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.”

Filed under: General Problems | 1 Comment »

https://www.facebook.com/rcnelsoninc/posts/1695943083778273

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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H. 723 introduced to curb over-prescription of opioid medications in Vermont

https://vtdigger.org/2018/01/28/h-723-introduced-curb-prescription-opioid-medications-vermont/

News Release — Rep. Linda Joy Sullivan
January 26, 2018

Contact:
Rep. Linda Joy Sullivan (D) of Bennington-Rutland
House Committee: Commerce and Economic Development
LSullivan@leg.state.vt.us

Vermont Representative Linda Joy Sullivan (Democrat, Bennington-Rutland) announced today the introduction of legislation seeking to stimulate industry-wide self-regulation by and among pharmaceutical manufacturers, physicians, and physician-affiliated hospitals and healthcare entities to curb the over-prescription of opioid medications in Vermont.

Sullivan was joined by over 20 other Legislators from both parties in co-sponsoring the legislation.

The bill, H.723, would through the creation of a new private cause of action make all providers associated with the care of individual patients legally accountable for injuries shown to have been caused by violations of standards governing the prescription of opioids already existing under Vermont regulations.

This proposed legislation would engraft into Vermont statute law the core of what are now largely advisory physician/provider guidelines promulgated by the Vermont Department of Health relating to the prescription of opioids. Violation of what will become new statutory standards of care would, when shown to have contributed to and caused an opioid addiction and associated injury, permit the commencement of a private cause of action against physicians and healthcare providers associated with the patient’s care (and potentially even to manufacturers). The standards would not displace or supersede any of the existing rules and guidelines promulgated by the Department of Health.

The Problem:

The dramatic increase in the last 20 years in the prescription of opioid pain relievers (“OPR”) has led directly to a 9-fold increase in the numbers of persons suffering opioid addiction, has spawned a huge market for illegal non-prescription substitutes such as heroin and has contributed to the frightening opioid death rates associated with what the U.S. Centers for Disease Control and Prevention has called the “worst drug overdose epidemic in U.S. history.” “The correlation between opioid sales, OPR-related overdose deaths and treatment seeking for opioid addiction is striking.” A. Kolodny, D.T. Courtwright, C.S. Hwang, P. Kreiner, J.L. Eadie, T.W. Cark and G.C. Alexander. 2015. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. The rate of opioid addiction in Europe is a fraction of that experienced in the United States. There is significant evidence that the opioid epidemic in the United States has its roots first in marketing efforts by the pharmaceutical industry and second in the development of prescription-writing practices among U.S. physicians that are far less conservative than those followed in other parts of the world.

The bill seeks to encourage an industry-wide, self-policing solution to a crisis contributed to by the pharma / healthcare industry in the United States that to this day profits from enormously high US prescription rates and accompanying medically-assisted treatment protocols for those patients in recovery.

Elements of the Proposed Legislation:

The proposed Act would first adopt in statutory form core provisions of Rules 5 and 6.4 of the existing Vermont Rules Governing the Prescribing of Opioids for Pain (e.g., maximum dosage and durational limits for initial and subsequent prescriptions, and required re-evaluations of long term prescriptions for chronic care) and would adopt the essence of Rule 6 of the Vermont Prescription Monitoring system, requiring prescribers to check the system before prescribing opioids.

Creation of a Private Cause of Action:

The Act would permit a person aggrieved of violations of Vermont opioid prescription standards to commence a law suit for actual or statutory damages. Individual patients have had difficulties prevailing in negligence suits across the United States, in large part due to the difficulty in proving that “prescription malpractice” in fact caused the patient’s later addiction and injury. The burden of proving causation would under the Act remain on the person bringing the law suit. However, in cases where there has shown to have been repeat violations of the standard, a rebuttable presumption of causation would be established, requiring the prescriber to demonstrate that the inappropriate prescription practices did not result in addiction or to legal injury to the patient.

