Health Canada eyes opioid restrictions for Hot painkiller? tramadol

Health Canada has established a review of the increasingly popular pharmaceutical medication tramadol — a move that could prompt the department to reverse its controversial, decade-old decision not to classify the drug as annbsp;opioid.

A change in the classification would place the medication on the same regulatory footing as opioids like morphine, hydromorphone and oxycodone. It would also subject tramadol to tighter controls and improved reporting and recordnbsp;maintaining.

Health Canada told The Globe and Mail late Tuesday that it is launching the review in response to recent statistics showing a dramatic increase in tramadol prescriptions. When the assessment is complete, the department will determine whether the medication should be reclassified and controlled as an opioid. Presently, the painkiller is marketed in Canada as anbsp;non-opioid.

“Scheduling decisions are done in consultation with stakeholders, to be able to balance all views,” a spokesman said in annbsp;email.

The review coincides with the release of new statistics Wednesday in the Canadian Institute for Health Information (CIHI) offering the most comprehensive publicly released nationwide review of opioid-prescribing trends. The report shows for the first time that physicians dispensed smaller amounts of opioids for shorter durations in each prescription between 2015 and 2016. While the institute describes the total decline as “great news,” it also highlighted concerns linked to the expanding use of two medications — tramadol andnbsp;hydromorphone.

Prescriptions for tramadol climbed 30 percent between 2012 and 2016. The CIHI report notes that Health Canada allows the drug to be marketed as a non-narcotic though the department recognized back in 2007 which higher-dose formulations of tramadol “could be mistreated or abused in thenbsp;potential.”

Wednesday’s report is aimed at addressing gaps in Canada’s capability to track a worsening and fatal opioid epidemic. Former health minister Jane Philpott vowed last November to create a central clearing house for monitoring prescribing trends, emergency-department visits and overdosenbsp;deaths.

Overprescribing is behind the opioid crisis, which has worsened in recent years with the arrival of illegal fentanyl, causing a sharp spike in overdosenbsp;deaths.

Canada ranks as the world’s second-biggest consumer of pharmaceuticalnbsp;opioids.

A Globe and Mail analysis found that Ottawa and the provinces have failed to take sufficient actions to halt the indiscriminate prescribing of opioids, a class of painkillers that includes hydromorphone, oxycodone andnbsp;fentanyl.

The fact that tramadol is contained in CIHI’s report is notable. Because Health Canada believes tramadol to be a non-narcotic, the section doesn’t list it as an opioid under the Controlled Drugs and Substances Act (CDSA). This puts the section out of step with global regulators. The World Health Organization and the United States’ Drug Enforcement Administration classify tramadol as an opioid. At the same time, the producers’ own scientific descriptions explain tramadol as an “opioidnbsp;analgesic.”

“It kind of walks and talks like a narcotic, but it is not categorized as one in Canada today,” said report co-author Michael Gaucher, that is CIHI’s manager of health and pharmaceuticals workforce information services. He said the institute included the medication in its report in large part because CIHI follows WHO’s classificationnbsp;system.

Because tramadol isn’t subject to the reporting requirements laid out in the CDSA, information about the extent of its abuse and misuse in Canada are lacking. South of the border, the U.S. Substance Abuse and Mental Health Services Administration found that the amount of emergency-department visits linked to the abuse or abuse of tramadol climbed from 6,255 to 21,649 between 2005 and 2011 — a rise of approximately 250 pernbsp;cent.

I believe [hydromorphone] is the sleeper opioid medication, if you will, that we fail … The dangers for dependency, abuse or overdose are very, very large. It can kill a lot ofnbsp;folks.

Dr. Benedikt Fischer, senior scientist, CAMH

Tara Gomes, a scientist at Toronto’s St. Michael’s Hospital, described Ottawa’s 2007 choice to continue to allow tramadol to be promoted as a non-opioid as a “odd” one. “We can begin to see more folks getting placed on tramadol and being told that it’s a safer alternative to other opioids, which is precisely what occurred with OxyContin all those years ago, and we have seen what that did,” shenbsp;stated.

Both Mr. Gaucher and Ms. Gomes spoke with The Globe before Health Canada’s announcement regarding thenbsp;inspection.

When tramadol came on the market in Canada in 2005, it had been marketed as a low-dose product along with acetaminophen — best known as the medication in Tylenol — and wasn’t considered to pose a substantial risk of abuse or dependence. By 2007, two drug companies gained approval for their once-daily, higher-dose formulations, even as among those companies struggled to find the identical merchandise approved for sale in the Unitednbsp;States.

That same year, Health Canada seriously considered — and then backed away from — a regulatory change that would have seen tramadol classified as a Schedule 1 drug under thenbsp;CDSA.

According to a July 7, 2007, posting in the federal government’s official newspaper, Health Canada recognized that higher doses of tramadol could cause dependence in much the same manner as other opioid painkillers, such as oxycodone andnbsp;morphine.

“Specifically, extended release formulations may be abused by dissolving, crushing, chewing or snorting the item, which might cause uncontrolled delivery of the opioid, and might lead to overdose and death,” the Canada Gazette posting stated. “This regulatory change will benefit Canadians because the higher management of tramadol will serve to minimize its own diversion, and the health risks associated with its illicitnbsp;use.”

