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.
Publications215 found, 100 shown here
- FDA-approved drug labeling for the study of drug-induced liver injuryMinjun 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 ..
- Literacy and misunderstanding prescription drug labelsTerry 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...
- Mining FDA drug labels using an unsupervised learning technique--topic modelingHalil 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...
- Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug useMichael 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...
- Timing of new black box warnings and withdrawals for prescription medicationsKaren 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...
- Improving patient understanding of prescription drug label instructionsTerry 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...
- Black box warning for topical calcineurin inhibitors and the death of common senseAlan 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...
- A safety assessment of topical calcineurin inhibitors in the treatment of atopic dermatitisMark 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...
- A review of patient-reported outcome labels in the United States: 2006 to 2010Ari Gnanasakthy
Novartis Pharmaceuticals Corporation, East Hannover, NJ 07936, USA
Value Health 15:437-42. 2012....
- Predictors of medication self-management skill in a low-literacy populationSunil 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...
- Pediatric drug labeling: improving the safety and efficacy of pediatric therapiesRosemary 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...
- Safety information in drug labeling: a comparison of the USA, the UK, and JapanRumiko 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...
- Examination of the relationship between oncology drug labeling revision frequency and FDA product categorizationRobert J Berlin
University of Minnesota, Minneapolis, USA
Am J Public Health 99:1693-8. 2009....
- Developing consumer-centered, nonprescription drug labeling a study in acetaminophenJennifer 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...
- Fake antimalarials in Southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarialsA 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...
- Improving drug labeling and counseling for limited English proficient adultsStacy 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...
- The variability and quality of medication container labelsWilliam 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...
- Accuracy of computer-generated, spanish-language medicine labelsIman 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...
- Misunderstanding and potential unintended misuse of acetaminophen among adolescents and young adultsLaura 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...
- What's in a label? An exploratory study of patient-centered drug instructionsLaura 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...
- Risk of unintentional overdose with non-prescription acetaminophen productsMichael 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...
- Current requirements and emerging trends for labelling as a tool for communicating pharmacovigilance findingsA 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...
- 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...
- Safety-related regulatory actions for biologicals approved in the United States and the European UnionThijs 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...
- Low literacy impairs comprehension of prescription drug warning labelsTerry 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...
- 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, 2001Catherine Acquadro
MAPI Research Institute, Lyon, France
Value Health 6:522-31. 2003..The working group therefore became known as the PRO Harmonization Group...
- Access to multilingual medication instructions at New York City pharmaciesLinda 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...
- To err is human: patient misinterpretations of prescription drug label instructionsMichael 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...
- Impact of medication packaging on adherence and treatment outcomes in older ambulatory patientsPhilip 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...
- Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic reviewWilliam 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...
- Comparison of the packaging and labeling of Target ClearRx with conventional prescription drug packaging and labelingR 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...
- What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labelingMary 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...
- Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART programAllen 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....
- Pharmaceutical promotion to physicians and First Amendment rightsAaron 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
- Diagramming patients' views of root causes of adverse drug events in ambulatory care: an online tool for planning education and researchMary 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...
- Inside the black box: current policies and concerns with the United States Food and Drug Administration's highest drug safety warning systemKylene 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...
- Unlicensed and off label prescribing of drugs in general practiceJ 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...
- The major role of clinicians in the discovery of off-label drug therapiesHarold J Demonaco
Massachusetts Institute of Technology Sloan School of Management, Cambridge, Massachusetts 02114, USA
Pharmacotherapy 26:323-32. 2006..S. Patent and Trademark Office...
- Recommendations on health-related quality of life research to support labeling and promotional claims in the United StatesD A Revicki
MEDTAP International, Bethesda, Maryland, USA
Qual Life Res 9:887-900. 2000....
- 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
- Trends in antimalarial drug deployment in sub-Saharan AfricaP 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...
- FDA guidance on off-label promotion and the state of the literature from sponsorsBruce M Psaty
Cardiovascular Health Research Unit, Department of Medicine, University of Washington, Seattle, Washington, USA
JAMA 299:1949-51. 2008
- Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication useWilliam 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...
- Use of pictorial aids in medication instructions: a review of the literatureMarra 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...
- Off-label medication use in adult critical care patientsIshaq 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...
- Examining the conspicuousness and prominence of two required warnings on OTC pain relieversLaura 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...
- Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labelsRichard 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...
- The US FDA 'black box' warning for topical calcineurin inhibitors: an ongoing controversyJohannes Ring
Department of Dermatology and Allergy Biederstein, Technical University of Munich, Munich, Germany
Drug Saf 31:185-98. 2008....
- Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trialsTareq 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....
- The effect of illustrations on patient comprehension of medication instruction labelsStephen 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...
- "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/riskShirley 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 ..
