Do Abuse-Deterrent Features on Painkillers Really Work?


The U.S. Food and Drug Administration (FDA) approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride). The new labeling includes the claim that the drug has properties expected to reduce abuse when the product is crushed.

Embeda abuse-deterrent properties are expected to reduce, but not completely prevent, misuse of the drug when tampered with. When the capsule is taken properly, only the morphine contained in the drug is released. However, if the structure of the tablet is manipulated, or crushed, the naltrexone is released blocking some of the euphoric effects of the morphine. Naltrexone can also bring on withdrawal symptoms in opioid dependent people.

Sharon Hertz, MD, acting director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, says that the science behind the development of abuse-deterrent properties for prescription opioids continues to evolve, but will not completely correct the problem of prescription opioid abuse. “But they [abuse-deterrent properties] can be a part of a comprehensive approach to combat the very serious problem of prescription drug abuse in the United States,” Hertz said.

Embeda extended release is an opioid analgesic used to treat severe pain. Patients taking Embeda found alternative treatments to be ineffective, and have pain that is severe enough to require daily, around the clock, long term opioid treatment. Abuse or misuse of Embeda can cause an overdose which may lead to death. The fear of abuse stems from the morphine base, which of course is a highly addictive opiate.

Interestingly, despite the PR and marketing hype of the approval of the abuse-deterrent labeling, a snapshot of the Embeda website clearly states, “There is no evidence that the naltrexone in Embeda reduces the abuse liability of [the drug].”

The FDA’s release includes the statement, “When swallowed intact, however, Embeda can still be abused or misused because the naltrexone is not expected to substantially block the euphoric effects of the morphine.”

While Pfizer and some chronic pain patients may disagree, most addiction treatment and prevention experts would probably say that another extended release prescription opioid on the market only increases the chances of someone becoming dependent on the drugs.

CDC Indicates Sharp Rise in Heroin and Opioid Overdoses in US

cdcodsOverdose deaths from heroin abuse and prescription pain medication abuse (opioids) increased through much of the United States in 2012. In fact, The Centers for Disease Control and Prevention (CDC) reviewed the data from 28 states and found that twice as many people died from prescription opioid overdoses than died from heroin overdoses.

There are a couple of things that appear to be driving the increase of heroin overdoses. First, there is the widespread exposure to painkillers that can often find addicts winding up on heroin. Second, there seems to be an increase in heroin supply to meet this increasing demand. No all prescription opioid users become heroin users, but previous research showed that 3 out of 4 new heroin users abused painkillers before using heroin.

Heroin’s cheaper price and increasing availability have been contributing factors. Since heroin and prescription painkillers are in the same category of substance, users experience the similar effects from both drugs. Therefore, the relationship between the two drugs is not surprising.

CDC Director Tom Frienden, MD, MPH says that reducing inappropriate prescribing practices is an important part of the strategy targeting overdoses from both heroin and the medications. “Addressing prescription opioid abuse by changing prescribing is likely to prevent heroin use in the long term,” he said.

Researchers also believe it is important to help those who are addicted to heroin and painkillers with effective treatment services in conjunction with the preventative measures. While some may recommend opioid replacement therapy, we work with facilities that help people fully detox from heroin and other opiates, and incorporate long-term residential treatment.

Senate Looking For Ways To Prevent Prescription Drug Abuse

aphaThe Senate has formed a committee called HELP (Health, Education, Labor, & Pensions), that is geared to preventing prescription drug abuse. The committee recently heard from the American Pharmacists Association (APhA) ways that the Senate could curb the amount of prescription drug abuse in our nation. The APhA recommended several ways in which the U.S. government could put a significant dent in the growing painkiller epidemic.

The APhA told the Senate that the DEA needed to be more vocal about health professionals’ roles and the expectations that the DEA had for them. It is a relatively new concept that primary care providers and other healthcare workers be included in those who are needed to fight the prescription drug abuse battle. Healthcare facilities all over the country have begun doing their own drug abuse screenings and establishing new policies that are intended to eliminate or significantly lower the amount of doctor shopping that occurs. However, the healthcare facilities that are taking these measures are doing so on their own, with no government regulation, and they are certainly not mandated to take these sorts of steps. The APhA recommended that the DEA step in and regulate these measures and include healthcare facilities that are not taking steps to preventing prescription drug abuse.

The group also recommended that the government support and increase the amount of sites established to safely dispose of prescription drugs. It is well known that many addicts get their start on prescription drugs by finding the pills in a medicine cabinet and begin experimenting. If the government supports and initiates more sites devoted to safe disposal, it is likely that those prescriptions will be kept out of the hands of a potential addict.

