News

Naloxone access urged as U.S. heroin use increases

February 12, 2014

In the U.S., heroin use increased 79% between 2007 and 2012, with four of five new heroin users having previously abused prescription opioids. In many states across the country heroin is much cheaper in comparison to street prices of prescription opioids such as oxycodone. The cheap price combined with the fact that heroin provides a longer-lasting high that is very similar to pharmaceutical opioids makes switching to heroin a logical next step for many prescription opioid users.

The New York Times published an article in their Health section on Monday on how prescription painkillers have become a gateway drug to heroin. The article below published yesterday by Bloomberg News states that heroin-related deaths jumped by 84 percent in New York City between 2010 and 2012. Gil Kerlikowske, director of the Office of National Drug Control Policy, has acknowledged heroin overdose deaths are a growing national crisis, and federal drug officials are urging that access to naloxone be expanded.

Naloxone access urged as U.S. heroin use increases
Bloomberg Businessweek - February 11, 2014

Relatives of heroin addicts should be allowed to keep an overdose antidote available as use of the illegal drug surges in the U.S., prompted by increased abuse of prescription painkillers, federal drug officials said.

As the street values of medicine-cabinet pills rise because of federal limits on their access, abusers have turned to drugs such as heroin that cost less, said Gil Kerlikowske, director of the Office of National Drug Control Policy. It's a "growing national crisis" that must be addressed with a new national focus on prevention and treatment, he said.

Heroin use increased 79 percent in the five years ended in 2012, with 669,000 people in the U.S. reporting they had taken the drug, according to the National Survey on Drug Use and Health last year. Actor Philip Seymour Hoffman died earlier this month from a suspected heroin overdose. Canadian actor Cory Monteith, best known for his role in the television show "Glee," died in July from a combination of heroin and alcohol.

"It's clear we're not going to arrest our way out of this problem," Kerlikowske said today on a conference call.

Four of five new heroin users previously used prescription drugs non-medically, he said.

"The pathway seems to moving from prescription drugs to heroin, which is a very dangerous development," Wilson Compton, deputy director of the National Institute on Drug Abuse, said during the call.

Heroin-related deaths jumped 84 percent in New York City in 2012 from 2010, according to the city's Department of Health and Mental Hygiene. Heroin overdoses in Boston rose 76 percent over the same period, Boston Mayor Martin Walsh said in a statement.

Continue reading at Bloomberg Businessweek...

In Vermont, a network of help for opiate-addicted mothers

February 2, 2014

Below is a recent article from KTEP El Paso about the state of care for opiate-addicted mothers in Vermont. In his 2014 State of the State address, Governor of Vermont Peter Shumlin remarked that Vermont is experiencing a "full-blown heroin crisis." With the number of babies being born to opiate-addicted mothers rising, treatment must be improved and made more accessible for these mothers and their babies throughout Vermont.

In Vermont, A Network Of Help For Opiate-Addicted Mothers
KTEP El Paso - January 29, 2014

It came as a surprise to many people when Vermont's governor recently devoted his entire 2014 State of the State address to what he called a "full-blown heroin crisis."

While it may not fit Vermont's bucolic image, the state's addiction problem has long been acknowledged. And as the state has expanded treatment, it's also been coming to grips with one of the most difficult and emotional aspects of the issue: addicted mothers.

Between 2005 and 2010, the number of babies with symptoms of opioid exposure tripled. Now treatment programs in Vermont, which were once meager and disjointed, are more numerous and accessible.

Bringing Help Together

As she swaddles her healthy day-old baby at Dartmouth-Hitchcock Medical Center, a young Vermont mother – who wants to remain anonymous because she comes from a small town — is more relieved than most. Not long before she became pregnant she hurt her back. A friend gave her some prescription painkillers.

"It didn't take long to go from 'This is all right to take sometime' to 'I've got to do it every day,' and I'm puking and having withdrawal symptoms if I'm not doing it," she says.

Most pregnant Vermont women addicted to opioids seek treatment. This mother was one of the first to go to a new Dartmouth-Hitchcock clinic that reflects a shift in how mothers like her are being cared for. From a location in a renovated mill, the clinic offers treatment, group counseling and psychiatric services and works in partnership with doctors at the hospital. Before the clinic opened, those services were scattered, uncoordinated and often hard to access.

Continue reading at KTEP El Paso...

