Timothy A. AAron, Sheffield Pharmacy and Franklin Pharmacy (Optimal Pain Control) Update (which I have previously posted in two separate blog entries but have joined here)--Fines Are Huge compared to What Most State Boards impose

Sunday, October 14, 2012

Franklin, Sheffield and Russellville Compounding Pharmacies In Alabama: Will these Supposedly Federal Health Care Fraud Investigations Now Become More in Light of the Meningitis Outbreak?

In August 2012, numerous agencies, including the FBI, DEA, FDA, Alabama's attorney general's Medicaid Fraud Unit and the Alabama Board of Pharmacy, here and here executed a search warrant on three Alabama phamacies, Franklin, Sheffield, and Russellville.  All three specialized in compounding drugs.  More specifically, all three were involved in compounding pain medication cremes.  At the time of the search, sources reported that it was not the compounded drugs in questions but the business practices of these pharmacies.  See here  The investigating agencies were seen carrying out boxes of documents that were confiscated from the facilities.  These documents were then supposedly taken to the FBI's Birmingham office for review.  The question of ownership of these pharmacies, which was previously reported on, see here, here and here  is still being reported on:

WHNT News 19 has schooled that Rodney Logan, a owners of both a Sheffield and Russellville pharmacies, was during one time business partners with Tim Aaron, who owns Franklin Pharmacy.
In a “Healthy Horizons” publication, an ad printed in Oct of 2010, showed ‘Optimal Pain Control’ as being a multiplication of Russellville Pharmacy, owned by Rodney Logan.

Since that publication, OPC RX has altered hands, and annals uncover it is now listed as being operated on Mustang Drive in Russellville.
It’s a same residence inventory as Franklin Pharmacy, that is owned by Tim Aaron, and employs scarcely dual hundred people.
Since a businesses split, Rodney Logan has non-stop another multiplication to a Sheffield Pharmacy, Sheffield Expert Compounding.
In fact, according to cinema posted on a company’s Facebook page, a laboratory for blending a drugs was combined in a bureau space subsequent to Sheffield Pharmacy.

Source is here.  No arrest have been made at this point, and it can take years to review and indict large health care fraud cases. But in light of the recent meningitis scare will the agencies now be taking a look at other charges such as misbranding drugs.  This blog already questioned whether or not these pharmacies were "manufacturing" instead of compounding.  See here.  Especially since it employed more than 200 people.  See here

From the Alabama State Board of Pharmacy]

TIMOTHY A. AARON, #10300

Guilty of counts one through five of statement of charges.

Pharmacies:

SHEFFIELD PHARMACY, #112477

Assessed monetary fine of $75,000.00.

FRANKLIN PHARMACY (OPTIMAL PAIN CONTROL) #113501

Assessed monetary fine of $75,000.00

found here

Alabama Board of Pharmacy: MEDAUS PHARMACY #111215 Assessed monetary fine of $30,000.00.

quoted from here

Inspire Network has a discussion About Compounding Medications --and warnings from consumers about some that people are recommending. Inspire also has links to this blog.

quoted from here

compounding pharmacy-warning

• By speranza · Today at 3:27 pm · 1 reply
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Warning re a compounding pharmacy, Russellville, which is recommended in several places on this site.




"In August 2012, numerous agencies, including the FBI, DEA, FDA, Alabama's attorney general's Medicaid Fraud Unit and the Alabama Board of Pharmacy, here and here executed a search warrant on three Alabama phamacies, Franklin, Sheffield, and Russellville. All three specialized in compounding drugs. More specifically, all three were involved in compounding pain medication cremes. At the time of the search, sources reported that it was not the compounded drugs in questions but the business practices of these pharmacies….”




