Ten Individuals Affiliated With Compounding Pharmacy, Including Owners, Pharmacist, Billing Manager, Sales Reps and Nurse Practitioner, Charged in Compounding Prescription Drug Case

In compounding cases, it is usually some very high billed creams that get attention. In a recent case, the government alleges that the defendants’ fraudulent conduct caused a prescription plan administrator to pay over $29,000 for one tube of a cream advertised as treating “general wounds.”
Another red flag in compounding cases are call centers with marketers. A recent case in Alabama has both. This case is also significant since it targeted many people who worked at the compounding pharmacy including sales representatives, billers, managers in addition to the owners and pharmacist.

On May 6, 2019, ten defendants were charged in a 103-count indictment, including a nurse practitioner, owners, a pharmacist, managers, sales representatives and billers, of an Alabama based pharmacy, Northside Pharmacy doing business as Global Compounding Pharmacy. 

The indictment charges them with fraudulently billing health care insurers and prescription drug administrators for over $200 million in prescription drugs.  An indictment contains only charges. A defendant is presumed innocent unless and until proven guilty.  The charges stem from a larger investigation that has to date resulted in 18 additional individuals being charged and signing plea agreements. 

According to the indictment, Global which allegedly described itself as “one of the top three largest compounding pharmacies in the United States,” primarily shipped compounded and other drugs from its Alabama facility, but did most of its prescription processing, billing and customer service at its “call center” in Clearwater, Florida. The company hired sales representatives who were located in various states and were responsible for generating prescriptions from physicians and other prescribers.  The company also worked with affiliated pharmacies.

The indictment describes a multi-faceted operation in which the defendants billed for medically unnecessary drugs.  The indictment alleges that the wrongdoing included:  

• paying prescribers to issue prescriptions; 
• directing employees to get medically unnecessary drugs for themselves, family members, and friends, to be filled and billed by Global and other related pharmacies; 
• altering prescriptions to add non-prescribed drugs including controlled substances such as Tramadol and Ketamine; 
• automatically refilling prescriptions—often as many as 12 times—regardless of patient need; 
• routinely waiving and discounting co-pays to induce patients to obtain and retain medically unnecessary drugs; and 
• billing for drugs without patients’ knowledge and hiding that conduct from patients by mailing the drugs to the home of Global's owner and president.  

According to the indictment, the defendants evaded and obstructed audits and questions about billings through various efforts, including by providing false information in response to audits and diverting their billing through affiliated pharmacies.  The defendants allegedly billed health insurance plans and their prescription plan administrators over $200 million and were paid over $50 million.

California Pharmacist Pleads Guilty in Federal Court in Los Angeles to Illegal Distribution of Prescription Opioids and Laundering the Proceeds of the Illicit Sales

The government likes giving catchy names to certain  investigations. A recent federal and state investigation into corrupt pharmacies, for example, was called dubbed “Operation Faux Pharmacy.” 

One of the cases from this investigation has resulted in a pharmacist and pharmacy each pleading guilty in federal court to one federal count of distributing oxycodone and one count of money laundering relating to the revenue generated by the sales. 

On April 29, 2019, California pharmacist Pauline Tilton and her pharmacy Oasis Pharmacy pleaded guilty to a federal charge of illegally distributing the opioid oxycodone, admitting in the plea agreement that she filled hundreds of counterfeit prescriptions. The red flag in this case was that the DEA number of the prescribing physician on the prescriptions was of a retired doctor.

California Pharmacist Charged With Filling Fraudulent Prescriptions for Oxycodone and Hydrocodone.

The opioid prescription cases keep coming. On April 11, 2019, a Fresno pharmacist, Ifeanyi Vincent Ntukogu of New Life Pharmacy, in Madera was indicted one count of conspiracy to distribute and possess with intent to distribute controlled substances and 17 counts of distribution of controlled substances (oxycodone and hydrocodone). The charges are only allegations; the defendants are presumed innocent until and unless proven guilty beyond a reasonable doubt.

