Canadian medical regulatory authorities undertook guideline development in response to:
- Physicians and other stakeholders seeking guidance regarding safe and effective use of opioids
- A growing concern about opioid misuse creating patient and public safety issues
- The lack of systematically developed national guidelines on opioid use for CNCP
8.1 Need for Guidance regarding Safe and Effective Opioid Use
Medical regulators, through various interactions with physician members and other stakeholders, recognized a growing need for guidance on opioid use for CNCP. The College of Physicians and Surgeons of Ontario, in 2007, completed an environmental scan to better understand needs in the area of chronic pain treatment — and their findings resonated with regulators across Canada. The environmental scan gathered information through multiple methods — surveys, key informant interviews, and focus groups:
- Key informant interviews with three teams of chronic-pain researchers (Ontario, Alberta, and international)
- Key informant interviews with medical professional practice leaders in pain and addiction
- Focus groups with two multidisciplinary chronic pain treatment teams
- Focus groups with nurses and pharmacists
- Consumer consultation using two focus groups and one-on-one interviews:
- Focus group 1: self-identified chronic-pain sufferers recruited at a public information session
- Focus group 2: consumer-support group for chronic-pain sufferers
- One-on-one interviews: chronic-pain sufferers recruited from an inner-city pain clinic
- Survey of a network of approximately 175 family physicians identified by peers as "educationally influential"
- Survey of approximately 50 physicians who work with CPSO in the quality management division, completing peer-assessments with family practitioners
Results for each data-gathering method were qualitatively analyzed for trends. These trends were organized into a model that depicts the potential solutions that should result in an ideal system for CNCP management (see Figure A-8.1). The most common input from physicians centered on the need for guidance about prescribing opioids safely. Physicians expressed their fears and uncertainty in light of "mixed messages from educators, pain specialists, and the College" and highlighted the need for clear, evidence-based practice guidance to assist with managing chronic-pain patients without fear of exposing themselves or their patients to unnecessary risk.
More recently, Wenghofer et al. completed a random survey of 658 primary-care physicians in Ontario. This study found:
- Only 44% of physicians reported opioid prescribing to be satisfying
- 57% agreed that "many patients become addicted to opioids"
- 58% had at least one patient with an opioid-related adverse event in the past year,
- Another 58% had concerns about the opioid use of one or more patients (Wenghofer 2009 in press).
8.2. Concerns regarding Patient and Public Safety Risks from Opioid Misuse
Medical regulators and others are concerned about 1) patient and public safety regarding opioid misuse and 2) disturbing prescribing trends emerging in the past decade in Canada.
Canada’s recorded prescription-opioid consumption increased by about 50% between 2000 and 2004 (International Narcotics Control Board 2006); the rate of increase for this period is greater than that of the United States. Canada is currently the world’s third-largest opioid analgesic consumer per capita (overall consumption includes use of opioids for acute and palliative pain) (International Narcotics Control Board 2009). In Ontario, oxycodone prescriptions rose by 850% from 1991 to 2007, from 23 prescriptions/1000 individuals per year to 197/1000 per year, and the average amount per prescription of long-acting oxycodone increased from 1830 mg to 2280 mg (Dhalla 2009). In other words, more patients are receiving opioids in larger quantities.
The increase in opioid prescribing has been accompanied by simultaneous increases in abuse, serious injuries, and overdose deaths among individuals taking these drugs (Kuehn 2007). From 1991 to 2004 in Ontario, the mortality rate due to unintentional opioid overdose increased from 13.7/million to 27.2/million/year, more than double the mortality rate from HIV (12/million) (Dhalla 2009). Studies have documented a major increase in prescription-opioid misuse and addiction throughout North America. For example, a prospective Canadian study found that illicit opioid users are more likely to use prescription opioids than heroin (Fischer 2006).
It has been argued that legitimate prescribers bear little direct responsibility for this, because overdose deaths and addiction arise primarily from drug diversion. However, a recent study (Dhalla 2009) showed that of 1095 overdose deaths in Ontario, 56% of patients had been given an opioid prescription within four weeks before death. In a study of opioid-dependent patients admitted to the Centre for Addiction and Mental Health in Toronto, 37% received their opioid from physician prescriptions, 26% from both a prescription and “the street,” and only 21% entirely from the street (Sproule 2009). A United States national study found that, of 1408 patients entering treatment of opioid abuse, 79% of male and 85% of female patients were first exposed to opioids through a prescription to treat pain (Cicero 2008). Furthermore, the total amount of diverted opioids is directly related to the total amount of prescribed opioids (Dasgupta 2006).
8.3 Lack of a Systematically Developed National Guideline on Opioids and CNCP
Although consensus statements existed and other jurisdictions had published guidelines on chronic pain management and opioid use, no single Canadian guideline existed that used a combination of 1) systematic methods for searching and appraising the literature and 2) a consensus process that included clinicians from multiple disciplines and specialties along with patients.