Advertisement

Developments and Future Directions of Prescription-Based Observational Cohort Pharmacovigilance

  • Deborah Layton
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

Lessons learnt from recent examples of drug safety hazards include the acknowledgment of discordance in learning about safety of new medicines during development as compared to during use within routine clinical practice, post marketing. Changes in pharmacovigilance regulations and legislation have given greater weight to the importance of post-marketing observational research and understanding more regarding natural variation in patients and their responses to treatment. In this chapter the origin and evolution of prescription-based event monitoring is described, with examples of real-life studies presented to offer some insight into the contributions and challenges of these post marketing systems in relation to monitoring the safety and use of new medicines.

Key words

Prescription-based event monitoring Post authorization safety studies Observational research Drug utilization 

References

  1. 1.
    Lenz W (1961) Kindliche Missbildungen nach Medikament -Einnahme wahrend der Graviditat. Dtsch Med Wochenschr 86:2555–2556Google Scholar
  2. 2.
    Committee on Safety of Drugs (1971) Report for 1969 and 1970. HMSO, LondonGoogle Scholar
  3. 3.
    Wright P (1975) Untoward effects associated with practolol administration: oculomucocutaneous syndrome. Br Med J 1(5958):595–598CrossRefGoogle Scholar
  4. 4.
    Dollery CT, Rawlins MD (1977) Monitoring adverse reactions to drugs. Br Med J 1(6053):96–97CrossRefGoogle Scholar
  5. 5.
    Wilson AB (1977) Post-marketing surveillance of adverse reactions to new medicines. Br Med J 2(6093):1001–1003CrossRefGoogle Scholar
  6. 6.
    Lawson DH, Henry DA (1977) Monitoring adverse reactions to new drugs: “restricted release” or “monitored release”? Br Med J 1(6062):691–692CrossRefGoogle Scholar
  7. 7.
    Inman W, Dollery C (1981) Post-marketing drug surveillance. In: Cavalla J (ed) Risk-benefit analysis in drug research. Proceedings of an international symposium held at the University of Kent at Canterbury, England, 27 March 1980. Springer, New York, pp 141–161Google Scholar
  8. 8.
    GMSC (1980) Prescription-event monitoring: pilot study approved. Br Med J 281(6254):1579–1584CrossRefGoogle Scholar
  9. 9.
    Taggart HM, Alderdice JM (1982) Fatal cholestatic jaundice in elderly patients taking benoxaprofen. Br Med J (Clin Res Ed) 284(6326):1372CrossRefGoogle Scholar
  10. 10.
    Anon (1983) Prescription-event monitoring: a new system for assessing drug safety. Reactions 86(1):2Google Scholar
  11. 11.
    British Medical Association Board of Science, British Medical Association Science & Education (2006) Reporting adverse drug reactions. A guide for healthcare professionals, London, UK. http://bmaopac.hosted.exlibrisgroup.com/exlibris/aleph/a21_1/apache_media/GYVFNJ1RT2PFNDUJ8IUKPUNTFVRF8G.pdf. Accessed 31 May 2006
  12. 12.
    Council for International Organizations of Medical Sciences (CIOMS), World Health Organisation (WHO) (2002) International ethical guidelines for biomedical research involving human subjects, Geneva, Switzerland. http://www.cioms.ch/publications/layout_guide2002.pdf
  13. 13.
    General Medical Council (2015) Good practice in prescribing and managing medicines and devices. http://www.gmc-uk.org/Prescribing_guidance.pdf_59055247.pdf. Accessed 31 Jan 2015
  14. 14.
    General Medical Council (2009) Confidentiality. http://www.gmc-uk.org/static/documents/content/Confidentiality_0910.pdf. Accessed 8 Jul 2011
  15. 15.
    Coulter D. Prescription event monitoring. Intensive Medicines Monitoring Programme. 17 Sep 2002. Personal CommunicationGoogle Scholar
  16. 16.
    Coulter DM (2002) Signal generation in the New Zealand Intensive Medicines Monitoring Programme: a combined clinical and statistical approach. Drug Saf 25(6):433–439CrossRefGoogle Scholar
  17. 17.
    Coulter DM (1981) Study of reasons for cessation of therapy with perhexiline maleate, sodium valproate and labetalol in the intensified adverse reaction reporting scheme. N Z Med J 93(677):81–84PubMedGoogle Scholar
  18. 18.
    Coulter DM (2000) The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiol Drug Saf 9(4):273–280CrossRefGoogle Scholar
  19. 19.
    Kubota K (1999) A design for prescription-event monitoring in Japan (J-PEM). Pharmacoepidemiol Drug Saf 8(6):447–456CrossRefGoogle Scholar
  20. 20.
