pharmacy | The Health Law Firm Blog

Two More Compounding Pharmacies Recall Drugs

By Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Florida Drug Database Aimed at Preventing Drug Abuse

Recently, Florida pharmacists, physicians and pain management clinics have received negative attention over frequent Drug Enforcement Administration (DEA) raids. Now, Florida is once again in the spotlight as the state has launched a drug database in an attempt to reduce drug abuse perpetuated by visits to the doctor.

According to the Orlando Sentinel, this database will allow physicians and pharmacists to review a patient’s prescription history before issuing prescriptions for painkillers like OxyContin and other powerful drugs.

These preventative measures are not new to Florida health care providers. After garnering a reputation for frequent drug trafficking, proliferated by pain management clinics, the state passed legislation banning many doctors from dispensing dangerous controlled substances in their offices.

Currently, use of the database is not mandatory, but legislators are hoping to make it a requirement in the future. Both the Florida Medical Association and the Florida Osteopathic Medical Association are urging members to retrieve information from the database before writing prescriptions.

With this new database, physicians, pharmacists and pain management clinics can help prevent visits from the DEA and Department of Health (DOH). Instead of writing prescriptions for powerful painkillers every time a patient comes calling, doctors can now judge whether a patient is really in need or abusing drugs. Being able to see every instance that a patient has filled a prescription for drugs like OxyContin and Valium will allow physicians and pharmacists to understand the whole picture If a patient is shopping around for drugs, it will be made apparent.

Keep the DEA from your practice by taking every precaution, including querying the database before writing or administering a prescription. For more information on DEA cases see this article about defending yourself in the event of an investigation. Pharmacists can learn about more legal matters concerning their profession here.

By The Health Law Firm|2024-03-14T10:00:25-04:00June 1, 2018|Categories: In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: drug database, florida, pain management, pain management clinics, pharmacisits, pharmacy, prescriptions|Comments Off

Florida Pain Clinics Can Expect More Bullying From Law Enforcement

Florida pain clinics really began to feel the impact of becoming law enforcement’s newest target about one year ago. This was based in part on televison “magazine” shows and investigative reporters’ shows and articles publicizing many abuses by patients who were “doctor shopping” and physicians who were allegedly “over-prescribing.”

More regulations were enacted, and lawmakers approved severe penalties for doctors accused of over-prescribing, including prison sentences. Most physicians were banned from dispensing drugs in their offices, and the governor created a Florida drug “strike team” whose mission was to eliminate any pain clinics that were found to be suspicious. The Florida Surgeon General and the Board of Medicine made announcements about the “crackdown” on “over-prescribing.”

According to the Orlando Sentinel, since the implementation of the new pain management and prescribing laws, the Florida strike force has made thousands of arrests and seized millions of pills in an effort to curb alleged over-prescribing and prescription drug abuse.

Now, after a year of strict regulations and punishments for Florida’s pain management physicians, pain clinics, pharmacists and pharmacies, the state is continuing to attack the pain management profession. While the planned measures aren’t as harsh as those that began a year ago, such as installing prescription drop boxes at police stations, they continue to place a stigma on the practice of pain management – a medical subspecialty with the purpose of alleviating the pain of suffering patients.

In addition, patients with true medical need for prescription pain medications are finding it increasingly difficult to even locate a physician to treat them, given the stigma and the possibility of arrest and prosecution. Medical ethicists have commented on this problem, an issue that will become increasingly problematic for the foreseeable future.

If you work in the pain management industry (physician, pharmacist, pain clinic, pharmacy, etc.) and feel that your medical license, pharmacy license, or business is at risk or is under investigation by the Drug Enforcement Administration (DEA) or Florida Department of Health (DOH), please visit our website at www.TheHealthLawFirm.com for more information about this.

