A call for international harmonization in therapeutic risk management

Pharmacoepidemiology and Drug Safety

Volumn 15, Issue 12, 2006, Pages 839-849

  Hirst, Ceri ^a   Cook, Suzanne ^b   Dai, Wanju ^c   Perez Gutthann, Susana ^d   Andrews, Elizabeth ^a  

^a RTI HEALTH SOLUTIONS   (United States)

^b GLAXOSMITHKLINE   (United States)

^c SANOFI   (France)

^d PFIZER INC   (United States)

Author keywords

International drug safety; Risk management

Indexed keywords

BOSENTAN; CISAPRIDE; DESOGESTREL; DEXTROPROPOXYPHENE PLUS PARACETAMOL; DOFETILIDE; GESTODENE; HYDROMORPHONE; ISOTRETINOIN; NEFAZODONE; ORAL CONTRACEPTIVE AGENT; SERTINDOLE; SOTALOL; TERFENADINE; THALIDOMIDE; TOLCAPONE; TROVAFLOXACIN;

ACNE; ADVISORY COMMITTEE; ARTICLE; BIRTH DEFECT; CLINICAL EFFECTIVENESS; DECISION MAKING; DRUG ALCOHOL INTERACTION; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG LABELING; DRUG LEGISLATION; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ERYTHEMA NODOSUM LEPROSUM; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; GENERAL PRACTICE; GOVERNMENT REGULATION; GRAFT VERSUS HOST REACTION; HEALTH CARE SYSTEM; HIGH RISK PATIENT; HUMAN; INTERNATIONAL COOPERATION; LICENSING; LIVER TOXICITY; MORTALITY; MULTIPLE MYELOMA; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SUICIDAL IDEATION; TERATOGENICITY; TORSADE DES POINTES; VENOUS THROMBOEMBOLISM;

DRUG THERAPY; HUMANS; INTERNATIONAL COOPERATION; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT;

EID: 33845599054     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1319     Document Type: Article

References (44)