    Kubota K, Kawabe E, Hinotsu S, Hamada C, Ohashi Y, Kurokawa K (2001) Pilot study of prescription-event monitoring in Japan comparing troglitazone with alternative oral hypoglycemics. Eur J Clin Pharmacol 56(11):831–838CrossRefGoogle Scholar
  21. 21.
    Kubota K (2002) Prescription-event monitoring in Japan (J-PEM). Drug Saf 25(6):441–444CrossRefGoogle Scholar
  22. 22.
    Layton D, Shakir SAW (2014) Prescription-event monitoring (PEM): the evolution to the new modified PEM and its support of risk management. In: Mann RD, Andrews EB (eds) Pharmacovigilance, 3rd edn. Wiley Blackwell, Chichester, UK, pp 359–384Google Scholar
  23. 23.
    Layton D, Shakir SA (2015) Specialist cohort event monitoring studies: a new study method for risk management in pharmacovigilance. Drug Saf 38(2):153–163CrossRefGoogle Scholar
  24. 24.
    European Commission (2012) Question and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance rules provided by directive 2010/84/EU amending directive 2001/83/EC and regulation (EU) No 1235/2010 amending regulation (EC) NO 726/2004. European Commission 2012. http://ec.europa.eu/health/files/pharmacovigilance/2012-07_qa_transitional_en.pdf
  25. 25.
    European Medicines Agency (2014) Guideline on good pharmacovigilance practices (GVP): Module V – Risk management systems (Rev 1). European Medicines Agency, LondonGoogle Scholar
  26. 26.
    Shakir SA, Wilton LV, Boshier A, Layton D, Heeley E (2001) Cardiovascular events in users of sildenafil: results from first phase of prescription event monitoring in England. BMJ 322(7287):651–652CrossRefGoogle Scholar
  27. 27.
    Boshier A, Wilton LV, Shakir SA (2004) Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in 1999. BJU Int 93(6):796–801CrossRefGoogle Scholar
  28. 28.
    European Commission (2008) Volume 9A - Pharmacovigilance for medicinal products for human use, Sept 2008. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9a_09-2008.pdf. Accessed 7 Apr 2009
  29. 29.
    Epstein M (2005) Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf 14(8):589–595CrossRefGoogle Scholar
  30. 30.
    European Network of Centres of Excellence for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) (2013) Guide on methodological standards bin pharmacoepidemiology (Revision 2). 18 June 2013 EMA/95098/2010 Rev.2Google Scholar
  31. 31.
    Depont F, Fourrier A, Merliere Y, Droz C, Amouretti M, Begaud B et al (2007) Channelling of COX-2 inhibitors to patients at higher gastrointestinal risk but not at lower cardiovascular risk: the Cox2 inhibitors and tNSAIDs description of users (CADEUS) study. Pharmacoepidemiol Drug Saf 16(8):891–900CrossRefGoogle Scholar
  32. 32.
    Margolese HC, Wolf Y, Desmarais JE, Beauclair L (2010) Loss of response after switching from brand name to generic formulations: three cases and a discussion of key clinical considerations when switching. Int Clin Psychopharmacol 25(3):180–182CrossRefGoogle Scholar
  33. 33.
    Moride Y, Abenhaim L (1994) Evidence of the depletion of susceptibles effect in non-experimental pharmacoepidemiologic research. J Clin Epidemiol 47(7):731–737CrossRefGoogle Scholar
  34. 34.
    Layton D, Shakir SAW (2011) Prescription-event monitoring. In: Strom BL, Kimmel SE, Hennessy S (eds) Pharmacoepidemiology, 5th edn. Wiley, Chichester, UK, pp 301–330Google Scholar
  35. 35.
    European Medicines Agency (2013) Guideline on good pharmacovigilance practices (GVP) Module VIII - Post-authorisation safety studies (Rev 1). EMA/813938/2011. European Medicines Agency, LondonGoogle Scholar
  36. 36.
    European Medicines Agency (2014) Guideline on good pharmacovigilance practices. Module VI - Management and reporting of adverse reactions to medicinal products. EMA/873138/2011 (rev1). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/09/WC500172402.pdf. Accessed 17 Nov 2014
  37. 37.
    Machin D, Campbell M, Fayers P et al (1997) Sample size tables for clinical studies. Table 7.1. Blackwell Science Ltd, Oxford, UKGoogle Scholar
  38. 38.
    Machin D, Campbell M, Fayers P et al (1997) Sample size tables for clinical studies. Table 7.2. Blackwell Science Ltd, Oxford, UKGoogle Scholar
  39. 39.
    Department of Health (2014) NIHR Clinical research network. Accessed 17 Nov 2014. Online SourceGoogle Scholar
  40. 40.
    European Medicines Agency (2012) Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions EMA/876333/2011 (Rev 1). European Medicines Agency, LondonGoogle Scholar
  41. 41.