Two other non-medical persons to whom the medications were allegedly dispensed were also charged: Kelo White was charged with one count of conspiracy to distribute and possess with intent to distribute controlled substances and 12 counts of possession with intent to distribute controlled substances. Donald Ray Pierre was charged with one count of conspiracy to distribute controlled substances, 10 counts of possession with intent to distribute controlled substances, and two counts of identity theft. 

According to court documents, Mr. Ntukogu allegedly filled fraudulent prescriptions for oxycodone and hydrocodone, Schedule II controlled substances, at his pharmacy New Life Pharmacy between December 2014 and November 2018, and then dispensed the controlled substances to Mr. White and Mr. Pierre. 

California Pharmacy Pays $75,000 Settlement for Failing to Keep Accurate Records of Controlled Substances Inventory

As part of the Drug Enforcement Administration's (DEA) increased enforcement on prescription addiction and prescribing, pharmacies are facing an increased number of inspections and audits on their inventory and recordkeeping. 

Recently, in June 2018, a pharmacy in Lakeside, California known as Archana Corporation doing business as Leo’s Lakeside Pharmacy and its owners paid $75,000 to resolve allegations that they failed to properly account for controlled substances. This is a civil settlement but it can also raise issues with the Pharmacy Board. 

Failure to comply with DEA rules and regulations can result in fines or loss of DEA permit. Schedule II prescription and inventory records must be available for two years. It is always a good idea for pharmacies to review their procedures and ensure that these records are being maintained properly since an audit can turn into an expensive and time-consuming dispute with the DEA and create collateral issues with the Pharmacy Board. 

Posted by Tracy Green, Esq.

Green and Associates

Investigation Into Compound Prescription Marketing by TYY-Affiliated Pharmacies Charges a Marketer and Two Podiatrists in Los Angeles

Marketing payments are driving many of the federal criminal cases involving compounding pharmacies. A recent Los Angeles federal case fits that profile. 

An indictment unsealed on June 26, 2018, alleged a wide-ranging conspiracy that was responsible for more than $250 million in claims for prescriptions (allegedly fraudulent or involving illegal referral fees or kickbacks) that were filled by compounding pharmacies in Nevada and Southern California. An Indictment is not evidence and the defendants charged are presumed innocent. 

The indictment charges Irena Shut with allegedly paying kickbacks to two podiatrists to authorize prescriptions written on pre-printed prescription pads designed to maximize insurance payments, regardless of the medical need for an expensive compounded formulary for each “patient.”

The indictment alleges that TYY Consulting, a Las Vegas, Nevada-based company used a nationwide network of marketers to refer prescriptions to TYY-affiliated pharmacies (New Age Pharmaceuticals, Roxsan, Concierge Compounding, Precise Compounding) in exchange for payments that the government is alleging are "kickbacks." 

It is alleged that  the health care plans paid out nearly $175 million to the pharmacies. Ms. Shut, who worked as a marketer for TYY, received approximately $6.8 million, some of which was, in turn, allegedly given to the charged podiatrists.

The charged podiatrists, Domenic Signorelli of Irvine and Robert Joseph of Huntington Beach, along with several other unnamed co-conspirator doctors, allegedly received improper payments (kickbacks) for “writing” the prescriptions. Once the prescriptions were filled, it is alleged that other members of the conspiracy submitted fraudulent claims to federal, state and private insurers for the compounded drugs. The insurers include the Department of Defense’s TRICARE program as well as federal and state workers’ compensation programs.

In addition to paying the charged podiatrists and other medical professionals, the Indictment alleges that TYY induced other doctors to participate in the scheme by offering prostitutes, fancy meals, and expensive event tickets.  

This case is related to other pending federal cases and there are numerous alleged unindicted marketers and doctors. It seems there will be other federal cases - whether plea agreements or further indictments - coming out of this matter. 

Pharmacy Owner And Pharmacist Sentenced To 160 Months In Prison For $4.3 Million Pain And Scar Compounding Creams Where Referral Payments Received When TRICARE Insurance Billed

The compounding cream cases where pharmacies engaged in marketing to obtain patients and where there were billings to TRICARE insurance continue. 

