Opioid Rescue Therapy, Not Just A Quick Fix…

91 Americans lose their lives every day to opioid overdose, according to the Centers for Disease Control and Prevention (CDC).  That is over 33,000 Americans each year, and the rate is only rising, actually having quadrupled since 1999.  It is now accurately categorized as an Epidemic and, appropriately, stringent private and public institutional changes are being implemented to minimize the likelihood of future abuse.  This includes limited pill counts, prescription drug monitoring platforms, closed formularies, etc.  These improvements reduce the likelihood of future dependency, but what about those already dependent, the most at risk for potential overdoses.  What can we do about them?

The first answer: Keep them alive.  Enter the growing availability of Opioid Rescue Therapies.  Two of the most commonly prescribed are Narcan® and Evzio®.  Both medications utilize naloxone, an opioid antagonist, which can be a life-saving treatment in the case of an opioid overdose.  Rescue Therapies have become standard issue to police, emergency medical personnel, and recently have become available over-the-counter without a prescription at participating CVS Pharmacy® locations in 41 states. The reason: they work.

However, we cannot have Rescue Therapy serve as just a ‘Band-Aid’. Furthermore, the issues of cost need to be addressed. There are currently multiple formulations of naloxone available, the cost of which varies dramatically. Evzio® ($4,500.00) is a brand-name naloxone auto-injector that uses a pre-filled device with a voice-prompt providing direction for use. Conversely, Narcan® ($150.00) is a fast-action nasal spray that also provides two doses, but at a fraction of the cost.

Prescribing naloxone should be viewed as one step in a comprehensive opioid risk assessment strategy. Patients, prescribers, and loved ones should periodically question the opioid doses/regimen employed. Is it effectively reducing pain and improving function with minimal side-effects?  Could a lower dose provide similar efficacy with a reduced overdose risk?  Has weaning been tried recently?  Has an opioid rotation to a lower dose alternative or non-opioid pain reliever been trialed?

When further examining treatment, it is also important to consider additional risk factors, such as other medications employed and co-morbidities. For example, patients with COPD or sleep apnea or who are prescribed opioids in conjunction with central nervous system (CNS) depressants such as diazepam or clonazepam are at a significantly increased risk for overdose.

While the decision to prescribe naloxone can be a necessary emergency step, it is important it be viewed as a window of opportunity for patients and prescribers alike to address the current medication regimen, while ensuring the most cost-effective naloxone formulation is easily accessible for the patients who need it most.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/opioid-rescue-therapy-not-just-quick-fix/

Exorbitant Price Increases in Workers’ Compensation

Sudden and exorbitant drug price increases in recent years have brought the annual cost of treatment for some patients to hundreds of thousands of dollars, and have forced others to go without, sparking outrage throughout the United States.

Price increases involving critical, life-saving drugs like EpiPen® and Daraprim® have been labeled “outrageous”, “predatory”, and “price gouging” events that solely drive drug company profits. The example of Daraprim®, a medication that had been available for 63 years yet had a 5,000% price increase in a single day, was so shocking it sparked a U.S. Senate special investigation and report. While drug price spikes involving prescriptions used in the group health setting have been widely covered in the press, unfortunately, the same pricing trend has occurred with several drugs used in the pain management setting for Workers’ Compensation injuries. The following chart contains three such examples:

Vimovo®: This brand-name combination NSAID/PPI was historically manufactured by AstraZeneca for approximately $2/capsule. However, in January 2014 the rights to manufacture Vimovo® were sold to Horizon Pharma, which increased the cost, overnight, to $16/capsule (a 700% price increase). Horizon has since increased the cost of Vimovo® on a regular basis with a current, exorbitant price of $2,710.90 ($45.18/capsule).

Pennsaid®: The price of this is topically applied NSAID was increased by 480% in one day in January 2015 by Horizon Pharma. Since that time the cost has risen even further to an excessive $2,716.02 per prescription.

Levorphanol: This “generic” opioid has only one manufacturer, Sentynl Therapeutics. Given they are the sole generic manufacturer of levorphanol, they have increased the cost by an astronomical 2,959% since 2011, currently charging nearly $50 per tablet.

