biomedical Sciences, The State University of New York at Buffalo, Buffalo, NY 14214, USA
    Mol Genet Metab 93:1-4. 2008
  41. ncbi Trends in antimalarial drug deployment in sub-Saharan Africa
    P B Bloland
    Malaria Epidemiology Branch, Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA
    J Exp Biol 206:3761-9. 2003
    ..The concept of analyzing and monitoring programmatic effectiveness allows for a more holistic understanding of these influences and allows for more unbiased, evidence-based decision making related to drug policy and deployment...
  42. doi FDA guidance on off-label promotion and the state of the literature from sponsors
    Bruce M Psaty
    Cardiovascular Health Research Unit, Department of Medicine, University of Washington, Seattle, Washington, USA
    JAMA 299:1949-51. 2008
  43. ncbi Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use
    William H Shrank
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital and Harvard Medical School, 1620 Tremont Street, Suite 300, Boston, MA 02120, USA
    Contemp Clin Trials 31:564-71. 2010
    ..Research shows that labels are variable, of poor quality, and not patient-centered. No real-world trials have evaluated whether improved medication labels can affect appropriate medication use, adherence or health outcomes...
  44. ncbi Use of pictorial aids in medication instructions: a review of the literature
    Marra G Katz
    New York Univeristy, New York, NY, USA
    Am J Health Syst Pharm 63:2391-7. 2006
    ..The effects of pictorial aids in medication instructions on medication recall, comprehension, and adherence are reviewed...
  45. ncbi Off-label medication use in adult critical care patients
    Ishaq Lat
    University of Chicago Medical Center, Chicago, IL 60637, USA
    J Crit Care 26:89-94. 2011
    ..This study evaluated the use of off-label medications in the intensive care unit (ICU) setting and their varying levels of evidence...
  46. pmc Examining the conspicuousness and prominence of two required warnings on OTC pain relievers
    Laura Bix
    School of Packaging, College of Agriculture and Natural Resources, Michigan State University, East Lansing, MI 48824, USA
    Proc Natl Acad Sci U S A 106:6550-5. 2009
    ..Evidence presented in this study suggests that 2 required warnings on 5 different OTCs are not prominent or conspicuous when compared with other elements of tested labels...
  47. ncbi Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels
    Richard J Willke
    Pfizer Inc, Bridgewater, NJ 08807, USA
    Control Clin Trials 25:535-52. 2004
    ..This term coincides with the explicit interest from drug development researchers and regulatory authorities in the appropriate utilization and reporting of treatment impact measures...
  48. ncbi The US FDA 'black box' warning for topical calcineurin inhibitors: an ongoing controversy
    Johannes Ring
    Department of Dermatology and Allergy Biederstein, Technical University of Munich, Munich, Germany
    Drug Saf 31:185-98. 2008
    ....
  49. ncbi Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials
    Tareq Mukattash
    Clinical and Practice Research Group, School of Pharmacy, Medical Biology Centre, Queen s University Belfast, 97 Lisburn Road, BT9 7BL Belfast, UK
    Eur J Clin Pharmacol 67:449-61. 2011
    ....
  50. pmc The effect of illustrations on patient comprehension of medication instruction labels
    Stephen W Hwang
    Centre for Research on Inner City Health, St Michael s Hospital, Toronto, Ontario, Canada
    BMC Fam Pract 6:26. 2005
    ..The goal of this study was to determine whether the addition of illustrations to these labels affects patient comprehension...
  51. ncbi "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
    Shirley Murphy
    US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Counter Terrorism and Pediatric Drug Development, Silver Spring, MD 20993, USA
    J Allergy Clin Immunol 117:34-9. 2006
    ..We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in ..
  52. doi Regulating off-label drug use--rethinking the role of the FDA
    Randall S Stafford
    Stanford Prevention Research Center, Program on Prevention Outcomes and Practices, Stanford University, Stanford, CA, USA
    N Engl J Med 358:1427-9. 2008
  53. ncbi Providing patients with written medication information
    M L Buck
    Children s Medical Center, Charlottesville, VA, USA
    Ann Pharmacother 32:962-9. 1998
    ..To review the literature and provide recommendations for the development and dissemination of written medication information to patients and their care providers...
