prescription of self-injectable epinephrine clinical audit g.krupa, m.thanneermalai paediatric...

PRESCRIPTION OF PRESCRIPTION OF SELF-INJECTABLE SELF-INJECTABLE

EPINEPHRINEEPINEPHRINE

Clinical AuditClinical Audit

G.Krupa, M.ThanneermalaiG.Krupa, M.Thanneermalai

Paediatric Department, YDHPaediatric Department, YDH

9/4/20089/4/2008

AnaphylaxisAnaphylaxisAnaphylaxis is an Anaphylaxis is an acute, systemic, and life-threatening acute, systemic, and life-threatening reactionreaction, usually mediated by an immunologic mechanism , usually mediated by an immunologic mechanism involving immunoglobulin E, that results in sudden systemic involving immunoglobulin E, that results in sudden systemic release of mast-cell and basophile mediators such as release of mast-cell and basophile mediators such as histamine and tryptase.histamine and tryptase.

Anaphylaxis has many clinical presentations, but Anaphylaxis has many clinical presentations, but respiratory compromise and cardiovascular collapse cause respiratory compromise and cardiovascular collapse cause the greatest concern, because they can potentially lead to the greatest concern, because they can potentially lead to fatalities. fatalities.

Clinical Criteria for Diagnosing Clinical Criteria for Diagnosing AnaphylaxisAnaphylaxis

((Allergy Clin ImmunolAllergy Clin Immunol. 2006). 2006)

Criterion 1Criterion 1Acute onset of an illness (minutes to several hours) with Acute onset of an illness (minutes to several hours) with

involvement of the skin and/or mucosal tissue (eg, involvement of the skin and/or mucosal tissue (eg, generalized hives, pruritus, or flushing, swollen generalized hives, pruritus, or flushing, swollen lips/tongue/uvula) and at least 1 of the following:lips/tongue/uvula) and at least 1 of the following:

a. Respiratory compromise (eg, dyspnea, a. Respiratory compromise (eg, dyspnea, wheeze/bronchospasm, stridor, reduced peak wheeze/bronchospasm, stridor, reduced peak expiratory flow, hypoxemia)expiratory flow, hypoxemia)

b. Reduced blood pressure or associated symptoms of b. Reduced blood pressure or associated symptoms of end-organ dysfunction (eg, hypotonia [collapse], end-organ dysfunction (eg, hypotonia [collapse], syncope, incontinence)syncope, incontinence)


((Allergy Clin ImmunolAllergy Clin Immunol. 2006). 2006) Criterion 2Criterion 2Two or more of the following that occur rapidly after exposure to a Two or more of the following that occur rapidly after exposure to a

likely allergen for that patient (minutes to several hours):likely allergen for that patient (minutes to several hours):

a. Involvement of the skin/mucosal tissue (eg, generalized hives, a. Involvement of the skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula)itch/flush, swollen lips/tongue/uvula)

b. Respiratory compromise (eg, dyspnea, wheeze/bronchospasm, b. Respiratory compromise (eg, dyspnea, wheeze/bronchospasm, stridor, reduced peak expiratory flow, hypoxemia)stridor, reduced peak expiratory flow, hypoxemia)

c. Reduced blood pressure or associated symptoms (eg, hypotonia c. Reduced blood pressure or associated symptoms (eg, hypotonia [collapse], syncope, incontinence)[collapse], syncope, incontinence)

d. Persistent gastrointestinal symptoms (eg, crampy abdominal pain, d. Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)vomiting)



Criterion 3Criterion 3Reduced blood pressure after exposure to known allergen for Reduced blood pressure after exposure to known allergen for

that patient (minutes to several hours)that patient (minutes to several hours)

Fulfilling any 1 criterion indicates that Fulfilling any 1 criterion indicates that

anaphylaxis is highly likelyanaphylaxis is highly likely

* * Mast cell serum tryptase is raised up to 5 hours following an Mast cell serum tryptase is raised up to 5 hours following an anaphylactic reaction.anaphylactic reaction.



