Shelley Stepanuik Ask Your Pharmacist
In this issue of The Journal, we introduce a new feature: Ask Your Pharmacist. Ask Your Pharmacist is a forum for the IBD community to ask questions of a pharmacist who also has a personal connection to IBD and to CCFC.
We’re pleased to introduce readers to Shelley Stepanuik, BSP, a community pharmacist in Smiths Falls, Ontario. Shelley is a graduate of University of Saskatchewan and has spent her entire 20+ year career helping people in the community pharmacy setting. She is a lifetime member of CCFC, having joined in 1988 after receiving her own diagnosis of Crohn’s disease.
must provide Health Canada with their own research studies in order to obtain a “bioequivalence” rating. For the most part, all prescription generics approved in Canada are deemed to be bioequivalent to the original brand drug.
Q: My health plan is now refusing to cover brand-name drugs at the same level as they used to, because they say if generic versions are available you’re supposed to take them instead. My colitis is currently in remission using a brand-name drug and I don’t want to take any chances.
I guess I have three questions: what is the difference between brand-name and generic drugs, are they equally as effective, and what can I do if switching causes me to get sick again?
A: This is a great (and popular) three-part question with a not-so-simple and slightly extensive answer!
In Canada, when a new medication comes into the marketplace, it enjoys the privilege of patent protection. This means, no other equivalent competitor product can be sold. As soon as the patent has expired on a drug, generic companies (seemingly often immediately) are ready to market their products. They
Note that I said “bioequivalent” not “identical.” For example, if a generic product label states that its tablets contain prednisone 50mg, then that tablet will indeed contain 50mg of the active drug prednisone. To that extent, the products could be considered “identical.” The difference, however, between the generic brand and the first original brand on the market will be in how the dosage form (i.e. the tablet) is put together (i.e. differences in fillers, dosage forms, coating or markings used) as well as possible differences in how the drug is delivered, absorbed or metabolized in the body.
The key to determining bioequivalence is based on bioavailability. Bioavailability is a measurement of the rate and extent (how fast and how much) the active ingredient (i.e. prednisone) in a pharmaceutical product gets into our body at the site where the drug is required to work. Bioequivalence, therefore, is determined by comparing bioavailability measurements between the original brand drug and the new generic brand product. There is an acceptable range in bioavailability differences permitted, so while the generic brand products may not have the identical bioavailability as the original brand, they are close enough to be classified as bioequivalent. This, in effect, implies that they should be equally as effective In more formal terms from Health Canada, the Industry Guidelines for Drug
Studies states: “Bioequivalence implies that the drug product can be expected to have the same systemic effects (both therapeutic and adverse) as the reference product when administered to patients under the conditions specified in the labeling.” Having stated this, people will on occasion notice a difference between different brands of the same drug. Sometimes there are improvements in desired effects. Sometimes there are additional adverse effects. Unfortunately, this is not predictable and it certainly does not happen to everyone.
Very soon after generic brands are available, provinces often add them to their list of the covered drugs they will pay for called a drug formulary. They term them “interchangeable,” which refers to the bioequivalence status given to each generic brand. The provinces then tend to pay either for the generic only, or up to the generic price for the original brand. Most private plans follow suit.
All provincial and many private plans follow a “mandatory generic substitution” policy as far as filling prescriptions is concerned. This means that even if the physician writes a brand name on the prescription, the pharmacies are obligated to fill it with the generic equivalent, unless you (verbally) or the physician (in writing) indicate a preference for the original brand (“no substitution”).
Given that generics cost so much less than brand-name products in Canada (in Ontario, up to half-price), it is understandable that all drug plans prefer them to be dispensed. I am always
8 The Journal EDITION 3 | 2011
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