Key points

  • In April 2018, the Therapeutic Goods Administration (TGA) advised consumers and health professionals of a constrained supply of adrenaline (epinephrine) 300 microgram autoinjectors (EpiPen).1
  • An adrenaline autoinjector is used for the emergency treatment of anaphylaxis (acute severe allergic reaction).1
  • Adrenaline (epinephrine) 150 microgram autoinjector (EpiPen Jr) supplies have not been affected.
  • A brand equivalent – adrenaline (epinephrine) 300 microgram autoinjector (Adrenaline Mylan) – has been made available on the Pharmaceutical Benefits Scheme (PBS) as an ‘a’ flagged substitute for the EpiPen autoinjector.2,3
  • A brand equivalent – adrenaline (epinephrine) 150 microgram autoinjector (Adrenaline Jr Mylan) – has also been made available on the Pharmaceutical Benefits Scheme (PBS) as an ‘a’ flagged substitute for the EpiPen Jr autoinjector.2,4,5 

EpiPen 300 microgram supply status

On 23 April 2018, the Australian sponsor of EpiPen – Alphapharm Pty Ltd (Mylan Australia) – released an update on the local availability of their 300 microgram adrenaline autoinjectors.6

The update confirmed that the supply of EpiPen 300 microgram autoinjectors in Australia is constrained as a result of manufacturing delays from Meridian Medical Technologies, a Pfizer company.6

The update reported that Pfizer anticipated production rates would increase over the coming months, but did not provide a definite time when the supply constraint would be resolved.6

Are EpiPen Jr autoinjector supplies affected?

No. There are sufficient supplies of adrenaline (epinephrine) 150 microgram autoinjector (EpiPen Jr) in Australia.6

Is there an EpiPen 300 microgram brand equivalent?

Yes. The adrenaline (epinephrine) 300 microgram autoinjector (Adrenaline Mylan) is now available on the PBS as an ‘a’ flagged brand equivalent to the EpiPen autoinjector.5,7

What is ‘a’ flagging?

Many medicines are available on the PBS under different brands. The Schedule of Pharmaceutical Benefits indicates where different brands are considered equivalent for the purposes of substitution at the point of dispensing by using ‘a’ flags.

The current practice of ‘a’ flagging in the Schedule of Pharmaceutical Benefits denotes that brand substitution may be undertaken by pharmacists at the point of dispensing without differences in clinical effect.8

What are the substituted brands? 

Adrenaline Mylan and Adrenaline Jr Mylan are additional trade names for EpiPen and EpiPen Jr autoinjectors, respectively.

The active ingredient in the Adrenaline Mylan, Adrenaline Jr Mylan, EpiPen and EpiPen Jr autoinjectors is identical and all are administered as intra-muscular injections.2-4,9,10

Like EpiPen and EpiPen Jr, the Adrenaline Mylan and Adrenaline Jr Mylan autoinjectors are for the emergency treatment of anaphylactic reactions to insect stings, drugs or other allergens.2,7 The instructions for administering Adrenaline Mylan and Adrenaline Jr Mylan are the same as for EpiPen and EpiPen Jr.3,4,9,10

PBS listing

Authority required

Adrenaline (epinephrine) 300 microgram/0.3 mL injection (Adrenaline Mylan) and adrenaline (epinephrine) 150 microgram/0.3 mL injection (Adrenaline Jr Mylan) are indicated for acute allergic reaction with anaphylaxis.2

Clinical criteria for initial PBS-subsidised supply for anticipated emergency treatment

Patients must have been assessed to be at significant risk of anaphylaxis by, or in consultation with, one of:

  • a clinical immunologist
  • an allergist
  • a paediatrician
  • a respiratory physician.

OR

Patients must have been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis.

Clinical criteria for continuing PBS-subsidised supply for anticipated emergency treatment

Patients must have previously been issued with an authority prescription for this drug.

Adrenaline (epinephrine) may be prescribed by nurse practitioners.

Authorised nurse practitioners may prescribe this medicine on the PBS.2 See the PBS website for more information on nurse practitioner PBS prescribing.

