International Trauma Care Conference Telford, May 2010International Trauma Care Conference Telford, May 2010

Point-of-care tetanus immunoassayPoint-of-care tetanus immunoassay

Dr Tricia Scott Ph.D. RGN, Senior Research Fellow,Dr Tricia Scott Ph.D. RGN, Senior Research Fellow,Department of Academic Emergency Medicine,Department of Academic Emergency Medicine,

South Tees Hospitals NHS TrustSouth Tees Hospitals NHS Trust

TetanusTetanus

Life threatening infectionLife threatening infection

Injury infected by clostridium tetaniInjury infected by clostridium tetani

Anaerobic organismAnaerobic organism

Deep penetrating woundsDeep penetrating wounds

Releases potent neurotoxinReleases potent neurotoxin

First symptom is ‘lockjaw’First symptom is ‘lockjaw’

Paralyses musclesParalyses muscles

Woody, R.C. and Ross, E.M. (1989) Neonatal tetanus (St Kilda, 19Woody, R.C. and Ross, E.M. (1989) Neonatal tetanus (St Kilda, 19 thth Century). The Lancet, June 10, p 1339Century). The Lancet, June 10, p 1339

““Between 1855 and 1876 accurate infant birth and death records Between 1855 and 1876 accurate infant birth and death records were kept…During that period there were 41 infant deaths out of 56 were kept…During that period there were 41 infant deaths out of 56 births; most of these deaths were ascribed to “sickness of eight births; most of these deaths were ascribed to “sickness of eight days”days”

……In 1890, the Rev. Angus Fiddes, who was convinced that the In 1890, the Rev. Angus Fiddes, who was convinced that the neonatal tetanus was the result of birth practices, decided to act. neonatal tetanus was the result of birth practices, decided to act. Fiddes believed that the traditional birth ritual of anointing the cut Fiddes believed that the traditional birth ritual of anointing the cut umbilical cord with a rag soaked in salt butter or other oils was umbilical cord with a rag soaked in salt butter or other oils was responsible…responsible…

..Instead of using salt butter, which was scarce on the island, she ..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 (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 was stored in the dried stomach of a solan goose, a container used for years without cleaning.”for years without cleaning.”

Tetanus trajectoryTetanus trajectory

Muscle spasm then rigidity:Muscle spasm then rigidity:

– Initially jaw muscles (lockjaw)Initially jaw muscles (lockjaw)– Leading to neck rigidityLeading to neck rigidity– Localised e.g. cranial nerve palsy after head woundLocalised e.g. cranial nerve palsy after head wound– Seizure–like activitySeizure–like activity– Risus sardonicusRisus sardonicus– Intense painIntense pain– Opisthotonos - intensifies with sudden noisesOpisthotonos - intensifies with sudden noises– Respiratory failure and mortalityRespiratory failure and mortality

TreatmentTreatment

Muscle relaxantsMuscle relaxants

Airway supportAirway support

Human anti-tetanus immunoglobulinHuman anti-tetanus immunoglobulin

Fluid supportFluid support

AntibioticsAntibiotics

Open the wound, cleanse, debrideOpen the wound, cleanse, debride

ITUITU

UK Incidence (10 August 2009) UK Incidence (10 August 2009) WHO ImmunizationWHO Immunizationand Surveillance, Assessment and Monitoringand Surveillance, Assessment and Monitoring

[accessed 30 November 2009][accessed 30 November 2009]

20082008 5520072007 4420062006 3320052005 101020042004 202020032003 141420022002 7720012001 7720002000 2219991999 No No

datadata19981998 No No

datadata

19971997 9919961996 101019951995 7719941994 4419931993 8819921992 7719911991 8819901990 181819891989 222219881988 232319871987 1515

Tetanus immunisationTetanus immunisation

Active immunityActive immunity

Adsorbed Tetanus Toxoid (ATT)Adsorbed Tetanus Toxoid (ATT)

