Indiana battles No. 1 rank in pharmacy robberies

http://www.indystar.com/story/news/2015/09/11/indiana-lead-nation-pharmacy-robberies/72091168/

If you are losing the war… isn’t it best to retreat, surrender or change the plan(s) ?  How many wars continue to be fought as the bodies keep piling up and the more bodies that pile up.. the more those declaring the war want to continue fighting..  It is almost like they relish at the mounting body count !

CVS and others have begun using time-delay safes and other measures to curb snatch-and-run prescription drug thefts.

Pharmacy robberies are rising nationwide as the prescription drug epidemic increases, and Indiana has the unwelcome distinction of leading the U.S. in these crimes.

More than 130 Indiana pharmacies have reported robberies since the start of 2015, according to the Drug Enforcement Administration, which tracks any incident in which prescription drugs are lost, said Greg Westfall, assistant special agent in charge in Indianapolis.

The Indiana Board of Pharmacy cites an even higher number, calculating a total of 151 robberies since the beginning of the year, said Ted Cotterill, the board’s director. Robbery attempts aren’t included in that figure.

Indianapolis alone has had more 130 pharmacy robberies, including attempts, according to the Indianapolis Metropolitan Police Department.

Although the numbers may differ, all agree that this year, Indiana has had more pharmacy robberies than any other state.

“This puts us at number one in the country at the moment, which is not the kind of number one that Indiana wants to be in any category,” Cotterill said.

To counter such thefts, CVS/pharmacy announced last week that it has installed time-delay safes in more than 150 stores in the Indianapolis metro area to deter would-be robbers.

Such thieves like to get in and out of a store as quickly as possible, but time-delay safes require pharmacy employees to enter a code and then for a period of time before a safe will open.

No other CVS market in the nation has time-delay safes, Michael DeAngelis, a CVS/pharmacy spokesman said in an email.

“After completing our study of time-delay safes this summer, we determined that now was the appropriate time to implement them in our Indianapolis stores,” DeAngelis said.

Walgreens, which also has the safes in a number of its stores in other states, installed them in Indiana last year, too.

While many hope that the time-delay safes can help turn around the pharmacy robbery rate, they shed no light on why these crimes are so prevalent in Indiana, a question many in the field have been asking for some time now.

“If I had the answer, I would tell you right now,” Cotterill said. Later this fall, the Indiana Board of Pharmacy plans to hold a roundtable with pharmacists and law enforcement experts to explore the question further and potentially arrive at some solutions.

Earlier this month, Gov. Mike Pence announced the creation of a task force specifically to address prescription drug abuse and heroin use.

But Indiana is far from alone. Many other states also are also battling such problems.

So why have pharmacy robberies skyrocketed here?

“It is kind of baffling,” said Todd Meyer, prosecuting attorney for Boone County, which has seen a number of major pharmacy robberies in recent months.

In recent years, Indiana also has cracked down on doctors overprescribing prescription narcotics, shutting down several so-called “pill mills.” In addition, the statewide database Inspect aims to identify patients filling multiple prescriptions for narcotics, who could then be diverting those pills.

These efforts, although positive, may have inadvertently fueled robberies, Cotterill said.

“While we have tightened the grip on prescribing and dispensing, we may have just driven that traffic elsewhere,” he said.

Another factor may have to do with the state’s penalty for juvenile offenders, those in law enforcement say. Many of the robberies have involved juveniles, in some cases, as young as 13.

If they get caught, the sentences they face likely will not be as harsh as for adults, said Patricia Baldwin, a prosecuting attorney for Hendricks County, where many Rockville Road pharmacies have been hit. Depending on the circumstances, they could get probation or a suspended commitment.

“The juveniles assume not much will happen,” Baldwin said. “If you can walk in and walk out with something that’s worth a lot of money, a lot of people take advantage of something like that.”

Pharmacy robberies have been going on in the state for almost a decade, says Ken Fagerman, author of the book “Staring Down the Barrel.” The former South Bend pharmacist recalled how his community organized to fight back with efforts such as a pharmacy crime watch.

