Walgreen’s Illegally Distributes Controlled Substances

Is Walgreen,s Pharmacy really “at the Corner of Happy and Healthy”, like their motto claims? Maybe not…

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The Drug Enforcement Agency (DEA) caught Walgreen’s Pharmacy red-handed.  Allegations claim they were knowingly and  illegally distributing controlled substances to known abusers and drug dealers. The DEA found an “unprecedented” number of record-keeping and dispensing violations of the Controlled Substances Act.

Walgreen’s agreed to an $80 million settlement to put the matter to rest.  Part of the deal required Walgreen’s to publicly admit that it had failed to comply with its responsibilities as a DEA registrant. Although they claim they do all they can to stop this activity, there is evidence it is still occurring, even after the large sum of money they were required to pay. According to a recent blog article on bytegeist.com, Walgreen’s is more concerned with making a dollar than the health of its customers.

How Does This Effect Me? 

I have written many times about the problem of prescription drug addiction in America. It is crucial to shut down the supply chains if this problem is ever going to be eliminated. Unlike illicit drugs,  prescription drug dealers aren’t standing on dimly lit street corners in the rough areas of town. To the contrary, much of the supply comes from doctors, pharmacies and clinics who are licensed to distribute  controlled substances. With this license, however, comes the responsibility of complying with the law. Unfortunately, many do not comply, and this effects all of us.

Controlled substances may only be prescribed and dispensed for a legitimate medical purpose. When this fundamental premise isn’t followed, illegal distribution and abuse emerge. Narcotics find their way into the hands of addicts and dealers who sell them illegally on the black market. Sadly, the prescription drug black market makes its way into schools and homes, and destroys lives and families. 

Kudos to the Drug Enforcement Agency for getting the attention of one national pharmaceutical chain. Let’s hope it sends a loud message to the others. We all must do our part, as they are, to stop this epidemic in America.

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FDA Panel Considers Tightening Rules on Hydrocodone Prescriptions

 According to recent statistics, the United States consumes 99 percent of all Hydrocodone in the world, yet the United States is merely 4.5 percent of the world’s population.  In 2010, an estimated 131.2 million prescriptions were written for Hydrocodone, making it the most prescribed drug in the United States.  Hydrocodone is a highly addictive painkiller and has been blamed on overdoses and deaths.

Prescription Painkiller Addiction is an Epidemic in the United States
Abuse of prescription painkillers in the United States is an epidemic.  Reports of pharmacies being robbed for Hydrocodone and other strong narcotic painkillers are all too commonplace.  Now the Drug Enforcement Administration (DEA) is asking for help from the Food & Drug Administration (FDA) to tighten regulations and make it more difficult to get prescription drugs containing Hydrocodone.  
 
“If Hydrocodone has more restrictive manners tied to it, it could help reduce the abuse potential,” says Special Agent Robert Hill of the DEA Pharmaceutical Investigations Section.
 
FDA Advisory Panel Could Mandate Tighter Restrictions on Hydrocodone
In response, the FDA convened an advisory panel for a two-day meeting on Thursday, January 24, 2013.  The panel is to consider tighter regulations for the prescribing of drugs and other products that contain Hydrocodone.  One of the proposed regulations would limit prescriptions of pills and cough syrups containing Hydrocodone to a 90-day supply.  Currently, these products are available to be filled with five refills within six months.  The advisory panel will also consider moving Hydrocodone-combination products like Vicodin up from a Schedule III to a Schedule II drug, which is more highly regulated.  Drugs currently in Schedule II include OxyContin and pure Hydrocodone.
 
Advocates of tighter restrictions on Hydrocodone believe that moving Hydrocodone-combination drugs to a Schedule II classification will make the drugs less available.  A similar measure was attempted in 2012 with a proposed amendment to the Prescription Drug User Fee Act (PDUFA), but lobbyists for pharmaceutical companies fought against the amendment, and ultimately it was defeated.
 
Big Pharma Looks to Cash-in on Hydrocodone with New Drugs
Another FDA panel recently voted against approving Zohydro, an extended-release drug that contains pure Hydrocodone.  Manufactured by Zogenix Inc., the new painkiller is ten times more powerful than Vicodin and highly addictive.  Although the FDA panel found that the new drug met FDA standards for safety and efficacy, it voted against approval of the drug based on its high potential for addiction.  The FDA will consider the panel’s findings, but may still approve Zohydro in March when it comes up for consideration.
 
For more information about Hydrocodone and prescription drug addiction, read:
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Why You Should be Concerned about Nationwide Drug Shortages

Dallas drug injury attorney explains how a nationwide drug shortage could put people in danger if they are not able to receive medicines used to treat common injuries.

In recent weeks, news stories about cancer drugs in dangerous short supply have been capturing headlines across the nation. But few people know that cancer drugs are not the only vital drugs in short supply.

