The Society has made the following submission to Pharmac in support of a current funding proposal for EpiPens. 


Submission to PHARMAC on the proposal to list adrenaline auto-injectors for emergency treatment of severe anaphylaxis

 

1.        This submission is made on behalf of the Nurses Society of New Zealand and Te Uniana of NSNZ Incorporated (“NSNZ”). NSNZ has members across all parts of the health service.

2.       NSNZ strongly supports the proposal to list adrenaline auto-injectors (AAIs) for emergency treatment of severe anaphylaxis, on both health and financial grounds. Access to AAIs provides New Zealanders with the best chance of surviving, should they suffer a serious anaphylactic reaction in the community, reducing mortality and morbidity.

3.       There is currently a worldwide increase in the rate of anaphylactic reactions.[1] This increase is especially seen in young people[2] and comes with a significant health and economic cost.[3]   

4.       Due to ethical barriers, there is a lack of randomised controlled trials on the efficacy of the use of adrenaline in the management of anaphylaxis. However, clinical experience and fatality reports from incidents where adrenaline was not administered for persons dying from anaphylaxis have resulted in a consensus of opinion that adrenaline is the best treatment for severe anaphylactic reactions. 

5.       Clearly, anaphylaxis happens quickly, it is unpredictable and progresses rapidly.  Many cases of fatal anaphylaxis have been found to be a result of adrenaline not being delivered in a timely manner or not administered at all.[4] AAIs enable the timely administration of an accurate dose of adrenaline, and in the correct manner, in the event of an anaphylactic emergency.

6.       The current funding for adrenaline in ampoules, which must be drawn up into a syringe at the correct volume then fitted with the appropriate needle and administered manually, effectively means that the safe, timely access to this life-saving treatment is not available in the community for many New Zealanders.

7.       AAIs are accepted as the gold-standard treatment for severe anaphylaxis in the community.[5]  Subsidised AAIs have been available in Australia since 2003 and in the United Kingdom since 2004. 

8.       AAIs have been shown to reduce mortality. During anaphylactic incidents where adrenaline is administered correctly, an 83% reduction in mortality rates can be expected[6] followed by a reduced duration of hospitalisation.[7]  

9.       As well as reducing mortality and morbidity, the availability of AAIs has the potential to reduce anxiety for those affected by severe anaphylaxis, including individual sufferers and their families and caregivers. Between 40% and 50% of patients who have suffered a severe anaphylactic reaction experience post-traumatic stress disorder and between 70% and 75% will experience anxiety or depression.[8] The quality of life of parents and caregivers of young people affected by anaphylaxis has been shown to be improved by the availability of AAIs, with a resulting reduction in anxiety for between 64% and 70% of study participants.[9]

10.    Training in the use of AAIs will be essential, to ensure that those who are required to use them are confident that they can do so correctly in a stressful situation. Potential users would need to know how to recognise the symptoms of anaphylaxis and how to properly administer adrenaline using the AAI.

11.     Severe anaphylaxis has been shown to frequently occur in individuals who have had no previous severe reactions.[10] For this reason, NSNZ supports the inclusion for funding of individuals who, despite not having suffered from severe anaphylaxis in the past, are assessed to be at significant risk of a future reaction.

12.     NSNZ also supports the proposal for the provision of two AAIs. It is essential that a second adrenaline dose be available, if required, for ongoing or progressive symptoms, following the administration of a first dose.[11]

13.    For many people with potentially serious allergies, access to AAIs is vital. The proposal to list AAIs for the emergency treatment of severe anaphylaxis will reduce mortality and morbidity for these New Zealanders, as well as reducing their anxiety and that of their families and caregivers.

 

[1] Yang, M.S., Kim, J.Y., & Kim, B.K. (2017). True rise in anaphylaxis incidence: epidemiologic study based on a national health insurance database. Medicine, 96(5).

[2] Lin, R.Y., Anderson, A.S., Shah, J.N., & Nurruzzaman, F. (2008). Increasing anaphylaxis hospitalisations in the first two decades of life: New York State, 1990–2006. Annals of Allergy, Asthma & Immunology, 101(4), 387–393.

