Diarrhea Drug Imodium Swept Up in Opioid Crisis Under FDA Rules

https://www.bloomberg.com/news/articles/2018-01-30/diarrhea-drug-imodium-swept-up-in-opioid-crisis-under-fda-rules#ampshare=https://www.bloomberg.com/news/articles/2018-01-30/diarrhea-drug-imodium-swept-up-in-opioid-crisis-under-fda-rules

Boxes of Johnson & Johnson’s popular antidiarrheal drug Imodium could soon contain far fewer caplets, under a U.S. Food and Drug Administration request that seeks to limit access of drug abusers to pills that can produce an opioid-like high.

The FDA is also considering whether it can use packaging to stem access to certain fast-acting opioids such as Vicodin and Percocet that are meant for short-term use, Gottlieb said. For example, doctors may opt to prescribe fewer pills if such opioids were packaged in three- or six-day blister packs, he said.

“Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing,” Gottlieb said.

The FDA warned in 2016 that people were using high doses of the active ingredient in Imodium, loperamide, to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. Taking the drug in large quantities could lead to serious heart problems that could be fatal, according to the agency.

“We’re evaluating the agency’s request and share their goal to prevent misuse and abuse,” Carol Goodrich, a spokeswoman for J&J, said in an e-mail.

On its website, J&J links to sellers who offered Imodium in packages of 24 to 48 caplets. Other stores, including Amazon.com Inc. and Walmart Inc., had generic versions available online in bottles of as much as 200 pills. Gottlieb said packaging restrictions should make it easier to limit sales, and he plans to ask online retailers to address loperamide abuse.

“If you’re selling a drug with the potential for abuse and misuse through an online website, you’re no longer in the business of selling widgets, or books,” Gottlieb said. “You have a social contract to take voluntary steps to help address public health challenges.”

Ten deaths from loperamide use were reported to FDA from its approval in 1976 through Dec. 14, 2015. The agency hasn’t updated those numbers, but it says abuse of the drug is on the rise. 

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http://www.pennlive.com/opinion/2018/01/heres_why_a_workers_comp_refor_1.html

In a recent op-ed for PennLive, Dr. George L. Rodriguez, of the Injury Rehabilitation Centers of Pennsylvania, said that state lawmakers have the “gall” to claim that a bill now before the state House will help address our state’s opioid crisis.

There is unmistakable evidence that this bill is good policy. In Ohio, when that state’s workers’ compensation system adopted a similar drug formulary, the use of opioids dropped by 29 percent in four years.

It’s prime time to tackle opioid abuse in the workers’ comp system, as thousands die each year in Pennsylvania, as recognized by Gov. Wolf when he declared a state emergency earlier this month.

A 2017 study by the Workers’ Compensation Research Institute found Pennsylvania to be the 2^nd highest state for the number of opioids per claim a 87 percent higher than the median state.

This formulary uses evidence-based research to reduce overprescribing and lower the risk of addiction for injured workers.

Rodriguez’s claim that the formulary bill was “written, introduced and passed in four days without public input” is uninformed.

Rodriguez insists this is a “cynical ploy by insurers and small employers to cut costs and increase profits.”

The bill (SB936), which is sponsored by Senate Insurance Committee Chairman Don White, R-Indiana, requires that all savings from the formulary go to reduce insurance premiums, not enhance company profits.

Those savings are important to small businesses struggling with the high cost of workers’ compensation insurance, which is expected to jump even higher in the coming months.

The writer claims the drug formulary concept is a “one size fits all approach” that hampers individual doctor’s choices. Programs such as CHIP and Medicare are already successfully using drug formularies.

Let’s make no mistake a unregulated prescription of opioids in the workers’ comp system is a gateway to abuse and addiction.

Rebecca Oyler is the legislative director for the National Federation of Independent Business (NFIB) Pennsylvania. She writes from Harrisburg.