  54. ncbi Non-compliance with drug treatment and reading difficulties with regard to prescription labelling among seniors
    Jocelyne Moisan
    Groupe de Recherche en Epidemiologie, Faculte de Pharmacie, Hopital du St Sacrement du CHA, Universite Laval, 1050 Chemin Ste Foy, Quebec, G1S 4L8 Canada
    Gerontology 48:44-51. 2002
    ..BACKGROUND; The link between experiencing difficulties in reading or understanding and non-compliance with drug treatment among seniors is not clearly established...
  55. ncbi Off-label prescribing among office-based physicians
    David C Radley
    Center for Evaluative Clinical Sciences, Dartmouth Medical School, Hanover, NH, USA
    Arch Intern Med 166:1021-6. 2006
    ..Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice...
  56. ncbi The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing
    Lauren Hammer Breslow
    Honorable Barbara S Jones, United States District Judge for the Southern District of New York, USA
    Harvard J Legis 40:133-93. 2003
    ..Congress should consider mandating pediatric studies in any future enactment of the legislation...
  57. ncbi FDA perspectives on supplement use by patients on antithrombotic therapy: dietary supplement regulatory overview
    Jason J Y Woo
    Division of Dietary Supplement Programs, Office of Nutritional Products, Labeling and Dietary Supplements, Food and Drug Administration, Room 4D032, CPK1 College Park, MD 20740, USA
    Thromb Res 117:193-6; discussion 201-7. 2005
  58. ncbi Changes in IVIG marketplace challenge pharmacists
    Cheryl A Thompson
    Am J Health Syst Pharm 62:2329-30, 2332. 2005
  59. ncbi Highlights and a hidden hazard--the FDA's new labeling regulations
    Jerry Avorn
    Harvard Medical School and Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women s Hospital, Boston, USA
    N Engl J Med 354:2409-11. 2006
  60. ncbi Pros and cons of off-label promotion investigations and prosecutions
    Michael K Loucks
    United States Attorney s Office for the District of Massachusetts, USA
    Food Drug Law J 61:577-83. 2006
  61. ncbi FDA labeling status of pediatric medications
    Esther Y Yoon
    Division of General Pediatrics, University of Michigan, Ann Arbor, MI 48109 0456, USA
    Clin Pediatr (Phila) 45:75-7. 2006
  62. ncbi Ephedra: yesterday, DSHEA, and tomorrow--a ten year perspective on the Dietary Supplement Health and Education Act of 1994
    Matthew J Seamon
    Nova Southeastern University College of Pharmacy
    J Herb Pharmacother 5:67-86. 2005
    ..An evaluation of these products demonstrates a general lack of efficacy and safety data. Thus, in the ten years since the passage of DSHEA, the dietary supplement industry remains controversial and a concern for consumer safety...
  63. ncbi Over-the-counter access to emergency contraception
    Diane S Aschenbrenner
    Johns Hopkins University School of Nursing, Baltimore, MD, USA
    Am J Nurs 106:34-6. 2006
    ..The article reviews the drug's method of action and recommended dosage, as well as what nurses need to know to counsel patients on what to expect when taking the medication...
  64. doi Off-label indications for medication use and the published literature
    Rebecca Dresser
    JAMA 300:1411; author reply 1411-2. 2008
  65. ncbi The federal preemption debate in pharmaceutical labeling product liability actions
    Jodie M Gross
    Harris Beach PLLC, New York, New York, USA
    Tort Trial Insur Pract Law J 43:35-70. 2007
  66. ncbi The case for preemption of prescription drug failure-to-warn claims
    Christine H Kim
    Food Drug Law J 62:399-422. 2007
  67. ncbi Antidepressants & suicide: putting the risk in perspective
    Robert H Howland
    University of Pittsburgh, School of Medicine, Western Psychiatric Institute and Clinic, PA 15213, USA
    J Psychosoc Nurs Ment Health Serv 45:15-9. 2007
    ..In this article, I will discuss this issue with the goal of putting the risk in perspective...
  68. ncbi Introduction to the new prescription drug labeling by the Food and Drug Administration
    Renu Lal
    Genentech, Inc, San Francisco, CA 94107, USA
    Am J Health Syst Pharm 64:2488-94. 2007
    The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described.
  69. ncbi Off-label or off-limits?
