HHS Proposes Rule to Ease Some Substance Abuse Disclosures

Allows patients to agree to broader release of info

WASHINGTON — Consent requirements would be eased for providers releasing their patients’ substance abuse diagnosis and treatment records under a proposed rule released earlier this week by the Department of Health and Human Services (HHS).

The proposed rule seeks to “modernize the [current federal law on substance abuse confidentiality] by facilitating the electronic exchange of substance use disorder information for treatment and other legitimate health care purposes, while ensuring appropriate confidentiality protections for records that might identify an individual, directly or indirectly, as having or having had a substance use disorder,” according to the text of the regulation.

The authors noted that the confidentiality law was originally written “out of great concern about the potential use of substance abuse information against individuals, causing individuals with substance use disorders to not seek needed treatment. The disclosure of records of individuals with substance use disorders has the potential to lead to a host of negative consequences including: loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration.”

Under the current law, “a federally assisted substance use disorder program generally may only release identifiable information related to substance use disorder diagnosis, treatment, or referral for treatment with the individual’s express consent,” the authors continued. “Now, over 25 years later, this proposed rule would make policy changes to the regulations to better align them with advances in the U.S. health care delivery system while retaining important privacy protections.”

For example, the Substance Abuse and Mental Health Services Administration (SAMHSA) “is proposing to allow, in certain circumstances, a patient to include a general designation in the ‘To Whom’ section of the consent form” — that is, allowing a general group of providers to disclose information — if the form includes an “explicit description” of the amount and kind of information that might be disclosed, the authors wrote.

SAMHSA also wants to require that patients who are permitting such a general disclosure can request and receive a list of entities to which their information has been disclosed.

With patients being able to use such a general designation, “we anticipate there would be more individuals with substance use disorders participating in organizations that facilitate the exchange of health information (e.g., health information exchanges) and organizations that coordinate care (e.g., accountable care organizations) … leading to increased efficiency and quality in the provision of healthcare for this population,” they continued.

In addition, SAMHSA also wants providers who disclose this information “to have in place formal policies and procedures addressing security, including sanitization of associated media, for both paper and electronic records.”

The rule also would change the medical emergency exception to the disclosure regulations “to give providers more discretion to determine when a ‘bona fide medical emergency’ exists.”

The rule also addresses medical research; it seeks to allow researchers that have substance abuse treatment data to link to data sets from federal data repositories.

HHS estimated that the costs associated with the new rule would be $74 million the first year, $47 million the second year, and about $15 million annually in years 3 through 10.

HHS is seeking comments on this rule; comments will be due by April 9th.

 

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Cutting off the opioid epidemic at the root

https://www.bostonglobe.com/opinion/2016/02/16/cutting-off-opioid-epidemic-root/EdovYeSsn5QbWtLY3ICY5J/story.html#comments

IT’S BEEN nearly two years since the state declared prescription drug and heroin addiction a public health emergency. Since then, we’ve had an all-hands-on-deck approach from lawmakers, police and fire chiefs, health professionals, and community groups.

But our collective efforts haven’t been enough. Until we change the culture around how opioids are prescribed, and dramatically reduce the number of pills available, people will continue to die.

Since 1999, the number of prescription painkillers sold in the United States has nearly quadrupled. In 2014, there were 4.6 million opioid prescriptions written in Massachusetts alone — enough for nearly every adult in this state to have a bottle of pills. Meanwhile, overdose deaths have risen by more than 300 percent.

We won’t solve this crisis until we cut it off at its root, by reducing the use of prescription opioid painkillers like Oxycontin, Vicodin, and Percocet. Cheap heroin is not a new problem; it’s been around for decades. What is new is that four out of five heroin users report having previously used a prescription opioid. These powerful drugs are a synthetic version of opium. They’re heroin in a pill.

The opioid epidemic is the direct result of years of overprescribing painkillers to everyday people, who get hooked on an extremely addictive substance, then turn to heroin when they can no longer afford to sustain an expensive pill habit.

While heroin is certainly a problem, three times as many Americans are hooked on opioids. Pharmaceutical companies told us for years that they weren’t addictive, but we know better now. Medical studies have shown that up to a third of long-term opioid users meet criteria for addiction, and that physical dependence can happen in as few as five days.

While the vast majority of prescribers are trying to do the right thing, we must end the illegal prescribing we know is taking place. My office has formed an investigative group to identify practitioners who are illegally prescribing opioids to people who shouldn’t have them. This partnership will allow state and federal law enforcement agencies to share information about those who run “pill mills” or prescribe to people with a history of substance abuse.

