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Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

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

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice or has to suffer the consequences of having no legal representation.

Administrative Proceedings Can be Complex.

In some cases, individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters, can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Legal Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases, it may even be possible to obtain a change in the forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing. Click here to read our blog on this matter and learn more.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

By The Health Law Firm|2019-10-10T19:22:13-04:00October 10, 2019|Categories: Pharmacy Law Blog|Tags: administrative procedure act, administrative proceeding, ALJ, Board of Pharmacy, Board of Pharmacy hearing, defense attorney, defense lawyer, department of health, deposition coverage, disciplinary charges, disciplinary complaint, FAC, final hearing, Florida Administrative Code, Florida Board of Pharmacy, formal hearing, health law firm, health professional, hearing representation, Informal hearing, last minute deposition coverage, legal defense for pharmacists, legal representation, legal representation for pharmacist, legal representation for pharmacy, local deposition coverage, negligence lawsuit, noticed of a deposition, pharmacist, pharmacy, Pharmacy and tagged Administrative Law Judge, professional liability insurance, rights for an appeal, Rules of Civil Procedure, Rules of Evidence, short notice of representation of pharmacy, short notice representation of pharmacist, subpoena, the health law firm|0 Comments

Central Florida Has Been Invaded By Zombies – No Twinkies Means No Food Source

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

You are already aware of Floridians’ fear of zombies, as shown by recent legislation against bath salts. Despite this, there continue to be reports of rampant zombie outbreaks across the Sunshine State. The zombie apocalypse has hit Central Florida, hard. As a citizen of Florida, you know you are not safe; not from zombies, not from British tourists, not from inability to count (notes in an election) and not from the state legislature. To make matters worse, Twinkies, the only food known to mankind that can survive a post-apocalyptic zombie outbreak (reference: Zombieland 2009) or a nuclear holocaust (reference: Family Guy, second season, third episode Dec. 26, 1999), may soon be out of production. Everyone knows Twinkies have a shelf life of 246 years.

Since Florida seems to be the only state infected with this flesh-eating disease, we are taking a poll. Should we be renamed “the Zombie State?”

A Run With the Living Dead in Clermont.

For those of your reading this blog from another state, you’re in luck. There is actual video footage of how bad the zombie outbreak has gotten in Florida. In Clermont, thousands of cardio-enthusiasts showed up to run a 5K course filled with numerous obstacles that forced participants to crawl in the sticky mud to avoid being pricked by barbed wire above and walking along an unstable beam of wood. Unfortunately, the runners were bombarded along the way by the living dead looking for a quick bite to eat. The participants had to protect their brains while running for their lives. Only the fastest survived.

To see video of attack, click here.

Zombies Take Over the University of Central Florida (UCF).

If you are in Florida and were hoping to take shelter on the campus of the University of Central Florida (UCF), you’re too late. From now until December 2, 2012, the campus will be crawling with zombies who have taken to the stage in a production called “Zombie Town: A Documentary Play.”

We’ve heard it’s not bad. Click here to read a review of the performance.

No Twinkies = No Hope.

By now you’ve heard Hostess, the maker of Twinkies, may be on its way to a complete shutdown. As you know, these delicious treats are the only food that can survive a zombie outbreak. If Hostess closes its doors, we are doomed for sure. Thank goodness Hostess and its striking union members are renegotiating. If Hostess does shut down, it’s rumored a Boca Raton, Florida, company will purchase the brand. We can only hope.

To read the latest on the Hostess debacle, click here.

Given the increasing number of zombie attacks in Florida, the price of Twinkies could soar into the hundreds of dollars each in Florida. Doomsday enthusiasts and disenchanted stock market investors are allegedly pouring funds into warehouse loads of Twinkies.

Is the Ban on Synthetic Drugs in Florida Working?

If you remember, Florida Governor Rick Scott signed House Bill 1175 on March 23, 2012. This bill outlawed more than 90 new forms of synthetic drugs. It modified Section 893.03(1)(c), Florida Statutes, by expanding the list of banned hallucinogenic substances in Schedule I of the Florida Comprehensive Abuse Prevention and Control Act. To view Florida HB 1175, click here. To read more on the ban, click here.

HB 1175 was in response to the first known zombie attack in Miami. This cannibalistic attack was allegedly because the one man was high on bath salts. It was rumored that one prominent Florida lawmaker stated that banning bath salts, smiles and other synthetic drugs should help to reduce the reported acts of cannibalism and zombie-like behavior in Florida.

