Current requirements and emerging trends for labelling as a tool for communicating pharmacovigilance findings

Drug Safety

Volumn 27, Issue 8, 2004, Pages 579-589

  Fontaine, A Leander ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

COMPUTER SYSTEM; DRUG INDUSTRY; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG MISUSE; DRUG NOMENCLATURE; DRUG PACKAGING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; INTERNET; INTERPERSONAL COMMUNICATION; MEDICAL RECORD; PATIENT COMPLIANCE; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; RISK MANAGEMENT; SIDE EFFECT; TREATMENT WITHDRAWAL;

CANADA; COMMUNICATION; DRUG LABELING; EUROPEAN UNION; HUMANS; JAPAN; MEDICATION ERRORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 3042662140     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427080-00009     Document Type: Review

References (37)

1. US Food and Drug Administration. Requirements on content and format of labelling for human prescription drugs and biologics; requirements for prescription drug product labels; proposed rule 65. Fed Regist 2000 Dec 22; 247: 81082-131
2. US Food and Drug Administration. Draft guidance for industry: content and format of the adverse reactions section of labelling for human prescription drugs and biologics [online]. May 2000. Available from URL: http://www.fda.gov/ cder/guidance/1888dft.pdf [Accessed 2004 Feb 14]
3. US Food and Drug Administration. Safety reporting requirements for human drug and biological products; proposed rule 68. Fed Regist 2003 Mar 14; 50: 12405-97
4. US Food and Drug Administration. Bar code label requirements for human drug products and biological products; final rule 69. Fed Reg 2004 Feb 26; 38: 9119-71
5. US Food and Drug Administration. Evaluating drug names for similarities: methods and approaches [online]. Public Meeting June 26, 2003. Meeting transcript and presentations available from URL: http://www.fda.gov/cder/ meeting/drugNaming.htm [Accessed 2004 Feb 15]
6. PhRMA Paperless Labelling Task Force. User requirements for paperless labelling [online]. 2000 Mar 17. Available from URL: http://srpub.phrma.org/ reports/03.17.00.user.reqs.pdf [Accessed 2004 Feb 15]
7. Levin R. DailyMed Initiative: enhancing patient safety through accessible medication information [online]. Presentation at DIA Electronic Document Management Plenary Session, February 2003. Available from URL: http://www.fda.gov/cder/regulatory/ersr/2003_02_13_dailymed/2003_02_13_dailymed. PPT [Accessed 2004 Feb 14]
8. US Food and Drug Administration. The Food and Drug Administration's Strategic Action Plan: protecting and advancing America's health: responding to new challenges and opportunities [online]. August 2003. Available from URL: http://www.fda.gov/oc/mcclellan/strategic.html#healthcare [Accessed 2004 Feb 14]
9. European Agency for the Evaluation of Medicinal Products. Work programme for the European Agency for the evaluation of medicinal products 2004 [online]. Available from URL: http://www.emea.eu.int/pdfs/general/direct/emeawp/005803en. pdf [Accessed 2004 Feb 13]
10. European Commission Directorate General III. Notice to applicants, Vol. 2A. Procedures for marketing authorisation [online]. Chap. 5. Variations. February 2004. Available from URL: http://pharmacos.eudra.org/F2/eudralex/vol-2/ home.htm [Accessed 2004 Feb 14]
11. National Health Surveillance Agency, Brazil. Resolução - RDC no 140, de 29 de maio de 2003 [online]. Available from URL: http://www.anvisa.gov.br/legis/resol/2003/rdc/140_03rdc.htm [Accessed 2004 Feb 15]
12. Minister of Health, Canada. Guidance for industry: product monograph [online]. Available from URL: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ product_monograph_e.html [Accessed 2004 Feb 15]
13. Japan Pharmaceutical Manufacturers Association. Pharmaceutical industry action to prevent medical accidents [online]. Available from URL: http://www.jpma.or.jp/12english/topics/topics030629_6.html [Accessed 2004 Feb 14]
14. Japan. Bar codes to stop medicine errors [online]. Medical News Today 2004 Jan 27. Available from URL: http://www.medicalnewstoday.com/index.php?. newsid=5549 [Accessed 2004 Feb 14]
15. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: clinical safety data management: definitions and standards for expedited reporting - E2A. October 1994 [online]. Available from URL: http://www.ich.org/MediaServer.jser?.@_ID=436&@_ MODE=GLB [Accessed 2004 Feb 14]
16. European Commission Enterprise Directorate General. Notice to Applicants, Volume 2C - regulatory guidelines [online]. Guideline on Summary of Product Characteristics. December 1999. Available from URL: http://pharmacos.eudra.org/ F2/eudralex/vol-2/C/SPCGuidRev0-Dec99.pdf [Accessed 2004 Feb 14]
