Improving communication of drug risks to prevent patient injury: Proceedings of a workshop

Pharmacoepidemiology and Drug Safety

Volumn 12, Issue 3, 2003, Pages 183-194

  Campbell, William H ^a   Califf, Robert M ^b  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Benefit; Communication; Patient safety; Risk; Therapeutics

Indexed keywords

AMITRIPTYLINE; ANTIARRHYTHMIC AGENT; ANTIFUNGAL AGENT; BEPRIDIL; CERIVASTATIN; CISAPRIDE; CLARITHROMYCIN; CYTOCHROME P450 3A4; ERYTHROMYCIN; FLUCONAZOLE; INDINAVIR; ITRACONAZOLE; KETOCONAZOLE; MACROLIDE; MAPROTILINE; MIBEFRADIL; NEFAZODONE; PHENOTHIAZINE DERIVATIVE; PROCAINAMIDE; PROCHLORPERAZINE; PROMETHAZINE; PROTEINASE INHIBITOR; QUINIDINE; RITONAVIR; SERTINDOLE; SOTALOL; TRICYCLIC ANTIDEPRESSANT AGENT; TROGLITAZONE; TROLEANDOMYCIN; UNINDEXED DRUG;

ARTICLE; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG METABOLISM; DRUG PACKAGING; FOOD DRUG INTERACTION; GASTROESOPHAGEAL REFLUX; GRAPEFRUIT JUICE; HEALTH CARE PERSONNEL; HEALTH EDUCATION; HEALTH PROMOTION; HEART ARRHYTHMIA; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HUMAN; LIVER TOXICITY; MEDICAL INFORMATION SYSTEM; MEDICAL RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; RHABDOMYOLYSIS; RISK ASSESSMENT; RISK FACTOR; TORSADE DES POINTES; WORKSHOP;

COMMUNICATION; DRUG AND NARCOTIC CONTROL; DRUG LABELING; GOVERNMENT AGENCIES; HEALTH PERSONNEL; PATIENT EDUCATION; PATIENTS; PHARMACEUTICAL PREPARATIONS; PHYSICIAN-PATIENT RELATIONS; RISK ASSESSMENT; RISK MANAGEMENT; SAFETY; UNITED STATES;

EID: 0037390847     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.761     Document Type: Article

References (31)

1. International Conference on Developing Effective Communications in Pharmacovigilance. The Erice Declaration. WHO Drug Inform 1998; 12: 80.
2. Janssen Pharmaceutica. Dear Health Professional letter. Available from: http://www.fda.gov/medwatch/safety/2000/Propul1.htm [24 June 2002].
3. Wyeth Ayerst Laboratories, Inc., Dear Healthcare Professional Letter. Available from: http://www.fda.gov/medwatch/safety/1998/duract3.htm [24 June 2002].
4. Hoffman-LaRoche, Inc. Roche announces voluntary withdrawal of Posicor. Available from: http://www.fda.gov/medwatch/safety/1998/mibefr.htm [24 June 2002].
5. US Food and Drug Administration. Rezulin to be withdrawn from the market. Available from: http://www.fda.gov/bbs/topics/NEWS/NEW00721.html [24 June 2002].
6. US Food and Drug Administration. Talk Paper: Bayer voluntarily withdraws Baycol. Available from: http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01095.html [24 June 2002].
7. Center for Drug Evaluation and Research. CDER Report to the Nation: 2000. Available from: http://www.fda.gov/cder/reports/RTN20OO/RTN2000-3.HTM [24 June 2002].
8. Bran S, Murray WA, Hirsch IB, Palmer JP. Long QT syndrome during high-dose cisapride. Arch Intern Med 1995; 155: 765-768.
9. Wysowski DK, Bacsanyi J. Cisapride and fatal arrhythmia. N Engl J Med 1996; 335: 290-291.
10. US Food and Drug Administration. Talk Paper: FDA strengthens warning label for Propulsid. Available from: http://www.fda.gov/bbs/topics/ANSWERS/ANS00882.html [24 June 2002].
11. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of Food and Drug Administration action. JAMA 2000; 284: 3036-3039.
12. Weatherby LB, Walker AM, Fife D, Vervaet P, Mausner MA. Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of 'Dear Doctor' letters. Pharmacoepidemiol Drug Safe 2001; 10: 211-218.
13. Kohn LT, Corrigan JM, Donaldson MS (eds). To Err Is Human: Building a Safer Health System. Institute of Medicine/National Academy Press: Washington, DC, 2000.
14. Institute For Healthcare Improvement. Idealized design of medication systems. Available from: http://www.ihi.org/idealized/idms/ci040lidms.asp [24 June 2002].
15. Agency for Healthcare Research and Quality. Centers for Education & Research on Therapeutics (CERTs). Available from: at http://www.certs.hhs.gov/ [24 June 2002].
16. Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999; 282: 1458-1465.
17. Woolf SH. Practice guidelines: a new reality in medicine, III: impact on patient care. Arch Intern Med 1993; 153: 2646-2655.
18. Woosley RL. Drug labeling revisions - guaranteed to fail? JAMA 2000; 284: 3047-3049.
19. US Food and Drug Administration. Federal Register Notice - Requirements on content and format of labeling for human prescription drugs and biologics: requirements for prescription drug product labels. Available from: http://www.fda.gov/cber/rules/labelfrm.htm [22 December 2000].
20. Lasker RD, Marquis MS. The intensity of physicians' work in patient visits - implications for the coding of patient evaluation and management services. N Engl J Med 1999; 341: 337-341.
21. Chi MA, Rupp MT. Evaluation of online prospective DUR programs in community pharmacy practice. J Assoc Managed Care Pharm 2000; 6: 29-32.
22. Hazlet TK, Lee TA, Hansten PD. Performance of community pharmacy drug interaction software. J Am Pharm Assoc (Wash) 2001; 41: 200-204.
23. Jones JK, Fife D, Curkendall S, Goehring E, Jr, Guo JJ, Shannon M. Coprescribing and codispensing of cisapride and contraindicated drugs. JAMA 2001; 286: 1607-1609.
24. Soumerai SB, McLaughlin TJ, Gurwitz JH, et al. Effect of local medical opinion leaders on quality of care for acute myocardial infarction: a randomized controlled trial. JAMA 1998; 279: 1358-1363.
25. Kiefe CI, Allison JJ, Williams OD, Person SD, Weaver MT, Weissman NW. Improving quality improvement using achievable benchmarks for physician feedback: a randomized controlled trial. JAMA 2001; 285: 2871-2879.
26. Bates DW. Using information technology to reduce rates of medication errors in hospitals. BMJ 2000; 320: 788-791.
27. Evans RS, Pestotnik SL, Classen DC, et al. A computer-assisted management program for antibiotics and other antiinfective agents. N Engl J Med 1998; 338: 232-238.
28. Buurma H, de Smet PAGM, van den Hoff OP, Egberts ACG. Nature, frequency and determinants of prescription modifications in Dutch community pharmacies. Br J Clin Pharmacol 2001; 52: 85-91.
29. Rosenthal MB, Berndt ER, Donohue JM, Frank RG, Epstein AM. Promotion of prescription drugs to consumers. N Engl J Med 2002; 346: 498-505.
30. Schmid SG. Geographic variation in medical costs: evidence from HMOs. Health Aff 1995; 14: 271-275.
31. Ashton CM, Petersen NJ, Souchek J, et al. Geographic variations in utilization rates in Veterans Affairs hospitals and clinics. N Engl J Med 1999; 340: 32-39.