Other measures that could help prevent such robberies include installing panic buttons in every pharmacy to allow employees to contact police immediately and alert other nearby stores to be on the alert. In one instance, four pharmacies close to one another were robbed within a matter of hours.

Implementing such initiatives would help empower pharmacists, Fagerman said.

“Because pharmacists are intimidated or practicing in fear, sometimes they do not question or defend the prescription drug supply the way they should,” he said. “This criminal element has been accustomed to this passivity and being issued anything they want on demand and getting away with it. … When you allow this situation to get out of hand which it has, it’s a self-perpetuating system.”

No one disputes that in Indiana, pharmacy robberies have gotten out of hand.

In the past year, the commercial robbery unit of the Indianapolis Metropolitan Police Department has focused almost entirely on pharmacy robberies, Lt. Craig McCartt said.

A few years ago, most of these robberies were conducted by people who were addicted to the drugs they were stealing. More recently, though, the bulk of the robberies have been committed by people who plan on selling the ill-gotten goods, McCartt said.

In many cases, the robber hands the pharmacy employee a note with a list of narcotics he is seeking. The note may imply that the robber has a weapon but rarely does he reveal it.

In some cases, adults approach youths and recruit them for such crimes, McCartt said. In other cases, the juveniles act on their own and wind up selling whatever prescription drugs that they steal.

“I think that the word spread at the high schools, through social media, that this was an easy source of money and everybody started doing it,” he said. “As we arrest these guys, there’s somebody right there to take their place immediately.”

The criminals also have not restricted their activity to Indianapolis city limits. Both Boone and Hendricks counties have seen a number of pharmacy robberies as well.

In many cases, the criminals have ties to Indianapolis gangs, Meyer said.

“All of us in the doughnut counties are kind of susceptible,” he said.

But at the end of the day, even the police say they do not know what’s driving the high number of robberies in this state.

“I wish I knew exactly,” McCartt said. “Honestly I think it could be any other city, any other state in the nation truly, but we just have misfortune of it being here.”

Call Star reporter Shari Rudavsky at (317) 444-6354. Follow her on Twitter: @srudavsky.

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Zohydro ‘Not a Public Health Risk’

http://www.painnewsnetwork.org/stories/2015/9/11/zohydro-not-a-public-health-risk

There was a storm of controversy surrounding Zohydro when it was first introduced in March 2014. The first single ingredient  hydrocodone painkiller sold in the U.S. was approved by the Food and Drug Administration over the objections of its staff and an advisory committee — which warned there was a potential for Zohydro to be abused even more than other hydrocodone products.

Addiction treatment experts also predicted Zohydro would fuel a new wave of painkiller addiction and overdoses. The Governor of Massachusetts even declared a state of emergency and tried unsuccessfully to ban Zohydro sales in his state.

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DEA blasted for no-warrant searches of patient records, court battle heats up

http://www.foxnews.com/politics/2015/09/11/clash-over-dea-no-warrant-searches-patient-records-heats-up/

Drug Enforcement Administration agents have been accessing personal medical files without a warrant, generating a backlash from doctors and privacy advocates who say the practice is intrusive and unconstitutional — and have taken the agency to court. 

“It’s just not right,” Texas attorney Terri Moore said. 

The controversial record searches are part of the government’s effort to crack down on illegal “pill mills” and prescription drug abuse. But they’ve set up a clash over privacy rights, and a legal battle is now playing out in the 5th and 9th Circuit appeals courts. Lower courts have issued conflicting rulings to date, with one backing the DEA and another demanding the agency get warrants if it wants to look at patient records. 

The DEA has been able to access medical files as well as private state prescription drug records that track patient medical histories by using what are known as administrative subpoenas, which unlike warrants signed by a judge do not require probable cause. Further, critics say the agency has “tricked” doctors into handing over documents by showing up with state medical board officials for searches and not identifying themselves, in turn giving the impression they’re with the board.

Mari Robinson, executive director of the Texas Medical Board, did not deny in a 2014 congressional hearing that the DEA did this on numerous occasions. She said the board often conducts joint investigations with the DEA, and “what they [DEA] do is up to them.” 