These recommendations and more were presented to the Senate by Michal Spira. In addition to hearing Mr. Spira’s talk, the Senate also heard suggestions from the Academy of Managed Care Pharmacy, American Society of Health-System Pharmacists, National Community Pharmacists Association, and National Association of Chan Drug Stores. All of this was in an attempt to lower the amount of dangerous prescription drugs available to children and teens throughout the country.

Colorado, Other States Seeing Increase in Benzo Addiction

rxbottle2Benzodiazepenes are strong anti-anxiety prescriptions that millions of people across the United States are taking, and many of them are abusing the drugs. Medications like Xanax or Klonopin are commonly prescribed to treat anxiety and insomnia in patients. However, doctors are noticing an alarming trend with these medications. Those who have been on the drug for a long period of time are experiencing adverse effects and are becoming highly addicted. Some patients are speaking out and saying that they wished they had never been put on the drug, or that they had done more research on the potential of the severity of their dependence.

Kelly McMillian started taking Klonopin in 2008 when she was 29 years old. She had gone to her doctor complaining of anxiety and insomnia. At first the medication worked wonders on her symptoms but then she realized that she couldn’t stop taking the drug. If she went a day without the powerful medication her anxiety would become extremely intense, and she wouldn’t sleep. She realized that she had an addiction to benzodiazepenes. In order for her to get off the drug she had to adhere to a strict program to slowly lessen the amount she was taking, so as to not have a seizure or any other of the harmful withdrawal symptoms that are associated with a benzo addiction.

In 2011 the amount of people passing away from drug overdoses surpassed that amount of people who died in drunk driving related accidents. Armed with that alarming news, doctors should be more vigilant in prescribing drugs that are highly addictive, like Xanax. Abruptly stopping a Xanax or any kind of benzo prescription can be extremely dangerous and life threatening. Doctors caution that those who want to stop taking benzos do so under the care of a physician. Some withdrawal symptoms that can occur when a person stops taking benzos are; seizures, insomnia, severe anxiety, intense cravings for the drug and suicidal thoughts.

The state of Colorado has noticed that more and more people in the state are addicted to benzos. Reports show that the amount of people who died from benzo-related causes have almost doubled between the years of 2003 and 2012. Law enforcement cautions that benzos are most dangerous when mixed with alcohol or other drugs.

Survey Indicates Doctors Not Prepared For Prescription Stimulant Diversion

stimulantserAccording to the CDC, over 10 percent of children between the ages of 4 and 17 have been given the label as having Attention Dificit Hyperactivity Disorder (ADHD), and almost 70 percent of them are given medication. The prescription stimulants given to these kids can have a large array of side effects, including addiction.

A recent survey of more than 800 doctors who specialize in ADHD turned up some interesting results. For starters, nearly three quarters of the doctors said they received no training on the prevention of prescription drug diversion in medical school, and over half said they didn’t in their residency or fellowhip programs either.

At the same time, these doctors did feel that they saw patients who were trying to obtain prescriptions for stimulants for disingenuous reasons, ranging from wanting a study aid to weight loss and diversion.

The subject of prescription stimulant diversion and abuse continues to come up as the problems associated with the drugs and students seem to escalate. A prime example of this includes the fact that emergency room visits involved stimulants like these quadrupled in just six years, going from more than 5,500 in 2005 to well over 22,000 by 2011.

A recent story in the New York Times quoted Duke University psychologist and professor emeritus Dr. Keith Connors, who said, “The numbers make it look like an epidemic. Well, it’s not. It’s preposterous. This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”

While many people seem to think that giving away medications to people isn’t as bad as selling it to them, laws say otherwise. “In the eyes of the law, there is no difference between someone giving away a pill or selling one; they are both prosecuted as unlawful distribution of a controlled substance,” said Andrew Adesman, MD, senior investigator and chief of developmental behavioral pediatrics at Cohen Children’s Medical Center of New York.

Many prescription drug abuse and recovery experts encourage parents to get second opinions regarding ADHD diagnoses and treatments, as over-prescribing continues to be a problem in America. Of course, if a young person truly does have a medical condition that needs to be address by a medication then it should be, but there also may be other doctors who have different options available. The more people become aware of the powerful side effects and abuse potential of various prescription drugs, the more they can avoid the potential problems associated with them.

Police Officials Dealing with Obstacles Shrouding Drug Overdose Data

holdernbcPolice officials say that efforts to combat the growing drug abuse crisis are hindered by the lack of recent data on drug deaths, especially heroin overdoses. During a national summit on drug abuse last week, nearly every police official who spoke complained about this problem, with several blaming patient privacy laws.