By The Health Law Firm|2024-03-14T10:00:28-04:00June 1, 2018|Categories: In the News, Pain Management, The Health Law Firm Blog|Tags: attorney for pain management, florida pain clinics, pain clinic laws, pain clinics, pharmacy|Comments Off

Osceola County Commissioners Vote to Regulate Pain Management Clinics

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 8, 2012, the Osceola County, Florida, Commissioners unanimously approved an ordinance that will regulate pain management clinics, according to the Orlando Sentinel. The ordinance will take effect on October 31, 2012, and will be in effect for 10 years.

Click here to see the ordinance passed at the Osceola County Commissioner’s meeting.

This is part of the continuing efforts by law enforcement to cut down on prescription drug abuse that plagues the state.

Ordinance Details.

The ordinance spells out what constitutes a pain management clinic, prohibits cash-only payments and requires pain management clinics to provide the names of employees to the county.

The ordinance also requires that clinics participate in the Department of Health’s (DOH) Prescription Drug Monitoring Program. That means pain management doctors will have to track and provide monthly reports on how many prescriptions are issued for controlled substances, and provide certain patient data, such as age ranges, race and gender.

Anyone caught violating these rules will be punished with the loss of their business tax receipt.

Any hospital or physician engaged in short-term treatment of pain (90 days or less) is exempt from the ordinance.

Seminole County Might Be Next.

Seminole County, Florida, Commissioners were set to vote on a similar ordinance at their meeting on October 9, 2012, but heard arguments from doctors. The ordinance will now be considered next month, according to the Orlando Sentinel.

Click here to read the entire article from the Orlando Sentinel.

Don’t Risk Your License. Read These Tips for Pain Management Doctors to Stay Inside the Law.

On top of following the new ordinance, Osceola County doctors and any doctor working in pain management, should read this article on tips to protect themselves from drug-seeking patients.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a healthcare professional, what do you think of this ordinance? Please leave any thoughtful comments below.

Source:

Breen, David. “Osceola Ordinance Targets Pill Mills.” Orlando Sentinel. (October 9, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-osceola-pain-clinic-ordinance-20121009,0,2467210.story

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2024-03-14T10:00:38-04:00June 1, 2018|Categories: In the Know, In the News, Pain Management, The Health Law Firm Blog|Tags: controlled substances, defense attorney, defense lawyer, Department of Health (DOH), doctor, florida pill mills, Florida prescription drug abuse, Florida prescription drug crackdown, nurse, Osceola County pill mills, Osceola pain clinics, overprescribing, pain clinics, pain management, pharmacies, pharmacists, pharmacy, physician, pill mill, prescription drug monitoring program, prescription drug trafficking|Comments Off

Two Separate Lawsuits Against Novartis Pharmaceuticals Corporation Allege Illegal Kickbacks and False Claims

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

NPC Accused of Treating Health Care Professionals to Expensive Dinners, Product Discounts and Fishing Trips.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Florida Doctors Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

NPC Denies All Claims.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

The Law Against Using Bribes in Exchange for Selling a Drug or Service.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblowers Who Report Fraud and False Claims Against the Government Stand to Receive Large Rewards.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities. Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent plaintiffs, patients, health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of these lawsuits? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From: http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From: http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From: http://www.justice.gov/opa/pr/2013/April/13-civ-481.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:00:48-04:00June 1, 2018|Categories: Health Care Industry, In the News, Medicare, Medicare Fraud, The Health Law Firm Blog, Whistleblower|Tags: anti-kickback statute, attorney's fees, CHAMPUS, defense attorney, defense lawyer, Department of Justice (DOJ), doctor, doctor kickbacks, false billing, false claims, false claims act, Florida health care attorney, Florida health care lawyer, health law, hospital, kickbacks, legal representation, medicaid, medicaid audit, Medicaid false claims, Medicaid fraud, medical group, medicare, medicare audit, Medicare false claims, Medicare fraud, Novartis Pharmaceuticals Corporation (NPC), pharmacist, pharmacy, physician, qui taim, qui tam relator, qui tam suits, the health law firm, TRICARE, unnecessary procedures, Veterans Administration, whistleblower, whistleblower attorney, whistleblower lawyer, whistleblower protection|Comments Off

Florida Walgreens Pharmacies Issued Inspection Warrants by the DEA

The recent investigation of a Walgreens distribution center and six Walgreens pharmacy stores in Florida shows that the U.S. Drug Enforcement Administration (DEA) is continuing to attack pharmacies, including the largest pharmacy chains.

