Transcript from FDA Hearing on Naloxone Access Now Available

As previously discussed on OPA, the U.S. Food and Drug Administration (FDA) organized a workshop this past April to examine access to naloxone as a means to reduce opioid overdose fatalities in the Unites States. FDA has now published the complete transcript of the event, available here (PDF). 


We will post choice excerpts in coming weeks, but the entire transcript is worth reviewing and referencing, and includes testimony from leading advocates, researchers, and officials from CDC, FDA and SAMHSA among others. 


One immediate way that advocates may follow up on the workshop is to submit comments on the subject, which FDA is accepting until June 12. Doing so will support efforts to convince FDA to take action on expanding naloxone access, which has included discussion of rescheduling the medication to remove prescription requirements. For information on how to submit comments and suggestions for doing so, follow this link. 

Pubmed May 2012 Update

This is actually an interim update because my last PubMed pull came up dry. We have papers from New Mexico, Serbia, and Italy, as well as a case report, addressing sociodemographics, depression, naltrexone, methadone, buprenorphine, and heart failure.

1) The influence of living along the U.S.-Mexico border on unintentional drug overdose death, New Mexico (USA), 2005-2009.

Shah NG, Lathrop SL, Flores JE, Landen MG.

Drug Alcohol Depend. 2012 Apr 16.

Comment: An analysis of New Mexico overdose deaths (many of us have been waiting with bated breath for a deeper analysis of deaths there). Authors found that living in a border region was associated with less overdose death, particularly from heroin or methadone; among their hypotheses is that this is a paradoxical benefit of reduced access to medical care and opioid prescriptions. 

2) [Differences in depression severity and frequency of relapses in opiate addicts treated with methadone or opiate blocker after detoxification].

Jovanović T, Lazarević D, Nikolić G.

Vojnosanit Pregl. 2012 Apr;69(4):326-32. Serbian.

Comment: Does anyone read Serbian? I'd love to see some additional comment on this intriguing paper. The issues around depot naltrexone versus agonist maintenance are becoming a real issue. The concerns around overdose death in the setting of naltrexone have not been adequately addressed. This paper appears to compare depression scales for patients on those two therapies, but I can't tell from the abstract exactly what the populations are or what the analysis showed.

Naloxone has Rensselaer Country Sheriffs enthusiastic about preventing overdose deaths

By Leo Beletsky, Elena Moroz

In our last entry, we talked about the innovative police program in Massachusetts who have successfully implemented the use of naloxone to reverse opioid overdoses. This program is one of the first among a growing number of police departments that are responding to the overdose epidemic in their communities by undergoing training on overdose prevention.

One the newest of these initiatives is a collaboration between The New York Department of Health and law enforcement in the rural Rensselaer County in upstate New York.

As we have previously discussed, police officers are often the first on the scene of an overdose and can provide critical response to avert death or brain injury resulting from these events. The pilot program in the rural Rensselaer County is particularly well placed because overdose victims here will often find themselves far from any ambulance or hospital. To date, this pilot is the first in New York State where police are trained to use naloxone. Other rural counties should follow suit and implement naloxone programs among first-responders.

The Harm Reduction Coalition has a round-up of recent online overdose resources, including a video on overdose and naloxone for prisoners (which I had the opportunity to review while it was being made - it's really good), a guide about naloxone for prescribers and pharmacists, and the new Prescribe to Prevent site. Check them out here. 

UK Government Committee Endorsed Naloxone Distribution

Harm reductionists in the United Kingdom were among the first to take up leadership on overdose prevention, and now in more good news the UK Advisory Council on the Misuse of Drugs (ACMD) has issued a new report (PDF) which concludes that:

"naloxone provision is an evidence-based intervention, which can save lives. Naloxone provision fits with other measures to promote recovery by encouraging drug users to engage with treatment services, and ultimately, keep them alive until they are in recovery."

Established in 1971 under the Home Office, the ACMD is Britain's chief independent advisory body on drug related issues. 

The report is worth reading and citing. Aside from being politically useful it provides a review of overdose prevention programs in the UK as well as summaries of British and international evidence for naloxone provision.

Important! FDA Accepting Public Comments on Naloxone Availability

Last month OPA reported on a U.S. Food and Drug Administration hearing on strategies for improving access to naloxone. FDA is now accepting public comments until noon EST June 12, 2012. The more comments that FDA receives, the more likely our allies in the U.S. federal government will be able to push the issue.


You may submit comments individually or on behalf of an organization through this link, or by going to www.regulations.gov, searching for "naloxone" and clicking the link for "Role of Naloxone in Opioid Overdose Fatality Prevention."


