-
1
-
-
33846453275
-
Risk perception of prescription drugs: Results of a national survey
-
Slovic P, Peters E, Grana J, et al. Risk perception of prescription drugs: results of a national survey. Drug Inf J 2007; 41 (1): 81-100
-
(2007)
Drug Inf J
, vol.41
, Issue.1
, pp. 81-100
-
-
Slovic, P.1
Peters, E.2
Grana, J.3
-
2
-
-
84875004435
-
-
US FDA. FDA alerts health care professionals of infection risk from repackaged Avastin intravitreal injections [online] [Accessed 2012 Mar 30]
-
US FDA. FDA alerts health care professionals of infection risk from repackaged Avastin intravitreal injections [online]. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ucm270296.htm [Accessed 2012 Mar 30]
-
-
-
-
3
-
-
84875007508
-
-
Fierce Healthcare. Hospitalizations for medication and illicit drug-related conditions on the rise among Americans ages 45 and older [online] [Accessed 2012 Mar 25]
-
Fierce Healthcare. Hospitalizations for medication and illicit drug-related conditions on the rise among Americans ages 45 and older [online]. Available from URL: http://www.fiercehealthcare.com/press-releases/ hospitalizationsmedication-and-illicit-drug-related-conditions-rise- amongamericans-? utm-medium=nlutm-source=internal [Accessed 2012 Mar 25]
-
-
-
-
4
-
-
84875006135
-
-
[Accessed Mar 25]
-
Lazar K. Nursing home drug use puts many at risk [online]. Available from URL: http://www.boston.com/news/health/articles/2010/03/08/antipsychotic-drug- use-for-dementia-patients-is-questioned/[Accessed 2012 Mar 25]
-
(2012)
Nursing Home Drug Use Puts Many at Risk [Online]
-
-
Lazar, K.1
-
5
-
-
84858376589
-
Antipsychotic prescribing in nursing homes
-
McCleery J. Antipsychotic prescribing in nursing homes. BMJ 2012; 344: 7
-
(2012)
BMJ
, vol.344
, pp. 7
-
-
McCleery, J.1
-
7
-
-
84875005807
-
-
Report of CIOMS Working Group VI [online] [Accessed Jun 3]
-
Management of safety information from clinical trials. Report of CIOMS Working Group VI [online]. Available from URL: http://www.cioms.ch/publications/ blurbs/man agement-of-safety-information.htm [Accessed 2012 Jun 3]
-
(2012)
Management of Safety Information from Clinical Trials
-
-
-
9
-
-
84867494153
-
Missing clinical trial data
-
Lehman R, Loder E. Missing clinical trial data. BMJ 2012; 314: 1-2
-
(2012)
BMJ
, vol.314
, pp. 1-2
-
-
Lehman, R.1
Loder, E.2
-
10
-
-
0142246385
-
Evidence based risk management: How can we succeed? Deliberations from a Risk Management Advisory Council
-
Perfetto EM, Ellison R, Ackermann S, et al. Evidence based risk management: how can we succeed? Deliberations from a Risk Management Advisory Council. Drug Inf J 2003; 37: 127-34
-
(2003)
Drug Inf J
, vol.37
, pp. 127-134
-
-
Perfetto, E.M.1
Ellison, R.2
Ackermann, S.3
-
12
-
-
0037275431
-
A model for the future conduct of pharmacovigilance
-
Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003; 12 (1): 17-29
-
(2003)
Pharmacoepidemiol Drug Saf
, vol.12
, Issue.1
, pp. 17-29
-
-
Waller, P.C.1
Evans, S.J.2
-
13
-
-
84875003268
-
-
European Medicines Agency. Annex C: template for EU risk management plan (EU-RMP). Doc. Ref. EMEA/192632/2006 [online] [Accessed Mar 25]
-
European Medicines Agency. Annex C: template for EU risk management plan (EU-RMP). Doc. Ref. EMEA/192632/2006 [online]. Available from URL: http://eudravigilance. ema.europa.eu/human/docs/19263206en.pdf [Accessed 2012 Mar 25]
-
(2012)
-
-
-
14
-
-
84875004554
-
-
Volume 9A of the rules governing medicinal products in the European Union guidelines on pharmacovigilance for medicinal products for human use [online] [Accessed 2012 Jun 3]