And he was wrong, the walking dead are alive, sort of, and well in Florida.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents 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. Its 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 about all the zombies around town? What are you doing to survive? Are you stocking up on Twinkies now? Tell us, do you think we should rename Florida the Zombie state? Vote in a poll on our Facebook page.

Sources:

Armstrong, Cassie. “Zombies Invade Clermont in 5K Challenge.” Florida 360. (November 17, 2012). From: http://www.orlandosentinel.com/multimedia/os-fla360-zombies-invade-clermont-in-5k-challenge,0,110644.story

Palm, Matthew. “Theater review: ‘Zombie Town: A Documentary Play’ from Theatre UCF.” Orlando Sentinel. (November 18, 2012). From: http://www.orlandosentinel.com/community/ucf/os-zombie-town-review-ucf-20121116,0,4007008.story

Hsu, Tiffany. “Hostess, Union to Give Talks Another Chance.” Orlando Sentinel. (Novemeber 2012). From: http://www.orlandosentinel.com/la-fi-mo-twinkies-hostess-union-mediation-20121119,0,4220893.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|2012-11-26T14:36:08-05:00June 1, 2018|Categories: In the Know, The Health Law Firm Blog|Tags: Attorney General, attorneys, bath salts, cannibalism, cannibalistic, dea, defense attorney, defense lawyer, doctor, drug bans, drug enforcement administration, drugs, florida, florida health attorney, Florida health lawyer, k2, laws, legal, nurse, pharmacies, pharmacists, pharmacy, physician, potpourri, prevention, smiles, synthetic cannabinoids, synthetic drug bill, synthetic drug use, synthetic drugs, synthetic marijuana, zombie attacks, zombies, zombiism|0 Comments

Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck’s Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.

Franck’s Pharmacy Ceases Production of Sterile Compounds.

Franck’s Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck’s Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck’s Pharmacy will continue to compound non-sterile human and veterinary medicine.

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

Franck’s Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used. For additional information on this, click here.

Prior Deaths of 30 Polo Ponies.

In an earlier unfortunate incident in 2009, Franck’s Pharmacy’s compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck’s Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck’s Pharmacy. The decision can be seen here.

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.

Sources Include:

Franck, Paul. “Urgent: Compounding Prescriptions Recall.” Franck’s Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/

Medina, Carlos E. “Franck’s Ceases Sterile Compounding Service.” Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

By The Health Law Firm|2012-06-04T17:39:25-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: CDC, compounding, drug recall, eye infections, FDA, florida, Franck's. Franck's pharmacy, fungal eye infections, Ocala, pharmacist, pharmacy|0 Comments

University of Miami Employee Allegedly Caught Red Handed Stealing More Than $14 Million in Cancer Drugs

By Michael L. Smith, J.D., R.R.T., Board Certified by The Florida Bar in Health Law

For three years, hundreds of life-saving cancer drugs disappeared from the shelves of the University of Miami’s (UM) Sylvester Comprehensive Cancer Center. A pharmacy technician at the center was arrested in connection to the thefts in May of 2011, and is accused of stealing more than $14 million in cancer drugs, according to the Miami Herald. The pharmacy tech faces four counts of grand theft, two counts of trafficking in contraband prescription drugs and one count of dealing in stolen property.

To read the entire article from the Miami Herald, click here.

Pharmacy had No System in Place to Keep Track of Supplies.

According to the Miami Herald, UM’s chief financial officer and a board member admitted that there were no controls at the cancer pharmacy to keep track of supplies. The pharmacy technician was apparently able to walk to refrigerators in the pharmacy and slip packages of Neulasta, a drug used by cancer patients, into his lab coat. Each box of Neulasta runs about $2,600 per dose. It’s obviously worth more than its weight in gold.

The fact that the pharmacy was missing hundred of syringes of drugs did not even get noticed until May 2011 when a pharmacy buyer at UM noticed something was off when she reviewed a new computer program that tracked drugs. The system showed hundreds of syringes full of Neulasta were missing from inventory. Since the new software was not reliable, the pharmacy buyer decided to hand-count the syringes. This was the first time anyone at the pharmacy noticed that drugs were missing.

Pharmacy Technician Used Lab Coat to Smuggle Drugs Out of the Pharmacy.

On June 1, 2011, hidden video surveillance cameras were installed in the pharmacy to view the refrigerators. On two separate occasions the cameras allegedly caught the pharmacy technician pocketing several boxes of Neulasta.