17. Council for International Organizations of Medical Sciences. Guidelines for preparing core clinical-safety information on drugs. 2nd ed. Report of CIOMS Working Groups III and V. Geneva: Council for International Organizations of Medical Sciences, 1999
18. European Commission Directorate General III. Notice to applicants. Vol. 2C. Regulatory guidelines: guideline on the readability of the label and package leaflet of medicinal product for human use [online]. September 1998. Available from URL: http://pharmacos.eudra.org/F2/eudralex/vol-2/C/g1981002.pdf [Accessed 2004 Feb 14]
19. US Food and Drug Administration. Concept paper: premarketing risk assessment [online]. March 2003. Available from URL: http://www.fda.gov/cder/ meeting/riskManageI.htm [Accessed 2004 Feb 14]
20. Heads of Agencies Ad Hoc Working Group. Establishing a European risk management strategy: summary report of the heads of agencies ad hoc working group [online]. Available from URL: http://heads.medagencies.org/heads/docs/ summary.pdf [Accessed 2004 Feb 14]
21. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Draft consensus guideline: pharmacovigilance planning (PVP) - E2E [online]. Available from URL: http://www.ich.org/MediaServer.jser?.@_ID=1195&@_MODE=GLB [Accessed 2004 Feb 14]
22. Goldman SA. Letter to the editor. JAMA 2002; 288 (8): 956-7
23. Japan Pharmaceutical Manufacturers Association. Pharmaceutical administration and regulations in Japan. March 2003 [online]. Available from URL: http://www.jpma.or.jp/12english/parj/index. [Accessed 2004 Feb 14]
24. EMEA. EMEA/CPMP Working Group with patient Organizations. Outcome of discussions, recommendations and proposals for action [online]. London, Apr 24, 2004. Doc. ref. EMEA/CPMP/5819/04/Final Available from URL: http://www.emea.eu. int/pdfs/human/patientgroups/581904.pdf [Accessed 2004 Apr 30]
25. Drugs@FDA web site [online]. Available at URL: http://www.accessdata.fda. gov/scripts/cder/drugsatfda/ [Accessed 2004 Feb 14]
26. European Public Assessment Report (EPAR) for products [online]. Available from URL: http://www.emea.eu.int/index/indexhl.htm [Accessed 2004 Feb 14]
27. Waller PC, Evans SJW. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003; 12: 17-29
28. Pharmaceutical Research and Manufacturers of America. Comments of the pharmaceutical research and manufacturers of America on the food and drug administration's proposed rule on requirements on content and format of labelling for human prescription drugs and biologics; requirements for prescription drug product labels. June 2001 [online]. Available from URL: http://srpub.phrma.org/fda.responses.html [Accessed 2004 Feb 14]
29. Sless D, Wiseman R. Writing about medicines for people. 2nd ed. Canberra: Pharmaceutical Benefits Branch, Department of Health and family Services, 1997
30. Kahn SN. Can MedDRA be used for labelling? Should it? Presented at the Drug Information Association (DIA) Annual Meeting, Jun 1999, Baltimore (MD)
31. Thomas MR, Holquist C, Phillips J. Med error reports to FDA show a mixed bag. FDA Safety Page [online]. Drug Topics 2001 Oct 1; 145 (19): 23-4. Available from URL: http://www.fda.gov/cder/drug/MedErrors/reports.htm [Accessed 2004 Feb 15]
32. Institute for Safe Medication Practices. International Medication Error Reporting Programs [online]. Available from URL: http://www.ismp.org/Pages/ mederr_intl.html#errlist [Accessed 2004 Feb 15]
33. US Food and Drug Administration. Concept paper: risk management programs [online]. March 2003. Available from URL: http://www.fda.gov/cder/meeting/ riskManageII.htm [Accessed 2004 Feb 14]
34. Buckley M. Improving drug prescribing practices in the outpatient setting: a market analysis. California HealthCare Foundation [online]. October 2002. Available from URL: http://www.chcf.org/documents/ihealth/ ImprovingDrugPrescribing.pdf [Accessed 2004 Feb 14]
35. ABDA Interactions Data Base - Datasheet. German Institute of Medical Documentation and Information [online]. Available from URL: http://www.dimdi.de/ de/db/dbinfo/dbmemo/ai00ger.html#datenfelder [Accessed 2004 Feb 14]
36. Oren E, Shaffer ER, Guglielmo J. Impact of emerging technologies on medication errors and adverse drug events. Am J Health Syst Pharm 2003; 60 (14): 1447-58
37. Covert-Kimmel K, Sensmeier J. A White paper: technological approach to enhancing patient safety, healthcare Information Management and Systems Society 2002 [online]. Available from URL: http://www.himss.org/content/files/ whitepapers/patient_safety.pdf [Accessed 2004 Apr 30]