- Regulating off-label drug use--rethinking the role of the FDARandall 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
- Providing patients with written medication informationM 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...
- Non-compliance with drug treatment and reading difficulties with regard to prescription labelling among seniorsJocelyne 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...
- Off-label prescribing among office-based physiciansDavid 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...
- The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testingLauren 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...
- FDA perspectives on supplement use by patients on antithrombotic therapy: dietary supplement regulatory overviewJason 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
- Changes in IVIG marketplace challenge pharmacistsCheryl A Thompson
Am J Health Syst Pharm 62:2329-30, 2332. 2005
- Highlights and a hidden hazard--the FDA's new labeling regulationsJerry 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
- Pros and cons of off-label promotion investigations and prosecutionsMichael K Loucks
United States Attorney s Office for the District of Massachusetts, USA
Food Drug Law J 61:577-83. 2006
- FDA labeling status of pediatric medicationsEsther Y Yoon
Division of General Pediatrics, University of Michigan, Ann Arbor, MI 48109 0456, USA
Clin Pediatr (Phila) 45:75-7. 2006
- Ephedra: yesterday, DSHEA, and tomorrow--a ten year perspective on the Dietary Supplement Health and Education Act of 1994Matthew 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...
- Over-the-counter access to emergency contraceptionDiane 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...
- Off-label indications for medication use and the published literatureRebecca Dresser
JAMA 300:1411; author reply 1411-2. 2008
- The federal preemption debate in pharmaceutical labeling product liability actionsJodie M Gross
Harris Beach PLLC, New York, New York, USA
Tort Trial Insur Pract Law J 43:35-70. 2007
- The case for preemption of prescription drug failure-to-warn claimsChristine H Kim
Food Drug Law J 62:399-422. 2007
- Antidepressants & suicide: putting the risk in perspectiveRobert 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...
- Introduction to the new prescription drug labeling by the Food and Drug AdministrationRenu Lal
Genentech, Inc, San Francisco, CA 94107, USA
Am J Health Syst Pharm 64:2488-94. 2007The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described.
- Off-label or off-limits?Mark Ratner
Nat Biotechnol 26:867-75. 2008
- Marketing off-label uses to physicians: FDA's draft (mis)guidanceAndy Gass
Am J Bioeth 8:1-3. 2008
- Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medicationsPraveen 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...
- FDA mulls over paperless labelingDonna Young
Am J Health Syst Pharm 64:1120, 1122. 2007
- Regulatory experts debate FDA's authorityDonna Young
Am J Health Syst Pharm 64:910, 912. 2007
- FDA's regulation of prescription drug labeling: a role for implied preemptionLeslie C Kendrick
Food Drug Law J 62:227-47. 2007
- Unlabeled drug samples and the learned intermediary: the case for drug company liability without preemptionSusan Poser
University of Nebraska College of Law, USA
Food Drug Law J 62:653-94. 2007
- Dicing with death : there's a good chance that the pills your doctor prescribed will do you no good and might even harm youHazel Muir
New Sci 191:38-41. 2006
- Experts weigh in on promotion, prescription of off-label drugsTracy Hampton
JAMA 297:683-4. 2007
- Institute of Medicine's new drug safety report: implications for CanadaAlan Cassels
School of Health Information Science, University of Victoria, Victoria, BC, Canada
CMAJ 175:1515-6. 2006
- Presumption of innocence: FDA's authority to regulate the specifics of prescription drug labeling and the preemption debateHoward L Dorfman
Bayer HealthCare LLC, West Haven, CT, USA
Food Drug Law J 61:585-622. 2006
- Issues in medication safetyLewis R Schwarz
Am J Health Syst Pharm 64:21; author reply 22, 24. 2007
- Off-label: just what the doctor orderedChristian Tomaszewski
J Med Toxicol 2:87-8. 2006
- Prescription drugs, products liability, and preemption of tort litigationCatherine D DeAngelis
JAMA 300:1939-41. 2008
- Over-the-counter sales of statins and other drugs for asymptomatic conditionsMary E Tinetti
Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA
N Engl J Med 358:2728-32. 2008
- Drug recalls and notification of practitionersMary Faut Rodts
Orthop Nurs 23:353-4. 2004
- Bar coding: old technology to the rescueJoyce Ochs
Manag Care 12:46-7. 2003
- The Rx-to-OTC switch of Claritin, Allegra, and Zyrtec: an unprecedented FDA response to petitioners and the protection of public healthHolly M Spencer
Am Univ Law Rev 51:999-1050. 2002
- Congress, the FDA, and the fair development of new medications for childrenRoss E McKinney
Department of Pediatrics, Division of Infectious Diseases, Duke University School of Medicine, Durham, NC 27710, USA
Pediatrics 112:669-70. 2003
- "Off-label" psychotropic medication use in childrenJudy Regan
Tennessee Department of Mental Health and Developmental Disabilities, Nashville, USA
Tenn Med 96:429-31. 2003
- Botulinum toxin and human serum albuminRaman Malhotra
Arch Ophthalmol 121:1661; discussion 1661-2. 2003
- The FDA, politics, and plan BJoseph B Stanford
N Engl J Med 350:2413-4; author reply 2413-4. 2004
- US adopts bar codes for drug productsMilan Korcok
CMAJ 170:1657. 2004
- The march toward rational therapeutics in childrenRichard 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...