Moore, lead attorney in one of the federal court cases, said doctor-patient confidentiality is sacrosanct and the DEA’s practices could undermine that trust. “People are going to doctors and giving over private information they believe is absolutely confidential,” Moore said. “Now they are going to be on guard, they’re going to say, ‘why am I going to tell my doctor everything if I think the government is going to get that information?’” 

The DEA strongly disagrees. “It is the DEA’s position that the DEA has issued administrative subpoenas in compliance with all applicable laws, policies and procedures,” DEA spokesman Lawrence Payne told FoxNews.com Friday. 

Payne also sharply disputed claims that investigators are posing as state board officials. “Recent reports of DEA investigators impersonating state medical board personnel are blatantly false. Because of ongoing litigation, DEA cannot comment further,” he said.  

Moore is lead attorney in the case of U.S. v. Abbas T. Zadeh, a Texas doctor who refused to hand over the records of 35 of his patients when the DEA demanded them through an administrative subpoena in 2013. 

Zadeh, a general family practitioner with over 60 years of experience in medicine, died Sept. 5 at the age of 90, according to Moore. Moore said before he died, Zadeh told her not to give in. 

“It was very important for him to stand up for the privacy of his patients,” said Moore, who believes the DEA is using the administrative subpoenas to circumvent the 4th Amendment, which prohibits unreasonable searches and seizures by the government. 

After losing his battle in a lower federal court earlier this year, Zadeh’s attorneys filed an appeal, which is pending before the 5th Circuit. They are waiting to see if the court will hear oral arguments, Moore said. 

“Conceivably, there is nothing more private than medical communications,” Nathaniel Lacktman, a Tampa, Fla., attorney who specializes in telemedicine, told FoxNews.com. “This could have a chilling effect on patients, if they think their records could be subpoenaed without probable cause.” 

The government argues they are legitimately pursuing violators of the Controlled Substances Act by tracking prescriptions on the Schedule II-IV list of controlled substances, which can include anything from oxycodone, morphine and percocet to amphetamines and anabolic steroids. These drugs normally are used with legitimate prescriptions to treat chronic pain, psychiatric disorders, addiction, ADHD, AIDS and more. 

The DEA says Congress gave the agency the tools to do this, and agents don’t need probable cause — they merely have to maintain that the records are relevant to an investigation, that the investigation is legitimate, and that the information gleaned from the search won’t be used inappropriately. 

The lower federal court in Zadeh’s case sided with the government, saying the DEA followed the law and did not violate the 4th Amendment because, “Congress granted the DEA the administrative subpoena power as a tool to conduct those investigations.” 

But, separately, an Oregon federal judge ruled in February that the DEA has no right to access prescription records in the state’s Prescription Drug Monitoring Program (PDMP) database without a court order. Most states have these databases, in which all pharmacies are mandated to record names, addresses and other information for patients who receive prescriptions for Schedule II-IV drugs. 

In one request, according to The Oregonian, the DEA asked for a year’s worth of records for all controlled substances prescribed by two unidentified doctors. In another, according to court documents, the state of Oregon was forced to comply with a subpoena forcing the PDMP to turn over all prescriptions written by one particular doctor over the course of seven months. 

The government has appealed the judge’s ruling and that case is now pending before the 9th Circuit. 

“We cannot argue that the DEA or any other law enforcement should be totally shut out of these records,” said Nate Wessler, staff attorney for the American Civil Liberties Union, which is representing four unnamed plaintiffs in the Oregon case whose records were searched, they believe, illegally. 

“We are saying they should go to a judge first and demonstrate probable cause and get a warrant — that is what the Fourth Amendment requires.”

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“… THERE IS NO CONSISTENT, HIGH QUALITY, EVIDENCE THAT THOSE WITH THE DEGREE OF “MD” BEHIND THEIR NAME… THAT THEY ARE CAPABLE OF PROVIDING COMPETENT MEDICAL CARE OR ADVICE …”

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E-Prescribing for Opioids Offers Opportunity to Combat Misuse, Diversion

http://www.empr.com/painweek-2015/eprescribing-opioids-preventing-misuse-diversion/article/438145/

