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Dr Thomas Kline: Myth 9: Milligram phobia “this is way too much”
Posted on January 19, 2020 by Pharmaciststeve
South FL: transitioned from “pill mills” to untold number of questionable “sober houses”
Posted on January 17, 2020 by Pharmaciststeve
Opioid Treatment Scam May Be Coming to Your State
FREDERICK, Md. – Donna Johnson, a working mother of four who lives in a quiet upscale neighborhood in suburban Maryland, is determined to thwart an insidious addiction treatment scam that’s spreading across the country.
It ensnared her son, then 21, in Florida five years ago when he was desperate for treatment for his addiction to opioid painkillers and heroin —and she was desperate to get him help.
Prompted by a man whom Johnson met online, she agreed to sending her son to South Florida, where he cycled through more than two dozen sober homes and treatment facilities over four years, receiving little actual therapy. He relapsed every time he was discharged, only to be picked up by another facilitator and admitted to another sober living program.
Now, Johnson fears that some of the same people who preyed on her son are setting up shop in Maryland, and she wants state elected officials to outlaw the deadly business scheme before it takes root.
Florida enacted an anti-kickback law in 2017 that gave police the authority to crack down on drug treatment fraud, and since then, similar laws have been enacted in Arizona, California, New York, Tennessee and Utah.
Here’s how the scam works: Seemingly caring people join recovery-related online chat groups, answer addiction hotlines advertised online or show up at fundraisers for addiction recovery. They typically say they’re in recovery themselves and are therefore uniquely qualified to help.
People with addiction and their families often don’t want to ask their doctors or pastors for help because they’re ashamed and want to hide their illness. So, turning to a stranger can be appealing.
To attract victims, “patient brokers,” as the scammers are known, typically offer free airline tickets and pocket money, according to prosecutors. They waive insurance deductibles and copays and tout the camaraderie and beach life the patients will enjoy in a place such as Florida. Parents, relieved that their son or daughter has finally consented to treatment, are eager to go along.
Past legal cases show the brokers can make initial commissions of as much as $2,000 per patient — and then rake in additional fees when they re-enroll the same patients after they relapse.
Opioid Treatment Programs Gear Up to Provide Suicide Care
Within two to four weeks of a patient checking into a sober home where treatment is subpar or nonexistent, insurers may stop paying claims under standard protocols for that type of service, and the fraudulent operators dump their young clients on the street, prosecutors say.
That’s when the shuffle begins.
The patients, mostly in their 20s, typically start using drugs again, sometimes aided by cash they’ve received as a goodbye gift from the treatment provider. Some die of an overdose because their tolerance for the powerful drugs has plummeted. Many become homeless.
Others might be picked up by a friendly recruiter who helps them get into another sober home, where their insurer is obliged by recent federal laws — the Affordable Care Act of 2010 and the Mental Health Parity and Addiction Equity Act of 2008 — to start paying again after they’ve relapsed.
Past cases show that the cycle can continue until the insurance company stops paying on the patient’s 26th birthday, when the Affordable Care Act allows insurers to drop dependent care coverage under a parent’s policy.
For Johnson, one of the first clues that something was amiss with the addiction treatment center she sent her son to in Florida was a $13,000 charge to her insurance company for drug testing that her son said he never received.
Excessive numbers of urine drug tests and widely varying prices for them are just part of the insurance fraud schemes perpetrated by many of the same operators who pay patient brokers to deliver customers, prosecutors say.
In Maryland, state Rep. Karen Lewis Young, a Democrat who represents Frederick, is drafting a patient brokering bill that she plans to propose in the next legislative session with Republican cosponsor Rep. Jesse Pippy, she told Stateline in an interview. The idea for the law, she said, came from Johnson.
“These marketers are looking for young people with good insurance and vulnerable parents who want to do anything they can for their children. They’re targeting them,” Young said.
“Who could be against outlawing patient brokering?” she asked.
Model Law
Dave Aronberg, the Palm Beach County, Florida, state attorney known for the nation’s first crackdown on patient brokering in 2016, said he and assistant state attorney Alan Johnson have been talking to advocates in Georgia, North Carolina, New Jersey, Ohio and Pennsylvania about enacting similar laws in their states.
They also worked with California officials to help craft a patient brokering law enacted there last year.
Initially, advocates for people with addiction opposed California’s law, worried it could be used to discriminate and concerned it could dampen a much-needed expansion in the addiction treatment business.