Information for prescribers

  • On 1 June 2018 Adrenaline Mylan and Adrenaline Jr Mylan autoinjectors became available on the PBS, as ‘a’ flagged brand equivalents to EpiPen and EpiPen Jr autoinjector, respectively.
  • When writing a prescription, prescribers are able to tick the ‘brand substitution not permitted’ box if they want to ensure the patient receives a particular brand of medicine.
  • If this box is ticked, by law the pharmacist cannot dispense a brand other than that prescribed.
  • In the context of EpiPen 300 microgram autoinjector supply constraints, and subsequent ‘a’ flagging of Adrenaline Mylan and EpiPen, prescribers may choose to leave the ‘brand substitution not permitted’ box unticked.
  • This will enable consumers to access the brand alternative, an ‘a’ flagged adrenaline autoinjector. 

Information for pharmacists

  • On 1 June 2018 Adrenaline Mylan and Adrenalin Jr Mylan autoinjectors became available on the PBS, as ‘a’ flagged brand equivalents to EpiPen and EpiPen Jr autoinjector, respectively.
  • On 18 May 2018, Mylan Australia advised that shipments of EpiPen 300 microgram autoinjector to pharmacies via wholesalers were exceeding usual demand, indicating that the supply chain was working again.1,11
  • EpiPen 300 microgram autoinjector orders can be placed with primary wholesalers even if the wholesaler is showing a stock level of zero.
  • For more information, pharmacists can call the EpiPen Customer Service Toll Free hotline on 1800 931 625 or email au.sales.support@mylan.com.
  • Brand substitution provides an opportunity for discussion and review of the patient’s Anaphylaxis Action Plan.12

Key points for consumers

  • Two new adrenaline (epinephrine) autoinjector products are now available on the PBS for emergency anaphylaxis treatment.
  • Adrenaline Mylan autoinjector is a brand equivalent to the EpiPen autoinjector.
  • Adrenaline Jr Mylan autoinjector is a brand equivalent to EpiPen Jr autoinjector.
  • The active ingredient in all these products is identical.
  • The instructions for administering Adrenaline Mylan and Adrenaline Jr Mylan are the same as for EpiPen and EpiPen Jr.
  • If you have any questions or concerns, call the Mylan Australia EpiPen Customer Service Toll Free hotline on 1800 931 625.
  • You may want to take this opportunity to discuss and review your Anaphylaxis Action Plan12 with your doctor or pharmacist. 

Where to get more information

Mylan Australia has created a dedicated EpiPen Customer Service Toll Free hotline on 1800 931 625. 

References

  1. Therapeutic Goods Administration. Medicine shortages: EpiPen 300 mcg adrenaline auto-injector. Canberra: TGA, 27 April 2018 (accessed 29 May 2018).
  2. Pharmaceutical Benefits Scheme. Adrenaline (epinephrine) Canberra: PBS, 2018 (accessed 30 May 2018).
  3. Alphapharm Pty Ltd. Adrenaline Mylan Product Information. Millers Point, NSW, Australia: Alphapharm Pty Ltd, 2018 (accessed 14 June 2018).
  4. Alphapharm Pty Ltd (Mylan Australia). Adrenaline Jr Mylan Product Information. Millers Point, NSW, Australia: Alphapharm Pty Limited, 2018 (accessed 14 June 2018).
  5. Pharmaceutical Benefits Scheme. Schedule of Pharmaceutical Benefits - Summary of Changes. Effective 1 June 2018. Canberra: PBS, 2018 (accessed 1 June 2018).
  6. Mylan Australia. 23 April 2018 Update: Availability of EpiPen 300 mcg Adrenaline (epinephrine) Auto-Injector and New EpiPen Toll-Free Hotline 1800 91 625. Sydney: Mylan Australia, 2018 (accessed 30 May 2018).
  7. Therapeutic Goods Administration. Public Summary Australian Register of Therapeutic Goods (ARTG). ADRENALINE MYLAN adrenaline (epinephrine) 0.3mg/0.3mL injection syringe auto-injector. Canberra: TGA, 1 March 2018 (accessed 30 May 2018).
  8. NPS MedicineWise RADAR. Brand equivalence: 'a' flagging explained. Sydney, 2013 (accessed 29 May 2018).
  9. Alphapharm Pty Ltd. EpiPen Jr Product Information. Millers Point, NSW, Australia: Alphapharm Pty Limited, 2017 (accessed 14 June 2018).
  10. Alphapharm Pty Ltd. EpiPen Product Information. Millers Point, NSW, Australia: Alphapharm Pty Limited, 2017 (accessed 14 June 2018).
  11. Mylan Australia. EpiPen supply status update 18 May 2018.
  12. Australasian Society of Clinical Immunology and Allergy. ASCIA Action Plans for Anaphylaxis. Sydney: ASCIA, 2017 (accessed 31 May 2018).