One law enforcement official said his department has to subpoena overdose data from the local medical examiner. Many also reported a lack of data on prescription medication overdose deaths in addition to the lack of heroin overdose data.

According to the Centers for Disease Control, overdoses from abuse of opiates, notably heroin and prescription painkillers, have been rising since 1992. From 1999 to 2010 alone, the number of drug overdose deaths jumped 102%.

Many officials suggested the use of a computer system similar to Compstat, which gives police near-real-time data on other crimes. Some departments have already taken steps to obtain opioid-related data on their own. For example, police in Washington, D.C., have begun mapping locations where naloxone – an anti-overdose drug – is used by firefighters and emergency medical technicians to locate high drug-use areas are in the city.

Identifying drug abuse centers isn’t always easy. Police Chief Thomas Smith of St. Paul, MN told the group that while heroin overdoses have plateaued or started to recede in his city, the more affluent suburbs of the greater Minneapolis area are seeing significant increases.

The meeting was called in D.C. to identify heroin and prescription drug abuse as a national problem, not just something to be dealt with on the state level. Among the attendees were U.S. Attorney General Eric Holder, FBI Director James Comey, Drug Enforcement Administration chief Michele Leonhart and Michael Botticelli, acting director of the White House’s Office of National Drug Control Policy.

“There has to be a law enforcement response to this but we also need to think of this as a public problem,” said Holder. The devastation caused by opioid abuse is sprawling beyond urban areas, affecting different types of communities across the nation at alarming rates. Many are hopeful that the summit will lay the foundation for an appropriate and effective response to the epidemic on a national level.

U.S. Senator Urges HHS to Overturn FDA Approval of Potent Painkiller

senatorjoemanchinSenator Joe Manchin (D – W.Va.) issued a letter on March 10th to Health and Human Services Secretary Kathleen Sebelius urging the Department to overturn the FDA’s approval of the new painkiller Zohydro. The drug is a powerful form of hydrocodone that has many people worried throughout the country.

In his letter, Manchin wrote, “For inexplicable reasons, the FDA approved Zohydro ER despite strong opposition from its own Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2 against allowing Zohydro ER to advance in the approval process. Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public.”

The Senator also expressed concern over multiple allegations that FDA officials have taken payments from pharmaceutical companies and that a “pay to play” system of corruption has been in place for some time in the world of legal drug marketing.

West Virginia is just one of the multiple states throughout the country that have seen the devastating effects of opioid painkiller abuse and addiction. Overdose deaths and a plethora of other problems have risen and caused hardship for millions of people. The drug is feared to have similarly devastating effects as OxyContin has had, which is an extended-release version of the powerful drug oxycodone. Zohydro is also an extended-release drug that is said to be many times stronger than other hydrocodone products currently on the market.

If you have a loved one struggling with an addiction to prescription painkillers or any other type of drugs, contact Addiction Treatment Services to find out more about intervention, rehabilitation, and other recovery resources.

Study Shows Physician Attitudes Reflect Level of Opioid Prescriptions

Science Daily reported on a study that was recently published in the Journal of Pain linking doctors’ attitudes toward opioids and the amount prescribed.

According to researchers, the study was designed to develop a reliable and valid measurement to assess current and evolving beliefs regarding opioids and opioid use in patients with chronic pain, with respect to location and specialty areas of practice. More than 1,500 doctors were included in the questionnaire that inquired about 38 different measures surrounding opiate narcotics. The five main areas examined were the perceived effectiveness, tamper-resistant formulations, impediments and concerns, medical education and Schedule II vs. Schedule III medications.

No significant differences were cited by the survey regarding geographical regions, but several were noticed among the varying medical specialties. Orthopedists were most cautious about concerns regarding long-term opioid use and had the least confidence in the efficacy of the drugs, whereas pain medicine and rehabilitation specialists were the most confident in efficacy.

The Science Daily article said that the majority of the doctors who were surveyed reported they use opioids in fewer than 30 percent of their patients with chronic non-cancer pain. However, physicians who see higher volumes of pain patients were more likely to prescribe opiates.

This survey comes at a time when narcotic pain medication abuse and overdoses are at an all-time high. Granted, there are additional problems when it comes to treating chronic pain patients who require opiates for better lives, but there is an even more difficult time in treating patients who begin abusing their pain medication, even if unintentionally as a result of tolerance.

Given the number of people who are chronic pain patients and are taking opiates, some addiction treatment centers have begun researching ways to deal with such a sensitive issue. If you or someone you love is struggling with chronic pain and also needs a rehabilitation program for prescription opiates, we can help.