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https://www.newsmax.com/politics/jeff-sessions-dea-crackdown-pharmacies/2018/01/30/id/840376/

The Drug Enforcement Agency will launch a nationwide investigation of pharmacies and prescribers in response to the ongoing opioid crisis, Attorney General Jeff Sessions told agents on Tuesday.

“DEA collects some 80 million transaction reports every year from manufacturers and distributors of prescription drugs. These reports contain information like distribution figures and inventory.

DEA will aggregate these numbers to find patterns, trends, statistical outliers — and put them into targeting packages,

” Sessions said in a speech at the U.S. Attorney’s Office in Louisville, Kentucky.

“That will help us make more arrests, secure more convictions — and ultimately help us reduce the number of prescription drugs available for Americans to get addicted to or overdose from these dangerous drugs.”

Last year, there were 42,249 deaths from opioids, as reported by the Centers for Disease Control and Prevention, which also found that overdoses from opioids account for more deaths per year than breast cancer.

“We still have a lot more work to do reduce violent crime and turn the tide of the opioid epidemic. That’s why we are also taking steps to decrease the number of overdose deaths,” Sessions continued.

“I have also assigned experienced prosecutors in opioid hot spot districts to focus solely on investigating and prosecuting opioid-related health care fraud. I have sent these prosecutors to where they are especially needed — including Kentucky.”

70 law enforcement members gave Session a STANDING OVATION … because this new program is going to provide them with more “bodies” to fill up the courts and jails and job security for all those in the room.

Within this report 42K died of opiate overdoses and it was stated that Session used the 64K overdose deaths in his presentation. I guess that pseudo-facts serves Session much better to make a point.

They also state that drug abuse increase and increased criminal activity is going hand in hand..   Does this mean that those dealing with the mental health disease of addiction will do just about anything to keep from going into withdrawal – what they call “dope sick” ?

Session is so far outside of his skill set… the above picture – does it suggest a “deer in headlights” look ?

Session is 180 degrees out of sync with the current and previous surgeon general who both has stated that addiction is a mental health issue and not a moral failing.

Nearly all statistics will produce a “bell curve”.. so from this statement from Session… the DEA will TARGET those at “each end of the bell curve” ?  Maybe  this is the same thing that the DEA does with estimated prescriber’s net worth… finding those that have a “above average” net worth and put them into a targeting package… so that they can FABRICATE a case and confiscate the prescriber’s assets using the civil assets forfeiture laws.  It makes sense, that every time that the DEA “takes out” the “biggest prescriber”… the “number two prescriber” becomes the “biggest prescriber”…  Until there is no entries in an array.. there will always be the “biggest” at the top of the array.

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www.ahealingplacetheestates.com/2018/01/30/how-moral-failing-perpetuates-the-opioid-crisis/

The opioid epidemic has impacted this nation drastically in the past few years, and little has changed. Legislators, law enforcement, doctors, and families are still attempting to grasp the root of the issue in order to produce solutions that will halt overdose deaths. There are multiple layers to this issue which is why it has been so difficult to produce results. However, one thing is clear; we cannot make lasting change if we continue to perceive this issue as a moral failing.  

What is Considered Moral Failing? 

In western culture a lot of shame is associated with illicit substance use. As a nation, we embraced alcohol after prohibition, and are beginning to witness the decriminalization of marijuana on a state by state basis. However, addiction to these and other illicit substances still carry with them a stigma of personal failure.  

With the understanding that recreational drug use can develop into addiction, the United States Government has attempted to eradicate recreational drug use for over a century. The Harrison Narcotics Acts of 1914 was the nation’s first federal drug policy that attempted to curb addictions to opiates and cocaine. This legislation targeted physicians who offered step down maintenance programs for drugs like morphine (which was commonly prescribed for aches and pains). 1 

Recreational drug use has and continues to be perceived as a moral, or criminal, offense within our communities. We have established laws that are designed to deter people from using and selling drugs with the threat of a prison sentence. However, a prison sentence is not an adequate solution to address the underlying causes of addiction.  