In a recent case, after a five-day trial of one count of conspiracy to pay health care kickbacks and paying and receiving kickbacks, a long sentence was handed out by a federal district court judge to a pharmacy owner and pharmacist.  

On March 30, 2018, the owner of a Florida pharmacy, Larry B. Howard, also a licensed pharmacist, was sentenced by U.S. District Judge Paul G. Byron to serve 160 months in prison and ordered to pay $4.3 million in restitution for his role in this case.

Tennessee Couple and Utah Pharmacy Indicted in San Diego Federal Court for $65 Million TRICARE Fraud Allegations Relating to Compounded Medications Mailed to Active Duty Military

Compounded medication cases continue to be filed by federal and state prosecutors. A case filed two weeks ago in San Diego (a military town) involves recruiting active military duty patients, a Utah pharmacy that shipped compounded medications, and a medical clinic in Tennessee who had doctors prescribe the medications based on telemedicine exams that did not meet TRICARE rules. 

The billing at issue here is solely  TRICARE, a government health care program that covers United States service members, retirees, and their dependents. It is not clear if there was also billing to third party insurance.  

On or about January 26, 2018, Jimmy Collins and Ashley Collins, a married couple living in Tennessee were Indicted and arraigned in San Diego federal court that they illegally billed TRICARE more than $65 million in pharmacy reimbursement funds.

CVS Pharmacy Inc. Pays $5 Million to Settle Alleged Violations of the Controlled Substance Act in Sacramento Federal Case

As is the norm, national chain pharmacies get fines and compliance plans while small businesses get criminally prosecuted. A recent settlement between the Department of Justice and Drug Enforcement Administration (DEA) with a national chain pharmacy is no different.

On or about July 5, 2017, CVS Pharmacy Inc. agreed to pay $5 million to resolve federal Controlled Substances Act (CSA) allegations that its pharmacies in the Eastern District of California failed to keep and maintain accurate records of Schedule II, III, IV, and V controlled substances. This payment covered only one federal court district. 

CVS also agreed to an administrative compliance plan with the DEA. The payment and plan resolve the United States’ allegations that during the period from April 30, 2011, through April 30, 2013, CVS pharmacies failed to provide effective controls and procedures to guard against diversion when CVS allegedly failed to:
(1) record the amount received and the date received of Schedule II drugs on DEA-222 Forms;
(2) maintain DEA-222 Forms and keep them separate from other records;
(3) record the date of acquisition of controlled substances in Schedules II through V; and
(4) maintain invoices for drugs in Schedules III through V and keep the records separate from non-controlled substance records; and conduct a biennial inventory on one specific day.

Under the settlement reached July 5, 2017, CVS acknowledged that its DEA-registered pharmacies were and are required to comply with the CSA, and that nine CVS pharmacies in the Eastern District of California failed to fulfill these recordkeeping obligations in a manner fully consistent with CVS’s responsibilities under the CSA. The settlement and compliance plan cover the 168 CVS pharmacies that operated in the Eastern District of California from April 30, 2011, through April 30, 2013.

The allegations resolved by this settlement were uncovered during a DEA investigation that began in 2012 after CVS self-reported thefts and losses of hydrocodone, a Schedule III drug at the time, at five of its Sacramento-area pharmacies. Under the CSA, DEA-registered pharmacies are obligated to report any thefts or significant losses of controlled substances to DEA.

On the compliance side, to address the issues uncovered by this investigation, CVS made improvements to its pharmacies in the Eastern District of California by, among other things, instituting annual CSA compliance training of its pharmacy staff, increasing loss prevention oversight, and excluding controlled substances prescriptions from the volume metric that can impact pharmacy staff compensation.

All non-chain pharmacies can learn from this compliance plan and how record keeping issues can result in large fines. It's especially critical for non-chains since they can get their DEA pulled and even criminal prosecution.

Posted by Tracy Green, Esq.

Email: tgreen@greenassoc.com

Office: 213-233-2260

Walgreen Paid $9.86 Million to Settle False Claim Allegations of Improper Medi-Cal Billings for Code 1 Drugs

It's not just small pharmacies that get false claims (qui tam) cases. The chains are ripe targets for cases but they have the resources to defend, pay settlements and stay in business. A recent case shows that even large pharmacies will settle rather than go to trial in these cases.

