Pharmacy World and Science

, Volume 25, Issue 3, pp 98–103 | Cite as

Risk assessment in clinical pharmacy

  • P.T.W. Hudson
  • H.-J. Guchelaar


Medication error forms a major proportion of the errors in the medical system. Despite many studies of adverse drug events, there are no systematic ways of ensuring safety, or of assessing how safe a pharmaceutical system is. Risk assessment is required in hazardous industries such as nuclear power or oil and gas. Risk assessments involve identifying the defences and assessing their effectiveness and are relatively uncommon in clinical pharmacy , as opposed to reactive approaches involving incident analyses. Risk factors, that degrade barriers, can be identified and their effect measured. A risk assessment structure for pharmacy processes is proposed that can also be used to support incident investigation and analysis processes and provide a standard for audit.

Medication error Methodology Risk assessment Safety management 


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  1. 1.
    Kohn L, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Committee on Quality of Health Care in America; Institute of Medicine. National Academy Press: Washington, DC, 2000.Google Scholar
  2. 2.
    Audit Commission, A spoonful of sugar. Medicines management in NHS hospitals. London: Audit Commission, 2001.Google Scholar
  3. 3.
    NRC Handelsblad, 1 May 2001.Google Scholar
  4. 4.
    Medication Safety Task Force, 2001.Google Scholar
  5. 5.
    Phillips DP, Christenfeld N, Glynn LM. Increase in US medication-error deaths between 1983 and 1993. Lancet 1998; 351: 643–4.Google Scholar
  6. 6.
    Bogner MS, Human error in medicine. Hillsdale, New Jersey: Lawrence Erlbaum, 1994.Google Scholar
  7. 7.
    Vincent C, Taylor-Adams S, Stanhope N. Framework for analysing risk and safety in clinical medicine. BMJ 1998; 316: 1154–7.Google Scholar
  8. 8.
    Senders J. Medical devices, medical errors and medical accidents. In M. Bogner, editor, Medical error. Hillsdale, New Jersey: Lawrence Erlbaum, 1994Google Scholar
  9. 9.
    Van Cott H. Human errors: their causes and reduction. In M. Bogner, editor, Medical error. Hillsdale, New Jersey: Lawrence Erlbaum, 1994.Google Scholar
  10. 10.
    Bernstein PL. Against the gods: the remarkable story of risk. New York: John Wiley & Sons, 1996.Google Scholar
  11. 11.
    Berwick DM. Not again! BMJ 2001; 322: 247–8.Google Scholar
  12. 12.
    Bickford Smith PJ. Designing safer medical devices requires financial and medical support. BMJ 2001; 322: 548.Google Scholar
  13. 13.
    Seal JRC. Erroneous intrathecal injections result from a problem with protocols. BMJ 2001; 322: 548.Google Scholar
  14. 14.
    Cook RI. Combatting medical errors - letter in reply. Lancet 2000; 356: 167.Google Scholar
  15. 15.
    Kelly WN. Potential risks and prevention, part 1: fatal adverse drug events. Am J Health Syst Pharm 2001; 58: 1317–24Google Scholar
  16. 16.
    Phillips J, Beam S, Brinker A, Holquist C, Honig P, Lee LY, Pamer C. Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm 2001; 58: 1835–41.Google Scholar
  17. 17.
    Kelly WN. Potential risks and prevention, part 2: druginduced permanent disabilities. Am J Health Syst Pharm 2001; 58: 1325–9Google Scholar
  18. 18.
    Reason JT, Carthey J, de Leval MR. Diagnosing 'Vulnerable System Syndrome': a prerequisite to effective risk management. Qual Health Care 2000; 10: 21–5.Google Scholar
  19. 19.
    Reason JT. Human error. Cambridge: Cambridge University Press, 1990.Google Scholar
  20. 20.
    Reason JT. Managing the risks of organisational accidents. Aldershot, UK: Ashgate, 1997.Google Scholar
  21. 21.
    Turner B. Man-made disasters. Oxford: Wykeham, 1978.Google Scholar
  22. 22.
    Wagenaar WA, Groeneweg J. 100 Accidents at sea - multiple causes and impossible consequences. Int J Man Machine Studies 1987; 27: 587–98.Google Scholar
  23. 23.
    Wagenaar J, Groeneweg J, Hudson PTW, Reason JT. Safety in the oil industry. Ergonomics 1994; 37: 1999–2013.Google Scholar
  24. 24.
    Reason JT, Shotton R, Wagenaar WA, Groeneweg J, Hudson PTW. Tripod - a principled approach to safety. Leiden University, Report for Shell International Exploration and Production, 1987.Google Scholar
  25. 25.
    Maurino D, Reason JT, Johnstoen N, Lee R. Beyond aviation human factors. Aldershot, UK: Ashgate, 1995.Google Scholar
  26. 26.
    Reason J. Human error: models and management. BMJ 2000; 320: 768–70.Google Scholar
  27. 27.
    Hudson PTW, Reason JT, Wagenaar WA, Bentley PD, Primrose M, Visser JP. Tripod Delta: proactive approach to enhanced safety. J Petroleum Technol 1994; 46: 58–62.Google Scholar
  28. 28.
    vd Graaf, GC, Milne D, Primrose M. HSE cases - some lessons learned. Exploration and Production Newsletter. Shell International, 1996.Google Scholar
  29. 29.
    Cullen The Hon Lord D. The public inquiry into the Piper Alpha disaster. 2 Vols. London: HMSO, 1990.Google Scholar
  30. 30.
    Tutuarima JA, Linskens ME, de Wit APM, Taat CW, de Haan RJ, Bossuyt PPM. Zuster, dokter of patient - incidentie en preventie van medicatiefouten in het AMC; een foutenanalyse. [Nurse, doctor or patient - incidence and prevention of medication errors in the AMC; an error analysis.] Internal Report, Amsterdam Medical Centre, 1995.Google Scholar
  31. 31.
    Dean D, Schachter M, Vincent C, Barber N. Causes of prescribing errors in hospital in-patients: a prospective study Lancet 2002; 359: 1373–8Google Scholar
  32. 32.
    Hudson PTW, Verschuur WLG, Lawton R, Parker D, Reason JT. Bending the rules II - the violation manual. Centre for Safety Science, Leiden University, 1997.Google Scholar

Copyright information

© Kluwer Academic Publishers 2003

Authors and Affiliations

  • P.T.W. Hudson
    • 1
  • H.-J. Guchelaar
    • 2
  1. 1.Centre for Safety Science, Department of Psychology, Faculty of Social SciencesLeiden UniversityLeidenThe Netherlands
  2. 2.Department of Clinical Pharmacy and Academic Medical centreUniversity of AmsterdamThe Netherlands

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