|Choosing generic drugs||Jul. 15, 2012|
|Written by: Marilyn Linton, QMI Agency|
|Are you taking a chance with your health?|
You get what you pay for. That sure goes for mushy, bruised bananas at half the price of unblemished fruit, but does it apply to medications? Many of us think that drugs that cost more must be better — even though 60% of all prescriptions dispensed in Canada in 2011 were the cheaper generics rather than the brand name drug.
But are they really the same? They’re supposed to be lower-cost versions of brand name medications whose patents have expired. In theory, they’re a copy of the original, even if they look slightly different. Unless specified, generics are usually the first choice because they cost less than their brand name counterparts.
The allowable variation is about 25%, he says: “They have to fall within a 25% window in terms of how fast they can be absorbed and how much of the drug is taken up.” In his view, one generic version could be 80% bioequivalent compared to the brand; another could be 125% bioequivalent.”
Dr. Raimar Lobenberg, chair of the Pharmaceutical Sciences Division of the University of Alberta, agrees: “They are similar within an approved range but they are not exactly the same as the brand.” He adds that some studies of generics indicate differences that show up in people who have a disease rather than in a healthy subject.
Sometimes fillers used can change the way a drug is absorbed, he adds. “Fillers also have a function to increase the solubility of a drug in the gut. It has to be dissolved in order to be absorbed.”
Mamdani adds that studies show the difference 4%. But that small difference means a lot if it results in a less effective dose or a dangerous side effect. Where the difference also may be important is in drugs that have a narrow therapeutic window where you need to be careful about dosing because they can be toxic if they go too high.
“Generic drugs are every bit as safe, potent and effective as brand name drugs,” says Richard Guest, president of Mylan Inc., a generic pharmaceutical company that recently launched choosinggenerics.ca as an educational tool to dispel myths around generics.
Some tips from the experts? Avoid generics that may have been produced in a country where oversight is minimal. Buy your generics in Canada and never online. Adds Lobenberg: “The issue of generics is not black and white. A generic can be less effective — or more effective. We only know that they are similar within an approved range. The pharmacist is the go-to person for questions about how a generic compares to its brand name drug.”
The people speak
At peoplespharmacy.com, U.S. consumers voiced concerns encountered when they switched from a branded drug to a generic: Everything from cough remedies to anti-depressants, anti-convulsants and blood pressure meds are mentioned. As for generic manufacturing being farmed out to countries where oversight is minimal — another red flag — Dr. Muhammad Mamdani says that Health Canada provides our oversight.
A generic must be bioequivalent to the brand name drug: Equal in dosage, safety, strength, quality, the way it works in the body and how it’s taken.
A physician with poor handwriting could be prescribing Losec, a gastro-intestinal drug which gets interpreted by the pharmacy as Lasix, a diuretic for heart failure. It’s easier to write omeprazole, Losec’s generic name: “Generic names are consistent, harder to mess up, whereas brand names are all over the map,” says Dr. Mamdani.
Brand drugs are patented for about 20 years. In most cases, generic drug companies apply to health Canada to sell a generic version after the brand drug’s patent expires. More are on the way.
Generics are very important for public health, says Dr. Raimar Lobenberg. “The sad part is there is not yet enough research, or monitoring, because we know there are a few grey areas. In some drugs the generic may even be better because the drug, off a 20-year-old patent, has had an opportunity to be improved.”
Why less cost?
Generic companies do not incur the same research and development costs as the brand name drugs and they’re cheaper to manufacture. In its fight to lower generic drug pricing, the British Columbia coalition betterpharmacare.org said that generic meds are reviewed and approved for sale in Canada more quickly than their brand name equivalents, thus lowering the overall cost to bring generics to market; Health Canada allows an abbreviated submission process for generics compared to brands.
|MORE COLUMNS BY MARILYN LINTON, QMI AGENCY|