On April 20, 2017, Walgreens paid $9.86 million to resolve civil lawsuit allegations that it violated the federal False Claims Act when it knowingly submitted claims for reimbursement to California’s Medi-Cal program for Code 1 Drugs that were not supported by applicable diagnosis and documentation requirements. There were no admissions. 

This settlement surrounded the nuances of pharmacy billing for Medi-Cal. Medi-Cal utilizes a formulary list, commonly known as “Code 1” drugs, which designates certain restrictions for each listed drug, including restrictions pertaining to diagnoses. Medi-Cal will reimburse certain Code 1 drugs only for approved diagnoses, taking into account criteria such as the drug’s safety, efficacy, misuse potential, and cost. Pharmacies confirm and certify that these Code 1 drugs are dispensed for the approved diagnoses. Walgreens may bill for drugs prescribed outside of the approved diagnoses, but it must submit a request to DHCS that includes a justification for the non‑approved use (often called a TAR).

Billing for Prescriptions Not Dispensed to Patients Results in 4 Year Sentence for Los Angeles Medical Clinic Manager After Federal Trial

Federal prosecutors used to devote healthcare fraud resources to mainly government programs and allow private insurance carriers to handle the cases with special investigation units or with state prosecutions. A recent case shows how private insurance healthcare fraud is being pursued forcefully. This is in large part due to the overlap between private and public and the fact that the federal government pays subsidies for tens of millions of people who have private insurance.

The recent case was one of ghost billing. On March 28, 2017, Michael Huynh, the office manager and purported part-owner of a Los Angeles area medical clinic in Reseda was sentenced to 51 months in federal prison for his role in billing private insurance plans for prescription medication that was never dispensed to insured patients and failing to report such income on his federal income tax returns. Following a seven-day trial in September 2016, Mr. Huynh was found guilty of one count of conspiracy to commit healthcare fraud and 11 counts of filing false tax returns.

Mr. Huynh, age 67, was sentenced by United States District Judge Otis D. Wright II. In addition to the prison term, Judge Wright ordered Mr. Huynh to pay just over $1.9 million in restitution to the victim insurance companies and back taxes – estimated to be nearly $950,000 – to the Internal Revenue Service.

      

The evidence introduced at trial showed that between January 2004 and November 2009 Mr. Huynh and a pharmacist (Farhad N. Dany Sharim,  a co-owner of Century Discount Pharmacy in Reseda) participated in a healthcare fraud scheme that billed private insurance plans for prescription medication that was never dispensed to insured patients. Mr. Sharim, age 57, previously pleaded guilty to conspiracy to commit healthcare fraud and will be sentenced by Judge Wright on May 1.

The evidence at trial was that Mr. Huyhn provided Mr. Sharim with fabricated prescriptions purportedly for patients of the medial clinic who were insured by healthcare benefit programs. Mr. Sharim's pharmacy then submitted false and fraudulent bills for prescription drugs that had not been dispensed to the patients and received substantial payments from various health care benefit programs to which it was not entitled. Mr. Sharim allegedly paid Mr. Huyhn and/or the medical clinic more than $1.1 million.

In addition to the healthcare fraud scheme, Mr. Huynh was charged with filing false federal tax returns for tax years 2007 through 2011 that underreported the medical clinic’s gross receipts and sales by more than $1.6 million.

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law

Office: 213-233-2260

Email: tgreen@greenassoc.com

Durable Medical Equipment Supply Owner and Operator Plead Guilty in Case Involving False Statements to Medicare About Inhalation Drugs Being Non-Compounded Drugs

Compounded medications and drugs have been under close scrutiny the past number of years. Claiming a drug is not compounded when it is compounded can be a "false claim" subjecting a business and its owners or managers subject to criminal prosecution and civil penalties. 

A recent case involving a durable medical equipment company and compounded inhalation drugs billed to Medicare shows what can happen where the drugs are not characterized properly on claims forms in order to avoid new billing rules.  

