In 2010, Canada edged past the United States to become the highest opioid-consuming country in the world on a per-capita basis. This is just one of the latest in a long line of statistics that unveil North America’s longstanding love affair with prescription opioids.
In recent years, differing approaches in Canada and the United States to the prescription and regulation of various forms of oxycodone (an opiate sold under the brand name OxyContin until Perdue Pharma’s patents expired) have caused tension between the two countries. Under increasing pressure from both America and a growing domestic opioid addiction problem, the Canadian government has indicated that it is considering new tamper-resistance regulations for all opioids in the market.
This would be precedent-setting worldwide. To evaluate their feasibility, at least three things must be evaluated: plausibility of scientific advances, underlying assumptions about addiction, and policy implications not only for opioid-addicts, but also chronic pain patients.
Opioid and Oxycodone Primer
Opioids are a family of drugs that include naturally occurring compounds in the opium poppy (morphine, codeine, and thebaine), as well as semi-synthetic hybridizations of these chemicals (heroin, oxycodone, hydrocodone), and synthetic replications (methadone). ‘Opiate’ refers to a smaller subset that comprises only these naturally occurring and semi-synthetic compounds.
All opioids have the benefit of providing pain relief with virtually no toxicity to the human body or impairment of consciousness, making them extremely useful in medical applications. Opioids closely resemble endorphins, which are chemical messengers that are naturally produced in the human body. Endorphins are well known for their ‘happiness’ and pain-numbing effects. For instance, endorphins are responsible for the ‘runner’s high’ phenomenon. Since opioids resemble endorphins, they bond to the opioid-receptors in our bodies meant for endorphins and have an analgesic, or pain relieving, effect. They also commonly cause euphoria, which is the chief cause of their recreational use.
Unfortunately, over time the body reacts to the presence of exogenous opioids by growing more opioid receptors. This leads to tolerance and the need to take more opioids to achieve the original effect. This is the mechanism by which individuals become physiologically dependent upon opioid consumption and it plays a significant role in addiction.
Oxycodone is an opiate derived from thebaine, as are most opiates in modern medical usage today. It is a component of a number of drugs (including Vicodin and Percocet), but received the most controversial press when marketed as OxyContin by Perdue Pharma in the mid-1990s. The particular formulation of OxyContin is a 12-hour slow release capsule for oral administration that comes in dosages ranging from 10-160mg. It is extremely useful as a prescription painkiller compared to other opioids for a variety of reasons: virtually no side effects, high oral bioavailability (the amount of the drug that eventually reaches the bloodstream when consumed orally), predictable chemical properties, small pill size, no ‘ceiling effect’ (meaning patients can increase doses almost indefinitely to combat tolerance), and long-acting powerful pain relief.
Regulations: A Tale of Two Countries
In the United States, Perdue Pharma’s OxyContin skyrocketed in popularity soon after its original release in 1995 due to a liberal era of opioid prescription practices, its extreme effectiveness, and initial underestimation of its addictive qualities. The latter was particularly devastating. It was assumed that due to the slow release formula and consequent lack of a ‘high’ associated with other opioids, that OxyContin would be less addictive than alternatives. The potential for abuse, however, was quickly discovered. Although when swallowed intact the capsules would slowly release oxycodone over a 12-hour time span, users only had to break or crush the pills to release the entire dosage at once.
The easily crushable pills became popular for recreational use and as a street drug, although many media accounts were overly sensational. For instance, other opioids such as Vicodin and Percocet had been being abused for years prior to the introduction of OxyContin and never lost significant (black) market share to OxyContin. Moreover, there were many dramatized accounts of OxyContin being responsible for ‘hooking’ people on opioids and abandoning then them to its cheaper substitute heroin when they ran out of money. This remains unsubstantiated given that heroin addiction rates in the United States have remained virtually unchanged at 0.1% since prior to the creation of OxyContin.
Nevertheless, in response to public outcry and media sensationalism, the United States cracked down on OxyContin prescribing practices. In 2010, Perdue Pharma pulled it from the American market and replaced it with OxyNEO, a newly patented tamper-resistant version that turns to gel rather than powder when crushed. In 2013, the United States banned all generic versions of the original OxyContin formula.