It always amazes me how these reporters just regurgitate numbers that some “expert” throws out without any analysis..  That ONE BOTTLE of opiates I guess that it doesn’t matter if the bottle contained 12 -20-30-120 doses… a BOTTLE IS A BOTTLE… Let’s break down the math.. presume that 25% of those 260 million prescription bottles are for people with ACUTE PAIN… ONE BOTTLE… ONE PATIENT… ONE TIME… that would leave 195 million prescription bottles for chronic painers… each chronic painer will normally get 12 prescriptions a year.. which would suggest that abt 16,000 chronic pain pts would get some sort of 24/7 pain management. It is estimated that we have 106 million chronic pain pts… do the math..that would leave abt 90 MILLION CHRONIC PAIN PTS .. get no therapy at all.. and that presumes that none of those 260 million prescriptions are diverted to the street.. which we know some of that happens. So those HIGH NUMBERS of opiate prescriptions filled would suggest that abt TEN PERCENT of the chronic pain community MAY GET adequate pain management. 

Here is one thing that no one will tell you about E-prescribing… you have your C-II electronically sent from your prescriber’s office to the neighborhood pharmacy… and the pharmacy is “out of stock” or “I’m not comfortable”… that Pharmacy/Pharmacist cannot print out the Rx and give it to you.. (has to be signed by the prescriber)… they cannot electronically transfer it to another store…  the only thing that they can do is notify the prescriber that they were not able to fill the Rx for you.  It could bring a whole new meaning to the term “Pharmacy Crawl”

LAS VEGAS — Prescription drug overdoses are responsible for more deaths in the United States than gun, knife, and motor vehicle injuries combined, with those involving opioid analgesics increasing 300% since 1999.

Approximately 260 million opioid prescriptions were written in 2012 alone, Surescripts data indicate. “That’s about one bottle of prescription-strength painkilling medication out there for every American, which is a staggering amount when you think about it,” said Sean P. Kelly, MD, an emergency medicine specialist at Beth Israel Deaconess Medical Center and an assistant clinical professor of emergency medicine at Harvard Medical School, both in Boston. 

Curbing the ongoing opioid epidemic, which Dr. Kelly called “unprecedented in scope,” will require a multifaceted attack. “One approach is to catch the problem upstream, at the moment of prescribing,” he said.

As the Chief Medical Officer of Imprivata, a software company involved in developing prescriber authentication technology to comply with Drug Enforcement Administration (DEA) standards for electronic prescribing of controlled substances (EPCS), Dr. Kelly works regularly with electronic health record (EHR) vendors to identify workflow solutions to inefficiencies in the prescribing process that make controlled substance misuse and diversion more likely.

“Getting better at understanding who we are prescribing to and how much we are prescribing is part of that,” Dr Kelly said. “We need a more transparent, easier to use, and safer system that leverages good technology.” 

Paper-based prescription systems are susceptible to fraud. Approximately one in 10 prescribers will have their DEA number forged and will need to go through the process of getting a new one at some point in their career, according to Dr. Kelly. 

In addition to security concerns, paper-based systems pose challenges for gathering metrics for meaningful use e-prescribing requirements. In the current environment, many prescribers of controlled substances are creating dual workflows—one for paper prescriptions and one for electronic—which introduces greater potential for errors, delays, and decreased provider and patient satisfaction. 

“As many as 60% of patients being discharged from the hospital or emergency department have at least one prescription for a controlled substance. If a patient leaves with multiple prescriptions, and one is for a controlled substance, many providers will convert the whole batch of prescriptions to the print prescription workflow,” explained Dr. Kelly. “This goes against meaningful use guidelines, and the provider is losing credit for the 4 prescriptions that could have been done electronically.”

In response to the need for more secure and efficient prescribing processes, the DEA first set forth regulations for EPCS in 2010, requiring all EPCS to be approved by the State Board of Pharmacies. The pharmacies used must be certified to accept controlled-substance prescriptions, and the EHR or third-party vendor that handles processing electronic prescriptions must also be certified for controlled substances. 

In addition to these regulations, participating subscribers must undergo identity proofing for supervised enrollment in an EPCS program at either an institutional or individual level and must use a system called two-way authentication, which Dr. Kelly has been instrumental in developing, to ensure that the correct provider is authorizing the controlled-substance prescription.

