Response from Service Ontario re: Epipens and a CALL TO ACTION!

Response from Service Ontario re: Epipens and a CALL TO ACTION!

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As many of you are already aware, there has been a long-term shortage of Epipens because of the manufacturing shortfall at King, which is a subsidiary of Pfizer. Nobody has answered the question of how such a long-term shortage has come about, and nobody knows when they will be readily available again to Canadians.

In the United States, there are alternative auto-injectors that have been approved by the FDA in response to the outcry at the ridiculously inflated cost of epipens and the shortages – which started out costing around $95 at the beginning of the decade, and now can cost $680 for a 2-pack!!! You’ll be even more furious when I tell you that the cost of a vial of epinephrine, which can be simply injected in the muscle with a regular needle, costs a mere $10 for several doses. Yes, for an entire VIAL.

Adrenaclick and Auvi-Q are two of the alternative auto-injectors of epinephrine, but get this: Auvi-Q costs $4500 for 2 pens!!! The pharmaceutical company, Teva, has just received approval for their generic auto-injector, however, the price has not yet been announced. It is rumored that it will be a much more affordable, and competitive device to the Epipen.

The problem in Canada is that we have no options. All we have is the Epipen. So I started a letter-writing campaign, and the only province that has responded is ServiceOntario. Here is what they had to say in response to my question as to why generic alternatives aren’t available in Canada:The EpiPen, manufactured by King, a subsidiary of Pfizer, and marketed by Mylan, has dominated the market.

I began a letter-writing campaign on the advice of our pharmacy, and so far have only received a response from one province – ServiceOntario. Here is what they had to say in response to my question of why generic epipens aren’t yet approved in Canada:

Dear Tessa,

Thank you for your email sent to ServiceOntario.

ServiceOntario provides general information and referrals for Ministry of Health and Long-Term Care (MOHLTC) programs and services

A drug manufacturer must submit its new drug product to the federal government’s Health Products and Food Branch (HPFB) at Health Canada, for review and approval. The HPFB is responsible for approving a drug for sale and marketing anywhere in Canada. Health Canada evaluates the product’s safety and efficacy and looks at a large volume of research including animal efficacy and toxicology studies. The federal review process can take between 1 and 2 years, depending on the nature of the product. Once the federal government approves the product, a Notice of Compliance (NOC ) and a Identification Number ( DIN ) for the product will be issued

Only after drug products have received a NOC and a DIN from the federal government can it be considered for listing in the Drug Benefit Formulary/Comparative Drug Index and coverage under the Ontario Drug Benefit (ODB ) Program.

Manufacturers can file a submission with the Ontario Drug Benefit (ODB) Program before a NOC is received. The submission will be screened for completeness; however, the review by the Committee to Evaluate Drugs (CED ), will only begin after the NOC is received.

Even if a product is approved for use in Canada, it will not automatically be listed as a benefit under the ODB program. It is the manufacturer’s responsibility to seek listing in the Formulary by filing a complete submission to the Ontario Ministry of Health and Long-Term Care’s ( MOHLTC ) Drug Program Services Branch ( DPSB ) for review by the CED.

You may wish to contact the Drugs Program Branch (DPB), whose mandate is to provide leadership in achieving optimal pharmaceutical services for the health protection and improvement of Ontario residents.

The DPB maintains a close partnership with industry, pharmacy, and medicine in order to better manage the drug programs. The Formulary identifies drug products designated as those brands of drugs that are considered to be interchangeable, and serves as a prescribing and reimbursement guide for doctors and pharmacists.

TTY: 416-327-4282 or Toll Free 1-800-387-5559

Fax: 416-327-8123

Email: [email protected]

Should you wish to make your concerns known to the Minister of Health and Long-Term Care, here is the contact information, should you wish to use it:

Hon. Christine Elliott

Minister of Health and Long-Term Care

10th Floor Hepburn Block

80 Grosvenor St

Toronto ON  M7A 2C4

Telephone: 416-327-4300

Fax: 416-326-1571

Website: http://www.health.gov.on.ca/en/ministry/minister.aspx 

To send the Minister of Health and Long-Term Care an email, you would visit the ministry’s web page below and click on the link:

Contact Us

http://www.health.gov.on.ca/en/common/default.aspx

Under the “What is your message about?” question, be sure to select “Questions for the Minister” in the pull-down menu.

Thank you again for contacting ServiceOntario.

Here is where we are at – today, my pharmacy received TWO epipens of the 100 that they ordered. They are sending out 100-piece orders daily, but don’t expect to get many. I’ve been checking the pharmacy daily, so I was lucky enough to get my hands on ONE epipen only. I will be checking back daily to see if they have received anymore, but with a son who has an anaphylactic allergy to bee stings AND to something completely unknown to us as of yet, I need four. One for purse, one for school, one for him to carry, and a backup in the house.

So this is where YOU come in. Write a letter to the Minister of Health and Long-Term care here asking that they actively pursue alternatives to the Epipen, and you can write to Pfizer here to demand that they change their manufacturing practices to ensure that no further shortages of the Epipen occur. I will write up form letters for anyone interested, and post them in Part II of this topic for you to simply sign and send in to the companies.

Nobody should have to risk their lives because of greedy, irresponsible corporations and governments that sit on their asses doing nothing (and let’s face it, there’s probably been a payout to the government to prevent alternatives from being approved in Canada – otherwise, how is this one delivery device still the only one available in a Pharmaceutical world where competitors are constantly making generic versions of medications and being approved?

Have you or a loved one been affected by this shortage? Share your story in the comments section so we can all pass on to the government and Pfizer the damage that they have done with their negligence.

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