Philpott should bring in regs to accelerate use of abuse-deterrent formulations for opioid medications

In last week’s Health Policy briefing in The Hill Times, Health Minister Jane Philpott outlined a compelling vision that will drive her mandate. From negotiating a new Health Accord, to addressing access to life-saving pharmaceuticals, to new investments in mental health, palliative care and First Nations health, there is no shortage of issues where her leadership is needed and welcome. As a father and fellow physician, I also support her stated intent to address “the moral imperative of responding to staggering mortality rates from suicide and substance abuse.” Canada currently finds itself in the midst of two related public health crises: the under-treatment of chronic pain and the challenges of prescription drug abuse, misuse and diversion. Chronic pain affects one in five Canadians along with their families and caregivers. It is a disease that needs to be addressed, and prescription opioids remain a safe and effective treatment for appropriately selected and monitored patients. However, these medicines do have a risk and tragically, we have seen the varied costs of prescription drug abuse. A human cost that has disproportionately affected young Canadians and our First Nations communities, a societal cost given the vast health care, societal and law enforcement resources expended, and the very personal cost of stigma against doctors, pharmacists and patients who responsibly prescribe, dispense and use these medicines respectively. In 2012, after more than a decade of research and development, Purdue Pharma replaced OxyContin in Canada, with OxyNEO, a product with features designed to deter its abuse and misuse. Since this transition, significant real-world evidence has been generated in both Canada and the United States that reveals: a reduction in the product’s abuse relative to OxyContin; fewer adverse event reports of overdose related to abuse/misuse; and, a marked decline in pharmacy thefts and losses of OxyNEO relative to the old formulation OxyContin. That is why products with abuse-deterrent features (ADFs) represent an important contribution by the pharmaceutical industry—brand and generic—to tackle the broad and growing issue of prescription drug abuse. On March 1, the U.S. Food and Drug Administration (FDA) reported that more than 30 such products are currently in various stages of development and that it has already approved five ADF products for use by American health-care professionals and American patients. While ADFs are not a “silver bullet” for addressing the complex societal issues of prescription opioid abuse, they are an important and available ‘upstream’ tool in a multi-faceted approach that can help to deter misuse, abuse, and diversion of these medicines. These ‘upstream’ tools complement other efforts such as prescription drug monitoring programs, prescriber education, law enforcement efforts and the broader provision of naloxone to first responders. All of these efforts are also consistent with a harm reduction approach. Converting one drug in the opioid class to a tamper-resistant or abuse-deterrent version would be expected to move abuse and diversion to non-deterrent medicines. This shift is referred to as the “balloon effect," and in fact actually demonstrates that abuse-deterrent technologies work. Therefore, it is important that this class of drugs be converted as the technologies are demonstrated by manufacturers, and approved by Health Canada. The quicker that occurs, the quicker we will see a benefit to public health. Purdue’s commitment is to introduce technologies designed to make our medicines less attractive or vulnerable to misuse and abuse while continuing to ensure they are safe and effective for patients. In the last Parliament, both the Senate Social Affairs, Science and Technology (November 2013) and the House of Commons Health (April 2014) committees recommended that Health Canada amend the Controlled Drugs and Substances Act regulations to make abuse-deterrent products a Canadian reality. These recommendations were informed by experts from the fields of medicine, pharmacy, public health, law enforcement, and addiction. Philpott has a window of immediate opportunity, framed by a public health urgency, to further expand the work of the last Parliament and align with the FDA by quickly introducing regulations to accelerate the use of abuse-deterrent formulations across the entire class of opioid medications. Dr. Craig Landau is the president and CEO of Purdue Pharma (Canada). He is an anesthesiologist with 25 years experience in private practice, the U.S. Army Reserve and industry. Purdue Pharma (Canada) is a member of Innovative Medicines Canada. The Hill Times

Philpott should bring in regs to accelerate use of abuse-deterrent formulations for opioid medications

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Philpott should bring in regs to accelerate use of abuse-deterrent formulations for opioid medications

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