Tag Archives: drug shortages

SECOND NOTIFICATION: Discontinuation of Frisium® (clobazam) Tablets in Canada

January 31, 2018

January 26, 2018

SECOND NOTIFICATION: Discontinuation of Frisium® (clobazam) Tablets in Canada

Dear Healthcare Professional and Epilepsy Patient Advocacy Organization,

As communicated first in July 2017, after careful consideration, Lundbeck has made the decision to discontinue the manufacturing of Frisium® (clobazam) Tablets in Canada. This decision was not triggered by a safety issue, but rather is based on the numerous generic clobazam alternatives available in Canada.

Due to an increased demand of Frisium in the second half of 2017, we now expect our current inventory to be depleted in the third quarter of 2018.

As mentioned before, Lundbeck first communicated this change well in advance to give healthcare professionals, patients and families as much notice as possible so that Frisium patients have ample time to successfully shift to an acceptable alternative clobazam therapy. Health Canada also was notified last summer. As well, we have listed our proposed discontinuation date on the drug shortages website in Canada.
As a company with a strong record of supporting the epilepsy community, Lundbeck is aware of the ongoing struggles many physicians and their patients experience in managing seizures. We are deeply committed to the epilepsy community, which is why we are taking several steps to ease this transition, including:

• Providing access to Lundbeck’s Medical Information team at 866 880 4636 to address questions or concerns. We will closely monitor responses from patients, their families and healthcare professionals and address concerns appropriately.

• Distributed two discontinuation letters to a comprehensive list of physicians, pharmacists and patient advocacy organizations throughout Canada in July 2017 and January 2018, providing more than a year’s lead time to enable a carefully thought-through treatment transition plan.
○ A final letter is scheduled for the summer of 2018.
○ Patient advocacy organizations will be encouraged to share all notifications for use in on and offline communications materials, as appropriate.

• Implementing allocation plans to ensure appropriate steady supply of the remaining Frisium tablets to the market based on historical demand.
• Conducting outreach to pharmaceutical wholesalers.

Again, please contact Lundbeck Medical Information at 866 880 4636 if you have any questions.
Sincerely,

Doug Williamson, MD
Chief Medical Officer, VP US Drug Development
Lundbeck

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.

Pharmaceutical companies need to explain why drug shortages occur in order to prevent them

February 4, 2016

By Deron Hamel

Stakeholders would be better positioned to offer solutions to prevent medication shortages if pharmaceutical companies provided public explanations about why shortages happen, says Suzanne Nurse, Epilepsy Ontario’s director of information and client services.

Following public consultation in 2014, the Canadian government announced it would be mandating the country’s pharmaceutical manufacturers to publicly announce medication shortages. Mandatory reporting is not in place yet, but even with compulsory reporting, processes need to be in place to prevent shortages of lifesaving medications, Nurse says.

Currently, six medications manufactured by Apotex that are commonly taken by people with seizure disorders are in short supply. These are divalproex, clobazam, levetiracetam, lamotrigine, pregabalin and topiramate.

There’s no explanation for the shortages, Nurse says. Lack of active ingredients, Canadian generic medication pricing policies and global factors have been proposed by some experts as possible causes of shortages, “but it’s all just speculation unless the manufacturers come forward and explain what is going on,” she says.

Shortages of epilepsy medications are “terrifying” for people needing the drugs and their families because of the health and safety risks, Nurse says, adding this is the third time in recent years clobazam, an anti-seizure medication, has been in short supply.

If public explanations were provided when drug shortages occur, stakeholders – whether independent agencies or government organizations – could play a part by working with others, nationally and internationally, to prevent shortages or to mitigate their impact, Nurse says.

For instance, providing explanations for drug shortages would allow global health-care regulators to work together to obtain ingredients that might be in short supply in one country but not in another.

Epilepsy Ontario and other advocacy organizations could play a role by creating dialogue with drug manufacturers to underscore the impact certain medications have on people’s lives, Nurse says.

“When we don’t know what’s happening, it makes it difficult to figure out what needs to be done to prevent it,” she says.

“Knowing what the biggest factors are behind shortages would help us identify what needs to be done to try to prevent them from happening.”

Mandatory reporting will give the public notice of which medications are in short supply, but without an explanation, it’s just a drug’s name on a list, she adds.

“The impact and the personal experience is lost,” Nurse says. “One of the roles Epilepsy Ontario plays is making sure that all the stakeholders that are involved in this issue are aware of how serious (drug shortages are) and how terrifying this is for people living with epilepsy.”

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.