The rule being avoided was that as of July 1, 2007, Centers for Medicare/Medicaid Services revised nationwide policy regarding compounded inhalation solutions. After July 1, 2007, all compounded inhalation solutions were denied as not medically necessary for dates of service on or after July 1, 2007. 

Florida Man Indicted for Receiving $20 Million in Marketing Fees From Compounding Pharmacy For Patients Covered by Tricare Health Insurance and Paying Telemedicine Companies to Prescribe Compounded Medication Prescriptions

Compounding pharmacies are facing investigations for marketing arrangements, drug misbranding as well as for health care fraud in billing workers' compensation insurance or Tricare health insurance. A recent case involves billings to Tricare, commission payments and the use of telemedicine in order to have providers issue the prescriptions. 

On December 13, 2016, Monty Ray Grow of Tampa, Florida was charged by Indictment which alleges that between September 2014 and June 2015, Mr. Grow received approximately $20 million in payments from a Broward County, Florida compounding pharmacy in exchange for recruiting and referring patients that were covered by the Tricare health care insurance program. The government alleges that these payments were "kickbacks." An Indictment is merely an accusation and every defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

The Indictment further alleges that Mr. Grow and others defrauded Tricare by paying telemedicine companies to provide compounded medication prescriptions to the recruited patients without conducting any physical examination of the patients as required by law. It is also alleged that these invalid prescriptions were issued without regard to the patients’ medical necessity.  The Indictment further alleges that Mr. Grow used the proeeds to buy real estate, luxury vehicles and securities.    

The time period here was key for Tricare which was to adopt new controls on compounded medication prescriptions in May 2015. The year before there was aggressive marketing of military families who were cold called about compounded medications. In 2004 Tricare paid $5 million for compounded medications but in the fist 3 months of 2015 alone, Tricare was billed at least $700 million. This is by all providers and it shows part of the reason Tricare became aggressive about compounding. The marketing of compounding medications directly to patients was aggressive across the country and this case is the first of more to come against compounding pharmacies, physicians and marketers.

Physicians Can Apply for Award Up To $105,000 for Serving In a Medically Underserved Area of California - Apply Dec. 1, 2016 to Feb. 28, 2017

Are you licensed in California and looking for a way to work in an underserved area and get student loan forgiveness? Physicians (allopathic or ostepopathic physician or surgeon) can apply for an award from the Steven M. Thompson Physician Corps Loan Repayment Program up to $105,000 in exchange for a service obligation in a medically underserved area of California. 

The link for the physican scholarship is: http://www.oshpd.ca.gov/HPEF/Programs/STLRP.html 

For more information go the website for this program (and for other health care provider scholarships) at State of California Office of Statewide Health Planning and Development, Health Professions Education Foundation.  There are also scholarships for Registered Nurses, LVNs, Dentists, Physician Assistants, Occupational Therapists, Pharmicists, SpeechTherapists, Certified Midwifes, Nurse Practitioners, and other health care providers and those deadlines vary. Review the website for deadline and application information.

This underserved area covers most of the state and is close to major urban areas. Visit the website link above for the map of the area covered.

Dallas Compounding Pharmacy and Three Individuals Agree to Consent Decree With Permanent Injunction to Prevent Distributing Adulterated Drugs

Compounding pharmacies have been under scrutiny, and a recent case shows the difficulties compounding pharmacies are having complying with recent changes in the law and regulations. Compoung pharmacies are also under scrutiny due to billing issues with insurance which has also put them under the spotlight.  A recent case shows what happens when retail pharmacies engage in compounding with regulation by the state and what happens when the U.S. Food and Drug Administration (FDA) alleges the drugs are adulterated.

There are some hot issues on new compounding regulations and how they affect the Compounding Quality Act signed into law in 2013 and the FDA's increased audits and inspections of outsourcing facilities or pharmacies who may not be properly classified. Compounding pharmacies are having issues in determine whether they fall within the 503A and 503B rules and are complying with the federal regulations.

The U.S. District Court for the Northern District of Texas entered a consent decree on January 11, 2016, for permanent injunction against Downing Labs LLC, Ashley Michelle Downing, Christopher Van Downing and Roger E. Mansfield to prevent them from distributing adulterated drugs in interstate commerce.