New Jersey Police to begin carrying Narcan

January 25, 2014

Narcan naloxone opiate overdose prevention kit

Police in the state of New Jersey will soon begin to carry Narcan (naloxone), a drug that is used to counteract overdoses of an opiate drug such as heroin or morphine. Since 2010, opiate overdose deaths in New Jersey have risen along with heroin use. For opiate overdose, naloxone is commonly administered by injection, though there is also a nasal spray available.

Naloxone works by counteracting the life-threatening depression of the central nervous system and respiratory system. Needle exchanges frequently distribute naloxone on its own or include it in safe injection kits as an overdose prevention method. In the U.S. alone, the Center for Disease Control (CDC) estimates that take-home doses of naloxone and training on its utilization have prevented 10,000 opiate overdose deaths.

N.J. heroin overdose surge prompts smart police response with Narcan antidote
NJ.com - January 5, 2015

Following in the footsteps of dozens of communities across the country, police in several New Jersey counties are expected to begin carrying a temporary antidote for drug overdoses.

The nasal spray Narcan can delay the effects of an opioid for 90 minutes, enough time to get an overdose victim to a hospital for life-saving treatment. Narcan or other forms of naloxone previously had been used only by hospital staff, but a law passed last year in New Jersey makes it legal for almost anyone to administer the antidote when life is on the line – the user's family, a bystander, police and first-responders.

The Opioid Antidote and Overdose Prevention Act, a "good Samaritan" law, protects those who render aid to overdose victims.

Police in Hunterdon, Ocean, Camden and Cape May counties could begin carrying the aerosol form of naloxone, which counteracts the effects of heroin and other opioids, in the next few months, the Star-Ledger's James Queally reported.

It's a necessary tool at a time when record numbers of people are struggling with heroin and prescription drug addiction across the state. Prescription drug abuse is now deemed an epidemic by the Centers for Disease and Control. But when the supply of oxycodone or other painkillers runs low or grows too expensive, many drug abusers switch to heroin.

And heroin use has surged in New Jersey since 2010, paving the way for a record number of deaths.

Continue reading at NJ.com...

New guideline on opioid withdrawal in children

January 14, 2014

A new paper published in Pediatrics in late-December sets out specific guidelines for managing opioid dependence and withdrawal in children. The clinical report by the American Academy of Pediatrics (AAP) Committee on Drugs and Section on Anesthesiology and Pain Medicine aims to raise awareness about opioid withdrawal symptoms in children, which can occur as early as 5 to 7 days after having been on an opioid.

The lead author Jeffrey Galinkin, MD, is a professor of anesthesia and pediatrics at the University of Colorado Health Science Center - Denver, and Director of Scientific and Medical Affairs at CPC Clinical Research in Aurora, Colorado. The full clinical report can be accessed in PDF and HTML on the website for Pediatrics, the official journal of the American Academy of Pediatrics

New Guideline on Opioid Withdrawal in Children
Medscape - January 9, 2014

Children's use of prescription opioids is growing, but until now there has been no guideline on managing withdrawal in this age group. Since abrupt discontinuation of these drugs can lead to discomfort, it's important to follow a set approach to opioid weaning.

That's the conclusion of a new Clinical Report by the American Academy of Pediatrics (AAP) Committee on Drugs and Section on Anesthesiology and Pain Medicine looking at iatrogenically induced opioid dependence and withdrawal in children.

The aim of the new paper, published online December 30 in Pediatrics, is to raise awareness, according to a lead author, Jeffrey Galinkin, MD, professor, anesthesia and pediatrics, University of Colorado Health Science Center, Denver, and director, Scientific and Medical Affairs, CPC Clinical Research, Aurora, Colorado.

"The key reason the AAP was keen to publish this paper and go forward with this guideline is that people are unaware that patients can get drug-specific withdrawal symptoms from opioids as early as 5 days to a week after having been on an opioid chronically."

Opioid prescriptions to children have more than doubled in the past decade. In 2009, about 7.2 million outpatient opioid prescriptions were dispensed for youngsters in the United States. Interestingly, the biggest prescribers are dentists, said Dr. Galinkin. Opioids are used primarily short term for pain related to a procedure or an acute injury.

Continue reading at Medscape... (registration required)

Attorney generals urge FDA to rethink approval of Zohydro

December 21, 2013

Back in October, Zogenix Inc. received approval from the Food and Drug Administration for an extended-release formulation of hydrocodone, Zohydro ER. Zohydro ER would be the first pure hydrocodone medication to be marketed in the United States. Late last week, however, a coalition of attorney generals from 28 states asked the FDA to reconsider its decision to approve Zohydro ER. In the U.S., hydrocodone is currently only available in combination formulations containing other drugs such as acetaminophen. Concerns have been raised over the abuse potential of Zohydro ER, which in its current form contains no anti-abuse mechanisms and can be easily crushed.