Additional symptoms and signs that may Additional symptoms and signs that may occur during anaphylaxis include:occur during anaphylaxis include:morbilliform rash, pruritus (skin signs aid in recognition but may morbilliform rash, pruritus (skin signs aid in recognition but may be absent or not observed in 10% of children with anaphylaxis; be absent or not observed in 10% of children with anaphylaxis; moreover, they may not be observed in reactions that end in moreover, they may not be observed in reactions that end in fatality)fatality)conjunctival erythemaconjunctival erythematightness in the throat, dysphagia, dysphonia, hoarseness, dry tightness in the throat, dysphagia, dysphonia, hoarseness, dry staccato cough, staccato cough, sensation of pruritus in the external auditory canalssensation of pruritus in the external auditory canalsnasal pruritus, nasal congestion, rhinorrhea, sneezingnasal pruritus, nasal congestion, rhinorrhea, sneezingchest pain, dysrhythmia, feeling of faintness/dizziness (near-chest pain, dysrhythmia, feeling of faintness/dizziness (near-syncope), paleness, cyanosis, syncope), paleness, cyanosis, confusion/altered mental status, an aura of doomconfusion/altered mental status, an aura of doomuterine contractionsuterine contractions

Role of EpinephrineRole of EpinephrineDirect-acting sympathomimetic agent Direct-acting sympathomimetic agent

with effects on many target organs.with effects on many target organs.

Increases vasoconstrictionIncreases vasoconstrictionDecreases mucosal oedemaDecreases mucosal oedemaIncreases inotropy/chronotropyIncreases inotropy/chronotropyIncreases bronchodilationIncreases bronchodilationDownregulates further mast-cell release of histamine, Downregulates further mast-cell release of histamine, tryptase, and other mediators of inflammation tryptase, and other mediators of inflammation

Self-injectable EpinephrineSelf-injectable EpinephrineIntramuscular injection of epinephrine into the lateral thigh Intramuscular injection of epinephrine into the lateral thigh (vastus lateralis) is the preferred route for therapy in first-(vastus lateralis) is the preferred route for therapy in first-aid treatment.aid treatment.

Epinephrine autoinjectors are currently available in only 2 Epinephrine autoinjectors are currently available in only 2 fixed doses: 0.15 mg and 0.30 mg.fixed doses: 0.15 mg and 0.30 mg.

On the basis of current, albeit limited, data, it seems On the basis of current, albeit limited, data, it seems reasonable to recommend autoinjectors with 0.15 mg of reasonable to recommend autoinjectors with 0.15 mg of epinephrine for otherwise healthy young children who epinephrine for otherwise healthy young children who weigh 10 to 25 kg and autoinjectors with 0.30 mg of weigh 10 to 25 kg and autoinjectors with 0.30 mg of epinephrine for those who weigh approximately 25 kg or epinephrine for those who weigh approximately 25 kg or more.more.

Technique for use auto-injectorTechnique for use auto-injector

Self-injectable EpinephrineSelf-injectable EpinephrineStudies have shown that only 50-75% of patients prescribed Studies have shown that only 50-75% of patients prescribed auto-injectors for self administration of adrenaline carry auto-injectors for self administration of adrenaline carry them around at all times.them around at all times.

Of these, only 30-40% were able to correctly demonstrate Of these, only 30-40% were able to correctly demonstrate how they would administer adrenaline to themselves.how they would administer adrenaline to themselves.

Many others have an imperfect understanding of when to Many others have an imperfect understanding of when to use adrenaline.use adrenaline.

When adrenaline is carried, there is a risk of excessive When adrenaline is carried, there is a risk of excessive patient confidence, what can result in delayed arrival at patient confidence, what can result in delayed arrival at hospital.hospital.

Indications for prescription of Indications for prescription of Self-injectable EpinephrineSelf-injectable Epinephrine


Epinephrine should be prescribed for children who have Epinephrine should be prescribed for children who have experienced anaphylaxis and may re-encounter the trigger experienced anaphylaxis and may re-encounter the trigger outside of a hospital setting. outside of a hospital setting.

In some circumstances, epinephrine for self-injection should In some circumstances, epinephrine for self-injection should be prescribed for persons who have not experienced be prescribed for persons who have not experienced anaphylaxis but are at increased risk of anaphylaxis on the anaphylaxis but are at increased risk of anaphylaxis on the basis of their specific comorbid medical conditions and basis of their specific comorbid medical conditions and medical-social evaluation.medical-social evaluation.