    Mark Ratner
    FDC Windhover
    Nat Biotechnol 26:867-75. 2008
  70. doi Marketing off-label uses to physicians: FDA's draft (mis)guidance
    Andy Gass
    Am J Bioeth 8:1-3. 2008
  71. ncbi Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications
    Praveen Kumar
    Department of Pediatrics, Northwestern Memorial Hospital and Children s Memorial Hospital, Chicago, IL, USA
    J Pediatr 152:412-5. 2008
    ..To study the current patterns of medication use, assess the extent of off-label parenteral medication use, and evaluate evidence for efficacy and safety of parenteral medications used off-label in neonates...
  72. ncbi FDA mulls over paperless labeling
    Donna Young
    Am J Health Syst Pharm 64:1120, 1122. 2007
  73. ncbi Regulatory experts debate FDA's authority
    Donna Young
    Am J Health Syst Pharm 64:910, 912. 2007
  74. ncbi FDA's regulation of prescription drug labeling: a role for implied preemption
    Leslie C Kendrick
    Food Drug Law J 62:227-47. 2007
  75. ncbi Unlabeled drug samples and the learned intermediary: the case for drug company liability without preemption
    Susan Poser
    University of Nebraska College of Law, USA
    Food Drug Law J 62:653-94. 2007
  76. ncbi Dicing with death : there's a good chance that the pills your doctor prescribed will do you no good and might even harm you
    Hazel Muir
    New Sci 191:38-41. 2006
  77. ncbi Experts weigh in on promotion, prescription of off-label drugs
    Tracy Hampton
    JAMA 297:683-4. 2007
  78. pmc Institute of Medicine's new drug safety report: implications for Canada
    Alan Cassels
    School of Health Information Science, University of Victoria, Victoria, BC, Canada
    CMAJ 175:1515-6. 2006
  79. ncbi Presumption of innocence: FDA's authority to regulate the specifics of prescription drug labeling and the preemption debate
    Howard L Dorfman
    Bayer HealthCare LLC, West Haven, CT, USA
    Food Drug Law J 61:585-622. 2006
  80. ncbi Issues in medication safety
    Lewis R Schwarz
    Am J Health Syst Pharm 64:21; author reply 22, 24. 2007
  81. pmc Off-label: just what the doctor ordered
    Christian Tomaszewski
    J Med Toxicol 2:87-8. 2006
  82. doi Prescription drugs, products liability, and preemption of tort litigation
    Catherine D DeAngelis
    JAMA 300:1939-41. 2008
  83. doi Over-the-counter sales of statins and other drugs for asymptomatic conditions
    Mary E Tinetti
    Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA
    N Engl J Med 358:2728-32. 2008
  84. ncbi Drug recalls and notification of practitioners
    Mary Faut Rodts
    Orthop Nurs 23:353-4. 2004
  85. ncbi Bar coding: old technology to the rescue
    Joyce Ochs
    Manag Care 12:46-7. 2003
  86. ncbi The Rx-to-OTC switch of Claritin, Allegra, and Zyrtec: an unprecedented FDA response to petitioners and the protection of public health
    Holly M Spencer
    Am Univ Law Rev 51:999-1050. 2002
  87. ncbi Congress, the FDA, and the fair development of new medications for children
    Ross E McKinney
    Department of Pediatrics, Division of Infectious Diseases, Duke University School of Medicine, Durham, NC 27710, USA
    Pediatrics 112:669-70. 2003
  88. ncbi "Off-label" psychotropic medication use in children
    Judy Regan
    Tennessee Department of Mental Health and Developmental Disabilities, Nashville, USA
    Tenn Med 96:429-31. 2003
  89. ncbi Botulinum toxin and human serum albumin
    Raman Malhotra
    Arch Ophthalmol 121:1661; discussion 1661-2. 2003
  90. ncbi The FDA, politics, and plan B
    Joseph B Stanford
    N Engl J Med 350:2413-4; author reply 2413-4. 2004
  91. pmc US adopts bar codes for drug products
    Milan Korcok
    CMAJ 170:1657. 2004
  92. ncbi The march toward rational therapeutics in children
    Richard L Gorman
    Department of Pediatrics, Univeristy of Maryland Medical School, Baltimore, USA
    Pediatr Infect Dis J 22:1119-23. 2003
    ..This paper details the slow progress over the last 25 years toward providing pediatric labeling and thus providing children with optimal protection and range of treatment options...