State AGs urge FDA to rethink approval of painkiller Zohydro
Reuters - December 12, 2013

Attorney generals from 28 U.S. states have asked the Food and Drug Administration to reconsider its approval of the powerful painkiller Zohydro ER, which Kentucky's top law enforcement official said could start an epidemic of abuse.

The drug, manufactured by Zogenix Inc of San Diego, was approved by the FDA in October.

In December 2012 a panel of outside experts convened by the agency had voted 11-2 against the drug's approval, citing its potential to cause addiction.

Kentucky Attorney General Jack Conway said his state had been hurt by abuse of prescription painkillers, especially OxyContin, and he feared more problems with Zohydro ER.

"The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high," Conway said.

Conway joined attorneys general from 27 states and the U.S. territory of Guam in signing a letter to FDA Commissioner Margaret Hamburg, dated Tuesday, asking that approval of Zohydro be reconsidered or that the drug be reformulated with chemical deterrents to abuse.

"State attorneys general do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed," the letter said.

The attorneys general said Zohydro reportedly is five to 10 times more potent than standard hydrocodone products.

The FDA approved the drug for daily, long-term treatment for which other options were inadequate. FDA spokeswoman Morgan Liscinsky said the agency would review the attorneys generals' letter and respond.

Abuse of OxyContin became so widespread that manufacturer Purdue Pharma changed its formula in 2010 so that the drug could not be injected or snorted as easily.

Continue reading at Reuters...

Montreal to get 4 supervised injection sites

December 12, 2013

Montreal will soon be home to four supervised injection sites for intravenous drug users — a huge victory for harm reduction in Canada. In 2003, the first supervised injection facility in North America was opened in Vancouver, B.C. under the name of Insite. For the past 10 years, Insite has remained the lone supervised injection facility in North America, providing assistance to thousands of injection drug users in the Downtown East Side while struggling to continue operating in face of federal government opposition.

Since its opening, Insite has been the focus of more than 30 studies published in peer-reviewed journals which have shown a wide array of benefits such as a reduction in drug-related crime, increased use of addiction treatment services, a decline in overdose deaths and the sharing of syringes, the prevention of dozens of new HIV infections each year, and a net-societal benefit of millions of dollars annually. In Europe, supervised injection facilities have largely gained acceptance, with several European countries now operating such facilities.

During the years since Insite first opened there has been a lot of talk about opening new supervised injection sites in other Canadian cities, with cities such as Montreal and Toronto being frequently mentioned. There is a clear need for these facilities in cities all over Canada — In a survey of injection drug users in London, Ontario published last month in the London Free Press, it was revealed that drug users in London are sharing needles and contracting Hepatitis C at rates much higher than the national average.

Montreal to get 4 supervised injection sites
CBC News - Dec. 11, 2013

Montreal will soon be home to four supervised injection sites for intravenous drug users. While the service is expected to cost $2.7 million annually, the Public Health Department said the health care system will ultimately come out the winner.

Richard Massé, the director of Montreal Public Health, argues that while the the experiment may seem expensive, the quality of life will improve for the people who live near the sites, and for the drug users.

Massé said the social gains will surpass the cost if people consider the complications associated with injection drug use — hepatitis C, HIV and overdoses, among others — and the risk of contamination associated with dirty needles left lying around.

"You gain more with these services than leaving people to deal with their health problems, not to mention the social costs for the population living nearby," said Massé.

Continue reading at CBC News...

References

Health Canada approves another generic oxycodone tablet

December 2, 2013

opiates generic oxycodone CR Apotex

Health Canada has approved another generic form of oxycodone, this time from Ranbaxy Laboratories. In late-2012, six pharmaceutical manufacturers received approval from Health Canada for a controlled-release formulation of oxycodone, essentially a generic form of OxyContin. In the U.S., the original OxyContin manufactured by Purdue Pharma was reformulated in 2010 to include new tamper-resistant features in an effort to make the tablets harder to abuse. In early 2012, Purdue began to market this new abuse-resistant formulation in Canada under the name of OxyNEO.