We have tried the same beaten path for so long, and have made little progress. Faced with the current opioid crisis, what is holding us back from making lasting changes that will benefit individuals, families, communities, and those struggling with an addictive disorder? 

Understanding the Solution 

Vox.com published an article that not only summed up people’s feelings towards the opioid epidemic, but also highlighted why we have not made progress in combatting it. To sum it up: Stigma. Our society has been indoctrinated with it and is why we need a new perspective now more then ever.  

Here is how German Lopez, author of the article, summed up his research: 

“Yet it came up again and again in my reporting. Why don’t we widely embrace opioid addiction medications [medicated assisted treatment or MAT], despite decades-old research supporting them? Stigma. Why do we resort to the criminal justice system to deal with addiction, even as that’s proven ineffective? Stigma. Why do we close down needle exchange programs that are proven to save lives? Stigma. What is the one thing Vermont had to overcome to build up its addiction treatment system? Stigma. Why won’t Congress approve the money experts agree is needed to address the crisis? You get the idea.”  

Granted, policies and regulations will not change overnight, nor will the public’s perception of the issue. However, with an epidemic that knows no race, gender, age, or income status, people are seeing first hand what addiction can do to a community. With people becoming more educated on addiction, as well as understanding the scientifically backed solutions, we can at the very least hope we are heading in the right direction. 

Why it can be difficult managing chronic pain and addiction 

Managing any addictive disorder can be a complex process. Add chronic pain into the mix, and it’s a whole new game. This is due to the fact that for years our standard of care for managing aches and pains was not so different from that in 1914. To put it simply, we as a western society have relied on opiates to manage all sorts of pain. We were never exposed, directed, or prescribed alternative methods of pain management. Instead of reserving opiates for post-surgical acute pain and end of life care, patients used their medications for years to manage varying chronic pain conditions. They were unknowingly making their pain conditions worse, and developing additional biological and psychological conditions.  

Using opioids as a long-term symptom management tool can result in patients becoming dependent on their medications, requiring more medication to achieve relief, becoming more sensitive to pain, as well as developing psychological conditions associated with their pain.  

To learn more about opioid dependence/addiction, click here. 

To learn more about developing hypersensitivity to pain from opioid use, click here. 

To learn more about psychological conditions associated with opioid use, click here.  

Offering Hope and Healing to those with Chronic Pain and Addiction 

Here at A Healing Place – The Estates, we all agree that coexisting conditions that accompany chronic pain must be addressed for sustainable recovery. Treating the whole person on a biological, psychological, social and spiritual levels is essential. Our founders reached out to other leading medical providers in the field and, as a result, built an outstanding team of professionals who allow us to offer modalities ranging from recovery-friendly medication management, equine therapy, to cognitive behavioral therapy (CBT). 

We are eager to introduce our transformative solutions for chronic pain to you and your family. If you have any questions regarding any aspect of our treatment program, feel free to contact our compassionate staff at 844-388-4100, or send an email to info@ahealingplacetheestates.com.  

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http://www.pharmacytimes.com/contributor/karen-berger/2018/01/oops-is-this-a-hipaa-violation

A recent Facebook discussion I found very interesting occurred in a chain pharmacy. Apparently, that day, the staff was filling quite a few antidepressant prescriptions and a pharmacy staff member joked something along the lines of ‘it must be depression day.’ In the waiting area one of the patients filling an antidepressant was extremely angry and offended. This patient complained to the corporate office and wanted to file a HIPAA violation complaint. There was a spirited discussion of whether this was indeed a HIPAA violation or unprofessional without being a HIPAA violation.

With no clear answer, I reached out to Angelo Cifaldi, RPh, JD, and Satish Poondi, RPh, JD* for their opinions. Both are pharmacist attorneys with many years of practice in the area of pharmacy law. They agreed that this scenario could be a Potential HIPAA violation. 

When this happens, the patient may choose to file a case with the Office for Civil Rights (OCR). If the OCR were to enter into a case like this based on a complaint, the outcome could be as simple as reviewing HIPAA policies and procedures with the entire pharmacy staff, or could be more complex, involving interviews with staff and patients and some kind of resolution.
 