If, in this financially turbulent pharmaceutical environment, you find patients on inordinately high-priced mediations such as Vimovo®, Pennsaid®, or levorphanol, often the prescriber is not aware of the exorbitant cost of these products and/or the safe, effective treatment options available. While primary consideration should always be clinical efficacy, having an open, transparent discussion with the prescribing provider about these unfortunate realities can only be of benefit to all parties with a vested interest in the outcome of care.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of  and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/exorbitant-price-increases-workers-compensation/

Saving Billions with Collaboration

Medical misdiagnoses happen. However, a recently released report shows a staggeringly-high incidence: As much as one-fifth of claims involve diagnosis errors that are extending the treatment of injured workers and costing the workers’ comp system billions.

Stunning Numbers

The 10-year study, conducted by Boston medical consultation service, Best Doctors, uncovered in an estimated 250,000 workers’ comp injuries 21% involved misdiagnosis and/or inappropriate medical treatment. In the most expensive top 5% of claims, error rates were estimated to jump as high as 50%. Cumulatively, these errors can add up to as much as $15 billion of the estimated $65 billion in workers’ comp claims expenditures annually nationwide.

Added Complications

Language barriers and misunderstandings may increase complications. Treatments take a wrong turn, sometimes resulting in the prescription of dangerous opioids and unnecessary treatment plans, increasing subsequent costs. Managing Director of Best Doctor Occupational Health Institute, Michael Shor, indicated that such findings remain consistent among all areas of the medical profession.

Blame?

It is irresponsible and simply wrong to place the blame on any one entity or component. It is critical to remember that medical professionals make every effort to ensure treatment is appropriate and that their patients receive the highest level of care available. But they are human, just like the injured workers, case managers, and insurance employees.

How to Improve

The first step in preventing the physical, emotional, and financial tolls of diagnoses errors that result in prolonged disability and jeopardized careers is simple: Collaboration. Essential to quality of care, particularly in complex cases, the collaborative effort of medical personal with employers, patients, carriers and workers’ comp case managers can provide improved quality assurance and help prevent these issues. Peer review of diagnoses and second opinions can likewise reduce issues at the pass, putting injured workers on a better path, circumnavigating unnecessary costs and extended recoveries.


About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/savings-billions-collaboration/

Can Technology Help?

State and local governments collect a lot of health data, but as it turns out, there are many roadblocks to putting that data to its highest and best use. Building a bridge, however, could create the potential for its use in battling the U.S. opioid epidemic, which is taking its toll in every corner of the country, across all ages and socioeconomic backgrounds. Just how could digging a little deeper into this data help to uncover the hidden facets of this epidemic?

Mining for Gold

Law enforcement, the healthcare sector, and human services collect a wide assortment of data when it comes to opioids, tracking sales through prescription drug monitoring programs, post-addiction treatment, overdoses, and deaths. While this data sometimes helps identify doctor shopping and over-prescribing, it does little to thwart addiction. Typically, little information is shared with other entities, or nationally, except as required by law. However in a few states, this data is being used for a higher purpose – compiled into a richer picture of the crisis in the hopes of taking control via a proactive, not reactive approach to the crisis – and neighboring states are taking notice.

Imitation is the Highest Form of Flattery

In Indiana, the state recently rolled out an opioid ‘crime dashboard,’ compiling data on overdoses from area health professionals and forensic labs. Used to deploy law enforcement, it is helping deliver aid to the areas hardest hit, ensuring enough anti-opioid prescriptions on-hand to counter the effects of the drugs and save lives. Massachusetts is now engaging in a similar attempt with their own available data.

Stepping Things Up a Notch

Bridging the divide between states, technological firms are also stepping-in – and stepping things up in the communications arena, to join forces nationwide. Meeting in Portland for a panel discussion, companies such as Massachusetts-based company Biobot Labs, whose human waste analytics can determine where drugs are being abused in particular areas, are teaming-up with others such as Chicago-based Triggr, designer of data-driven, personalized addiction-recovery systems that combine a mobile app with human interaction to identify and thwart relapse, and looking to ways their diverse skill and data sets can contribute to fighting the epidemic. The end goal? Making the shift from thwarting fatal overdoses, to that of early detection and overdose prevention.

