Prescribing and Dispensing Policies to Address Harms Associated With Prescription Drug Abuse

Executive Summary

Background

Prescription opioids, benzodiazepines, and stimulants are primarily used in the management of pain, insomnia and anxiety, and attention-deficit/hyperactivity disorder, respectively. Certain opioids are also used to treat opioid dependence (e.g., methadone). While these drugs are important therapeutic options in clinical practice, they also have the potential for misuse, abuse, and diversion for non-medical use due to their psychoactive properties. Over the past decade, the harms associated with prescription drug abuse are increasingly becoming a public health and safety concern in Canada. There has been a significant increase in the number of people seeking treatment for addiction to prescription drugs; an increase in the number of youth who report having used prescription opioids for non-medical use; and an increase in the number of overdose deaths associated with prescription opioids.¹

Purpose

This Environmental Scan explores existing policies and strategies
that aim to reduce harms from prescription opioids, stimulants,
and benzodiazepines in the following five areas:

• Additional education for practising health care professionals
• Formulary and reimbursement policies
• Prescription writing and dispensing requirements
• Prescription drug–monitoring programs (PDMPs)
• Regulatory measures and oversight activities.

The Scan provides an overview of such policies in Canada and four reference countries (the United States, the United Kingdom, Australia, and New Zealand). It does not provide a comprehensive review or appraise the effectiveness of these policies, nor does it recommend one policy option over another. The Environmental Scan serves to illustrate the range of possible policy options and potentially inform future direction to achieve safe and effective use of opioids, stimulants, and benzodiazepines.

Sources of information

This Environmental Scan synthesizes information gathered from four different sources:

1. Limited literature search and targeted Web-based research
2. Information gathered from Health Canada’s consultations with regulatory colleges of physician and surgeons, dentists, and nurses from various Canadian provinces
3. Information reported in CADTH’s Environmental Scan Narcotics, Benzodiazepines, Stimulants, and Gabapentin: Policies, Initiatives, and Practices Across Canada (2014)²
4. CADTH survey of federal, provincial, and territorial public drug benefit plans conducted in May 2015 (hereafter, 2015 CADTH survey of public drug plans).

Of note: most of the information identified through these sources focused on opioids compared with benzodiazepines and stimulants.

Education for Health Care Professionals

Generally, additional education for practising health care professionals in Canada for the appropriate prescribing of opioids, stimulants, and benzodiazepines is not part of standards of practice and related clinical practice guidelines. Regulatory bodies may include additional education requirements in quality assurance processes, opioid substitution therapy regulation, misconduct procedures, or for those new to prescribing opioids (e.g., nurse practitioners).

In the US, pain facilities include mandatory education requirements for prescribing opioids.

In May 2015, new federal funding was announced in Canada to improve prescribing practices for prescription drugs that have a high risk of abuse or addiction. Projects will aim to support the development of new guidelines and training and tools for health care practitioners.³

Formulary and Reimbursement Policies

Public drugs plans in Canada currently list opioids, stimulants, benzodiazepines, and opioid substitute therapies, although some have quantity and refill restrictions. Some drugs, like methadone, oxycodone (OxyNEO), fentanyl, and methylphenidate, require prior approval in some jurisdictions.

Only Health Canada’s Non-insured Health Benefits Program and Newfoundland and Labrador have requirements for a rationale or special authorization for higher doses of opioids. In almost all jurisdictions where public drug plans have listed OxyNEO (a tamper-resistant formulation), they have done so under the Exceptional Drug Status program or special authorization.

Excepting the Department of National Defence Canadian Armed Forces drug plan, public drug plans that participated in the 2015 CADTH survey do not reimburse naloxone. Naloxone, however, is available in some Canadian cities (e.g., Edmonton) and provinces (e.g., Ontario and British Columbia) through public health harm reduction programs.^4,5 In July 2015, Health Canada announced its intention to review the prescription-only status of Naloxone. Naloxone is reimbursed under public health drug plans in Australia, while reimbursement in the US is unclear.

Prescription-Writing and -Dispensing Policies

To a varying degree, most Canadian jurisdictions have requirements such as refill restrictions, patient identification and records, limits on prescription-validity period, and use of paper-based tamper-resistant prescription pads or electronic PDMPs.

Some Canadian, US, and New Zealand jurisdictions have payer incentives for pharmacist activities that address suspected misuse and abuse, such as refusing to fill a prescription. Some jurisdictions also restrict patients to a limited number of pharmacies or prescribers for accessing opioids, stimulants, and benzodiazepines.

Prescription Drug–Monitoring Programs

Most Canadian jurisdictions have some form of PDMP, or have programs in development.¹ Monitoring of the precise range of specific opioids, stimulants, or benzodiazepines varies across Canada, but most of the PDMPs monitor at least one of these drugs. In 2014, Federal, Provincial and Territorial (FPT) Health Ministers, with the exception of Quebec, agreed to establish an FPT Prescription Monitoring Program Network with a mandate to focus on access and privacy related to prescription monitoring data. National utilization information is not presently tracked. In May 2015, Health Canada announced funding for the Canadian Institute for Health Information to develop a coordinated national approach for the monitoring and surveillance of prescription drug abuse in Canada.⁶

In the US, the majority of states have PDMP legislation.⁷ Entities responsible for administering the PDMP vary greatly by state, and a range of PDMP access restrictions and requirements exist.⁸ Interoperability between the various state systems is also a challenge due to a series of legal and technical issues.⁷

Other Regulatory Measures and Oversight Activities

Tamper-resistant formulation grants and changes in drug approval regulations, including abuse deterrent labelling, have been promoted by the US government.^9-12 Similarly, Health Canada is currently consulting with Canadians on its draft Proposed Tamper-Resistant Properties of Drugs Regulations.¹³

Of the jurisdictions covered by this Scan, the US appears to have made the most investment in programs and policies to address prescription drug harms. Many state and local strategies exist to expand upon the US federal government’s National Drug Control Strategy.¹⁴ The US Department of Health and Human Services will use new funding to focus on educational resources, increasing the use of naloxone, and expanding the use of medication-assisted treatment for opioid addiction.¹⁵

Conclusion

The issue of prescription drug abuse is common to all the jurisdictions studied in this Scan. Policies and strategies to reduce prescription drug harms are developed and executed by various authorities and differing combinations are applied in each jurisdiction.

Some of the emerging trends identified by this Scan include the development of educational tools to change prescriber behaviour; investment in improving access, scope, and functionality of PDMPs; reconsidering access requirements for naloxone; and regulatory agencies’ exploration of tamper-resistant formulations of opioids.