But to combat the opioid crisis more fully, we need societal change. The Centers for Disease Control and Prevention has proposed nationwide guidelines to help medical professionals across the country understand when and how opioids should be used, particularly for chronic pain. The pharmaceutical lobby and some sectors of the medical community have pushed back against these guidelines, calling them too restrictive. But here’s my view: Thousands are dying, and something desperately has to change. Thirty-six other state attorneys general share that view and recently wrote a similar letter in support of the guidelines.

There’s another simple solution that can be put in place immediately: We need prescribers to check the state’s prescription monitoring program every time they write a prescription for highly addictive drugs. The program can flag when a patient is receiving multiple prescriptions, doctor shopping, or showing signs of addiction. Right now, only one in four doctors checks. Governor Baker has proposed that all prescribers check the prescription monitoring program every time they write one of these prescriptions. When New York State passed a similar mandate in 2012, it saw a 75 percent drop in doctor shopping. This modest step can save lives and is time well spent.

Those who continue to push back against safeguards like these should spend time with any of the thousands of parents across this state who have lost a child to opiate addiction. All too often, theirs are stories of high school athletes and honor roll students who became hooked on opioids after an injury. Others began by experimenting at a party — but if our medicine cabinets weren’t full of prescription painkillers, our kids wouldn’t have such easy access to them.

We can’t hear those stories any longer and fail to act. Other countries have figured out how to manage pain without releasing a flood of dangerous drugs into their communities. We need to do the same. If we don’t, the deaths will continue.

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Lawmakers zeroing in on anti-meth plan

http://www.thenewsdispatch.com/news/indiana_state_news/article_09af0bb9-8ec6-5030-8793-b5a109206e24.html

Once again the bureaucrats have put Pharmacists in a position that if they get the wrong drug in the wrong hand.. there are consequences.. and if they “just say no” ..there is no consequences for the Pharmacists.  For the last 5+ yrs, Indiana has used a national electronic database called NPLEx. A great concept, however.. there is no confirmation of the driver’s license presented against some valid driver’ license database .. like the BMV’s database. Of course, they could move to a digital finger print reader.. instead of using driver’s license… which it is very difficult to change/fake/forged.  Since this database is up and running in dozens of states those going from store to store and state to state would be identified and the Pharmacist would have a very valid reason not to sell them PSE, but that would be using 21st century technology against 21st century criminals..

INDIANAPOLIS (AP) — Pharmacists say there are tell-tale signs that a customer is buying cold medicine to make methamphetamine: They peer behind the pharmacy counter, ask for the highest dosage and make multiple purchases in the same hour.

But despite pharmacists’ confidence in identifying such people, some pharmacy chains fear that proposed legal changes in Indiana that would leave it to pharmacists to decide whether to reject suspected meth makers outright or require them to get a prescription for such medicines could lead to confrontations and put them in danger.

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A vaccine for drug addiction is in the works

http://news.medill.northwestern.edu/chicago/a-vaccine-for-drug-addiction-is-in-the-works/

Imagine this, you have someone that has been a addict and has been vaccinated and successfully refrained from abusing opiates.. and they are involved in a accident or develop a disease that now cause them to be in mod-severe chronic pain.  Now you have a chronic pain patient who has been vaccinated against opiates working in their body, and we address/treat their control pain with what ?

Treating drug addiction with a vaccine might become a solution to combat prescription drug and heroin addiction and the rapid rise in overdose deaths.

A vaccine, which has undergone tests in animal subjects so far, holds promise, said Dr. William Compton, deputy director of the National Institute on Drug Abuse. The vaccine would “produce an antibody response which would latch onto the drug of use…and because they’re large molecules they will not be able to cross the blood-brain barrier.”

Compton focused on the prescription drug and heroin addiction epidemic at a panel on the “Neuroscience Clues to the Chemistry of Mood Disorders and Addictions” on Saturday. He said the vaccine might be our best solution, speaking at the American Association for  the Advancement of Science conference in Washington D.C.

He estimated there are 200 million prescriptions written for opioids a year in the United States. Usually prescribed for pain, many remain unused and get in the hands of family and friends.

As prescription drugs are chemically similar to heroin, if a patient becomes addicted to prescription drugs, heroin is a logical next step on the journey to addiction.  In 2014, more than 50,000 Americans died of drug overdoses, including 19,000 who died of prescription drug overdoses and 10,000 who died of heroin overdose. The remaining overdoses were due to other commonly abused drugs.

National Overdose Death Rates, Number of Deaths from Prescription Drugs

National Overdose Death Rates, Number of Deaths from Heroin

“Science can help in many ways,” he said.