Nationwide, hospitals and ambulance companies have had to ration supplies of hundreds of medications used to treat common injuries.  Some of the most commonly used drugs in short supply are:

  • Midazolam & Valium—used to treat seizures
  • Morphine & Fentanyl—used to treat pain
  • Zofran—used to treat nausea and vomiting
  • Benadryl & Epinephrine—used to treat allergic reactions
  • Mannitol—used to control pressure in patients who have head injuries

In the Dallas-Fort Worth area, paramedics who work for Medstar are using drugs past their expiration dates in some cases, because they simply do not have a stable supply of the medicines.  While the drugs can be made by local pharmacists, they typically do not last as long as those provided by the drug companies.

Attempting to address the shortage, President Obama signed an Executive Order just last year in which he directed the FDA to prevent and reduce the number of drug shortages that have been growing over the past few years. 

Pharmaceutical companies that manufacture these drugs have cut back manufacturing significantly, arguing that they make little profit on these common drugs.  But the Department of Justice has launched an investigation into whether some of these pharmaceutical companies are creating artificial shortages in order to increase demand, and therefore, increase prices.  If pharmaceutical companies have been illegally price-gouging or stockpiling medications, they could face criminal charges.

For now, the FDA is taking steps to protect consumers and prevent price gouging by instituting early notification requirements of potential drug shortages.  Unfortunately, this may be another case of big pharma putting profits before patients and consumer safety.

To learn more about the pharmaceutical industry, download my FREE ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com.

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DEA Fines Las Vegas Pharmacy in Violation of Federal Drug Laws

Lam’s Pharmacy of Las Vegas agreed to settle civil charges that it violated federal drug laws on February 7, 2012. The settlement is a record $1 million to be paid by the non-chain pharmacy.

The Drug Enforcement Administration (DEA) and U.S. Attorney’s Office in Las Vegas have been working in unison to identify pharmacies violating federal drug laws and hold them accountable for their illegal acts.  On February 7, 2012, the work of these two units paid off when Lam’s Pharmacy of Las Vegas agreed to pay a $1 million settlement fine for violations of federal drug laws.

The DEA began investigating Lam’s Pharmacy in 2006, starting with the company’s receipt and distribution of controlled substances.  After years of investigation, the DEA took the evidence it had collected to Nevada’s U.S. Attorney Daniel Bogden, alleging that Lam’s had violated the Controlled Substances Act.

Lam’s violation of the Controlled Substances Act was a civil violation, rather than a criminal violation.  Still, Bogden stresses that “Civil settlements such as this are an extremely important component in our strategy to combat unlawful prescription drug trafficking in Nevada.”

The $1 million settlement is the largest civil settlement under the Controlled Substances Act against a pharmacy that is not a chain-operated pharmacy.  Bogden promises to continue to enforce violations of federal drug laws by physicians, pharmacies, and pharmacists both civilly and criminally.  The DEA has made clear to pharmacies that they have a corresponding duty not to participate in distributing controlled substances when no valid medical purpose exists.

Although Lam’s did not admit to any wrongdoing or liability, the company has agreed to surrender its DEA registration and pay the settlement within 14 business days. Additionally, Lam’s will be sold, but the business will continue to operate in Las Vegas under new management and a new name.

I would like to congratulate the Justice Department on successfully holding Lam’s Pharmacy accountable for its violations of federal drug laws.  I hope that both the DEA and Justice Department will continue to search out pharmacies that are contributing to the pill mill problem in this nation.

To learn more about prescription drug addition, read my article “America’s Growing Addiction” at www.vanweylaw.com.

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Senator Warns FDA about New, Stronger Painkillers

New York Senator Charles Schumer is warning the FDA that approving a new painkiller containing pure hydrocodone could have disastrous consequences across the nation. Painkillers that contain hydrocodone currently on the market are known to be highly addictive and have caused fatal overdoses.

New York Senator Charles Schumer has seen the effects of prescription drug addiction in his state and has vowed to fight it.  He warns that a new painkiller promising to be 10 times stronger than Vicodin could lead to more violent and deadly drug store robberies.

In June 2011, New York resident David Laffer was charged with robbing a Long Island drug store of more than 10,000 highly addictive prescription painkillers and killing four people in the pharmacy.  He and his wife had been doctor shopping before the robbery in an effort to get prescription pain pills like hydrocodone, which is highly addictive.

Nationwide, more than 1,800 pharmacies have been robbed in the past three years alone.  Long Island alone has experienced a 125 percent increase drug store robberies.

“It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the growing prescription drug crisis, new super-drugs could well be on their way, flooding the market.  The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics” Senator Schumer said.