Local property owners said the bill didn’t go far enough to restrict the sober homes that were proliferating in their neighborhoods. And treatment companies and their attorneys wanted to make sure that handing out small freebies to their patients wouldn’t get them in hot water.
By describing how the patient brokering law worked in Florida, Aronberg and Johnson said, they were able to illustrate that the California law would improve the health and safety of people with addictions, while boosting relations between sober homes and their surrounding neighbors.
Aronberg also testified before Congress as it developed a 2018 federal anti-kickback law aimed at the addiction treatment industry.
In July, the National Alliance for Model State Drug Laws, which is funded by the U.S. Department of Justice, released a template for a patient brokering statute based on Florida’s 2017 law.
“We’re seeing patient brokering and other unscrupulous forms of marketing show up all over the country now,” said Gary Tennis, president of the model drug law group.
“Even if it hasn’t hit your state yet, it’s coming,” he cautioned. “States need to be prepared with the right tools to combat it.”
The federal anti-kickback law only applies to federal health care programs and is not broad enough to address the full range of false marketing, insurance fraud and patient brokering that is occurring in the industry, Tennis and others say.
According to Aronberg, Palm Beach County police have arrested 95 allegedly fraudulent treatment operators and patient brokers in the past two years. The arrests and investigations, along with the local media attention they have garnered, have stanched the flow of vulnerable, young drug-addicted patients to South Florida, primarily from out-of-state, he said.
As a result, drug overdose deaths in Palm Beach County declined from 647 in 2017 to 400 in 2018, nearly a 40% drop, according to the state’s medical examiner.
Aronberg stressed that states need to take a multi-layered approach to beating addiction fraud. In 2017 and 2018, the Florida Legislature appropriated roughly $300,000 to help create a sober home task force to improve law enforcement strategies, develop new treatment industry ethics policies and inform the public about addiction treatment fraud. Those groups have been invaluable, he said.
“Forcing the addiction treatment industry to change its marketing approach made a huge difference,” Aronberg said. “That’s what lured unsuspecting people down to South Florida to ostensibly go through rehab.
“More than 75 percent of Palm Beach patients came from out of state, only to leave in an ambulance or a body bag,” he said.
“We believe we’ve cleaned up well over a majority of the problem here. Unfortunately, some of it has moved to other states,” he said. “Florida may now be the safest place you can send your loved one for treatment.”
Supply and Demand
In an opioid epidemic that is killing at least 130 U.S. residents every day, the demand for addiction treatment started rising sharply about a decade ago.
And with private insurers newly required to pay for behavioral health services to help people quit, the addiction treatment industry started booming.
The drug treatment industry became fertile ground for fraud once insurance money started rolling in, because unlike the rest of the medical profession, it historically had consisted of mostly small companies whose owners were in recovery themselves and were only lightly regulated by federal or state licensing and accreditation agencies, explained Peter Thomas, quality assurance officer for the National Association of Addiction Treatment Providers.
“In the past, most treatment providers were in the business because they wanted to help others, not because they wanted to make money,” Thomas said.
In the past several years, though, investors who cared more about profits than patients have gotten into the business, he said. Insurance companies were taken advantage of and by 2016, they responded by tightening up their claims processing and authorization procedures, Thomas said.
“These changes have also challenged ethical treatment providers. But the scrutiny will be worth it if it weeds out the bad actors.”
Insurance providers argue that addiction treatment fraud not only puts patients’ lives in danger, but that it also raises overall health system costs and increases premiums for everyone, not just those sent to sober homes.
“These ‘sober homes’ are often associated with providers that do not provide evidence-based addiction treatment, frequently bill excessively for urine drug screening tests, and may be fraudulently billing multiple insurers for one patient’s services,” said Cathryn Donaldson, communications director for insurance industry trade group America’s Health Insurance Plans, in a statement to Stateline.
“Even more alarming, there are reports of ‘sober homes’ that may perpetuate access to drugs that keep people addicted rather than assisting them in recovery, exacerbating the crisis,” she said.
Helping Hand
Addicted since he was 17 after taking the opioid painkiller Percocet at a party, Marc had completed a 28-day intensive residential treatment program at a Maryland addiction center. But soon after he left treatment, it became clear he needed more help.
In an online group called The Addict’s Mom, Johnson found a young man who told her he was in recovery and would be willing to help her son get the treatment he needed. He told Johnson he’d look after her son and even gave him a free plane ticket to Florida.