If drugs can’t cross from the circulatory system into the brain through the blood-brain barrier, Compton said the “intoxication reinforcement” would be halted. If addicts can’t get “high” from drugs, they are less likely to abuse them.

Compton used an “empty wallet” analogy to describe how this vaccine would allow addicts to “spend” on drugs, but not get the payback of a “high.”

Compton said this vaccine would be part of a three-part strategy aimed at combatting the drug addiction epidemic which includes: helping addicts, reversing drug overdoses, and preventing addiction.

Illustration of Anti-Drug Vaccine from NIDA

Along with vaccines, Compton said that the NIH is working on a buprenorphine implant that can also help addicts combat their addiction.

The implant would be inserted under the skin, like several birth control products said Compton, and would allow for a steady dose of opioid replacements drugs like buprenorphine for six months.

“It would be very small, minimally invasive and would last six months,” said Compton. “As a clinician, that sounds marvelous to me. Every day [my patients] have to decide ‘today am I going to stay healthy or am I going to go back into my drug using pathway?”

He said the implant can make the decision for them for at least six months to help them kick addiction.

Scientific solutions to reverse overdose include naloxone, available since the 1970s and now in use by police and first responders.  Compton said the NIH has announced a naloxone nasal spray, but scientific solutions to prevent addiction are.

Compton said that most heroin addiction begins with prescription drug or opioid addictions prescribed for pain. If less addictive non-opioid alternatives were invented to treat pain, fewer patients might become addicted in the first place.  One of these alternatives involves transmitting constant, low current to the brain through a series of electrodes attached to the scalp.

“Transcranial brain stimulation [might] change the perception of pain just as opioids,” said Compton. “Maybe we can do it in less problematic ways.”

Whether science can solve the United State’s drug addiction epidemic, which saw death rates from prescription drug and heroin overdose quadruple over the past 15 years, Dr. Michel Kazatchkine, who is a member of the global commission on drugs policy with the United Nations, said that polices and society must work on the problem as well.

“We are all working under the international drug control that is based on international United Nations conventions and these conventions aim at the health and welfare of mankind. However, the way drugs are understood or perceived in the public opinion, the way people who use drugs are dealt is far from actually going in direction of achieving these goals.”

Kazatchkine said that these problems will be addressed when the UN General Assembly Special Session on Drugs convenes for the first time since 1998, in three months time to discuss international solutions to drug addiction.

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Feel This Pain: Ankylosing Spondylitis

Ankylosing spondylitis is an inflammatory disease. The more common symptoms are a heaviness in the feet and lower back and extremely swollen hands, and at its worst it can cause some of the vertebrae in your spine to fuse together. Sounds charming, doesn’t it?

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Want Viagra? Not without a note from the wife

http://www.courier-journal.com/story/news/politics/2016/02/12/want-viagra-not-without-note-wife/80294772/#

Now this here is first, although probably not for long in today’s political climate. If you can believe it Rep. Mary Lou Marzian has a plan for Kentucky men’s”johnsons”. Kentucky men would have to visit a doctor twice and have signed permission from their wives before obtaining a prescription for Viagra, Libivi male enhancement or other such drugs for erectile dysfunction, according to a bill filed by a state legislator Thursday.

Rep. Mary Lou Marzian, a Louisville Democrat, the sponsor of House Bill 396, said it is merely an effort to protect men’s health and ensure they are informed about a drug with potentially dangerous side effects.

“I want to protect these men from themselves,” said Marzian, a nurse.

HB 396 also specifies that only married men may obtain the drug and requires “a man to make a sworn statement with his hand on a Bible that he will only use a prescription for a drug for erectile dysfunction when having sexual relations with his current spouse.”

“This is about family values,” Marzian said.

THE COURIER-JOURNAL

Abortion ultrasound bill approved by committee

 But she acknowledged the bill is a pointed response to several anti-abortion measures in the current legislative session, including Senate Bill 4, which requires a woman seeking an abortion to get counseling 24 hours in advance of the procedure from a health professional. The counseling must be in person or via live telecommunications.

SB 4, called the “informed consent” bill, passed last week and was signed into law by Gov. Matt Bevin.

Marzian, an abortion-rights supporter, said HB 396 also is meant to protest intervention by a predominantly male General Assembly into women’s health.

“Do we really want a bunch or legislators interfering in private, personal, medical decisions?” she asked.

Marzian said she doesn’t expect her bill to get very far. But she’s not done.

Marzian said she also plans to file a bill requiring potential gun buyers to obtain counseling 24 hours in advance from victims of gun violence before the purchase.

