Traceability of biologicals: Present challenges in pharmacovigilance

Expert Opinion on Drug Safety

Volumn 14, Issue 1, 2015, Pages 63-72

  Vermeer, Niels S ^a,b   Spierings, Irina ^a   Mantel Teeuwisse, Aukje K ^a   Straus, Sabine MJM ^b,c   Giezen, Thijs J ^d   Leufkens, Hubert GM ^a,b   Egberts, Toine CG ^a,e   De Bruin, Marie L ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d Hospital Pharmacy of Haarlem   (Netherlands)

^e UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

Adverse drug reaction reporting systems; Biologicals; Biosimilars; Electronic healthcare databases; Follow on biologics; Pharmacovigilance; Product identification; Similar biological products; Traceability

Indexed keywords

BETA1A INTERFERON; HUMAN GROWTH HORMONE; BIOLOGICAL PRODUCT;

CLINICAL PRACTICE; DATA BASE; DRUG EXPOSURE; DRUG INFORMATION; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; HEALTH PRACTITIONER; HUMAN; PHARMACY; POSTMARKETING SURVEILLANCE; REVIEW; DRUG DATABASE; DRUG LABELING; STANDARDS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOLOGICAL PRODUCTS; DATABASES, PHARMACEUTICAL; DRUG LABELING; HUMANS; PHARMACOVIGILANCE;

EID: 84918524651     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2015.972362     Document Type: Review

References (53)

1. 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
2. Ebbers HC, Mantel-Teeuwisse AK, Moors EH, et al. Todays challenges in pharmacovigilance: what can we learn from epoetins?. Drug Saf 2011;34(4):273-87
3. 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
4. Sharma B. Immunogenicity of therapeutic proteins. part 3: impact of manufacturing changes. Biotechnol Adv 2007;25(3):325-31
5. Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 2014;28(4):363-72
6. Schellekens H, Jiskoot W. Erythropoietin-associated PRCA: still an unsolved mystery. J Immunotoxicol 2006;3(3):123-30
7. 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
8. Hunt D, Kavanagh D, Drummond I, et al. Thrombotic microangiopathy associated with interferon beta. N Engl J Med 2014;370(13):1270-1
9. 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
10. Fox JL. Debate over details of US biosimilar pathway continues to rage. Nat Biotechnol 2012;30(7):577
11. The INN crowd. Nat Biotechnol 2013;31(12):1055
12. Silverman E. Biosimilars: whats in a name?. BMJ 2014;348:g272
13. Schellekens H. A divided INN crowd. Nat Biotech 2014;32(2):132
14. 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
15. 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-befpiaen.pdf [Last accessed 25 September 2014
16. 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
17. 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
18. Datamatrix adopted by French pharmaceutical industry. 2011. Available from: http://eipg.eu/wpcontent/uploads/2013/11/EIP8-Feb11- P14.pdf [Last accessed 30 July 2014
19. 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-2011-62en.pdf [Last accessed 30 October 2014
20. 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
21. Drug Supply Chain Security Act ; 2013. Available from: www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/[Last accessed 30 July 2014
22. Infosys. Pharmaceutical serialization track & trace. 2014. Available from: www.infosys.com/SAP/collaterals/Documents/pharmaceutical-serialization-guide-tocountry- wise.pdf [Last accessed 30 July 2014
23. 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
24. 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
25. 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
26. 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
27. Chen WC, Chang P, Chen LF. Developing a camera-phone-based drug barcode reader and support system. AMIA Annu Symp Proc 2006;882
28. Harmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64(8):743-52
29. 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
30. 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
31. 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/ICHProducts/Guidelines/Efficacy/E2B/Step4/E2B-R2--Guideline.pdf [Last accessed 30 October 2014
32. 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. The updated EU pharmacovigilance legislation contains a specific paragraph about the importance of ensuring traceability of biological products, and the hereto related obligations for EU member states
33. 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
34. Solomon DH, Massarotti E, Garg R, et al. Association between diseasemodifying 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
35. Bernatsky S, Lix L, ODonnell 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
36. Zink A, Askling J, Dixon WG, et al. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009;68(8):1240-6
37. 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
38. 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
39. Koch-Henriksen N. The Danish Mult Scler Registry: a 50-year follow-up. Multiple Sclerosis 1999;5(4):293-6
40. 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
41. Counterfeit version of Avastin in US distribution. 2012. Available from: www.fda.gov/drugs/drugsafety/ucm291960.htm [Last accessed 30 July 2014
42. 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
43. Pagliari C, Detmer D, Singleton P. Potential of electronic personal health records. BMJ 2007;335(7615):330-3
44. Castel J, Figueras A, Pedrós C, et al. Stimulating adverse drug reaction reporting. Drug Saf 2003;26(14):1049-55
45. 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
46. 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
47. 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
48. 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
49. 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
50. 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-09-2008én.pdf [Last accessed 30 July 2014
51. 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-2012én.pdf [Last accessed 30 October 2014
52. 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
53. 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