[3] Turner, P.J., Campbell, D.E., Motosue, M.S., & Campbell, R.L. (2020). Global trends in anaphylaxis epidemiology and clinical implications. In Practice 8(4), 1169–1176.

[4] Soar, J., Pumphrey, R., Cant, A., Clarke, S., Corbett, A., & Dawson, P. (2008). Working group of the Resuscitation Council (UK). Emergency treatment of anaphylactic reactions – guidelines for healthcare providers. Resuscitation, 77(2), 157–169.

[5] McDonald, E.M., & Cooper, E. (2019). When every second counts: ampoule versus adrenaline auto-injector administration for life-threatening allergy. New Zealand Medical Journal, 132(1505), 79–82.

[6] Pumphrey, R.S. (2000). Lessons for management of anaphylaxis from a study of fatal reactions. Clinical and experimental allergy, 30(8), 1144–1150.

[7] Gold, M.S., & Sainsbury, R. (2000). First aid anaphylaxis management in children who were prescribed an epinephrine autoinjector device (EpiPen). Journal of Allergy and Clinical Immunology, 106(1), 171–176.

[8] Lee, Y., Chang H.Y., Kim S.H., Yang, M.S., Koh, Y.I., Kang H.R., & Ye, Y.M. (2020). A prospective observation of psychological distress in patients with anaphylaxis. Allergy, Asthma and Immunology Research, 12(3), 496–506.

[9] Allen C.W., Bidarkar M.S., vanNunen S.A., & Campbell D.E. (2015). Factors impacting parental burden in food-allergic children. Journal of Paediatrics and Child Health, 51(7), 696–698.

[10] Pumphrey R. (2004). Anaphylaxis: can we tell who is at risk of fatal reaction? Current opinion in allergy and clinical immunology, 4(4), 285–290.

[11] Lieberman, P., Nicklas, R.A., Oppenheim, I., Kemp, S.F., Lang, D.M., & Bernstein, D.I. (2010). The diagnosis and management of anaphylaxis practice parameter: 2010 update. Journal of Allergy and Clinical Immunology, 126(3), 477–480.

 

The Society has made the following submission to Pharmac in support of a current funding proposal for EpiPens. 


Submission to PHARMAC on the proposal to list adrenaline auto-injectors for emergency treatment of severe anaphylaxis

 

1.        This submission is made on behalf of the Nurses Society of New Zealand and Te Uniana of NSNZ Incorporated (“NSNZ”). NSNZ has members across all parts of the health service.

2.       NSNZ strongly supports the proposal to list adrenaline auto-injectors (AAIs) for emergency treatment of severe anaphylaxis, on both health and financial grounds. Access to AAIs provides New Zealanders with the best chance of surviving, should they suffer a serious anaphylactic reaction in the community, reducing mortality and morbidity.

3.       There is currently a worldwide increase in the rate of anaphylactic reactions.[1] This increase is especially seen in young people[2] and comes with a significant health and economic cost.[3]   

4.       Due to ethical barriers, there is a lack of randomised controlled trials on the efficacy of the use of adrenaline in the management of anaphylaxis. However, clinical experience and fatality reports from incidents where adrenaline was not administered for persons dying from anaphylaxis have resulted in a consensus of opinion that adrenaline is the best treatment for severe anaphylactic reactions. 

5.       Clearly, anaphylaxis happens quickly, it is unpredictable and progresses rapidly.  Many cases of fatal anaphylaxis have been found to be a result of adrenaline not being delivered in a timely manner or not administered at all.[4] AAIs enable the timely administration of an accurate dose of adrenaline, and in the correct manner, in the event of an anaphylactic emergency.

6.       The current funding for adrenaline in ampoules, which must be drawn up into a syringe at the correct volume then fitted with the appropriate needle and administered manually, effectively means that the safe, timely access to this life-saving treatment is not available in the community for many New Zealanders.

7.       AAIs are accepted as the gold-standard treatment for severe anaphylaxis in the community.[5]  Subsidised AAIs have been available in Australia since 2003 and in the United Kingdom since 2004. 

