The Changing Landscape of the Fight Against Opioid and Heroin Addiction and the Availability of Naloxone

by Dorsey & Whitney LLP

In recent months, the Obama administration and many health and pharmaceutical players at the state and local levels have focused their attention on the national opioid epidemic. Based on recent findings from the National Center for Injury Prevention and Control, approximately 40 Americans die each day from overdoses involving prescription opioids. Additionally, according to the National Institute of Drug Abuse, in 2014 approximately 10,000 Americans died from heroin overdose.

To shed light on the matter, the White House declared a week last month as Prescription Opioid and Heroin Epidemic Awareness Week. Additionally, forty-six governors have agreed to take steps to address the nation’s opioid addiction by signing the NGA Compact to Fight Opioid Addition which seeks to reduce inappropriate prescribing of opioids and changing the nation’s understanding of opioids and addition, and ensuring a path to recovery for individuals suffering from addiction. The DEA continues to expand its Prescription Take-Back programs, with the next one being held on October 22, 2016.

However, many have recognized that in addition the need for awareness and policies to reduce the chances that an individual becomes addicted to opioids, there is also a need for the wider availability of the life-saving drug, naloxone, for those currently suffering from opioid addiction.

As a result of this need, the FDA recently launched a 2016 Naloxone App competition aimed at developing a mobile phone application that can connect opioid users, family members, and bystanders with nearby carriers of naloxone in an emergency overdose situation.

Likewise, at the state and local level, governments have been revising state laws to authorize the dispensing of naloxone without a prescription; such changes have allowed more and more pharmacies to dispense naloxone without a prescription, greatly increasing access to the lifesaving drug. Rite Aid, for example, recently announced that naloxone is now available without a prescription in its pharmacies in 17 states; CVS and Walgreens have implemented similar policies. Midwest states that have implemented regulations or policies regarding administration of naloxone by pharmacies include: Illinois, Missouri, Wisconsin, Nebraska, Minnesota and South Dakota (note: Minnesota and South Dakota allow dispensing of naloxone under a protocol or collaborative practice agreement).

The effort to make naloxone available to those in need has expanded to some pharmacy manufacturers who have also been donating naloxone to state agencies, community pharmacies, treatment centers, and health care providers. For example, Mallinckrodt Pharmaceuticals recently announced the donation of 30,000 drug deactivation pouches in Hennepin County, Minnesota.

Additionally, state officials have expanded their plans to distribute naloxone to a number of different agencies. Colorado, for example, recently accounted plans to distribute naloxone to first responders in seventeen counties with high rates of drug overdoses. Many other states have announced similar plans.

Yet, even with so many industry players, lawmakers, and the public agreeing that greater action to curb opioid abuse and make naloxone more easily available to those in need, there continues to be disagreements and difficult questions that must be addressed. Recently, for example, a joint FDA advisory panel split on whether the injectable .4mg dose of naloxone should remain the current standard, or whether that dosage standard should be raised.

For now, given the daily changes in policy and laws related to naloxone dispensing, the pharmacy industry should continue to monitor applicable state and federal law, and, if a pharmacy determines that it can, and will, dispense naloxone without a prescription, it should adopt appropriate protocols and policies at the corporate and store level to ensure any required record keeping, reporting, or counseling requirements are met. Additionally, retail pharmacies should consider adopting policies and procedures for emergency situations involving an individual presenting themselves at the store for naloxone while experiencing an overdose. The pharmacies’ legal counsel should be involved in drafting and reviewing these policies to ensure compliance with state and federal laws.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Dorsey & Whitney LLP | Attorney Advertising

Written by:

Dorsey & Whitney LLP

Dorsey & Whitney LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.