(Update: August 29, 2018) Shortage Situation Involving EpiPen (0.3mg) Auto-Injectors

Shortage Situation involving EpiPen (0.3mg) Auto-Injectors

Update – August 29, 2018

Health Canada: Health Minister announces access to a U.S.-approved epinephrine auto-injector

Health Canada has issued an Interim Order to import Auvi-Q epinephrine auto-injectors for an initial period of two weeks while approval is sought to extend the order for up to one year.

Advice for pharmacists

Auvi-Q 0.3 mg is expected to be available for pharmacies to order from McKesson by the end of the week and in pharmacies as of September 7, 2018.
Auvi-Q is classified as a schedule 2 drug.
Pharmacists should continue to conserve the supply of Epipen and Auvi-Q. Auvi-Q comes in a box with 2 auto-injectors plus a trainer. Health Canada permits pharmacists to open the box and dispense 1 Auvi-Q to each patient.

Pfizer Canada has indicated that it has resumed shipments of EpiPen but that the supply of both EpiPen and EpiPen Jr continues to be limited while it works to return supply to normal levels.

PharmaCare Coverage of Auvi-Q

PharmaCare now covers AUVI-Q when EpiPen is not available due to short supply.

See BC PharmaCare's September 5 Newsletter for information on Auvi-Q and PharmaCare Coverage.

Questions about Auvi-Q?

Please see the following FAQs and answers regarding the Auvi-Q temporary supply, provided by Health Canada and Kaleo, the Auvi-Q manufacturers.

Auvi-Q temporary supply FAQs

August 2, 2018

Following previous shortage announcements in 2018, Health Canada and Pfizer Canada have announced that the shortage of EpiPen^® auto-injectors (0.3 mg/0.3 mL) at pharmacies is expected to worsen during the month of August.

EpiPen^® auto-injectors (0.3 mg/0.3 mL) have been in short supply since as early as January 2018 with PharmaCare placing a limit for EpiPen products in PharmaNet to two per dispense for PharmaCare-paid claims starting in April 2018.

EpiPen^® and EpiPen Jr^® auto-injectors are used to deliver an emergency treatment of adrenaline (epinephrine) to patients who are at risk or have a history of life threatening allergic reactions (anaphylaxis).

There are currently no alternative epinephrine auto-injectors available in Canada.

While Pfizer Canada continues to be able to supply EpiPen Jr^® auto-injectors (0.15 mg/0.15 mL), supply is limited and being managed at a national level.

Pharmacies should not attempt to place orders for amounts in excess of previously used stock.

Pfizer Canada does not expect to be able to provide new supply until the end of August and is asking pharmacists to keep this in mind when dispensing EpiPen^® (0.3 mg/0.3 mL) and EpiPen Jr^® (0.15 mg/0.15 mL) auto-injectors.

Advice for Patients

Patients in possession of an EpiPen^® (0.3 mg/0.3 mL) or EpiPen^® Jr auto-injector (0.15 mg/0.15) should note that these products expire on the last day of the month indicated on the package (e.g. products with an August expiry date do not expire until August 31).

Patients experiencing an anaphylactic reaction should use expired EpiPen^® auto-injectors if no other EpiPen^® or epinephrine format is available. After using an expired EpiPen^®, patients or their caregivers should contact 9-1-1 immediately.

Patients are encouraged to visit drugshortagescanada.ca or contact Pfizer Canada directly for up-to-date information about the shortage and estimated re-supply dates. Patients with questions or concerns about the shortage may also wish to speak with their pharmacist or primary care provider.

Providing access to other forms of epinephrine

Pharmacists faced with a situation in which EpiPen^® cannot be supplied and no other reasonable alternatives are available, may use their professional judgement to consider providing other forms of epinephrine as an interchangeable product.

In cases where an EpiPen^® cannot be obtained as a result of the shortage, providing ampoules or vials of epinephrine and syringes together with training on preparing the syringe and administration is an alternative pharmacists could consider.

As with all medications, the pharmacist is responsible for ensuring a drug is appropriate for the patient, and providing consultation on proper use. This includes directions for use and administration.

Patient Resources on Use and Administration of
Other Forms of Epinephrine

The College worked with the BC Pharmacy Association to develop information for patients on how to use other forms of epinephrine in the case of an allergic reaction.

Pharmacists will need to work together with others on the patient’s care team, and draw on their professional judgement and knowledge (and applicable resources and references as needed) to determine the best course of action for patients in need of epinephrine.

Interchangeable Drugs

Section 25.8 of the Health Professions Act defines an “interchangeable drug” as “a drug that contain the same amount of the same active ingredients, possesses comparable pharmacokinetic properties, has the same clinically significant formulation characteristics and is to be administered in the same way as the drug referred to in a prescription.”

For more information about how to approach drug interchangeability, see the College’s Drug Interchangeability Update.

Prescriptions Required for Epinephrine Ampoules and Vials

While an EpiPen^® does not require a prescription under the Drug Schedules Regulation, ampoules and vials of epinephrine do require a prescription.

If a patient requests EpiPen® and does NOT have a prescription, they will need to obtain a prescription from a physician or nurse practitioner.
If a patient has an existing prescription or brings in a new prescription for EpiPen®, pharmacists can provide the patient with ampoules or vials of epinephrine if an EpiPen® is unavailable.

Resources

Aug 30, 2018