opioid surveillance and policy: a canadian perspective by tara gomes, mhsc
TRANSCRIPT
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Opioid Surveillance and Policy:A Canadian Perspective
Opioid Overdose SummitDecember 1, 2015
Tara Gomes
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Outline
• The State of Opioid Prescribing in Ontario, Canada
• Policy Decision-Making in Canada:– Tamper-deterrent LA oxycodone– Legislation and PDMP– Generic LA oxycodone
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Opioid Prescribing Trends in Ontario, Canada
23 per 1000229 per 1000OxyContin added to
Formulary
Dhalla et al. CMAJ 2009Dhalla et al. CMAJ 2009. Updated
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Increasing Rates of Opioid Related Deaths
Gomes et al. Addiction. 2014
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Public Health Impact:Proportion All Deaths that are Opioid-Related
2010: 1 in 8 deaths among young adults related to opioid overdose
Gomes et al. Addiction. 2014
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Drug Overdose Deaths in the USA
http://www.cdc.gov/homeandrecreationalsafety/rxbrief/
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By 2010…
• Canada and USA have the highest opioid consumption per capita in the world:
– Canada: 753 mg MEQ dispensed per capita, annually
– USA: 693 mg MEQ dispensed per capita
http://ppsg-production.heroku.com/chart
Canada
USA
Note: consumption does not include hydrocodone. Inclusion of hydrocodone leads to USA having higher consumption than Canada
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REFORMULATION OF LA OXYCODONE
Canadian Policy-Making
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Canadian and US Policies
2010 20132011 2012
November 2011: Ontario Narcotics Safety and Awareness Act
August 2010: Tamper-deterrent LA oxycodone introduced in the USA
February 2012: Tamper-deterrent LA oxycodone introduced in Canada
November 2012: OxyContin patent expires: Canada
April 2013: OxyContin patent expires: USA
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Canadian and US Policies
2010 20132011 2012
November 2011: Ontario Narcotics Safety and Awareness Act
August 2010: Tamper-deterrent LA oxycodone introduced in the USA
February 2012: Tamper-deterrent LA oxycodone introduced in Canada
November 2012: OxyContin patent expires: Canada
April 2013: OxyContin patent expires: USA
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Tamper-deterrent LA Oxycodone:Canadian Implications
• OxyContin replaced with OxyNeo essentially “overnight” in Canada – February 2012
• Provincial Drug Programs: – Public funding for drug coverage is managed provincially in
Canada– In general, access to LA Oxycodone became more difficult once
OxyNeo was introduced
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Trends in LA Opioid Prescribing (mg MEQ) in Canada
Gomes et al. 2015. CNODES Analysis. Available: http://www.researchgate.net/publication/279770891
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Tamper-Deterrent LA Oxycodone: Canadian implications
• Access to OxyNeo not consistent across the country:
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Ontario: Tight restrictions
Gomes et al. 2015. CNODES Analysis. Available: http://www.researchgate.net/publication/279770891
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Manitoba: General Benefit
Gomes et al. 2015. CNODES Analysis. Available: http://www.researchgate.net/publication/279770891
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Reformulation and Opioid Prescribing in the US and Canada
2010 20132011 2012
November 2011: Ontario Narcotics Safety and Awareness Act
August 2010: Tamper-deterrent LA oxycodone introduced in the USA
February 2012: Tamper-deterrent LA oxycodone introduced in Canada
November 2012: OxyContin patent expires: Canada
April 2013: OxyContin patent expires: USA
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?
Reformulation and Opioid Prescribing in the US and Canada
• In Canada, the original OxyContin formulation remained available until February 2012.
2010 20132011 2012
August 2010: Tamper-deterrent LA Oxycodone replaces OxyContin in the USA
February 2012: Tamper-deterrent LA Oxycodone introduced in Canada
Present
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OxyContin Reformulation:US Implications
• Did dispensing of OxyContin in areas of Canada close to US border crossings increase following the introduction of OxyContin-OP in the US?
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OxyContin Reformulation:US Implications
• Opioids dispensed by pharmacies close to the US-Canada border (Ontario only) between April 1, 2010 and February 29, 2012
• 6 Border Crossings of Interest:– Ambassador Bridge (Detroit – Windsor)– Detroit-Windsor Tunnel (Detroit – Windsor)– Blue Water Bridge (Port Huron – Sarnia)– Queenston-Lewiston Bridge (Lewiston – Niagara Falls– Rainbow Bridge & Whirlpool Rapids Bridge (Niagara Falls –
Niagara Falls)
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Number of OxyContin Tablets Dispensed
Gomes et al. Open Medicine. 2012. 6(4)Gomes et al. Open Medicine. 2012
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Number of OxyContin Tablets Dispensed
Gomes et al. Open Medicine. 2012. 6(4)Gomes et al. Open Medicine. 2012
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Warnings
• Ontario College of Pharmacists
• College ofPhysiciansand Surgeonsof Ontario
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Number of OxyContin Tablets Dispensed
Gomes et al. Open Medicine. 2012. 6(4)Gomes et al. Open Medicine. 2012
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Why Detroit? Why the Tunnel?