To see the security camera footage, click here.

The second time the pharmacy technician was allegedly captured on video, he was confronted and forced to hand over his lab coat containing the cancer drugs. He immediately confessed to selling the drugs and allowed investigators to search his home. There investigators found 163 doses of Neulasta and other cancer-fighting drugs. All together the drugs found had a value of more than $700,000, according to the Miami Herald.

It is currently unknown whether he will ever get his lab coat back. He may have to exchange it for a striped one or an orange jump suit.

Security and Controls Now Up To Par.

As soon as the theft was confirmed, security and inventory controls of pharmaceuticals at Sylvester were reviewed and strengthened, according to the Miami Herald. A follow up audit found that the pharmacy’s inventory controls are now sufficient.

The pharmacy is seeking reimbursement for losses from the employee and the pharmacy’s insurance.

Recent Article on Employee Embezzlement.

George F. Indest, another health attorney with our firm, recently wrote several articles on prevention of employee embezzlement. Although the articles are written for smaller health care providers than universities, many of the general principles contained in these would apply to larger employers, as well.

To see the Medical Economics article, click here.

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? What do you think of the fact that it took the university so long to find out the inventory was missing? Have you heard of people stealing drugs from pharmacies before? Please leave any thoughtful comments below.

Sources:

Dorschner, John. “How Did $14 Million in Drugs Vanish from a UM Pharmacy?” Miami Herald. (August 6, 2012). From: http://www.miamiherald.com/2012/08/06/2936916/how-did-14-million-in-drugs-vanish.html

Creamer, Alyssa. “University of Miami Employee, Manuel Pacheco, Allegedly Looted Pharmacy For Over $14 Million In Cancer Drugs.” Huffington Post. (August 9, 2012). From: http://www.huffingtonpost.com/2012/08/09/um-employee-steals-14-million-cancer-drugs_n_1760155.html?view=print&comm_ref=false

About the Author: Michael L. Smith, J.D., R.R.T., is Board Certified by The Florida Bar in Health Law. He 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 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|2012-11-13T15:20:47-05:00June 1, 2018|Categories: In the Know, Pharmacy, The Health Law Firm Blog|Tags: defense attorney, defense lawyer, legal representation, Miami defense lawyer, pharmacist, pharmacy, pharmacy technician, stolen drugs, University of Miami, University of Miami cancer drugs, University of Miami Sylvester Comprehensive Cancer Center|0 Comments

Boca Raton Compounding Pharmacy Shuts Its Doors After Receiving an Emergency Suspension Order

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

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

Rodent Feces, Dead Bugs and a Sink Full of Dirty Water all Found at Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A film of powder covered surfaces in the drug-compounding area, where containers of drugs were open. Information on patients and prescriptions was missing, and drug labels were missing important information on the dose, lot number and prescribing physician.

Apparently the compounding pharmacy had been cited in past inspections for similar issues.

To read the Health News Florida article, click here.

All Compounding Pharmacies Are Now Under Pressure.

The compounding pharmacy can have a DOH hearing before final action is taken. The suspension is in effect until final disciplinary action, until the suspension is lifted or the case is appealed.

This inspection and ESO occurred in the wake of a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. I previously wrote a blog on the Massachusetts compounding pharmacy shutting down. To read more click here.

It’s believed because of the meningitis outbreak, all compounding pharmacies are under the microscope.

Another Florida Compounding Pharmacy in Trouble Due to Fungal Growth.

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 I wrote on this.

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?

Do you think the Boca Raton compounding pharmacy was unfairly served with an ESO due to the meningitis outbreak? Or do you think it is better for the Florida DOH to be safe rather than sorry? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “State Finds Pharmacy Conditions ‘Deplorable,’ Suspends License.” Health News Florida. (October 26, 2012). From: http://wusfnews.wusf.usf.edu/post/state-finds-pharmacy-conditions-deplorable-suspends-license

Florida Department of Health. “Department of Health Takes Action Against Florida Pharmacy.” DOH. (October 26, 2012). Press Release From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2011/08/102612RejuviESO.pdf

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.

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.

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.

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.

New Popular Drug Called “Smiles” Outlawed in Florida – Zombie Attacks Still a Threat!

