Tag Archives: medication shortage

Gov’t needs to take a proactive response to stem drug shortages: Epilepsy Ontario

May 19, 2016

By Deron Hamel

One of the greatest frustrations Epilepsy Ontario deals with during shortages of seizure-control medications is when impending drug shortages are identified but Health Canada and the provincial drug programs do nothing to try to prevent them, says Suzanne Nurse.

Nurse, Epilepsy Ontario’s director of information and client services, says that 2016 has been one of the worst years, so far, for shortages of medications needed by people living with epilepsy since shortages began about five years ago.

Pharmaceutical companies have gone into shortage on multiple anti-seizure drugs. Lack of information about the shortages as well as lack of processes to prevent and manage them is putting people at risk as well as creating serious anxiety for people living with epilepsy and their families, she adds.

“There seems to be a failure to recognize how drug shortages evolve,” Nurse says. “We can see when a serious shortage is coming, one that will have an impact on people with epilepsy. We just can’t understand why (Health Canada and the provincial drug programs) that are overseeing the drug-shortage response can’t see it.

“We evaluate a couple of key factors: Are there only a few suppliers of a drug? Is the shortage expected to last a long time? Are the major suppliers affected? If the answers are ‘yes,’ ‘yes’ and ‘yes,’ then it’s pretty clear a serious problem is heading our way.”

Currently, there are significant shortages of two common anti-seizure medications in Canada: divalproex sodium and clobazam.

“We had to wait until we were in the middle of a crisis to get a response to the divalproex shortage. We’re still waiting to even get an acknowledgement of the seriousness of the clobazam shortage.”

Apotex Inc. first posted shortages of divalproex sodium on drugshortages.ca in June 2015; however, a collaborative effort to address the shortage did not begin until March 2016. The good news is that the response co-ordinated by Health Canada helped turn this around and generic formulations of divalproex sodium are beginning to recover, starting with the 500 mg strength tablets. It will take longer for the brand-name tablets, Epival, to recover.

Just as we’re starting to get out of the woods on divalproex, clobazam is now developing into a major problem. Apotex first reported a clobazam shortage in December. The drug was supposed to be restocked in mid-April, but about a month before the shortage was expected to end the date was pushed back to September. It has since been pushed back to Nov. 30. Pharmacies are now having trouble obtaining generic clobazam as well as the brand name tablets (Frisium).

Epilepsy Ontario wants to see a proactive response to anticipated drug shortages to prevent them from happening in order to reduce the impact on people living with epilepsy. With both the clobazam and divalproex sodium shortages, federal and provincial agencies were contacted to inform them of the impending shortages, but no proactive action was taken, Nurse says.

The drug shortages, coupled with the erratic changing of restock dates, are putting people’s safety at risk, Nurse says.

“Any shortages of medication that control seizures are of serious concern because epilepsy is a condition that you need to maintain good control of – missing a dose of a drug or changing medications, any kind of change like that can affect seizure control, so any drug shortage is a serious concern,” she says.

“The clobazam shortage is an even greater concern than most of the drug shortages that we deal with for epilepsy. There is no other drug like clobazam that can replace it when it is in shortage.”

Follow alerts on the Epilepsy Ontario website for updates on these drug shortages:

Divalproex sodium (Epival) alert
https://epilepsyontario.org/alert/alert-divalproex-sodium/

Clobazam (Frisium) alert
https://epilepsyontario.org/alert/alert-clobazam/

If you have feedback on this story, or have a story of your own that you would like to share, please contact the newsroom at 800-294-0051, ext. 23, or e-mail deron(at)axiomnews.com. You can also leave a comment below.

Medication Alert: Divalproex Sodium (Epival)

December 19, 2015

Canadian pharmaceutical companies are reporting shortages of divalproex sodium (Epival), also known as valproic acid.

As of Thursday December 17, a total of fifteen divalproex sodium shortages were posted on drugshortages.ca by Abbott Laboratories Limited*, Apotex Inc., Pro Doc Limitée, Sanis Health Inc. and Teva Canada Limited. None of the pharmaceutical companies have provided an explanation for the shortages.

This situation is a serious concern. The estimated resupply dates currently range from December 24, 2015 to April 30, 2016. These dates are estimates and could change. Drug shortages, or back-orders, at the level of the pharmaceutical companies do not always result in shortages at community and hospital pharmacies. Although the longer a shortage lasts the greater the likelihood that it could have an impact on patients.

If you or a family member have been prescribed divalproex sodium (Epival), contact your pharmacist and ask about the availability of your medication.

If your pharmacist runs into any difficulty obtaining divalproex sodium they may be able to find some from a different supplier, another drug store, or another chain.