It was questioned whether or not these pharmacies were "manufacturing" instead of compounding.”




http://www.lawofcompoundingmedications.com/2012/10/franklin-sheffield-and-r ussellville.html

Additional federal criminal charge that compounding pharmacists and pharmacies may face in additional to those in Ronald H. Clark's list is Tax Fraud or Evasion

Ronald H. Clark, PhD and JD. has an overview of a number of the potential federal criminal charges compounding pharmacies and pharmacists may facein

A Brief Primer on Pertinent Federal Criminal Statutes Related to Health Care Fraud

Handbook of Extemporaneous Preparation A Guide to Pharmaceutical Compounding

here

Absolute Must read: Seeing Through the Murky Vial: Does the FDA Have the Authority to Stop Compounding Pharmacies from Pirate Manufacturing? Michael W. Snow · Oct-29-2013 · 66 VAND. L. REV. 1609 (2013)

read here

FDALaw blog FDA Makes Zohydro ER the First Approved Single-Entity Hydrocodone Analgesic, First ER/LA Opioid to Contain Hydrocodone, and First ER/LA Opioid With New Labeling By Delia A. Stubbs -

October 29, 2013

The amount of government activity on issues involving controlled substances last week makes the furlough seem like a figment of our imagination.  Following issuance of a press release on hydrocodone rescheduling and a court ruling on DEA’s delay on the scheduling of FYCOMPA (see prior posts here and here) on Friday, FDA announced its approval of New Drug Application (“NDA”) No. 202880 for Zogenix, Inc.’s (“Zogenix’s”) single-entity, extended-release, hydrocodone pain-killer drug, Zohydro ER.  FDA’s approval renders Zohydro ER the first U.S. approved single-entity hydrocodone product, the first extended-release/long-acting (“ER/LA”) opioid analgesic to contain hydrocodone, and the first ER/LA opioid analgesic to display new labeling proposed for that class of drugs.

Although Congress placed single-entity hydrocodone in Schedule II, when it first passed the Controlled Substances Act in 1970, Zohydro ER is the first drug subject to that rule.  Fortunately for Zogenix, this pre-determined schedule means that Zogenix need not wait to market Zohydro ER while DEA determines whether and in which schedule to place the drug.  This is in sharp contrast to the experience of manufacturers of new chemical entities (“NCEs”) with abuse-potential, who customarily agree to refrain from marketing their products until DEA issues a final scheduling order, which can take over a year, and who may lose their exclusivity rights in the interim.  (See prior posts here and here, and a challenge to FDA’s position on the start of the exclusivity clock here.)

continue to read here

Ronald H. Clark, PhD and JD. has an overview of a number of the potential federal criminal charges compounding pharmacies and pharmacists may face

A Brief Primer on Pertinent Federal Criminal Statutes Related to Health Care Fraud

Behind the Scenes

The FDA Bad ad campaigning is a perfect example of the work that goes on behind the scenes everyday in federal agencies--that the public may but most likely does not know about until the program is announced.  The agency sees or learns of a need, and the work begins. Lots of work.  It is not like a privately owned business where you decide you will put an ad in the local newspaper and puff it is done.  There are layers and layers of  hoops that must be jumped through to reach the final result.  It doesn't happen over night.  You may have seen a need for the Bad ad campaign years ago and questioned why the FDA was doing more about bad ads...little did you know the FDA was already working on the problem, putting a plan in place and jumping through all the hoops needed to get the Bad ad campaign launched.

Information on How to Report Bad Ads to the FDA

Frequently Asked Questions

1. Can I report anonymously?

Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information. 

2. Will OPDP be able to stop the misleading promotion?           

In many cases, yes, especially if the appropriate evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.

3. What will happen to my complaint once I have contacted OPDP?           

The information you provide will be sent to the Regulatory Review Officer in OPDP responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities. 

4. How do I learn more?

To learn more about OPDP in-service training for large medical group/hospitals call 301-796-1200.

---

Report: Contact Information

The Office of Prescription Drug Promotion (OPDP)

Phone: 855-RX-BADAD or 855-792-2323

E-Mail: BadAd@fda.gov

Write:  FDA/CDER/OPDP

          5901-B Ammendale Rd                                         

          Beltsville, MD 20705-1266   

Fax:    301-847-8444

---

OPDP's Mission

OPDP is responsible for ensuring truthful advertising and promotion of prescription drugs. 

Our mission is to…

• Protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.
• Guard against false and misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs.

How Many of Us Have Seen These Examples of Violations of Ads in Prescription Drugs--

Examples of Violations

Example of Omission of Risk

You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.           

This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.

Example of Uses Not Addressed in Approved LabelingYou are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.

