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. Shelley Stepanuik, BSP, is 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.

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 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.

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 empathetic to someone who is stable with their bowel condition and is reluctant to change their brand.   Financially, though, it is probably worth trying.  

In Ontario, those with the provincial drug plan coverage are expected to try generic brands if they expect usual payment coverage.  If adverse reactions occur with the generic brand, and it then becomes medically necessary to stay with the original brand, the physician must become involved.  The doctor must file an Adverse Drug Report (ADR) with Health Canada.  This is to document that an effort was made to use the generic brand, but it has become medically necessary to stay with the original brand. A copy of the form is to be provided to the pharmacy along with the “no sub” prescription for the brand product.  This order then becomes a “request” to the drug plan, one could say, to once again pay fully for the original brand. (This, of course, presumes that the original brand drug is still part of the formulary.)  Drug formularies and rules around “no sub” prescriptions are different in every province.  Your pharmacist will know the details.

If you are not a beneficiary of the provincial drug plan but have private insurance through your employer, I suggest you first contact your insurance plan about their reduction in payment levels when brand names are dispensed.  Ask if a submitted ADR form and a “no sub” prescription is enough for them to reconsider covering the original brand for you up to its full price.  While insurance companies can often seem like the bearers and deciders of bad news, they ultimately are only doing what the employer has instructed and agreed for them to do.  Once you have spoken with the insurance company, your next place to start dialogue would be the Human Resources or Benefits Coordinator at your place of employment.

In Canada, some pharmaceutical manufacturers are offering to pay the difference between brand and generic products.  Most of these situations are not for medications related to Crohn’s or colitis, but ask your pharmacist anyway. 

It is my professional opinion that if you are taking one generic brand and your condition stabilizes or goes into remission, it is wise to stay with that generic brand.  Bioequivalence is a comparison of one generic brand against the original brand, and not a comparison of one generic brand against another.  Different pharmacies have different policies about this, but many are willing to stock your brand to accommodate your needs. Canadian pharmacies have experienced some of the worst drug stock shortages ever in the last couple of years, and they are still a problem. At times, therefore, you will not have a choice of what brand you get, as there may only be one available.