Tearing Down the Walls

As history has shown in this epidemic, simply collecting and storing relevant data is not enough. Data must be better analyzed and integrated to produce positive results. Future collaborations such as these will be integral in making impactful decisions and better allocating resources. Multi-stakeholder organizations – a joint committee or joint taskforce – will be key, as no network yet exists between state and local governments. Law enforcement, alongside the healthcare and IT arena must work together to breakdown current barriers, unifying – not isolating – via a cohesive strategy. Though this will be no small task, the sharing of such data on a national level is crucial. If the trend continues, tens-of-thousands of American lives could depend on it in the coming years.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.

Original content posted on http://ans-solutions.com/can-technology-help/

Government Struggles to Hold Opioid Manufacturers Accountable

For the first time ever, the U.S. DEA targeted a prescription drug manufacturer for their role in black market opioids and damages incurred. Mallinckrodt Pharmaceuticals, one of the largest national manufacturers of the highly addictive generic painkiller oxycodone, one of the leading drugs responsible for the more than 15,000 overdose deaths in 2015, was accused of shirking its responsibility to report suspicious drug orders.

Who’s to Blame For The Opioid Epidemic?

Created at Mallinckrodt’s Hobart, NY facility, oxycodone shipped via its distributor network, including KeySource, Sunrise Wholesale and Cardinal Health, who later supplied the pills to retailers, including pharmacies and hospitals accused of illegally diverting the drugs. Discovered in a 2009 Tennessee Drug Task Force sting and linked back to Mallinckrodt’s distributors Florida retailers, 2010-2011 DEA investigations uncovered large amounts of Mallinckrodt oxycodone – such as the 41 million KeySource Medical oxycodone tablets delivered to Florida retailers in 2010 – about 2.5 pills for every man, woman and child in the state. Accused of splitting orders to conceal shipment amounts, KeySource was ordered by the DEA to halt, later relinquishing its distribution license. Distributors Sunrise Wholesale and Cardinal Health likewise delivered vast quantities of Mallinckrodt’s oxycodone to pharmacies in Florida. 500 million Mallinckrodt pills ended up in Florida from 2008-2012 — 66% of state oxycodone sales. A 2011 subpoena following this the discovery further revealed, 6 weeks after the Tennessee task force alerted Mallinckrodt to the drugs found in the 2009 sting, Mallinckrodt shipped another 2.1 million tablets their Sunrise distributor, 92,400 tablets of which were sold to Dr. Barry Schultz, the Delray Beach doctor whose oxycodone was found in Tennessee. Schultz was later convicted of drug trafficking and manslaughter (for a related overdose death). In one day, he prescribed 1,000 tablets to a single patient. Ultimately, the DEA and federal prosecutors alleged Mallinckrodt ignored its responsibility to report suspicious orders, in violation of the Controlled Substances Act.

Shirking Responsibilities?

Under federal law and DEA policy, pharmaceutical companies are required to “know their customers,” monitoring amounts, frequencies, and patterns of drug orders, immediately notifying the DEA of suspicious activity – or risk losing their license to manufacture and sell controlled substances, as well as civil and criminal penalties. Though Mallinckrodt maintained publicly the company has worked hard to fight drug diversion, internal case summaries prepared by federal prosecutors indicated Mallinckrodt’s response was that ­‘everyone knew what was going on in Florida but they had no duty to report it.’ Sources familiar with settlement talks indicated Mallinckrodt acknowledged its responsibility to report suspiciously large orders, but contended the DEA did not require manufacturers to know about (or be responsible for) ‘their customers’ customers,’ further pointing to conflicting DEA advice as to legal responsibilities. Prosecutors considered a whopping 43,991 unreported orders from distributors and retailers suspicious.

Uncharted Waters

Appalled by the rising opioid death toll, the DEA’s push to hold drug manufacturers accountable was hoped to be a wake-up call, putting the industry on notice for its responsibilities in the diversion of drugs to the black market. Instead, after years of industry investigations spanning five states to build the massive case, the results mirrored the DEAs previous attempt to hold wholesale distributors accountable. The case stalled. Fierce company resistance and intense lobbying efforts may have played a role in the lack of legal action pursued. The case settled for $35 million in fines and no admission of wrongdoing.