The Act would provide that:

1. Any person who demonstrates that he or she has subsequently, and as a proximate result of a physician/provider’s violation of one or more of the Act’s objective standards, developed an opioid dependency resulting in injury to that person, would be entitled to pursue a private cause of action. There would a three-year statute of limitations from the date of the physician’s violation.

2. In the event that a physician/provider is shown to have committed two or more violations of those standards, a rebuttal presumption would exist that the prescription malpracticewas the cause of the injury

3. In the event that there are three or more violations of the statute involving the same patient, exemplary (or “punitive”) damages could be awarded.

4. In the event that the action involves four or more violations committed by a physician in a 12-month period that involved the prescription, as to each violation, an opioid identified as produced and distributed by an individual pharmaceutical manufacturer, thatmanufacturer would be deemed liable jointly and severally liable without fault for the actual damages shown to have resulted.

5. In all cases, the physician’s employer and other affiliated entities (hospital, clinic,Accountable Care Organization (“ACO”), practice group etc.) would be jointly and severally responsible in any such action to the same extent as the physician.

The Need for Vicarious Liability and Manufacturer Strict Liability:

Most common law employers are legally, or vicariously, responsible for the misdeeds of their employees. A healthcare entity may be responsible directly for damages caused by its physician employee. The proposed Act would extend this concept of respondeat superior to care entities beyond common-law employers with which the physician / prescriber has an ownership interest in or other professional (patient-related) affiliation. That is, hospitals, practice groups, ACOs, clinics and other healthcare entities responsible in whole or in part for the care of the patient would also be legally responsible for the injuries caused by “prescription malpractice.” This provision of the Act is intended to promote internally within the healthcare industry collaborative, self-policing opioid prescription writing processes, protocols and training initiatives.

The Act would also impose liability on pharmaceutical companies without fault, provided that there are shown to have been four predicate violations involving the patient and a specific manufacturer-produced opioid within a 12-month period. While the pharmaceutical manufacturer may not have had actual knowledge of the inappropriate prescription practices, the Act is predicated on the concept that pharmaceutical manufacturers have immensely profited from the uptick in opioid prescription practices knowing that the distribution of their products was subject to inappropriate practices and excessive prescription-writing by individual prescribers. As such, the proposed Act would impose a form of “enterprise liability” based on a manufacturer’s having put into the stream of commerce — and into the control of a reasonable foreseeable class of negligent prescribers – a dangerous instrumentality.

Representative Sullivan acknowledged, “While this proposal is going to be opposed by manyhealthcare providers, we’re suffering an industry-created crisis that requires an industry-wide fix. We cannot continue to defer entirely to decisions made by individual physicians without some level of accountability within the healthcare industry as a whole.”

Sullivan emphasized that the prospect of liability at the entity level should encourage true internal industry oversight of individual prescribers. “The imperative to ‘heal thyself,’ can’t be limited to physicians. By imposing industry-wide accountability we might finally achieve meaningful prescription-writing protocols and internal safeguards and reviews.”

Sullivan added, “Remember, we would not be creating new standards. Vermont’s Department of Health has already adopted the standards on which a patient could seek to recover damages.” Sullivan also downplayed the likelihood of an onslaught of frivolous litigation. “A former patient would still have to charge and prove that he or she was injured because of the physician’s violations – given the nature of addiction that will in many cases be difficult and attorneys already have an obligation to certify that the allegations of injury and causation are made in good faith. However, the operation of a rebuttable presumption where there have been repeat violations, and the ability of a claimant to be awarded statutory damages, should permit greater access to the courts. That alone will provide a true incentive for practitioners to address this crisis in a meaningful – and truly effective — way.”

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http://www.therepublic.com/2018/01/28/01282018cr_coroner_testing/

New toxicology tests that provide revealing information on the fatal substances consumed by Bartholomew County overdose victims are a window to potential solutions, giving officials deeper insight into rapidly changing trends that will help address the epidemic on a law enforcement level and a policy response by government, the coroner’s office says.

They come at a cost, however, with the high-level testing costing $250 or more — three to four times more than a standard drug panel conducted at the local hospital, officials said.