Generic versions of OxyContin have been banned in the United States by the FDA because they are too easily crushed and snorted or injected, and only the newer formulation of OxyContin bearing the imprint 'OP' are sold there. The U.S. is dealing with a painkiller abuse epidemic that is killing tens of thousands of people a year. According to a recent article in the Globe and Mail, the U.S. has begun seeing generic oxycodone CR tablets coming in from Canada, and they have been putting pressure on Canada to outlaw generic versions of oxycodone.

Health Canada approves addictive form of oxycodone as U.S. urges ban
The Globe and Mail - Nov. 27, 2013

Health Canada recently approved a generic, addictive form of oxycodone just as U.S. officials were urging their Canadian counterparts to ban such formulations of the powerful painkiller. The green light to Ranbaxy, India's biggest drug maker, came soon after the White House Office of Drug Control Policy reminded Health Minister Rona Ambrose of the dangers posed by generic forms of the opioid. The U.S. has been pressing Canada to outlaw generic oxycodone, citing studies that show the more addictive formulations are migrating south of the border.

Health Canada, meantime, defended itself, saying it "rigorously" assesses every drug's safety and efficacy before approving it. "These decisions are made by experts in the department based on science; the minister is not consulted on day-to-day drug approvals," said spokeswoman Leslie Meerburg. She added Health Canada is working to help companies develop tamper-resistant opioid formulations that might help reduce the risk of abuse.

Continue reading at The Globe and Mail...

This news comes at the same time as the results of a recent survey published in the current issue of the journal PAIN indicate that oxycodone is the preferred drug of choice among prescription opioid abusers. Of the more than 3,500 opioid-dependent individuals in drug-treatment programs across the United States who were surveyed, 45 percent indicated oxycodone to be their favored drug of choice. A majority of the oxycodone abusers reported snorting or injecting the crushed pills. Hydrocodone, the opioid in Vicodin, was preferred by 30 percent of the respondents. An article with the full results of the survey is available on the

SAMHSA Opioid Overdose Prevention Toolkit

November 25, 2013

At the end of August this year, The Substance Abuse Mental Health Services Administration (SAMHSA) released the Opioid Overdose Prevention Toolkit as part of the International Overdose Awareness Day. The toolkit aims to reduce the number of fatal opioid overdoses by providing education for clinicians, patients, communities, first responders, overdose survivors, and their family members. SAMHSA is offering the toolkit for free on their website in both print and electronic (PDF) formats. You can also download the five parts of the toolkit in PDF format right here:

SAMHSA Opioid Overdose Prevention Toolkit

The Opioid Overdose Prevention Toolkit is the first federal resource promoting safety and prevention information for persons at risk for overdose, such as how to recognize and respond appropriately to overdose, specific drug-use behaviors to avoid, and the role of naloxone in preventing fatal overdose. The toolkit provides communities and local governments with material to develop policies and practices to help prevent and respond appropriately to opioid-related overdose. Prescribers will find evidence-based guidance for safe prescribing practices, identifying patients at risk for overdose, engaging them in prevention and risk-reduction efforts, and accessing opioid-dependence treatment.

Each year, drug overdose has claims the lives of tens of thousands worldwide. During the last decade in the U.S. alone, opioid analgesic overdoses have claimed 125,000 lives. (Centers for Disease Control and Prevention) In 2012, the number one cause of death in 17 U.S. states was prescription drug abuse, surpassing the number of fatalities caused by motor vehicle accidents. (American Society of Interventional Pain Physicians) In countries throughout the world, overdose deaths attributed to opioid analgesics continue to increase with no signs of slowing down. International overdose statistics can be found on the International Overdose Awareness Day website.

Further Reading

Supreme Court challenge launched over prescription heroin access

Last month, Federal Minister of Health Rona Ambrose introduced new regulations to prevent the approval of prescription diacetylmorphine (heroin) through Health Canada's Special Access Programme (SAP). Providence Health Care and five patients in B.C. are now challenging that decision in court, arguing that the updated regulations prevent the delivery of life-saving treatment to patients suffering from severe drug addiction. Also partnering with Providence in the legal challenge is Pivot Legal Society. Pivot played a role in the establishment of InSite, the first sanctioned supervised injection site in North America, and was also involved in the lengthy legal battle to keep InSite open in the face of federal government opposition. The following is an excerpt from the press release by Providence Health Care, and below is a link to the complete press release.

Providence Health Care and Patients File Constitutional Challenge to Federal Government Decision
November 13, 2013

Providence Health Care (Providence) and five SALOME patients launched a constitutional challenge today to overturn a recent decision by the federal government of Canada that prevents the delivery of life-saving treatment to vulnerable addictions patients.