Because there is a possibility of lawsuits stemming from HIPAA violations, Mr Cifaldi and Mr Poondi noted that a pharmacy may have liability insurance that only covers physical damages and not emotional distress as would potentially occur with a HIPPA violation. In the ‘depression day’ case, it is difficult to evaluate damages. Perhaps it is a small town and people hear this private health information, and the patient feels as if his/her reputation is damaged.

The outcome may depend on many factors such as an investigation, practices of the pharmacy, where it occurred, how identifiable the patient was. (Was he the only patient there or were there ten people there?) The U.S. Department of Health and Human Services website shows how many HIPAA complaints there have been and how they were resolved. 

Mr Cifaldi and Mr Poondi reported that they are generally seeing more lawsuits against providers based on privacy violations. For example, a patient tells the pharmacy that no one else may pick up their medication. Let’s say this never gets recorded anywhere (it seems some pharmacies do not have a reliable system to enforce this), then someone else picks up the medication and discovers for example that his/her spouse has HIV, and then a lawsuit is filed against the pharmacy.

Building on that, Mr Cifaldi and Mr Poondi agreed that an important tip for pharmacists is to check their malpractice insurance policy. If you don’t have malpractice insurance, do you need it?

Our expert lawyers absolutely agree that not only should we sign up for malpractice insurance, but we should get as much as we can afford. Even if the pharmacy has malpractice insurance, every pharmacy employee (anyone behind the counter—pharmacists, technicians, cashiers) should invest in an insurance policy. HPSO and Pharmacists Mutual are two reputable companies that offer this service at an affordable rate. 
 
Since many malpractice insurances only cover physical injuries and not emotional distress without a physical injury, Mr Cifaldi and Mr Poondi recommended checking policies carefully to see what is covered. A HIPAA violation may not be covered if the particular policy only covers physical damages. The lawyers emphasize that a thorough review of the policy is necessary. Is it an aggregate policy or is it per occurrence? What is the limit? Does the insurance include paying the lawyers or is that separate? 

Mr Cifaldi and Mr Poondi explained that pharmacy malpractice can be an expensive litigation. If a case drags on for five years, and the policy covers $500,000, but the lawyers cost $500,000 then there is nothing left to pay for the damages. Always know what your insurance covers and how it works.
 
In summary, HIPAA violations can be very serious and may result in extensive (and expensive) litigation to the entire pharmacy team. Remember that we are in a fishbowl and there are eyes and ears everywhere. If you do not yet have individual malpractice insurance, now is the time to sign up. Read the policy carefully and ask questions to make sure you are covered in every possible scenario. If you already have coverage, be sure to review your coverage so if you find yourself in a litigation, you will be covered as much as possible. 
 
*information from Mr Cifaldi and Mr Poondi is general information and not legal advice. Consult your lawyer for legal advice 

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http://www.ctpost.com/business/article/Purdue-faces-uphill-battle-to-overcome-opioid-12528026.php

A growing number of prosecutors and politicians accuse Purdue Pharma of fueling the national opioid crisis. The maker of the maligned opioid OxyContin says there is another side to the story.

Amid an avalanche of Oxy-related lawsuits in recent months, the Stamford-based pharmaceutical company has mounted several major campaigns aimed at showing a commitment to combatting the epidemic of opioid abuse. But many medical professionals and public officials are responding to the PR push with deep skepticism, saying the company needs to do much more to back up its claims.

“It strikes me as very hypocritical that these companies that have made billions off selling opioids and have been involved in the overmarketing of these drugs for years now say they want to be part of the solution,” said Dr. Jeff Gordon, immediate past president of the Connecticut State Medical Society. “However, if they are being serious, I welcome them now coming on board. But one has to be very realistic about what their past is.”

