Use of risk management planning to enhance safety of medicines

International Journal of Pharmaceutical Medicine

Volumn 21, Issue 6, 2007, Pages 415-426

  Carbarns, Ian R I ^a   Hudson, Andrew J ^a   Wang, Rebecca ^a   Arnold, Barry D C ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Benefit risk assessment; European Medicines Agency; Food and Drug Administration; Japanese Ministry of Health, Labour and Welfare; Legislation; Pharmaceutical industry; Pharmaceutical risk management; Postmarketing surveillance; Regulatory process

Indexed keywords

CYCLOOXYGENASE 2 INHIBITOR; INSULIN; ISOTRETINOIN; LUMIRACOXIB; RISPERIDONE; ROFECOXIB; THALIDOMIDE;

ACNE; AUTISM; BIRTH DEFECT; DRUG INDUSTRY; DRUG LABELING; DRUG MARKETING; DRUG PACKAGING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; ERYTHEMA NODOSUM LEPROSUM; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; INTRACARDIAC THROMBOSIS; JAPAN; LAW; MEDICATION ERROR; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; UNITED STATES;

EID: 36348978670     PISSN: 13649027     EISSN: 14735679     Source Type: Journal    
DOI: 10.2165/00124363-200721060-00006     Document Type: Review

References (29)