“He seemed genuinely concerned about Marc, so I trusted him,” Johnson said. “He promised me he wouldn’t leave him on the street.”
But that’s exactly what happened.
Johnson had heard about fraudulent treatment centers in Florida that discharged kids when their insurance ran out, leaving them with nowhere to live and vulnerable to relapse.
But back then, she said she put too much trust in what she now realizes was a patient broker, and she didn’t fully understand how the scam worked.
Now she does. And she’s educating anyone who will listen, including state lawmakers, local county officials and state agencies.
Johnson’s son moved in and out of Florida treatment centers for four years and then got recruited to a California rehab center. That’s when Johnson intervened and brought him back home.
When Johnson talks to Maryland government officials and parents, she shares her worries that some of the charlatans she and her son encountered in Florida have moved to other states and may be running the same kind of scams there.
“I feel like I’m starting to make progress,” Johnson said on a recent warm afternoon as the sun poured through her office window.
“There are days when I can’t look at my computer or even engage with anyone on the phone. But that’s usually only for a day, and then somebody will call and I’m right back at it.”
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The DEA made more than 8,850 seizures worth $539 million in 2017
Posted on January 17, 2020 by Pharmaciststeve
Lawsuit: DEA seizes father’s life savings at airport without alleging any crime
A woman who was attempting to transport over $82,000 of her father’s life savings on an airplane had the cash seized by the Drug Enforcement Administration (DEA) without any crime being alleged, according to a lawsuit filed Wednesday.
The Washington Post reports that the cash belonged to 79-year-old Terry Rolin, who saved it up over his lifetime. His daughter, Rebecca Brown, told reporters that he was aging and worried about keeping so much cash on hand, so he asked her during one of her visits to open a joint bank account. Brown said was catching a flight home from Pittsburgh to Boston the next day and didn’t have time to stop at a bank, so she planned to bring the money in her carry-on.
The incident occurred at the Pittsburgh International Airport on Aug. 26.
Brown said that while she was going through a security checkpoint, the cash showed up on a security scan and she was questioned by agents with the Transportation Security Administration (TSA). After explaining that the money was her father’s life savings, she was allowed to proceed to the gate.
At the gate, Brown was confronted by a DEA agent who subjected her to additional questioning before insisting that she put her father on the phone to confirm the story. Brown said that her father, who suffers mental decline, was unable to verify some details.
“He just handed me the phone and said, ‘Your stories don’t match,’” Brown told the Post. ”‘We’re seizing the cash.’“
Once on the plane, Brown said she frantically called her father and left seven messages trying to explain what happened.
The lawsuit says Brown was never told that her or her father were under suspicion of committing a crime–there is no limit to the amount of cash passengers on domestic flights in the US can carry. A search of her bag at the airport turned up no contraband. According to the Post, neither she or her father have criminal records.
In October, Brown received a notice that the DEA would permanently seize the cash, saying it would be used to combat crime.
The federal, class-action lawsuit was filed against the DEA, TSA and agency officials, claiming the agencies violate the Constitution’s ban on unlawful search and seizures by taking cash without probable cause. It seeks the return of Rolin’s money totaling $82,373 as well as an injunction against the practice.
“This is something that we know is happening all across the United States,” said Dan Alban, a senior attorney for the Institute of Justice, which filed the lawsuit on behalf of Brown and Rolin. “We’ve been contacted by people who have been traveling to buy used cars or buy equipment for their business and had their cash seized.”
The practice is known as civil asset forfeiture, in which law enforcement agencies have the power to seize cash and property that they assert has been involved in criminal activity. The owner of the property doesn’t even need to be found guilty of a crime for their property to be seized.
According to the Post, The DEA made more than 8,850 seizures worth $539 million in 2017.
Both the DEA and TSA declined to comment on the lawsuit.
Brown explained to reporters that her grandparents kept their savings in cash because they lived through the bankruns of the Great Depression, and her father picked up the habit.
Brown said that her father’s loss of savings has prevented him from getting treatment for tooth decay and gum disease, and prevented the family from fixing his pickup truck, which is his only means of transportation.
“I get they are trying to quash drug distribution, but this is a blatant overreach,” Brown told the Post. “This is a working person, a taxpaying citizen of the United States trying to take care of her elderly parent, and they took the money.”
