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HF Report on Delays in Filling Flumazenil Prescriptions

The Hypersomnia Foundation has become aware that Pavilion Pharmacy, a provider of flumazenil cream and sublingual lozenges in the United States, has been unable to fill new or renewing prescriptions for this drug.

We have contacted the company owner and asked him to provide information on this issue. Our questions and his responses are provided below.

How does Pavilion Pharmacy obtain flumazenil?

Pavilion Pharmacy previously received its supply of flumazenil from a company in Canada that imported the drug from a manufacturer in China. The Canadian company receives and inspects the drug to verify its purity and then ships it to Pavilion Pharmacy in Georgia, where pharmacists create the cream and lozenges that dissolve under the tongue. However, changes in government regulations that took place a few months ago created a delay in drugs being shipped from Canada into the United States. This delay could be up to three months, so Pavilion sought a new flumazenil supplier. They identified a new supplier, located in Florida, that would also bring the flumazenil from China but would not be subject to the same regulations for importing the drug from Canada that would delay the shipment.

If the new supplier didn’t have the same shipping delay, what happened?

When the supplier in Florida received the shipment of flumazenil two weeks ago, they tested it, and Pavilion Pharmacy reported that the supplier found out on May 26, 2015, that the drug did not meet purity standards. Therefore, the supplier was not able to send the flumazenil on to Pavilion.

What now?

In anticipation of the shipping delay from Canada imposed by the new regulations, Pavilion Pharmacy had placed an order with their Canadian supplier several months ago. As of May 26, 2015, that shipment is in Canada, has passed inspection, is packaged, and is ready to ship to Pavilion once Health Canada gives written authorization for the shipment. Pavilion Pharmacy has been told that that authorization should occur on May 28, 2015. Once Pavilion Pharmacy receives the package of flumazenil, the pharmacists will immediately begin compounding the drug into lozenges and cream and filling prescriptions (new or refills) in the order in which they were received. Pavilion staff will also call each person who is expecting a new prescription or refill to find out if they want the drug to be sent via overnight delivery.

What is the Hypersomnia Foundation doing?

The Hypersomnia Foundation has no connection to Pavilion Pharmacy. However, we understand that this issue is of concern to many people with idiopathic hypersomnia and have, therefore, reached out to Pavilion Pharmacy to obtain this information. We will contact Pavilion Pharmacy again on Thursday, May 28, 2015, and provide an update for you once we have spoken with the owner.

UPDATE

As of Friday, May 29, 2015, Pavilion Pharmacy did not have any updates to report on the flumazenil shortage. The meeting between the supplier in Canada and Canadian Health is scheduled to take place on Monday, June 1, 2015. Once the meeting occurs, the supplier still needs to wait for the paperwork from  Canadian Health before shipping the drug to Pavilion Pharmacy. There is no date available for when the product will ship. The Hypersomnia Foundation will continue to monitor the situation and provide information as it becomes available.
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