Major campaigns

Last month, Purdue ran a full-page ad across print and digital platforms in The Hill, The New York Times, Politico, Roll Call, USA Today, The Wall Street Journal, The Washington Post and Hearst Connecticut Media’s daily newspapers.

The ad says the company has made its opioids more difficult to abuse, worked on non-opioid pain medications, and distributed to prescribers and pharmacists federal prescribing guidelines. It also says there are too many prescription opioid pills in medicine cabinets and expresses support for initiatives that limit the length of initial opioid prescriptions. In addition, it calls for doctors to check prescription drug monitoring programs before writing prescriptions.

“No one solution will end the crisis, but multiple, overlapping efforts will. We want everyone engaged to know you have a partner in Purdue Pharma,” the ad says. “This is our fight, too.”

The company also includes a pop-up link to the letter on its website’s homepage.

Similar ads are scheduled to run in the first quarter of this year, according to Purdue officials. They declined to disclose the cost of the campaign. Several estimates peg the cost of such ads in publications like The New York Times at more than $150,000.

“It’s an advertising technique that is trying to reframe their image in the community and their association with the opioid crisis,” said Debbie Danowski, an associate professor of communications and media arts at Sacred Heart University. “From what I can see in this ad, it’s kind of a lot of talk and not any real concrete action. Imagine the number of people they could be helping by using the money they’re spending on those ads on treatment centers for those who have become addicted to their drugs.”

Among other recent campaigns, the company teamed last fall with the public-private agency The Governor’s Prevention Partnership to launch a series of spots about the opioid crisis on iHeartRadio stations.

The partnership marked the latest chapter in a two-decade alliance between Purdue and The Governor’s Prevention Partnership, which focuses on education about youth issues, including substance abuse. In addition to a base of $50,000 Purdue contributed last year to the Partnership, the company paid approximately $250,000 for the PSA spots.

“We’ve done our due diligence and have been in a relationship with them for 20 years,” Jill Spineti, president and CEO of The Governor’s Prevention Partnership, said in an interview last year. “We know they use a scientific approach to prevention. They’ve put a lot of resources into prevention to do the right thing.”

Last June, Purdue and the National Sheriffs’ Association announced the second round of a program that gives officers across the country overdose kits and training for the naloxone drug, which can reverse opioid overdoses.

NSA officials credit the Purdue-funded initiative with helping to save some 120 lives since its late 2015 pilot-phase launch. In the first stage, NSA officers distributed 500 naloxone kits to 12 local law enforcement agencies in several states.

But other groups, like the Connecticut State Medical Society, said they have not received much support from Purdue and other opioid makers.

“The ball is in their court,” Gordon said. “If they want to reach out to us physicians in Connecticut to find ways to work with us and reach out to the public, I think we would welcome that opportunity. I think it would be a plus all around. It’s a team approach.”

Despite the increased PR, Purdue executives continue to shy away from speaking beyond prepared statements about the opioid crisis. The company has not made CEO and President Craig Landau available for an interview with Hearst Connecticut Media since he started in the position last June.

Legal pressure continues

So far, the PR initiatives have not stanched the torrent of litigation the company faces from local and state prosecutors across the country for alleged deceptive marketing and irresponsible distribution of OxyContin.

New York City last week sued the company and several other pharmaceutical firms, seeking $500 million in damages. Earlier this month, 18 Connecticut municipalities — including Bridgeport, Fairfield and Newtown — filed a similar lawsuit.

“If successful, the (ad) campaign could soften the hardest positions against Purdue,” said Robert Bird, a professor of business law in the University of Connecticut’s business school. “And softening public sentiment may reduce public pressure on the folks who are aggressively pursuing this litigation.”

But Ohio Attorney Gen. Mike DeWine said he was unmoved by the full-page ads. He cited his disappointment in the company’s response to the lawsuit he filed last May.

