Opioid Surveillance and Policy: A Canadian Perspective by Tara Gomes, MHSc

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

Opioid Prescribing Trends in Ontario, Canada

23 per 1000229 per 1000OxyContin added to

Formulary

Dhalla et al. CMAJ 2009Dhalla et al. CMAJ 2009. Updated

Increasing Rates of Opioid Related Deaths

Gomes et al. Addiction. 2014

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

Drug Overdose Deaths in the USA

http://www.cdc.gov/homeandrecreationalsafety/rxbrief/

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

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

Canadian and US Policies

2010 20132011 2012






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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

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


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Manitoba: General Benefit


Reformulation and Opioid Prescribing in the US and Canada

2010 20132011 2012






?

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

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?

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)

Number of OxyContin Tablets Dispensed

Gomes et al. Open Medicine. 2012. 6(4)Gomes et al. Open Medicine. 2012



Warnings

• Ontario College of Pharmacists

• College ofPhysiciansand Surgeonsof Ontario



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


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

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


Patent Expiry

2010 20132011 2012






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

Implications of Generic LA Oxycodone in Canada

~20%


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Inconsistency across Canada

Ontario Quebec

47%13%


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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/

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

Thank you!

[email protected]

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Opioid Surveillance and Policy: A Canadian Perspective by Tara Gomes, MHSc

Health & Medicine