Research: From evidence to policy: The Scottish national naloxone program

A new article tells the story of naloxone in Scotland - how it went from an idea to a national program. While the whole article is an interesting case study, some of my favorite parts are on empowerment and reductions in drug-related deaths:


"Similar to Glasgow and Lanarkshire, the qualitative feedback from those followed up in the Inverness project also highlighted increases in confidence and self-esteem among the participants who attended for a re-supply interview. Indeed, clients themselves appeared to look on the training as providing them with a degree of responsibility and seemed to relish their role as peer educators. Clients who had been trained were also hugely successful in engaging their peers with the project which complemented staff attempts to recruit participants to training sessions."


also


"Potentially, the most significant impact the Inverness pilot made locally, and indeed nationally, was the unexpected and almost immediate impact on DRD rates. In 2008, prior to the pilot starting, there were 20 DRDs [drug-related deaths] in the Inverness area covered by the pilot (Ross, personal communication, May 2011). By the end of 2009 there were 13 DRDs, 8 of which occurred prior to the pilot commencing in July. In 2010 that number had fallen to just two DRDs. Moreover, DRD figures for the wider Highland Council area (which incorporates Inverness) had fallen from 20 in 2008, to just 6 in 2010 (GRoS, 2011). While it is impossible to directly infer a causal relationship here, and attribute these falls in DRDs directly to the naloxone programme, it does present a strong case for further investigation, specifically exploring whether there are other influencing factors present, e.g. a concurrent decrease in drug availability in the area or increases in treatment provision."

Coming to the International AIDS Conference? Join OPA at the HIPS party!

For those of you coming to DC next week for the International AIDS Conference, OPA affiliates Matt Curtis and Phillip Coffin invite you to turn out with us to support one of our favorite sex worker health and rights organizations, HIPS. The event is a fundraiser and art show at the Iron Horse Tap Room on Tuesday July 24, from 6-9 pm and modestly priced at $20. Get your tickets here.


More on HIPS below the fold.

Department of Foreseeable Consequences: Tamper resistant OxyContin leads people to use more heroin

The New England Journal of Medicine today published a letter by Drs. Theodore Cicero, Matthew Ellis and Hilary Surratt that presents their research into how people who illegally use prescription opioids responded to the introduction of tamper-resistant OxyContin.  In a nutshell:

[T]he selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse-deterrent formulation to just 12.8% 21 months later (P<0.001). Simultaneously, selection of hydrocodone and other oxycodone agents increased slightly, whereas for other opioids, including high-potency fentanyl and hydromorphone, selection rose markedly, from 20.1% to 32.3% (P=0.005). Of all opioids used to “get high in the past 30 days at least once," OxyContin fell from 47.4% of respondents to 30.0% (P<0.001), whereas heroin use nearly doubled.

The idea with tamper-resistant formulation of OxyContin is that it's difficult crush pills for snorting or put them into solution for injecting (though users quickly found ways to do so by further processing the pills). What the authors have shown is that, at least in their small sample, this seems to have worked: significantly fewer people are using OxyContin to get high. What they haven't found is any reduction in overall opioid use.


And the kinds of opioid use people are turning to in lieu of OxyContin is what makes this a public health failure and an overdose concern: people appear to largely be turning to much more dangerous drugs. Heroin use, of course, carries risks associated with impurities in the cut, which in some cases may contribute to vein damage, infections, or a variety of toxic effects. The variable quality of street heroin, moreover, increases the likelihood that users' tolerance will fluctuate, thereby increasing overdose risk. Increased use of high potency opioids such as fentanyl is an obvious overdose risk, and indeed has been linked to spikes in overdose mortality in a number of locations. 

PubMed June 2012 Update

This chart was produced in 2007 to demonstrate the increase in overdose literature in the late 1990s and early 2000s - a trend that has continued. Twenty years ago there would have been 1 article for this post every 3-4 months, which may have been okay since you would have received it by actual post. 


Read on for a month of 8 papers laden with epidemiology...

1) HCV Infection Prevalence Lower Than Expected among 18-40-Year-Old Injection Drug Users in San Diego, CA.