According to the Canadian Pharmacists Association’s guide on drug shortages, Step 1 is for pharmacists to exhaust every avenue to supply the medication. This may require looking beyond their regular sources of supply and contacting other wholesalers or calling the manufacturers. Your pharmacist also has access to resources and information through the Ontario Pharmacists Association.

If the situation worsens and your pharmacist is not able to locate any divalproex sodium for you, it is important to work with your pharmacist and your health care provider to manage the drug shortage in the safest way possible.

During a shortage, your pharmacist and health care provider may explore options that could include filling your prescription with a different strength tablet or substituting a different medication. If your dosing instructions change, ensure you understand the instructions and ask questions if it isn’t clear.

When a drug is unavailable in Canada, Health Canada’s Special Access Program (SAP) will consider requests from health care providers for access to the drug from outside the country. The SAP can be reached 24 hours a day, 365 days a year, and the program strives to process requests within 24 hours of receipt.

It is important to continue to take your medication as indicated. It can be frightening when an epilepsy drug is in short supply but skipping doses, taking less medication, or suddenly stopping an antiseizure drug is dangerous. This can lead to breakthrough seizures, more prolonged seizures or life-threatening events.

If you need any assistance or if you would like to be notified of any updates, please let us know. Call our office at 905-474-9696 or toll-free 1-800-463-1119 or email [email protected].

Click here for frequently asked questions about drug shortages

Click here for additional information about the Health Canada Special Access Program

* This company may be listed on drugshortages.ca incorrectly. Epival is no longer marketed by Abbott Laboratories Limited. According to the Health Canada drug product database, Epival is currently marketed by BGP Pharma. It appears that old drug shortage notifications from 2012 were re-used instead of creating a set of new notifications for the current Epival shortages.

Mother calls for more action to develop mandatory drug-shortage database

March 21, 2014

When Diana went to fill her daughter’s clobazam prescription last week, she was in for a big surprise when the pharmacy told her it couldn’t supply her with all the medication her daughter needed.

Diana was unaware there was a medication shortage.

With the help of Epilepsy Ontario, Diana was able to get an additional supply of clobazam for her daughter, but it still isn’t enough of the medication to last until the shortage is slated to end in early May.

Since then, Diana has been spending much of her free time phoning pharmacies asking if they have clobazam in stock. This causes another hurdle for Diana because if she has to switch pharmacies, she needs to go back to her daughter’s neurologist and get a new prescription. Once a patient is prescribed clobazam, it can only be switched once to another pharmacy.

Through her efforts, Diana was able to obtain another clobazam supply that her daughter can use until the start of April, but that still isn’t enough medication to last her daughter until the shortage ends.

“It’s very frustrating — I’m very anxious about this,” Diana says, adding she also finds herself checking the online Canadian Drug Shortage Database to see if updates on the shortage are posted.

Diana says the high level of stress she and other people go through during medication shortages could be averted if pharmaceutical companies were mandated by federal law to provide notices of impending drug shortages so people could get their medications ahead of time, or, if needed, ease off one medication and start on a new one.

Diana has a clear picture of what this should look like.

“If there were drug-shortage notices that went out to all pharmacies, patients who have, for example, a prescription for clobazam, could get a phone call or an e-mail notifying them that there is the possibility of a shortage coming up, and an outline would be given for what steps need to be taken,” she says.

Given that pharmacies already have systems in place to notify people when prescriptions are due to be refilled, Diana says she doesn’t see why existing systems can’t be updated to include shortage notices.

Diana is also taking the initiative to write her MP’s office to explain the need for a mandatory drug-shortage database — and she’s encouraging others to follow suit.

Clobazam, which is marketed by several pharmaceutical companies in Canada, is a common medication prescribed to people with seizure disorders. The medication is usually prescribed to work in tandem with other pharmaceuticals. While several companies manufacture the drug, some people with epilepsy can experience changes in their seizure control when they switch brands.

There have been multiple shortages of anti-seizure medications over the past few years, and this is at least the second clobazam shortage in 14 months. In January 2013 Epilepsy Ontario issued a notice that pharmacies had back orders of clobazam.

In September, new guidelines were established that have been developed by government, industry and other stakeholders clearly outlining the expectations, roles and responsibilities for all stakeholders during a medication shortage.

Adhering to these guidelines is important to ensure safety for people with chronic conditions requiring medications, says epilepsy information specialist Suzanne Nurse.

“When it comes to managing drug shortages, early notification from drug manufacturers is key,” she says.

Writer: Deron Hamel

If you have feedback on this story, or have a story of your own that you would like to share, please contact the newsroom at 800-294-0051, ext. 23, or e-mail deron(at)axiomnews.ca. You can also leave a comment below.