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

In previous blogs we’ve mentioned that Florida Governor Rick Scott signed House Bill 1175 on March 23, 2012. This bill outlawed more than 90 new forms of synthetic drugs and included bath salts, among others. It modifies Section 893.03(1)(c), Florida Statutes, by expanding the list of banned hallucinogenic substances in Schedule I of the Florida Comprehensive Abuse Prevention and Control Act. To see Florida HB 1175, click here. To see the entire list of banned substances, click here.

As you are no doubt aware, this was due, in part, to the recent outbreak of zombie attacks in the state of Florida. To see my prior blog on this, click here.

A new drug is popping up on the market with the name 2C-I or “smiles.” This drug is on the list of banned hallucinogenic substances, but has been linked to a number of deaths across the country.

Click here to learn more on the dangers of taking smiles.

Actor Thought to Have Taken Smiles Prior to Death.

According to CBS News, Johnny Lewis, an actor on the TV show “Sons of Anarchy,” is believed to have taken smiles before allegedly killing his landlady and falling to his death. Detectives believe the actor also had mental health issues.

To see the CBS News story, click here.

Florida’s Synthetic Drug Legislation Imposes Restrictions on Synthetic Substances.
The law that was passed in Florida put in place restrictions to prevent abuse of synthetic substances including certain synthetic cannabinoids and synthetic stimulants. Many of the synthetic substances are also commonly known as synthetic marijuana, smiles, bath salts, K2, potpourri, and incense.

The large quantities of synthetic substances are included in HB 1175 because the chemical compounds in these substances are easy to change. The ease of converting these substances into illegal drugs helps illegal drug makers, users and sellers to avoid arrest and prosecution. For example, one synthetic substance might be illegal under the Florida Comprehensive Abuse Prevention and Control Act, but a minor change in the molecular makeup might make the substance legal. Florida residents who desired to become zombies could just take one of these synthetic substances (don’t ask how). They no longer have to go to Haiti or watch “Weekend at Bernie’s” three times in a row.

Banning Synthetic Drugs Was An Attempt To Reduce Cannibalistic Attacks.

Who can forget the story of the Miami cannibal believed to have been on bath salts?

To refresh your memory, click here to see the story from CNN. Warning this does include actual video of the attack.

It was rumored that one prominent Florida lawmaker stated that banning bath salts, smiles and other synthetic drugs should help to reduce the reported acts of cannibalism and zombie-like behavior in Florida.

Manufacturers and Retailers, Watch Your Back.

The passing of HB 1175 could mean more issues for manufacturers and retailers of any products utilizing synthetic substances such as bath salts, herbal incense, or potpourri. If you manufacture or sell any product that is composed of synthetic substances you should regularly test your products to ensure that you are in full compliance with the new law.

On October 2, 2012, a Port Orange, Florida, store owner was charged with drug possession with intent to sell. Officials accused him of selling synthetic drugs, including marijuana and bath salts.

To see the Orlando Sentinel story on this arrest, click here.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents 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. Its 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 about the ban on synthetic drugs? Do you think it is working or not working? Please submit any thoughtful comments below.

Sources:

Jaslow, Ryan. “‘Smiles’ Druge Implicated in Actor’s Death: What Are They?” CBS News. (September 28, 2012). From: http://www.cbsnews.com/8301-204_162-57522571/smiles-drug-implicated-in-actors-death-what-are-they/

Weiss, Piper. “2C-I or ‘Smiles’: The New Killer Drug Every Parent Should Know About.” Yahoo. (September 20, 2012). From: http://shine.yahoo.com/healthy-living/2c-smiles-killer-drug-every-parent-know-234200299.html

Hernandez, Arelis. “Store Owner Accused of Selling Synthetic Drugs, Bath Salts.” Orlando Sentinel. (October 2, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-bath-salts-arrest-20121002,0,7437907.story

CNN. “Security Video Shows Entire Miami ‘Zombie’ Attack.” CNN. (May 30, 2012). From: http://news.blogs.cnn.com/2012/05/30/security-video-shows-entire-miami-zombie-attack/

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|2012-10-17T14:04:31-04:00June 1, 2018|Categories: In the Know, In the News, The Health Law Firm Blog|Tags: Attorney General, attorneys, bath salts, cannibalism, cannibalistic, dea, defense attorney, defense lawyer, doctor, drug bans, drug enforcement administration, drugs, florida, florida health attorney, Florida health lawyer, k2, laws, legal, nurse, pharmacies, pharmacists, pharmacy, physician, potpourri, prevention, smiles, synthetic cannabinoids, synthetic drug bill, synthetic drug use, synthetic drugs, synthetic marijuana, zombie attacks, zombies, zombiism|0 Comments

Drug Enforcement Agency (DEA) Blocks Shipping of Controlled Substances at Walgreens Distribution Center in Florida

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

On September 14, 2012, the Drug Enforcement Agency (DEA) blocked the Walgreens distribution center in Jupiter, Florida, from shipping oxycodone and other controlled drugs to its pharmacies in Florida and the East Coast with an immediate suspension order, according to the DEA. In the press release, the DEA called the Walgreens distribution facility an “imminent danger” to the public.