-
Volume 9A of the rules governing medicinal products in the European Union guidelines on pharmacovigilance for medicinal products for human use [online]. Available from URL: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a- 09-2008-en.pdf [Accessed 2012 Jun 3]
-
-
-
-
15
-
-
84875005853
-
-
US Department of Health and Human Services, FDA. Guidance medication guides: distribution requirements and inclusion in risk evaluation and mitigation strategies (REMS). November 2011 [online] [Accessed 2012 Aug 23]
-
US Department of Health and Human Services, FDA. Guidance medication guides: distribution requirements and inclusion in risk evaluation and mitigation strategies (REMS). November 2011 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/ Guidances/UCM244570.pdf [Accessed 2012 Aug 23]
-
-
-
-
19
-
-
78649913565
-
Testing, testing ... user testing and how it will revolutionise how we think about patient information leaflets
-
April
-
Raynor DK Testing, testing ... user testing and how it will revolutionise how we think about patient information leaflets. Pipeline April 2005; 86: 4-5
-
(2005)
Pipeline
, vol.86
, pp. 4-5
-
-
Raynor, D.K.1
-
22
-
-
84875007436
-
-
Annex I: summary of product characteristics, and annex III: labelling and package leaflet. Version 8, 07/2011 Rev. 1, 10/2011 [online] [Accessed 2012 Mar 30]
-
Annex I: summary of product characteristics, and annex III: labelling and package leaflet. Version 8, 07/2011 Rev. 1, 10/2011 [online]. Available from URL: http://www.emea. europa.eu/docs/en-GB/document-library/Template-or-form/ 2009/10/WC500004368.pdf [Accessed 2012 Mar 30]
-
-
-
-
23
-
-
84875006797
-
-
CMDh. Position paper on user testing of package leaflet: consultation with target patient groups (compliance with article 59(3) of council directive 2001/83/EC). Doc. Ref: CMDh/234/2011, February 2011 [online]. Available form URL: [Accessed 2012 Mar 11]
-
CMDh. Position paper on user testing of package leaflet: consultation with target patient groups (compliance with article 59(3) of council directive 2001/83/EC). Doc. Ref: CMDh/234/2011, February 2011 [online]. Available form URL: http://www.hma.eu/fileadmin/dateien/Human-Medicines/CMD-h-/procedural- guidance/Consulation-Patients Groups/CMDh-234-2011.pdf [Accessed 2012 Mar 11]
-
-
-
-
24
-
-
84875006584
-
-
The Helen Hamlyn Research Centre. A guide to the graphic design of medication packaging. Second edition [online] [Accessed 2012 Mar 11]
-
The Helen Hamlyn Research Centre. A guide to the graphic design of medication packaging. Second edition [online]. Available from URL: http://www.hhc.rca.ac.uk/cms/files/npsa-design-for-patient-safety-.pdf [Accessed 2012 Mar 11]
-
-
-
-
25
-
-
84867545783
-
New words for cautionary and advisory labels make them easily understood
-
Mar
-
Harris E, Enright D. New words for cautionary and advisory labels make them easily understood. Pharm J 2011 Mar; 286: 278-9
-
(2011)
Pharm J
, vol.286
, pp. 278-279
-
-
Harris, E.1
Enright, D.2
-
26
-
-
84875003382
-
-
EMA. Committee for Human Medicinal Products (CHMP). Guideline on the acceptability of names for human medicinal products processed through the centralised procedure CPMP/328/98 [online] [Accessed 2012 Aug 23]
-
EMA. Committee for Human Medicinal Products (CHMP). Guideline on the acceptability of names for human medicinal products processed through the centralised procedure CPMP/328/98 [online]. Available from URL: www.ema.europa.eu/pdfs/human/regaffair/032898en.pdf [Accessed 2012 Aug 23]
-
-
-
-
27
-
-
84875007072
-
-