Weakened by formalinWeakened by formalin

Antigen is recognisedAntigen is recognised

Creates antibody responseCreates antibody response

Up to 20 years immunityUp to 20 years immunity

Passive immunityPassive immunity

Human Tetanus Immunoglobulin Human Tetanus Immunoglobulin (HTIG)(HTIG)

Incomplete immunisationIncomplete immunisation

Plus dirty woundPlus dirty wound

Delivers ready-made antibodiesDelivers ready-made antibodies

Also may give antibioticsAlso may give antibiotics

When given with ATT leads to When given with ATT leads to immediate and long-term immunityimmediate and long-term immunity

World Health OrganisationWorld Health Organisation

Five-doses Adsorbed Tetanus Toxoid childhood Five-doses Adsorbed Tetanus Toxoid childhood immunisationimmunisation

2 months2 months3 months3 months4 months4 monthsPre-schoolPre-schoolSchool leaverSchool leaverPlus sixth dose after 10 years and,Plus sixth dose after 10 years and,

One dose of human tetanus immunoglobulin if history of One dose of human tetanus immunoglobulin if history of incomplete immunisation and presenting with a dirty woundincomplete immunisation and presenting with a dirty wound

UK Department of HealthUK Department of Health

Claims five doses of ATT is sufficientClaims five doses of ATT is sufficient

On condition that HTIG is given for high-risk woundsOn condition that HTIG is given for high-risk wounds

Plus ATT for travellers to remote regionsPlus ATT for travellers to remote regions

Reduces adverse reaction ratesReduces adverse reaction rates

Does it guarantee immunity?Does it guarantee immunity?

Does it compromise immune status? Does it compromise immune status?

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

Service evaluationService evaluation

Two accident and emergency departments (A&E) at Two accident and emergency departments (A&E) at South Tees Hospitals NHS TrustSouth Tees Hospitals NHS Trust

Data retrieved for the period 01 November 2008 to 30 Data retrieved for the period 01 November 2008 to 30 November 2009November 2009

Patient age, sexPatient age, sex

Primary and secondary treatment optionsPrimary and secondary treatment options

Literature review conducted in November 2009 suggestedLiterature review conducted in November 2009 suggested

Potential cost-benefit of point-of-care tetanus immunoassayPotential cost-benefit of point-of-care tetanus immunoassay Immediate single analysis test using one drop of patient’s blood Immediate single analysis test using one drop of patient’s blood whilst in the EDwhilst in the ED

Patients do not accurately recall their tetanus immune status Patients do not accurately recall their tetanus immune status (Cooke, 2009; Fishbein, 2006)(Cooke, 2009; Fishbein, 2006)

Could point-of-care tetanus immunoassay provide a cost-benefit Could point-of-care tetanus immunoassay provide a cost-benefit mechanism for swift and accurate tetanus serum antibody levels?mechanism for swift and accurate tetanus serum antibody levels?

Cavenaille and Duchateau (2005) declared a 40% reduction in ED Cavenaille and Duchateau (2005) declared a 40% reduction in ED tetanus boosters and 80% reduction in HTIG administration using tetanus boosters and 80% reduction in HTIG administration using immunoassayimmunoassay

Potential to guarantee definitive treatment options whilst Potential to guarantee definitive treatment options whilst preventing additional risks associated with over-immunisationpreventing additional risks associated with over-immunisation

Any prospective change to the A&E department tetanus Any prospective change to the A&E department tetanus prophylaxis practice must guarantee no less a level of prophylaxis practice must guarantee no less a level of seroprotection than already exists and preferably should enhance seroprotection than already exists and preferably should enhance patient safety, comfort and choicepatient safety, comfort and choice

Data codesData codes

Code 24 Code 24 Tetanus (the category heading) Tetanus (the category heading)

Code 241 Code 241 Tetanus immuneTetanus immune

Active immunizationActive immunization

Code 242Code 242 Tetanus toxoid courseTetanus toxoid course

Code 243Code 243 Tetanus toxoid boosterTetanus toxoid booster

Code 245Code 245 Combined tetanus toxoid, diptheria and polio courseCombined tetanus toxoid, diptheria and polio course