Providence and the five patients filed a Notice of Civil Claim in the BC Supreme Court today jointly, requesting, among other things, a declaration that the new federal government regulations infringe on the Charter Rights, are unconstitutional, and should be struck down.

"To patients like me, diacetylmorphine (heroin) assisted treatment has proven to be life-saving and stabilizing," said David Murray. "To deny this treatment and to go against all medical evidence – and even Health Canada's own decision – is heartless and harmful."

The legal action comes in the wake of Federal Minister of Health Rona Ambrose's October 3, 2013 changes to federal regulations making diacetylmorphine a restricted substance under the Food and Drug Act, preventing it from being available through Health Canada's Special Access Programme (SAP).

SAP is designed to let patients in exceptional cases get medications normally not available in Canada. Through SAP, Providence doctors had requested – and received – access to diacetylmorphine for 21 of the participants exiting the SALOME research study in Vancouver, before the regulations closed off access to this treatment.

SALOME (The Study to Assess Longer-term Opioid Medication Effectiveness) is a clinical study, headed by Providence's Centre for Health Evaluation and Outcome Sciences researchers, that tests alternative treatments for people with chronic heroin addiction who are currently not benefiting sufficiently from available treatments such as oral methadone. The study aims to determine alternative treatments for people with chronic heroin addiction not benefitting sufficiently from available treatments such as oral methadone.

The science supports this course of treatment. Six similar trials comparing medically-prescribed heroin and methadone (including NAOMI) involving more than 1,500 patients have provided unanimous evidence in support of the effectiveness of this treatment for long-term heroin-dependent individuals. Data is available from six countries: Switzerland, the Netherlands, Spain, Germany, the United Kingdom and Canada.

Heroin-assisted treatment has been officially adopted in the United Kingdom, Switzerland, Germany, Denmark and the Netherlands.

Read the full press release at Providence Health Care's website...

Further Reading

Three new buprenorphine/naloxone medications approved by FDA

In 2012, Reckitt Benckiser Pharmaceuticals discontinued their supply of brand name Suboxone tablets in the U.S. due to increasing concerns with pediatric exposure. Brand name Suboxone is now only available in the U.S. in the form of sublingual films.

On February 25, 2013 the FDA approved generic preparations of buprenorphine/naloxone sublingual tablets from Amneal Pharmaceuticals and Actavis. These two generic versions have been on pharmacy shelves now since April 2013. Reckitt Benckiser had requested that the FDA refuse applications from generic drug makers unless they adopted stricter packaging standards.

Orexo received FDA approval on July 3, 2013 for a third buprenorphine/naloxone sublingual tablet to be marketed under the name of 'Zubsolv.' Compared with the buprenorphine film, Zubsolv has been shown to have a higher bio-availability, along with an accelerated dissolve time, reduced tablet size, and an improved menthol taste. In the U.S., Zubsolv has been available since its launch in September 2013.

Zubsolv buprenorphine/naloxone tablets are available in strengths of 1.4mg/0.36mg and 5.7mg/1.4mg. On the website for Zubsolv, Orexo claims: "Because of its advanced formulation, more of the medication in ZUBSOLV tablets gets into the bloodstream than with Suboxone tablets. This means a lower dose of ZUBSOLV is similar to a higher dose of Suboxone."

Zubsolv (Orexo Inc.)

buprenorphine/naloxone
sublingual tablets

Zubsolv buprenorphine/naloxone sublingual tablets Orexo

1.4 mg/0.36 mg

white, triangular, bevelled-edge tablet
Imprint: 1.4 / blank

5.7 mg/1.4 mg

white, round, bevelled-edge tablet
Imprint: 5.7 / blank

Amneal Generics

buprenorphine/naloxone
sublingual tablets

Amneal buprenorphine/naloxone sublingual tablets generic

2 mg/0.5 mg

orange, round, biconvex tablet
Imprint:A / 14

8 mg/2 mg

orange, round, biconvex tablet
Imprint: AN 415 / blank

Actavis Generics

buprenorphine/naloxone
sublingual tablets

Actavis buprenorphine/naloxone sublingual tablets generic

2 mg/0.5 mg

white/off-white, round tablet
Imprint: crescent moon logo / 154

8 mg/2 mg

white/off-white, round tablet
Imprint: crescent moon logo / 155

Further Reading

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