Institute for Safe Medication Practices. ISMP's list of confused drug names [online] [Accessed 2012 Aug 23]
-
Institute for Safe Medication Practices. ISMP's list of confused drug names [online]. Available from URL: http://www.ismp. org/tools/ confuseddrugnames.pdf [Accessed 2012 Aug 23]
-
-
-
-
28
-
-
84875006481
-
-
WHO, The Joint Commission. Look-alike, sound-alike medication names [online] [Accessed 2012 Aug 23]
-
WHO, The Joint Commission. Look-alike, sound-alike medication names [online]. Available from URL: http://www.ccforpatientsafety.org/common/pdfs/ fpdf/Presskit/PS-Solution1.pdf [Accessed 2012 Aug 23]
-
-
-
-
29
-
-
80052871414
-
Does package design matter for patients? the association between package design and patients' drug knowledge
-
Wilke T, Mueller S, Kai N, et al. Does package design matter for patients? The association between package design and patients' drug knowledge Pharm Med 2011; 25 (5): 307-17
-
(2011)
Pharm Med
, vol.25
, Issue.5
, pp. 307-317
-
-
Wilke, T.1
Mueller, S.2
Kai, N.3
-
30
-
-
34248570702
-
Effect of content and format of prescription drug labels on readability, understanding, and medication use: A systematic review
-
Shrank W, Avorn J, Rolon C, et al. Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic review. Ann Pharmacother 2007; 41 (5): 783-801
-
(2007)
Ann Pharmacother
, vol.41
, Issue.5
, pp. 783-801
-
-
Shrank, W.1
Avorn, J.2
Rolon, C.3
-
31
-
-
0036913686
-
Labeling and 'Dear Doctor'letters: Are they noncommittal?
-
van Grootheest ACK, Edwards IR. Labeling and 'Dear Doctor'letters: are they noncommittal? Drug Saf 2002; 25 (15): 1051-5
-
(2002)
Drug Saf
, vol.25
, Issue.15
, pp. 1051-1055
-
-
Van Grootheest, A.C.K.1
Edwards, I.R.2
-
32
-
-
0037390847
-
Improving communications of drug risks to prevent patient harm: Proceedings of a workshop
-
Campbell WH, Califf RM. Improving communications of drug risks to prevent patient harm: proceedings of a workshop. Pharmacoepidemiol Drug Saf 2003; 12: 183-94
-
(2003)
Pharmacoepidemiol Drug Saf
, vol.12
, pp. 183-194
-
-
Campbell, W.H.1
Califf, R.M.2
-
33
-
-
3042613505
-
Communication of medical product risk: How effective is effective enough?
-
Goldman SA. Communication of medical product risk: how effective is effective enough? Drug Saf 2004; 27 (8): 519-34
-
(2004)
Drug Saf
, vol.27
, Issue.8
, pp. 519-534
-
-
Goldman, S.A.1
-
34
-
-
30344457849
-
Communicating safety information to physicians: An examination of Dear Doctor letters
-
Mazor KM, Andrade SE, Auger J, et al. Communicating safety information to physicians: an examination of Dear Doctor letters. PharmacoepidemiolDrug Saf 2005; 14: 869-75
-
(2005)
PharmacoepidemiolDrug Saf
, vol.14
, pp. 869-875
-
-
Mazor, K.M.1
Andrade, S.E.2
Auger, J.3
-
35
-
-
84861228157
-
Impact of FDA drug risk communications on health care utilization and health behaviors: A systematic review
-
Dusetzina S, Higashi A, Dorsey ER, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review Med Care 2012; 50 (6): 466-78
-
(2012)
Med Care
, vol.50
, Issue.6
, pp. 466-478
-
-
Dusetzina, S.1
Higashi, A.2
Dorsey, E.R.3
-
36
-
-
84859898969
-
Impact of safety-related regulatory action on clinical practice: A systematic review
-
Piening S, Haaijer-Ruskamp FM, de Vries JTN, et al. Impact of safety-related regulatory action on clinical practice: a systematic review. Drug Saf 2012; 35 (5): 373-85
-
(2012)
Drug Saf
, vol.35
, Issue.5
, pp. 373-385
-
-
Piening, S.1
Haaijer-Ruskamp, F.M.2
De Vries, J.T.N.3
-
38
-
-
84875006067
-
-