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A Key to a Successful Mediation – Hiring the Right Mediator
Posted on January 16, 2020 by Pharmaciststeve
Whеthеr уоur legal dispute involves a personal injury case, wrongful death case, insurance claim, family law, divorce, child custody (click here to get lawyers helping obtain child custody), оr child support case, уоu ѕhоuld strongly consider mediation tо attempt tо resolve уоur legal dispute thrоugh settlement, but Jensen divorce requirements is an important step if you’re following legal procedures.. If уоu hаvе аn attorney representing уоu, mediation wіll probably bе discussed durіng thе pendency оf уоur case. Yоu ѕhоuld tаkе a lead role іn assisting уоur attorney durіng thе process оf selecting a qualified аnd experienced mediator іn order tо optimize уоur chance оf successfully resolving уоur legal dispute. The Yaffa Family Law Group can help couples have an amicable divorce.
Definition оf Mediation
Mediation іѕ аn effective alternative dispute resolution method bу whісh parties tо a legal dispute agree tо hire a neutral thіrd party tо serve аѕ thе mediator. Thе mediator’s role іѕ tо learn thе facts оf thе case аnd arguments оf аll parties, tо promote communication bеtwееn thе parties, аnd tо facilitate thе parties wіth respect tо formulating a potential settlement оf thе legal dispute. Thе mediator remains neutral аnd ѕhоuld nоt provide legal advice tо thе parties.
Wіth respect tо аlmоѕt еvеrу civil lawsuit filed іn State Courts іn Texas, Judges wіll order thе attorneys аnd thе parties tо mediation prior tо trial. Hоwеvеr, thе process іѕ non-binding, meaning thаt уоu mау choose tо settle уоur case, оr alternatively, уоu mау choose nоt tо settle уоur case аnd proceed wіth уоur case іn Court. Nо оnе саn force уоu tо settle уоur case durіng mediation.
Whеthеr уоur legal dispute involves a civil lawsuit, a dispute іn whісh a lawsuit hаѕ уеt tо bе filed, аnd whеthеr оr nоt уоu hаvе аn attorney оr аrе representing уоurѕеlf, mediation саn bе used tо attempt tо resolve thе dispute wіth thе opposing party.
Goals оf Mediation
Thе purpose оf mediation іѕ tо provide thе parties a safe setting іn whісh settlement negotiations саn tаkе place аnd іn whісh a neutral thіrd party mediator саn assist thе parties іn exploring аnd facilitating potential settlement. Thе mediator ѕhоuld ensure thаt thе parties mediate іn good faith, meaning thаt еасh party agrees tо engage аnd participate іn thе process.
An effective mediator ѕhоuld accomplish thе following:
1. Preparation – properly prepare fоr thе mediation bу reviewing аll information provided tо thе mediator bу thе parties concerning thе case;
2. Neutrality – remain neutral аt аll times;
3. Nо legal advice – refrain frоm providing legal advice tо thе parties;
4. Understanding – ensure thаt аll parties know аnd understand thе process аnd rules оf mediation;
5. Communication – facilitate communication аnd settlement negotiations bеtwееn thе parties; аnd
6. Settlement Agreement – draft a quality Mediated Settlement Agreement incorporating аll terms оf thе settlement іn accordance wіth thе parties’ instructions.
Advantages оf Mediation
Thе advantages оf mediation аrе numerous аnd include thе following:
1. Cost Savings – ends thе need fоr continued expensive attorney’s fees, expert expenses, аnd costs оf litigation;
2. Avoidance оf Risk – lessens thе risks fоr thе parties іn thаt thе parties choose аnd formulate thе terms оf settlement, аѕ opposed tо leaving thе decision wіth respect tо thе legal dispute tо a Judge аnd jury;
3. Tіmе Savings – саn potentially resolve thе legal dispute іn a оnе day mediation session, аѕ opposed tо continued litigation whісh саn tаkе mаnу months оr еvеn years.
In family law cases, divorce mediation іѕ especially beneficial tо parents wіth children whо need tо learn tо negotiate аnd resolve disputes wіth еасh оthеr fоr thе best іntеrеѕt оf thе children.
Hiring a Quality Mediator
Hiring thе correct mediator as such m&a in Singapore are fоr уоur case optimizes thе potential fоr settlement оf уоur legal dispute. In choosing аnd hiring a quality mediator іn уоur case, уоu ѕhоuld learn thе background аnd experience оf thе potential mediator аnd consider thе following:
Iѕ thе mediator a licensed attorney whо hаѕ handled cases similar tо уоur legal dispute?
