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Thursday, October 30, 2014

DEA Proposes Rescheduling Naloxegol

There have been several changes made to drug policy this year; perhaps the most important being the Drug Enforcement Administration’s (DEA) reclassification of hydrocodone combination products, such as Vicodin, to Schedule II. Reclassifying such drugs will hopefully reduce prescription drug abuse, by only allowing patients to receive the drugs for up to 90 days without receiving a new prescription.

Under the Controlled Substances Act, many of Schedule II drugs, both legal and illegal, can be derived from opium alkaloids; drugs such as oxycodone, hydrocodone and heroin are the most commonly abused. Powerful illegal narcotics like methamphetamine, as well as legal Adderall and Ritalin, are also considered Schedule II drugs. People caught illegally dealing or possessing Schedule II drugs face criminal penalties.

However, some believe that there are drugs that have been misclassified as Schedule II, such as the opiate-based painkiller naloxegol, according to The Hill. The Obama administration is proposing that naloxegol be removed from the federal drug schedule, citing research finding the medication “does not possess abuse or dependence potential.”

This fall, the Food and Drug Administration (FDA) approved naloxegol (Movantik) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. Naloxegol’s manufacturer, AstraZeneca, submitted a petition seeking its removal from the Schedule II classification on grounds that the drug, prescribed for non-cancer chronic pain, is not prone to abuse. The DEA agreed with AstraZeneca’s findings that the drug does not meet Schedule II classification requirements.

A recommendation by the Department of Health and Human Services, and the DEA’s own analysis, the agency is now proposing to delist the drug.

“The DEA finds that these facts and all relevant data demonstrate that naloxegol does not possess abuse or dependence potential,” the DEA said. “Accordingly, the DEA finds that naloxegol does not meet the requirements for inclusion in any schedule, and should be removed from control under the CSA.”

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Tuesday, October 28, 2014

Social Hosting Laws Curb Underage Drinking

A new study has found that in areas where strict social hosting laws exist, teenagers are less likely to consume alcohol at parties. Social hosting laws are measures taken in communities to curb underage drinking by holding adults responsible if teens drink on their property. Parents can be held responsible for teenage drinking even if they claim they were unaware the drinking was occurring, reports Business Standard.

Researchers from the Prevention Research Center in Oakland, California examined 50 communities in California, half of which had social hosting laws. The findings showed that teens in communities that had strict social hosting laws were less likely to say they drank at parties.

“It does look like there is less-frequent drinking among teenagers in cities with stringent social host laws, even when other city and youth characteristics that are related to underage drinking are controlled for,” said lead researcher Mallie Paschall in a news release. “So these laws might be an effective strategy for reducing hazardous drinking.” Paschall points out that, “Most kids get alcohol from social sources, not commercial ones.”

Adults can incur stiff civil penalties for providing alcohol to teens or by giving teenagers a safe haven to consume alcohol, according to the report. The penalties usually come in the form of large fines, which are quickly administered, Paschall said. In some communities, however, police are unwilling to enforce social hosting laws, either from lack of support from the public or from the local prosecutor’s office.

In the future, the researchers will look at the rates of teen drinking before and after social hosting laws are passed. They will also look at the effect social hosting laws have on teenage drunk driving.

The findings are published in the Journal of Studies on Alcohol and Drugs.

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Thursday, October 23, 2014

Supplements Containing Banned Drugs Still for Sale

Dietary supplements that have been recalled as the result of Food and Drug Administration (FDA) bans on the drugs they contain, often continue to be sold, sometimes for years after the recall, according to doctors at Harvard Medical School. More than 400 supplement brands containing banned pharmaceutical drugs have been identified by the FDA and recalls have been issued for 70 percent of them, according to Reuters.

The Harvard Medical School study looked at 27 supplements for sports enhancement, weight loss and sexual enhancement that were recalled between 2009 and 2012. The supplements were purchased from the manufacturers' websites at least eight months and up to four years after they were recalled.

The researchers found 18 of the 27 supplements still contained the banned pharmaceutical ingredient that got the drug recalled in the first place. Two-thirds of the supplements looked at in the study were manufactured in the United States, the article notes.