    Layton D, Kimber A (2014) Abstract no: 802. Feasibility of adjusted parametric methods to model survival data as a tool for signal strengthening: an example in modified prescription-event monitoring (M-PEM). 30th International conference on pharmacoepidemiology & therapuetic risk management (ISPE), 24–27 Oct 2014, Teipei, Taiwan. Pharmacoepidmiol Drug Saf (S1):1–497Google Scholar
  42. 42.
    Wilton LV, Stephens MD, Mann RD (1999) Visual field defect associated with vigabatrin: observational cohort study. BMJ 319(7218):1165–1166CrossRefGoogle Scholar
  43. 43.
    Posner K, Oquendo MA, Gould M, Stanley B, Davies M (2007) Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA’s pediatric suicidal risk analysis of antidepressants. Am J Psychiatry 164(7):1035–1043CrossRefGoogle Scholar
  44. 44.
    Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA et al (2011) The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 168(12):1266–1277CrossRefGoogle Scholar
  45. 45.
    Layton D, Qayum N, Osborne V, Davies M, Shakir S (2014) Abstract no: 451. The application of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) algorithm to evaluate suicidal ideation and behaviour within a post-authorisation safety study. 30th International conference on pharmacoepidemiology & therapuetic risk management (ISPE), Teipei, Taiwan, 24–27 Oct 2014. Pharmacoepidmiol Drug Saf (S1):1–497Google Scholar
  46. 46.
    Prescribing Observatory For Mental Health (POMH - UK) 2015 The antipsychotic dosage ‘ready reckoner’. Royal College of Psychiatrists. 31 Jan 2015. Online SourceGoogle Scholar
  47. 47.
    Layton D, Osborne V, Al-Shukri M, Shakir SA (2014) Indicators of drug-seeking aberrant behaviours: the feasibility of use in observational post-marketing cohort studies for risk management. Drug Saf 37(8):639–650CrossRefGoogle Scholar
  48. 48.
    Layton D, Qayum N, Doe C, Freemantle S, Shakir S (2015) Abstract no: 138. Evaluating prescriber concordance with prescribing: results from a post-marketing study. 31st International conference on pharmacoepidemilogy and therapeutic risk management, Boston, United States, England, 22–26 Aug 2015. Pharmacoepidemiol Drug Saf 24(Suppl 1):1–587Google Scholar
  49. 49.
    Osborne V, Davies M, Layton D, Shakir SA (2016) Utilisation of extended release quetiapine (Seroquel XL™ ); Results from an observational cohort study in England. Eur Psychiatry 33:61–67CrossRefGoogle Scholar
  50. 50.
    Davies M, Wilton L, Shakir S (2013) Safety profile of modafinil across a range of prescribing indications, including off-label use, in a primary care setting in England: results of a modified prescription-event monitoring study. Drug Saf 36(4):237–246CrossRefGoogle Scholar
  51. 51.
    Buggy Y, Cornelius V, Fogg C, Kasliwal R, Layton D, Shakir SA (2013) Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Drug Saf 36(7):521–531CrossRefGoogle Scholar
  52. 52.
    Buggy Y, Cornelius V, Wilton L, Shakir SA (2011) Risk of depressive episodes with rimonabant: a before and after modified prescription event monitoring study conducted in England. Drug Saf 34(6):501–509CrossRefGoogle Scholar
  53. 53.
    Layton D (2015) Abstract no: 295. Applying the ready reckoner (RRec) tool for assessing antipsychotic (AP) prescribing within post-authorisation safety studies (PASS). 31st International conference on pharmacoepidemilogy and therapeutic risk management, Boston, United States, England, 22–26 Aug 2015. Pharmacoepidemiol Drug Saf (Suppl 1):1–587Google Scholar
  54. 54.
    European Network of Centres of Excellence for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) (2013) E-register of studies. An observational post-authorization modified prescription-event monitoring safety study to monitor the safety and utilization of asenapine (Sycrest) in the primary care setting in england. Online SourceGoogle Scholar
  55. 55.
    European Network of Centres of Excellence for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) (2014) E-register of studies. An observational post-authorization safety specialist cohort event monitoring study (SCEM) to monitor the safety and utilization of rivaroxaban (Xarelto®) for the prevention of stroke in patients with AF, treatment of DVT and PE, and the prevention of recurrent DVT and PE in the secondary care hospital setting in England and Wales. Online SourceGoogle Scholar
  56. 56.
    European Network of Centres of Excellence for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) (2014) E-register of studies. A cohort study to monitor the safety and use of prolonged-release quetiapine. Online SourceGoogle Scholar