“They can put as many ads as they want to out there, but that’s not dealing with the problem,” DeWine said in an interview last week. “They’ve refused our invitation to come forward and talk. I find that really speaks for itself. Why don’t we take this opportunity to start talking and try to reach an agreement, so that Purdue Pharma can be part of the solution instead of just being the creator of the problem?”

pschott@scni.com; 203-964-2236; Twitter: @paulschott

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AUGUSTA — In New Hampshire, an online map locates scores of pharmacies where anyone can buy an over-the-counter dose of naloxone, a medication that saves lives by reversing the effects of an opioid overdose.

In Utah, the state health director issued a standing order authorizing any pharmacist to dispense naloxone.

But in Maine – where an average of one person a day dies of an overdose – Gov. Paul LePage and his administration have stifled efforts to expand access to the life-saving drug.

Rules that would allow Maine pharmacists to dispense naloxone over the counter have sat on LePage’s desk for five months. Other rules that would allow overdose prevention groups and needle exchanges to distribute naloxone to clients haven’t even been drafted by the Department of Health and Human Services – two years after the Legislature passed the law.

Gov. LePage: Narcan ‘does not truly save lives.’

The administration’s inaction comes even as conservative Republicans nationally – including President Trump and former New Jersey Gov. Chris Christie – have called for increased and widespread access to the overdose antidote.

Although it’s unknown how many deaths may have been prevented had LePage moved more quickly, what is clear is that Maine is falling behind most other states – including many headed by Republican governors or controlled by Republican legislatures – that have made naloxone available to save lives.

Rep. Karen Vachon, R-Scarborough, who sponsored the legislation to make naloxone widely available, said some have still failed to recognize that substance use disorder is an illness that should be treated. Too many people, she said, blame the individual trapped in addiction, which often starts with the use of opioid painkillers prescribed by a doctor.

“I just don’t know how they consider themselves pro-life,” said Vachon, who describes herself as a devout Catholic. The stories of those who recover from addiction are stories of redemption that show the value of human life, she said.

CRIPPLING LAWMAKERS’ EFFORTS

The state’s failure to publish rules for dispensing naloxone has left pharmacists without official guidance. As a result, some of Maine’s largest pharmacy chains, including Hannaford and CVS, say they will not dispense the medication over the counter until the rules are put in place. Maine’s attorney general, Janet Mills, contends that the pharmacy board could publish the rules but the board’s president, Joe Bruno, has said the board is following protocol in awaiting LePage’s approval.

LePage said “I don’t know a thing about it,” when asked about the naloxone rules on Jan. 19. His press secretary has said only the rules are “pending” in the governor’s office.

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“Naloxone does not truly save lives; it merely extends them until the next overdose,” LePage wrote when he vetoed a naloxone bill in 2016. “Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction.”

Bruno, a pharmacist who owns Community Pharmacies, a chain of nine pharmacies across the state, has refused multiple requests for comment from the Maine Sunday Telegram and Portland Press Herald. Anne Head, LePage’s commissioner for the Department of Financial and Professional Regulation, the state agency that oversees the pharmacy board, also has not responded to multiple requests for comment.

Some lawmakers, including legislative leaders, said they’ve been blamed for not doing enough to address Maine’s opioid crisis, but the reality is that the LePage administration is crippling lawmakers’ efforts.

“It is just clear that the Legislature has intended for years now to make sure that we are doing everything we can to save people’s lives, I believe in the hopes that we can get them into treatment and then get people back on their feet,” said House Speaker Sara Gideon. “And this doesn’t help; we are losing people every day and every single life is worth saving every time.”

Gideon, D-Freeport, and Senate Minority Leader Troy Jackson, D-Allagash, sent a letter Friday to LePage and Bruno urging them to release the rules. Neither man responded.

Maine reported 376 drug overdose deaths in 2016, more than double the number just three years earlier. The Attorney General’s Office has not finalized the numbers for 2017 yet, but Maine was still averaging more than one overdose death a day for the first six months of last year. For the past several years, the vast majority of deaths were caused by heroin, the powerful synthetic opioid fentanyl, or a mix of opioids.

