Addiction expert questions recently approved anti-opioid implant

Virtual Opioid (V.3) | Create Feelings of Euphoria | Binaural/Monaural Fusion | Meditation Audio

The Food and Drug Administration (FDA) approved the first-ever implant to fight opioid abuse last week, offering hope amid an epidemic that killed nearly half a million Americans between 2000 and 2015. But some addiction experts are arguing that making the implant commercially available is premature, as questions remain over whether it would do more harm than good.

The matchstick-size implant, Probuphine, was developed by Braeburn Pharmaceuticals and Titan Pharmaceuticals, and is designed to release buprenorphine over a period of six months.

Buprenorphine is used to treat opioid dependence including narcotic painkillers and heroin. It"s part of a class of medications called opioid partial agonist-antagonists and works to prevent withdrawal symptoms when someone stops taking opiod drugs by producing similar effects to these drugs.

Probuphine developers say the rod-like device is designed to make the drug less susceptible to abuse or illicit resale, which is a common issue with oral drugs currently on the market. However, Probuphines four rods must be surgically implanted into a patients arm, and thats just one area where Dr. Indra Cidambi, an addiction expert and detox specialist, sees problems arising.

Doctors of osteotherapy, internists and psychiatrists are three-fourths of the prescribers, Cidambi told FoxNews.com. That means these are the offices which dont have a setup to perform a minor surgical procedure.

This barrier brings a divided-care component into play, raising questions over which doctor will be responsible for overseeing the patients care, she said.

It should be that the prescriber and implanter are in the same office, but its difficult to get two doctors in the office in the same time frame, Cidambi said.

Another concern is whether patients will continue with psychiatric care and lifestyle changes after receiving the implant, Cidambi said. Patients prescribed oral buprenorphine may be prone to mixing the drug with another opioid obtained illegally to achieve a high, but therapy can help dissuade patients from taking part in such behavior.

When you mix buprenorphine with opioids, there is an increased risk of respiratory depression. Thats what you see when a parent goes into a childs room and theyre not audible, Cidambi said. When someone is on these four rods, theyre not following therapy theyre easily combining the drugs, and that can lead to death.

Patients may also forget the drug is helping them achieve their sobriety, leaving them under the false impression that they dont need to attend therapy or adjust their lifestyle changes. In turn, rather than addressing the problem, the device could lead to co-abuse and eventually relapse after the six-month period of Probuphine ends, Cidambi said.

According to the Centers for Human and Health Services, fewer than half of the estimated 2.2 million Americans who need treatment for opioid abuse are receiving help. Those who are receiving care are typically prescribed either methadone, which is available only in government-endorsed clinics, or buprenorphine, which is available as a pill or a strip of film. Probuphine works to release 8 milligrams of buprenorphine, which means potential candidates would need to require a low dose.

Its really for those doing well on buprenorphine and dont need a high dose, Dr. Adam Gordon, a professor of medicine at the University of Pittsburgh and member of the advisory panel who voted in favor of approving Probuphine, told NPR in January. Will they need to be on it six more months, maybe many times over their entire life? When is a good time to stop treatment? These are unanswered questions.

Cidambi also questioned the removal process. She cited a clinical trial in which, despite following proper procedure, only seven of 15 participating surgeons successfully removed all four rods.

Im not saying that they shouldnt come up with a new medication to address the problem, but we need to be more practical, Cidambi said. Every medication has its pros and cons. Im questioning, why complicate it more than what it is right now?

Despite concerns from experts like Cidambi, Braeburn Chief Executive Behshad Sheldon told Reuters ahead of the devices FDA approval that the company has high hopes for the implant.

I intend to make this the most successful implant thats ever been marketed and I think its absolutely possible given the unmet need, Sheldon said.

The company is aiming to implant a patient with Probuphine by June 21.

Reuters contributed to this report.

Source: http://www.foxnews.com/health/2016/06/02/addiction-expert-questions-recently-approved-anti-opioid-implant.html

Continue Reading ..

Florida drug database and "Pill Mills" curbed state"s top opioid prescribers

America"s Epidemic of Opioid Abuse

In the first year that two Florida laws aimed at curbing opioid prescriptions were in effect, the state"s top opioid prescribers wrote significantly fewer prescriptions of this type of pain medication, a new analysis led by researchers at the Johns Hopkins Bloomberg School of Public Health finds.