Downing Labs was a state pharmacy regulated by the state. When Downing was named in a news investigation of having billed for compounding creams and gels not delivered to patients, they became a target of investigation. In addition, Downing decided to obtain FDA approval as an outsourcing facility and after inspection did not agree to recall drugs as demanded by the FDA.

San Diego Pharmacy Owners Pay $750,000 to Resolve Civil Drug Diversion, Record Keeping and Logbook Allegations After DEA Audit

On November 17, 2015, a group of San Diego pharmacies and their owners paid $750,000 to the federal government to resolve allegations that they mishandled significant amounts of highly addictive and frequently abused prescription narcotics, as well as ephedrine or pseudoephedrine products. This was a civil settlement with the DEA and any true wrongdoing of a criminal nature appeared to be done by pharmacy technicians.

In addition to paying $750,000 in settlement to the government, Medical Center Pharmacy has committed to implementing new inventory control procedures to assure full accountability of all controlled substances.

Miami-Area Pharmacy Owner Sentenced to 42 Months in Prison for Role in $1.5 Million Medicare Part D Fraud Scheme

A Miami-area pharmacy owner,Tamara Esponda, was sentenced November 17, 2015 to 42 months in prison for her role in the submission of more than $1.5 million in fraudulent claims to Medicare Part D. This was a case of ghost billing - billing for drugs that were not prescribed or provided to patients.

This is the kind of black and white case that one expects in health care fraud and is not one that involves complex regulatory issues. This also involves identity theft issues where there is billing of patients' Medicare without their consent. Miami, Los Angeles, and New York continue to be the areas with the most health care fraud prosecutions.

Obama Says US Will Tackle Prescription Drug Abuse

The New York Times reporting on President Obama’s visit on Wednesday October 21, 2015 to West Virginia is in this article entitled “US Will Tackle PrescriptionDrug Abuse.” In the article, it notes that: “Experts say few prescription drug health care providers are properly trained to safely prescribe painkillers, while access to medication-assisted treatment for addicts is too difficult.”

President Obama's visit to West Virginia comes as politicians are grasping for a policy response, including presidential candidates in both parties. Former Secretary of State Hillary Rodham Clinton has laid out a $10 billion plan that promotes treatment over incarceration. New Jersey Gov. Chris Christie has visited drug rehabilitation centers and talked up his work to create drug courts at home that mandate treatment over jail time for non-violent offenders.

Before leaving the White House, Obama ordered federal agencies that employ health care providers to offer training on prescribing painkillers. They also must review their health insurance plans and address policies that might prevent patients from receiving medication as part of their treatment.

A Centers for Disease Control and Prevention (CDC) report released in July 2015 found the number of people who reported using heroin within the past year had nearly doubled from 2002 to 2013. Heroin use was up among nearly all demographic groups, but showed particular spikes among women and non-Latino whites. Researchers say two factors are driving the trend: the rise in abuse of opioid painkillers — drugs that are often a precursor to heroin — and the increasing availability of cheap heroin.

Researchers found that most users reported using at least one other drug in combination with heroin, which contributes to high overdose rates. Between 2002 and 2013, the rate of heroin-related overdose deaths nearly quadrupled, and more than 8,200 people — by some estimates, one in every 50 addicts — died in 2013, according to the CDC.

Commentary: It is curious that now that the demographic of drug abusers is non-Latino whites, there is more emphasis on treatment than incarceration. Heroin use was never seen as a drug for whites but now that it is - the attention is properly focused on it. Better late than never. Substance abuse it turns out does not respect anyone and it does not discriminate against race or economic status. However, it takes the mainstream to get affected before our policies change. 

Perhaps our nation has learned something from criminalizing drug possession – including the shameful past of mandatory minimums for crack cocaine and other drugs that sent many people of color or of low socioeconomic status to prison for many years for the crime of being an addict. If this is what it takes, then it is still the right thing to do. It reminds me of the times when AIDS was regarding as an issue affecting gay men but when it began to effect others, the country took action. This is a national health issue and highlights the issues with addiction that have been around for years.