Garfein RS, Rondinelli A,Barnes RF, Cuevas J, Metzner M, Velasquez M, Rodriguez D, Reilly M, Xing J,Teshale EH.

J Urban Health. 2012 Jul 6.[Epub ahead of print]

Comment: Focusing on the overdose component of the manuscript: Dr Garfein and colleagues found a relatively low rate of lifetime overdose in this cohort of 18-40 year olds of 28.1% (an analysis of these data with overdose as the outcome is clearly warranted). Most notably, they found an independent association of history of overdose with HCV infection. 

     This is consistent with other recent data suggesting an association between overdose and other drug-related risk behaviors such as syringe sharing. A poster this month at the International AIDS Conference shows that those who administer naloxone at their most recent witnessed overdose are less likely to share syringes than those who didn't administer naloxone. Moreover, the reductions in overdose we have seen in regions with well-funded naloxone distribution programs have been far more impressive than mathematical modeling would suggest. All together, these data force me to wonder if naloxone distribution has an effect well in excess of its ability to reverse an overdose.

2) Estimating the prevalence of illicit opioid use in New York City using multiple data sources.

McNeely J, Gourevitch MN, Paone D, Shah S, Wright S, Heller D.

BMC Public Health. 2012 Jun 18;12(1):443. [Epub ahead of print]

Comment: An excellent team of authors has attempted the perhaps impossible task of estimating the number of opioid users in New York City - a task that was hard enough with heroin alone. The results seem consistent enough to what would be predicted by large-scale epidemiologic studies to be of substantial use in future. I've asked for additional thoughts on this approach and will post comments when they come.

3) Low-Frequency Heroin Injection among Out-of-Treatment, Street-Recruited Injection Drug Users.
Harris JL, Lorvick J, Wenger L, Wilkins T, Iguchi MY, Bourgois P, Kral AH.

J Urban Health. 2012 Jun 12. [Epub ahead of print]

Comment: Among "low frequency" heroin users (who used 1-10 times in the past 30 days) 7.0% had overdosed in the past year. Among "high frequency" heroin users, 14.8% had overdosed in the past year. So infrequent heroin injectors overdose less in this sample. The low frequency injectors were marginally older, which may partially explain less overdose (that is, users who survive to older ages are less likely to overdose in a given year), yet I am still somewhat surprised by this result as I would presume low frequency injectors would have low or inconsistent opioid tolerance that might raise their risk of overdose. At this time, we clearly can't consider bouts of abstinence as a behavioral risk factor for overdose.

4) Vital signs: risk for overdose from methadone used for pain relief - United States, 1999-2010.

Centers for Disease Controland Prevention (CDC).

MMWR Morb Mortal Wkly Rep.2012 Jul 6;61:493-7.

Comment: Methadone has been the likely culprit for a large portion of prescription opioid deaths in the U.S. in the past 8-9 years. This likely occurred for a couple of reasons. First, extended release oxycodone was associated with a surge in opioid overdose deaths 10-12 years ago, so switching to methadone as the long-acting opioid seemed reasonable at the time. Unfortunately, dosing of methadone is complicated, with a non-linear dose-response curve that makes doses over 30mg dangerous for methadone-naive patients. 

Family members get involved in OD prevention

by Maya Doe-Simkins

Overdose education and naloxone distribution (OEND) has fundamentally changed the way that harm reduction service providers and friends and family of drug users interact -- it is a “game changer.”  

Syringe exchanges, for example, have often (though definitely not always) had a tenuous relationship with loved ones of drug users -- there is a very acute response to knowing that you are frantically doing everything you can think of to entice your child/partner/family member to stop injecting heroin and find “recovery,” while someone at an exchange is giving that person clean needles, cookers, tourniquets, filters. Public health practitioners acknowledge the two events can and should happen in tandem. Some loved ones find solace in knowing that needle exchange workers are taking care of their loved ones with supplies and seeing them for the wonderfully complex people they are -- but there is no denying that it is intense to know that there are people out there handing out injection equipment to a person whose potential abstinence consumes so much of your time and energy.