- Importing prescription drugs: risky businessLonie Hassel
Groom Law Group, Chartered, Washington, D C, USA
Empl Benefits J 28:83-6. 2003....
- Off-label pharmaceutical use: balancing information, risks, and benefitsChris M Kozma
Manag Care Interface 17:29-30. 2004
- New drugs of 2003Daniel 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...
- Inappropriate advertising of dietary supplementsMario L de Lemos
N Engl J Med 348:2255-6; author reply 2255-6. 2003
- The drug development process and the pregnant womanMarilynn 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...
- The product label: how pharmacokinetics and pharmacodynamics reach the prescriberPatrick 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....
- Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactionsDiane 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...
- Safety of newly approved drugs: implications for prescribingRobert J Temple
JAMA 287:2273-5. 2002
- 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...
- Voices of children and adolescents with incurable cancer on Phase I or II TrialsPamela 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...
- Promoting Safe Use of Pediatric Liquid Medications: A Health Literacy ApproachHsiang Shonna Yin; Fiscal Year: 2013DESCRIPTION (provided by applicant): Variable and poor-quality drug labeling has been cited as a leading cause of medication errors and adverse drug events...
- Obstetrical Pharmacology Research Network - Data Coordination and Analyses CenterLinda 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...
- Promoting Health Literacy for Newly Prescribed Medications via the EMRMichael 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.
- Measuring pediatric inpatient medication useTamar 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, ..
- Enhanced Prescription Drug Label Design to Improve Patient Understanding and UseMichael 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. ..
- PEDIATRIC PHARMOCOLOGY RESEARCH UNITJeffrey Blumer; Fiscal Year: 2003..All these technologies will be crucial to the future of pediatric therapeutics and drug labeling for infants and children.
- Pharmacotherapy for Minor DepressionRobert 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. ..
- Antidepressant Use and SuicideSusan 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. ..
- Early Diagnosis of Neonatal CandidiasisDaniel Benjamin; Fiscal Year: 2008..abstract_text> ..
- Comparative Safety and Effectiveness of Stimulants in Medicaid Youth with ADHDAlmut G Winterstein; Fiscal Year: 2010....
- Clinical Predictors of Antiretroviral FailureDaniel Benjamin; Fiscal Year: 2003..abstract_text> ..
- Medication Management Decisions in SchizophreniaMark 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. ..
- Increased Access to Emergency Contraceptive PillsElizabeth 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. ..
- Auditory Perception of Drug Names: Neighborhood EffectsBruce Lambert; Fiscal Year: 2006..abstract_text> ..
- MDR1 and Related Proteins during HIV PI ExposureDavid 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. ..
- Pharmacogenetics and Cardiovascular EventsBruce Psaty; Fiscal Year: 2006..The primary defense is replication: we would therefore welcome collaboration from others in the Pharmacogenetics Network in validation efforts. ..
- CYP3A Function in Aging AfricanAmericansDavid 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. ..
- Role of EETs in Growth of Human Endothelial CellsMeetha 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. ..
- Improving Employment among Gynecologic Cancer SurvivorsLINDA FRAZIER; Fiscal Year: 2006..unreadable] [unreadable]..
- Clinical Knowledge Hub - Conceptual Integration of Rules, Data Sets, and QueriesGunther Schadow; Fiscal Year: 2010....
- GERIATRIC CLINICAL EPIDEMIOLOGY TRAINING GRANTSTEVEN HALBERT; Fiscal Year: 2007..g., clinical trials, case control, cohort research, etc.), and the faculties' commitment to collaborative research. [unreadable] [unreadable]..
- Renal Transplantation, Homocysteine Lowering & CognitionIrwin 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. ..
- Pressure Ulcer Prevention and Treatment MediaRichard Goldsworthy; Fiscal Year: 2008..unreadable] [unreadable] [unreadable] [unreadable]..
- Training in Medication Compliance and Health LiteracySunil 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. ..
- WGA Study to Identify Genetic Variants Associated with CV Events in CHSBruce 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) ..
- Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco AddictionJon 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. ..
