Traceability of biologicals: present challenges in pharmacovigilance

Bibliography

• Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346(7):469–75
   PubMed Web of Science ®Google Scholar
• Ebbers HC, Mantel-Teeuwisse AK, Moors EH, et al. Today’s challenges in pharmacovigilance: what can we learn from epoetins? Drug Saf 2011;34(4):273-87
   PubMed Web of Science ®Google Scholar
• Crommelin DJA, Storm G, Verrijk R, et al. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm 2003;266(1-2):3-16
   PubMedGoogle Scholar
• Sharma B. Immunogenicity of therapeutic proteins. part 3: impact of manufacturing changes. Biotechnol Adv 2007;25(3):325-31
   PubMed Web of Science ®Google Scholar
• Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 2014;28(4):363-72
   PubMed Web of Science ®Google Scholar
• Schellekens H, Jiskoot W. Erythropoietin-associated PRCA: still an unsolved mystery. J Immunotoxicol 2006;3(3):123-30
   PubMedGoogle Scholar
• Gouw SC, van der Bom JG, Ljung R, et al. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2014;368(3):231-9
   Web of Science ®Google Scholar
• Hunt D, Kavanagh D, Drummond I, et al. Thrombotic microangiopathy associated with interferon beta. N Engl J Med 2014;370(13):1270-1
   PubMed Web of Science ®Google Scholar
• IMS Institute for Healthcare Informatics. The global use of medicines: outlook through 2017. 2013. Available from: http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health 20Institute/Reports/Global_Use_of_Meds_Outlook_2017/IIHI_Global_Use_of_Meds_Report_2013.pdf [Last accessed 30 October 2014]
   Google Scholar
• Fox JL. Debate over details of US biosimilar pathway continues to rage. Nat Biotechnol 2012;30(7):577
   PubMed Web of Science ®Google Scholar
• The INN crowd. Nat Biotechnol 2013;31(12):1055
   PubMed Web of Science ®Google Scholar
• Silverman E. Biosimilars: what’s in a name? BMJ 2014;348:g272
   PubMedGoogle Scholar
• Schellekens H. A divided INN crowd. Nat Biotech 2014;32(2):132
   PubMed Web of Science ®Google Scholar
• Vermeer NS, Straus SM, Mantel-Teeuwisse AK, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance databases. Drug Saf 2013;36(8):617-25
   PubMed Web of Science ®Google Scholar
• European Federation of Pharmaceutical Industries and Associations (EFPIA). A vision for the coding and identification of pharmaceutical products in europe. Version 4.0, January 2008. Available from: http://ec.europa.eu/health/files/counterf_par_trade/doc_publ_consult_200803/114_b_efpia_en.pdf [Last accessed 25 September 2014]
   Google Scholar
• Code of Federal Regulations, Barcode label requirements, title 21, sec.201.25 (21CFR201.25), revised as of April 1, 2013. Available from: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.25 [Last accessed 30 July 2014]
   Google Scholar
• European Medicines Agency, Committee for medicinal products for human use (CHMP). Guideline on plasma-derived medicinal products (EMA/CHMP/BWP/706271/2010); 21 july 2011. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109627.pdf [Last accessed 30 July 2014]
   Google Scholar
• Datamatrix adopted by French pharmaceutical industry. 2011. Available from: http://eipg.eu/wp-content/uploads/2013/11/EIP8-Feb11-P14.pdf [Last accessed 30 July 2014]
   Google Scholar
• European Parliament and Council of 1 July 2011. Directive 2011/62/EU of the European Parliament and of the Council of 9 June 2011, amending directive 2001/83/EC on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf [Last accessed 30 October 2014]
   Google Scholar
• European Commission, health systems and products, pharmaceuticals. Delegated act on the detailed rules for a unique identifier for medicinal products for human use, and its verification. Concept paper submitted for public consultation. Brussels; 2011. Available from: http://ec.europa.eu/health/files/counterf_par_trade/safety_2011-11.pdf [Last accessed 30 July 2014]
   Google Scholar
• Drug Supply Chain Security Act ; 2013. Available from: www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ [Last accessed 30 July 2014]
   Google Scholar
• Infosys. Pharmaceutical serialization track & trace. 2014. Available from: www.infosys.com/SAP/collaterals/Documents/pharmaceutical-serialization-guide-to-country-wise.pdf [Last accessed 30 July 2014]
   Google Scholar
• Summary of Product Characteristics Inflectra, Remicade, and Remsima. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/ [Last accessed 30 July 2014]
   Google Scholar
• Poon EG, Keohane CA, Yoon CS, et al. Effect of bar-code technology on the safety of medication administration. N Engl J Med 2014;362(18):1698-707
   Google Scholar
• Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: monitoring and patient education--2012. Am J Health Syst Pharm 2013;70(9):787-803
   PubMed Web of Science ®Google Scholar
• Bar coding on pharmaceutical packaging cuts costs and improves patient safety. Available from: www.gs1ie.org/Download_Files/Healthcare_Files/Haemophilia_Treatment_Traceability_Case_Studyv2.pdf [Last accessed 30 July 2014]
   Google Scholar
• Chen WC, Chang P, Chen LF. Developing a camera-phone-based drug barcode reader and support system. AMIA Annu Symp Proc 2006;882
   PubMedGoogle Scholar
• Harmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64(8):743-52
   PubMed Web of Science ®Google Scholar
• Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov 2009;8(10):779-82
   PubMed Web of Science ®Google Scholar
• Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf 2013;36(2):75-81
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Data elements for transmission of individual case safety reports E2B(R2). 5 February 2001. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2B/Step4/E2B_R2__Guideline.pdf [Last accessed 30 October 2014]
   Google Scholar
• European Parliament and Council of 31 December 2010. Directive 2010/84/EU of The European Parliament and of the Council of 15 December 2010, amending, as regards to pharmacovigilance, Directive 2001/83/EC on the Community Code relating to medicinal products for human use
   Google Scholar
• European Medicines Agency. Heads of Medicines Agencies. Guideline on good pharmacovigilance practices (GVP). module VI – Management and reporting of adverse reactions to medicinal products. 22 June 2012. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129135.pdf [Last accessed 30 July 2014]
   Google Scholar
• Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA: The Journal of the American Medical Association 2011;305(24):2525-31
   PubMed Web of Science ®Google Scholar
• Bernatsky S, Lix L, O’Donnell S, Lacaille D; CANRAD Network. Consensus statements for the use of administrative health data in rheumatic disease research and surveillance. J Rheumatol 2013;40(1):66-73
   PubMed Web of Science ®Google Scholar
• Zink A, Askling J, Dixon WG, et al. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009;68(8):1240-6
   PubMed Web of Science ®Google Scholar
• Strangfeld A, Hyrich K, Askling J, et al. Detection and evaluation of a drug safety signal concerning pancreatic cancer: lessons from a joint approach of three European biologics registers. Rheumatology 2011;50(1):146-51
   PubMed Web of Science ®Google Scholar
• Fischer K, Ljung R, Platokouki H, et al. Prospective observational cohort studies for studying rare diseases: the European PedNet Haemophilia Registry. Haemophilia 2014;20(4):e280-6
   PubMed Web of Science ®Google Scholar
• Koch-Henriksen N. The Danish Mult Scler Registry: a 50-year follow-up. Multiple Sclerosis 1999;5(4):293-6
   PubMed Web of Science ®Google Scholar
• European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified. 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/04/WC500165501.pdf [Last accessed 30 July 2014]
   Google Scholar
• Counterfeit version of Avastin in US distribution. 2012. Available from: www.fda.gov/drugs/drugsafety/ucm291960.htm [Last accessed 30 July 2014]
   Google Scholar
• Jha AK, Doolan D, Grandt D, et al. The use of health information technology in seven nations. Int J Med Inf 2008;77(12):848-54
   PubMed Web of Science ®Google Scholar
• Pagliari C, Detmer D, Singleton P. Potential of electronic personal health records. BMJ 2007;335(7615):330-3
   PubMed Web of Science ®Google Scholar
• Castel J, Figueras A, Pedrós C, et al. Stimulating adverse drug reaction reporting. Drug Saf 2003;26(14):1049-55
   PubMed Web of Science ®Google Scholar
• Figueiras A, Herdeiro MT, Polónia J, Gestal-Otero J. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 2006;296(9):1086-93
   PubMed Web of Science ®Google Scholar
• Ortega A, Aguinagalde A, Lacasa C, et al. Efficacy of an adverse drug reaction electronic reporting system integrated into a hospital information system. Annals of Pharmacotherapy 2008;42(10):1491-6
   PubMed Web of Science ®Google Scholar
• Medicines and Healthcare products Regulatory Agency (MHRA). New study launched for pharmacists to report adverse drug reactions electronically. 21.2010. Available from: www.ema.europa.eu/docs/en_GB/document_library/Press_release/2014/04/WC500165501.pdf [Last accessed 25 September 2014]
   Google Scholar
• World Health Organization (WHO). Biological Qualifier, an INN proposal, INN Working Doc 14.342. Revised draft July 2014. Available from: http://www.who.int/medicines/services/inn/bq_innproposal201407.pdf [Last accessed 25 September 2014]
   Google Scholar
• Koster E, Blom L, Philbert D, et al. The utrecht pharmacy practice network for education and research: a network of community and hospital pharmacies in the Netherlands. Int J Clin Pharm 2014;36(4):669-74
   PubMed Web of Science ®Google Scholar
• Rules Governing Medicinal Products in the European Union, Volume 9A,Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2008. Available from: http://Ec.Europa.Eu/Health/Files/Eudralex/Vol-9/Pdf/vol9a_09-2008_en.pdf [Last accessed 30 July 2014]
   Google Scholar
• European parliament and Council of 27 January 2003. 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. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf [Last accessed 30 October 2014]
   Google Scholar
• European Medicines Agency, Committee for medicinal products for human use (CHMP). Guideline on similar biological medicinal products. 30 October 2005. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf [Last accessed 30 July 2014]
   Google Scholar
• European Medicines Agency. Questions and answers on biosimilars medicines (similar biological medicinal products). 27 September 2012. Available from: www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf [Last accessed 30 July 2014]
   Google Scholar