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Generic Medication Substitution
Health Canada has approved Teva-Methylphenidate ER-C (formerly Nova-methylphenidte ER-C) , a methylphenidate-based product with a time-released delivery system, as a generic substitute for ConcertaTM. The actual delivery mechanism is not the same as ConcertaTM and - despite attempts to find out more – we have been unable to obtain additional details on the delivery system of this medication . The visual appearance of the medication is very similar to Concerta. However, unlike ConcertaTM, Teva-Methylphenidate ER-C can easily be divided, crushed and powdered, which could potentially increase its abuse potential.
As with all other generic products, Teva-Methylphenidate ER-C was made available in Canada after demonstrating bioequivalence to ConcertaTM according to Health Canada criteria. Simply put, the criteria requirement is that - at any given time - the amount of medication (methylphenidate) in the bloodstream must be 80% to 125% of the amount of the same medication that would be in the blood stream if ConcertaTM was taken. Health Canada made their decision in this case based on blood levels recorded in 25 healthy adults.
However, bioequivalence does not always mean equal therapeutic effect. What we do know is that the time necessary to obtain the maximal concentration (Tmax) is less for Novo-Methylphenidate ER-C than ConcertaTM. ConcertaTM peaks at 7.6 hours and Novo-Methylphenidate ER-C peaks at 4.6 hours.
CADDAC is requesting that more research be required before substitution approval for a generic is given. Studies looking at therapeutic effectiveness, symptom control and possible side effects should be required in a variety of age groups. Abuse potential of a new medication should also be looked at.
At this time, pharmacists have the right to substitute an innovative or original product for a generic product and in many provinces this can be done without notifying the patient or caregiver. Some private health insurance companies may already have requested that this new generic medication be substituted for the brand name medication. Some provincial health plans have done the same. Physicians need not be notified that a medication substitution has occurred.
It is logical that close follow-up should occur when a medication is being substituted. However, in some cases, the patient may not even be aware that a substitution has occurred and could therefore not alert their physician to this.
A patient has the option to reject the proposed substitution. However, if the patient is covered by a public medication insurance program, or in certain cases a private insurance program, he or she may be required to pay more for the original product. Physicians may decide to write "do not substitute" on the prescription.
CADDRA, the Canadian ADHD Resource Alliance, is suggesting that only clinical experience will help answer the questions of clinical efficacy and abuse potential. They believe that, in the mean time, Teva-Methylphenidate ER-C should be considered an additional ADHD treatment option instead of a product that can automatically replace ConcertaTM. Each case is unique and it is crucial to personalize treatment, taking into account the needs of the individual patient.
CADDAC agrees with this position. CADDAC is certainly not apposed to generic medication - many of the patients and families we advocate for would benefit from a cost reduction and some could afford a long-acting medication for the first time.
CADDAC's concern is that the process used to approve substitution is not rigorous enough. We are aware of more than one instance where the generic medication failed to provide equal symptom control with serious impact to the child and their family.
CADDAC is therefore alerting our membership and the ADHD community about the issue.
Please note that the medication substitution may work very well for you or your child. We are not suggesting that there will be an problem for all, or even for most people, but we believe patients have a right to know about this situation.
Knowledge is the best tool that we have at this time so we are asking that if you have experience with this medication, either positive or negative, to access our comment page and send your comments to CADDAC.
Health Canada has also explained that they must receive an Adverse Reaction (side effect) reporting form, to recognize and any action to be taken in this issue. Any reaction which involves a lack of effectiveness due to this switch to generic medication, qualifies as an Adverse Reaction. Please access all information to report to Health Canada through our site page titled "Health Canada - Adverse Reaction - Form & Guide".
We will be monitoring comments that are sent in and encouraging those that have had any issues to also request that their doctors contact CADDRA at www.caddra.ca
Your comments will be kept strictly confidential.
If a time arises that CADDAC deems it necessary to alert Health Canada about comments that we have received, you will be contacted first by e-mail if you have given us permission to do so. At that time we will ask if you are comfortable with any or all of your information being shared.
TO ACCESS OUR COMMENT PAGE CLICK HERE
This letter & following correspondence was sent to Health Canada and Provincial Drug Plans to express some concerns CADDAC had regarding the substitution of a generic medication in place of Concerta, especially if patients were not informed.Letter from CADDAC to Dr. Supriya Sharma, Health Canada - February 2010Follow up Letter from CADDAC to Dr. Supriya Sharma, Health Canada - September 2010