Changes will allow drugs to reach shelves faster
Health: Shorter transition from prescription to over-the-counter
By: By Tanya Kostiw
| Posted: Wednesday, May 16, 2012 02:48 pm
The waiting period for prescription drugs to become available on the shelf could be shortened when the federal government implements changes to the process.
After Health Canada approves a prescription drug to be marketed over the counter without a prescription, it must go through a regulatory process to be removed from Schedule F of the Food and Drug Regulations.
This process can take up to 20 months, said Etienne Ouimette, director of the Strategic Horizontal Policy Division of Health Canada's Health Products and Food Branch.
Under the new approach, the list indicating which substances have prescription status will be updated outside of the regulatory process.
This new process cuts red tape without compromising safety, said Ouimette.
“It allows Canadians to have access to over-the-counter drugs on a more timely basis,” he said.
The new process will allow government to use fewer resources as steps are eliminated and it could lead to companies introducing more over-the-counter drugs, which would give consumers more variety, Ouimette said. Companies could also market drugs in Canada first instead of in the United States because the system will be more streamlined, he added.
Okotoks Shoppers Drug Mart pharmacy owner Bob Brown said the move to cut out red tape is a good step, but he doesn't expect the new changes to significantly benefit consumers.
“There's very few products that we sit on here in Canada that people are waiting for with bated breath to turn OTC (over-the-counter),” he said.
Brown deals with clients who are frustrated they need a prescription for medication they have been taking for years, however, the patient's underlying medical condition could be why a prescription is needed, he explained.
Medications could be established as safe for public access, he said, but could cut out a necessary visit to a doctor. He gave the example of stomach remedies that can mask the symptoms of an ulcer. A perforated ulcer can be almost immediately life-threatening, he explained.
Pharmacists have to understand a patient's underlying medical condition to make a reasonable recommendation, Brown said. If the condition is not visible or a physician hasn't recently assessed it, it is almost out of a pharmacist's scope of practice to recommend something, he said.
“By facilitating access to that medicine you could allow something quite dangerous to happen,” he said.
Okotoks physician Dr. Grant Hill said there are many over-the-counter drugs available in the United States that Canadians still need prescriptions for at home. The American system is better for turning drugs to over-the-counter status if there is no good reason for a prescription to be written over and over again, he said.
“If this is a move towards the system similar to the U.S. where the red tape is less, then I think it is beneficial,” he said of the changes in Canada, as long as they are equivalent to the American system.
Synthroid, which is prescribed to people with thyroid problems, could benefit from becoming an over-the-counter drug as there is little likelihood of users running into serious trouble with it, Hill said. However, the required dose can change and medical professionals should still be involved, he added.
Pharmacists, who are medication experts, should remind patients to consider mentioning at their next physical assessment how they've been on a drug for a number of years and had no changes, he said.