This presentation would be illegal because it promotes an unapproved use.

Example of Overstating the Effectiveness

“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”

This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.

FDA Bad Ads: A few key pieces of information

Prescription drug advertising must:

• Be accurate
• Balance the risk and benefit information
• Be consistent with the prescribing information approved by FDA
• Only include information that is supported by strong evidence

What types of promotion does OPDP regulate?

• TV and radio advertisements
• All written or printed prescription drug promotional materials
• Speaker program presentations
• Sales representative presentations 

OPDP does not regulate promotion of:

• Over-the-Counter Drugs
• Dietary Supplements
• Medical Devices

Common Violations:

• Omitting or downplaying of risk
• Overstating the effectiveness
• Promoting Uses Not Addressed in Approved Labeling 
• Misleading drug comparisons 

quoted from here

KUDOS to the FDA on its Bad AD Education Materials and Allowing for these Bad Ads to now have a process and place to be Report--Step in right direction to clean Up this Area!!

United States: FDA’s Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival? Last Updated: October 29 2013 Article by Peter Reichertz Sheppard Mullin Richter & Hampton

HERE

Woman in Tennessee Infected With Injection From New England Compounding Company Meningitis Case Faces Bills and Collections From the Same Hospital That Gave Her the Injection…This Needs a Fix

READ HERE

Truthful Prescription Drug Advertising and Promotion--This is What I posted about yesterday--Look At What A Great Job FDA is doing on getting the message out and education the public

Truthful Prescription Drug Advertising and Promotion

 

FDA's Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.  The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program's goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency: e-mail BadAd@fda.gov or call 855-RX-BADAD. Bad Ad CME/CE course and Educational Case Studies:  As part of FDA's Bad Ad program, OPDP introduces a new CME/CE e-learning course and case studies to raise healthcare providers (HCP) and HCP students' awareness of misleading prescription drug promotion and other common regulatory concerns. Please click on the buttons to the right to access these resources.  Content on this Page Bad Ad Program: 2011-2012 Year End Report Bad Ad Program: 2010-2011 Year End Report Examples of Violations Frequently Asked Questions Report: Contact Information The OPDP Mission
	View Brochure (PDF- 400KB)

Second Question of the Day October 29, 2013 What should state boards of pharmacy be doing in light of the fact that the federal compounding legislation will be voted on by the Senate and will most likely pass in some form or another? Start reviewing and revising their rules and regulations as soon as the legislation is passed?

Question of the Day October 29, 2013 Is it really worth it to be the Pharmacist in Charge when you are exposed to an overwhelming amount of criminal and civil liability for others mistakes and actions? Should professional liability insurance for the PIC be adjusted to include the extra potential right now of criminal and civil liability?

Royal Palm Compounding Pharmacy and Mark Rubin--I hope someone from the Florida Board of Pharmacy is Paying Attention

I have written about this topic before here but readers will want to read this information.  Maybe the Florida Board of Pharmacy will finally take action about Royal Palm Compounding Pharmacy, LLC and Mark Rubin.  Here is more information to be considered.

Mark Rubin had a small community pharmacy in Boca Raton (Express Care Pharmacy) that did everything (regular drugs, durable medical equipment (bedside commodes, etc) and some limited compounding. He sold that pharmacy (and transferred the patient account info) to either a CVS or a Publix pharmacy. 

- Mark Rubin then started the 1st Royal Palm Specialty Pharmacy in Wellington, FL (a part of Palm Beach County known as Royal Palm Beach). This pharmacy was located in a non-descript "office building" with no obvious sign that it was a pharmacy, no direct patient walkthrough (they did exclusive mail orders to physician and veterinarian office and/or patient homes). This is the modus operandi of a rogue compounding pharmacy (e.g. KRS Global Biotechnology d/b/a GBTRx Pharmacy). The pharmacy will use aggressive sales tactics by holding exhibiting booths at national conferences such as the American Academy of Anti-Aging Medicine (A4M); employ sales reps on a national basis whose income is based almost exclusively on commission; will tout to prescribers (doctors, veterinarians, etc) the "profit-making potential" of prescribing/dispensing/reselling compounded drugs to their patients (i.e. GBTRx's PowerPoint presentation "Compounding Pharmacy: Gateway to Enhancing Revenue"); they will sell compounded drugs to physicians for further resell/dispensing to their patients (which is in direct violation of Federal and State laws/rules such as Rule 64B6-27.700(2), Florida Administrative Code); they will engage in split-fee/patient-brokering agreements with prescribers that restrict the patients' free choice of pharmacy (patient pays physician for services including medication, physician faxes order to pharmacy, pharmacy drop ships drugs to patient, pharmacy bills physician a lower "wholesale price" for the drugs, both prescriber and pharmacy make $$$ by charging patient inflated costs of medication because he/she is stuck using a  pharmacy that exploits them for financial gain; and will tout certain drugs as safe and effective for certain conditions despite evidence that these drugs are not effective, and not even absorbed into the body (e.g. Sublingual HCG for weight loss). 