Now the insurance companies need to treat addiction as a disease and provide health insurance coverage. One of the issues that arises is that once an addict is detoxed, the health insurance companies claim “no medical necessity” and refuse to provide coverage for residential programs that last over 30 days.

Physicians also need to be trained to spot those who are not simply “dependent” on painkillers but have become addicted. Since once those prescription drugs will not be prescribed, it seems that patients are then going to seek heroin or other drugs from non-medical sources and this is how heroin and prescription drugs get intertwined.

Practice point: Physicians and pharmacists need to take as much continuing education in these areas. Simply refusing to write prescriptions is not the answer. Yet this is now what is being reported. Post-surgery patients are being denied more than a couple of days of painkillers and physicians and pharmacists are running scared. 

Part of the answer is creating new systems, new type of consent forms and patient education which is also in writing, and perhaps having pain patients watch videos which detail that the warning labels are NOT advisory or suggestive but that mixing other drugs, exceeding dosage or mixing alcohol is a life or death issue. If one overdose death can be prevented - it is worth it. Pharmacists need to increase the warnings even for those who have taken the medications before - with the Internet some people think they are their own physicians and know better than the physicians or pharmacists.

All this takes time and of course insurance companies do not pay for "counseling" patients but this can be systemized for the health of patients and so that physicians and pharmacists are not blamed if the patient abuses or misuses the prescribed drugs. If we could put "black box" labels on any medications that could cause death when not taken as prescribed, it should be done. This is part of the FDA's domain and all the regulatory and licensing agencies need to work together in order to address this crisis.

Posted by Tracy Green, Esq.
Green and Associates, Attorneys at Law

September 26th is National Prescription Drug Take-Back Day. Be Careful With Your Excess Prescription Medications.

Today, September 26th, is National Prescription Drug Take-Back Day. 

It’s a day where you can safely, conveniently, and responsibly dispose of expired and unwanted prescription drugs at collection sites in your community. 

This way no one else takes your medications in a way not intended. It used to be that we had to lock up our liquor cabinets, but now we need to lock up our medicine chests and make sure that no one has access to controlled substances. Young people especially may view these prescription drugs as "safe" and not be aware of the danger when they take them in excess of as prescribed or when they are mixed with other drugs or alcohol.

Whether it is that someone might use them for unintended purposes (such as recreational partying or getting high) or may use them to harm themselves or end their life, we have to be careful. Here’s why this matters: More Americans are dying from drug overdoses by improperly using prescribed medications. 

Here's a link on where you can take the drugs. Enter your zip code. Flushing down the toilet affects our drinking water and it is preferable to have them destroyed.  Throwing them away is not ideal either. This is the safest way to make sure the drugs are destroyed in the proper manner.  Physicians and Pharmacists can encourage their patients to do so as well.

http://www.deadiversion.usdoj.gov/drug_disposal/…/index.html

Posted by Green and Associates, Attorneys at Law.

FAQ About Rescheduling All Hydrocodone Combination Products from Federal Schedule III to Federal Schedule II

We have received questions from physicians and pharmacies about the new DEA rules for hydrocodone combination products (HCPs).  Effective October 6, 2014, the DEA rescheduled HCPs from federal Schedule III to federal Schedule II.  This change impacts how hydrocodone combination products are prescribed and dispensed in California. Federal requirements for prescribing and dispensing Schedule II controlled substances will apply to all hydrocodone combination products. This means, among other thing, a very limited ability to orally prescribe HCPs (see below) and ability to authorize refills.

This “up scheduling” is a major change for California. According to CURES, over 1 billion dosage units of HCPs were dispensed last fiscal year in California. HCPs are the most frequently prescribed opioid in the United States: nearly 137 million prescriptions for HCPs were dispensed in 2013.

Here are frequently asked questions and answers: 

Question 1: Does this mean California law has also reclassified ALL hydrocodone combination products as Schedule II controlled substances?

Answer 1: This is a technical question where federal law governs. Technically, there has been no equivalent change to California law, or to the controlled substance schedules in California. But for many intents and purposes, the practical effect will be the same: that all prescribers and practitioners in California will be required to treat HCPs as Schedule II controlled substances.