On Wednesday, April 4, 2012, the DEA issued inspection warrants to the Florida Walgreens distribution center and six pharmacies. According to the warrant, the DEA is investigating these Walgreens pharmacies in Florida to determine if the pharmacies are dispensing controlled substances outside the scope of their registration in violation of federal laws and regulation.

The warrant was filed in U.S. District Court, Middle District of Florida and also stated that under the U.S. Controlled Substances Act, a warrant may be issued for valid public interest and without the type of probable cause needed under criminal law.

The inspection warrants will allow DEA investigators to review pharmacy’ records and receipts. The pharmacies are not required to stop selling controlled substances, which include painkillers like oxycodone and hydrocodone, during the DEA’s inspection.

The inspection of Walgreens’ pharmacies in Florida is only one of the latest attacks against pharmacies and pain management clinics by the DEA. Earlier this year, the DEA suspended Cardinal Health’s license to distribute controlled substances from one of its distribution centers in Florida. Two CVS pharmacies in Florida were also targeted by the DEA and suspended from selling controlled substances. Both companies are currently fighting the orders in court.

If you own or work at a pharmacy or pain clinic, visit our website at www.TheHealthLawFirm.com to learn more about legal matters concerning pain management and prescribing.

By The Health Law Firm|2024-03-14T10:00:29-04:00June 1, 2018|Categories: In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: dea, inspection, pharmacists, pharmacy, walgreens|Comments Off

CVS Possibly Under Investigation for Medicare Fraud

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Contacted By the Government About an Investigation.

A related article in Reuters states that CVS said it has not been contacted by the government about the investigation. The pharmacy also said, as a policy, the company does not condone unauthorized refills. Officials said to allow unauthorized prescription refills could be considered insurance fraud, especially if insurers were not refunded for any drugs rejected by patients.

The probe might be, in part, related to the programs offered by many drugstores that allows a pharmacy to refill prescriptions even before a refill request has been made by the patient.

Click here to read the entire article from Reuters.

So far there is no news from the OIG for the HHS officially confirming this investigation.

Cause for Investigation?

It is unclear to me why there would be any cause to investigate CVS, if Medicare was not being billed until the customer actually picked up the prescription. If the customer fails to pickup the prescription, every drug store I know of restocks the medication after a short period and no one is ever billed for it. It seems that it would be a quick and simple matter for the OIG to check this.

Furthermore, it could also be argued that CVS is actually promoting good health by this practice. Patients may forget to renew or refill their prescriptions or may fail to notice they are running low.

Two Sanford, Fla., CVS Stores Make Headlines.

On September 12, 2012, the U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. The two pharmacies are no longer able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision was in response to a government crackdown on the distribution of painkillers. Click here to read a blog on this story.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this story? Do you think CVS is doing anything wrong? How is this any different from the practice of many managed care plans mailing out 90 days of medications to its patients at a time? Please leave any thoughtful comments below.

Sources:

Lazarus, David. “CVS Caremark Prescription Refills Under Scrutiny, Source Says.” Los Angeles Times. (October 12, 2012). From: http://www.latimes.com/business/la-fi-lazarus-20121012,0,1032269.column

Alawadhi, Neha, Wohl, Jessica, and Morgan, David. “CVS Unaware of Any Government Prescription Refill Probe.” Reuters. (October 12, 2012). From: http://www.reuters.com/assets/print?aid=USBRE89B19520121012

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Drug Enforcement Administration (DEA) agents along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic on June 14, 2013. According to the Orlando Sentinel, agents searched for evidence at the clinic associated with multiple doctors. DEA agents stated the clinic was operating as a “pill mill” and allegedly diverting legal prescriptions for illegal purposes. No one was arrested during the raid. Longwood is a suburb of Orlando.