Code 246Code 246 Combined tetanus toxoid, diptheria and polio Combined tetanus toxoid, diptheria and polio boosterbooster

Passive immunizationPassive immunization

Code 244Code 244 Human anti-tetanus immunoglobulin Human anti-tetanus immunoglobulin

Trust expenditure on tetanus vaccinationTrust expenditure on tetanus vaccination

DTP vaccination is £5.34, HTIG is £27.98. The Trust DTP vaccination is £5.34, HTIG is £27.98. The Trust administered 454 DTP vaccinations (2009-2010), a total of administered 454 DTP vaccinations (2009-2010), a total of £2424.36 and 9 HTIG vaccinations at a total of £251.82£2424.36 and 9 HTIG vaccinations at a total of £251.82

Disposables concern: needles at 0.01p each; kidney dishes Disposables concern: needles at 0.01p each; kidney dishes at 0.029p each and; pre-injection wipes at 0.017p eachat 0.029p each and; pre-injection wipes at 0.017p each

Individual price of a selected immunoassay product is £4.87 Individual price of a selected immunoassay product is £4.87 purchased in packages of 40 complete with purchased in packages of 40 complete with immunochromatographic platforms, safety lancets, pipettes, immunochromatographic platforms, safety lancets, pipettes, stickers and diluentstickers and diluent

DTPDTP @@ £5.34 x 454£5.34 x 454 = = 2424.36 2424.36HTIG HTIG @@ £27.98 x 9£27.98 x 9 = = 251.82 251.82Sub-totalSub-total 2676.18 2676.18

DisposablesDisposablesNeedles FTR044Needles FTR044 @@ £1.44 pk100£1.44 pk100 == 6.66 6.66Kidney dishes FTA108Kidney dishes FTA108 @@ £2.98 pk100£2.98 pk100 == 13.79 13.79Injection wipes MRB308Injection wipes MRB308 @@ £1.73 pk100£1.73 pk100 == 8.00 8.00 Sub-totalSub-total 28.45 28.45

Total (current practice)Total (current practice) 2704.63 2704.63

ImmunoassayImmunoassay @@ £4.87 x 463 £4.87 x 463 == 2254.81 2254.81

Estimated savingEstimated saving 449.82 449.82

ConclusionConclusion

Estimated cost-savings of £449.82 over a 12-month period appears Estimated cost-savings of £449.82 over a 12-month period appears minimalminimal

However, the use of immunoassay extends beyond a cost-saving However, the use of immunoassay extends beyond a cost-saving calculation to one which fully embraces patient choice.calculation to one which fully embraces patient choice.

Some instances will confirm the unprotected status of patients who Some instances will confirm the unprotected status of patients who will then need a vaccination (active, passive or both vaccines) with will then need a vaccination (active, passive or both vaccines) with associated costs.associated costs.

The worst financial scenario would occur should this group be in the The worst financial scenario would occur should this group be in the majority.majority.

Countered by the possibility that those who are seroprotected do not Countered by the possibility that those who are seroprotected do not receive an unnecessary injection. receive an unnecessary injection.

Impact on the patient experience Impact on the patient experience

Provides accurate immune status within ten minutesProvides accurate immune status within ten minutes

Ensures only tested patients with tetanus antibodies below the Ensures only tested patients with tetanus antibodies below the seroprotection level would receive the required prophylaxisseroprotection level would receive the required prophylaxis

Reduces invasive intervention from a deep intramuscular injection Reduces invasive intervention from a deep intramuscular injection to a finger pin-prick for seroprotected patientsto a finger pin-prick for seroprotected patients

Reduces risk of complications associated with unnecessary Reduces risk of complications associated with unnecessary tetanus vaccination in seroprotected patients e.g. pain at injection tetanus vaccination in seroprotected patients e.g. pain at injection site, mild fever, infection, abscess, cellulitis and impact on site, mild fever, infection, abscess, cellulitis and impact on hospital length of stay, haematoma, neuropathy, allergic response hospital length of stay, haematoma, neuropathy, allergic response including anaphylaxisincluding anaphylaxis

