By Pat Anson, Editor
At a time when the U.S. Food and Drug Administration is actively promoting the development of more opioid pain medication with abuse deterrent formulas (ADFs), Canada is saying the drugs are too expensive and will have “little to no effect” in the fight against opioid abuse and addiction.
Health Canada last week rejected a proposed regulation that would require all medications containing the painkiller oxycodone to have tamper resistant properties. ADFs generally make it harder for drug abusers to crush or liquefy opioids so they can be snorted or injected.
“(After) a review of the latest scientific evidence, the department has concluded that this specific regulatory approach, requiring tamper-resistance, would not have had the intended health and safety impact,” Health Canada said in a statement.
“Specifically, requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use.”
Like the United States, Canada has a severe and growing drug problem. According to the World Health Organization, Canada consumes more opioid painkillers per capita than any other country.
But Health Canada recently told drug makers to conduct more research demonstrating that ADFs do not change the safety and effectiveness of drugs. Until those studies are completed, the agency said it would rely on programs educating patients and prescribers about the safe use of opioids.
Purdue Pharma Canada released a statement saying it was disappointed in Health Canada’s decision and asked Health Minister Jane Philpott to reconsider.
“We continue to believe products with features designed to deter misuse, abuse and diversion, can and do have a positive impact on public health, based on the abundance of published evidence,” Purdue said in a statement. The company also urged Canada to “align with the FDA” by moving to require ADFs “across the entire class of opioids.”
In 2010, Purdue's OxyContin became the first opioid to be reformulated to make it harder for addicts to crush or liquefy. Since then, four other ADF opioids have been approved by the FDA and drug makers have spent hundreds of millions of dollars developing new formulas to make opioids even harder to abuse. Last month the FDA issued draft guidance encouraging drug makers to develop generic versions of opioids with ADF.
A major issue that has slowed the use of opioids with ADF is their cost. According to the Healthcare Bluebook, a website that estimates the market price of medications, the fair price for a 60-day supply of OxyContin 20mg in southern California is $352. A 60-day generic version of oxycodone -- without abuse deterrence -- retails for as little as $138.
Many health insurers have been reluctant to pay the extra cost of ADF. A recent study found that only a third of Medicare Part D plans cover OxyContin and in many cases prior authorization is needed. Oxycodone, however, is covered by all Medicare Part D plans and prior authorization is rarely required.
Another recent study found that over a quarter of patients admitted to drug treatment facilities in the U.S. were still abusing OxyContin, five years after it was reformulated.