Examples of factors that may indicate the need Examples of factors that may indicate the need to prescribe epinephrine for personsto prescribe epinephrine for persons

"at risk" of anaphylaxis"at risk" of anaphylaxis

Reaction historyReaction history Reaction to trace allergen exposure Reaction to trace allergen exposure Repeat exposures likely Repeat exposures likely Specific food triggers known to be associated with Specific food triggers known to be associated with severe/fatal reactions (e.g., peanut, tree nut, seafood) severe/fatal reactions (e.g., peanut, tree nut, seafood) Generalized urticaria from insect venomGeneralized urticaria from insect venom

Certain comorbiditiesCertain comorbidities Asthma Asthma Use of nonselective β-blockersUse of nonselective β-blockers

Additional factorsAdditional factors Initial reaction details unclear, possible anaphylaxis Initial reaction details unclear, possible anaphylaxis Those living in a remote area away from medical care/accessThose living in a remote area away from medical care/access

Self- injectable EpinephrineSelf- injectable EpinephrineEveryone who has an Epinephrine syringe needs:Everyone who has an Epinephrine syringe needs:

Written instructions on how and when to use EpinephrineWritten instructions on how and when to use EpinephrineTo know what they should do if they have needed to use the device (i.e. to To know what they should do if they have needed to use the device (i.e. to call an ambulance)call an ambulance)To be aware of the expiry dates of the device and know now and where To be aware of the expiry dates of the device and know now and where they obtain a replacement.they obtain a replacement.To carry their treatment with them at all times.To carry their treatment with them at all times.

In the case of children:In the case of children:Parents, relatives, child- minders, nursery staff, playgroup staff and Parents, relatives, child- minders, nursery staff, playgroup staff and schoolteachers should know how to give epinephrine ( and understand any schoolteachers should know how to give epinephrine ( and understand any allergen avoidance measures that should be taken)allergen avoidance measures that should be taken)Canteen staff should be aware of the foods that these allergic children Canteen staff should be aware of the foods that these allergic children must avoid.must avoid.

Individuals should also be encouraged to wear an engraved Individuals should also be encouraged to wear an engraved identify bracelet or necklace giving details of their allergy and its identify bracelet or necklace giving details of their allergy and its treatment (www.medicalert.org.uk). This information can be life-treatment (www.medicalert.org.uk). This information can be life-saving.saving.

Audit objectiveAudit objectiveTo find out how many self- injectable epinephrine were To find out how many self- injectable epinephrine were prescribed in Paediatric Department in YDH during the period prescribed in Paediatric Department in YDH during the period of one year ( June 2006- September 2007)of one year ( June 2006- September 2007)To find criteria of anaphylaxis.To find criteria of anaphylaxis.To find and evaluate recognised standards/guidelines for To find and evaluate recognised standards/guidelines for prescribing self- injectable epinephrine.prescribing self- injectable epinephrine.To find out whether prescription of self- injectable epinephrine To find out whether prescription of self- injectable epinephrine in Paediatric Department in YDH was justified according to in Paediatric Department in YDH was justified according to recognised standards.recognised standards.To find out whether the management of the patients who To find out whether the management of the patients who needed self- injectable epinephrine was appropriate and needed self- injectable epinephrine was appropriate and whether it was based on current knowledge and recognised whether it was based on current knowledge and recognised standards.standards.To discuss how to improve management of the patients who To discuss how to improve management of the patients who require self- injectable epinephrine.require self- injectable epinephrine.To decide whether and what guidelines regarding prescription To decide whether and what guidelines regarding prescription of self- injectable epinephrine should be implemented in of self- injectable epinephrine should be implemented in Paediatric Department in YDH.Paediatric Department in YDH.

Audit methodologyAudit methodologyRetrospective StudyRetrospective Study

Sample Size- 25 children who have been prescribed Sample Size- 25 children who have been prescribed self- self- injectable epinephrine in Paediatric Department in YDH injectable epinephrine in Paediatric Department in YDH during the period of one year ( June 2006- September 2007)during the period of one year ( June 2006- September 2007)

Professional literature searchProfessional literature search Evaluation of 18 articles from literature regarding Evaluation of 18 articles from literature regarding anaphylaxis and prescription of self- injectable epinephrine.anaphylaxis and prescription of self- injectable epinephrine.Majority of articles are no more than 5 years old. Majority of articles are no more than 5 years old. Majority of articles contain information regarding Majority of articles contain information regarding indications for prescribing self- injectable epinephrine.indications for prescribing self- injectable epinephrine.Minority of articles say clearly which patients should be Minority of articles say clearly which patients should be prescribed self- injectable epinephrine.prescribed self- injectable epinephrine.

Audit resultsAudit results

16

54

0

2

4

6

8

10

12

14

16

anaphyl. risk unjustified

Sample size- 25 children up to 16 y of age

Patients with anaphylaxis (n- 16)Patients with anaphylaxis (n- 16)

5

3

4

2

1

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

eggs (1-nt) peanuts other nuts(1-nt)

insectstings (nt)

unidentified(nt)

Causative allergens

Patients with anaphylaxis (n- 16)Patients with anaphylaxis (n- 16)

6 6

14

3

1

0

2

4

6

8

10

12

14

adrenaline steroids chlorphen. nebs not docum.