To see the entire press release from the DEA, click here.

Back in April 2012, the DEA served an administrative inspection warrant at the same facility, as well as its six top retail Walgreens pharmacies in Florida. To see my blog post on that story, click here.

DEA Suspension Order Only Stops the Distribution of Controlled Substances.

The DEA said the Jupiter distribution center has been “the single largest distributor of oxycodone products in Florida” since 2009. The DEA issued the suspension order because it believes Walgreens failed to maintain proper controls to ensure its retailers didn’t dispense drugs to addicts and drug dealers.

The order only applies to the Jupiter distribution center and only suspends the distribution of controlled substances.

Whether or not bath salts fall into this category is unclear. The Florida Legislature recently banned the sale of bath salts and 90 other substances to help stop the big face-eating zombie outbreak in Florida. See my blog on bath salts and the zombie outbreak in Florida.

Recently, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. The two stores are accused of dispensing an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances. There is a blog on this story on our website, click here to read it.

Millions of Oxycodone Pills Purchased by Walgreens Stores.

According to a USA Today article, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. One pharmacy in Oviedo, Florida, went from ordering more than 80,000 oxycodone pills in 2009, to nearly 1.7 million in 2011.

Click here to read the USA Today article.

Continued War on Prescription Drug Abuse.

According to the DEA, this is an effort to curb Florida’s prescription drug epidemic. Special Agent Mark Trouville, with the DEA’s Miami Division, said all DEA licensees “have an obligation to ensure that medications are getting into the hands of legitimate patients. When they choose to look the other way, patients suffer and drug dealers prosper.”

Neither Agent Trouville nor the DEA was, apparently, requested to comment on the bath salts ban and its effect on the zombie outbreak, however.

Oxycodone Numbers Published for Shock Value.

I really do not see why the public or our elected representatives are shocked and awed by the meaningless numbers and statistics used in connection with these matters. The fact that Walgreens, the biggest pharmacy retailer in Florida, might distribute over a million oxycodone pills in a year, is a meaningless statistic by itself. If a doctor prescribes a pain management patient a prescription for three (3) pills a day, that is approximately 90 pills per month or 1,080 pills per year. If Walgreens has only 1,000 patients with such a prescription in a year throughout the entire state of Florida, that is in excess of one million (1,000,000) pills per year. I would venture to guess that many single Walgreens retail stores have more than 1,000 customers per day, much less all Walgreens stores throughout Florida.

My point is that any such statistics are meaningless out of context and are only meant to sound huge of one doesn’t stop and think about it.

Another concern is that many, if not the vast majority of the Walgreens customers who now will not be able to get their prescriptions filled, are legitimate pain management patients with legitimate prescriptions written by legitimate physicians.

Where Do Legitimate Chronic-Pain Patients Turn?

I am constantly being contacted by patients who are in dire straits, suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

If the largest legitimate chains of pharmacies in the state and nation are not allowed to fill these prescriptions, where will these suffering patients turn? Are these actions driving our citizens into the hands of shady independent pharmacies that have fewer safeguards and less accountability? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? I hope not.

Thank you. I will get off my soapbox now.

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.

Sources:

Leinwand, Donna. “DEA Inspects Walgreens for Oxycodone Probe.” USA Today. (September 15, 2012). From: http://www.usatoday.com/news/nation/story/2012/09/14/walgreens-and-oxycodone/57782912/1

Pavuk, Amy. “DEA Blocks Controlled-Substance Distribution at Florida Walgreens Facility.” Orlando Sentinel. (September 14, 2012). From: http://articles.orlandosentinel.com/2012-09-14/news/os-walgreens-dea-suspension-20120914_1_distribution-center-dea-miami-field-division

DEA. “DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida.” DEA.gov. (September 14, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml

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. He does not own stock in Walgreens or any other pharmacy.

“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.