Generic drugs less equivalent than we think?

The popular belief is that generic drugs are only a cheaper equivalent of original drugs. However, this is not what Jacinthe Leclerc, a professor in the Department of Nursing at UQTR, believes has done several studies on the subject.
I n fact, three studies conducted by Ms. Leclerc containing data on more than 500,000 Quebecers with cardiovascular disease revealed the same conclusion: patients who switched from an original drug to a generic drug visited more often than hospital those who were still using the original drugs. This increase varies between 8 and 20%, according to the study.

As part of her practice as a clinician nurse, Ms. Leclerc came up with the idea of ​​doing this type of study. She also made the subject of her doctoral thesis, published in 2017. “On several occasions, I observed patients who went from the original to the generic, or vice versa, [who] had side effects or therapeutic sub-dosage. It’s happened enough in the clinic that I asked myself, ” What are the differences? ”

In Canada, generic drugs account for 71.8% of prescriptions, according to the Canadian Generic Pharmaceutical Association. The only difference with the original, according to many health professionals, is only the price, which can be up to ten times cheaper for a patient who turns to the credits.

Original and generic, more or less equivalent

The difference between an original and generic medicine is in the inactive ingredients that compose them. Each medicine contains an active ingredient, which makes the medicine work. This one is the same in the original drug and in the credits.

However, differences in inactive ingredients can impact patient health, says Leclerc. “It makes sure that if you absorb less quickly, less well, or faster and in greater proportion, you can see differences in our control of the disease,” she says. It should be noted that these differences are also valid between generic drugs of the same original drug.

The hypothesis put forward by Ms. Leclerc, as well as by several other researchers on the same subject, is that these differences make hospital visits increase when there is a change between an original drug and the generic.

In Canada, the difference in bioavailability margin, the proportion of the drug that is found in the blood, between an original drug and its generics, must be a maximum of 20% for the majority of drugs available in the country. Ms. Leclerc believes that Health Canada should lower this margin, but can not prove beyond doubt that this is the solution to the current problem. “We can not certify it with the data we currently have. The last study that could answer the question should be conducted, along with clinical data, hospital records … It would be very expensive, “says Leclerc.

A dangerous difference?

The effects of a change between an original drug and a generic drug can be dangerous, according to Ms. Leclerc. Some studies reveal that patients with epilepsy may experience more epileptic seizures from an original to a generic. The same is true for researchers conducting osteoporosis studies, which reveal that this change could lead to more fractures and stomach pain.

The difference between the original and generic drug would also affect patients with mental health problems, something that Ms. Leclerc found while practicing nursing. “In psychiatry, patients were, for example, in schizophrenia, took an original medication, and then in generic substitution, they found themselves, sometimes, with symptoms of overdose, with drowsiness, a very fast heart rate [.. .] or conversely, a recrudescence of symptoms of psychosis. ”

In 2015, under the Barrette reform, people insured by the public drug insurance plan were forced to turn to generic drugs to receive compensation. If patients want to use the original medicine, they must pay the difference. This measure was put in place to save $ 40 million a year. On the other hand, Ms. Leclerc wonders if the government really saves, considering the increase in hospital visits for patients who are switching from an original drug to a generic drug.

When this measure came into force, some drugs were exempted, such as clozapine, which is prescribed in severe cases of mental health disorders. This suggests that the Department of Health and Social Services may be aware of the risks of switching from an original drug to the generic, according to Ms. Leclerc.

The latter also mentions that more and more private insurance plans are also choosing to adopt similar measures. For insurers, original drugs can cost up to five times the price of a generic.

An education challenge

Ms. Leclerc considers that one of the main challenges in this area is to educate health professionals about these risks. “If a patient arrives with a side effect as a result of the substitution, it is often brushed aside,” she says.

However, Ms. Leclerc does not blame the employees of the health system. “What we hear from the outset is that it’s the same thing, but it’s cheaper. We can not blame them, that’s what we learn at school. It’s not entirely true that it’s just the cost and the color of the pill that are changing. ”

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