  93. ncbi Importing prescription drugs: risky business
    Lonie Hassel
    Groom Law Group, Chartered, Washington, D C, USA
    Empl Benefits J 28:83-6. 2003
    ....
  94. ncbi Off-label pharmaceutical use: balancing information, risks, and benefits
    Chris M Kozma
    Manag Care Interface 17:29-30. 2004
  95. ncbi New drugs of 2003
    Daniel A Hussar
    Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, 600 South 43rd St, Philadelphia, PA 19104 4495, USA
    J Am Pharm Assoc (2003) 44:168-206; quiz 207-10. 2004
    ..To provide information regarding the most important properties of the new therapeutic agents marketed in 2003...
  96. ncbi Inappropriate advertising of dietary supplements
    Mario L de Lemos
    N Engl J Med 348:2255-6; author reply 2255-6. 2003
  97. ncbi The drug development process and the pregnant woman
    Marilynn C Frederiksen
    Northwestern University Medical School, Chicago, IL 60611, USA
    J Midwifery Womens Health 47:422-5. 2002
    ..The sections on fertility, pregnancy and lactation would be combined, since they are a continuum. A provision is also being made to incorporate information from pharmacokinetic and pharmacodynamic studies relevant to pregnancy...
  98. ncbi The product label: how pharmacokinetics and pharmacodynamics reach the prescriber
    Patrick J Marroum
    Division of Pharmaceutical Evaluation, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Pharmacokinet 41:161-9. 2002
    ....
  99. ncbi Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions
    Diane K Wysowski
    Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA
    Arch Intern Med 165:1363-9. 2005
    ..The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems...
  100. ncbi Safety of newly approved drugs: implications for prescribing
    Robert J Temple
    JAMA 287:2273-5. 2002
  101. ncbi Science in the regulatory setting: a challenging but incompatible mix?
    Elizabeth A Yetley
    Office of Dietary Supplements, National Institutes of Health, 6100 Executive Blvd, Rm 3B01, MSC 7517, Bethesda, MD 20892 7517, USA
    Novartis Found Symp 282:59-68; discussion 69-76, 212-8. 2007
    ..The underlying assumption is that scientists who have a basic understanding of the interface between science and policy decisions can more effectively provide scientific input into these decisions...

Research Grants66

  1. Voices of children and adolescents with incurable cancer on Phase I or II Trials
    Pamela S Hinds; Fiscal Year: 2011
    ..S. Food and Drug Administration (FDA) has released guidance concerning the use of PROs in trials to support drug labeling, including clear language requiring PROs in pediatrics and not parent or clinician proxy reports...
  2. Promoting Safe Use of Pediatric Liquid Medications: A Health Literacy Approach
    Hsiang Shonna Yin; Fiscal Year: 2013
    DESCRIPTION (provided by applicant): Variable and poor-quality drug labeling has been cited as a leading cause of medication errors and adverse drug events...
  3. Obstetrical Pharmacology Research Network - Data Coordination and Analyses Center
    Linda M Brown; Fiscal Year: 2013
    ..unusual tissues such as placenta and cord blood, and (3) some data may be submitted to the FDA in support of drug labeling, which has implications for quality assurance and control in the protocols...
  4. Promoting Health Literacy for Newly Prescribed Medications via the EMR
    Michael Wolf; Fiscal Year: 2009
    ..Results from this line of research will directly inform clinical care and state and federal policies associated with drug labeling and prescribing.
  5. Measuring pediatric inpatient medication use
    Tamar Lasky; Fiscal Year: 2009
    ..These can in turn inform the full range of policy and practice decisions, including drug labeling, warnings, and removal from the market, which require an understanding of the number of children affected, ..
  6. Enhanced Prescription Drug Label Design to Improve Patient Understanding and Use
    Michael S Wolf; Fiscal Year: 2010
    ..This study will advance the science related to Rx labeling practices. Findings will directly inform clinical practice and state and federal policies for improving patient medication information and safety. ..
  7. PEDIATRIC PHARMOCOLOGY RESEARCH UNIT
    Jeffrey Blumer; Fiscal Year: 2003
    ..All these technologies will be crucial to the future of pediatric therapeutics and drug labeling for infants and children.
  8. Pharmacotherapy for Minor Depression
    Robert Howland; Fiscal Year: 2004
    ..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
  9. Antidepressant Use and Suicide
    Susan Busch; Fiscal Year: 2009
    ..The significance of this project lies in its potential to help clinicians and policymakers assess and manage competing risk and benefit claims. ..