Enter take home naloxone. Families and friends of drug users are acutely aware of the lurking possibility of overdose -- I met one woman who went to three wakes in one week. Possessing naloxone gives loved ones a reprieve from the nagging fear and allows people to breathe a little more easily.  What parents and family members have done with the extra breath is talk -- to local health service organizations, local, state and federal elected officials, the police, the media, each other, the drug users they care about, pharmaceutical manufacturing companies, grant making organizations, and importantly organizations that provide harm reduction services. 

In Massachusetts, “non-users” (friends/family/service providers) approached syringe exchange and drop in programs that were providing OEND services to train them -- in church basements, around the kitchen table, etc. In recognizing that training this group of people is different than training drug users about overdose, a “Friends & Family” curriculum was developed. (Curriculum and accompanying power point can be downloaded here.)  

But that wasn’t enough -- fierce and vocal family members themselves wanted to be able to participate in spreading the training and materials to save lives.  A parent group, Learn To Cope, has been approved to be trainers & some members now provide overdose education and naloxone in addition to the practical, logistical and emotional support that they had been offering families.  

This graph, presented to the FDA in April 2012, shows the breakdown of “users” (self- identified current or ever) and “non-users” enrolled in four years at various sites -- about 1/3 of the people who get trained in Massachusetts to recognize overdose and administer naloxone are “non-users”.  Parents, other family, and friends of drug users are incredible advocates for better overdose prevention programs.

Normalization of naloxone

There has been a deluge of support for take-home naloxone lately. 

To name just a few (mostly U.S.) developments ...

•  The UK Advisory Council on the Misuse of Drugs endorsed take-home naloxone.
• The American Medical Association endorsed take-home naloxone, thanks to the efforts of a group of medical students.
• The US Food and Drug Administration convened a major meeting on take-home naloxone.
• The US Substance Abuse and Mental Health Services Administration is including take-home naloxone guidelines in their overdose prevention kit.
• The US National Institute on Drug Abuse funded the first R01 for naloxone distribution.
• Rhode Island passed a recent Good Samaritan law that included both naloxone and protection from prosecution components.
• Connecticut passed a law intended to expand availability of take-home naloxone.
• Gil Kerlikowske, Director of the US Office of National Drug Control Policy, spoke in favor of take-home naloxone on June 10th 2012 at the College on Problems of Drug Dependence conference in Palm Springs. In fact, 3 of his 14 recommended action items involved naloxone availability.

It seems that overdose death, like fatality from motor vehicle accidents, is finally being recognized as preventable, and naloxone as the seatbelt. 


This is not remotely a comprehensive list of what's happening. Please post other developments, by commenting here or by contacting an editor to publish a more detailed story.

American Medical Association Endorses Naloxone-Based Overdose Prevention as its Official Policy

By Leo Beletsky, Elena Moroz
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A Press Release from the American Medical Association on June 19th, 2012 stated the following on AMA’s new policy on community-based programs offering naloxone to prevent opioid overdoses:


PROMOTING PREVENTION OF FATAL OPIOID OVERDOSE: Opioid addiction and prescription drug abuse places a great burden on patients and society, and the number of fatal poisonings involving opioid analgesics more than tripled between 1999 and 2006. Naloxone is a drug that can be used to reverse the effects of opioid overdose. The AMA today adopted policy to support further implementation of community-based programs that offer naloxone and other opioid overdose prevention services. The policy also encourages education of health care workers and opioid users about the use of naloxone in preventing opioid overdose fatalities.

Wanted: Overdose Prevention Tailored to Women

By Leo Beletsky, Elena Moroz
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Over the past 20 years, the overall prevalence of fatal opioid overdose has tripled.  Historically, the risk of overdose among men had been significantly higher; over the last decade, however prevalence of opioid overdose deaths has been increasing faster among women than men. With the gender gap decreasing, women now face a greater risk for opioid drug overdose than ever before.

Women of all racial and socioeconomic backgrounds are facing greater risk of overdose from opioid drugs. Recent data sheds light on the role of pregnancy as one the possible channels for increasing opioid dependence, which is a precursor to overdose. In the past, neonatal abstinence syndrome had been documented primarily in underserved urban areas, it is increasingly observed in hospitals across geographical and socioeconomic strata.  However women who live in the South, Midwest and the East appear to be at an elevated risk than those in the West of the United States. Overdose is most common among middle aged women (45-55 years old).

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.