International Trauma Care Conference Telford, May 2010 Point-of-care tetanus immunoassay

1. International Trauma Care Conference Telford, May 2010Point-of-care tetanus immunoassay Dr Tricia Scott Ph.D. RGN, Senior Research Fellow, Department of Academic Emergency Medicine, South Tees Hospitals NHS Trust

3. Tetanus Life threatening infection Injury infected by clostridium tetani Anaerobic organism Deep penetrating wounds Releases potent neurotoxin First symptom is ‘lockjaw’ Paralyses muscles

4. Woody, R.C. and Ross, E.M. (1989) Neonatal tetanus (St Kilda, 19th Century). The Lancet, June 10, p 1339 “Between 1855 and 1876 accurate infant birth and death records were kept…During that period there were 41 infant deaths out of 56 births; most of these deaths were ascribed to “sickness of eight days” …In 1890, the Rev. Angus Fiddes, who was convinced that the neonatal tetanus was the result of birth practices, decided to act. Fiddes believed that the traditional birth ritual of anointing the cut umbilical cord with a rag soaked in salt butter or other oils was responsible… ..Instead of using salt butter, which was scarce on the island, she (midwife) used the ruby-red oil from the fulmar, a local bird. This oil was stored in the dried stomach of a solan goose, a container used for years without cleaning.”

5. Tetanus trajectory Muscle spasm then rigidity: • Initially jaw muscles (lockjaw) • Leading to neck rigidity • Localised e.g. cranial nerve palsy after head wound • Seizure–like activity • Risus sardonicus • Intense pain • Opisthotonos - intensifies with sudden noises • Respiratory failure and mortality

6. Treatment Muscle relaxants Airway support Human anti-tetanus immunoglobulin Fluid support Antibiotics Open the wound, cleanse, debride ITU

7. 2008 5 2007 4 2006 3 2005 10 2004 20 2003 14 2002 7 2001 7 2000 2 1999 No data 1998 No data 1997 9 1996 10 1995 7 1994 4 1993 8 1992 7 1991 8 1990 18 1989 22 1988 23 1987 15 UK Incidence (10 August 2009) WHO Immunizationand Surveillance, Assessment and Monitoring[accessed 30 November 2009]

8. Active immunity Adsorbed Tetanus Toxoid (ATT) Weakened by formalin Antigen is recognised Creates antibody response Up to 20 years immunity Passive immunity Human Tetanus Immunoglobulin (HTIG) Incomplete immunisation Plus dirty wound Delivers ready-made antibodies Also may give antibiotics When given with ATT leads to immediate and long-term immunity Tetanus immunisation

9. World Health Organisation Five-doses Adsorbed Tetanus Toxoid childhood immunisation 2 months 3 months 4 months Pre-school School leaver Plus sixth dose after 10 years and, One dose of human tetanus immunoglobulin if history of incomplete immunisation and presenting with a dirty wound

10. UK Department of Health Claims five doses of ATT is sufficient On condition that HTIG is given for high-risk wounds Plus ATT for travellers to remote regions Reduces adverse reaction rates Does it guarantee immunity? Does it compromise immune status?

11. “Emergency practitioners in England are more likely to administer tetanus prophylaxis in line with World Health Organisation rather than England’s (29% of departments) guidelines suggesting a more cautious decision-making process” (Savage et al 2007).

12. Service evaluation Two accident and emergency departments (A&E) at South Tees Hospitals NHS Trust Data retrieved for the period 01 November 2008 to 30 November 2009 Patient age, sex Primary and secondary treatment options

13. Literature review conducted in November 2009 suggested Potential cost-benefit of point-of-care tetanus immunoassay Immediate single analysis test using one drop of patient’s blood whilst in the ED Patients do not accurately recall their tetanus immune status (Cooke, 2009; Fishbein, 2006) Could point-of-care tetanus immunoassay provide a cost-benefit mechanism for swift and accurate tetanus serum antibody levels?