The new painkillers, which contain pure hydrocodone, could come onto the market as early as 2013, with big pharmaceutical companies looking to cash in on the $10 billion prescription painkiller market.  At present, hydrocodone is classified as a strictly controlled Schedule II drug under the 1970 Controlled Substances Act. 

Products that contain hydrocodone and another painkiller like acetaminophen fall into Schedule III, which is less strictly controlled.  Some experts argue that because of this, highly addictive hydrocodone has been given to more patients, which has increased abuse of the drug and overdose rates in the United States.

A prescription painkiller that contains pure hydrocodone could lead to more accidental overdoses, leading to more emergency room visits.  Experts say that already thin hospital emergency room resources could become even more strained if this new drug is allowed on the market.  In 2008 alone, emergency room visits related to hydrocodone abuse totaled more than 86,000, up more than 400 percent from 2000 when an estimated 19,000 visits were recorded.

To learn more about prescription drug addiction, read my article “America’s Growing Addiction” at www.vanweylaw.com

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A Tribute to Ken & Esther Scarborough

The Scarborough family of Kountze, Texas, has been instrumental in the fight against prescription drug addiction. After their son died from a prescription drug overdose, the Scarboroughs realized the need to help other families who had lost a loved one.

Far too many families have been devastated by a loved one’s addiction to prescription drugs. Unlike the images we conjure up when we think of a typical drug addict, the faces of prescription drug addiction are the faces of ordinary Americans. One of the casualties of prescription drug addiction was Christopher Scarborough, the 25 year-old son of Ken and Esther Scarborough of Kountze, Texas.

I came to know the Scarboroughs when I represented them in a legal case, which sought to hold the negligent parties accountable for Christopher’s death and to raise awareness about these pill mills, which often masquerade as pain management clinics. In the lawsuit, we alleged that the healthcare providers and clinic owners were nothing more than “drug dealers” who were trying to pass off their “pill mill” as a legitimate pain management clinic.

When Christopher went to this walk-in “pain management clinic,” he was prescribed a cocktail of more than 300 highly addictive narcotic pills, without even receiving an exam or seeing a doctor. Shortly thereafter, Christopher tragically died of an accidental overdose.

Rather than dwell on their son’s heartbreaking death, the Scarboroughs have chosen to help other families who have lost loved ones to prescription drug addiction and accidental overdose.

Since their son’s death, the Scarboroughs have worked every day to fight against the prescription drug epidemic in their son’s name. In 2009, they founded Parents Against Prescription Drug Abuse (PAPDA), a 501(c)(3) nonprofit corporation. They have also testified before the Texas Senate, worked to pass legislation to regulate the so-called pain clinics, given countless talks, and comforted other parents who have also lost their children to prescription drug overdoses.

The Scarboroughs need your help to continue their fight. You can help by making a tax deductible contribution to PAPDA at www.papda.net. Your contribution, no matter how slight, will help Ken and Esther keep fighting every day to prevent the reckless prescribing of narcotics from claiming another innocent life.

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Sanchez v. Wal-Mart Update

 On December 25, 2010, the Nevada Supreme Court issued its opinion in Sanchez v. Wal-Mart et al. Disappointingly, the Court held that under the circumstances of this case, pharmacies do not owe a duty of care to unidentified third parties like those injured by the impaired driver, Patricia Copening, in this case. The Court further held that Nevada’s pharmacy statutes and regulations, including NRS 453.1545, are not intended to protect the general public from the type of injury sustained in this case and do not express standards of care that extend to unidentified third parties like the appellants in this case. 

The good news is that the Nevada Supreme Court left open important questions that deserve answers different from the conclusions arrived at in this case. Significantly, the Court limited its holding to unidentifiable third parties affected by pharmaceutical practices before 2006 because the events in this case took place before 2006. The Court related that under 2006 amendments to its regulations, reflected in NAC 639.753, the Board of Pharmacy may have imposed a duty on pharmacies or created a special relationship that could justify imposing a duty in favor of third parties. The Court expressly did NOT determine whether that regulation does impose such a duty or create such a relationship.

Further, the Court did not discuss whether pharmacies owe a duty of care to customers or to identifiable third parties, such as relatives of customers. The Court’s holdings applied only to unidentifiable third parties.

 

Although I had hoped that the majority would reach different conclusions, I do applaud Justice Cherry and Justice Saitta for their well-reasoned dissent in this case. They argued that in the same way that the courts recognize that a special relationship exists between an innkeeper and guest, a teacher and student, and an employer and employee, a special relationship also exists between a pharmacist and a pharmacy customer. Therefore, pharmacies have a duty to take measures to protect foreseeable victims, like the third parties injured in this case, from foreseeable harm. The pharmacies should have foreseen the possibility that Patricia Copening would harm the victims in this case because of the actual notice that the pharmacies received from the Task Force, warning them that Copening had bought $4,500 hydrocodone pills within a 12-month period by having numerous prescriptions filled at 13 different pharmacies. After receiving this notice, the pharmacies should have recognized that Copening may be misusing the prescription drugs and that continuing to fill Copening’s prescriptions for hydrocodone or SOMA could result in harm to Copening or to others. They had a duty to review her records and to consider the Task Force letter before filling additional prescriptions.