  57. 57.
    Kaner EF, Haighton CA, McAvoy BR (1998) ‘So much post, so busy with practice--so, no time!’: a telephone survey of general practitioners’ reasons for not participating in postal questionnaire surveys. Br J Gen Pract 48(428):1067–1069PubMedPubMedCentralGoogle Scholar
  58. 58.
    Templeton L, Deehan A, Taylor C, Drummond C, Strang J (1997) Surveying general practitioners: does a low response rate matter? Br J Gen Pract 47(415):91–94PubMedPubMedCentralGoogle Scholar
  59. 59.
    Stocks N, Gunnell D (2000) What are the characteristics of general practitioners who routinely do not return postal questionnaires: a cross sectional study. J Epidemiol Community Health 54(12):940–941CrossRefGoogle Scholar
  60. 60.
    Inman W, Pearce G (1993) Prescriber profile and post-marketing surveillance. Lancet 342(8872):658–661CrossRefGoogle Scholar
  61. 61.
    Key C, Layton D, Shakir SA (2002) Results of a postal survey of the reasons for non-response by doctors in a Prescription Event Monitoring study of drug safety. Pharmacoepidemiol Drug Saf 11(2):143–148CrossRefGoogle Scholar
  62. 62.
    Department of Health (2006) Best research for best health: a new national health research strategy. Department of Health, LondonGoogle Scholar
  63. 63.
    Mackenzie IS, MacDonald TM, Shakir S, Dryburgh M, Mantay BJ, McDonnell P et al (2012) Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes. Br J Clin Pharmacol 73(5):801–811CrossRefGoogle Scholar
  64. 64.
    Urquhart J (1999) Pharmacoeconomic consequences of variable patient compliance with prescribed drug regimens. PharmacoEconomics 15(3):217–228CrossRefGoogle Scholar
  65. 65.
    Dunbar-Jacob J, Mortimer-Stephens MK (2001) Treatment adherence in chronic disease. J Clin Epidemiol 54(Suppl 1):S57–S60CrossRefGoogle Scholar
  66. 66.
    Andrews EB, Margulis AV, Tennis P, West SL (2015) Opportunities and challenges in using epidemiological methods to monitor drug safety in the era of large automated health databases. Curr Epidemiol Rep 1:194–205CrossRefGoogle Scholar
  67. 67.
    van Grootheest AC, Groote JK, de Jong-van den Berg LT (2003) Intensive monitoring of new drugs based on first prescription signals from pharmacists: a pilot study. Pharmacoepidemiol Drug Saf 12(6):475–481CrossRefGoogle Scholar
  68. 68.
    Suggate E, Layton D, Brown D, Shakir S (2015) Abstract no:P159. The application of the Columbia classification algorithm of suicide assessment (C-CASA) algorithm to evaluate suicidal ideation and behaviour within a post-authorisation safety study. 15th Annual Meeting of the International Society of Pharmacovigilance, Prague, Czech Republic, 27–30 Oct 2015. Drug Saf 38(10):935–1048CrossRefGoogle Scholar
  69. 69.
    White NJ (1994) Needs in developing countries: current state of antimalarial drug resistance. Council for International Organizations of Medical Sciences, c/o World Health Organization, Geneva, Switzerland, pp 126–135Google Scholar
  70. 70.
    Suku CK, Hill G, Sabblah G, Darko M, Muthuri G, Abwao E et al (2015) Experiences and lessons from implementing cohort event monitoring programmes for antimalarials in four African countries: results of a questionnaire-based survey. Drug Saf 38(11):1115–1126CrossRefGoogle Scholar
  71. 71.
    Dodoo AN, Fogg C, Nartey ET, Ferreira GL, Adjei GO, Kudzi W et al (2014) Profile of adverse events in patients receiving treatment for malaria in urban Ghana: a cohort-event monitoring study. Drug Saf 37(6):433–448CrossRefGoogle Scholar
  72. 72.
    Bassi PU, Osakwe AI, Isah A, Suku C, Kalat M, Jalo I et al (2013) Safety of artemisinin-based combination therapies in Nigeria: a cohort event monitoring study. Drug Saf 36(9):747–756CrossRefGoogle Scholar
  73. 73.
    Duncombe C, Kerr SJ, Ruxrungtham K, Dore GJ, Law MG, Emery S et al (2005) HIV disease progression in a patient cohort treated via a clinical research network in a resource limited setting. AIDS 19(2):169–178CrossRefGoogle Scholar
  74. 74.
    De Alwis KN, Abeysinghe MR, Wickramesinghe AR, Wijesinghe PR (2014) A cohort event monitoring to determine the adverse events following administration of mouse brain derived, inactivated Japanese Encephalitis vaccine in an endemic district in Sri Lanka. Vaccine 32(8):924–930CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Deborah Layton
    • 1
    • 2
  1. 1.Drug Safety Research UnitSouthamptonUK
  2. 2.IQVIALondonUK

Personalised recommendations