Good morning.
I also am a member of the Best Medicines Coalition, and I'm also here today as a representative of the Canadian Epilepsy Alliance.
I'm going to describe, just as an example, what's been happening in the field of epilepsy as a result of drug shortages.
People with chronic medical conditions such as epilepsy require consistent access to medications.
Epilepsy is a chronic neurological disorder that's characterized by recurrent seizures. The main treatment for epilepsy is anti-epileptic drugs, or AEDs, and they must be taken daily to prevent recurrent seizures. When AEDs are stopped or changed abruptly, recurrent seizures can be more severe or more prolonged than previous seizures. Prolonged seizures lasting more than five minutes are a medical emergency and can be life-threatening.
Between late 2009 and now, there have been shortages of at least five different AEDs, and that's a conservative estimate. Some of these medications are manufactured by a single pharmaceutical company. The AED shortages have led to some people being switched to a different formulation, if there is one available, or being switched cold turkey to an alternate drug. It's actually not known if there have been other people affected by a shortage who have simply stopped taking their medication without seeking medical care.
Some people switched to an alternate AED have experienced episodes of prolonged seizures, which are life-threatening. Physicians who specialize in epilepsy have reported that they have had patients with previously good seizure control experience breakthrough seizures as a result of drug shortages.
Even if people have enough medication on hand to see them through a shortage or are able find a pharmacy that still has some stock of their drug, there is a tremendous amount of stress, because people are not sure they are going to have enough drug to last them through the shortage. They are concerned that they will run out.
People with good seizure control have worried about the potential impact of breakthrough seizures on their health and also on their independence, because they could result in the loss of a driver's licence. And unfortunately, for some people, it could result in the loss of their careers.
Parents, spouses, and other family members have been very concerned about the safety of their loved ones.
People have been extremely frustrated and upset by the lack of information about drug shortages. Individuals affected by shortages do not have a place to go for general information pertaining to drug shortages, for information about specific drugs, or for advice on what they should do. Some people have had very good support from their health care providers and/or their pharmacists, but they still seek an authority on drug shortages for additional information.
Many people with epilepsy who have been affected by drug shortages are initially shocked when they find that their drug is not available. They are often very angry when or if they find out that there is no regulation to ensure supply. And they are desperate to see their drug back on pharmacy shelves.
If the committee has questions later, I have examples of individual patient situations.