Looks Well Worth Attending: Great Topics: American Society for Pharmacy Law Developments in Pharmacy Law Seminar XXIV November 14-17, 2013 Omni Amelia Island Plantation Amelia Island, Florida For Seminar information, click here to view the Registration Brochure. Earn up to 15 legal and pharmacy continuing education credits!

for schedule click here

American Society for Pharmacy Law RX Ipsa Loquitur Newsletter

I just received my first copy of the American Society for Pharmacy Law (ASPL)  RX Ipsa Loquitur Newsletter September/October 2013.  If you aren't a member, you should consider joining.  On the first page is a discussion of United States v. Gracie, __F.3d ___, 2013 WL 5303479 (1st Cir. 2013) .  Make sure you read this case about a Pharmacist in Charged who was charged and  pled guilty to violating 18 U.S.C 666, soliciting and accepting kickbacks.  This case involved a pharmacist who filed Internet Pharmacy Prescriptions.  The discussion of this case in the ASPL newsletter is a must read.  If you don't get the newsletter, the appeal to the First Circuit Court of Appeals can be read here

October 28, 2013 Long-term care advocates denounce FDA over new hydrocodone restrictions

The U.S. Food and Drug Administration has announced it will seek restricted access to hydrocodone painkillers, prompting a concerned response from long-term care stakeholders.
 
Hydrocodone drugs such as Vicodin are commonly prescribed for pain relief, but are implicated in prescription drug abuse that many say has reached epidemic levels. Lawmakers and agencies such as the Drug Enforcement Administration have pressed the FDA to move hydrocodone products from a Schedule III to a Schedule II classification. On Thursday, the FDA announced it will do so.
 
If accepted, the move would mean that nurses and other allied health professionals would not be able to prescribe these drugs, and automatic prescription refills would be limited. Healthcare providers and trade associations have argued that tightening controls around hydrocodone would harm patients who rely on it to relieve chronic pain. Many of these individuals are elderly and reside in long-term care facilities.
 
"The FDA's reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care," stated Kevin Schweers, a spokesman for the National Community Pharmacists Association. 
 
Federal agencies including the Department of Health and Human Services still must sign off before hydrocodone is reclassified, and the FDA in March told legislators that this process could be lengthy. However, lawmakers were quick to applaud the FDA's decision last week.
 
Sen. Joe Manchin (D-WV) said the reclassification would save “hundreds of thousands of lives.”

quoted from here

Washington Post FDA seeks to curb abuse of prescription painkillers

By Editorial Board, Monday, October 28, 6:22 PM

FEW BLESSINGS of modern science are entirely unmixed, and so it is with the development of powerful synthetic or semi-synthetic opioid analgesics — painkillers such asfentanyl and hydrocodone. Prescribed by the tens of millions in recent years for their power to relieve otherwise crippling pain in the victims of disease and injury, these pills have turned into a $7.3 billion-per-year business. Yet they also pose a major public health risk because of their ready availability and addictiveness to many patients.