  10. Early Diagnosis of Neonatal Candidiasis
    Daniel Benjamin; Fiscal Year: 2008
    ..abstract_text> ..
  11. Comparative Safety and Effectiveness of Stimulants in Medicaid Youth with ADHD
    Almut G Winterstein; Fiscal Year: 2010
    ....
  12. Clinical Predictors of Antiretroviral Failure
    Daniel Benjamin; Fiscal Year: 2003
    ..abstract_text> ..
  13. Medication Management Decisions in Schizophrenia
    Mark Olfson; Fiscal Year: 2003
    ..The results will inform quality improvement programs by identifying key modifiable determinants of the quality of medication management in the community treatment of schizophrenia. ..
  14. Increased Access to Emergency Contraceptive Pills
    Elizabeth Raymond; Fiscal Year: 2004
    ..These secondary analyses should help explain the primary biologic outcomes and should be useful in the development of counseling messages and service protocols in the future. ..
  15. Auditory Perception of Drug Names: Neighborhood Effects
    Bruce Lambert; Fiscal Year: 2006
    ..abstract_text> ..
  16. MDR1 and Related Proteins during HIV PI Exposure
    David Greenblatt; Fiscal Year: 2005
    ..The findings will be of importance in understanding lipid disorders related to PIs as well as the kinetics of drugs used to treat HIV and related disorders. ..
  17. Pharmacogenetics and Cardiovascular Events
    Bruce Psaty; Fiscal Year: 2006
    ..The primary defense is replication: we would therefore welcome collaboration from others in the Pharmacogenetics Network in validation efforts. ..
  18. CYP3A Function in Aging AfricanAmericans
    David Greenblatt; Fiscal Year: 2006
    ..This study should provide important mechanistic information on the role of age, gender, and ethnicity as sources of variability in CYP3A-mediated drug metabolism and response. ..
  19. Role of EETs in Growth of Human Endothelial Cells
    Meetha Medhora; Fiscal Year: 2006
    ..It will impact on the potential for development of EETs as therapeutic agents during and after cardiac ischemia and acute lung injury. ..
  20. Improving Employment among Gynecologic Cancer Survivors
    LINDA FRAZIER; Fiscal Year: 2006
    ..unreadable] [unreadable]..
  21. Clinical Knowledge Hub - Conceptual Integration of Rules, Data Sets, and Queries
    Gunther Schadow; Fiscal Year: 2010
    ....
  22. GERIATRIC CLINICAL EPIDEMIOLOGY TRAINING GRANT
    STEVEN HALBERT; Fiscal Year: 2007
    ..g., clinical trials, case control, cohort research, etc.), and the faculties' commitment to collaborative research. [unreadable] [unreadable]..
  23. Renal Transplantation, Homocysteine Lowering & Cognition
    Irwin Rosenberg; Fiscal Year: 2007
    ..Demonstrating the cognitive benefits of lowering homocysteine may pave the way to nutritional modification of cognitive decline in RTRs and other high-risk groups and even in the general population. ..
  24. Pressure Ulcer Prevention and Treatment Media
    Richard Goldsworthy; Fiscal Year: 2008
    ..unreadable] [unreadable] [unreadable] [unreadable]..
  25. Training in Medication Compliance and Health Literacy
    Sunil Kripalani; Fiscal Year: 2008
    ..If successful, the proposed research could serve as a model for other interventions to improve compliance and cardiovascular care, particularly among low-literate and underserved populations. ..
  26. WGA Study to Identify Genetic Variants Associated with CV Events in CHS
    Bruce Psaty; Fiscal Year: 2009
    ..The proposed three-part study is efficient, has excellent power to detect small to modest-sized hazard ratios, provides a large sample of WG scans for aim 2, and includes an external replication. (End of Abstract) ..
  27. Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
    Jon Ebbert; Fiscal Year: 2009
    ..No drug therapies have been shown to be effective for helping smokeless tobacco users quit for good. The purpose of this study is to test drugs that can be used to help smokeless tobacco users quit for good. ..
  28. BALANCING SURVIVAL AND OTOTOXICITY IN CISPLATIN THERAPY
    Yuelin Li; Fiscal Year: 2003
    ....