Investigation Spreads to South Florida.

According to WESH-TV, during the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. DEA agents would not say how many people they were investigating, but they did say this raid was the result of a two-year long investigation.

In addition to the Longwood pain clinic, DEA agents said they are also searching locations in Brevard County, Florida, where associates of the Longwood clinic allegedly live.

To watch the WESH-TV report, click here.
Two Doctors Associated With the Longwood Clinic Allegedly “Blacklisted” by Pharmacy.

According to the Orlando Sentinel, two doctors associated with the Longwood clinic were allegedly “blacklisted” in 2011, by CVS Pharmacy. This means that CVS notified those physicians that the pharmacy chain would no longer fill prescriptions they wrote for certain drugs such as oxycodone, due to suspiciously high prescribing rates. To read a previous blog on the CVS blacklist, click here.

Click here to read the entire Orlando Sentinel article.

The Longwood pain clinic is currently closed. Whether this will be temporary or permanent is unknown at this time.

Different Clinic, Similar Storyline.

This raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. To read a blog on two Orlando-area pharmacists recently arrested on charges of alleged drug trafficking, click here. Even the biggest pharmacy chains are not immune to investigations. Walgreens just agreed to pay $80 million to settle a DEA investigation into the chain’s dispensing practices of prescription drugs. To read more, click here.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think about all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

McDaniel, Dave. “Agents Raid Longwood Pain Clinic.” WESH-TV. (June 14, 2013). From: http://www.wesh.com/news/central-florida/seminole-county/agents-raid-longwood-pain-clinic/-/17597106/20572512/-/item/0/-/afpnwwz/-/index.html

Pavuk, Amy. “Agents Raid Longwood Pain Clinic.” Orlando Sentinel. (June 14, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-professional-pain-care-raid-20130614,0,3826330.story#tugs_story_display
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Anti-Prescription Drug Abuse Campaign in Pinellas County

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Pinellas County has started a new billboard campaign aimed at curbing prescription drug abuse. The billboard message reads, “We’re shutting down Pill Mills in Pinellas County.” The first two billboards were erected on April 1, 2012. Several smaller boards will be put up in the next few weeks, with even more planned for the future. This continues the long-standing battle by Pinellas County law enforcement authorities against pain management clinics that they describe as “pill mills.” Pinellas County includes the cities of St. Petersburg, Clearwater and Seminole.

The billboard message is a statement from local coalition groups who have partnered with Pinellas County in order to curb the area’s prescription drug abuse problem. In 2010, Pinellas County allegedly had the most occurrences of accidental overdose deaths from prescription drugs when compared to all other counties in Florida.

The intention of Pinellas County in establishing this billboard campaign may be aimed at stopping prescription drug abuse, but the billboards also shed negative light on legitimate pain management clinics and physicians. Although anti-prescription drug abuse campaigns are laudable, these efforts should focus on assisting those with actual prescription drug abuse history, rather than creating a scapegoat out of the pain management industry.

If you work in the pain management industry (physician, pharmacist, pain clinic, pharmacy, etc.) and feel that your medical license, pharmacy license, or business is at risk or is under investigation by the Drug Enforcement Administration (DEA) or Florida Department of Health (DOH), please visit our website at www.TheHealthLawFirm.com for more information about this.