At the same time, the law did not effect the extreme concentration of opioid prescribing among a small group of providers -- approximately four percent of prescribers accounted for 40 percent of the prescriptions for opioid painkillers that made up two-thirds of all such pills prescribed in Florida. Primary care physicians made up more than half of the top prescribers. These findings suggests both the potential impact of policies at curtailing prescriptions among high-volume prescribers and the limits of the new policies, since many physicians still prescribed at high rates.

The new analysis followed patients and prescribers from July 2010 through November 2012; the two policies were implemented in late 2011. The first policy created the state"s Prescription Drug Monitoring Program (PDMP), a database that tracks individual prescriptions, including patient names, dates and amounts prescribed, so physicians can be on the lookout for people with multiple prescriptions from multiple doctors, something associated with addiction and illicit use. The second law addressed so-called "pill mills," loosely regulated pain clinics that often see disproportionately high levels of opioid prescriptions. Florida"s "pill mill" measure requires clinics to register with the state and to be owned by a physician.

During the one-year period after the law went into effect, the researchers estimate that opioid prescriptions by Florida"s top opioid prescribers fell 6.2 percent and the total volume prescribed by this group dropped 13.5 percent (compared to a scenario in which the laws were not implemented). In this group, the number of patients also dropped, by 5.1 percent. (The top four percent included 1,526 providers out of a total of 38,465 in the state.) Among the remaining 96 percent of prescribers, prescriptions slipped a mere 0.7 percent.

The findings will appear online June 2 in the journal Drug and Alcohol Dependence.

Opioid misuse and abuse has reached epidemic proportions in the U.S., with an average of 44 people dying from opioids each day. To address the epidemic, the Centers for Disease Control and Prevention recently issued new guidelines for prescribers initiating opioids for non-cancer pain in primary care. The guidelines recommend that prescribers use opioids only after other treatments have failed and that they use them at lower doses and shorter durations than in the past. In addition, every state in the country except for Missouri now has a Prescription Drug Monitoring Program in place.

"Our findings indicate how state policies such as PDMPs may reduce opioid use among the highest prescribers," says Hsien-Yen Chang, PhD, an assistant scientist in the Bloomberg School"s Department of Health Policy and Management and the study"s lead author. "But our report also shows that programs like PDMPs must be complemented by many other measures to combat the epidemic of addiction and non-medical opioid use."

For the analysis, the researchers compared prescription data from IMS Health"s LRx for both Florida and Georgia, which at the time did not have either a prescription database or a "pill mill" policy in place. The research team compared opioid prescriptions between July 2010 and June 2011 -- before the laws went into effect -- with those made between October 2011 and November 2012. (The three-month interval, July 2011 through September 2011, allowed for Florida"s two new laws to take effect.) The researchers identified the top, or "high risk," providers who prescribed the most opioid painkillers for four consecutive quarters. (By "high risk" prescribers, the authors mean those most likely to prescribe opioids. They note that it is a quantitative rather than a qualitative descriptor.)

Chang notes that the researchers did not have information about patients" diagnoses, and could therefore not assess the degree to which the prescriptions were clinically appropriate, either before or after the policies went into effect.

"When we looked at the prescription numbers in the year before the two laws went into effect, we were very surprised at how concentrated the prescriptions were among a subset of prescribers," says the study"s senior author G. Caleb Alexander, MD, MS, an associate professor in the Bloomberg School"s Department of Epidemiology. "At the same time, these aren"t the only prescribers that we should worry about. There is an unmistakable correlation between the volume of opioids on the market and injuries and deaths from these drugs, and health care providers have a shared responsibility for the extent that these products are prescribed."

The authors note that it is difficult to fully separate the impact of the PDMP and the pill-mill law. But they argue that doctors should get in the habit of checking the database before they write a prescription.

"At some point, checking the prescription database before prescribing an opioid should be just as routine as doing a kidney test before starting a new blood pressure treatment," Dr. Alexander says. "I think we"ll get to that point; we"ll see prescription databases used like these other tools and have an even greater impact."

Source: http://news.google.com/news/url?sa=t&fd=R&ct2=us&usg=AFQjCNGQBU10B0ZkDkxYVSY-pYtVgoOtfw&clid=c3a7d30bb8a4878e06b80cf16b898331&cid=52779125282506&ei=knNQV6iiDInH3QGF6rHoDg&url=https://www.sciencedaily.com/releases/2016/06/160602083239.htm

Continue Reading ..