  29. Conditioned Placebo Effects & Treatment of Hypertension
    Thomas Pickering; Fiscal Year: 2005
    ..The demonstration of a conditioned placebo effect that produces a sustained reduction of BP could result in more economical treatment with fewer side effects. ..
  30. ADMINISTRATIVE/EDUCATION CENTER FOR INNATE IMMUNITY PGA
    Scott Weiss; Fiscal Year: 2004
    ..abstract_text> ..
  31. High Dose Nicotine Patch Therapy for Spit Tobacco Users
    Jon Ebbert; Fiscal Year: 2004
    ..Our goal is to reduce the prevalence of ST use and decrease the incidence of oropharyngeal cancer through the development of effective treatment options for ST users. ..
  32. A MULTI-CENTER THERAPY TRIAL FOR ACUTE LIVER FAILURE
    William Lee; Fiscal Year: 2004
    ..The overall goal is to apply modern clinical, epidemiological and virological techniques to the study of this rare but devastating illness. ..
  33. DIET, IMMUNE MODULATION, AND ASTHMA IN EARLY LIFE
    Scott Weiss; Fiscal Year: 2002
    ....
  34. HAART Regimens in Substance Abusers
    David Greenblatt; Fiscal Year: 2003
    ....
  35. THROMBOTIC, INFLAMMATORY & GENE MARKERS OF CVD IN WOMEN
    Paul Ridker; Fiscal Year: 2002
    ....
  36. SECONDARY PREVENTION TRIAL OF VENOUS THROMBOSIS
    Paul Ridker; Fiscal Year: 2002
    ....
  37. ANTIRETROVIRAL THERAPIES AND SUBSTANCE ABUSE
    David Greenblatt; Fiscal Year: 2002
    ..The in vitro model, if validated, has the potential to provide clinically important information on interactions involving HIV treatments and abusable drugs, at relatively low cost and with no human drug exposure. ..
  38. Health care utilitzation in homeless people
    Stephen Hwang; Fiscal Year: 2005
    ..Findings will be relevant to health care providers, insurers, and others who share a responsibility for improving the health of Americans who are homeless. ..
  39. MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISM
    Bruce Psaty; Fiscal Year: 2001
    ....
  40. Hormone Replacement Therapy and Prothrombotic Variants
    Bruce Psaty; Fiscal Year: 2005
    ..Power for primary and secondary aims is excellent. Information from this project may help physicians counsel women about HRT to maximize either effectiveness, or safety, or both. ..
  41. Genome-wide case-only study of antihypertensive drug-gene interactions
    Bruce M Psaty; Fiscal Year: 2010
    ....
  42. CLINICAL RESEARCH CURRICULUM
    BRIAN STROM; Fiscal Year: 2004
    ..I. and co-PI s in the three distinct aspects of Clinical Research targeted by this program represent particular features of this proposal. ..
  43. MIND-BODY-BEHAVIORAL MED CLINICAL TRIALS INFRASTRUCTURE
    Karina Davidson; Fiscal Year: 2008
    ..The ultimate goal will be to make our findings available to 3 target audiences: 1) the network of investigators at Columbia; 2) the behavioral medicine community; and 3) the general medical community. ..
  44. KNOWLEDGE EMPOWERMENT FOR YOUTH WITH SOLID TUMORS
    Judith Jones; Fiscal Year: 2004
    ..Once developed, the CD-ROM will be marketed so that it will be available to all adolescents with solid tumors. ..
  45. Antipsychotics and Mortality in Older Patients
    HELEN KALES; Fiscal Year: 2009
    ..The results of this study will be of immediate relevance to clinicians and policymakers. ..
  46. Complex Isopathic Drug Development for Neuroprotection
    Wayne Jonas; Fiscal Year: 2003
    ....
  47. Prescription Drug Coverage and Health Outcomes in Elders
    Jennifer Tjia; Fiscal Year: 2008
    ..abstract_text> ..
  48. IMPROVING COMMUNICATION WITH IVF PATIENTS ABOUT RISKS SUCH AS MULTIPLE BIRTHS
    LINDA FRAZIER; Fiscal Year: 2008
    ..The new materials will also help couples who achieve pregnancy to manage risks for increased maternal and neonatal problems among IVF singletons and multiples. [unreadable] [unreadable] [unreadable]..