Two-way authentication requires prescribers to meet two of the following requirements at the point of writing the electronic prescription: something you know (ie, a password or token), something you are (Federal Information Processing Standard [FIPS]-compliant fingerprint biometrics), or something you have (FIPS-compliant token or hands-free authentication via a password-protected software application).

“The DEA requires a witness at the hospital level who signs off that the fingerprint is authentic and specific to the prescriber, and one other person in the hospital who has a DEA number who testifies that our process is complete,” explained Dr. Kelly. “Two-signature verification is required for supervised enrollment, which allows the fingerprint to be logged into the software system or a token to be assigned. This confirms, ‘I am who I am, and I’m logged into the system correctly.’”

He said the same procedure can be mimicked in smaller private practices, with a practice manager or lead physician serving as the witness or via a third-party credentialing service provider. 

Since the DEA first issued its guidelines, uptake of EPCS has varied by state. In 2015, there were 2.1 million EPCS, with New York accounting for 54%. 

As of August 27, 2013, most prescribers in the state of New York are required by law to consult the Internet System for Tracking Overprescribing-Prescription Monitoring Program (I-STOP/PMP) Registry when writing prescriptions for schedule II, III, and IV controlled substances. Legislators there have also made it mandatory to use EPCS by March 27, 2016. 

If done correctly, EPCS offers substantial benefit to health systems, physicians, and patients. Health systems have an opportunity to improve patient satisfaction, lower fraud risk, enforce state and federal regulations, and better meet meaningful use e-prescribing requirements.

For physicians, EPCS offers the potential to eliminate dual workflows, reduce errors and fraud, limit exposure of their DEA number, and improve patient satisfaction. For patients, EPCS has the potential to improve overall satisfaction, increase medication adherence, reduce trips to the physician’s office, and reduce wait times at the pharmacy. 

“We’ve reach a critical mass. Technology is getting better and we are now getting to the point where there is a strong push toward adopting EPCS,” Dr. Kelly concluded.

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I was wondering if you could help me decide if my rights of a customer have been violated or not at a Walgreens. I went to have a prescription for percocet refilled on 9/10. The pharmacist said my insurance would not accept the prescription because the prior Dr. authorization letter I had on file expired after one year and a new one was necessary. I agreed to wait however since my prescribing doctor was away for the week for vacation, I knew it could be a few days until the matter is resolved. I then said I don’t mind bypassing my insurance for now and offered to pay for the prescription out-of-pocket in full just for this month. The pharmacist said that they could not as it is against policy to fill pain meds without having insurance. Can they legally turn me down even offering to pay out of pocket with a prescription in hand?

Do I have some sort of case here? Is this legal? If not, what may I do about it?

Thank you for your time

Of course, a pt wanting to pay CASH for a controlled med when they have insurance is a RED FLAG … however when the pt has insurance that won’t pay – because of a PA and the prescriber is on vacation… and the not filling the Rx is going to throw the pt in withdrawal.. refusing to fill for cash because of extenuating circumstances because of company policy… does this mean that the Pharmacists has relinquished their professional discretion to some corporate bureaucrat ? We can program computers to make such black/white decisions… do we need six year collage PharmD’s to follow a “decision chart”

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Leading Pain Physician Starts Mandatory Opioid Tapering Program

http://nationalpainreport.com/leading-pain-physician-starts-mandatory-opioid-tapering-program-8827407.html#comments

I am sure that these 100 pts have other co morbidity issues… so is this prescriber “tapering” them off of the meds for their other medical issues ? Doesn’t suggest this in the article ? More discrimination by the medical community ?

A noted Denver area pain physician has a dilemma.

He’s retiring. He has over 100 patients who use opioids on a daily basis and he’s pretty sure no other doctor will take them.

Dr. Richard Stieg is not your normal run of the mill pain physician. The 78-year old Aurora, Colorado doctor is a founding member and former president of the American Academy of Pain Medicine who has served the pain world in many capacities. (Here’s his bio)

He understands as well as anyone that given the intense scrutiny that the federal government has put on the medical profession regarding opioid prescribing practices the chances are these patients will not be picked up by other doctors if they are using opioids daily. It’s a trend being seen all over the country.

