There is a prescription opioid crisis in Canada. While these drugs are effective in treating acute pain, and pain near the end of life, the evidence to support long-term use in patients with chronic pain is weak, and for many people the harms exceed the benefits. Prescription opioids are also highly addictive and easily misused.
In Ontario, the number of deaths related to prescription opioid overdoses increased five-fold from 1991 to 2004. Recent media reports suggest that the numbers are still climbing. Studies have found that prescription opioids are now the street drug of choice in large Canadian cities.
However, the national picture of harm related to prescription opioid use is hazy. Canadian researchers have noted that that there is “fragmented, unsystematic and insufficient” national data and monitoring of prescription opioid use, misuse and deaths. Beyond monitoring, experts have suggested that Health Canada needs to do more to regulate the pills themselves, and the uses that they are approved for.
While Health Canada has a defined regulatory role in the approval and labeling of new and currently available drugs, the federal government has been criticized for not doing enough. There are other federal government bodies – including the Public Health Agency of Canada – which experts say could play a larger role in improving the monitoring of prescription opioid use and harm.
Prescription opioid crisis: national leadership needed?
The toll of prescription opioid-related harm is manifest through the growing number of overdose deaths, increased demand for opioid addiction treatment programs and a state of emergency declared in some First Nations communities due to prescription opioids.
There is a growing chorus from advocacy groups, non-governmental organizations, and health care providers that the federal government needs to step into more of a leadership role to help tackle the complex problem of prescription opioid-related harm.
One area that has been identified is around Health Canada’s drug approvals and decision making.
Experts have pointed to the November 2012 Health Canada approval of the generic form of OxyContin, oxycodone, as an example of poor Health Canada decision making related to prescription opioids. The patent on OxyContin expired, and it was replaced with a more tamper –resistant formulation, known as OxyNEO, which is difficult to snort, chew or inject. Generic oxycodone lacks the same tamper-resistant formulation, which makes it easy to snort or inject.
Leona Aqlukkaq, federal Health Minister at the time, responded to critics by saying that approval of this drug was appropriate, given the evidence supporting its safety and use. In a letter to provincial Ministers of Health, Minister Aglukkaq articulated that much of what is needed to deal with prescription opioid misuse “all clearly falls under provincial and territorial jurisdiction” as well as “the medical professionals they regulate.”
Provincial regulatory bodies for physicians, pharmacists and dentists are among the organizations which have taken a leading role in sharing guidelines to educate members about prescribing and monitoring practices for prescription opioids.
For example, the College of Physicians and Surgeons of Alberta does a great deal of education and quality assurance about prescription opioids. Education initiatives include the Prescription Prescribing Practices Program which provides education and peer support to physicians about prescription opioids. The College also has a long-standing monitoring program in place, known as the Triplicate Prescription Program, which monitors the prescribing and use of drugs prone to misuse and abuse, and includes drugs like Oxycontin and Dilaudid. Research from the United States has found that such monitoring programs work and can reduce misuse, drug diversion and overdoses. Janet Wright, Assistant Registrar for the College says that the education and monitoring programs are in place “to make more information available to physicians about their own prescribing practices, and their patients.”
Rona Ambrose, appointed as federal Health Minister in July 2013, has hinted at prescription opioids becoming an area where the federal government will take a more active role. Ambrose stated in November 2013 that the National Anti-Drug strategy is being expanded to include prescription opioids and that research is underway to “provide much needed information on this important topic.”
What would a more active federal government role look like in dealing with prescription opioids?
Learning from the US approach to prescription opioids
The International Narcotics Control Board reports that prescription opioid misuse and harm represents “a major public health threat” in North America. Canada has the the second-highest prescription opioid consumption rate worldwide, just behind the United States. The United States Centers for Disease Control and Prevention (CDC) has called prescription opioid misuse a “dangerous epidemic”.
In the United States, overdose numbers from prescription opioids like Oxycontin and Percocet have quadrupled in the last 15 years. The United States CDC reports that for every death caused by prescription opioids, there were nine admissions to drug treatment centres.
The United States Food and Drug Administration (FDA) has a mandate to protect public health and ensure drugs are safe and effective. Unlike Health Canada, the FDA did not approve generic OxyContin. The FDA decision noted that the risk of misuse and harm outweighed the benefits of this medication.
A Canadian Medical Association Journal news article wrote that the FDA decision “calls into question” Health Canada’s approval of generic Oxycontin.
