Generic Medication Bioequivalence Follow-up/ Medication Shortages

The last time CADDAC posted on this topic was October of 2017 so we thought that it was long past time for some up-dates. Also, some new issues have arisen that may be of interest to you.

Bioequivalency

CADDAC met with Health Canada to share feedback on issues with some ADHD generics prior to their review of the bioequivalency guidelines. Health Canada completed their review of the bioequivalency guidelines in July of 2018. They realized that where multiphasic plasma concentration profiles were found to be integral to the products therapeutic effect their general standards may not be sufficient for some modified release products.

For this reason Health Canada made the standards for these products somewhat more stringent by aligning them with the EU approach. However, they did not align them with FDA standards which would have resulted in less variation of the generics that were approved. The new standards came into effect on September 1^st 2018, but did not apply to medications already on the market.

Teva Methyphidate ERC

The Teva brand of long acting methylphenidate was recently discontinued, so in the future you will not be able to access this medication. This medication was not evaluated using the new Health Canada more stringent guidelines.  CADDAC, as well as treating physicians, received feedback from patients and caregivers of decreased length of symptom control and increased side effects, compared to the brand medication since this medication was released.

ADHD Generic Medication Shortages

Also, issues of generic medication shortage and generic pharmacy preferences may still be causing issues for children and adults with ADHD. Did you know that when you fill your prescription you may be receiving a different generic medication every time? This will depend on which brand of generic medication is currently available and which generic medication your pharmacy chooses to stock and use to fill your prescription – understandably price may have something to do with this.

For some this may not be an issue, but since Health Canada standards for bioequivalency still allow for slight variations in generic medications you may notice a difference in effectiveness, length of duration of symptom control or the number and severity of side effects. Unless you ask to be notified or specifically look at the name of the medication on the bottle you won’t know when the brand of your generic has been switched.

For many people receiving these medications the differences will be subtle or non-existent; however for others who are be more sensitive to medication changes this could cause an issue. If you, or your child, are sensitive to changes in medication and are experiencing any of these issues you may wish to pay attention to changes in your generic medication.

If these fluctuations are effecting your functioning you may wish to look into receiving the brand medication through the free Innovicares CoPay assist card.