Tests that the Bartholomew County Coroner’s Office have been conducting and chronicling for a year could become mandatory statewide in a bill approved by the Indiana State Senate last week. Senate Bill 139 passed in a 47-2 vote in the Senate, sending it to the House for consideration. If it were to become law, coroners would be required to obtain information about the deceased from INSPECT, Indiana’s prescription monitoring program.

Coroners would also have to extract and test certain body fluids and provide Indiana Department of Health officials with notice of the person’s death, along with test results and any information about the controlled substances involved. Indiana coroners would have to do this each time they suspect a cause of death to be an accidental or intentional overdose.

Bartholomew County has been conducting more extensive investigations and toxicology testing for suspected overdose deaths since the beginning of 2017. That resulted in a year-end report that documented that there were 30 confirmed overdose deaths last year, 26 of them opioid-related.

Coroner Clayton Nolting said the state’s idea to make that thoroughness a standard statewide is a great idea, but he questions where the money to pay for it would come from.

The deeper information is valuable, however, because it helps law enforcement, hospital officials and those involved in helping people understand what types of drugs are being used, they said.

Knowing that information can help police and first responders be more effective in reducing harmful drug use and overdoses, as the tests detail what types of drugs are being distributed and used locally.

By running the more extensive drug tests, Nolting and deputy coroner Jay Frederick have discovered that many overdose victims are dying after ingesting multiple substances, rather than just heroin or just fentanyl. Some Bartholomew County overdose victims are combining heroin with alcohol, fentanyl and hydrocodone, creating a lethal mix that lowers the person’s breathing rate so far that they die.

In-depth toxicology is far more expensive than a $70 standard toxicology panel at a local hospital. As the county coroner’s office works to determine a specific cause of death, tests that break down the type of opioid and its concentrations costs $200 to $250, Nolting and Frederick said.

To test for an exotic opioid — what is known as U-47700, carfentanil, Etizolam or other combinations being manufactured in drug labs — it’s another $135.

Nolting predicted that many of the smaller counties around Indiana will not have the money to run the kind of tests the bill might require.

“Those department will be blowing through their budgets by June or July,” he said.

Nolting returned to the Bartholomew County Council in December and received an additional appropriation of $14,016 for the 2017 budget after logging 145 death cases by the end of the year. Previous Coroner Larry Fisher had budgeted for the office to handle 115 cases last year.

The money covered expenses for autopsies, toxicology, labs, X-rays and other tests the coroner’s office utilizes, Nolting said.

“Our state is facing an opioid epidemic like we have never witnessed before,” said Senate Bill 139’s author, Sen. Jim Merritt, R-Indianapolis. “We cannot address individual communities’ needs without having the data to back up claims. Requiring coroners to record this information will increase the accuracy and specificity of Indiana’s drug overdose death data, which will help us in attacking this epidemic quickly and more effectively.”

Of course there was a report last year in the BOSTON GLOBE

Only 8.3 percent of those who died had a prescription for an opioid drug

where only 8.3% of OD’s had a legal prescription for at least one of the opiates that showed up in their toxicology.

And .. “Our state is facing an opioid epidemic like we have never witnessed before,” said Senate Bill 139’s author, Sen. Jim Merritt, R-Indianapolis. “We cannot address individual communities’ needs without having the data to back up claims. Requiring coroners to record this information will increase the accuracy and specificity of Indiana’s drug overdose death data, which will help us in attacking this epidemic quickly and more effectively.”