• Detroit is the primary distribution center for Michigan’s High Intensity Drug Trafficking Area
• Ambassador Bridge and D-W Tunnel prescribing regions are similar in:– Size– Population density – Number of pharmacies – Close to major thoroughfares in the US and Canada
• But, Ambassador Bridge is a busier commercial crossing, while the D-W Tunnel does not carry commercial traffic and connects directly to the downtown Detroit core
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LEGISLATION & INTRODUCTION OF PDMP
Canadian Policy-Making
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Ontario Narcotics Safety and Awareness Act: November 2011
• Objectives:– Promote appropriate prescribing and dispensing practices for
narcotics and other controlled substances– Identify and reduce the abuse, misuse and diversion of these
drugs – Reduce the risk of addiction and death from the abuse or misuse
of these drugs.• Key Initiatives:
– Ministry of Health can collect, use, and disclose information that relates to the prescribing and dispensing of monitored drugs – Narcotics Monitoring System (March 2012)
– Prescriber must be identified on prescriptions– Warnings in effect for double doctoring and polypharmacy
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Evaluating Impact
• Objective: Did Ontario’s policies lead to any shifts in inappropriate prescribing of monitored drugs?– Opioids– Benzodiazepines– Simulants
• “Potentially inappropriate use”– Early refill (ie prescription dispensed within 7 days of a
previously filled Rx of 30 day duration or higher)
– Different pharmacy dispensed the drug
– Different prescriber wrote prescription for drug
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Prevalence of Inappropriate Prescribing of Monitored Drugs in Ontario
Reduced to 1%
However, ~1 million prescriptions for monitored drugs still meet this definition which is very likely representative of misuse
Gomes et al. CMAJ Open. 2014
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Strengths of the Ontario PDMP
• Improved data access:– First time that all prescription opioid data has been collected by
the Ministry - has allowed identification of high prescribers who warrant follow-up
– Ministry now knows who prescribes and dispenses all opioids in the province
• Tools for pharmacists:– Enhanced warnings for pharmacists to help them identify
potential drug seeking behaviour• Impact:
– Our study shows that has led to some measurable reductions in potentially inappropriate prescribing behaviour
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Limitations of Ontario’s Approach
• Data access:– Prescribers do not have access to the database– Pharmacists are put in role of ‘gatekeeper’ to monitored drugs
• Data quality:– Multiple kinds of ID can be used – but not linked
• Data monitoring:– What does government do with this data? – Who is responsible for monitoring/surveillance?– Can data be shared with law enforcement?
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GENERIC LA OXYCODONE
Canadian Policy-Making
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Patent Expiry
2010 20132011 2012
November 2011: Ontario Narcotics Safety and Awareness Act
August 2010: Tamper-deterrent LA oxycodone introduced in the USA
February 2012: Tamper-deterrent LA oxycodone introduced in Canada
November 2012: OxyContin patent expires: Canada
April 2013: OxyContin patent expires: USA
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Patent Expiry in US and Canada
OxyContin Patent Expiry
Canada: Approves generic LA oxycodone
Several (6+) companies manufacturing generic
drug
Drug seeking behaviour, cross-
border trafficking?
Provincial Formulary listing?
USA: Does not allow generic LA oxycodone
“Poses an increased potential for certain
types of abuse”
Removes competition for tamper-deterrent
drug
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Implications of Generic LA Oxycodone in Canada
~20%
Gomes et al. 2015. CNODES Analysis. Available: http://www.researchgate.net/publication/279770891
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Inconsistency across Canada
Ontario Quebec
47%13%
Gomes et al. 2015. CNODES Analysis. Available: http://www.researchgate.net/publication/279770891
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Implications for the US
• Although generic LA Oxycodone not manufactured in the US – could it move across the border from Canada?
• Cross-sectional time series analysis:– All 113 US-Canada border crossings grouped into 50 prescribing
regions close to the border– Investigated whether uptake of dispensing in these regions after
introduction of generic LA oxycodone in Canada
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Dispensing of Generic LA Oxycodone near US-Canada border
Gomes et al. CMAJ Open. 2015
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Key Findings
• No evidence of large-scale trafficking of generic, non-tamper deterrent LA oxycodone from Canada into US
• However only dispensed drugs: losses/thefts not included in this analysis
Source: http://globalnews.ca/news/1441882/how-pilfered-canadian-pills-become-a-hot-u-s-commodity/
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What have we learned?
• Opioid use and abuse continues to impose a significant public health burden in Ontario
• Policy impacts across borders must be considered– Unified approach to policy-making needed– Both within Canada and across the border with the US
• We need to learn from our successes and failures– Need for ongoing policy development/revision– Narcotics Monitoring System improvements through broader access
and better patient tracking– Shifting availability of tamper deterrent formulations