2010 Jan 11-13; Washington, DC 39. ABPI. Pharmacovigilance and the internet: a call for change. A white paper from the ABPI Pharmacovigilance Expert Network, 13 June 2011 [online] [Accessed Aug 23]
-
Acharya N, Hochstetler H. Healthcare provider focused communications. 9th Annual DIA Conference on Contemporary Pharmacovigilance and Risk Management Strategies. 2010 Jan 11-13; Washington, DC 39. ABPI. Pharmacovigilance and the internet: a call for change. A white paper from the ABPI Pharmacovigilance Expert Network, 13 June 2011 [online]. Available from URL: http://www.abpi.org. uk/our-work/library/industry/Pages/pharmacovigilance-the-internet.aspx [Accessed 2012 Aug 23]
-
(2012)
Healthcare Provider Focused Communications. 9th Annual DIA Conference on Contemporary Pharmacovigilance and Risk Management Strategies
-
-
Acharya, N.1
Hochstetler, H.2
-
39
-
-
33847032106
-
Pharmaceutical websites and the communication of risk information
-
Davis JJ, Cross E, Crowley J. Pharmaceutical websites and the communication of risk information. J Health Commun 2007; 12 (1): 29-39
-
(2007)
J Health Commun
, vol.12
, Issue.1
, pp. 29-39
-
-
Davis, J.J.1
Cross, E.2
Crowley, J.3
-
40
-
-
84863406852
-
Direct to consumer internet advertising of statins: An assessment of safety
-
Williams B, Brown D. Direct to consumer internet advertising of statins: an assessment of safety. Pharmacoepidemiol Drug Saf 2012; 21: 352-65
-
(2012)
Pharmacoepidemiol Drug Saf
, vol.21
, pp. 352-365
-
-
Williams, B.1
Brown, D.2
-
41
-
-
41749118479
-
Analysis of US Food and Drug Administration warning letters false promotional claims relating to prescription and over-The-counter medications
-
Salas M, Martin M, Pisu M, et al. Analysis of US Food and Drug Administration warning letters false promotional claims relating to prescription and over-the-counter medications. Pharm Med 2008; 22 (2): 119-25
-
(2008)
Pharm Med
, vol.22
, Issue.2
, pp. 119-125
-
-
Salas, M.1
Martin, M.2
Pisu, M.3
-
42
-
-
84875004904
-
-
NDA 20-553, OxyContin (oxycodone HCl controlledrelease) tablets, MACMIS ID# 11400. Released by FDA: 1/17/03. Posted by FDA: 1/22/03 [online]. Available from URL: [Accessed 2012 Mar 11]
-
NDA 20-553, OxyContin (oxycodone HCl controlledrelease) tablets, MACMIS ID# 11400. Released by FDA: 1/17/03. Posted by FDA: 1/22/03 [online]. Available from URL: http://www.pharmcast.com/WarningLetters/Yr2003/Jan2003/ PurduePharma0103.htm [Accessed 2012 Mar 11]
-
-
-
-
43
-
-
34248587164
-
Direct-to-consumer advertising of pharmaceuticals
-
Gellad ZF, Lyles KW. Direct-to-Consumer Advertising of Pharmaceuticals. Am J Med 2007; 120: 475-80
-
(2007)
Am J Med
, vol.120
, pp. 475-480
-
-
Gellad, Z.F.1
Lyles, K.W.2
-
45
-
-
84875004003
-
-
Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration and Office of Planning, Office of the Commissioner, Food and Drug Administration and Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services. A supplementary test of distraction inDTC advertising using an implicit measure, the affect misattribution procedure. June, 2011 [online] [Accessed 2012 Mar 30]
-
Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration and Office of Planning, Office of the Commissioner, Food and Drug Administration and Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services. A supplementary test of distraction inDTC advertising using an implicit measure, the affect misattribution procedure. June, 2011 [online]. Available from URL: http://www.fda.gov/downloads/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/UCM285379. pdf [Accessed 2012 Mar 30]
-
-
-
-
46
-
-
84875004706
-
-
Clinical Human Factors Group [online] [Accessed 2012 Jun 3]