The FDA has been seen by some Canadian observers as more transparent and activist in their approach to tackling prescription opioids. The FDA makes efforts to get public input, as well as share decisions in a transparent, open way, including through blogs by leading FDA decision makers. Morgan Liscinsky, a FDA spokesperson notes that these strategies are compelled by “strongly held opinions regarding prescription opioids” and that public input “contributes to the agency’s [FDA’s] decision making process.”
In contrast, there are no comparable Health Canada communications, and responses to criticisms are often met only with statements published in the media releases section of Health Canada’s website.
Although Health Canada has been described as lagging behind the FDA, the FDA still has its critics, including Andrew Kolodny, a psychiatrist and President of Physicians for Responsible Prescribing (PROP). Kolodny argues that the FDA isn’t doing enough to “have a serious impact on the epidemic.” He says the FDA could do more – including narrowing the scope of uses for prescription opioids to only severe or end of life pain. “Had the FDA done this a decade ago, thousands of lives could have been saved” he says.
In addition, the October 2013 FDA decision to approve Zohydro ER, a new extended-release prescription opioid that lacks tamper-resistant formulation has been widely criticized. Critics include attorney generals from 28 states who submitted a formal letter to the FDA requesting that they reconsider the Zohydro decision.
Anna Mehler Paperny, a journalist who has covered prescription opioids says “the FDA approval on Zohydro is out of keeping on their approach to prescription opioids.” She highlights that observers will be watching carefully to see how Health Canada responds to a request by Zohydro’s manufacturers approval.
Advocates press Health Canada to narrow labeling, better monitor prescription opioid use and misuse
“Health Canada and the FDA aren’t doing enough” when it comes to regulating prescription opioids says Ada Guidice Thompson. She describes herself as a bereaved mother. Guidice-Thompsons’ son Michael died of a prescription opioid overdose in 2004. Michael had been prescribed opioids by his physicians to treat kidney stone pain. Guidice Thompson is now active in RxReform – a group made up largely of family members of those who have died due to prescription opioid-related harm.
She believes that “overprescribing is fueling the epidemic”, and the uses for prescription opioids need to be narrowed. Guidice Thompson says that these powerful drugs should only be used for end of life, or acute pain. She believes that Health Canada should change the labeling on these drugs to vastly narrow the permitted uses. She notes Health Canada’s mandate to ensure drugs are safe, and highlights that while the safety of short-term use of prescription opioids for acute pain has been well established, “no one has proven that they [prescription opioids] are safe and effective for long-term chronic, non-cancer pain.”
David Juurlink, a physician and researcher at Sunnybrook Health Sciences in Toronto agrees saying, changing the labeling would be helpful, but may not make a difference in practice. Juurlink notes that “doctors are free to prescribe” and “the practice is entrenched.”
However, Juurlink does note that changing the label could be part of a larger approach by the federal government to deal with prescription opioid misuse. He also highlights that a lack of national information around “the harm of these drugs ” saying “no one at the federal level can tell you how many Canadians last year died of prescription opioid-related causes.”
First Do No Harm Report – will it lead to change?
In March 2013, a landmark report First Do No Harm: Responding to Canada’s Prescription Drug Crisis was released by the Canadian Center on Substance Abuse (CCSA). The CCSA is a non-governmental organization with a legislated federal mandate to reduce the harm of drugs and alcohol. The CCSA receives funds directly from the federal government. Report recommendations were aimed at improving prevention, education, monitoring and surveillance as well as enforcement to curb prescription opioid-harm and misuse.
Recommendations which relate directly to federal government ministries and agencies include the development of a standardized pan-Canadian surveillance system to better grasp the harm these drugs are causing nationally and bring together the current patchwork of provincial and territorial information sources on prescription opioid-related harm.
A Canada-wide prescription monitoring program was also recommended. Such a program could build on prescription monitoring programs already in place in some provinces through regulatory colleges, like the Alberta Triplicate Prescription Program.
The recommendations also highlight that Health Canada could strengthen regulation and review legislation related to the safety of these drugs, but did not explicitly mention narrowing the labeling of uses for prescription opioids.
However, nearly one year after the publication and release of this report, it is unclear what steps have been taken to act upon, or respond to the recommendations. The recommendations outline which levels of government, agencies and organizations should act as leads on these recommendations, and identified leads include Health Canada, the Public Health Agency of Canada, as well as regulatory colleges, industry, First Nations groups and patient and family associations.
David Juurlink says that “it isn’t clear how the government is responding to the CCSA report” saying that “perhaps they are doing something, but if so it isn’t apparent.” Juurlink says this is one more reason why increased federal government transparency is needed to deal with the prescription opioid crisis.