1. Committee for Medicinal Products for Human Use. Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005). London: European Medicines Agency. 2005 Nov 14 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/euleg/9626805en.pdf [Accessed 2007 Jul 10]
2. Honig P, Phillips J, Woodcock J. How many deaths are due to medical errors? [letter]. JAMA 2000 Nov 1; 284 (17): 2187-8; author reply 2189
3. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of Food and Drug Administration regulatory action. JAMA 2000 Dec 20; 284 (23): 3036-9
4. Cluxton RJ, Li Z, Heaton PC, et al. Impact of regulatory labeling for troglitazone and rosiglitazone on hepatic enzyme monitoring compliance: findings from the state of Ohio medicaid program. Pharmacoepidemiol Drug Saf 2005 Jan; 14 (1): 1-9
5. Woosley RL. Drug labeling revisions: guaranteed to fail? JAMA 2000 Dec 20; 284 (23): 3047-9
6. Edwards B. Managing the interface with marketing to improve delivery of pharma-covigilance within the pharmaceutical industry. Drug Saf 2004; 27 (8): 609-17
7. Uhl K, Cox E, Rogan R, et al. Thalidomide use in the US: experience with pregnancy testing in the S.T.E.P.S. programme. Drug Saf 2006; 29 (4): 321-9
8. Brinker A, Kornegay C, Nourjah P. Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART program. Arch Dermatol 2005 May; 141 (5): 563-9
9. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: pharmacovigilance planning: E2E. Step 4 version. Geneva: International Conference on Harmonisation Secretariat; 2004 Nov 18 [online]. Available from URL: http://www.ich.org/cache/compo/475-272-1.html#E2E [Accessed 2007 Jul 10]
10. Heads of Agencies Working Group. Establishing a European risk management strategy: summary report of the Heads of Agencies Working Group. 2003 Jan [online]. Available from URL: http://www.hma.eu/uploads/media/ ERMS_summary_report.pdf [Accessed 2007 Nov 2]
11. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union 2004 Mar 31: 34-57 [online]. Available from URL: http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf [Accessed 2007 Jul 10]
12. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [as amended]. Official Journal of the European Union 2001 Nov 28: 67-128 [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-1/consol_2004/human_code.pdf [Accessed 2007 Jul 10]
13. European Commission. Guildeline on pharmacovigilance for medicinal products for human use [online]. Available from URL: http://ec.europa.eu/ enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9A_2007-01.pdf [Accessed 2007 Jul 10]
14. Committee for Medicinal Products for Human Use. Annex C: template for EU risk management plan (EU-RMP) [EMEA/192632/2006]. London: European Medicines Agency, 2006 Sep 27 [online]. Available from URL: http://www.emea.europa.eu/ pdfs/human/euleg/19263206en.pdf [Accessed 2007 Jul 10]
15. US Food and Drug Administration. Guidance for industry: premarketing risk assessment. Rockville (MD): Food and Drug Administration, 2005 Mar 25 [online]. Available from URL: http://www.fda.gov/cber/gdlns/premarkrisk.pdf [Accessed 2007 Jul 10]
16. US Food and Drug Administration. Guidance for industry: development and use of risk minimization action plans. Rockville (MD): Food and Drug Administration, 2005 Mar 25 [online]. Available from URL: http://www.fda.gov/ cber/gdlns/riskminim.pdf [Accessed 2007 Jul 10]
17. US Food and Drug Administration. Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment. Rockville (MD): Food and Drug Administration, 2005 Mar 25 [online]. Available from URL: http://www.fda.gov/cber/gdlns/pharmacovig.pdf [Accessed 2007 Jul 10]
18. Baciu A, Stratton SP, Burke SP, editors. The future of drug safety: promoting and protecting the health of the public. US Institute of Medicine of the National Academies. Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice. Washington, DC: The National Academies Press, 2006 Sep [online]. Available from URL: http://books.nap.edu/openbook.php?isbn=0309103045 [Accessed 2007 Jul 10]
19. Title IX - enhanced authorities regarding postmarket safety of drugs. In: Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (September 27, 2007) [online]. Available from URL: http://www.fda.gov/oc/initiatives/HR3580.pdf [Accessed 2007 Nov 2]
20. Arnold B. Risk management: according to plan? Good Clin Pract J 2006; 13 (12): 20-4
21. Medicines and Healthcare products Regulatory Agency. Always read the leaflet: getting the best information with every medicine. Mail 2006 Jul-Aug; 156: 5 [online]. Available from URL: http://www.mhra.gov.uk/home/idcplg? IdcService=GET_FILE&dDocName=CON2024252&RevisionSelectioBoard on Population Health and Public Health Practice. Washington, DC: The National Academies Press, 2006 Sep [online]. Available from URL: http://books.nap.edu/ openbook.php?isbn=0309103045 [Accessed 2007 Jul 10]
22. Miller D, Bennett I, Hollis K, et al. A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme. Aliment Pharmacol Ther 2006 Sep 1; 24 (5): 869-78
23. Novartis Pharma AG. Lumiracoxib post-launch enhanced pharmacovigilance and risk management plan. London: Medicines and Healthcare products Regulatory Agency, 2006 Dec 5 [online]. Available from URL: http://www.mhra.gov.uk/home/ idcplg?IdcService=GET_FILE&dDocName=con2022708&RevisionSelectionMethod= Latest [Accessed 2007 Jul 10]
24. Novartis Pharma AG. Prexige (lumiracoxib) safety specification. London: Medicines and Healthcare products Regulatory Agency, 2006 Dec 15 [online]. Available from URL: http://www.mhra.gov.uk/home/idcplg?IdcService= GET_FILE&dDocName=con2022709&RevisionSelectionMethod=Latest [Accessed 2007 Jul 10]
25. Medicines and Healthcare products Regulatory Agency. Variation assessment report: risperidone for treatment of autism in children and adolescents. London: Medicines and Healthcare products Regulatory Agency, 2006 Oct 12 [online]. Available from URL: http://www.mhra.gov.uk/home/idcplg?IdcService= GET_FILE&dID=25074&noSaveAs=0&Rendition=WEB [Accessed 2007 Jul 10]
26. Pfizer Inc. Advisory Committee Briefing Document: Exubera® (insulin [rDNA origin] powder for oral inhalation) 1 mg and 3 mg. Rockville (MD): Food and Drug Administration, 2005 Sep 8: 217-26 [online]. Available from URL: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Ex- ubera.pdf [Accessed 2007 Jul 10]
27. Medicines and Healthcare products Regulatory Agency. Risk management plans. Mail 2006 May-Jun; 155: 3-4 [online]. Available from URL: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName= CON2023868&RevisionSelectionMethod=LatestReleased [Accessed 2007 Jul 10]
28. Medicines and Healthcare products Regulatory Agency. Scientific advice for risk management planning. Mail 2006 Nov-Dec; 158: 4. Available from URL: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName= CON2025314&RevisionSelectionMethod=LatestReleased [Accessed 2007 Jul 10]
29. Munro J, O'Sullivan D, Andrews C, et al. Active monitoring of 12,760 clozapine recipients in the UK and Ireland: beyond pharmacovigilance. Br J Psychiatry 1999 Dec; 175: 576-80