“There’s no question that these supplements that contain pharmaceuticals are not allowed to be sold, there are clear-cut laws,” lead author Dr. Pieter A. Cohen told Reuters.

A supplement containing the weight loss drug sibutramine has been linked to heart attack and stroke. Another contained the laxative phenolphthalein which has been tied to cancer.

"Dietary supplement manufacturers and distributors are legally responsible for marketing a safe product that is not adulterated, and that complies with FDA’s good manufacturing practice regulations for dietary supplements," the FDA told Reuters.

However, the FDA warns, "The supply chain for these products is extremely fragmented; one product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States. The individuals and businesses selling these products generally are difficult to locate, operate out of residential homes, and distribute via internet, small stores, and mail. Products are shipped through the international mail facilities and are often misdeclared as unrelated goods to avoid detection. Even after recall and enforcement action against one major distributor, the product may continue to be widely sold."

The findings appear in JAMA.

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Tuesday, October 21, 2014

Buprenorphine Maintenance Over Detox

Buprenorphine has become the standard in treating opioid addiction. Whether it is used for detoxification or for maintenance, many in the field of addiction believe that formulations of buprenorphine, drugs like Subutex and Suboxone, are more effective than methadone.

There are two schools of thought regarding buprenorphine treatment with regards to detoxification and maintenance. Some addiction professionals hold that the sooner a patient gets off all opioid related substances, the better. While some believe that there is a greater chance of long term abstinence if the transition is more gradual.

New research from Yale University indicates that buprenorphine maintenance therapy is more effective than detoxification when treating prescription opioid dependence, Health Canal reports. The researchers followed 113 patients with prescription opioid dependence over the course of 14-weeks.

The participants were separated into two groups, a maintenance group and a detox group. In both groups, patients received drug counseling and were attended to by doctors and nurses. The maintenance group received ongoing buprenorphine therapy over the 14-week period. The detox group received six weeks of stable doses of buprenorphine followed by three weeks of tapering doses.

Over the 14-week period the detox group tested positive for illicit opioid use more often than those in the maintenance group, lead researcher Dr. David Fiellin reported in JAMA Internal Medicine. The research showed that detox group patients were less likely to stay in treatment or abstain from using opioids after they stopped taking buprenorphine.

“For prescription opioid dependence, buprenorphine detoxification is less effective than ongoing maintenance treatment, and increases the risk of overdose and other adverse events,” Fiellin said in a news release. “It is very common for patients seeking treatment to request detoxification.”

“They want to be off of everything as soon as possible as opposed to considering long-term treatment, but unfortunately there’s no quick fix for the disease. The majority of patients will do better if they receive ongoing maintenance treatment.”

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Thursday, October 16, 2014

Study: Stimulants for School - Not Summer

Schools continue to be more demanding, even at the elementary level, students at some schools are required to learn multiple languages and take more advanced math courses than ever before. While a higher caliber of schooling may lead to greater success later in life, unfortunately, some students cannot handle the load and doctors end up prescribing stimulant medications to mitigate the issue. In many cases, students are not taking drugs like Adderall and Ritalin for a deficit, but rather as an aid to keep up with the increasing academic demands.

Children ages 4 to 17, who take ADHD medication, increased from 4.8 percent in 2007 to 6.1 percent in 2011, according to the Centers for Disease Control and Prevention


In fact, a new study indicates that children are 30 percent more likely to take drugs for attention deficit hyperactivity disorder (ADHD) during the school year than in the summer, USA Today reports. Findings that would imply that ADHD drugs, in many cases, are not taken to treat a disorder.

The study’s findings come from researchers at Yale, New York University and the University of Wisconsin-Madison, according to the article.

The study showed that children from wealthier families who live in states with stricter academic standards are more likely to use ADHD drugs only for school. Whereas the children from lower-income families in states with less strict school standards were more likely to take the drugs year-round.

Higher-income families are more likely to follow their own judgment about medication decisions, filling prescriptions when they believed the medication was warranted. Lower-income families follow their doctors' recommendations and fill prescriptions for the medication all year long, according to the article.

“As schools become more academic, as a consequence we’re seeing an increase in school-based stimulant use,” said researcher Marissa King of the Yale School of Management. “Kids are actually just trying to manage a much broader shift in the way the school day is structured.”