So he’s created a project to help patients taper off their use of opioids.

“Reaction from patients has been less enthusiastic that I had hoped,” Dr. Stieg told the National Pain Report. “Many have refused to comply with even starting a tapering program.” Dr. Stieg understands that and believes it is a combination of fear and reluctance on part of patients who have used opioids for a long time.

Stanford Pain Psychologist Beth Darnall understands the slow rate of adoption.

“We have done a poor job in giving non-addicted people with chronic pain outpatient pathways to support them with opioid tapering. The program we are testing aim to gives patients pain psychology support with their opioid taper.”

Dr. Stieg read Beth Darnall’s Less Pain, Fewer Pills and the two are working together on the project and have created a study that may ignite a conversation about how pain patients are being treated, or not treated, when it comes to reducing opioid use.

Even for patients who are on board with the program, there are barriers to tapering.

The insurance companies aren’t cooperating with reducing patients’ opioid doses.

“It’s beyond frustrating when you write a new prescription for an opioid that they want pre-authorization even if you are reducing the prescription,” Dr. Stieg said. “It’s an unnecessary roadblock and one that most single doctor practices like mine aren’t staffed to do.”

A doctor’s office can spend 30 minutes on hold waiting to talk to someone at the insurance company and then according to Dr. Stieg, “have to explain my reasoning to someone who doesn’t have the training or the background to understand.”

The insurance companies, he thinks, have put these roadblocks to save money.

Another problem is the big-chain pharmacies who he said “have put arbitrary guidelines based on no science whatsoever into place which make it difficult to write a prescription.”

Dr. Stieg will soldier on with his project because, as he says, “my patients need it.”

The project is time consuming for his practice.

He has sent a letter to each patient letting them know he is retiring and has met with dozens of them already.

Following the initial meeting, there is follow-up by Dr. Stieg and his staff every two weeks for four months. The tapering program includes urine drug screens and tracking for marijuana use.

A second tier of the program, depending on the insurance coverage the patient has, will include follow up with psycho-therapeutic support.

A third tier of the program, also again depending on the insurance coverage, includes biofeedback therapy.

The plain-speaking Dr. Stieg says his program isn’t new.

“30 years ago all pain centers were trying to get people off drugs and center on therapies that addressed the cause of the pain,” he said. “It’s what we are trying to do.”

For Dr. Darnall, the project will gather important information and give a “real world look at what people are going through and what’s needed to better support them.  A medical taper alone does not address symptoms of distress that may arise when reducing opioids. We need to provide better pathways to help patients reduce their distress and their pain so that they can succeed with the taper. Also, people need to know that when opioids are tapered slowly and successfully, most patients report less pain.”

And she believes it will make the case that systematic psychological support services should be part of any tapering effort. (Most insurance health plans don’t cover them, which is another hurdle for many chronic pain patients)

But the project goes forward. And there is a lot to learn.

For Dr. Stieg, what is learned from his mandatory opioid tapering program is one last gift he hopes to give the profession of treating pain.

We’ll keep you apprised.

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NABP Announces New Website on Rx Abuse

http://www.pharmacytimes.com/publications/issue/2015/September2015/NABP-Announces-New-Website-on-Rx-Abuse?utm_source=GoogleNews&utm_medium=GoogleNews&utm_campaign=PharmacyTimesNews

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Expert says sleep deprivation is ‘torture,’ calls for later work day

http://www.whas11.com/story/news/nation-now/2015/09/09/expert-sleep-deprivation-torture-later-work-day/71936336/

An Oxford University researcher says forcing ourselves to work before 10 a.m. doesn’t line up with our bodies’ circadian rhythms.

If you need validation that being at work before 10 a.m. feels like “torture,” here it is.

Early schedules go against the body’s natural “clock” and can impact learning and health, Paul Kelly, an honorary clinical research fellow at Oxford University’s Sleep and Circadian Neuroscience Institute said, BBC reported.

Kelly addressed a crowd at the British Science Festival in Bradford, England, and said making people under age 55 work before 9 a.m. is not conducive to a productive work force.