Sources Include:

WFTS Staff, “County Sends Billboard-sized Message About Prescription Drug Abuse,” ABC Action News (Apr. 6, 2012). From: http://www.abcactionnews.com/dpp/news/state/county-sends-billboard-sized-message-about-prescription-drug-abuse

“We’re Shutting Down Pill Mills in Pinellas County,” Tampa Bay Newspapers (Apr. 10, 2012). From: http://www.tbnweekly.com/pinellas_county/content_articles/041012_pco-01.txt

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com

By The Health Law Firm|2024-03-14T10:00:29-04:00June 1, 2018|Categories: In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: Administrative Hearing, Board of Pharmacy, Clinic Licensure, Drug Enforcement Administration (DEA), Florida Department of Health (DOH), investigation, medical license, Pain Management Clinic Enforcement, pharmacist, pharmacy, Pharmacy License, physician, Pill Mill Law Enforcement|Comments Off

New England Compounding Pharmacy Linked to Meningitis Outbreak Suspected of Violated License

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The compounding pharmacy behind the meningitis outbreak was allegedly not following the requirements of its state license, according to the Massachusetts Department of Health (DOH) in a released statement on October 10, 2012.

To read the entire statement from the Massachusetts DOH, click here.

The New England Compounding Center (NECC) shipped more than 17,000 vials of a steroid to pain clinics in 23 states, including Florida. The Centers for Disease Control and Prevention (CDC) is now reporting 214 cases of meningitis and 15 deaths associated with the fungal infection. NECC has surrendered its license and has recalled all medications. To see a blog I previously wrote about the recall and compounding facility shutting down, click here.

Under Law NECC Was Only Suppose to Produce Medication for Patient-Specific Prescriptions.

The Massachusetts DOH representative said under state law the NECC was only supposed to produce medications for patient-specific prescriptions. It is believed the company violated state law governing those pharmacies.

Apparently the DOH has had issues with the NECC prior to the outbreak. According to the statement, in 2006 the NECC received a warning letter from the Massachusetts DOH. The letter stated the company was operating more like a drug manufacturing firm than a compounding pharmacy.

All Compounding Pharmacies Now Under the Microscope.

On October 10, 2012, the Board of Pharmacy sent out an alert to all compounding pharmacies in Massachusetts to reinforce the state rules. The Board also issued an order requiring that all compounding pharmacies in the state sign an affidavit attesting compliance with all laws and regulations. The Massachusetts DOH officials do not believe any other pharmacies are operating outside of the rules, but said the alert was a precautionary measure.

Click here to see the alert from the Board of Pharmacy.

Compounding Pharmacy in Florida Faced Fungal Outbreak.

Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of this story? Please leave any thoughtful comments below.

Sources:

Smith, Michael. “Meningitis: Pharmacy in Outbreak Violated License.” MedPage Today. (October 11, 2012). From: http://www.medpagetoday.com/Neurology/GeneralNeurology/35276?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news

Biondolillo, Madeleine Dr. “Statement of Dr. Madeleine Biondolillo Director of the Bureau for Health Care Safety and Quality.” Department of Public Health Massachusetts (October 10. 2012). From: http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy-necc-biondolillo-statement.doc

Associated Press. “CDC: US Meningitis Outbreak Growing, 14 Dead.” Florida Today. (October 11, 2012). From: http://www.floridatoday.com/viewart/20121011/HEALTH/121011041/CDC-US-meningitis-outbreak-growing-14-dead?odyssey=tab%7Ctopnews%7Ctext%7CLocal%20News

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2024-03-14T10:00:39-04:00June 1, 2018|Categories: DEA, In the Know, Pharmacy, The Health Law Firm Blog|Tags: Board of Pharmacy, Centers for Disease Control and Prevention (CDC), compounding, defense attorney, defense lawyer, Drug Enforcement Agency (DEA) attorney, drug recall, licensing issues, meningitis, meningitis outbreak, meningitis outbreak Florida, New England Compounding Center (NECC), pharmacist, pharmacy, pharmacy attorney, pharmacy investigation, pharmacy lawyer, product recall, U.S. Food and Drug Administration (FDA)|Comments Off