“I’m just making sure the government is taking care of your safety,” she said

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Facebook Pain Groups Attacked by Spammers

http://www.painnewsnetwork.org/stories/2016/2/13/facebook-pain-groups-attacked-by-spammers

By Pat Anson, Editor

The websites all have innocent sounding names, like Personal Medical Treatments, Personal Health, and Health Care Solutions Plus.

Their articles also sound interesting, with titles like “7 Ways to Relieve Fibromyalgia Pain” and “Alternatives Treatments: The Rx for Chronic Pain is Changing.”

But when you dig a little deeper things don’t add up. The websites have no advertising, so how are they funded? Why do they all seem to be based in Pakistan or Panama?  Did “Zafar Iqbal” really write that article about alternative pain treatments in Duluth, Minnesota?

And why are all of their articles apparently stolen from other websites – a clear violation of copyright laws?

Those are some of the questions being asked by administrators and members of chronic pain support groups on Facebook, who have been deluged with thousands of links to these bogus websites for the last few months.

The links are usually posted by new group members who only recently joined Facebook and have very little information in their profiles. As fast as the bogus links and the suspicious posters are deleted, they return under new names with new links to articles such as the following:

“To a Friend With a Chronic Illness Who’s Feeling Hopeless” was apparently stolen from The Mighty.com. 

“How Painkillers Make Headaches and Chronic Pain Worse Over Time” was taken from TheHeartySoul.com.

“In the Shadow of an Opioid Crisis, Super Bowl Ad Spotlights Chronic Pain Patients” (allegedly written by the mysterious Zafar Iqbal) was copied and pasted from StatNews (the real author is Rebecca Robbins).

Pain News Network has been victimized in this scam too. Columnist Ellen Lenox Smith emailed me this week asking why her column “8 Tips for Patients Newly Diagnosed with Ehlers-Danlos”  reappeared without permission in CaringCare.Info.

“Is this appropriate?” Ellen wanted to know.

No Ellen, it is not. It’s called plagiarism.

The problem has become so acute that the administrators of a large Facebook support group recently closed it to new members.

“Due to an attack by plagiaristic & duplicate posters we are putting a temporary moratorium on new members,” wrote Barbara Mills, who made the move reluctantly because she knows many pain sufferers are looking for friendship and support in Facebook groups such as hers.

Barbara told me in the recent past she was offered money to post the links herself, but declined.

More is at stake here than plagiarism, copyright laws and unhappy editors like me who hate seeing their articles stolen. I think the ultimate goal of these con artists is to hack into our computers and smartphones. Click on one of their links, and you could pick up an unwanted cookie, computer virus, or even a “keylogger” that can be used to record your internet activity, usernames and passwords.

People who sign up for their newsletters by a providing their email address are also putting themselves at risk, not just for a deluge of spam, but for malicious programs such as a “trojan horse” they could download without even knowing it.

If you’re a Facebook member and you see these suspicious posts, what should you do?

• If you’re not familiar with the website, don’t share or “like” it. That only spreads the post like a virus to your friends and other groups. It’s also precisely what the spammers want you to do.
• If you see someone constantly sharing links to bogus websites, check the poster’s profile.  If they have only a few photos, no friends and just recently joined Facebook, chances are they are fake.
• If you’re an administrator and you see these bogus posts appearing in your closed Facebook group, you may have to start deleting offenders and close your group to new members until the problem stops.
• Report suspicious posts and posters to Facebook by clicking here.
• Keep your anti-virus software up-to-date and your firewall on.

If you’re feeling really adventurous, you can visit HypeStat, which I use to see how legit a website is.  Enter the website’s URL, click search and scroll down the page. You’ll see what country a website is registered in and how long they’ve been around. 

You might even run into the prolific Zafar Iqbal, who has apparently abandoned Duluth and is now writing articles about British Airways crews making peanut allergy announcements and how cannabis kills 30,000 people a year.  

Facebook has been a godsend for pain sufferers around the world seeking support, friendship, and solutions to their chronic pain issues. It’s a shame that others are taking advantage of the pain community — which is already under attack in so many ways, not just online. 

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Injuries, medication errors, expired food: ABC27 investigates county, state-owned nursing homes

http://abc27.com/2016/02/12/injuries-medication-errors-expired-food-abc27-investigates-county-state-owned-nursing-homes/

HARRISBURG, Pa. (WHTM) – ABC27 continues to investigate nursing homes after first reporting new, disturbing violations in Golden Living facilities.

Reports from the Department of Health over the last two years show violations and subsequent measures to fix problems in York and Cumberland county-owned nursing homes.