Reduces risk of needle-stick injury from unnecessary vaccinationReduces risk of needle-stick injury from unnecessary vaccination

ReferencesReferences

Cavenaille JC and Duchateau J.Cavenaille JC and Duchateau J. 2005 2005 ‘Use of Tetanos Quick Stick (TQS) in emergency ‘Use of Tetanos Quick Stick (TQS) in emergency departments’.departments’. Urgences Congress 2005, Paris, France. Urgences Congress 2005, Paris, France. Cooke MWCooke MW 2009 Are current UK tetanus prophylaxis procedures for wound management optimal? 2009 Are current UK tetanus prophylaxis procedures for wound management optimal? Emerg Med JEmerg Med J..2626:845-8:845-8Department of HealthDepartment of Health 2006 2006 Immunisation against infectious disease – ‘The Green Book’.Immunisation against infectious disease – ‘The Green Book’. At: At: http://www.dh.gov.uk/en/Policyandguidance [accessed 25 January 2010]. [accessed 25 January 2010].Fishbein, DB. Willis CB, Cassidy WM, et al.Fishbein, DB. Willis CB, Cassidy WM, et al. Determining indications for adult vaccination: patient Determining indications for adult vaccination: patient self-assessment, medical record, or both? self-assessment, medical record, or both? VaccineVaccine 2006; 2006;2424:803-18.:803-18.Parker M.Parker M. Emergency nurse practitioner management of tetanus status and tetanus-prone Emergency nurse practitioner management of tetanus status and tetanus-prone wounds. wounds. International Emergency NursingInternational Emergency Nursing. 2008;. 2008;1616:266-71.:266-71.Savage JE, McGuiness S, Crowcroft NS.Savage JE, McGuiness S, Crowcroft NS. Audit of tetanus prevention knowledge and practices in Audit of tetanus prevention knowledge and practices in accident and emergency departments in England. Emerg Med J. 2007;accident and emergency departments in England. Emerg Med J. 2007;2424:417-21.:417-21.Simonsen O, Bentzon MW, Kjeldsen K, et alSimonsen O, Bentzon MW, Kjeldsen K, et al. Evaluation of vaccination requirements to secure . Evaluation of vaccination requirements to secure continuous antitoxin immunity to tetanus. continuous antitoxin immunity to tetanus. VaccineVaccine, 1987;, 1987;55:115-22.:115-22.Simonsen O, Badsberg JH,Simonsen O, Badsberg JH, Kjeldsen K, et alKjeldsen K, et al. 1986 The fall-off in serum concentration of tetanus . 1986 The fall-off in serum concentration of tetanus antitoxin immunity to tetanus after primary and booster vaccination. antitoxin immunity to tetanus after primary and booster vaccination. Acta Pathol Microbiol Immunol Acta Pathol Microbiol Immunol ScandScand 1986; 1986;9494:77-82.:77-82.Stubbe, M. Mortelmans, JM. Desruelles, D. Swinnen, R. Vranckx, M. Brasseur, E. Lheureux, Stubbe, M. Mortelmans, JM. Desruelles, D. Swinnen, R. Vranckx, M. Brasseur, E. Lheureux, PE.PE. Improving tetanus prophylaxis in the emergency department: a prospective, double-blind cost- Improving tetanus prophylaxis in the emergency department: a prospective, double-blind cost-effectiveness study. Emerg Med J. 2007; effectiveness study. Emerg Med J. 2007; 2424:648-53:648-53World Health Organisation.World Health Organisation. 2009 WHO Immunization and Surveillance Assessment and 2009 WHO Immunization and Surveillance Assessment and Monitoring at: Monitoring at: http://www.who.int/immunization_monitoring/en/globalsummary/countryprofileresult.cfm [accessed [accessed 30 November 2009]30 November 2009]

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