‘We cannot change our 24-hour rhythms,” Kelly said. “You cannot learn to get up at a certain time. Your body will be attuned to sunlight, and you’re not conscious of it because it reports to the hypothalamus, not sight.”

He noted that staff and students are usually sleep deprived and called the problem an “international issue.”

Kelly and researchers at Oxford University are currently recruiting 100 schools around the United Kingdom to take part in a study on delayed school start times and student performance.

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FDA Panelists to Assess Opioid/Food Interactions

http://www.medpagetoday.com/Neurology/GeneralNeurology/53477?xid=nl_mpt_DHE_2015-09-10&eun=g578717d0r

If this follows the same path as to when Purdue make Oxycontin abuse-deterrent… the FDA revoked the NDA (New Drug Application) which meant that a LESS EXPENSIVE GENERIC could no longer be produced… This abuse-deterrent IR form of Oxycodone could mean that the LESS EXPENSIVE GENERIC could be pulled from the market if/when the FDA pulls the NDA for that form of Oxycodone.  If this comes to pass, pts can expect higher out of pocket costs and more resistance of health insurance companies to pay for a more/very expensive form of Oxycodone .

Two FDA advisory committees will meet jointly this week to evaluate two new abuse-deterrent opioids — one of them an immediate-release version, potentially the first of its kind to incorporate anti-abuse technology.

Most abuse-deterrent formulations have thus far focused on extended-release opioids.

The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will evaluate Purdue Pharma’s abuse-deterrent, immediate-release oxycodone (Avridi) on Thursday, Sept. 10 and Collegium Pharma’s abuse-deterrent, extended-release oxycodone (Xtampza) on Friday, Sept. 11.

Purdue’s Drug

Like other abuse-deterrent opioids, Avridi is shored up against intravenous and intranasal routes, although the immediate-release drug can still be abused orally, the FDA said.

But the bigger issue highlighted by FDA is that the drug appears to be less bioavailable when taken with food — and for a product that’s supposed to be dosed as frequently as every 4 hours, the agency has questioned whether that’s possible.

If patients mistakenly dose the drug with food and don’t feel pain relief shortly thereafter, they may take more medicine, the FDA said — potentially leading to a greater risk of overdose.

“Opioid analgesics are generally taken without regard to food, and it is not clear whether labeling would be sufficient to change long-standing behaviors of both prescribers and patients,” the agency wrote in a briefing document.

Purdue argues that a label indicating the drug must be taken with food should take care of those concerns.

The company didn’t perform any new efficacy studies of the drug. Instead, it is relying on efficacy data from immediate-release oxycodone (Roxicodone) studies done before that formulation’s approval in 2000.

Purdue did perform four new safety studies totaling 264 patients.

Collegium’s Drug

On Friday, the two advisory committees will decide whether a fifth abuse-deterrent, extended-release opioid should be on the market.

Collegium’s Xtampza uses DETERx technology to prevent abuse via the intravenous and intranasal routes. It’s comprised of tiny beads of oxycodone in solution, which are stored in a capsule.

In a press release, the company said it provides label information for patients who have difficulty swallowing to “administer the capsule contents directly into their mouth, sprinkled onto soft food, or via feeding tubes.”

But the product is still supposed to be a deterrent against intravenous and intranasal abuse.

Unlike Avridi, Xtampza’s bioavailability is increased when taken with food — as much as five-fold, according to FDA briefing information.

“Fluctuations in oxycodone levels may occur if the product is not taken consistently with the same amount of food,” the agency warned.

Collegium argues that label instructions to take their product on an empty stomach should take care of that problem — but as with Avridi, the FDA notes that opioids are not typically taken with food and it’s unclear “if labeling would be sufficient to change long-standing behaviors.”

The FDA said it initially advised Collegium to reformulate the product to avoid the food effect, but its final version was still susceptible to increased bioavailability with food, so the agency recommended additional studies to demonstrate safety when taken with food.

Panelists will rely on that data to decide whether Xtampza should be the fifth abuse-deterrent, extended-release opioid approved for marketing.

The four others include three from Purdue — OxyContin, Targiniq, and Hysingla — and Pfizer’s Embeda.

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