Small Potatoes

The proposed settlement, a mere fraction of the 44,000 federal violations pointed to in the investigation which could have cost the company $2.3 billion in fines, amounts to small potatoes for a company that posted $3.4 billion in revenue and $489 million in profit in 2016. In a later February 2017 SEC filing, Mallinckrodt even noted the investigation “will not have a material adverse effect on its financial condition” because it had set aside the funds.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.

SOURCES:
https://www.washingtonpost.com/graphics/investigations/dea-mallinckrodt/?_hsenc=p2ANqtz-9DxkF3wbuslmavvDf3o8CSw_0KLDObRAx7Ah4JgQ2Vi7_84yvAVhoUcmcpQyMQ-LDuL7935zGFyhc7J8njQ-cALSVCEg&_hsmi=51277531&utm_campaign=Rx%20Summit&utm_content=51277531&utm_medium=&utm_source=hs_email&utm_term=.ebaec91ff136
http://www.reuters.com/article/us-mallinckrodt-settlement-idUSKBN1751JM
https://www.opensecrets.org/lobby/clientsum.php?id=D000022900

Original content posted on http://ans-solutions.com/government-struggles-to-hold-opioid-manufacturers-accountable/ 

Can States Surpass Federal & Address Big Pharma?

With some states and areas across the country on the receiving end of opioid painkiller prescription shipments that outnumber the people housed therein, state officials are beginning to address the link between the opioid crisis, Big Pharma, and the heavy burden weighing on their municipalities. In an attempt to hold Big Pharma accountable, they’re taking a page out of past lawsuits against tobacco companies – and suing them.

Key Players

Until now, these multibillion dollar companies have been sidelined in the fight against the opioid epidemic. Now they’re being looked at as star players by city, county, state, and federal officials – even the DEA has taken notice, responding in-kind. This year, in a push to hold opioid manufacturers and distributors responsible, multiple lawsuits have been launched…

States Join Forces in the Fight Against Opioids

Taking the lives of 40 Americans each day, the total economic burden of prescription opioid overdose is costing the country $78.5 billion per year – and these states are taking action…

• Missouri
  Most recently, Missouri’s filed suit against 3 opioid manufacturers, alleging a deliberate campaign of fraud to convince doctors and the public against the highly-addictive, life-threatening potential of the drugs.
• Mississippi
  Suing Purdue Pharma and 7 others, Mississippi lawsuits are borrowing tactics used in their successful fight against tobacco companies in 1998, alleging companies misrepresented the dangers of opioids to doctors and patients, marketing the drug as rarely addictive, and a safe substitute for non-addictive pain medications like ibuprofen or naproxen. But pharmacy companies don’t want the suit to go through – not until FDA-ordered studies on long-term risks/benefits are completed, which could take several years.
• Ohio
  Ohio filed suit against multiple manufacturers for false advertising, Medicare fraud, and violation of the Ohio Corrupt Practices Act, claiming the companies knew (or should have known) their drugs weren’t safe or effective.
• Illinois
  Illinois is taking part in multi-state investigations into manufacturers, with 2 lawsuits in-play. One against Insys, for the deceptive marketing of highly-addictive Subsys for the off-label treatment of back and neck pain in efforts to gain huge profits. Another, an anti-trust suit against the makers of Suboxone, used to treat opioid addiction, alleging a scheme to block generics to artificially inflate prices.
• East Tennessee
  Prosecutors representing 9 counties are taking aim at Big Pharma using the Tennessee Drug Dealer Liability Act, or ‘crack tax’ law. Designed to hold dealers criminally and financially responsible for the effects of the drugs they distribute, the suit labels drug makers as dealers, further accusing them of lying about the addictive properties of opioids, aggressively pushing them as miracle cures for all types of pain. The state AG is investigating its options in pursuing its own legal action.
• New York
  8 NY counties have joined in seeking compensation for expenses caused by the state’s growing drug problem, alleging marketing omitted critical information about the addictive nature of the drugs and risks associated with long-term use.
• Everett, Washington
  They city of Everett filed suit against Purdue Pharma, makers of OxyContin, alleging the company was intimately aware its drug was being funneled into the black market, yet did nothing.