Sen Jim Merritt still hasn’t figured it out that we are dealing with a mental health issue and IT IS NOT CONTAGIOUS .. thus it can’t be a EPIDEMIC …

When they have a couple of years worth of data – at considerable expense – and the data point to the fact that the vast majority of OD’s are from illegal substances… go after the street dealers and leave all the addicts/substance abuser to fend for themselves… more house break ins, more pharmacy robberies and other criminal activities to allow them to deal with their mental health disease of addiction

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Mr.Ariens I have had a pharmacist that refused to fill a pain medication  that I’m on. My doctor has had me on a chronic pain management program for four years due to a horrible motorcycle accident, a car wreck, I was paralyzed 2 years ago and had to undergo surgery to remove pressure off of my spinal cord ,arthritis,  and the list truly goes on I’m told she violated my civil rights and was wrong is this true? How can a pharmacist override a doctor taking care of me for 40 years is she allowed

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Patty has MS, Crohn’s, severe spinal damage from an infection and is going to have major fusion surgery Feb 14th, 2018.  Her Part D Envisions RX company is requiring an ‘Opioid Safety’ form.  Patty has been caught between the company and her doctor’s office, as the company has said they haven’t received the paperwork.  However, the doctor’s office provided time/date stamped copies to her.  It has now been denied twice, although approved last month, and Patty has been stable on these medications (Opana ER and Hydromorphone, but they only approved the Hydromophone) for 11 months, and has been on daily opioids for 17 years.

Envisions RX is now sending it to a third party for approval, with the Clinical Director refusing to review the file.  The doctor’s office is insisting that everything has been done right.  Additionally, the doctor appears to think if he just changes Patty’s medication, it will get approved.  Patty is stable on her medication, and would the ‘Opioid Safety’ form would still be necessary.

According to your article ‘Using the PA Process to Deny Necessary Medication‘, Patty should talk to Medicare and file an ’emergency determination’ with Envisions RX and the third party company to receive an answer in 72 hours.  Patty had both these medications approved on Dec. 12th, 2017 which were pre authorized until Dec. 31st, 2018.  This “Opioid Safety’ form appears to just be a formality, as the medications have already been approved?  Furthermore, the Hydromorphone didn’t appear to need the safety form, just the Opana ER??  Patty believes the safety form is required for medications over 200 MME?

This situation has been extremely stressful for Patty.  Her sister was kind enough to pay for the outrageous $1400 for the Opana ER, but obviously can’t do that on a regular basis.  Patty is preparing for a very serious surgery, and the stress has increased her blood pressure to up to 223/138, which is extremely dangerous and they wanted to call the paramedics.  Since then, her blood pressure has continued to be dangerously high.  Can you please advise Patty with the details she should include in her 72 hour emergency appeal request?  Her number is xxx-xxx-xxxx and she is copied on this email, as well.

Thank you for all you do and publish for our pain community.  Without your knowledge and dedication, we would continue to drift even more. 

Filed under: General Problems | 2 Comments »

Hi Steve,

I found your article, dated 2014. Much has evolved since then regarding opioid medications. I wonder if you can offer me some guidance..

My new insurance company (Medical Mutual) has just denied my regular pain medication, Hydrocodone — which I take for a myriad of painful disorders, including a rare central nervous system disease which distorts my body and causes spasms in muscles, organs, lungs. My medical records span 30 years: I see 7+ doctors on a regular basis. There is abundant medical evidence of my chronic, severe, incurable pain.

I called the insurance company and was told, “A pharmacist has signed off on this.” They would not give me the pharmacist’s name.

My questions:

Am I entitled to a copy of this denial? (These insurance premiums are paid by my husband and his employer!)

How can a pharmacist decide what is best for a patient without reviewing medical records?

What can I do? How do I fight for myself against an all-powerful insurance company?

I have been on social security disability since 2006.

Thanks in advance,
So one of the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy – especially medication…  So apparently this “Pharmacist”  at this particular insurance company has self-anointed his/herself with the legal authority to change/deny a pt’s long term medication therapy. or someone at the insurance company (Medical Director ?) has given others the authority to practice medicine under his/her license ?

There are so many people within the health care industry that are bending/breaking all sorts of rules/laws… and all the authorities who are suppose to be upholding these various rules/laws are turning a blind eye to what is going on… 

Have you ever notice that on some roads where speed limits are poorly enforced… that fair number of drivers routinely driving way past the speed limits ?

Human nature being what it is… if people do things illegal without any consequences… they will continue down that same path or maybe expand the areas in which they break rules/laws… until some time that there are consequences

Filed under: General Problems | 1 Comment »