Question 2: Are prescriptions written for HCPs before October 6, 2014 that are presented to the pharmacy for dispensing on or after October 6, 2014 to be dispensed as a Schedule II or Schedule III controlled substance? 

Answer 2: If the prescription is first presented on or after October 6, it must follow federal Schedule II requirements. For example, this means no HCP prescription issued on or after this date may authorize any refills. It also means that as of October 6 oral, telephone or fax-transmitted prescriptions for HCPs are no longer possible. 

Question 3:  Can the remaining refills for HCP prescriptions written and filled before October 6 as a Schedule III, be dispensed after October 6?   

Answer 4:  Yes. The DEA has stated that it will allow refills on HCPs written and initially filled before October 6 (under Schedule III requirements and limitations), to be dispensed up to six months from October 6, 2014 (until April 8, 2015). This extends the Schedule III treatment of prescriptions for HCPs written and initially dispensed prior to October 6, 2014 to the maximum allowable period for Schedule III refills. Of course, the original date on the prescription cannot exceed 180 days, or the maximum allowable period for Schedule III refills. 

If there are any questions for prescribing physicians or dispensing pharmacists, err on the safe side and seek consultation so that you comply with the federal laws and regulations. Patients may be frustrated by the change in the law but do not let them pressure you into prescribing or dispensing unless you are fully compliant. 

Posted by Tracy Green, Esq.

Green and Associates, Attorneys at Law 

California Board of Pharmacy Obtains Interim Suspension Order Against Pharmacy and Pharmacist Due To Counterfeit Drugs and Violations of Pharmacy Law

Over the past seven years, there has been increased investigations on illegal drug diversion at pharmacies and the sale of counterfeit prescription medications at pharmacies. There have been companies and individuals which have been accused of buying back prescription medications from patients and selling them to distributors who create false records of authenticity or selling them to pharmacies at a reduced price.  

In a recent California Pharmacy Board case, the Board sought and obtained an Interim Suspension Order against a pharmacy, Adams Square Pharmacy in Glendale, California, arising from the pharmacy returning counterfeit Cialis to Eli Lilly through a pharmaceutical reverse distributor. This was pursuant to Business and Profession Code Section 494(a)(2) on the grounds that the pharmacy posed a danger to the public health, safety and welfare. the judge also found that the return of the counterfeit Cialis was dishonesty, fraud or deceit. Here is a copy of the decision on the interim order.  The order shut down the pharmacy. The order also precludes the pharmacist owner Margarita Kazarian from working as a pharmacist in charge.  The Los Angeles Times also reported on this matter.  The Pharmacy Board has indicated that it will file an Accusation against Ms. Kazarian by July 1, 2014.

The primary ground for the suspension was that the pharmacy had counterfeit Cialis tablets in its stock. This was discovered when  the Cialis returned by the pharmacy was found to be counterfeit Lilly drug product and were returned in a genuine Lilly packaging and container. The Pharmacy Board conducted an inspection on November 11, 2013 and found more counterfeit Cialis in the pharmacy and numerous other Pharmacy Board violations.

Pharmacies need to be vigilant in their ordering and be careful when ordering from distributors who are selling trade name drugs at prices below the manufacturers. There are currently federal criminal cases filed throughout the country regarding the operation of businesses dealing in counterfeit drugs or drugs that have been recycles through the system through pharmacies or patients. In the Los Angeles area, there were groups who bought prescription drugs from patients and then repackaged them with fake certificates and resold them into the stream of commerce. This is considered illegal drug diversion.

Pharmacies should check their stock, their suppliers and make sure this does not happen to them.  In addition, the pharmacies should be ready for inspections without the issues that this pharmacy faced which included failing to maintain adequate records of sales, disposition, and acquisition of medications; expired medications on the shelf; overfilled containers; etc.  This is also considered unprofessional conduct.

Posted by Tracy Green, Esq.
Green and Associates, Attorneys at Law
Phone: 213-233-2260
Email: tgreen@greenassoc.com