Whаt type оf training does thе mediator possess?
Whаt type оf reputation does thе mediator hаvе wіth respect tо hіѕ peers?
Sоmе quality mediators аrе nоt attorneys аnd nоt аll mediations require thе mediator tо bе аn attorney tо bе successful іn settling thе case; hоwеvеr, іt іѕ оftеn helpful tо hire a mediator whо іѕ аn attorney аnd hаѕ handled legal cases similar tо thе parties case. Thе benefit оf hiring ѕuсh аn attorney аѕ уоur mediator іѕ thаt thе attorney hаѕ knowledge аnd experience concerning thе law аnd whаt mау оr mау nоt happen wіth respect tо legal rulings аnd decisions thаt mау affect уоur case.
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one of the 10 largest U.S. wholesale drug distributors: will stop distributing controlled pharmaceuticals
Posted on January 15, 2020 by Pharmaciststeve
New York drug distributor exits opioids after admitting role in crisis
NEW YORK (Reuters) – A New York company that was the first drug distributor to face U.S. felony charges for its role in fueling the opioid crisis said on Tuesday it will stop distributing controlled pharmaceuticals, which include opioids.
Rochester Drug Co-Operative Inc (RDC) announced the decision after agreeing last April to settle the charges by paying a $20 million fine and accepting independent monitoring, under a five-year deferred prosecution agreement.
RDC, one of the 10 largest U.S. drug distributors, said controlled pharmaceuticals represent a relatively small percentage of its sales but “significant legal and compliance expenses,” and that those costs are “simply not sustainable.”
The Rochester, New York-based company will keep distributing non-controlled, generic and private label drugs, as well as healthcare supplies. It said it serves 1,300 retail pharmacies, long-term care pharmacies and home healthcare stores.
In settling with the government, RDC admitted to having distributed oxycodone, fentanyl and other controlled substances to pharmacies despite internal “red flags” that they would be used improperly.
Opioids have contributed to more than 400,000 deaths since 1997, according to the U.S. Centers for Disease Control and Prevention.
Federal prosecutors have opened a criminal probe of whether several drug companies intentionally allowed large quantities of opioids to be shipped, contributing to the nationwide crisis.
At least two distributors, AmerisourceBergen Corp and McKesson Corp, have said in regulatory filings that they have been in communications with prosecutors’ offices.
RDC’s former chief executive, Laurence Doud, pleaded not guilty last April to criminal charges of conspiring to both distribute illegal drugs and defraud the government.
Jeff Eller, an RDC spokesman, said it is premature to discuss implementation of the deferred prosecution agreement.
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Virginia: another constitutional right attempting to be taken away
Posted on January 15, 2020 by Pharmaciststeve
Virginia is in the fight of it’s life to protect the 2nd Amendment rights guaranteed to all citizens of the Commonwealth. Watch this video and share it with everyone to help us defend our rights.
The only way to stop a BAD GUY WITH A GUN… is with a GOOD GUY WITH A GUN.
the action of a church member taking down a shooter… limiting the shooter to only killing TWO PEOPLE
What we know about the man who shot, killed Texas church attacker
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Eli Lilly Introduces New Lower-Priced Versions of Humalog Insulin Products
Posted on January 15, 2020 by Pharmaciststeve
Eli Lilly Introduces New Lower-Priced Versions of Humalog Insulin Products
Insulin manufacturers are continuing efforts to provide more cost-savings options to patients with diabetes.
Today, Eli Lilly announced new plans that include 50% lower list prices for certain insulin products that will be available by mid-April, according to a company press release. This will include lower-priced versions of insulin lispro protamine and insulin lispro injectable suspension 100 units/mL (Humalog Mix 75/25 KwikPen) and insulin lispro injection 100 units/mL (Humalog Junior KwikPen).
Lilly initially introduced its first lower-priced insulin, insulin lispro injection 100 units/mL, in May 2019 at a 50% lower list price than the branded version.
Combined, these 3 insulin products comprise of more than 90% of prescriptions written for a mealtime insulin manufactured by Lilly, according to the release. Insulin lispro injectable suspension 100 units/mL, in particular, is one of Lilly’s most prescribed insulin, with approximately 600,000 prescriptions filled in the last 12 months, Lilly said.