  49. Childhood Asthma Research and Education Network: Denver Site
    Stanley Szefler; Fiscal Year: 2008
    ..End of abstract.) [unreadable] [unreadable]..
  50. Satin Use and the Risk of Site Specific Cancers
    Denise Boudreau; Fiscal Year: 2005
    ..abstract_text> ..
  51. Psychobiology of IV Naloxone & Lactate in Normals
    Donald Klein; Fiscal Year: 2005
    ..This would further validate this model. It may also suggest new approaches to anti-panic agents, such as mixed opiate agonist-antagonist. ..
  52. Brief Dental Office Intervention with Tobacco Quitline
    Jon Ebbert; Fiscal Year: 2005
    ..S. adult population smoking; and 3) 75% of smokers quitting for at least one day or longer because they are trying to quit. ..
  53. Modeling the Effect of Drugs in Intergomics by Linking Drug Ontology and Pathways
    Gunther Schadow; Fiscal Year: 2010
    ..This will allow researchers to understand better the effect which drugs have on the results of laboratory tests which measure a large number of proteins and chemicals in the body at the same time. ..
  54. Genetic Screen for Antipsychotic Drug Response
    David Pickar; Fiscal Year: 2005
    ..This work has the potential of impacting the individual patient with schizophrenia as well as broader needs in related health care delivery. ..
  55. Trends in and Outcomes of Medication Use in Older Adults
    Bruce Psaty; Fiscal Year: 2004
    ..abstract_text> ..
  56. Pharmacogenetics and Antithrombotic Therapy
    Brian Gage; Fiscal Year: 2003
    ..Using high performance liquid chromatography, we will measure the levels of the 2 enantiomers of warfarin and test Hypothesis 4: Clearance of S-warfarin will be significantly decreased in the presence of 2C9 SNPs. ..
  57. Bilirubin-induced Auditory Neuropathy in Preterms
    SANJIV AMIN; Fiscal Year: 2008
    ..abstract_text> ..
  58. ANTIHYPERTENSIVE DRUG/GENE INTERACTIONS AND CV EVENTS
    Bruce Psaty; Fiscal Year: 2004
    ..58 (the difference between an odds ratio of 0.46 and 0.79 in subjects with and without the variant, respectively). Power for other primary aims is excellent; power for secondary aims is good to excellent. ..
  59. DYNAMIC TECHNIQUES FOR TREATMENT EFFECTIVENESS ANALYSES
    ANDREW LEON; Fiscal Year: 2008
    ..In summary, this interdisciplinary project will inform methodologists about the proposed data analytic strategy and inform clinicians about effectiveness of treatments for PD, BDD, and bipolar depression. ..
  60. Antidepressant Treatment and Suicidality: Biostatistical/Methodological Solutions
    Robert Gibbons; Fiscal Year: 2006
    ..Collaboration with members of the VA (Cunningham, Valenstein), Kaiser Permanente (Clarke, Gullion), PHARMO (Erkens) and the Indian Health Service (Perez) is an integral part of the proposal. [unreadable] [unreadable] [unreadable]..
  61. Immune Thrombocytopenia and Low-Level Mercury Exposure
    Jodi Segal; Fiscal Year: 2006
    ..Segal with the necessary support for successful completion [unreadable] [unreadable] [unreadable]..
  62. Value of New Drug Labeling Knowledge for e-Prescribing
    Gunther Schadow; Fiscal Year: 2006
    Study the value that the upcoming FDA mandated electronic drug labeling HL7 standard will bring to existing and emerging Computerized Provider Order Entry (CPOE) systems and e-prescribing tools on the example of the Regenstrief Medical ..
  63. ECG Educational Software for Health Professionals
    Richard Goldsworthy; Fiscal Year: 2002
    ..Finally, ECG manufacturers will be contacted for phase 3 partnerships for machine-specific support packages. ..
  64. STARstreams: Multimedia and Conflict Resolution
    Richard Goldsworthy; Fiscal Year: 2003
    ..STARStreams will be a cost-effective means of providing conflict resolution support to large numbers of students. ..
  65. WSTDtv: Adolescent Multimedia STD Prevention Curriculum
    Richard Goldsworthy; Fiscal Year: 2009
    ..Intended to address this gap, the effort proposed herein describes the development of WSTDtv - an STD/HIV curriculum for use by teachers in middle school and early secondary school classrooms. ..