-
Clinical Human Factors Group [online]. Available from URL: http://www.chfg.org [Accessed 2012 Jun 3]
-
-
-
-
47
-
-
84875004123
-
-
Supreme Court of the United States. Wyeth v. Levine. No. 06-1249. Argued November 3, 2008-Decided March 4, 2009 [online] [Accessed 2012 Mar 25]
-
Supreme Court of the United States. Wyeth v. Levine. No. 06-1249. Argued November 3, 2008-Decided March 4, 2009 [online]. Available from URL: http://www.law.cornell. edu/supct/html/06-1249.ZS.html [Accessed 2012 Mar 25]
-
-
-
-
49
-
-
84875005429
-
-
Exchange censures British Biotech [online]. Available from URL: [Accessed 2012 Mar 11]
-
Exchange censures British Biotech [online]. Available from URL: http://www.execreview.com/1999/06/exchange-censuresbritish-biotech/[Accessed 2012 Mar 11]
-
-
-
-
50
-
-
84875005431
-
-
The United States Department of Justice, Office of Public Affairs. Allergan agrees to plead guilty and pay 600 million to resolve allegations of off-label promotion of Botox. Wednesday, September 1, 2010 [online]. [Accessed 2012 Mar 11]
-
The United States Department of Justice, Office of Public Affairs. Allergan agrees to plead guilty and pay 600 million to resolve allegations of off-label promotion of Botox-. Wednesday, September 1, 2010 [online]. Available from URL: http://www.justice.gov/opa/pr/2010/September/10-civ-988.html [Accessed 2012 Mar 11]
-
-
-
-
51
-
-
77957135591
-
Bitter pills for pharma
-
Newman M. Bitter pills for pharma. BMJ 2010; 341: 632-3
-
(2010)
BMJ
, vol.341
, pp. 632-633
-
-
Newman, M.1
-
52
-
-
77956579687
-
Rosiglitazone: What went wrong
-
Cohen D. Rosiglitazone: what went wrong. BMJ 2010; 341: 530-5
-
(2010)
BMJ
, vol.341
, pp. 530-535
-
-
Cohen, D.1
-
55
-
-
84875006941
-
-
European Public Health Alliance Direct-to-consumer communication by pharmaceutical companies? Europeans deserve better [online]. [Accessed 2012 Mar 11]
-
European Public Health Alliance Direct-to-consumer communication by pharmaceutical companies? Europeans deserve better [online]. Available from URL: http://www.epha.org/a/3925 [Accessed 2012 Mar 11]
-
-
-
-
56
-
-
34248556349
-
Consumers' preferences for the communication of risk information in drug advertising
-
Davis JJ. Consumers' preferences for the communication of risk information in drug advertising. Health Aff (Millwood) 2007; 26 (3): 863-70
-
(2007)
Health Aff (Millwood)
, vol.26
, Issue.3
, pp. 863-870
-
-
Davis, J.J.1
-
57
-
-
35148880584
-
Numeric, Verbal and visual formats of conveying health risks: Suggested best practices and future recommendations
-
Lipkus IM. Numeric, Verbal and visual formats of conveying health risks: suggested best practices and future recommendations. Med Decis Making 2007; 27: 696-713
-
(2007)
Med Decis Making
, vol.27
, pp. 696-713
-
-
Lipkus, I.M.1
-
58
-
-
79960606711
-
Low health literacy and health outcomes: An updated systematic review
-
Berkman ND, Sheridan SL, Donahue KE, et al. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med 2011; 155 (2): 97-107
-
(2011)
Ann Intern Med
, vol.155
, Issue.2
, pp. 97-107
-
-
Berkman, N.D.1
Sheridan, S.L.2
Donahue, K.E.3
-
60
-
-
50949107982
-
Randomized controlled trial of a pictogram-based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children
-
Yin HS, Dreyer BP, van Schaick L, et al. Randomized controlled trial of a pictogram-based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children. Arch Pediatr Adolesc Med 2008; 162 (9): 814-22
-
(2008)
Arch Pediatr Adolesc Med
, vol.162
, Issue.9
, pp. 814-822
-
-
Yin, H.S.1
Dreyer, B.P.2
Van Schaick, L.3
|