‘A VITAL MED THAT NEEDS TO BE EVERYWHERE’

Maine law allows a medical doctor to issue a standing order to a pharmacy to allow the distribution of naloxone without a prescription, but there is no readily available list of those pharmacies. Staff photo by Joe Phelan

While Maine has failed to act, other states – including Texas, Georgia, Kentucky and West Virginia – have moved to expand access to naloxone, building an increasing body of evidence of how the drug can save lives.

In North Carolina, for example, a state harm reduction coalition, under a statewide standing order, distributed 15,870 naloxone doses in 2015 and recorded that 1,547 of those were used to reverse an overdose. In the year before the law was changed, only 201 naloxone doses were dispensed by outreach workers, who recorded 30 overdoses reversed.

Robert Childs, executive director of the North Carolina Harm Reduction Coalition, said the growing presence of fentanyl – an opioid that is 50 times as potent as heroin – in the black market drug supply makes widespread access to naloxone even more pressing.

“It is a vital med that needs to be everywhere in America and especially around people that use drugs or have a history of drug use at that level,” Childs said, adding that naloxone availability is even more important in rural states like his and Maine, where response and transport times for emergency medical services can be delayed.

Beyond what Childs considers the human rights issue of saving a person’s life are the financial costs of overdose treatment.

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In North Carolina, Childs said the average cost of an overdose response that involves an ambulance service and a hospital emergency room intervention is $17,000. He said the costs of treating a patient who has not entered respiratory distress because of a naloxone dose is far less.

“It’s not just a human rights issue, we are talking about costs,” Childs said. “If we as a society are paying more and more costs for overdose-related issues and drug dependency, it is foolish to treat those in an emergency room setting.”

Maine paramedics and EMTs regularly use naloxone to save lives. In 2017 emergency medical personnel gave naloxone 1,534 times, down from 2,380 doses in 2016 and comparable to the 1,585 doses given in 2015. About 70 police departments in Maine are also now administering naloxone, with funding for the drug being provided by the Office of the Attorney General. The program, which started in 2016, has documented 350 overdose reversals.

Portland Police Chief Michael Sauschuck also told the Legislature’s Health and Human Services Committee this month that officers in his department had used naloxone on overdose victims 95 times over the last 15 months.

ACCESS MIXED AT MAINE PHARMACIES

Maine law allows a medical doctor to issue a standing order to a pharmacy to allow the distribution of naloxone without a prescription. Walgreen’s has obtained a standing order and sells naloxone at its Maine stores.

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But many pharmacies have no standing orders, and others have flatly said they will not distribute the drug without the rules from the Maine Board of Pharmacy.

Bruno, the pharmacist and board chairman, has said that “most” pharmacies in Maine could provide the drug without a prescription, using a standing order. However, the pharmacy board does not identify where those pharmacies are located, nor does there appear to be any readily obtainable listing elsewhere.

At least one of Bruno’s pharmacies, Community Pharmacy in Randolph, has a standing order to provide naloxone without a prescription to a friend or family member of a person at risk of an overdose, according to a pharmacist who answered a reporter’s phone call last week. The pharmacist said the antidote was stocked in a nasal version and that while most insurance policies cover at least a portion of the drug’s cost, the cash price for a two-dose rescue kit was $170.

An employee at another of Bruno’s pharmacies, located in Saco, said that store could not dispense the drug without a prescription from a doctor.

Other states are broadly promoting access to naloxone, with some states like Kentucky even creating online registries and locator maps showing pharmacies where over-the-counter naloxone is available. Many state websites supplement naloxone directories with links to other resources related to addiction recovery.

In New Hampshire, the state’s Department of Health and Human Services has created an awareness campaign, as well, featuring an online map detailing pharmacies with standing orders to dispense naloxone over the counter. The site also spells out New Hampshire’s law on obtaining a prescription for naloxone and provides links to additional resources, including where free naloxone rescue kits can be found. Vermont and Massachusetts also have similar campaigns and programs.