The announcements comes after Novo Nordisk also recently introduced its new insulin cost-savings options for patients experiencing difficulties affording their medications. These plans include short-term free, immediate supply for patients in urgent need with a prescription and a $99 purchase program. Novo Nordisk also offers authorized generic versions of their NovoLog and Novolog Mix.
According to Lilly, the lower-priced version of Humalog Mix75/25 will be known as Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen (100 units/mL). The lower-priced version of insulin lispro injection 100 units/mL will be known as Insulin Lispro Injection Junior KwikPen (100 units/mL). Both prices will have a list price of $265.20 for a package of 5 KwikPens.
“The cost of insulin at the pharmacy varies dramatically depending on a person’s insurance coverage,” Mike Mason, president, Lilly Diabetes, said in a statement. “These lower-priced insulins may reduce out-of-pocket costs, especially for people in the coverage of Medicare Part D, the uninsured or those with high-deductible insurance plans.”
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Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
Posted on January 14, 2020 by Pharmaciststeve
Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Cross contamination with another drug substance, Enalapril Maleate
- Company Name:
- Taro Pharmaceuticals U.S.A., Inc.
- Brand Name:
-
Taro Pharmaceuticals
- Product Description:
-
Lamotrigine Tablets, USP 100mg
Company Announcement
Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200110005522/en/External Link Disclaimer
Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. There is potential with chronic exposure to Enalapril Maleate to impact users particularly if they are small children or pregnant women. Enalapril Maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021).
Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall. Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with FDA regulatory requirements.
Lamotrigine 100 mg Tablets are indicated for Epilepsy and Bipolar disorder. This product is packaged in white plastic bottles with screw cap closure, and each bottle contains 100 tablets. Each bottle is labeled to indicate the name of the product, Lamotrigine Tablets USP, 100 mg, the NDC #51672-4131-1 (see image of container label below), the lot number 331771 and expiration date of June 2021.
Lamotrigine 100 mg Tablets, Lot # 331771 were distributed to wholesale distributors in the US market between August 23 and August 30, 2019. These wholesale customers may have further distributed Lot # 331771 to retail pharmacies for prescription dispensing to patients who were prescribed 100 mg Lamotrigine Tablets.
Taro is notifying its distributors and customers by Phone, E-mail, and Letters via US Mail and is arranging for return of any containers or quantities of Lamotrigine 100 mg Tablets, Lot # 331771 (exp. June 2021). Consumers that have any quantities of Lamotrigine 100 mg Tablets, Lot # 331771 being recalled should stop using this product and return it to the pharmacy that dispensed it. Retailers, pharmacies and distributors should stop distributing or dispensing this product and return it to Taro.
Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 AM and 7:00 PM US Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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Chronic pain patients concerned about proposed federal law
Posted on January 14, 2020 by Pharmaciststeve
https://www.fox4now.com/news/local-news/chronic-pain-patients-concerned-about-proposed-federal-law
PUNTA GORDA, FLA. — For Debra Alleig, this is the best way she can describe the chronic pain she’s lived with for 17 years.
“It’s like for me a huge toothache. Like a dull, burning, constant, gnawing, nerve-ending root pain kind of,” said Alleig, “If I want to make soup, let’s say I’ll come out, cut an onion. If it’s real bad, I will go back to bed and lay down for half an hour.”
It started with back pain and then hip pain.
One spinal fusion and a hip replacement later and the aching is still there.
Over the years she been prescribed different treatments and has found that opioids work best to give her some quality of life.
But she says recent crackdowns on opioids have left chronic pain sufferers like her dealing with random drug tests, decreasing doses and sometimes being mislabeled as addicted.
“Am I dependent on my medication? Yes. Because otherwise, I would be in bed crying,” said Alleig.
She says that’s why proposed federal laws, like the NOPAIN Act gives her pause.
Those who back the bill say if passed, it would make it easier for doctors to prescribe non-opioid pain management to patients dealing with acute pain.
“This legislation is in now way shape or form intended to impact those patients ability to get access to these needed medications. The only thing that this legislation does is that it says that we think providers and patients deserve choices like they do in many other healthcare decisions and we think that pain should be no different,” said Chris Fox, the Executive Director of Voices for Non-Opioid Choices.
Still, some living with chronic pain say they’d rather keep the government out of their medical decisions.
“You go back to regular doctors treating patients. They diagnose and treat. Not our legislators. Not the government. But our doctors,” said Alleig.