“Kids are having more pressure on them to have more sustained attention,” she said.

It is worth pointing out that the research showed that even when children from either end of the socioeconomic spectrum were treated by the same doctor, children with wealthier parents were more likely to use ADHD drugs only during the school year.

The findings appear in the American Sociological Review.

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Tuesday, October 14, 2014

Prescription Opioid Abuse Hindered by Marijuana Legalization

The fight against prescription opioid abuse in America can be hindered by the marijuana legalization movement, according to Michael Botticelli, the Acting Director of the White House Office of National Drug Control Policy. While marijuana activists continue to argue that pot is harmless, Botticelli says one in nine people who use marijuana will become addicted to the drug, the Associated Press reports.

The use of marijuana at an early age increases the risk of developing dependency on other drugs, including prescription painkillers and heroin, Botticelli points out.

“It’s hard to say at one level that we want to think about prescription drug abuse and heroin abuse without looking at how to prevent kids from starting to use other substances from an early age,” he said at a town hall forum on opioid abuse in Maine.

Unlike previous U.S. Drug Czars, Botticelli's story is different in light of the fact that he is in long-term recovery from a substance use disorder, with more than 25 years of sobriety. “My personal story is very illustrative of what we see with people who go on to significant addiction later in life,” he told the AP.

Maine, not unlike many other states, has been hit hard by the prescription opioid and heroin epidemic that continues to ravage the lives of American citizens. What’s more, Maine is also a state that leans toward marijuana legalization, a trend which could lead to young Americans starting the cycle of addiction early on - possibly leading to opioid abuse.

Prescription drug abuse has been a problem in Maine for years, which has led to a surge of heroin abuse, according to the article. In 2012 and 2013, dozens of pharmacies were robbed for the stock of prescription opioids.

Over the next five years, 19 Maine communities will receive $7.5 million to fight drug abuse, Botticelli said at the forum.

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Thursday, October 9, 2014

FDA Officials Defend Zohydro Approval

The Food and Drug Administration (FDA) officials are responding to the activist group FedUP!, a coalition of doctors, addiction professionals, and loved ones of the victims of the prescription opioid epidemic, who called for the FDA Commissioner’s resignation last week. FedUp! lashed out at FDA Commissioner Margaret A. Hamburg over her decision to defend the FDA’s approval of the pure hydrocodone drug Zohydro ER. The agency approved Zohydro despite their own panel of experts voting against the drug's approval -  citing high potential for addiction.

Three FDA officials say the drug’s approval was warranted and that it is misguided to advocate for restricting the use of one opioid, instead of confronting the widespread issue of abuse and inappropriate prescribing, The Wall Street Journal reports.

In the Journal of the American Medical Association (JAMA), FDA officials wrote, “The problem of opioid overdose demands well-informed policies. The actions taken by FDA may help to reverse the epidemic…Policies that focus on a single drug can divert focus from broader, further-reaching interventions… The concerns over Zohydro ER should be seen in the greater context of the opioid epidemic. Singling out one drug for restrictions is not likely to be successful.”

FedUp! is not the first or the only group who is against the FDA’s approval of Zohydro. Governors from five New England states, members of Congress and the Senate, and attorneys general from 28 states, have urged the FDA to amend its decision. Despite the outcry from multiple sectors, including highly informed experts in the fields of addiction and medicine, the FDA continues to stick to their guns.

In an attempt to show that the agency is making efforts to curb the epidemic, the FDA officials say the agency is addressing the need for painkillers with tamper-resistant features. Pointing out that “although this is an appealing policy solution, the science of abuse deterrence is uncertain and evolving… No marketed opioid with purported abuse-deterrence technologies has been shown to deter oral abuse – the most common route – or to reduce addiction or death.”

Whether approval of the drug Zohydro was the right decision, or not is irrelevant. Certainly, no one can argue that approving the drug has helped the prescription drug epidemic. While the FDA and officials fight over what to do, people continue to lose their lives. The list of addictive medications is too extensive, the incentives for doctors to over prescribe are staggering, and the options for patients who become dependent on these drugs are minimal.

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