In fact, abuse of prescription medications is overtaking that of “street drugs” such as heroin and cocaine. The Centers for Disease Control and Prevention (CDC) spoke of a pain-pill overdose “epidemic” that cost 15,000 lives in the United States in 2008, up from 4,000 in 1999. Nearly half a million emergency-department visits in 2009 were because of people misusing or abusing prescription painkillers, according to the CDC, while nonmedical use of prescription painkillers costs health insurers up to $72.5 billion annually.

continue to read here

And the compounding related jobs just keep being announced...218 added to indeed

Show:  all jobs - 218 new jobs

Compounding Pharmacist & Sterile Compounding Techs - new

Catapult  4 reviews - Mesquite, TX

Compounding Pharmacist: 1. Sterile Compounding Techs: 2-3.... 6 days ago - save job - block - email - more...

Part-Time Compounding Pharmacist - new

Health Dimensions - Farmington Hills, MI 48331

Health Dimensions Professional Compounding Pharmacy located in Farmington Hills MI, is looking for a part-time 2 days per week Pharmacist.... Apply with your Indeed Resume 6 days ago - save job - block - email - more...

Pharmacy Technician II - Sterile Compounding - new

S2 - BioScrip - Scranton, PA - +2 locations

Responsible for sterile compounding under the supervision of a pharmacist, to include cleanroom maintenance, completing documentation, and drug compounding.... 11 days ago - save job - block - email - more...

STERILE COMPOUNDING PHARMACIST / GREAT OPPORTUNITY - new

ABPS (American Business Personnel Services, Inc.) - Little Rock, AR

We have an immediate need for a full-time Sterile Compounding Pharmacist to work at our state-of-the-art pharmacy.... Rx Career Center - 2 days ago - save job - block - email - more...

Compounding Pharmacist - new

Soliant Health  16 reviews - Manatee County, FL - +1 location

Pharmacist must posess 10 years verifiable compounding experience, proficient knowledge ofsterile and non-sterile compounding, excellent leadership and... 7 days ago - save job - block - email - more...

Compounding Pharmacist: Ophthalmology Expertise - new

Community Pharmacy - Winter Park, FL 32789

Rapidly growing early stage pharmacy in Orlando, FL area seeks experienced seniorcompounding pharmacists with ophthalmology expertise to lead the organization... Apply with your Indeed Resume 11 days ago - save job - block - email - more...

Pharmacist IV Compounding - new

Strategic Healthcare Alliance Group - Newport, VT

Pharmacist 2.5 FTE Technicians 2.0 FTE. Compounding Skills, Automation Skills, Clinical and Operational. There is tech support.... Apply with your Indeed Resume 5 days ago - save job - block - email - more...

Compounding Pharmacist position - new

Soliant Health  16 reviews - Manatee County, FL

The pharmacist will be responsible for assisting the pharmacys manager with the daily operations of a high quality pharmacy department.... 6 days ago - save job - block - email - more...

Non-Sterile Compounding Pharmacist - new

RPh on the Go  8 reviews - Florida - +1 location

Pharmacy Compounding Expert (non-sterile) needed for this Permanent opportunity near Sarasota, FL. 10+ years compounding experience.... RPhOnTheGo - 4 days ago - save job - block - email - more...

Compounding Pharmacist- Non-Sterile - new

RPh on the Go  8 reviews - Sarasota, FL

Pharmacy Compounding Expert (non-sterile) needed for this Permanent opportunity near Sarasota, FL. 10+ years compounding experience.... RPhOnTheGo - 4 days ago - save job - block - email - more...

Compounding Pharmacist: Ophthalmology Expertise

Community Pharmacy - Winter Park, FL

pharmacist in State of Florida PCAB pharmacist... compounding strongly preferred Experience in sterile and non-sterile compounding environments Ability to...

Apply with your Indeed Resume

Sponsored by Community Pharmacy - 11 days ago

Pharmacist IV Compounding

Strategic Healthcare Alliance Group - Newport, VT

Clinical/Staff Pharmacist (inpatient) Dates of... Staff Size: Pharmacist 2.5 FTE Technicians 2.0 FTE Job Responsibilities: Compounding Skills, Automation...

Apply with your Indeed Resume

Sponsored by Strategic Healthcare Alliance Group - 5 days ago

Central coastal area, CA

RPh on the Go  8 reviews - Central, CA

Traveling Pharmacist in Central coastal area, CA. RPh... preferred though pharmacists with practice in IV rooms or sterile compounding will qualify. RPh on the Go...

Sponsored by RPhOnTheGo - 11 days ago