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Medicines Management Patient Group Direction for the Supply/administration of Adrenaline (Epinephrine) for Treatment of Anaphylaxis by accredited community Pharmacists. Rationale To enable a pharmacist, working on the Isle of Wight, who has received specific training and has been assessed as competent to administer immunisation in accordance with the following patient group directions and recommendations issued by the of Health (1998), the Royal Pharmaceutical Society of Great Britain (2007), the NMC Code of Professional Conduct (2002) and the NMC Guidelines for the Administration of Medicines (2002), as appropriate. Define situation/condition Criteria for inclusion Emergency treatment of acute anaphylactic reaction following the administration of a vaccine or other injectable medication. Any patient who is exhibiting symptoms or signs of anaphylaxis, or a severe allergic reaction, i.e.: Cardiovascular collapse Unrecordable blood pressure/hypotension/tachycardia (>120 bpm) Severe or worsening bronchospasm or angio-oedema Audible wheeze, difficulty breathing or stridor Severe or worsening swelling of lips, face, tongue or neck Diffuse erythema and /or urticaria Peripheral oedema Young children rarely faint sudden loss of consciousness should be presumed to be anaphylaxis in the absence of a strong central pulse. If in any doubt at any age treat as anaphylaxis. First Line Management: 1. Send for additional health professional assistance; 2. Dial 999 (if possible, send a responsible adult whilst you stay with the patient) and state that there is a case of suspected anaphylaxis; 3. Never leave the patient alone; 4. Lie the patient down, ideally with the legs raised (unless the patient has breathing difficulties); 5. Administer oxygen if available; If breathing stops, mouth to mouth/mask resuscitation should be performed. Page 1 of 6 1

Criteria for exclusion Action if excluded Contraindications Action if contraindications Action if patient declines 2. Characteristics of staff Qualifications required Additional requirements Continued education & training requirements Practicing Pharmacists registered with the RPSGB who have completed the PCT approved training to deliver this service Pharmacy actively engaged with service delivery and completion of the two day vaccination training programme provided by M and K up dates; Basic life support and anaphylaxis-provided by trust and full understanding of PGD. Annual assessment of competency arranged through occupational health IOW NHS trust. Annual update in BLS and anaphylaxis. The pharmacist should be aware of any change to the recommendations for the medicine listed. Continued professional development is the responsibility of the pharmacist. He/ She should keep up to date with developments in areas relevant to this PGD. 3. Description of Treatment Name of Medicine Legal status of medicine Adrenaline (Epinephrine) Injection BP 1:1000 (1mg/mL) POM Dose Under 6 months 150micrograms IM (0.15ml) 6 months-6 years 150micrograms IM (0.15ml) 6 12 years 300micrograms IM (0.30ml) Over 12 years* 500micrograms IM (0.5ml) *Use 300mcg if the patient is small or prepubertal Note auto-injectors for self-administration should not be used as a substitute for a proper anaphylaxis pack. However, if adrenaline auto-injector is the only available adrenaline preparation when treating anaphylaxis, health care providers should use it. Cautions Patients taking beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors should receive 50% of the usual dose of adrenaline because of a potentially dangerous drug interaction. Although cocaine may also interact with the actions of adrenaline, anaphylaxis is sufficiently rare to not recommend either Page 2 of 6 2

withholding immunisation or undertaking routine questioning about recreational drug use in individuals attending for vaccination. In the unlikely event of collapse in someone who is suspected of having recently taken cocaine, adrenaline should be used only with extreme caution and using a reduced dose. Route Frequency Total dose/number of doses Intramuscular injection normally to the thigh Dose may be repeated every 5 minutes Repeated every 5 minutes until the patient has been transferred to ambulance/hospital care Page 3 of 6 3

Drug Adrenaline (Epinephrine) Injection BP 1:1000 (1mg/mL) Follow up treatment Written/verbal advice for patient Specify method of recording supply and /or administration Contraindications/ Cautions Patients taking betablockers, tricyclic antidepressants or monoamine oxidase inhibitors should receive 50% of the usual dose of adrenaline because of a potentially dangerous drug interaction. Although cocaine may also interact with the actions of adrenaline, anaphylaxis is sufficiently rare to not recommend either withholding immunisation or undertaking routine questioning about recreational drug use in individuals attending for vaccination. In the unlikely event of collapse in someone who is suspected of having recently taken cocaine, adrenaline should be used only with extreme caution and using a reduced dose. Transfer to hospital Common Adverse Effects In therapeutic doses adrenaline may cause effects such as anxiety, fear, dry mouth, tremor, headache, palpitations, arrhythmias, hypertension, along with restlessness and coldness of extremities. Headache is most common. Interactions Patients taking beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors should receive 50% of the usual dose of adrenaline because of a potentially dangerous drug interaction. Although cocaine may also interact with the actions of adrenaline, anaphylaxis is sufficiently rare to not recommend either withholding immunisation or undertaking routine questioning about recreational drug use in individuals attending for vaccination. In the unlikely event of collapse in someone who is suspected of having recently taken cocaine, adrenaline should be used only with extreme caution and using a reduced dose. Patient s name Name of medicine, dose and form administered Date administered and site of injection Manufacturer of product, batch, and expiry date Name of nurse who administered the medication GP record and nursing notes Notes See SPC Page 4 of 6 4

Procedure for reporting ADRs to Medical Practitioner Adverse reactions should be reported to the Committee on Safety of Medicines using the Yellow Card reporting system..any adverse reaction should also be reported to the Patients GP. Management of Group Directions: Group direction developed by: Authorizing Doctor/s: Mr Kevin Noble Community Pharmacy Lead IW PCT Mr Paul Jerram Head of Medicines Management IW PCT Dr John Partridge- Clinical Governance Lead Signature. Date applicable: Senior Pharmacist. Dr John Partridge Date signed off Usually 2 years or as appropriate Signature. Clinical Directorate Pharmacist Approved by Pharmacy Group. Mr Kevin Noble- Community Pharmacy Lead Signature.. Mr Paul Jerram- Head of Medicines Management Signature Approved by Clinical Standards Group Mr Paul Jerram- Head of Medicines Management Signature Signed by chair of committee (making the Trust liable for the supply and administration of medicines under the PGD, subject to its proper application by authorised and competent personnel. The group direction is to be read, agreed to, and signed by all staff it applies to. One copy is to be given to the health professional, another kept in the department. Page 5 of 6 5

I have read the group direction and agreed to use it in accordance with the criteria described. All professionals who will be using the PGD need to read it and sign. Their review date should ideally be linked to appraisals or other personal review processes to ensure that they are still competent to be approved practitioners under the PGD Name: Signature: Date: Name: Signature: Date: Name: Signature: Date: Page 6 of 6 6