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In Maine, Dr. Christopher Pezzullo, the state’s chief health officer, has not issued a standing order for naloxone, as his counterparts in other states have done. In a report he issued in 2016 on the state’s response to the opioid crisis, Pezzullo makes no mention of expanding access to the antidote.

Pezzullo did not respond to a request for comment and apparently forwarded the Sunday Telegram’s request for an interview to Emily Spencer, spokeswoman for the Maine Department of Health and Human Services. Spencer sent an email to the Telegram saying it should direct questions about naloxone to the pharmacy board.

HARM REDUCTION PROGRAMS IN MAINE

One place where Mainers can get naloxone is at Portland’s India Street Free Clinic needle exchange program, which offers naloxone rescue kits under the standing order of the clinic’s medical director, a physician. Zoe Odlin-Platz, a community health promotion specialist with the clinic, said the program distributed 2,791 doses of naloxone in 2017, and those doses were used to reverse 291 overdoses. The program has been in place since 2015 and has distributed more than 5,000 doses of naloxone.

Those who request a naloxone kit not only receive training on how to use it but also information on what causes overdoses and current information about the potency of drugs circulating in the city at that time.

“The presence of fentanyl on the streets of Portland has certainly had a major impact on the rates of overdose that we are hearing,” Odlin-Platz said.

Other harm reduction programs in Maine, like those run by the Health Equity Alliance, have also been distributing naloxone rescue kits to clients who may be at risk or to those who have a loved one at risk of a drug overdose.

Kenny Miller, the alliance’s executive director, said his organization distributed 252 kits in 2016, of which 60 kits were reportedly used to reverse an overdose, and in 2017 the organization distributed 190 kits and recorded between 95 and 100 overdose reversals. The alliance distributes the kits from its Bangor and Ellsworth offices at no cost. Miller says they do so under the standing order of a doctor, but without the pharmacy rules approved they are operating in a “gray area.”

“But we cobbled together our own program because we could not in good conscience sit back and watch people die,” Miller said.

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www.nationalpainreport.com/is-a-solution-to-chronic-pain-treatment-underway-in-canada-8835371.html

By Ed Coghlan.

How the Canadian province of British Columbia is approaching the treatment of chronic pain might be worth watching.

“There has really been a lack of any appropriate response to chronic pain in our province and in our country,” said Maria Hudspith, executive director of Pain BC, the only non-profit society in Canada to bring together clinical experts and policy-makers to work on chronic pain management initiatives.

In June 2016, B.C. doctors became the first in Canada to face mandatory standards for prescribing opioids and other addictive medications.

She said that after the standards were introduced; doctors began weaning patients off pain medication which left people suffering, especially if they don’t have access to other options for pain relief.

“We have documented cases of people who are no longer able to work, they’ve maxed out their sick time, they’re contemplating going on disability,” she said.

“We know that to effectively treat chronic pain means more than just giving them prescription medicine, she said.”

Her group – which is what is called a collective impact model – includes physicians, patients, business, pharmaceutical and policy maker is pressing the provincial government to make an investment in how chronic pain is treated.

They are working to secure an investment for the expansion of services that can create multi-modal treatment of chronic pain.

Hudspith’s group is pressing for an inter-disciplinary approach to treatment, give family doctors more time to treat a patient (currently the average office visit assuming you can get one is 7 minutes) and robust clinical education programs.

“People recognize the treatment of chronic pain is an important issue,” she told The National Pain Report. “We are pleased the government is working with us on developing an action plan that makes sense.”

Her group is what she calls a “Big Tent” involving clinical, research, business and legal experts. She also pointed out that her group doesn’t any take funding from pharmaceutical companies.

She told CTV, “Chronic pain is a very misunderstood condition. The approach needs to be very different from other chronic conditions that are very well understood.”

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Why Untreated Chronic Pain is a Medical Emergency

By Alex DeLuca, M.D., FASAM, MPH;

Written testimony submitted to the Senate Subcommittee on Crime and Drugs regarding the “Gen Rx: Abuse of Prescription and OTC Drugs” hearing; 2008–03–08.

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