 

The dissent also argued that the legislature designed various Nevada statutes to protect others against the type of injury that the appellants suffered in this case. According to the language of NRS 639.213 and 639.0070(1)(a), pharmacology affects the public safety and welfare, and the Board must adopt regulations pertaining to pharmacy practice in order to protect the public. Those provisions, coupled with other statutes that require pharmacists to ensure that substances are being dispensed only for medically necessary purposes, make it apparent that the legislature “intended to prevent pharmacy shopping and the overfilling of certain controlled substances, and ultimately to protect the general public from prescription-drug abuse and its effects.” Based on those statutes, the appellants in this case should be able to file a lawsuit against the pharmacies for negligence per se.

 

The law provides standards for pharmacists confronted with suspect prescriptions.  The Controlled Substances Act (Title 21 CFR 1306.04) recognized a pharmacist’s independent duty to determine whether a prescription has been issued for a "legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" before dispensing the controlled substance to the customer.  The DEA’s Pharmacist’s Manual emphasizes this responsibility in its chapter "Prescription Requirements," section "Purpose of Issue," and again in its  chapter "Dispensing Requirements," sections "Internet Pharmacy" and "Central Fill Pharmacy." 

 

It is important to remember that sometimes pharmacies are the last line of defense and that a prescription is only worth the paper it is written on until it is filled.  Pharmacies and pharmacists cannot morally or legally turn a blind eye to suspect prescriptions and expect to suffer no consequences.

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Nevada Supreme Court weighs pharmacists’ liability for narcotics distribution

In the legal profession, we have an expression: "an oral contract is worth the paper it’s written on." I think of this when considering the distribution of controlled substances. My rendition is : "a prescription is worth the paper it’s written on until it is filled".

Pharmacists have the legal responsibility to ensure that a prescription is written for a valid medical purpose prior to filling it. However, a case that is currently pending in the Nevada Supreme Court may help to better define the duty of pharmacists in preventing prescription drug diversion.

The case, Sanchez vs. Wal-Mart et al, asks whether drugstores must use information at their disposal to protect the public from potentially dangerous customers.

As Amy Merrick reported in her article on SanchezCase Spurs Pharmacies’ Fears of Lawsuits Over Drug Abuse, Patricia Copening bought nearly 4,500 doses of prescription painkillers in one year.  In June 2003, the Nevada Prescription Controlled Substance Abuse Prevention Task Force, which administers a computerized program mandated by Nevada Revised Statutes 453.1545 to track prescriptions for controlled substances, sent letters to 14 pharmacies in the Las Vegas area “warning them that Ms. Copening had purchased during the prior year 60 prescriptions, or nearly 4,500 doses, of controlled substances.” There is no record of any pharmacist so much as noting the task-force letter in Ms. Copening’s records.  Instead, the pharmacies continued to allow Ms. Copening to buy large quantities of hydrocodone and Soma, a cocktail “said to produce a euphoria similar to that induced by heroin.” 

On June 4, 2004, a year after the warning letters were sent to the pharmacies, Ms. Copening, under the influence of hydrocodone, ran her car into a 21-year-old delivery van driver, killing him at the scene, and hit a 33-year-old man, causing a head injury, broken right leg, and other wounds.  Ms. Copening faced charges of reckless driving, driving while intoxicated, and being involved in a fatal accident.  The injured and his family and the family of the deceased filed suit against Ms. Copening, the doctors responsible for most of the prescriptions, and multiple pharmacy-chain owners, including Wal-Mart, Walgreen, CVS Pharmacy and Rite-Aid.  Now the Nevada Supreme Court is left to define the responsibility that the pharmacies should have taken to protect the public from the effects of prescription drug abuse. 

In my opinion, this should serve as a wake-up call to pharmacies and large drugstore chains. They have the tools at their disposal to fight prescription drug diversion. If they can develop sophisticated systems to track the productivity of the pharmacists and to track inventory losses, they can also do a better job of slowing the flow of controlled substances for illicit purposes. Tracking productivity and inventory losses is good for drug stores because it helps make them more profitable. Saying no, on the other hand, costs money. Warranted refusals to fill prescriptions means "no sale." Make no mistake that these drugstores are about making money. This is one reason why holding pharmacies responsible for monetary damages is important. It is only when they think that they could be hit in the pocketbook for their negligence that they might take heed.

We at the Pill Mill Monitor will be watching this interesting case and will keep you posted.

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