The proposal was supported by provincial and territorial licensing bodies like the College of Pharmacists of British Columbia along with the Saskatchewan College of Pharmacists. However, the department faced resistance from officials from two tramadol producers who voiced concern over the proposednbsp;change.

In the long run, Health Canada didn’t go through with the regulatorynbsp;change.

Two decades later, in 2009, Health Canada conducted another assessment of the health and safety risks related to tramadol, but reasoned that the medication didn’t warrant a reclassification as an opioid. “The available evidence suggested that tramadol had reduced potential for abuse compared to other prescription opioids,” the department said in its announcement Tuesdaynbsp;evening.

The CIHI report also revealed that physicians are prescribing higher-potency painkillers in an increasing speed, despite increased awareness of the dangers of addiction and overdoses related to strongnbsp;opioids.

Strong opioids accounted for 57.3 percent of prescription painkillers dispensed by retail pharmacies across Canada in 2016, a five-percentage-point growth fromnbsp;2012.

Benedikt Fischer, a senior scientist at Toronto’s Centre for Addiction and Mental Health, said it isn’t known whether the tendency toward prescribing strong opioids has provided care for patients — “probably not,” he said — because the evidence for the effectiveness of those drugs isnbsp;restricted.

“But it has put more people at greater risk, specifically in respect to misuse, possible addiction and also death,” said Dr. Fischer, whose earlier research on opioid-prescribing tendencies is mentioned in the CIHInbsp;report.

The amount of prescriptions for hydromorphone, an extremely potent controlled-release drug, jumped 57 percent over the last five decades, accounting for one of every five opioid prescriptions in 2016. The medication is largely supporting the movement away from weak opioids to possibly highly addictive strongnbsp;painkillers.

Many physicians began shifting patients to hydromorphone in 2012, after the blockbuster drug OxyContin — a brand-name model of oxycodone produced by Purdue Pharma — was no longer available in Canada. Previously, the nation’s top-selling long-acting opioid, OxyContin also became a lightning rod in the early 2000s, as reports of dependence and overdoses exploded. Purdue pulled the drug from the marketplace; alternative painkillers, especially hydromorphone, stuffed thenbsp;emptiness.

“I believe [hydromorphone] is the sleeper opioid medication, if you will, that we fail,” Dr. Fischer said. “It’s almost the exact same profile as oxycodone, but we have not really been paying plenty of focus on it. … The dangers for dependency, abuse or overdose are very, very large. It can kill a lot ofnbsp;folks.”

Hydromorphone is five times more powerful than morphine, and morphine, consequently, is five to ten times more powerful thannbsp;codeine.

As part of this trend away from weak medications, the amount of prescriptions for codeine declined 10 percent over the previous five decades. Nonetheless, it remains the most frequently prescribed opioid in Canada. One of the less-potent opioids, tramadol, which is comparable in strength to codeine, bucked thenbsp;trend.

CIHI used numbers from health-data firm Quintiles IMS to compute that opioid prescriptions increased to 21.5 million in 2016, up 7 percent over the five decades. (The Globe reported in March that prescriptions for opioids totalled 19 million in 2016, according to data in Quintiles IMS that didn’t consist of tramadol and another codeine products. Tramadol accounted for 70 percent of thenbsp;discrepancy.)

What the crisis resembles across thenbsp;nation

In regards to the amount of prescriptions dispensed during the study period, Quebec’s data didn’t differ significantly from other states. But with respect to the real amount of opioids prescribed, the state was at the base of the low end — and by far. Doctors in Quebec are prescribing smaller quantities of opioids each prescription, whether through reduced dosages or briefer treatments. In September, the Canadian Institute for Health Information (CIHI) released a report that found Quebec also had the lowest rate of opioid-related hospitalizations. “Understanding the relationship between opioid prescribing and injuries such as hospitalizations in Quebec could have beneficial implications for best practices in the long run,” Wednesday’s reportnbsp;states.

Health professionals in the Atlantic state prescribed the second-largest amount of opioids per 1,000 people, behind only Alberta. Unlike Alberta, which saw its opioid quantities decrease between 2015 and 2016, Newfoundland and Labrador saw a 0.8-per-cent gain in the number of opioids prescribed per 1,000 during the same period. Only one other state — Saskatchewan — saw an increase in amounts, up 0.5 percent. Benedikt Fischer, a senior scientist at Toronto’s Centre for Addiction and Mental Health, said that although much of the attention has been on the catastrophe unfolding in the west, and to some extent Ontario, “some of the lingering issues are from the east, where we are not paying so muchnbsp;focus.”

The biggest decreases in the number of opioids prescribed per 1,000 people between 2015 and 2016 were seen in British Columbia and Nova Scotia, down 11.8 percent and 6 per cent respectively. The report notes that the College of Physicians and Surgeons in both of these provinces endorsed fresh opioid-prescribing guidelines issued by the U.S. Centers for Disease Control and Prevention shortly after they came out in March, 2016. Experts said the U.S. guidelines — that tackle treating patients with acute pain, where opioid addiction often starts — could be one of the reasons B.C. and Nova Scotia watched their amounts decline between 2015 and 2016. Greater awareness of this outbreak in hard-hit B.C., by way of instance, may also have contributed to the reduction in the number of opioids prescribednbsp;there.

Courtesy: The Globe And Mail

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