14. Cavenaille and Duchateau (2005) declared a 40% reduction in ED tetanus boosters and 80% reduction in HTIG administration using immunoassay Potential to guarantee definitive treatment options whilst preventing additional risks associated with over-immunisation Any prospective change to the A&E department tetanus prophylaxis practice must guarantee no less a level of seroprotection than already exists and preferably should enhance patient safety, comfort and choice

15. Data codes Code 24 Tetanus (the category heading) Code 241 Tetanus immune Active immunization Code 242 Tetanus toxoid course Code 243 Tetanus toxoid booster Code 245 Combined tetanus toxoid, diptheria and polio course Code 246 Combined tetanus toxoid, diptheria and polio booster Passive immunization Code 244 Human anti-tetanus immunoglobulin

16. Trust expenditure on tetanus vaccination DTP vaccination is £5.34, HTIG is £27.98. The Trust administered 454 DTP vaccinations (2009-2010), a total of £2424.36 and 9 HTIG vaccinations at a total of £251.82 Disposables concern: needles at 0.01p each; kidney dishes at 0.029p each and; pre-injection wipes at 0.017p each Individual price of a selected immunoassay product is £4.87 purchased in packages of 40 complete with immunochromatographic platforms, safety lancets, pipettes, stickers and diluent

17. DTP @ £5.34 x 454 = 2424.36 HTIG @ £27.98 x 9 = 251.82 Sub-total 2676.18 Disposables Needles FTR044 @ £1.44 pk100 = 6.66 Kidney dishes FTA108 @ £2.98 pk100 = 13.79 Injection wipes MRB308 @ £1.73 pk100 = 8.00 Sub-total 28.45 Total (current practice) 2704.63 Immunoassay @ £4.87 x 463 = 2254.81 Estimated saving 449.82

18. Conclusion Estimated cost-savings of £449.82 over a 12-month period appears minimal However, the use of immunoassay extends beyond a cost-saving calculation to one which fully embraces patient choice. Some instances will confirm the unprotected status of patients who will then need a vaccination (active, passive or both vaccines) with associated costs. The worst financial scenario would occur should this group be in the majority. Countered by the possibility that those who are seroprotected do not receive an unnecessary injection.

19. Impact on the patient experience Provides accurate immune status within ten minutes Ensures only tested patients with tetanus antibodies below the seroprotection level would receive the required prophylaxis Reduces invasive intervention from a deep intramuscular injection to a finger pin-prick for seroprotected patients Reduces risk of complications associated with unnecessary tetanus vaccination in seroprotected patients e.g. pain at injection site, mild fever, infection, abscess, cellulitis and impact on hospital length of stay, haematoma, neuropathy, allergic response including anaphylaxis Reduces risk of needle-stick injury from unnecessary vaccination

20. References Cavenaille JC and Duchateau J. 2005 ‘Use of Tetanos Quick Stick (TQS) in emergency departments’. Urgences Congress 2005, Paris, France. Cooke MW 2009 Are current UK tetanus prophylaxis procedures for wound management optimal? Emerg Med J.26:845-8 Department of Health 2006 Immunisation against infectious disease – ‘The Green Book’. At: http://www.dh.gov.uk/en/Policyandguidance [accessed 25 January 2010]. Fishbein, DB. Willis CB, Cassidy WM, et al. Determining indications for adult vaccination: patient self-assessment, medical record, or both? Vaccine 2006;24:803-18. Parker M. Emergency nurse practitioner management of tetanus status and tetanus-prone wounds. International Emergency Nursing. 2008;16:266-71. Savage JE, McGuiness S, Crowcroft NS. Audit of tetanus prevention knowledge and practices in accident and emergency departments in England. Emerg Med J. 2007;24:417-21. Simonsen O, Bentzon MW, Kjeldsen K, et al. Evaluation of vaccination requirements to secure continuous antitoxin immunity to tetanus. Vaccine, 1987;5:115-22. Simonsen O, Badsberg JH,Kjeldsen K, et al. 1986 The fall-off in serum concentration of tetanus antitoxin immunity to tetanus after primary and booster vaccination. Acta Pathol Microbiol Immunol Scand 1986;94:77-82. Stubbe, M. Mortelmans, JM. Desruelles, D. Swinnen, R. Vranckx, M. Brasseur, E. Lheureux, PE. Improving tetanus prophylaxis in the emergency department: a prospective, double-blind cost-effectiveness study. Emerg Med J. 2007; 24:648-53 World Health Organisation. 2009 WHO Immunization and Surveillance Assessment and Monitoring at: http://www.who.int/immunization_monitoring/en/globalsummary/countryprofileresult.cfm [accessed 30 November 2009]

21. Thank you