8.       AAIs have been shown to reduce mortality. During anaphylactic incidents where adrenaline is administered correctly, an 83% reduction in mortality rates can be expected[6] followed by a reduced duration of hospitalisation.[7]  

9.       As well as reducing mortality and morbidity, the availability of AAIs has the potential to reduce anxiety for those affected by severe anaphylaxis, including individual sufferers and their families and caregivers. Between 40% and 50% of patients who have suffered a severe anaphylactic reaction experience post-traumatic stress disorder and between 70% and 75% will experience anxiety or depression.[8] The quality of life of parents and caregivers of young people affected by anaphylaxis has been shown to be improved by the availability of AAIs, with a resulting reduction in anxiety for between 64% and 70% of study participants.[9]

10.    Training in the use of AAIs will be essential, to ensure that those who are required to use them are confident that they can do so correctly in a stressful situation. Potential users would need to know how to recognise the symptoms of anaphylaxis and how to properly administer adrenaline using the AAI.

11.     Severe anaphylaxis has been shown to frequently occur in individuals who have had no previous severe reactions.[10] For this reason, NSNZ supports the inclusion for funding of individuals who, despite not having suffered from severe anaphylaxis in the past, are assessed to be at significant risk of a future reaction.

12.     NSNZ also supports the proposal for the provision of two AAIs. It is essential that a second adrenaline dose be available, if required, for ongoing or progressive symptoms, following the administration of a first dose.[11]

13.    For many people with potentially serious allergies, access to AAIs is vital. The proposal to list AAIs for the emergency treatment of severe anaphylaxis will reduce mortality and morbidity for these New Zealanders, as well as reducing their anxiety and that of their families and caregivers.

 

[1] Yang, M.S., Kim, J.Y., & Kim, B.K. (2017). True rise in anaphylaxis incidence: epidemiologic study based on a national health insurance database. Medicine, 96(5).

[2] Lin, R.Y., Anderson, A.S., Shah, J.N., & Nurruzzaman, F. (2008). Increasing anaphylaxis hospitalisations in the first two decades of life: New York State, 1990–2006. Annals of Allergy, Asthma & Immunology, 101(4), 387–393.

[3] Turner, P.J., Campbell, D.E., Motosue, M.S., & Campbell, R.L. (2020). Global trends in anaphylaxis epidemiology and clinical implications. In Practice 8(4), 1169–1176.

[4] Soar, J., Pumphrey, R., Cant, A., Clarke, S., Corbett, A., & Dawson, P. (2008). Working group of the Resuscitation Council (UK). Emergency treatment of anaphylactic reactions – guidelines for healthcare providers. Resuscitation, 77(2), 157–169.

[5] McDonald, E.M., & Cooper, E. (2019). When every second counts: ampoule versus adrenaline auto-injector administration for life-threatening allergy. New Zealand Medical Journal, 132(1505), 79–82.

[6] Pumphrey, R.S. (2000). Lessons for management of anaphylaxis from a study of fatal reactions. Clinical and experimental allergy, 30(8), 1144–1150.

[7] Gold, M.S., & Sainsbury, R. (2000). First aid anaphylaxis management in children who were prescribed an epinephrine autoinjector device (EpiPen). Journal of Allergy and Clinical Immunology, 106(1), 171–176.

[8] Lee, Y., Chang H.Y., Kim S.H., Yang, M.S., Koh, Y.I., Kang H.R., & Ye, Y.M. (2020). A prospective observation of psychological distress in patients with anaphylaxis. Allergy, Asthma and Immunology Research, 12(3), 496–506.

[9] Allen C.W., Bidarkar M.S., vanNunen S.A., & Campbell D.E. (2015). Factors impacting parental burden in food-allergic children. Journal of Paediatrics and Child Health, 51(7), 696–698.

[10] Pumphrey R. (2004). Anaphylaxis: can we tell who is at risk of fatal reaction? Current opinion in allergy and clinical immunology, 4(4), 285–290.

[11] Lieberman, P., Nicklas, R.A., Oppenheim, I., Kemp, S.F., Lang, D.M., & Bernstein, D.I. (2010). The diagnosis and management of anaphylaxis practice parameter: 2010 update. Journal of Allergy and Clinical Immunology, 126(3), 477–480.