- BALANCING SURVIVAL AND OTOTOXICITY IN CISPLATIN THERAPYYuelin Li; Fiscal Year: 2003....
- Conditioned Placebo Effects & Treatment of HypertensionThomas 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. ..
- ADMINISTRATIVE/EDUCATION CENTER FOR INNATE IMMUNITY PGAScott Weiss; Fiscal Year: 2004..abstract_text> ..
- High Dose Nicotine Patch Therapy for Spit Tobacco UsersJon 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. ..
- A MULTI-CENTER THERAPY TRIAL FOR ACUTE LIVER FAILUREWilliam 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. ..
- DIET, IMMUNE MODULATION, AND ASTHMA IN EARLY LIFEScott Weiss; Fiscal Year: 2002....
- HAART Regimens in Substance AbusersDavid Greenblatt; Fiscal Year: 2003....
- THROMBOTIC, INFLAMMATORY & GENE MARKERS OF CVD IN WOMENPaul Ridker; Fiscal Year: 2002....
- SECONDARY PREVENTION TRIAL OF VENOUS THROMBOSISPaul Ridker; Fiscal Year: 2002....
- ANTIRETROVIRAL THERAPIES AND SUBSTANCE ABUSEDavid 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. ..
- Health care utilitzation in homeless peopleStephen 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. ..
- MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISMBruce Psaty; Fiscal Year: 2001....
- Hormone Replacement Therapy and Prothrombotic VariantsBruce 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. ..
- Genome-wide case-only study of antihypertensive drug-gene interactionsBruce M Psaty; Fiscal Year: 2010....
- CLINICAL RESEARCH CURRICULUMBRIAN 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. ..
- MIND-BODY-BEHAVIORAL MED CLINICAL TRIALS INFRASTRUCTUREKarina 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. ..
- KNOWLEDGE EMPOWERMENT FOR YOUTH WITH SOLID TUMORSJudith Jones; Fiscal Year: 2004..Once developed, the CD-ROM will be marketed so that it will be available to all adolescents with solid tumors. ..
- Antipsychotics and Mortality in Older PatientsHELEN KALES; Fiscal Year: 2009..The results of this study will be of immediate relevance to clinicians and policymakers. ..
- Complex Isopathic Drug Development for NeuroprotectionWayne Jonas; Fiscal Year: 2003....
- Prescription Drug Coverage and Health Outcomes in EldersJennifer Tjia; Fiscal Year: 2008..abstract_text> ..
- IMPROVING COMMUNICATION WITH IVF PATIENTS ABOUT RISKS SUCH AS MULTIPLE BIRTHSLINDA 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]..
- Childhood Asthma Research and Education Network: Denver SiteStanley Szefler; Fiscal Year: 2008..End of abstract.) [unreadable] [unreadable]..
- Satin Use and the Risk of Site Specific CancersDenise Boudreau; Fiscal Year: 2005..abstract_text> ..
- Psychobiology of IV Naloxone & Lactate in NormalsDonald 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. ..
- Brief Dental Office Intervention with Tobacco QuitlineJon 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. ..
- Modeling the Effect of Drugs in Intergomics by Linking Drug Ontology and PathwaysGunther 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. ..
- Genetic Screen for Antipsychotic Drug ResponseDavid 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. ..
- Trends in and Outcomes of Medication Use in Older AdultsBruce Psaty; Fiscal Year: 2004..abstract_text> ..
- Pharmacogenetics and Antithrombotic TherapyBrian 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. ..
- Bilirubin-induced Auditory Neuropathy in PretermsSANJIV AMIN; Fiscal Year: 2008..abstract_text> ..
- ANTIHYPERTENSIVE DRUG/GENE INTERACTIONS AND CV EVENTSBruce 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. ..
- DYNAMIC TECHNIQUES FOR TREATMENT EFFECTIVENESS ANALYSESANDREW 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. ..
- Antidepressant Treatment and Suicidality: Biostatistical/Methodological SolutionsRobert 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]..
- Immune Thrombocytopenia and Low-Level Mercury ExposureJodi Segal; Fiscal Year: 2006..Segal with the necessary support for successful completion [unreadable] [unreadable] [unreadable]..
- Value of New Drug Labeling Knowledge for e-PrescribingGunther Schadow; Fiscal Year: 2006Study 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 ..
- ECG Educational Software for Health ProfessionalsRichard Goldsworthy; Fiscal Year: 2002..Finally, ECG manufacturers will be contacted for phase 3 partnerships for machine-specific support packages. ..
- STARstreams: Multimedia and Conflict ResolutionRichard Goldsworthy; Fiscal Year: 2003..STARStreams will be a cost-effective means of providing conflict resolution support to large numbers of students. ..
- WSTDtv: Adolescent Multimedia STD Prevention CurriculumRichard 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. ..