Distributors Sinking, Similar Challenges Against Manufacturers Possible 

CVS, Walgreens, Walmart, McKesson, Cardinal Health, KeySource, Sunrise Wholesale and more are facing charges and paying fines – sometimes multiple times. Some suits have settled. Others have resulted in criminal convictions. Could Big Pharma be next? Though manufacturers vigorously reject the argument they’ve fueled the current opioid crisis, it’s hard to ignore the overdose deaths – more than 300,000 since 1999. But opioids (opium, morphine, heroin) have been around, literally, for centuries, and their highly-addictive properties well-known.

More Lawsuits On the Way

Lawyers currently working these cases note a growing number of jurisdictions showing interest. States are joining forces in the current investigation, with dozens more lawsuits expected. The ultimate hope? That if enough attorneys general are able to join forces in bringing suits, they can accomplish what the federal government has been unable to… And snowball the lawsuits into a massive settlement that might finally put an end to practices that have fueled the deadliest drug overdose crisis in U.S. history.

About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ compensation insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.

Sources:
https://www.vox.com/policy-and-politics/2017/6/7/15724054/opioid-companies-epidemic-lawsuits
https://www.theatlantic.com/business/archive/2017/06/lawsuit-pharmaceutical-companies-opioids/529020/
https://www.levinlaw.com/government-opioid-lawsuit
https://www.washingtonpost.com/national/the-drug-industrys-answer-to-opioid-addiction-more-pills/2016/10/15/181a529c-8ae4-11e6-bff0-d53f592f176e_story.html?utm_term=.a364db6d5fe7

Original content posted on http://ans-solutions.com/can-states-surpass-federal-address-big-pharma/

How Does Doctor Shopping Impact The Opioid Epidemic?

Surprisingly, the non-medical prescription of drugs, including opioids, continues, with only states holding legislation against this dubious practice smothering the flames helping stoke the opioid addiction fire. Since 1999, deaths from prescription opioids have quadrupled, alongside opioid sales of painkillers such as oxycodone (Oxycontin) and hydrocodone (Vicodin). But this hasn’t stopped opioid abusing patients from trying to nab a couple of extra pills by ‘doctor shopping,’ the practice of hopping from physician to physician and playing the numbers until finding a doctor who will meet the patient’s desire for a few extra pills. Luckily states nationwide, alongside the insurance and healthcare community, are becoming increasingly aware of these issues, and are attempting to stem this contributing facet of the epidemic through the use of prescription drug monitoring programs (PDMPs). And a new study has shown them astonishingly successful.

An Easy-to-Use, Effective Means of Curbing ‘Doctor Shopping’

Physicians utilizing these state-run electronic prescription databases, mandatory in some states and voluntary in others, offers them access to each patients prescription history, and the opportunity to see drug types and quantities prescribed to patients before breaking out the prescription pad. In addition to thwarting potentially deadly drug interactions and excessive dosages, a recent study has shown that these programs are highly effective for reducing the non-medical prescription of drugs, boasting a whopping 80% reduction in the odds two (or more) doctors would dole out pain relievers for non-medical reasons to a single patient in states with mandatory PDMP use, and slashing the odds 56% in states with voluntary participation. Every state except Missouri now has one of these programs. Other studies have also shown states tracking a wider range of potentially addictive medications and updating databases weekly witnessed the biggest reduction in overdose deaths.

Won’t Patients Turn to Illicit Substances?

Public health advocates have had this worry for quite some time, but the current study pointing to the massive, 80% reduction in non-medical prescription of opioids in those states with mandatory programs also uncovered some reassuring news. PDMPs did not, in fact, lead to an increase in doctor shopping individuals turning to heroin. This offers hope for the promise of PDMPs as part-and-parcel of a multifaceted, comprehensive strategy toward fighting the nation’s opioid epidemic, which steals the lives of 91 Americans each day.


About the Author: Anthony Sambucini is a founding principal and the Chief Executive Officer of ANS Solutions. Anthony specializes in bridging the goals of clinical innovation and business strategy that have helped propel ANS Solutions into a national leader in Pharmacotherapy Review Services for workers’ comp insurers and ANS Pharmacotherapy Review Program is the most advanced, results-oriented drug utilization review program in the industry. As a consultant to insurance carriers and attorneys, Anthony customizes services based on the particular needs of the client and oversees all activities related to business development and company operations. For more information about ANS Solutions visit http://ans-solutions.com/.


Original content posted on http://ans-solutions.com/how-does-doctor-shopping-impact-the-opioid-epidemic/