1. International Society for Pharmacoepidemiology (ISPE). Statement on regulatory systems to improve pharmaceutical safety. Accessed 6 July 2005 at http://www.pharmacoepi.org/resources/regstatement0205.pdf.
2. Hyslop DL, Read HA, Masica DN, Kotsanos JG. Pharmaceutical risk management: a call to arms for Pharmacoepidemiology. Pharmacoepidemiol Drug Safe 2002; 11(5): 417-420.
3. FDA Guidance for industry: development and use of risk minimization action plans. March 2005. Accessed 6 April 2005 at http://www.fda.gov/ cder/guidance/6358fnl.htm
4. Waller PC, Evans SJW. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Safe 2003; 12(1): 17-29.
5. Heads of Agencies. Establishing a European risk management strategy: summary report of the heads of agencies ad hoc working group. 2001. Accessed 25 June 2004 at http://heads.medagencies.org/heads/docs/ summary.pdf.
6. EMEA Guidance on Risk Management Systems for Medicinal Products for Human Use. November 14, 2005. Accessed 28 February 2006 at http://www.emea.eu.int/pdfs/human/euleg/9626805en.pdf
7. Andrews EB, Gilsenan A, Cook S. Therapeutic risk management interventions: feasibility and effectiveness. J Am Pharma Assoc 2004; 44(4): 491-500.
8. World Health Organization. WHO Programme for International Drug Monitoring. Accessed 3 November 2004 at http://www.who-umc.org/ whoprog.html.
9. Coulter DM. The New Zealand Intensive Medicines Monitoring Programme in Pro-active Safety Surveillance. Pharmacoepidemiol Drug Safe 2000; 9: 273-280.
10. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of Food and Drug Administration regulatory action. JAMA 2000; 284: 3036-3039.
11. Weatherby LB, Walker AM, Fife D, et al. Contraindicated medications dispensed with cisapride: temporal trends in relation to sending of 'Dear Doctor' letters. Pharmacoepidemiol Drug Safe 2001; 10: 211-218.
12. EMEA. Committee for Proprietary Medicinal Products (CPMP) opinion following an article 31 referral for cisapride. Accessed 14 October 2004 at http://www.emea.eu.int/pdfs/human/referral/cisapride/2484402en.pdf.
13. Janssen-Cilag. Communication with Janssen-Cilag Medical Information Department. Called October 5, 2004, on +44 800 731 8450.
14. Janssen-Cilag. Press statement: product license for Prepulsid (cisapride) to be suspended. Accessed 3 November 2004 at http://www.janssen-cilag.co.uk/product/pdf/sst00059.pdf.
15. LaPointe NMA, Chen A, Hammill B, DeLong E, Kramer JM, Calif RM. Evaluation of the dofetilide risk-management program. Am Heart J 2003; 146: 894-901.
16. Wang T, Bergstrand RH, Thompson KA. Concentration-dependent pharmacologic properties of sotalol. Am J Cardiol 1986; 57: 1160-1165.
17. FDA. Accutane pregnancy exposure may have increased under risk management plan, FDA says. FDA Advisory Committee, 2004b. Available at http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/ Dermatologic+and+Ophthalmic+Drugs/022604_AccutaneDay1/ 0226-2704_accutaneP2.htm.
18. FDA. FDA Announces Enhancement to Isotretinoin Risk Management Program. November 2004. Accessed 19 July 2005 at http://www.fda.gov/bbs/topics/ ANSWERS/2004/ANS01328.html
19. McEwen J. Risk management from an Asian/Pacific Rim regulatory perspective. Drug Safety 2004; 27(8): 491-497.
20. Szerewski A, Mansour D. The 'pill scare': the responses of authorities, doctors and patients using oral contraception. Hum Reprod Update 1999; 5(6): 627-632.
21. Farmer RDT, Williams TJ, Simpson EL, Nightingale AL. Effect of 1995 pill scare on rates of venous thromboembolism among women taking combined oral contraceptives: analysis of General Practice Research Database. Br Med J 2000; 321: 477-479.
22. Child TJ, Rees M, MacKenzie IZ. Pregnancy terminations after oral contraceptive scare. Lancet 1996; 347: 1260-1261.
23. Furedi A. The public health implications of the 1995 'pill scare'. Hum Reprod Update 1999; 5(6): 621-626.
24. Ministry of Health for New Zealand. Ministry reinforces advice on third general contraceptives. Accessed 23 March 2005 at http://www.moh.govt.nz/ moh.nsf/0/a5a1abbf60c91db64c25677c0008243e?Op.htm.
25. Thomson D. How a risk management programme can ensure safety in thalidomide use. Pharmaceutical J 2004; 272: 190-191.
26. Segal ES. Implementation and management of a post-marketing surveillance program compared to a patient registry: the bosentan experience. Presentation to the CBI Forum; March 18, 2005.
27. FDA. Suicidality in children and adolescents being treated with antidepressant medications. FDA Public Health Advisory, October 15, 2004a. Accessed 29 October 2004, at http://www.fda.gov/cder/drug/ antidepressants/SSRIPHA200410.htm
28. Tsintis P, La Mache E. CIOMS and ICH initiatives in pharmacovigilance and risk management. Drug Saf 2004; 27(8): 509-517.
29. ICH E2E: Pharmacovigilance Planning (PvP). November 2004. Accessed 11October 2005 at http://www.ich.org/ MediaServer.j-ser?ID=1195&MODE=GLB.
30. FDA briefing on ICH E2E: Pharmacovigilance Planning (PvP). April 2005. Accessed 6 July 2005 at http://www.fda.gov/cber/gdlns/ichpvp.htm.
31. CIOMS VI: Management of safety information from clinical trials. Accessed 11 October 2005 at http://www.cioms.ch/ framen_magement_of_safety_information.htm.
32. Lumpkin MM. International pharmacovigilance: developing cooperation to meet the challenges of the 21st century. Pharmacol Toxicol 2000; 86(S. 1): 20-22.
33. Berry DC, Raynor DK, Knapp P, Bersellini E. Patients' understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales. Drug Saf 2003; 26(1): 1-11.
34. Goldman SA. Communication of medical product risk. Drug Saf 2004; 27(8): 519-534.
35. CIOMS. 1991. International guidelines for ethical review of epidemiological studies. Accessed 27 July 2005 http://www.cioms.ch/ frame_1991_texts_of_guidelines.htm
36. ISPE. 2004. Guidelines for good pharmacoepidemiological practices. Accessed 27 July 2005 at http://www.pharmacoepi.org/resources/ guidelines_08027.cfm
37. Strom BL (ed.). Pharmacoepidemiology (4th edn). John Wiley & Sons, 2005.
38. Hartzema AG, Porta M, Tilson HH (eds). Pharmocoepidemiology: An Introduction. (3rd edn). Cincinnati Harvey Whitney Books, 1998.
39. Mann R, Andrews E (eds). Pharmacovigilance. John Wiley & Sons2002.
40. May FW, Rowett DS, Gilbert AL, McNeece JI, Hurley E. Outcomes of an educational outreach service for community medical practitioners: non-steroidal anti-inflammatory drugs. Med J Australia 1999; 170(10): 471-474.
41. O'Brien T, Oxman AD, Davis DA, Haynes RB, Freemantle N, Harvey EL. Educational outreach visits: effects on professional practice and health care outcomes. The Cochrane Library 1997; Issue 4: CD000409.
42. Mosely JNS. Risk management: a European perspective. Drug Saf 2004; 27(8): 499-508.
43. EMEA. Pharmacovigilance in the European economic area. December 2001. Accessed 25 June 2004 http://www._aceudravigilance.org/human /index.asp.
44. EMEA. The European Medicines Agency road map to 2010: preparing the ground for the future. EMEA/H/34163/03/Rev 2.0. 23-3-2004. Accessed 25 June 2002 at http://www.eudravigilance.org/human/docs/ RoadMapDiscussionPaper.pdf.