York County’s Pleasant Acres Nursing and Rehabilitation Center had the most violations. The last inspection made public happened in November.

The report says a resident fell out of his wheelchair and suffered a head injury. He started to have headaches, his pupils were not reacting to light, and his speech was garbled and slurred.

The nursing home notes say a doctor was notified two days after the fall, but the Department of Health says there’s no evidence of a doctor’s evaluation until nine days after the fall. That’s when the resident went to the hospital. Medical reports show he had a fracture.

Pleasant Acres Administrator Marlin Peck says after the Department of Health finished his inspection, his staff found evidence of the doctor’s evaluation from two days after the fall. It is standard practice for the department not to include documents found after the evaluation. ABC27 has not seen evidence of that evaluation.

In other reports, inspectors found “dried bowel movement” on a shower floor, a lack of evidence that some residents were bathed properly, a “medication error rate of 11.1 percent,” and in some cases, the facility flat-out not running tests that doctors ordered.

Inspectors also wrote about sanitary concerns in the kitchen in 2015  after they discovered some food in the pantry expired in 2011.

The Department of Health also wrote that the facility failed to provide care that “maintains or enhances each resident’s dignity and respect.”

That same violation was found in a July inspection of Claremont Nursing Home and Rehabilitation Center in Cumberland County.

Other reports showed the facility “failed to maintain effective infection control techniques.”

There was also a 2014 violation of failing to “maintain clean and sanitary rooms.”

Additionally, there was an incident in 2014 when a patient sat outside for several hours and later went to the hospital for “neurogenic shock and severe hypothermia.”

Claremont Administrator Raymond Soto says the facility has made a lot of progress over the last several months; he took over as administrator in August 2015. He says recent inspections have gone well, and the facility is expecting an improvement in its CMS rating as a result.

South Mountain Restoration Center is the state-owned facility in Franklin County. It was only inspected five times in the last two years, but a March 2014 report does show violations.

They include failing to “carry out staff drills using their emergency procedures and evacuation techniques.” The facility also “failed to document the number of residents moved to another location during each fire drill.”

Paperwork from the Department of Health shows those practices changed shortly after that inspection.

All the nursing homes involved say they’ve fixed the violations and are currently following state and federal regulations.

Get breaking news, weather and traffic on the go. Download the ABC 27 News App and the ABC 27 Weather App for your phone or tablet.

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I find this bill very interesting in the fact that the legislature has to specifically give civil immunity to a Pharmacist for the refusal to sell PSE to someone.  Once again, the legal system is forcing Pharmacists to “diagnose” a person’s need for a medication… which Pharmacists are not authorized to do under the Indiana Pharmacy Practice Act. Does this mean, under Indiana law that a Pharmacist can be held civilly liable for refusing to fill any legit/on time/medically necessary Rx ? Do other states have similar laws ?

EPHEDRINE OR PSEUDOEPHEDRINE (SMALTZ B) Requires the Indiana board of pharmacy (board) to adopt
emergency rules that are effective July 1, 2016, concerning: (1) professional determinations made; and (2) a
relationship on record with the pharmacy; concerning the sale of ephedrine or pseudoephedrine. Requires the board
to: (1) review professional determinations made; and (2) discipline a pharmacist who violates a rule concerning a
professional determination made; concerning the sale of ephedrine or pseudoephedrine. Allows the board, in
consultation with the state police, to declare a product to be an extraction resistant or a conversion resistant form of
ephedrine or pseudoephedrine. Specifies that a person who is denied the sale of a nonprescription product containing
pseudoephedrine or ephedrine is not prohibited from obtaining pseudoephedrine or ephedrine pursuant to a
prescription. Allows a pharmacist to deny the sale of ephedrine or pseudoephedrine on the basis of the pharmacist’s
professional judgment, and provides the pharmacist with civil immunity for making such a denial. Provides that a
purchaser who has a relationship on record with the pharmacy may purchase pseudoephedrine or ephedrine. Allows
the pharmacist to provide certain pseudoephedrine or ephedrine products to a purchaser who does not have a
relationship on record with the pharmacy or for whom the pharmacist has made a professional judgment that there is
not a medical or pharmaceutical need. Adds ephedrine or pseudoephedrine to the definition of “controlled substance”
for purposes of the Indiana scheduled prescription electronic collection and tracking (INSPECT) program. Removes an
expired provision. Makes technical changes.
Current Status: 2/8/2016 – Referred to Senate Corrections & Criminal Law
Recent Status: 2/8/2016 – First Reading
2/3/2016 – Referred to Senate
SB80

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