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Prescription-Drug Policing: The Right To Health Information Privacy Pre- and Post-Carpenter
Posted on January 13, 2020 by Pharmaciststeve
Prescription-Drug Policing: The Right To Health Information Privacy Pre- and Post-Carpenter
This Article operates at the intersection of privacy law, Fourth Amendment doctrine, and prescription-drug surveillance instigated by the U.S. drug-overdose crisis. Reputable reporting sources frequently frame that ongoing crisis as a prescription-drug-overdose “epidemic.” Current epidemiological data, however, indicate that the majority of American overdose deaths are now a result of illicit and polysubstance drug use and not prescription-opioid misuse. The prescription-opioid-centric frame has nonetheless sparked the rapid rise of surveillance of prescribers and patients in the form of state prescription-drug monitoring program (“PDMP”) databases. State PDMPs, which maintain and analyze significant data concerning every dispensed controlled substance, surreptitiously collect a stunning amount of sensitive health information.
PDMPs are predominantly law enforcement investigative tools dressed up in public-health-promoting rhetoric. Under the guise of rogue prescriber, pill mill, and doctor–shopper crackdowns,
the Drug Enforcement Administration (“DEA”) routinely self-issues subpoenas that permit the agency to conduct warrantless sweeps of the voluminous data stored in state PDMP databases.
These rampant law enforcement sweeps procure highly sensitive health information and raise serious constitutional privacy concerns. The Supreme Court’s recent Fourth Amendment decision in Carpenter v. United States , however, may limit the DEA’s otherwise unfettered access to state PDMP databases.
Carpenter and the Fourth Amendment doctrines central to its holding motivate this Article and animate its two core contentions. First, pertinent pre-Carpenter precedent requires the DEA to obtain a warrant in order to conduct sweeps of state PDMP databases. Second,
courts are even more likely to rule that warrantless DEA searches of highly sensitive health-care data run afoul of the Fourth Amendment in the post-Carpenter world. Simply stated, patient prescribing records stored in state PDMP databases are entitled to Fourth Amendment protection.
IF you wish to read all 79 pages, click on the link above. Carpenter vs United states was about the government going thru a person’s cell phone history without a properly signed warrant.
There is growing list of letters from various large healthcare corporations and/or office practices owned by a large healthcare corporation.. that state that they are going to limit or stop prescribing opiates and/or controlled substances.
They are making a PUBLIC STATEMENT that they are going to start discriminating against pts who have a valid medical necessity for controlled substances and most/all of those pts are considered a COVERED ENTITY under the Americans with Disability Act and Civil Rights Act and it is a civil rights violation.
Most/all of these healthcare corporations have NO FEAR of pts… they fear the DEA because NO PT has sued them for civil rights discrimination.
If you are a pt being discriminated against and you have one of these “denial of care letters” or know someone who has and is being discriminated against you should be contacting law firms that deal with civil rights violation… in talking to these law firms there needs to be two things you need to make clear… you are NOT TALKING ABOUT MALPRACTICE… you are talking about civil rights violation and that there is probably HUNDREDS OR THOUSANDS OF OTHER PTS being discriminated against. All are being DENIED APPROPRIATE CARE because of the medication that you have a valid medical necessity to help optimize your quality of life and you are being ABUSED by this healthcare corporation and its employees.
You let them start talking about MALPRACTICE … it is a loser discussion… because the defendant will hire a “expert” that will testify that he/she was following standard of care and best practices and your legal team will hire a expert that will testify that the plaintiff was not… it comes a he said … she said… and many states have caps on awards for malpractice and many are so low that even if the law firm wins a malpractice case on ONE PT… they will probably not cover their expenses if they take the case on a contingency basis.
If any attorney doubts the detrimental effects of under/untreated pain.. the above chart should change their mind.
Imagine if the pts that successfully sues these healthcare corporation.. would agree to put part of their settlement into a non-profit whose sole purpose to hire PR, Lobby and Law firms to fight for the rights of the chronic pain community. After all, isn’t getting pts their medications and optimize their quality of life what it is all about ? While the legal profession is circling like vultures around major healthcare corporations – think hospitals, chain pharmacies, insurance/PBM industry… the non profit can start taking on Congress and challenging the unconstitutional laws that they have passed and hopefully prevent future laws that will harmful to the chronic pain community if allowed to get thru Congress.
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