Here are some suggestions sent out today by Harm Reduction Coalition's Whitney Englander:

(1) We need to generate VOLUME to FDA for the docket on the public workshop - numbers matter (2) The messages in the comments should be - as much as possible - to include references to the science, evidence, data, etc. - especially anything in the MMWR, or other data produced or published by government (e.g., NIDA, SAMHSA, FDA, CDC, etc.) (3) Any additional references to information or statements by other groups about the problem of overdose (e.g., data from American Hospital Association) and how naloxone will be a good remedy (4) We should extrapolate the data to illustrate what the "market" could be for naloxone -number of households with prescription opioids, number of American households with children/teenagers, etc.  anything to show that the potential market is bigger than what the industry rep suggested it is (5) Anything regarding economic impact - the cost of overdose - cost of emergency services/emergency department cost of someone who doesn't get emergency services right away and experiences brain damage from lack of oxygen, etc. - show the impact on society and economy (6) Be sure to make clear there is no adverse impact on people who do not have opioids in their system - science to illustrate this and anything regarding lack of side effects or nominal adverse effects - that the benefits FAR outweigh any possible problems with naloxone's use/expanded access.

And a few more guidelines from Maya Doe-Simkins:

On the comment page, fill in the fields and paste your comment of 2000 characters or less. 

All submitted comments are public record, which means that they are publically available, but comments from individuals will not be displayed on the website, unless you specifically request it.

Unless you are representing an organization, select "Individual Consumer" under the "Category" choice. 

You can use 2000 characters for an overview and submit a much lengthier statement as a PDF attachment, including letter on letterhead if available, graphs, figures, published papers, pictures, photos, etc. So, no need to feel constrained to 2000 characters if you have more to say!

Tips for crafting comments that may be helpful in expanding naloxone access:Comments should focus less on IF naloxone works, and more about the pros and cons of giving it to lay overdose bystanders and how simple (or not) that process is/should be. 

These are issues that have the potential to impede expanded naloxone access.  Consider addressing one or more in your comments if you are able:

• Is the training simple?/ Do people feel well prepared to use it?/ If you did use it, could you/the person who used it easily remember instructions?
• Does having naloxone increase drug use or decrease treatment?
• Does having naloxone during an overdose mean that people won’t call 911?
• Any bad outcomes after using naloxone?  Naloxone has a shorter half-life than opioid drugs- has anyone ever re-overdosed after the Narcan wore off?  If yes, what happened?
• Anyone who used naloxone or had it used on them by a lay person may want to mention if it was nasally administered or injected.
• If you are a provider/prevention/public health organization, Has it changed your service delivery?  How much training is necessary? 
• If the price or availability of naloxone has been a concern, please mention this!

Personal experience is powerful if you are comfortable sharing

If you submit comments, please advise Eliza Wheeler (wheeler [at] harmreduction.org) and Alice Bell (abell [at] pppgh.org) of your submission.

The Quincy Police Department: Pioneering Naloxone Among First Responders.

By Leo Beletsky, Elena Moroz

In Massachusetts, opioid overdose is the leading cause of accidental fatality; it ranks third overall behind heart disease and cancer. In this state, 60% of all poisoning deaths are due to opioid overdoses. Communities just outside of Boston, including Quincy and Lynn have been particularly hard-hit. These areas have three times more heroin-related ER visits than the rest of the country. Heroin, not alcohol, is the most common substance of abuse in Abington, Quincy and Weymouth. Other opioids besides heroin are also abused more frequently in New England than any other region of the United States.

In response to the rising number of opiate overdoses in the area over the past 10 years, the Massachusetts Department of Public Health (MDPH) launched a program to facilitate bystander intervention. The Overdose Education and Naloxone Distribution (OEND) program has reached out to thousands of drug users, their caregivers and other members of the community, distributing naloxone and authorizing bystander administration. The program has also expanded to training non-medical first responders, including fire fighters and police, after a group of drug users’ parents, advocated for increased police involvement in the program.

Nancy is the mother of Brendan, who was a college-bound honor student and an athlete at Boston College High School. It was a shock to everyone when Brendan developed an addiction to his father’s pain medication – OxyContin. The addiction lead Brendan to heroin, homelessness, problems with the law and finally a near-fatal overdose event. Kathy’s son Michael also found his way to opioid addiction through painkillers. When Michael suffered a motorcycle accident, he became addicted to Vicodin and later transitioned to heroin, also surviving an overdose.