In contrast, the Canadian federal government has allowed prescriptions of OxyContin and its subsequent generics to soar relatively unabated. In 2012, in response to U.S. complaints about OxyContin (then pulled from the U.S. market) trickling into the U.S. from Canada the federal government encouraged the provincial governments to address the problem. Many provinces instituted changes so that they refused to pay to cover anything but OxyNEO (the new tamper-resistant formulation), although they have no control over what private insurance companies will pay for.
The effect was largely a substitution of other less-regulated and potentially subpar opioids in prescribing practices, although some patients did switch to OxyNEO. U.S. pressure increased in 2013, which led to crossed wires between Canadian Health Minister Rona Ambrose and Health Canada. Ambrose hinted at an oxycodone crackdown in October 2013, only to have controversy flare one month later in November when Health Canada approved two cheap and easily crushable generic versions of OxyContin.
Most recently, in the summer of 2014, Ambrose has indicated that Ottawa is moving to impose tamper-resistant standards on all opioids in the Canadian market. This would surpass the stringency of current US standards, which are not uniform across opioids.
A Made-In-Canada Solution to Prescription Opioid Addiction?
While news of the Canadian government’s intention may please Ambrose’s American counterparts, despite plausible skepticism based on Canada’s last policy about-face on the issue, are these standards a good idea?
The first outstanding concern is that tamper-resistant drug formulations are not insurmountable barriers to abuse. In fact, the most common method of prescription drug abuse is not crushing pills in order to snort or inject for a quick high. More commonly, people simply take more than the prescribed dosage or mix their prescription with other opioids, alcohol, or sedatives.
Overdoses of opioids can be fatal through depression of the respiratory system. Alcohol and sedatives exacerbate this effect and most opioid-related deaths involve a mixture of drugs, including alcohol. At the moment there is no drug formulation that can prevent accidental or intentional overdose, although IntelliPharmaceutics is working to develop a new intelligent slow-release formulation of oxycodone that can tell if a patient has overdosed and in response will stop releasing the active oxycodone. However, the product is still in testing and there is no word as to whether it can detect the presence of other opioids, alcohol, or sedatives in the user’s system.
Another concern is a substitution effect. By making crushable forms of prescription opioids less available, black market dealers will have an incentive to smuggle in non-regulated opioids from the United States and other countries (a reversal of the current U.S.-Canada (black) market contamination dilemma) and opioid abusers will switch to these imported drugs or to heroin. This is especially likely if current funding for methadone clinics (treatment programs for opioid addiction) is not expanded. It stands to reason that if programs aimed at prescription drug abuse reduction only target the supply of drugs and not the demand for them, there will always be a (black) market incentive to meet that demand.
This speaks to the need to conceptualize addiction holistically; to determine and treat root causes including intergenerational trauma in indigenous communities (where opioid addiction rates are highest), poverty, mental illness, abuse, and other systemic social risk factors. Lastly, a dramatic change to opioid standards will mean a drastically shrunken availability of prescription opioids until pharmaceutical companies can catch up. While this is unlikely to significantly deter opioid abusers, it is likely to make it more difficult for patients legitimately requiring drugs for chronic pain conditions to access optimal care.
Ultimately, the proposed standard could be a great step towards combating prescription opioid abuse. Yet this is true only if: effective new tamper-resistant and overdose-resistant drug formulations are able to be created and approved quickly, it is part of a larger package of policies focused on addiction prevention (addressing root causes) and rehabilitation (methadone clinics), and if action is taken in concert with the Americans to avoid bootlegged pharmaceuticals.
Sarah Littisha Jansen is in her first year of the PhD program in International Conflict Management and Resolution at the Norman Paterson School of International Affairs. She completed her B.A. Honours at Glendon College of York University in International Studies and Études françaises and did undergraduate research in Kosovo/a on Serbian-Albanian bilingualism and its implications for building sustainable peace