Treatment

Patients with increased risk of Patients with increased risk of anaphylaxis ( n-5 )anaphylaxis ( n-5 )

1. general rash - peanuts ( oral chlorphenamine).1. general rash - peanuts ( oral chlorphenamine).

2. swelling and irritation of back of throat –peanuts 2. swelling and irritation of back of throat –peanuts

3. local urticaria - cream containing peanuts3. local urticaria - cream containing peanuts

and perioral rash - fishand perioral rash - fish

4. urticaria and periorbital angioedema - eggs and peanuts 4. urticaria and periorbital angioedema - eggs and peanuts

( no treatment required).( no treatment required).

5. perioral rash and swelling – peanuts5. perioral rash and swelling – peanuts

In all above cases causative allergen was In all above cases causative allergen was identified by skin prick tests or RAST.identified by skin prick tests or RAST.

Unjustified prescription (n-4)Unjustified prescription (n-4)1. rash to eggs (confirmed by tests, no treatment required).1. rash to eggs (confirmed by tests, no treatment required).

2. rash, facial and eyes swelling to pollens? (not confirmed by 2. rash, facial and eyes swelling to pollens? (not confirmed by tests, needed oral chlorphenamine) .tests, needed oral chlorphenamine) .

3. facial, periorbital swelling and throat tightness to tuna, 3. facial, periorbital swelling and throat tightness to tuna, haddock, mayonnaise? ( not confirmed in tests, oral haddock, mayonnaise? ( not confirmed in tests, oral chlorphenamine).chlorphenamine).

4. urticaria, lips and ears swelling and vomiting 2x ,normal BP 4. urticaria, lips and ears swelling and vomiting 2x ,normal BP and normal HR, no bronchospasm – no obvious trigger (not and normal HR, no bronchospasm – no obvious trigger (not tested, IM adrenaline, oral prednisolone, oral tested, IM adrenaline, oral prednisolone, oral chlorphenamine).chlorphenamine).

Audit conclusionsAudit conclusionsThere are not any recognized standards or guidelines for There are not any recognized standards or guidelines for prescribing self-injectable epinephrine in the UK at the prescribing self-injectable epinephrine in the UK at the moment.moment.

Professional literature search and evaluation of articles Professional literature search and evaluation of articles have showed that self-injectable epinephrine should be have showed that self-injectable epinephrine should be prescribed for children who have experienced anaphylaxis prescribed for children who have experienced anaphylaxis and considered for persons who have not experienced and considered for persons who have not experienced anaphylaxis but are at increased risk of anaphylaxis.anaphylaxis but are at increased risk of anaphylaxis.

Audit conclusionsAudit conclusionsPrescription of self-injectable epinephrine in Peadiatric Prescription of self-injectable epinephrine in Peadiatric Department in YDH is not based on any local guidelines.Department in YDH is not based on any local guidelines.

In majority of the cases prescription of epinephrine was In majority of the cases prescription of epinephrine was justified.justified.

11/16 patients with anaphylaxis underwent tests to confirm 11/16 patients with anaphylaxis underwent tests to confirm the causative allergen. the causative allergen.

7/16 patients with anaphylaxis were admitted to Ward 10.7/16 patients with anaphylaxis were admitted to Ward 10.

It was not clearly stated in the notes whether the patients It was not clearly stated in the notes whether the patients were explained when and how to use self- injectable were explained when and how to use self- injectable epinephrine.epinephrine.

It was not written in the notes whether the patients were It was not written in the notes whether the patients were encouraged to buy and carry identify bracelets.encouraged to buy and carry identify bracelets.

There was nothing written in the notes about liaison with There was nothing written in the notes about liaison with schools, nurseries, child-minders.schools, nurseries, child-minders.

Audit recommendations Audit recommendations To introduce guidelines regarding indications for To introduce guidelines regarding indications for prescription of self-injectable epinephrine in Paediatric prescription of self-injectable epinephrine in Paediatric Department in YDH.Department in YDH.

To introduce guidelines instructing how each patient who To introduce guidelines instructing how each patient who needs to have self-injectable epinephrine prescribed should needs to have self-injectable epinephrine prescribed should be managed.be managed.

To follow guidelines every time when self- injectable To follow guidelines every time when self- injectable epinephrine is considered or needs to be prescribed.epinephrine is considered or needs to be prescribed.

To do re-audit in 2 years in order to check compliance of To do re-audit in 2 years in order to check compliance of the guidelines.the guidelines.

prescription of self-injectable epinephrine clinical audit g.krupa, m.thanneermalai paediatric...

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